vol - 4, issue - 4, supl – 1, sept 2013 issn: 0976-7908 tiwari et al

Vol - 4, Issue - 4, Supl – 1, Sept 2013 ISSN: 0976-7908 Tiwari et al

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PHARMA SCIENCE MONITOR

AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES

FORMULATION AND EVALUATION OF CEFADROXIL DISPRSIBLE

TABLET

Tiwari Bhupendra R.*, Rane Bhushan R., Pawar Sunil P.

P.S.G.V.P.M.’S College Of Pharmacy Department Of Pharmaceutics Shahada, Dist. Nandurbar, Maharashtra

ABSTRACT The demand for fast dissolving tablets has been growing during the last decade especially for the geriatric and pediatric patients. The main objective of this study was to formulate and evaluate the fast dissolving tablets of Cefadroxil using natural and synthetic superdisintegrants in different concentration. Various formulations were prepared by direct compression using different concentration of superdisintegrant i.e. croscarmellose,isolated Aloe vera powder , sago starch to achieve optimum release profile, disintegration time and hardness. Dibasic calcium phosphate was used as diluent/disintegrent and starch as binding agent. The initial compatibility studies between the drug and excipients were carried out using FTIR spectroscopy. The tablets were evaluated for weight variation, hardness, friability, in-vitro disintegration time, dispersiontime, percentage of drug release and Assay characteristics . Hardness indicated good mechanical strength around 5-7 kg/cm2 for all the batches. The results of in-vitro disintegration time indicated that the tablets dispersed rapidly in mouth within 50 secs. It was concluded that superdisintegrants addition technique is a useful method for preparing orally disintegrating tablets by direct compression method. Key words: Fast dissolving tablet, direct compression method, croscarmellose, isolated Aloe vera powder,Sago starch.

INTRODUCTION

An ideal dosage regimen in drug therapy of disease is the one which immediately attains

the desired therapeutic effect of drug in plasma and maintain it constant for entire

duration of treatment [1].

The drug may be administered by variety of routes of dosage forms. The oral route of

drug administration is most widely held and has been successfully used for conventional

delivery of drugs. It offers the advantage of convenience, ease of administration, greater

flexibility in dosage forms design, ease of production and cheap [1,30]. Hence it is adopted

wherever possible. It is probable that at least 90 % of all drug is used to produce systemic

effects are administered by oral route. [1, 12]

Cefadroxil is broad spectrum antibiotic having bacteriocidal activity against gram

positive as well as gram negative bacteria. It is white to off white powder, sparingly



soluble in water. It is reported to have biological half-life of 3 to 5 hour. So aim of the

present work is to enhance dissolution of the drug by formulating its fast disintegrating

tablets.[11]

Tablets

Tablets may be defined as solid pharmaceutical dosage forms containing drug substance

with or without suitable diluents and prepared by either direct compression or moulding

methods [1, 7].

Advantages of tablets

They are a unit dosage form and offer the greatest dose precision and the least content

variability.

Their cost is lowest of all oral dosage forms.

They are lightest and most compact of all oral dosage forms.

They are in general the easiest and cheapest to package and shipment of all oral

dosage forms.

They may provide the greatest ease of swallowing with the least tendency for “hang-

up” above the stomach. Especially when coated, provided that tablet disintegration is

not excessively rapid.

They lend themselves to certain special release profile products such as enteric or

delayed release products.

They are better suited to large scale production than other unit oral forms.

Tablets have the best combined properties of chemical, mechanical and

microbiological stability.[4,7]

Disadvantages of tablets

The major drawback for a tablet dosage form is that they are large in size.

Some drugs resist compression into dense compacts owing to their amorphous nature

or flocculent low density character.

Drugs with poor wetting, slow dissolution properties, intermediate to large dosage or

any combination of these features may be difficult or impossible to formulate and

manufacture as a tablet that will still provide adequate or full delay bioavailability.

Difficult for pediatric and geriatric patient swallow.[3,5]



Characteristics of an Dispersible tablets

Taste of medicament

As most of drugs are unpleasant, Dispersible drug delivery system usually contain the

medicament in the taste masked. Delivery systems dissolve or disintegrate in the

patient mouth, thus relaxing the active ingredients which come in contact with the

taste buds and hence taste masking of drug becomes critical for patient compliance.

Hygroscopicity

Several Dispersible Dosage forms are hygroscopic and cannot maintain physical

integrity under normal conditions of temperature and humidity which calls for

specialized product packaging.

Friability

In order to allow Dispersible tablets to dissolve or disintegrate in oral cavity they are

made of either porous or compressed into tablets with very low compression force,

which makes the tablet friable which are difficult to handle, often requiring

specialized peel-off blister packing.[13]

Desired criteria for Dispersible Tablets (DT)

Dispersible Tablets should

Not require water to swallow but it should dissolve or disintegrate in the mouth in

matter of seconds.

Be portable without fragility concern

Have pleasing mouth feel

Leave minimal or no residue in the mouth after oral administration

Exhibit low sensitivity to environmental conditions as humidity and Temperature

Allow the manufacture of tablet using conventional processing and packaging

equipment as low cost.[3,14]

Mechanism of drug release

The drug release from Dispersible tablet (DT) due to the action of super disintegrating

like croscarmellose sodium, Sago Starch, Alovera Powder in the formulation[8].

Superdisintegrants provides quick disintegration due to combined effect of swelling and

water absorption by the formulation as an effect of swelling of super disintegrates. The



wetted surface of the carrier increases, and promotes the wettability, dispersability of the

system and there by enhance the disintegration and dissolution [8].

Material and method :-

Cefadroxil should be gift sample from Lupinwith an analytical grade, crosscarmellose is

collected from Rosswell industry and other polymers are also analytical grade collected

[10, 16].

CHARACTERIZATION OF DRUG

UV spectrophotometric study

The stock solution of pure drug was prepared in distil water the solution was further

diluted (10µg/ml) and scanned between 263 nm by UV-visible spectrophotometer [10].

Preparation of calibration curve of cefadroxil

(i) Preparation of standard stock solution: Cefadroxil (10 mg) was first dissolved in of

distilled water (10 ml) (IP, 2007). This solution (10 ml) was then transferred to a 10 ml

volumetric flask. The volume of solution was made up by using the water to give a

solution of concentration 100 µg/ml [10].

(ii) Working stock solution: The standard stock solution was then appropriately diluted

with distilled water to obtain a series ofcefadroxil solution in the concentration range of

10-50µg/ml. The absorbance of all the solutions was measured against blank at 263 nm

using Single beam spectrophotometer. A standard plot of absorbance v/s concentration of

drug was plotted. This graph was used for the estimation of drug concentration in the fast

dissolving tablets for in-vitro drug release studies [10, 16].

Infrared spectrum

The Infrared absorption spectral analysis of drug was carried out by IR

spectrophotometer. Drug was mixed with IR grade KBr in 1:1 proportion and spectrum

was recorded. It was compared with the reference IR spectrum of cefadroxil [11].



PREFORMULATION STUDIES

Table 1:General Composition and Application of CefadroxilