pharmatome the souvenir
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Abstract and Proceedings of National Conference "Evolving Pharmaceutical Regulatory & Quality System Framework” held at Warananagar. -Souvenir coordinator Mr. Kiran PatilTRANSCRIPT
PharmaTome PharmaTome The souvenir
Evolving Pharmaceutical Regulatory & Quality System Framework
“Pharma Profession have gone to the extent of penetrating the consumer mind withNeuromarketing”
Dr. Vijay BambulkarIPA, President, Mumbai
Dr. C. K. KokateVice- Chancellor,
KLE University, Belgaum, Karanataka
3 & 4 March 2012Special Issue
Patron
Hon. G. D. PatilSecretary, SWVSM
Co- Convenor
Dr. Ujwala S. ChouguleAdmin. Officer
Convenor
Dr. John I. DisouzaPrincipal
Director Regulatory & Medical Affairs,
Johnson & Johnson Limited
I am glad to know about the two-day AICTE sponsored national conference on “Evolving Pharmaceutical Regulatory and Quality System Framework” at TKCP, Warananagar on
rd th3 and 4 March, 2012.Tatyasaheb Kore College of Pharmacy is working under the parent organization, Shri Warana Vibhag Shikshan Mandal, Warananagar and it gives me immense pleasure and pride that a national technical event is held in rural part of India. I am delighted to look at the fast pace of TKCP, which has made a identity of its own in just seven years of establishment. Also, the research funds it receives continuously from AICTE, UGC and Shivaji University, Kolhapur cannot be underestimated. With serene feelings, I congratulate Dr John I Disouza, Principal, TKCP and his faculty members for the efforts and wish them a grand success. An amalgamation of national and international speakers will add much luster to the knowledge of the delegates. I convey them my best wishes.
Hon’ble Shri G. D. PatilSecretary,
Shri Warana Vibhag Shikshan Mandal, Warananagar
Patron’sPatron’sDesk
It gives me great pleasure to place before you, “souvenir and abstract book” scientific proceedings of AICTE sponsored national conference on “Evolving Pharmaceutical Regulatory and Quality System Framework”.Shri Warana Vibhag Shikshan Mandal's Tatyasaheb Kore College of Pharmacy is located in a small town of Warananagar and is booming high with vision and strong support of our Chairman Hon. Vinayraoji Kore and encouragement and guidance of our Secretary Hon. G. D. Patil. Incepted in 2004; with mission to “Excel in Professional Pharmacy Education through Student Centered Learning, Scholarly Research and Service to Society”. It has rapidly made an identity of its own for quality oriented education. Support for research and scientific meets is another facet of TKCP. With this view, AICTE sponsored this National Conference and allowed us to bring many eminent personalities from industry, corporate world and stake holders of pharmaceutical academia together. We are indebted to AICTE for their financial support and also to the various well wishers who helped us, directly or indirectly. Happy reading!!!
Dr. John DisouzaPrincipal
Tatyasaheb Kore College of Pharmacy, Warananagar
ConvenerConvenerDesk
Co-ConvenerCo-ConvenerDesk
I, the co-convener of the organizing committee, have the privilege and pleasure of to be the part of AICTE sponsored two days National Level Conference on “Evolving Pharmaceutical
rd thRegulatory and Quality System Frame work” from 3 & 4 March 2012. We, the local organizing committee, are committed to make this conference a unique one with a variety of exciting high quality programme.I feel pleased and proud to announce that conference is pioneering work in generating quality human resource and undertaking need based research helped in ushering white revolution in India.My abundant blessing and grace, no doubt, I can assure you that, it will be a memorable two days with all grand success.I would like to express Heartfelt thanks to The Hon'ble Secretary G.D. Patil Sir & I congratulate Dr. J .I. Disouza Sir, all other members of the organizing committee, for the herculean task undertaken in hosting this important National Level Conference event at our campus.
rd thI look forward to welcoming all delegates to an energetic and informative on 3 & 4 March 2012 for National Level Conference.
Dr.Ujwala S. ChouguleAdministrative officer, Tatyasaheb Kore College of Pharmacy, Warananagar
EditorialEditorialDesk
I would like to thank organization body to conducting national conference
rd th on 3 and 4 march 2012 at
Warananagar and offering such a marvelous opportunity of souvenir coordinator. During my operational episode I witnessed this grand conference and observed it from all close quarters. This conference has enlighten the bright minds of youth pharmacist and also aspires about achieving its own industrial goal. Many topics under the category 'Pharmatome' are found to be resources available for burgeoning scientists. I hope you will find the information inside to be very helpful and worth talking. The conference provided such a nice platform for creative spawning. There is a huge amount of interesting information foryou to scan over and find the information of your interest.To conclude, I would like to mention that, this abstract book will definitely serve as Lamppost for all of us. The name implies pharma Digest. This abstract book is result of scavenging of all vital moments and information that I witnessed during this magnificent occasion.Hoping a bright future to all of you.Thanking you.
'TATYASAHEB KORE COLLEGE OF PHARMACY, WARANANAGAR 'EVOLVING PHARMACEUTICAL REGULATORY AND QUALITY SYSTEM FRAMEWORK'
'PHARMATOME'
Mr. Kiran Patil Souvenir Coordinator
Tatyasaheb Kore College of Pharmacy, Warananagar
Speakers
Profile
Speakers
Profile
Speakers Profile
Having worked at esteemed research organizations, Dr. Sanjay Boldhane has huge experience in NDDS, generic product development and IPR. He graduated, post- graduated and obtained doctorate from Shivaji University, Kolhapur. His interests include platform technologies for Oral Controlled Release Systems, Co-crystal techniques, Nano/Lipid Suspenions/Solutions and Metered Dose Transdermal Spray. Presently, he is working as Associate Director at Abbott Healthcare. Earlier, he was associated with Panacea Biotech, Orchid Healthcare, Lupin Ltd. and Almet Corporation. He has 15 patents to his credit and has published 15 papers in various journals and presented 2 papers. He has also worked as BOS member of Shivaji University, Pune University and North Maharashtra University, Jalgaon.
Dr. Vijay Bambulkar
Director Regulatory & Medical Affairs,
Johnson & Johnson LimitedTopic: Regulatory Framework for Fast
Moving Consumer Goods
Speakers Profile
Currently the General Manager (Qualtiy) at GSK Ltd., Mr Kulkarni has worked as Director (Quality) at Baxter Ltd. and Sanofi Aventis. He graduated from Shivaji University and Goa University. Apart from this, he has also worked as Manager-Quality Assurance at Ranbaxy; Manager - Quality Systems & Regulatory Affairs, Indoco Remedies Ltd; Executive-Quality Services, Novartis and Executive- Quality Assurance, Rhone-Poulenc. He has huge experience on QBD and QMS systems.
Mr. Abhijit Kulkarni
General Manager Quality,
GlaxoSmithKline Pharmaceuticals Ltd.
Topic: ICH Q10: Pharmaceutical Quality System
Speakers Profile
Having worked at esteemed research organizations, Dr. Sanjay Boldhane has huge experience in NDDS, generic product development and IPR. He graduated, post- graduated and obtained doctorate from Shivaji University, Kolhapur. His interests include platform technologies for Oral Controlled Release Systems, Co-crystal techniques, Nano/Lipid Suspenions/Solutions and Metered Dose Transdermal Spray. Presently, he is working as Associate Director at Abbott Healthcare. Earlier, he was associated with Panacea Biotech, Orchid Healthcare, Lupin Ltd. and Almet Corporation. He has 15 patents to his credit and has published 15 papers in various journals and presented 2 papers. He has also worked as BOS member of Shivaji University, Pune University and North Maharashtra University, Jalgaon.
Dr. Sanjay Boldhane
Sr. Group Leader, Innovative Drug Delivery Research, Pharmaceutical R & D, Abbott Healthcare Private LimitedTopic: Regulatory requirement for NewProducts [505b(2)]
Speakers Profile
Having worked at esteemed research organizations, Dr. Sanjay Boldhane has huge experience in NDDS, generic product development and IPR. He graduated, post- graduated and obtained doctorate from Shivaji University, Kolhapur. His interests include platform technologies for Oral Controlled Release Systems, Co-crystal techniques, Nano/Lipid Suspenions/Solutions and Metered Dose Transdermal Spray. Presently, he is working as Associate Director at Abbott Healthcare. Earlier, he was associated with Panacea Biotech, Orchid Healthcare, Lupin Ltd. and Almet Corporation. He has 15 patents to his credit and has published 15 papers in various journals and presented 2 papers. He has also worked as BOS member of Shivaji University, Pune University and North Maharashtra University, Jalgaon.
Mr. Shrinivasa Chunekar Deputy Director, Quality Assurance,
Serum Institute of India LimitedTopic: Quality Systems for Vaccines, Sera &
Biological products
Speakers Profile
Dr C S Patil had obtained his doctorate from the prestigious Panjab University, Chandigarh. He is presently Deputy General Manager at Panacea Biotech, Navi Mumbai. In the past he was associated with Nicholas Piramal India Ltd. as a Research Associate.
Dr. Chandrashekhar Patil Deputy General Manager, Pharmacology and Toxicology,
Panacea Biotec LimitedTopic: Pharmaceutical Regulatory Framework in
Preclinical Testing
Conference
Conference
DetailsDetails
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System Framework
National Level Conference on
Q
rd th3 - 4 March, 2012
Venue:Shree Warana Vibhag Shikshan Mandal'sTATYASAHEB KORE COLLEGE OF PHARMACYWarananagar, Tal: Panhala, Dist: Kolhapur, 416 113 (MS)Phone: (02328) 223501, 223526, Fax: 223501; Website: www.tkcpdwarana.orgEmail: [email protected], [email protected]
PatronHon. G. D. Patil
ConvenorDr. John I. Disouza
Co- ConvenorDr. Ujwala S. Chougule
Secretary, SWVSM
Admin. Officer Principal
Mr. V. H. Potdar 9270649855
Co-ordinator Co- Coordinator
Mr. S. A. Payghan9096202858
Mr. A. K. Mullani9423800871
Stage Co-ordination
Mr. M. C. Mahanthesh9850385969
Accommodation Recreation
Mr. S. C. Burli9527003373
Mrs. S. S. Shinde9960892930
Inaugural/valedictory
Souvenir
Mr. K. S. Patil 7798884959
Mr. R. A. Patil 9850594845
Transportation Felicitation
Ms. V. D. Khanvilkar9421150762
Ms. S. R. Patki9881446227
Anchoring Conference kit
Mr. S. D. Chavan 9421204929
Invitation Catering
Mr. C. M. Jamkhandi8805567832
Mr. M. V. Shinde9623159491
Mr. D. A. Bhagwat9561350999
Scientific
Stage Decoration
Mrs. H. A. Mangale8888619950
Ms. S. R. Desai 9890108676
Registration Expert Invitee
Mr. Z. J. Tamboli 9595907847
Mr. A. S. Sherikar 9527003375
Discipline
Oral PresentationMs. V.V. Dashwant
8956162334
Poster Presentation
Mr. V. S. Mule9823916005
Committee Members
Oral PresentationOral Presentation
Abstracts Abstracts Abstracts
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Tatyasaheb Kore College of Pharmacy, Warananagar
DEVELOPMENT OF CONTROLLED POROSITY OSMOTIC PUMP TABLET FOR ORAL
ADMINISTRATION OF METFORMIN AND GLIPIZIDE
S. C. Patil, D. A. Bhagwat, J. I. Disouza
Research Student, Shivaji University, Maharashtra, India.
Dept. of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar,
Tal: Panhala, Dist: Kolhapur, MS. India
Abstract:
Osmotically controlled oral drug delivery systems (OCODDS) utilize osmotic pressure as the
energy source for the controlled delivery of drugs. Drug release from these systems is independent of pH
and hydrodynamic conditions of the gastro-intestinal tract (GIT) to a large extent, and release
characteristics can be easily adjusted by optimizing the parameters of the delivery system. A system that
can deliver multi- drug at prolonged rate is very important for the treatment of various chronic diseases
such as diabetes, asthama and heart diseases. Type 2 diabetes mellitus emerges as a result of multiple
pathophysiologic changes. If the pharmacotherapy of type 2 diabetes should be tailored to the underlying
pathophysiology, it would be necessary to use a combination of agents with complementary mechanisms
of action. The two principal defects in type 2 diabetes are insulin deficiency and insulin resistance.
Therefore, combining an insulin-providing agent with an insulin-sensitizing agent will augment the
efficacy of current antihyperglycemic agents. The objective of present study is to develop controlled
porosity osmotic pump (CPOP) that can deliver drugs having complementary mechanism of action i.e.
insulin providing agent (glipizide) with insulin sensitizing agent (metformin) in controlled manner upto
12 hrs. It was prepared by incorporating drugs in the core and coated with various types (PVP, PEG 400,
HPMC) and levels (30, 40, 50 % w/w of polymer) of pore former at weight gain of 8, 12 and 15%.
Keywords: Osmotic controlled oral drug delivery system, solid dispersion, spray drying etc.
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RAPID EPITOPE ANALYZER FOR DIAGNOSIS AND PROGNOSIS OF COLON CANCER
CELLSPatil A.R,, Patil K.S, Desouza J.I.
Tatyasaheb Kore College of Pharmacy, Warananagar,Tal-Panhala, Dist- Kolhapur-416113, India.
Email: -
Abstract:
Helix pomatia agglutinin (HPA) is a lectin that has been used extensively in histopathology, since
its binding to tissue sections from colon cancers is correlated with the worst prognosis for the patients.
The lectin recognizes á-d-N-acetylgalactosamine (áGalNAc) containing epitopes which are only present
in cancer cell lines having a high likelihood to undergo metastasis, such as the HT29 cancer colon cell
line. Several colon cancer cell lines have also been shown to be labeled, although IGROV1, an ovarian
cancer cell line, is not. The crystal structures of the lectin complexed with two GalNAc containing
epitopes associated with cancer, the Tn (áGalNAc-Ser) and Forssman (áGalNAc1-3GalNAc) antigens,
show the lectin's specificity for GalNAc is due to a particular network of hydrogen bonds. These
structures provide the molecular basis for the use of HPA in metastasis research. Use of bio informatics
tool like ELF (Epitope location finder) is software based technique used to find out exact epitope from
group of the antigenic protein but fail in case of cancer detection. So new bio-informatics tool devised
proved to be promising method that will help in the diagnosis and prognosis of the cancer therapy via
software given name “Kiabhi” that constructed specially for colon cancer available at
.Revalidation is carried by HPA that bind only with colon cancer cell as antigen
antibody reaction.Keywords: HPA (helix pomata agglutinin), á-d-N-acetylgalactosamine (áGalNAc).
www.abhikiran.com
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RAPID EPITOPE ANALYZER FOR DIAGNOSIS AND PROGNOSIS OF COLON CANCER
CELLSPatil A.R,, Patil K.S, Desouza J.I.
Tatyasaheb Kore College of Pharmacy, Warananagar,Tal-Panhala, Dist- Kolhapur-416113, India.
Email: -
Abstract:
Helix pomatia agglutinin (HPA) is a lectin that has been used extensively in histopathology,
since its binding to tissue sections from colon cancers is correlated with the worst prognosis for the
patients. The lectin recognizes á-d-N-acetylgalactosamine (áGalNAc) containing epitopes which are
only present in cancer cell lines having a high likelihood to undergo metastasis, such as the HT29 cancer
colon cell line. Several colon cancer cell lines have also been shown to be labeled, although IGROV1, an
ovarian cancer cell line, is not. The crystal structures of the lectin complexed with two GalNAc
containing epitopes associated with cancer, the Tn (áGalNAc-Ser) and Forssman (áGalNAc1-
3GalNAc) antigens, show the lectin's specificity for GalNAc is due to a particular network of hydrogen
bonds. These structures provide the molecular basis for the use of HPA in metastasis research. Use of bio
informatics tool like ELF (Epitope location finder) is software based technique used to find out exact
epitope from group of the antigenic protein but fail in case of cancer detection. So new bio-informatics
tool devised proved to be promising method that will help in the diagnosis and prognosis of the cancer
therapy via software given name “Kiabhi” that constructed specially for colon cancer available at
.Revalidation is carried by HPA that bind only with colon cancer cell as antigen
antibody reaction.Keywords: HPA (helix pomata agglutinin), á-d-N-acetylgalactosamine (áGalNAc).
www.abhikiran.com
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Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
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KINETIC STUDIES OF MUTUAL PRODRUG OF DICLOFENAC AND
METHOCARBAMOL
Bhatia N. M., Chucha K., *Shirsat V.B.,
Bharati Vidyapeeth College of Pharmacy, Department of Quality Assurance,
Near Chitranagari, Kolhapur 416013, India.
E-mail: [email protected]
Abstract:
Prodrug has been the concept of retro metabolic drug design that incorporates targeting,
metabolism and the duration of action consideration into the design process. Prodrug of Diclofenac was
prepared by condensation with methocarbamol. The synthesized prodrug was characterized and 1confirmed by physicochemical, IR, H NMR and MS. In vitro hydrolysis was studied in pH ranging from
1.2 to 7.4, simulated gastric fluid (SGF), simulated intestinal fluid (SIF) where it was found to be stable,
and in human plasma and liver homogenate where it was rapidly hydrolyzed, suggesting that the prodrug
remains unhydrolysed in the stomach however rapidly cleaved by esterase in blood to give the parent
drug after absorption. Result of protein binding study shows that the synthesized prodrug binds to a less
extent as compared to the parent drug. The ester prodrug was evaluated for analgesic, anti inflammatory
activity, skeletal muscle relaxant activity and was found to possess comparable activity with that of the
parent drugs. Furthermore, T.S. specimen of the stomach also shows significant reduction in gastric ulcer
formation to mice gastric mucosa as compared to parent carboxylic acid drug.
Keywords: Diclofenac, Methocarbamol, non-steroidal anti-inflammatory drugs (NSAIDs), skeletal
muscle relaxants, analgesic activity, anti inflammatory activity.
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IMPACT OF IMPURITIES ON QUALITY, SAFETY OF DRUGS AND
PHARMACEUTICALSSrinivas Reddy B*, Ramya Rathod B, Venkata Sai T, Dr. Prathima Srinivas
Sri Venkateshwara College of Pharmacy and Research Centre, Madhapur, Hyderabad -500081
Abstract:
Pharmaceutical impurities are the unwanted chemicals that remain with the active
pharmaceutical ingredients or developed during formulation or upon aging of both API and formulation.
Tremendous attention is given for the impurity profiling of pharmaceutical products in present time.
Impurities can endanger the human health by affecting quality, safety and efficacy of the products. Due to
the noticeable impacts of impurity on quality of pharmaceuticals, impurity control in pharmaceutical
products is a primary goal of drug development. To assure the quality and safety of drugs, impurities must
be monitored carefully. It is important to understand what constitutes an impurity and to identify the
potential sources of such impurities, the control of pharmaceutical impurities in a pharmaceutical
industry is an important task to the formulator. ICH has formulated workable guidelines regarding the
control of impurities in pharmaceutical drug substance as well as formulations. It is necessary to isolate
and characterize an impurity and therefore selective analytical methods are developed to monitor them.
We present here a description of different types of impurities and their origin in relation to ICH
guidelines, specification limits and qualification of impurities. Different methods of impurity profiling
which are routinely used for monitoring impurities, the causes of degradation and the possible remedies
shall also be discussed with case studies.
Keywords: Quality, Safety, Impurity profiling, Qualification threshold
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USE OF ERYTHRINA INDICA FLOWER EXTRACT AS A NATURAL INDICATOR IN
ACID BASE TITRATION
Rahul Londhe*,Ramling Patrakar.
Shree Santkrupa College of Pharmacy, Ghogaon (karad) Maharashtra, India 415111
Email:[email protected]
Abstract:
Erythrina indica, also known as Indian coral tree, it is a medium-sized, spiny, deciduous tree. It is native
to the tropical and subtropical regions of eastern Africa, the Indian Subcontinent, northern Australia, and
the islands of the Indian Ocean The present work highlights the use of Erythrina Indica Flower extract as
an acid base indicator in different types of acid base titrations. The equivalence points obtained by the
flower extract coincided with the equivalence points obtained by standard indicators. In case of weak
acid and weak base titration, the results obtained by the flower extract matched with the results obtained
by mixed indicator. This natural indicator was found to be a very useful, economical, simple and accurate
for the said titration.
Keywords: Erythrina Indica Flower, Acid base indicator, Natural indicator.
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IN SILICO DESIGN OF NOVEL GP120 BINDING LIGANDS; BASED ON COMBINING
APPROACH OF STRUCTURE BASED AND LIGAND BASED DRUG DESIGN
Vinayak D. More*, Dr. M. S. Bhatia, R. B. Nikam.
Department of Pharmaceutical chemistry, Bharati Vidyapeeth's College of Pharmacy, near
chitranagari, Kolhapur. Maharashtra. India.416013.
Abstract:
Sequential CD4 receptor and co-receptor binding are prerequisites to start fusion of viral (HIV)
envelope and cellular membrane. The viral envelope glycoprotein mainly gp120 interacts with CD4
receptor. However, no approach to targeting the CD4-gp120 interaction has been successful in clinical
practice. The high-resolution three-dimensional structures of gp120 were downloaded from
bioinformatics online tool. VLife Molecular Design Suite (MDS) version 3.5 has been applied to get
cavities in the gp120 structure and online sever tools Pocket Finder and Q-site Finder tools were applied
for modeling novel binding sites in gp120. The various regions of these sites were studied for
complementary electrostatic potential, complementary hydrophobicity, probable hydrogen bonding, pi-
stacking and other interactions. Furtherly chemical database was extensively used to design novel
ligands. Refinement of this design was done by KNN based 3D QSAR study of already reported gp120-
CD4 inhibitors. The k-nearest neighbor (kNN) technique supported with Stepwise (SW) forward
selection method was exclusively applied. Data set of 32 molecules was used to develop four different 3D
QSAR models. The highly significant two models describe different descriptors along with their range of
field values for hypothetical pharmacophore with maximum binding affinity. These results were
exploited to make design of novel potential ligand more rational and more specific. Proposed chemical
scaffolds are versatile and key for further development of novel class of anti-HIV drugs.
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NEW APPROACH TO HPLC METHOD DEVELOPMENT FOR
SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND
FENOFIBRATE IN RABBIT PLASMAa b a a
Somnath D. Bhinge , S.M. Malipatil , Abhijeet Jondhale , Anil S Savali , Chandrakant S c
MagdumA B C
RMES's College of Pharmacy, Gulbarga, HKES's College of Pharmacy, Gulbarga. Rajarambapu College of
Pharmacy, Kasegaon.
Abstract:
An accurate, rapid and simple reversed-phase high performance liquid chromatography (RP-HPLC)
method was developed and validated for simultaneous estimation of atorvastatin calcium and fenofibrate
in rabbit plasma. Plasma samples were treated with acetonitrile to precipitate proteins. Chromatographic
separation was accomplished using CAPCELL PAK C (4.6mm x 250mm, 5 m) analytical column with a 8
mobile phase consisting of phosphate buffer and acetonitrile (28:72). Detection and quantification were
performed by UV/Vis detection at 260 nm. The lower limits of detection and quantification were 0.05 µg -1 -1 -1 -1
mL and 0.20 µg mL for atorvastatin calcium and 0.07 µg mL and 0.35 µg mL for fenofibrate -1
respectively. The calibration curves are linear over the concentration range 1 to 40 µg mL for both
atorvastatin and fenofibrate in rabbit plasma. The method was quantitatively evaluated in terms of
linearity, precision, accuracy, recovery, selectivity, and stability. The proposed method is simple,
convenient and suitable for the analysis of atorvastatin calcium and fenofibrate in rabbit plasma.Keywords - Atorvastatin calcium, fenofibrate, rabbit plasma, High performance liquid chromatography.
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NOVEL CONCEPT OF FORMULATION AND EVALUATION OF PARACETAMOL DISPERSIBLE TABLETS
*1 1Chinmay Anand , Prof. Dr. G. Vidya Sagar
1Veerayatan Institute of Pharmacy, Jakhaniya, Tal. Mandvi-Kutch 370460, Gujarat, India
*Corresponding Author: [email protected]
Abstract: The dosage forms with rapid dispersion technology, fast dissolving technology have received ever-increasing demand during last decade, due to its better patient compliance. The acceptance from a unique class of customers and utility of formulation in several aspects resulted in development of various novel concepts of fast dissolving tablets and dispersible tablets. As per world Health Organization, Tablets are solid dosage forms usually obtained by single or multiple compressions of powder or granules. Development of Oral Dispersible Tablets of Acetaminophen or Paracetamol is selected due to its popularity and availability in a variety of therapeutic markets, both Over the Counter OTC and by Prescription. Formulation aspects behind selection of API are its bitterness, insoluble and poor compressibility properties. Paracetamol is mild anti-inflammatory drug with potent antipyretic and analgesic action. The proposed formulation of Novel dispersible tablets with Paracetamol is combined of a base mixture of drug and polyacrylic copolymer A Cationic Ion Exchange resins in various proportions among other pharmaceutically acceptable components. Various combination of formulation with drug resin and artificial sweetener such as Aspartame, Neotame, Suchralose, and Saccharin with super Disintegrant such as Crospovidone, Croscarmellose Sodium, and Primogel used in formulation trial F- 1 to F - 8. Direct compressible grade of diluents with direct compression method are used for compression of tablets. The prepared formulations were evaluated for various physical parameters such as uniformity of weight, thickness variation, hardness, friability test, dispersion test, wet ability test, disintegration test for tablets, physical evaluation of blend such as particle size distribution, bulk density of granules, angle of repose, water and moisture content . The prepared formulations were also evaluated for various analytical parameters such as content uniformity, assay, and drug release of tablets with dissolution test. Physical evaluation for bitterness was performed by using human volunteer to confirm the acceptance of taste. Among the variation formulations formulation F-5 was found satisfactory on the basis of physico- chemical evaluation and taste evaluation.KEYWORDS: Dispersible Tablets, Paracetamol, Dissolution Test, Super Disintegrant, Taste Masking Resins
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
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IN-VITRO CYTOTOXIC PROPERTY OF METHANOL EXTRACT OF SEEDS OF
CUCURBITA PEPOKulkarni A. A*, Adnaik R. S, Magdum C. S, Mohite S. K
Rajarambapu College Of Pharmacy, Kasegaon Dist Sangli (MS)*Email:
Abstract:
Cucurbita pepo (C.pepo) is a perennial creeping herb belonging to family Cucurbitaceae. It
mainly contains fixed oils such as Linoleic acid, stearic acid, oleic acid, palmitic acid and others. Along
with these it also shows the presence of cucurbitacins, vitamins and minerals. The plant is used in the
treatment of many diseases like anti inflammatory, diuretic, antimutagenic, antiulcer. The present study
was undertaken to screen cytotoxic activity of C.pepo. Different extract of C.pepo were taken and brine
shrimp lethality bioassay was done to analyse the activity. The lethality of methanol extract of C.pepo
with the brine shrimp was evaluated. The cytotoxicity shown by this fraction indicates the presence of
potent bioactive compounds and antitumor activity which can have clinical and therapeutic application in
most life threatening diseases like tumours or cancer.
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MODIFYING POLYMERS TO NEW EDGE: GRAFTING*Shaikh K. N., Payghan S. A., Disouza J.I.
*Dept. of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Shivaji University,
Warananagar, Kolhapur, Maharashtra, India (416113).
Abstract:
Polymers play an essential role in the emergence of the modern world. Though polymers are
legion, sometimes they cannot fulfil the demand, depending on their properties. Improvements in
polymers are tremendously important because they will widen the scope of application. One trend in
modern civilization is to effect gradual replacement of natural materials with either all synthetic materials
or modified natural materials. In the polymeric age, it is essential to modify the properties of a polymer.
Modification is essential to meet various challenges. The next generation awaits polymer modification as
it opens up new possibilities. Surface and bulk properties can be improved easily by modifying
conventional polymers. Sometimes, balancing of properties is needed, and this is possible only through
modification of polymers. Polymer modification is required to bring specific properties to the modified
material, such as enhanced thermal stability, multiphase physical responses, compatibility, impact
response, flexibility, and rigidity. Thus polymer modification improves the processibility of the
polymers. There are several means to modify polymer properties like blending, grafting, and curing, but
grafting is one of the promising methods. Grafting can be done by chemical treatment, photo-irradiation,
high-energy radiation technique, etc. Several factors control grafting. In the past years grafting has been
emphasised for its various applications. The modified polymers through grafting have a bright future and
their development is practically boundless.
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
0-11
Abstracts Abstracts Abstracts
Poster PresentationPoster Presentation
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COMPARATIVE STUDY OF GLIMEPIRIDE TABLETS OF VARIOUS MARKETED
FORMULATION*Devkar.Swati R ,Devkar preeti R, I.D.Raut ,S.K.Mohite
Rajarambapu College of Pharmacy, Kasegaon, Tal.Walwa, Dist Sangli-415404, M.S. India, E-
mail: [email protected]
Abstract:
The objective of present study was to evaluate different parameter like Weight Variation, Hardness
testing, Friability testing, Disintegration testing and Dissolution testing of Glimepiride tablets of
various marketed formulation.
is an anti-diabetic drug (sulfonylurea-type) used along with a proper diet and exercise
program to control high blood sugar. It is used in patients with type 2 (non-insulin-dependent
diabetes). It is available as different brand in market like Glimy ,Glimestar, Glador, Glimiprex etc.
Glimepiride was completely absorbed, with peak plasma concentration (Cmax) of 88±21ng/ml attained
at 2.7±1.4 hours. The areaunder the plasma concentration-time curve (AUC) increased linearly .Protein
binding of glimepiride is >99.5% and the volum of distribution is 8.8 L.Glimepiride is mainly
metabolized in the liver. Its major metabolites are hydroxymethyl and carboxyl derivatives. The total
body clearance (CL/F) of glimepiride is 2.7 to 3.2 L/h after a single oral dose. Comparative study of
Glimepiride of various marketed formulation was carried out by estimating different parameters
like,weight variation,Hardness test, Thickness, Disintegration test and In vitro drug release study.From
the results of these parameter it was concluded that Glimiprex is a better release formulation than the
other formulation of glimepiride as it shows better drug release,and less percent friability.
Keywords: Glimepiride tablets of various marketed formulation,Weight Variation, Hardness testing,
Friability testing, Disintegration testing , Dissolution testing
Glimepiride
diabetes
AICTE Sponsored
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rd th3 - 4 March, 2012
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FORMULATION AND EVALUVATION EXTRUSION - SPHERONIZER & MODIFIED
DRUG DELIVERY SYSTEM PELLET
Mr.Krishnakar G. Patil
RRKS's college of Pharmacy, Bidar, Karnatka-India
Email: [email protected]
Abstract:
Aim: To Formulation Development & Evaluation of modified drug delivery system pellet Terbutaline
Sulphate, for the treatment of nocturnal asthma. Objective: To formulation & Evaluation of
Terbutaline Sulphate pellet 5mg dose used in treatment for nocturnal asthma. Pellets provide a
reduction in the dosage regimen & gastrointestinal irritation, minimizing the dose dumping effect
moreover controlling the drug release & increasing the absorption of the active ingredient. The
reproducibility of the release characteristics from pellet formulation is also much better with respect to
the single-unit dosage forms. “The drug release characteristic of time. Course and/or location are
chosen to accomplish therapeutic or convenience objective not offered by conventional dosage forms”
Methods: extrusion spironization, Wurster Coating method is used to preparation of modified drug
delivery system pellet.
Composion: Extrusion - spheronizer: To prepared extrusion spironization to required unit composion
Mannitol powder, Lactose Anhydrous, Klucel LF, Avicel 101, prednisone, Sodium Lauryl sulphate,
Disodium hydrogen phosphate, Distill water. Coating solution Preparation for optimization
formulation: To prepared unit composion Seal coating (20%) such as Pearlitol SD 200, Purified
Water. To prepared unit composion enteric Coating (15%) such as Hydroxyl propyl methyl cellulose
phthalate (HP 55), TEC, Isopropyl Alcohol, Dichloro methane. Result: Dissolution: 0.1 N Hcl in
which 2hrs drug not released folled by 6.8 phosphate buffer 92 % drug release within 20 min by USP-I
by using 50 rpm. Future Scope: To prepared suitable dose for maximum quantity of drug and also
increase safty, efficacy and maximum absorption of dose and reduce the dosage dumping by increasing
the bioaivbility of drug and formulation of suitable pharmaceutical formulation.
AICTE Sponsored
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rd th3 - 4 March, 2012
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ENHANCEMENT OF THE DISSOLUTION RATE OF A POORLY WATER SOLUBLE
DRUG BY FORMATION OF SPRAY-DRYING OF
SOLID LIPID NANOPARTICLESSunita S.Shinde, Avinash H.Hosmani
Research Scholar, JJT University, Jhunjhunu, Rajasthan, IndiaDept. of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar,
Tal: Panhala, Dist: Kolhapur, MS. India
Abstract:
The slow dissolution rate exhibited by poorly water-soluble drugs is a major challenge in the drug
development process. Following oral administration, drugs with slow dissolution rates generally show
erratic and incomplete absorption which may lead to therapeutic failure. The aim of this study was to
improve the dissolution rate and subsequently the oral absorption and bioavailability of a model poorly
water soluble drug,by formation of Spray-drying of solid lipid nanoparticles.SLN are interesting
colloidal drug delivery systems, since they have all the advantages of fat emulsions and polymeric
nanoparticles They open a broad field of applications including i.v.,oral and dermal administration. The
less cost-intensive spray-drying technique was investigated for SLN as an alternative method to
lyophilization. Spray-drying is widely used in the chemical, the food and the pharmaceutical industries.
It is commonly used to process milk, eggs, ceramics and fertilizers. It converts a liquid into a dry system
in a one-step process and can produce fine, dust-free powders as well as agglomerated ones, to precise
specifications. In our laboratories, we have used spray drying in an attempt to enhance the dissolution
rate of a model drug, In this paper, we report on the preparation and characterization of these particles and
their in vitro dissolution.
Keywords: Solid lipid nanoparticles (SLN); Spray-drying; surfactants, in-vitro study.
AICTE Sponsored
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rd th3 - 4 March, 2012
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ANTIMICROBIAL STUDY OF HIBISCUS SABDARIFFA LINN LEAVES EXTRACTSudhir S. Mulay*, Kailash R. Biyani
Anuradha College of Pharmacy, Chikhali, Dist. Buldhana (M.S.)[email protected]
Abstract:
Higher plants have been exploited as a source of biologically active compounds since antiquity.
The microbial disease is one of the most frequently occurring diseases in all ages, races and sexes.
Current strategies to overcome the global problem of antimicrobial resistance include research in
finding new and innovative antimicrobials from plants. The purpose of this study was to evaluate the in-
vitro antibacterial activity of ethyl acetate and aqueous extracts of leaves of Hibiscus sabadariffa linn
using the agar plate and MIC method against human pathogenic micro-organisms. In both the methods,
ethyl acetate fraction exhibited good inhibitory activity. Ethyl acetate fraction showed good inhibitory
property with MIC values ranging from 62.5µg/ml to 125µg/ml. Aqueous extract showed moderate
activity with MIC values ranging from 125 to 250µg/ml while the 95% ethanol showed minimum
activity ranging from 250 to 500µg/ml.
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ANALGESIC AND ANTI-INFLAMMATORY ACTIVITIES OF XANTHIUM
STRUMARIUM L.* 1 2Mohammed Rageeb Mohammed Usman , Shaikh Sajid R. , Md. Abullais Md. Usman
*Ph. D Scholar, JJT University, Rajasthan - 333001, India.1Oriental College of Pharmacy,Sanpada, Navi-Mumbai - 400705, Maharashtra, India.
2Smt. Sharadchandrika Suresh Patil College of Pharmacy, Chopda - 425107, Maharashtra, India. E-
mail: [email protected]
Abstract:
Xanthium Strumarium L. compositae, is a common weed found in India. The whole plant, specially root
and fruit, is used as medicine. According to ayurveda, Xanthium Strumarium L. is anthelmentic,
antipyretic, antiepileptic, diuretic, cooling laxative, fattening, alexiteric, and tonic, digestive and
improves appetite, voice, complexion, and memory. The petroleum ether extract of Xanthium
Strumarium L. was evaluated for analgesic and anti-inflammatory activity at the doses of 250 and 500
mg/kg body weight. The tail immersion and acetic acid writhing response in mice were used to assess
analgesic activity. The acute toxicity study of the extract had shown no sign of toxicity up to a dose level
of 2000mg/kg body weight. Carrageenan induced paw edema in rats, which is an acute model used to
assess anti-inflammatory activity. The extract has inhibited paw edema in dose related manner. A dose
dependent analgesic action was obtained against tail immersion and writhing test indicating that
analgesic activity may be involved in the inhibition of the pain. Thus the petroleum ether extract of
Xanthium Strumarium L. possess significant analgesic and anti-inflammatory activities.
Keywords: Xanthium Strumarium L., Anti-inflammatory, Analgesic, Writhing, Phytomedicines.
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
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AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
PHYTOCHEMICAL AND PHARMACOGNOSTIC EVALUATION OF ERYTHRINA INDICA LINN. LEAVES
1 2 3A. M. Patel *, S. M. Kurbetti , R.V. Savadi
1*Research Scholar, Shri Jagdishprasad Jhabarmal Tibrewala University, dist. Jhunjhunu, Rajasthan-
333001, India. E-mail :- [email protected]. of Pharmacognosy and Phytochemistry, SGM College Of Pharmacy Mahagaon,
Gadhinglaj. Kolhapur, Maharashtra, India.3Principal, Arvind Gavali College Of Pharmacy, Satara, Maharashtra, India.
Abstract:
Erythrina indica Linn (Febaceae) is a medium-sized, spiny, deciduous tree normally growing to 27 meter
tall, found in Bengal and many parts of India especially in southern and western India. The current study
was carried out to provide requisite pharmacognostic and phytochemical details about the plant. In the
microscopic studies, the leaves showed the presence of branched trichomes, vascular bundles, palisade
cells, collenchyma cells, spongy parenchyma and paracytic type of stomata. The total ash, acid insoluble
ash, water-soluble ash and sulfated ash were observed to 5.1±0.2%, 2.0±0.3%, 2.9±0.2% and 6.0%
respectively. Water soluble, alcohol soluble and petroleum ether soluble extractive values were found to
be 18±1.1%, 11±1.0% and 7±0.9% respectively. Moisture content was found to be 3.8±2.0%. The dried
leaf powder was subjected for soxhlet extraction using ethanol for 5 hours and for maceration by using
water for 48 hours. The aqueous extract of leaves revealed the presence of Glycosides, Alkaloids,
Carbohydrates, Tannins, Proteins, Saponins, Flavonoids, and Phenolic Compounds, while ethanolic
extract of leaves showed the presence of Alkaloids, Flavonoids, Saponins, Proteins, Steroids,
Carbohydrates, Tannins, and Phenolic compounds. The result of this study can be useful in setting
some diagnostic indices for the identification and the preparation of the monograph of the plant. Keywords : Erythrina indica, Febaceae , Phytochemical, Tannins, Traditional medicines.
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CHROMATOGRAPHIC QUANTIFICATION OF CAFFEINE, CHLORPHENIRAMINE
MALEATE AND DICLOFENAC SODIUM FROM THEIR NOVEL MULTICOMPONENT
FORMULATION AND PLASMA
R. A. Patil*, S. J. Melawane and M. S. Bhatia
Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra (India) 416 013
Abstract:
Reversed phase High performance liquid chromatography method (RP-HPLC) for separation
and estimation of Caffeine, Chlorpheniramine Maleate and Diclofenac Sodium from their
multicomponent tablet formulation and biological fluids was developed. The separation of three
drug components was carried on a JASCO HPLC system with HiQ-Sil C18HS column (250 x 4.6 mm,
5µm) using methanol: 0.1% sodium salt of n-hexane sulfonic acid (60:40 v/v) pH adjusted to 4 with 0.1
M orthophophoric acid as mobile phase by isocratic elution with a flow rate of 1.0 ml/min and detection
wavelength of 255 nm. Ezetimibe was used as internal standard. For formulation analysis method,
Beer's law was obeyed in the concentration range of 2 to 130 µg/ml of Caffeine, 1 to 96 µg/ml of
Chlorpheniramine Maleate and 2 to 200 µg/ml of Diclofenac Sodium. For plasma analysis method,
Beer's law was obeyed in the concentration range of 50 to 300 ng/ml of Caffeine, 50 to 300 ng/ml
of Chlorpheniramine Maleate and 100 to 600 ng/ml of Diclofenac Sodium. The developed method
successfully estimates drugs from their tablet formulation and plasma with mean assay values of 99.24 ±
0.86 and 89.59 ± 2.67 % for Caffeine, 98.92 ± 0.98 and 88.28 ± 1.92 % for Chlorpheniramine Maleate
and 99.83 ± 0.68 and 92.58 ± 1.93 % for Diclofenac Sodium respectively. The method for formulation
and plasma analysis were validated as per the ICH Q2B (R1) and USFDA guidelines respectively. The
results of validation studies proved applicability of method in biopharmaceutical and pharmacokinetic
studies of these drugs.
Key Words: RP-HPLC, Caffeine, Chlorpheniramine Maleate and Diclofenac sodium.
P-8
USE OF ERYTHRINA INDICA FLOWER EXTRACT AS A NATURAL INDICATOR IN
ACID BASE TITRATION
Rahul Londhe*, Ramling Patrakar.
Shree Santkrupa College of Pharmacy, Ghogaon (karad) Maharashtra, India 415111
Email:[email protected]
Abstract:
Erythrina indica, also known as Indian coral tree, it is a medium-sized, spiny, deciduous tree. It is native
to the tropical and subtropical regions of eastern , the , northern , and
the of the The present work highlights the use of Erythrina Indica Flower extract as
an acid base indicator in different types of acid base titrations. The equivalence points obtained by the
flower extract coincided with the equivalence points obtained by standard indicators. In case of weak
acid and weak base titration, the results obtained by the flower extract matched with the results obtained
by mixed indicator. This natural indicator was found to be a very useful, economical, simple and
accurate for the said titration.
Key Words: Erythrina Indica Flower, Acid base indicator, Natural indicator.
Africa Indian Subcontinent Australia
islands Indian Ocean
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SELF-EMULSIFYING DRUG DELIVERY SYSTEM A NOVEL APPLICATION IN DRUG DELIVERY OF HYDROPHOBIC DRUGS
*1 2 3Prasad Patrekar , A. H. Hosmani , I. D. Gonjari
1 Adarsh Institute of Pharmacy, Vita. Tal-Khanapur, Maharashtra, India.415311
2 Govt. College of Pharmacy, Ratnagiri, Maharashtra, India. 415612
3 Assistant Director AICTE, New Delhi - 110001
Corres.Author:
Abstract: Oral route for drug administration is the easiest & most convenient. Poor aqueous solubility is the
major problem in oral formulation due to the rate of dissolution and rate of permeation through biomembrane are two critical slower rate determining processes in orally administered drug. About 40% new active entities are poorly water soluble or hydrophobic in nature. These poorly water soluble drugs create challenges to scientist to develop enhanced bio-avaibility for oral formulations. Various technological strategies are reported including derivatization, solid dispersions, cyclodextrin complex formulations, micronization and more to enhance bioavaibility. Apart from these self-emulsifying drug delivery system (SEDDS) is much focused due to its excellent efficiency in delivering poorly water soluble drugs with enhanced solubility, dissolution, absorption and bioavaibility. SEDDS are lipid based formulations. These systems are ideally isotropic mixture of oil, surfactants & co-solvents that form fine oil-in-water (o/w) emulsion or micro emulsion on mixing with aqueous phase with little or no energy input. With SEDDS bioavaibility of the drug increased & quantity of drug which is required for desired effect is decreased. This review article explains how self-emulsifying drug delivery system can enhance solubility & bioavaibility of drug & SEDDS technology is a novel application in drug delivery and solve problems associated with delivery of hydrophobic drugs.
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SIMULTANEOUS ESTIMATION OF CANDESARTAN CILEXETIL AND
HYDROCHLORTHIAZIDE IN TABLET DOSAGE FORM BY UV
SPECTROPHOTOMETRIC METHOD.
Bhadke Tejaswini K*, Kesur Bhavik R, Mohite Shrinivas K, Magdum Chandrakant S.
Rajarambapu College of Pharmacy, Kasegaon, Maharashtra, India.
E-mail: [email protected]
Abstract:
Candesartan cilexetil is a prodrug of candesartan which belongs to angiotensin II receptor blocker.
Hydrochlorthiazide is a diuretic. Both of the drugs are used in treatment of hypertension. A simple,
sensitive and reproducible UV Spectrophotometric method was developed using the solvent 0.1 N
NaOH for simultaneous estimation of candesartan cilexetil and hydrochlorthiazide in tablet dosage
form. Candesaratan cilexetil and hydrochlorthiazide exhibited absorbance at 251nm and 273nm in 0.1N
NaOH and followed Beer's law in the concentration range of 4 28µg/ ml and 2 - 14µg/ml respectively.
The results of analysis were validated statistically and by recovery studies confirmed the accuracy and
precision of the method.
AICTE Sponsored
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SCHEDULE HX: COMBATING ANTIBIOTIC RESISTANCE ENHANCING PROFESSIONAL INTEGRITY OF INDIAN PHARMACIST
Patil A.R., Biradar K. S., Patil K.S.Tatyasaheb Kore College of Pharmacy, Warananagar,
Tal-Panhala, Dist- Kolhapur-416113, India. Email: -
Abstract:Antibiotic resistance (AR) is burning question from some decades & result into 150000 deaths. The present study focused on causes of AR and to explore factors which influence malpractices of usage antibiotics and suggest corrective measure. Literature study from various magazines, websites, was done to understand whether misuse of antibiotic is key factor which increases the antibiotic resistance. 40 prescriber, 40 pharmacist, 40 patients & FDA officers were approached in urban & rural area of Kolhapur, Sangali district. Self-administered questionnaires were developed for study. Out of 120 of these participants 50% are from rural area and 50% from urban are taken for effective result in our survey. Total contributers in AR has been found as 55% prescribers, 27% pharmacist, 10% patients, 5% society. Various determinants are found which affect on antibiotic usage. Health ministry is planning to implement Schedule HX to combat AR. There are certain limitations which have not taken into consideration like, 1.Less availability of tertiary care hospitals, 2. Economic loss of Pharmacist, 3.Availability of medicines in emergency cases. 4. Tertiary care hospitals not affordable. This bridge can be connected by setup of governing body which is initiated in kolhapur by the name “thyrocare” and there is need of stringent regulation to combat this situation & strapping “iron will” in health care professionals to organise campaign to provoke awareness which we initiated. Keywords: Antibiotic resistance, Schedu le HX, Tertiary care hospitals.
AICTE Sponsored
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rd th3 - 4 March, 2012
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MULTIPATHWAY INDUCTION PROGRAM: PANACEA FOR IMPROVING PROFESSIONALISM IN NOVICE STUDENTS
Biradar K. S., A.R. Patil, Patil K. S., Tatyasaheb Kore College of Pharmacy, warananagar,
Tal- Panhala, Dist- Kolhapur- 416113. E-mail:
Abstract:Pharmacy education needs re-engineering for improving professionalism in students by innovative technique. The objective of this work it to design & define an induction program comprising set of programs for newly admitted students, to implement this induction program and to find the outcome of induction program on student behavior by continual assessment. A multi-pathway Induction Program is designed by arranging a FGD (Focused group discussion) in between 5 academicians & 2 industrialists. As per the conclusion induction program is arranged for two consecutive batches as they get admitted in college. Behavior assessment of these 2 batches and a first batch for which induction program was not conducted (N=198). Continual behavior assessment was carried out in 3 month, 12 month & 18, 24 month for second year batch & in 3 month for first year batch. Evaluation is carried out by taking responses from teachers (20) and mentor's (20), with help of questionnaire and their academic growth and behavior. The responses were graded with low (0-30%), moderate (31-70%) & high (71-100%). As per conclusion of FGD following programs such as 1.Welcoming to fresher's, 2. Introduction to institute, 3.Academic planer, 4.peer mentoring programs, 6.White coat ceremony, 7. Introduction to committees, 8. Outside speakers for update recent trends are arranged. Behavior assessment result found that newly admitted students have more professionalism, integrity, collaboration with faculty by arranging induction program. Hence institutions, administrators, practitioners, have to consider it for implementation in novice student for upgrading pharmacy profession.
Keywords: - behavior assessment, professionalism, Student integrity.
AICTE Sponsored
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rd th3 - 4 March, 2012
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FORMULATION AND DEVELOPMENT OF TASTE MASKED AMBROXOL
HYDROCHLORIDE SUSPENSION USING ION EXCHANGE RESINS
1 2Bharat V. Jain* , Dr. Shashikant D. Barhate
1 Ph.D Scholar, JJT University, Jhunjhunu, Rajasthan
2 Shri Sureshdada Jain Inst. of Pharmaceutical Education and Research, Jamner, M.S
Email id:
Abstract:
In the present work the attempt was made to prepare taste masked suspension of Ambroxol
Hydrochloride by abating the intensely bitter taste of Ambroxol Hydrochloride. Taste abatement was
done by complexing of Ambroxol hydrochloride with different Ion Exchange Resins (IER) like
Tulsion 335 and Indion 214 in different ratios. The prepared suspensions were evaluated for taste, drug
content, particle size, viscosity, sedimentation volume and drug release. The resonates prepared with
drug- T343 ratio (1:2) at pH 8, gave maximum drug loading. Suspension containing above resinates
showed more than 80% In vitro drug release within 30 min. Prepared formulation also showed good
stability and can retain its palatable taste. The developed formulation was an additional advantage like
simplification of manufacturing procedure and is economical. Thus, the “patientfriendly dosage
form” of bitter drugs, especially for pediatric, geriatric, bedridden, and noncooperative patients, can be
successfully formulated using this technology.
AICTE Sponsored
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HEPATOPROTECTIVE ACTIVITY OF EUPHORBIA HIRTA LINN. AGAINST CCL4 INDUCED LIVER TOXICITY IN RAT
Vinod V. Takale*1, R.V.Savadi 2, Ansar M. Patel 3*1 Research Scholar, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Dist-
Jhunjhunu, Rajasthan, India. 333001 2 Principal, Arvind Gavali College of Pharmacy Satara, Dist- Satara, Maharashtra, India.
3 Principal Sant Gajanan Maharaj College of Pharmacy, Gadhingaj, Dist- Kolhapur, Maharashtra, India.
Abstract:
The leaves of Euphorbia hirta Linn. is said to be valuable in traditional medicine for the various diseases
including Hepatotoxicity. To give scientific background to the above traditional claim, the leaves of
Euphorbia hirta Linn. were evaluated for its Hepatoprotective activity. In the present study, shade dried
and coarsely powdered leaves were first defatted with petroleum ether (40-60) after that successively
extracted with methanol. The methanolic extract was concentrated & dried under reduced pressure, then
it is used for Pharmacological investigations. The toxicity studies were carried out as per OECD
guidelines and the doses were fixed at 200 mg/kg b.w. and 400 mg/kg b.w. The Methanolic extract was
evaluated for in vivo Hepatoprotective activity by using CCl4 induced hepatotoxicity model. The
Methanolic extract showed better effect at the dose of 400 mg/kg b.w in lowering elevated SGOT, SGPT,
ALP, total bilirubin and direct bilirubin levels in hepatotoxic rats. Histopathological studies showed that
the Methanolic extract showed minimal hepatocytes necrosis and Good number of binucleate
regenerating hepatocytes. Key words: Euphorbia hirta Linn, Hepatoprotective, CCl4, Methanolic extract.
E-mail- [email protected]
AICTE Sponsored
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rd th3 - 4 March, 2012
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PROTECTIVE EFFECT OF ANTI-OXIDANTS ON L-ARGININE INDUCED ACUTE
PANCREATITIS IN RATSSandeep Biradar*, Veeresh Bantal
G Pullareddy College of pharmacy, Mehdipatnam, Hyderabad-500028
E-mail: [email protected]
Abstract:
Background: Development of acute pancreatitis, an inflammatory disorder of the exocrine part of
pancreas, involves oxidative stress and inflammatory mediators. The present study evaluates the
beneficial effect of myrcene and limonene, potential antioxidant and anti-inflammatory agent on L-
Arginine induced pancreatitis in rats. Methods:Wistar rats of either sex (n = 84) were divided into 7
groups (n = 12), Group 1: control (saline), Group 2: disease control (L-Arginine, 2.5 g/kg, i.p., two times
with one hour interval), Group 3, 4, 5 and 6: test groups (received myrcene 100 and 200 mg/kg, limonene
100 and 200 mg/kg, p.o., respectively one hour after the last injection of L-Arginine), Group 7: standard
group (methyl prednisolone 30 mg/kg, p.o., one hour after the last injection of L-arginine). Half of the
animals were sacrificed at 24 hours (study I) and remaining half were sacrificed at 72 hours (study II)
after the last injection of L-Arginine. Blood was collected for estimation of serum amylase and lipase
while isolated pancreas, lungs, liver and kidney for the estimation of bio-chemical parameters and
histological examination. Results: Administration of L-Arginine significantly developed acute
pancreatitis characterized by elevated levels of serum amylase and lipase at 24 hours compared to
normal control group. Treatment with myrceneand limonene dose dependentlydecreased the serum
amylase and lipase levels, restored the antioxidant status of pancreas. Treatment with myrceneand
limonene further restored the L-Arginine altered histoarchitecture of pancreas, lungs, liver and kidney.
Conclusion: Treatment with myrcene and limonene significantly ameliorated the L-Arginine induced
pancreatitis.
Keywords:Acute pancreatitis; L-Arginine; myrcene, limonene; Oxidative stress; Inflammation
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
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CONTENT ORIENTED ADVERTISEMENT: HALLMARK TO CONFER DETAILING OF
COUNTER-INTUITIVE PHARMACEUTICAL PRODUCTS Ghate B.U, Mohite Y.A, Patil K.S., D'souza J. I.
Tatyasaheb Kore College of Pharmacy, Warananagar, Tal- Panhala, Dist- Kolhapur-416113, India. Email:
Abstract:
Advertisement (Ads) is wide form of promotion of Counter-intuitive pharmaceutical product by
organizing paid time for advertising a message. The present study was aimed to identify various means of
pharmaceutical Ads and their evaluations regarding their benefits and hazards; to suggest better and
effective advertisement; development of new strategies to bring out effectiveness and for better
understanding of Ads. Evaluation of Ads from different Medias like TV (50), Newspaper (130),
magazines (50) and radio (5) considering factor such as safety, efficacy, and contra-indication was done
by panel. Panel consists of academicians, reputed pharmacist, and well known physician, FDA officers,
industrialist and layman-patient. Focused group discussion was conducted on product detailing &
content oriented Ads to reach the final conclusion. Survey revealed that ads from different Medias,
specially published in news paper are 1. Less understood or more confusing to consumer because of less
content details, brand logo, product detailing; 2. Misguiding and with wrong statements; 3. Without
emphasis on safety, side effects, contraindication etc. Certain Ads provoke the consumer's desire by
various visual methods and animations. Study concludes that today's health-conscious society demands
to know more about drug therapy. “Learned intermediary doctrine” is becoming outdated model of the
doctor-patient relationship. Content oriented Ads can be the best mean to serve the purpose.
AICTE Sponsored
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FORMULATION AND EVALUATION OF ORAL SUSTAINED RELEASE TABLET OF
PROPRANOLOL HCL USING INDION234 AS
ION EXCHANGE RESIN MATERIALGhorpade S.M.*, Gandhi S.M., Magdum C.S., Mohite S.K.
Rajarambapu College of Pharmacy,Kasegaon ,Tal-Walwa ,Dist-Sangli (MH)Email:- [email protected]
Abstract:
The major drawback of sustained release or extended release tablets is dose dumping, resulting in
risk of toxicity. The use of IER has occupied an important place in the development of controlled or
sustained release systems because of their better drug-retaining properties and prevention of dose
dumping. Propranolol HCl is a beta blocker agent administered on twice a day dosage regimen in the
treatment of hypertension.In the present study, resinates of Propranolol HCl were formulated using
Indion -234 resins.Drug loading process was optimized with respect to drug:resin ratio, duration of
stirring ,pH of loading solution, and resinates were characterized using IR spectroscopy for
compatibility study.
Optimum drug loading was seen at pH of 3.5 in drug-resin ratio of 1:1 at 3 hours of stirring using
magnetic stirrer.The matrix tablets were prepared by using resinate along with other excipients such as
Avicel PH-102, HPMC etc. and prepared tablets were analyzed for its thickness, hardness, friability,
weight variation, drug content and in-vitro release studies.Tablet thus formulated provided sustained
release of drug over a period of 12 hours with first order kinetics. The release of drug from resinate
controls diffusion of drug molecules through polymeric material into aqueous medium The results
suggest that the Indion-234 is useful in developing sustained release matrix tablets of Propranolol HCl.
Resins thus promises considerable utility in the development of oral sustained release drug delivery
systems.
AICTE Sponsored
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A MULTIDISCIPLINARY APPROACH TO PREVENT PRESCRIPTION ERRORS
ENSURING THE PATIENT SAFETYGandhi S.M.*, Mohite S.K. , Gujar P.P. , Ghorpade S.M.,
Rajarambapu college of pharmacy,Kasegaon ,Tal-Walwa ,Dist-Sangli (MH)[email protected]
Abstract:
Medicines are part of most people's lives. Any Mistakes with medication increases the risk of
something going wrong. The rational use of drugs begins with a correct prescription; nevertheless, this
stage is where more than 50% of all treatments present errors. Our aim is to detect the most frequent
prescription errors, in order to justify the implementation of pharmaceutical care services at the hospitals
as well as the inclusion of pharmacists as part of the health care team. Sample of 220 prescriptions were
evaluated for their appropriateness according to basic pharmacotherapeutic variables. We visited 12
physicians to know their prescription writing habit, process of decision making and view regarding
prescription errors. Also interviewed 60 pharmacist near karad ,kasegaon ,islampur(MH,India)to know
problems occurs during prescription interpretation.
We find that the quality of most of the prescription was unsatisfactory both in terms of layout and the
content of the drug prescribed. Many prescriptions had illegible handwriting, Confusing drug names,
Polypharmacy practice. There are no pharmacists advising patients at community pharmacies,
expanding irrational use of drugs. This may preventable by having computational systems and by having
more pharmacists for monitoring prescriptions, advising physicians and taking care of patients.
Prescription orders should include essential parameters related to patient and drugs. The pharmacist
should check with the prescriber if any information is missing or questionable. All health care
professionals should have a common vision and goal to prevent medication errors. A multidisciplinary
approach to solving the problem of prescription errors is required which ensuring the patient safety
AICTE Sponsored
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ENHANCEMENT OF DISSOLUTION OF CINNARIZINE BY
SOLID DISPERSION METHOD
Hemant R. Kakade,*1 Anilkumar J. Shinde, Harinath N. More
Department of Quality Assurance, Bharati Vidyapeeth College of Pharmacy,
Near chitranagari, Kolhapur. E mail- [email protected]
Abstract:
The aim of present study was to enhance the solubility of poorly soluble drug Cinnarizine by the binary
solid dispersion techniques, Consisting drug and polymers. Cinnarizine is H1 antagonist widely used in
treatment of the vertigo, motion sickness and vomiting. In the present work solid dispersion was prepared
with poloxamer188 and poloxamer407 by the use of solvent evaporation method with ratios 1:1, 1:2 to
1:5 of drugs and poloxamers respectively. Solid dispersions were characterized by IR spectroscopy, in-
vitro dissolution study and Scanning electron microscopy. The infrared spectra suggested that there was
no chemical interaction between Cinnarizine and poloxamers. Equilibrium solubility studies showed
that drug solubility was enhanced as the polymer content increased. Dissolution showed that more than
80% drug releases within 10 min, SEM analysis revealed that drug morphology was changed the particle
appear porous and size of particle also reduced.
Keywords: solid dispersion, Binary system, poloxamer188 & poloxamer407.
AICTE Sponsored
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MODIFIED RELEASE FORMULATION DRUG DELIVERY SYSTEM FOR
CARDIOVASCULAR DRUGS2, 3 2, 3 1 2
Patil Atul , Kundu Subrata , Srinivasan Ganga , Borkar Nitin1 2VES College of Pharmacy, Mumbai University ; VerGo Pharma Research Laboratories Pvt.Ltd ; JJT
3 University [email protected]
Abstract:VP108 (code named) is the drug used for treatment of cardiovascular diseases and often limited its application due to its limited pH dependant solubility & bioavailability, in the present research work an attempt has been made to design a platform drug delivery technology# to use solublizers and pH modifiers in the core such that release of solublizers from the core is modulated to alter the release of active in association with rate modulating polymers. The release of solublizer and design of polymeric rate controlling system is configured such that sufficient amount of pH modulator or Solublizer is released specific to pH and significantly improves the solubility & there by release of the active in the said medium or pH. Most of the drugs are either basic in nature or acidic in nature & have pH dependent solubility, surprisingly we have found that by modulating the release of solublizer or pH modifier from the dosage form we can enhance the solubility and or release of active in unfavorable pH region where drug is insoluble and doesn't have sufficient solubility. Experimental Design: Formulation Development: Model drugs from cardiovascular category having pKa between 8- 10 were selected. BCS solubility of the same was carried out to understand their solubility behavior. Different solublizers and pH modulators were identified to understand the concentration required to achieve sufficient solubilisation. The important task was establishing required amount of Solublizer in the core and providing a rate controlling polymeric coating on the core to control the release of Solublizer to modulate release of drug from core. Analytical Methods: A HPLC method was developed to detect Solublizer and active in the dissolution method, the release of Solublizer or pH modulator was targeted or altered to achieve desired release for the actives.Result and Discussion: A Solublizer release based modulated drug delivery system can be developed with mixture of polymeric materials in bead or tablet dosage form In present research work a successful attempt has been made to develop a platform drug delivery technology. To develop a robust formulation which is scalable & commercially viable optimization of each process steps & composition was done to achieve a similarity factor F2 more than 60. Attempt was made to understand the principle mechanism of drug release from formulation and it appears to be by diffusion mechanism based on data of mathematical modeling. Conclusion: A Solublizer and ER polymer based drug delivery system can be designed to provide uniform drug release across the pH conditions for poorly soluble drugs of cardiovascular categories. This Provides cost effective generic or life cycle management opportunity for the drug & formulation thus provides tremendous business potential by minimizing health care management cost. Acknowledgments: VerGo Pharma Research for providing research facility. #Note: This technology is patented and final approval is awaited for the patent application Ref: 329/MUM/2012.
AICTE Sponsored
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rd th3 - 4 March, 2012
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CACTUS : WONDER MEDICINAL PLANT EXPLORED FROM SEMIARID REGION
Adake A.K, Patil R.R, G.V.PatilRajarambapu College of Pharmacy, Kasegaon, Tal. Walwa, Dist Sangli 415404, MS, India.
E-mail: Abstract:
Plants have played a significant role in maintaining human health and improving the quality of human
life for thousands of years and have served humans well as valuable components of medicines,
seasonings, beverages, cosmetics and dyes . Ethnopharmacological studies on such herbs/medicinally
important plants continue to interest investigators throughout the world. One such plant, Opuntia ficus-
indica invites attention of the researchers worldwide for its pharmacological activities ranging from
anti-inflammatory to anticancer activities. Opuntia ficus-indica is also known as prickly pear cactus.
Prickly pears are also known as "tuna", " " or nopales, from the word nôpalli for the pads, or
nostle, from the Nahuatl wordnôchtli for the fruit; or cactus.. The prickly pear cactus is unique
among cacti, and in fact among all plants, in that each part of the plant may be used for some healthful
purpose. The fruit of the cactusalso known as the pulp or tunacan be eaten much like other fruits. Cactus
Fruit Opuntia contain a range of in ample quantities, notably substituted .
Identified compounds of medical significance include , , ,
, and .
Keywords: Pricly pear fruits, seeds and pads, antioxidants on plasma LDL cholesterol concentration,
vitamins and minerals, antihyperglycemic effects, immune-stimulating, BPH
nopal Nahuatl
paddle
alkaloids phenethylamines
3-methoxytyramine candicine hordenine N-
ethyltyramine tyramine
AICTE Sponsored
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COSMETIC REGULATIONS: A COMPARATIVE OVERVIEW1 * 1 1 2Shalaka V. Patil , Rohini S. Patil, Rahul S. Adnaik, Durgacharan A. Bhagwat
1. Rajarambapu College of Pharmacy, Kasegaon, Tal: Walwa, Dist: Sangli,
MS. India. E-mail:
2. Tatyasaheb Kore College of Pharmacy, Warananagar, Tal: Panhala,
Dist: Kolhapur, MS. India
Abstract:
In a world new cosmetic regulations are being promulgated at an alarming rate. In view of the ever
growing market of the cosmetic countries has been setting up their own directive to regulate such
products. The current regulations of cosmetics are stringent. There are different regulatory bodies
worldwide having their own regulations to ensure safety of the cosmetic products. The major cosmetic
market constitutes of European Union (EU), United States of America (USA) .The regulations in these
territories are used as a model for the developing world. There may be different specific regulatory
systems; they have a common goal of ensuring that cosmetic products are safe and properly labeled. In
the industrialized countries these regulations have evolved to the point where they are rather extensive
and, largely because the United States and European Union are the two largest markets in the world for
cosmetic products. The cosmetics market in India is growing at 15-20% annually, twice as fast as that of
the United States and European market. Indian cosmetic industry is matured enough and responsible to
ensure the quality and safety of its products. The cosmetic regulations in India are complex and time
consuming for pre marketing approval. It is therefore important for a cosmetic manufacture to
understand the difference in regulatory system in India when compare to USA and EU. The aim of the
present review is to compare the cosmetic regulations in USA, EU and India.
AICTE Sponsored
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SOLID SELF MICRO EMULSIFYING DRUG DELIVERY SYSTEM OF
CARDIOVASCULAR DRUG FOR ENHANCED BIOAVAILABILITY1 2Durgacharan A. Bhagwat*, John I. D'Souza
1. Research Scholar, JJT University, Jhunjhunu, RajasthanE-mail:
2. Tatyasaheb Kore College of Pharmacy, Warananagar, Tal: Panhala, Dist: Kolhapur, MS. India. E-mail:
Abstract:
Improvement of bio-availability of drugs is one of the greatest challenges in drug formulations. Self
micro emulsifying drug delivery systems (SMEDDS) have shown great promise for enhancing
bioavailability of low solubility compounds. Conventional SMEDDS are normally prepared in a liquid
dosage form that can be administered in soft gelatin capsules, which have some disadvantages especially
in the manufacturing process. Incorporation of a liquid self-emulsifying formulation into a solid dosage
form may combine the advantages of SMEDDS with those of a solid dosage form and overcome the
disadvantages of liquid formulations. In view of this, the present investigation was aimed at developing
Solid-SMEDDS for poorly soluble cardiovascular drug for enhanced bioavailability. In this study
solubility of drug was determined in various oil, surfactant and co-surfactant. Pseudoternary phase
diagrams were used to evaluate microemulsification existence area. Three component SMEDDS
formulation were established and selected combinations were exposed to spray drying using water
soluble solid carrier. S-SMEDDS formulations were tested for reconstitution properties and solid state
characterization. The in-vitro dissolution studies of S-SMEDDS filled into hard gelatin capsule and pure
drug were carried out. Results showed that the mean droplet size of all reconstituted S-SMEDDS were
very low and all were found to be <100 nm. Drug releases from S- SMEDDS formulations were found to
be significantly higher as compared with that of pure drug. Thus study concluded with S-SMEDDS
provides useful solid dosage form to improve solubility and dissolution rate of poorly soluble
cardiovascular drug and concomitantly bioavailability.
Keywords: Self microemulsifying drug delivery system, bioavailability enhancement
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FORMULATION AND EVALUATION OF FLOATING TABLET OF CAPTOPRIL
PATEL P.V., PATEL R.P., SHAH DHARMESH
SHRI JAGDISHPRASAD JABARMAL TIBREWALA UNIVERSITY
(JHUNJHUNU, RAJASTHAN),
Email id: - [email protected]
Abstract:
The present study was undertaken to prolong the release of orally administer. floating tablets of Captopril
was prepared by using different grade of hydroxypropylmethylecellulose. Formulations were optimized
using different viscosity grades of hydroxypropylmethylecellulose. Lactose and citric acid were used in
different concentration as a channeling and chelating agent to obtain best optimized formulation and
designed to prolong the gastric residence time (GRT). Formulations were evaluated by floating lag time
and in vitro drug release method. Results revealed that the effect of channeling and chelating agent at
different concentration had significant effect on the release of the drug from hydrophilic matrix tablet.
Three different viscosity grades of hydroxypropylmethylecellulose namely K100M, K 15M and K 4M
were used as a floating polymer or intention of polymer. It was observed that different viscosities not only
influence the drug release from hydrophilic matrix but they also affect the floating properties of tablets.
Dissolution profiles were subjected for various kinetic treatments to analyze the release pattern of the
drug and we found that drug release by diffusion mechanism and followed square root kinetics or
Higuchi's kinetics. The in vitro release profiles of drug from all the plots shows high linearity (r2= 0.9813
to 0.9954). Optimized formulations were again subjected for thickness, friability, hardness, uniformity
of content, uniformity of weight, in vitro dissolution, Floating lag time, floating time and stability
studies. Results revealed that the floating formulation of the Captopril is the best formulation to obtain
better therapeutic effect and hydroxypropylmethylecellulose at a concentration of 35% up to some extent
it increases the Bioavailability of the drug to retain the dosage form on the desired site for effective period
of the time.
AICTE Sponsored
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rd th3 - 4 March, 2012
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DEVELOPMENT AND IN VITRO CHARACTERIZATION OF SUSTAINED RELEASE
PELLETS OF VENLAFAXINE
Patel Vipul.V., Patel R.P., Patel N.R., Patel S.S.
Shri Jagdishprasad Jabarmal Tibrewala University (Jhunjhunu, Rajasthan),
Email Id.: [email protected]
Abstract:
Sustained release formulation of Venlafaxine hydrochloride based on solution/suspension layering
technology was developed and evaluated. Venlafaxine hydrochloride is a highly water-soluble drug so it
is suitable to develop sustained release dosage form. Venlafaxine is a short acting drug so developed
formulation provides the advantages of sustained release formulations. The developed formulation is
equivalent to US marketed product effexor regarding in vitro release. The developed formulation
provides advantages of easily amenable to mass production using conventional fluid bed processor.
The non-pariel seeds were used as starter seeds. Various binders were tried for binding the drug on to the
non-pariel seeds. After changing the binders and optimizing the parameters, as binder was finalized. A
seal coat was applied on the drug coated nonpareil seeds using the same binder. Finally functional coating
was performed using various concentrations of the polymer. The concentration of polymer was
optimized based on dissolution studies. The dissolution data were matched with the marketed product in
different media. A reproducible batch was prepared using the same formulation and parameters.
Evaluation tests like dissolution, sieve analysis, TD, BD, assay, friability, and angle of repose were
performed.
Stability studies were also performed using walk-in stability chamber for a month at 40 ºC ± 75 % RH.
After six months the pellets were evaluated. Effect of curing on pellets was also determined.
AICTE Sponsored
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MODIFIED RELEASE DRUG DELIVERY SYSTEM FOR ANTIEPILEPTIC DRUG Kundu 2, 3 2, 3 1 2Subrata , Patil Atul , SrinivasanGanga , BorkarNitin
1 2VES College of Pharmacy, Mumbai University ; VerGo Pharma Research Laboratories Pvt.Ltd ;JJT
3 University Email:
Abstract:In the present research work an attempt has been made to design a platform drug delivery technology of single system three layered modified release pellets dosage form. In which loading dose of the drug is present at the surface of the sphere and then delayed release portion and finally the modified release part of the drug at the centre on the core sugar or microcrystalline sphere. The release of drug from the immediate release portion is adjusted through the use of suitable solubilizer and the release from the modified release portion is modulated through the different ratio of rate controlling polymer and the pore former in the multiple dissolution medium. Experimental Design: Formulation Development: One of the model drugs from anti-epileptic category was selected. BCS solubility of the same was carried out to understand their solubility behaviour. Different solublizers were identified to understand the concentration required to achieve sufficient drug release from immediate release portion. Properties of drug were evaluated to understand their process limitation, solubility and dispersibility. Each pellet consists of three portions, Modified release portion at the centre, then delayed release portion and finally solubilized immediate released portion at the surface of the pellet. Drug suspension was prepared with suitable binder and anti-foaming agent in hydro-alcoholic solvent system and first portion of the drug suspension was layered on the core sugar spheres then coated with modified release polymer. Second portion of the drug suspension was layered followed byextended release coat and then coated with delayed release polymer coat. Finally, a solubilizer was dissolved into the third portion of the drug suspension and loaded on the surface of the delayed release portion and considered as immediate release portion. In vitro drug release Studies: Dissolution studies were carried out in 0.1N HCL for 2 hr after that pH 5.5 Phosphate Buffer (0.01M) for 2 hrs followed by pH 6.8 Phosphate Buffer (0.01M) for 14 hrs in USP I dissolution apparatus with 900ml media volume and 50 RPM. (n=6) Result and Discussion: Drug release profile can be sustained up to 18 hour and beyond that also. Drug release profile can be modified with the pore forming agent and rate controlling polymer at modified release layer or delayed release layer. As the pore forming agent concentration increases the drug release increase mostly at the centre of the release profile. Drug release from the immediate release portion can be modified with different solublizers and by changing their concentrations. (RSD < 5%) Conclusion:A modified release polymer based drug delivery system can be designed to provide uniform drug release across the pH conditions for sparingly soluble drugs of antiepileptic categories. This Provides cost effective and novel drug delivery system of existing molecule for life cycle management with higher patient compliance thus provides tremendous business potential by minimising health care management cost. Acknowledgments: VerGo Pharma Research Laboratories Pvt. Ltd. for providing research facility.
Keywords: Delayed release polymer, extended release polymers, Pore former, Solublizer, Platform Drug Delivery Technology.
AICTE Sponsored
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Tatyasaheb Kore College of Pharmacy, Warananagar
SYNTHESIS AND ANTIMICROBIAL STUDIES OF SOME NOVEL SCHIFF BASES
S.Shah N.N*, M.A.Baseer, P.A.Kulkarni. P.G. Department of Chemistry , Yeshwant College, Nanded -431602, Maharashtra ,India
e-mail : ,Abstract:
The chemistry of the caron-nitrogen double bond plays a vital role in progresses of chemistry science.Schiff base exhibit a plethora of bioactivities viz, antitubercular ,anticancer antibacterial, antifungal,analgesic, CNS depressant, anti-inflammatory, anticonvulsant , insecticidal, plant growth inhibitors ,anti mouse hepatitis virus (MHV) , inhibition of herpes simplex virus type 1 (HSV-1) and
adenovirus type 5 (Ad 5 ), anti cancer, anti mosquito larvae and herbicidal activities .Schiff bases are used as protective agent in natural rubber. Schiff's bases includes industrial synthesis of high value life
saving beta lactam antibiotics from class of penicillins and cephalosporins. Schiff bases are used as starting material for the synthesis of various bioactive heterocyclic compounds like 4-thiazolidinones, 2-azetidinones, benzoxazines and formazans. Schiff-base compounds have been used as fine chemicals and medical substrates. These wide application and diverse potential biological activities of Schiff bases prompted us to synthesize new Schiff bases containing heterocyclic moiety and to as certain their microbial activity. A series of Novel Schiff bases were synthesized from 4-[2-(5-Ethyl-pyridin-2-yl)-ethoxy]-phenyl amine by reacting with different aromatic aldehydes via condensation reaction. The
1newly Synthesized Schiff bases were confirmed by TLC, melting points, IR, H-NMR and mass spectra . The compound were evaluated for antibacterial activity against Bacillus subtilis gr +ve, Pseudomonas aeruginosa gr ve , Staphylococcus aureus gr +ve, Escherichia colive and antifungal activity against Aspergillus niger, Aspergillus Flavus, Curvularia, Alternaria. All the compounds shows moderate to good activity against different micro-organisms. Keywords: 4-[2-(5-Ethyl-pyridin-2-yl)-ethoxy]-phenyl amine, aromatic aldehydes, Schiff bases, antimicrobial activity.
AICTE Sponsored
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SIMULTANEOUS ESTIMATION OF METAPROLOL SUCCINATE AND OLMESARTAN MEDOXOMIL FROM CAPSULE DOSAGE FORM BY FIRST ORDER DERIVATIVE
SPECTROSCOPIC METHOD.Swapnil D Jadhav, Shraddha M Kumbhar, Vandana D Patel* and Manish S Bhatia
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Near Chitranagari, Kolhapur 416013.
Abstract:Metaprolol succinate (MET) and Olmesartan medoxomil (OLM) are used in combination for treatment of hypertension. The present work deals with simple spectrophotometric method development for simultaneous estimation of MET and OLM in capsule formulation (OLSAR-M). The method employed was a first order derivative spectroscopy. For determination of sampling wavelength, 10 ìg/ml of each of MET and OLM were scanned on UV-630 double beam spectrophotometer in 200-400 nm range. The sampling wavelengths were 214 nm for OLM where MET showed zero crossing point and 231 nm for MET where OLM showed zero crossing point in first order derivative spectroscopy. For this method, linearity was observed in 10-90 ìg/ml for MET and 5-45 ìg/ml for OLM. The recovery studies confirmed accuracy of proposed method and low values of standard deviation confirmed precision of method. The method is validated as per ICH guidelines. The proposed method can be optimized further for simultaneous estimation of both drugs from biological fluids, used in pharmacokinetic and bioequivalence studies.Keywords: Derivative Spectroscopy, Metaprolol, Olmesartan, OLSAR-M, ICH.
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LIPOSOMES AND ETHOSOMALLY ENTRAPPED CLOTRIMAZOLE: A VIEW TO
IMPROVE THERAPEUTIC RESPONSE OF ANTIFUNGALPatel S.S., Patel V.V., Patel R.P., Patel N.R.
Jagdishprasad Jhabarmal Tibrewala (JJT) University, Rajasthan, India
Abstract:
The aims of the present study were to prepare and evaluate topical ethosomes of Clotrimazole and
comparison of release profile with liposome. Studies were performed on ethosomes containing 20%,
30%, and 40% w/w ethanol. A liposomal formulation, aqueous drug solution and 30% ethanol in water
also prepared for comparative study.
Ethosomes and liposomes were characterized for shape, particle size, and entrapment efficiency. Further,
sonication was done to reduce the size and to get more uniform size and shape and showed better
characterization than unsonicated ethosomes. Comparison of in-vitro skin permeation studies was
carried out using Franz diffusion cells. After the in-vitro release study, cadaver skin was cleaned on both
sides and the drug accumulation in the skin was extracted with 10 ml distilled alcohol and drug
concentration was determined Spectrophotometrically. The stability studies were conducted for a period
of 6 months. Optimized ethosomal formulation (ethosome prepared by sonication and containing 30%
w/w ethanol) showed 162.27ìg/cm²/hr across the human cadaver skin as compared to 28.84ìg/cm2/hr for
liposomes. The size of clotrimazole ethosomes was found to be within the range of 0 18.180 ìm and the
average diameter were found to be 5.595 ìm. Drug accumulated study showed more than 23 % of drug
was deposited into skin and only and 1.26 %, 1.54 % for liposomes respectively. The vesicular size
analysis showed ethosomes prepared without sonication decreased as the concentration of ethanol
increased with the largest vesicles size 5.595 ìm containing 20% ethanol and smallest 3.070 ìm
containing 40% ethanol. Efficient delivery of drug to deep skin strata from ethosomal drug applications
found to be very much beneficial in localizing the drug to desired site, reducing possible side effects and
other drawbacks associated with conventional treatments. Release kinetic of CLZ from ethosomes was
found to be zero order. Ethosomes were found stable in refrigeration and room temperature during
storage of 8 weeks Current work was aimed at exploring ethosome as topical drug delivery vehicle so as
to achieve optimal localized concentration and prolonged action.
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ANTIBACTERIAL ACTIVITY OF GREEN TEA (CAMELLIA SINENSIS) EXTRACTS
AGAINST VARIOUS BACTERIA ISOLATED FROM ENVIRONMENTAL SOURCES*# # ## ### ###
Sandip Patil , Amit Kumar , P.C.Sharma , Ajay Kumar , Payal Thakur , Vinayak ##
Shinde
# Dept. of Microbiology, Faculty of Biotechnology, Shoolini University of Biotechnology and Management Sciences, Solan, Himachal Pradesh, India -173212.
## Dept. of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warnanager. Maharashtra.
###Dept. of Microbiology, Shooloni Institute of Biotechnology and Management Sciences, Solan, Himachal Pradesh. India- 173212.
Abstract:
Tea is cultivated in many countries of the world. India is largest tea (black tea) producer in world
followed by Japan (green tea) and China. In the present study Camellia assamica (Green tea) leaves
extracts were tested for antibacterial activity against various bacteria isolated from environmental
sources. Different bacteria were isolated from sewage samples collected from different places at Solan
Himachal Pradesh. Isolated bacteria were identified by Gram staining and biochemical tests. A total of
six bacteria were identified at Department of Microbiology at SILB Solan (H.P) Green tea leaves
extracts were tested for antibacterial activity. Tea leaves were collected from Palampur, Himachal
Pradesh. Three different extracts were prepared by using standardized protocols. All the extracts were
tested for antibacterial activity by disc diffusion method. Antibacterial assay was performed at 10µl,
20µl, and 30µl concentrations. Significant antibacterial activity was reported for all extracts with results.
Aqueous extracts has shown little antibacterial activity against six bacteria isolated. Maximum
antibacterial activity was found in methanolic extracts. Our study reflects the chemotherapeutic use of
green tea.
Key Word Green Tea, Extract, Antimicrobial Activity.
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Tatyasaheb Kore College of Pharmacy, Warananagar
SYNTHESIS OF SILVER NANOPARTICLES USING ONE-POT GREEN METHODKulkarni A.S., Karande K.M., Mastud P.R.
Satara College of Pharmacy, Satara. Plot No.1539, Behind Spicer India Ltd., New additional M.I.D.C., At Degaon, Satara. 415 004 (M.S.)
Abstract:
The current technique used for the preparation of silver nanoparticle is a modification of one pot
method described by Vigneshwaran et al. Nanoparticles can be synthesized either chemically or
biologically. The chemical process for synthesis of silver nanoparticles is more elaborate and leaves
behind toxic effect that adversely affects the ecosystem on the other hand green synthesis of Ag Nps is
less time consuming, less costly and more ecofriendly. Stable silver nanoparticles have been
synthesized by using soluble starch as both the reducing and stabilizing agents; this reaction was carried 0
out at 15 psi, 121 c for 5 min. Nanoparticles thus prepared are found to be stable in aqueous solution over
a period of one week at room temperature. Silver nanoparticles are prepared using soluble starch acting
as both the reducing and stabilizing agents. The aldehyde terminal of soluble starch is used to reduce
silver nitrate while the starch itself stabilized the silver nanoparticles. The nanoparticle was further
characterized by UV VIS spectroscopy which revealed that the formation of Ag NPs by yielding the
typical silver Plasmon absorption maxima at 430 nm. FTIR spectra revealed the involvement soluble
starch for reduction of silver nitrate.
Keywords: Silver nanoparticles; soluble starch; Green chemistry; Sonication; Bioreduction.
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Tatyasaheb Kore College of Pharmacy, Warananagar
COMPARATIVE ANTI-INSECT ACTIVITY OF ACETONE EXTRACT OF DIFFERENT
SEEDSRathod A.M.* Salunkhe R.M., Nadaf S.J. Jarag R. J., Killedar S.G.
Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra - 416013, [email protected]
Abstract:
Traditional medicines are still very commonly used in India for anti insect purposes. The
indiscriminate use of chemical pesticides has given rise to many serious problems, including toxic
residue, increasing cost of application, environment pollution, development of resistance and hazards
from handling has been reported from all over the world. Therefore, the development of bio-insecticides
has been focused as a viable pest control strategy in recent years for ecological, safety and economical
alternative to synthetic one in managing pests. Hence the demand for search of natural plant products has
been increased. Present study was aimed to screen and compare the anti-insect activity of acetone
extracts of five different seeds. The insect repellant activity was carried out using Tribolium castaneum
as test organism by ring arena method. Insecticidal activity was performed by contact poison test
method. The activity was performed by using 30 fresh first generation insects each time and %
repellency and insecticidal activity was determined along with control (plain acetone) and standards
(Citronella oil 10% in acetone for repellant test and Celphos 5% w/v in acetone for insecticidal activity)
at tested concentrations. Study reveals that neem seed extract shows very promising insect repellant and
insecticidal activity (78% and 95%) respectively, followed by custard apple (62% and 85%),
sapota,(60% and 81%) fenugreek (55% and 72%) and tamarind seeds (45% and 58%).
Keywords: Anti-insect activity, Tribolium castaneum.
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
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Tatyasaheb Kore College of Pharmacy, Warananagar
PHYTOCHEMICAL SCREENING AND ANTIOXIDANT ACTIVITY OF FLOWERS
(INFLORESCENCE) OF SACCHARUM OFFICINARUM LINN.*Bhore N. V., Pishawikar S. A., Mahamuni S. S., Kadane S. A., Chavan S. V.
Bharati Vidyapeeth College of Pharmacy, Department of Pharmaceutical Chemistry,Near Chitranagari, Kolhapur (M.S.) 416013, India.
Presenting author's E-mail: Abstract:
Saccharum officinarum Linn having flowering region known as arrowing has soft-rinded, puffy
nature. The extracts of Sugarcane inflorescence was carried out using petroleum ether, chloroform,
Dichloromethane, Ethyl acetate, n-Butanol, Methanol and Distilled water as solvents. The
phytochemical investigation of extracts revealed the presence of alkaloids, tannins, anthraquinones,
reducing sugars, saponins, flavonoids, polyphenols, steroids and terpenoids. Some of these fractions
were screened for free radical scavenging activity (Antioxidant) using 2, 2-diphenyl-1-picrylhydrazyl
radical (DPPH). In DPPH scavenging assay, free radicals are involved in the process of lipid
peroxidation and play a cardinal role in numerous chronic diseases like cancer, coronary heart disease
and ageing. Thus the ability to scavenge free radicals in order to minimize oxidative damage to living
cells is very important. The better scavenging activity of Saccharum officinarum L. could be linked to
the presence of secondary plant products like flavonoids and phenols, which have the ability to
scavenge hydroxyl radicals and lipid peroxy radicals. On the basis of activity shown further
investigation as separation, isolation and characterization of chemical constituents using HPTLC and
spectroscopic method will be done.
Keywords: Saccharum officinarum L., Inflorescence, Antioxidant activity, DPPH, Secondary
metabolites.cal drug delivery vehicle so as to achieve optimal localized concentration and prolonged
action.
AICTE Sponsored
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Tatyasaheb Kore College of Pharmacy, Warananagar
APIS MELLIFICA (HONEY) ENHANCES WOUND HEALING ACTIVITY OF TRIDAX PROCUMBENS, CURCUMA LONGA AND TERMINALIA CHEBULA
Salunkhe R.M.*; Rathod A. M., Jarag R. J., Pawar A.A., Ninganure S.S.
Department of Pharmacology, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur,
Maharashtra, India-416013 [email protected]:
Aim of our work is to prepare cream containing combination of juice of Tridax procumbens, aqueous
extract of Curcuma longa, dried ripe fruits of Terminalia chebula and Apis mellifica (honey). Cream was
evaluated for physical parameters and wound healing property by excision and dead space wound model.
The plants used were authenticated in botany department in Shivaji University, Kolhapur. Protocol
approved by IAEC BVCOP Kolhapur. The cream was prepared by using extract of fresh leaves of T.
procumbens, decoction of C. longa, decoction of fruit of T. chebula and A. mellifica. Four different
creams were formulated by different percentage of excipients. All formulations F-1, F-2, F-3 and F-4
were subjected for preliminary evaluation like PH, viscosity, spreadability and extrudability. The
prepared cream showed considerable difference response in both models as comparable to those of a
standard drug Nitrofurazone ointment (0.2% w/w NFZ) in terms of percentage closure, time of
epithelization, scar size. F-4 showed batter physical parameters for cream so it can use for wound healing
studies. The time required for complete epithelization in excision type of wound healing was 10.4 days in
test group compare to 17.4 days in control group and 15.8 days in base treated group. Scar size studies
indicated that the list scar size was found for formulation F-4 applied wound when compared with control
and base formulated treated groups. Histopathological studies for dead space wound model showed more
collagen content, fibroblast population, infiltrating cells and thickness of the tissue which confirm
enhancement wound healing activity of T. procumbens, C. longa, T. chebula with A. mellifica.
AICTE Sponsored
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Tatyasaheb Kore College of Pharmacy, Warananagar
COLORIMETRIC METHOD DEVELOPMENT FOR REPAGLINIDE USING FLOWER
EXTRACT OF DELONIX REGIA*Chavan D. S., Pishawikar S. A., Nale A. B., Garud S. H. , Khetmar S. S.Bharati Vidyapeeth College of Pharmacy, Department of Quality Assurance,
Near Chitranagari, Kolhapur (M.S.) 416013, India. Presenting author's E-mail:
Abstract:
There are natural plant pigments available in shoots, flowers, fruits or roots or plants that can be extracted
and used as acid base indicators. The use of natural dyes as acid-base indicators was first reported in 1664
by Sir Robert Boyle in his collection of essays “Experimental History of Colors”. It is found that natural
pigments obtained from plants have been used as pH indicators in titrometric analysis. Colorimetric
method using flower extract of Delonix regia was developed for estimation of Repaglinide based on
following principal - Anthocyanins are polyphenolic in nature. In tautomeric form of phenol in general is
going to be acidic, as electrons on oxygen are going to get delocalized in aromatic ring, making it easier +
for removal of H as H i.e. proton making it acidic. While amide due to presence of loan pair of electron
on nitrogen is going to show basic nature which contributes in formation of color-complex between
amide moiety present in drug and the color pigment obtained from Delonix regia Beer's law is followed
in the ranges from 5-40µg, Correlation Coefficient was found to be 0.9996. Result of accuracy and
precision shows that developed method is simple, precise and accurate.
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Tatyasaheb Kore College of Pharmacy, Warananagar
PRELIMINARY PHYTOCHEMICAL INVESTIGATION AND ANTIULCER ACTIVITIES OF PALMYRA PALM
A.V.Yadav, Madhuri Patil, Tejaswini Kakade*,Sana mokashi.
GIPER, Limb Satara Department of Pharmacognosy and Phytochemistry, Survey No. 990, Tal. &
Dis. Satara, pin code-4151002 Maharashtra India.
E-Mail:[email protected]
Abstract:
The fruit of Palmyra palm. (Borassus flabellifer Linn) belonging to family Areaceae reported to be useful
in treatment of gastric ulcer. In pharmacological screening the effect of different extracts (300mg/kg) p.
o. of fruits of Palmyra palm. was evaluated for their antiulcer profile by using aspirin Pylorus ligation and
ethanol induced models using albino rats. Various parameters like volume of gastric content, pH of
gastric content, free acidity, total acidity, ulcer index were determined. These results were comparable to
that of standard drug (Ranitidine). Treatment with aqueous extract of fruits of Palmyra palm
significantly showed the antiulcer activity as compared to control and other extracts. The
histopathological study of stomach also supported the above results. The phytochemical analysis carried
out revealed the presence of saponins, tannins, flavonoids, carbohydrates, amino acids and phenolic
compounds in the extracts.
Keywords: Anti-ulcer, Palmyra palm. Aspirin pylorus ligation, Ranitidine.
AICTE Sponsored
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rd th3 - 4 March, 2012
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Tatyasaheb Kore College of Pharmacy, Warananagar
FORCED DEGRADATION STUDY OF STRONTIUM RANELATE ACCORDING TO ICH
GUIDELINESAshwini S. Swami*, Sachin A. Pishawikar and Harinath N. More
Department of Pharmaceutical Chemistry, Bharti Vidyapeeth College of PharmacyKolhapur, Maharashtra 416 013. (INDIA) Email:[email protected]
Abstract:
Strontium ranelate (SR) is chemically designated as distrontium 5-[bis (2-oxido-2- xoethyl) amino]-
4-cyano-3-(2-oxido-2-oxoethyl) thiophene-2-carboxylate is used for treating osteoporosis as well as
postmenopausal osteoporosis. SR has a dual mode of action, both increasing bone formation and
decreasing bone resorption, which rebalances bone turnover in favour of bone formation and increases
bone strength. Forced degradation studies help facilitate pharmaceutical development as well in areas
such as formulation development, manufacturing, and packaging, in which knowledge of chemical
behaviour can be used to improve a drug product. The International Conference on Harmonization (ICH)
guidelines indicates that stress testing is designed to determine the intrinsic stability of the molecule by
establishing degradation pathway in order to identify the likely degradation products and to validate the
stability indicating power of the analytical procedure used. ICH guidelines 'stability testing of new drug
substances and products' Q1A(R2) and (Q1B) requires that stress testing should be carried out to
elucidate the substance. The present study involved the effect of acid, alkali, light, hydrogen peroxide
and temperature on the stability of SR. HPLC method has been developed to study the SR in pure form as
well as for degradation products. In the present work, degradation study using HPLC according to ICH
guides for strontium ranelate show that thermal treatment, UV light (up to 24 hrs) and alkali treatment
have negligible effect on the degradation of SR, whereas acidic and oxidative environment degrade the
API to significant extent.
Key words: osteoporosis, strontium ranelate, HPLC, forced degradation, ICH guidelines
AICTE Sponsored
Evolving Pharmaceutical Regulatory & Quality System FrameworkNational Level Conference on
rd th3 - 4 March, 2012
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Tatyasaheb Kore College of Pharmacy, Warananagar
PHYSICOCHEMICAL EVALUATION OF POORLY WATER SOLUBLE DRUG BY SOLID
DISPERSION TECHNIQUEIndapure Deepak D.*,Salunkhe Sharad B.,Shinde Sunita S.Shete Amol S.
Shri Vitthal Education & Research Institutes College of Pharmacy, Pandharpur. Tal: Pandharpur. Dist.: Solapur, Maharashtra, India, E-mail*: [email protected]
Abstract:
For an orally administered drug to get into systemic circulation, it must be sufficiently soluble to dissolve
in the gastro-intestinal fluid. Once the drug has dissolved it must then be sufficiently permeable to be
absorbed across the gastrointestinal wall. Poorly soluble drugs may benefit from formulation
approaches that overcome poor solubility and dissolution rate limited bioavailability. The enhancement
of oral bioavailability of poorly water soluble drugs remains one of the most challenging aspects of drug
development. Complexation, precipitation, adsorption, salt formation, particle size reduction, etc. have
commonly been used in industry to solubility of the drug, there are practical limitation with these
techniques the desired bioavailability enhancement may not always be achieved. Therefore formulation
approaches are being explored to enhance bioavailability of poorly water-soluble drugs. One such
formulation approach that has been shown to significantly enhance absorption of such drugs is to
formulate prepare solid dispersion using spray drying technique and solvent evaporation method.
Atorvastatin is a hypolipidemic drug, which is often administered orally. Atorvastatin exhibits very
slightly soluble and as a consequence it exhibits low bioavailibity after oral administration. Therefore
the improvement of Atorvastatin dissolution from its oral solid dosage forms is an important issue for
enhancing its therapeutic efficiency. The present study was enhancement of dissolution rate of poorly
water soluble drug. The solid dispersion was using porous carrier where Aerosil200 was selected as
adsorbent. By spray drying and solvent evaporation method the resultant complexes were evaluated for
drug content, dissolution rate, XRD, FTIR, DSC and SEM.
Keywords: Atorvastatin, Spray drying, solvent evaporation, solubility, etc.
AICTE Sponsored
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rd th3 - 4 March, 2012
P-39
EXTRACTION OF HIBISCUS ROSA SINENSIS LINN. AND IT'S USE IN ANALYTICAL
METHOD DEVELOPMENT
Jadhav D. V. * , Pishawikar S. A., Kalantre U. L. , Khabale R. S. , Raut J. N.
Bharati Vidyapeeth College of Pharmacy, Department of Pharmaceutical Chemistry,
Near Chitranagari, Kolhapur (M.S.) 416013, India.
Presenting author's E-mail: [email protected]
Abstract:
Purpose: There are different types of pigments obtained from plants such as Chlorophylls, Carotenoids,
Flavonoids, Phytochroms, Phycobilins, Betalains. These are used for coloring cloths, as food colorants
and in analysis as acid- base indicators. A successful attempt has been done for the first time to use them
in developing analytical spectrophotometric method for amide linkage containing drug. Methods: A
simple, accurate, sensitive and reliable method have been developed for the determination of
glybanclamide in bulk and pharmaceutical formulation. Using extract of Hibiscus Rosa Sinensis Linn. A
calibration curve was constructed at optimum experimental conditions using absorbance values at 605
nm versus concentration in the range of 5 to 40 µg/ml. High value of the correlation coefficient
(r=0.9996) indicates a good linearity and adherence of the method to Beer's law. Developed
method is validated using ICH QB2 guidelines Result: The absorbance of the pale yellow colored
complex was measured spectrophotometrically at 605 nm against reagent blank. From Calibration
graphs Beer's law is followed in range of 5 to 40µg/ml with correlation coefficient 0.9996, while the
LOD and LOQ was 0.27, 0.79 respectively. Conclusion: As use of extracted pigment is done for amide
group containing class of hypoglycemic agents, further study to develop simple, accurate, sensitive and
reliable Visible Spectrophotometric methods for different types of drug formulations can be done and
the methods can be used in carrying out routine analysis.
Keywords: Hibiscus Rosa Sinensis Linn, calibration curve, Beer's law, ICH QB2 guidelines.
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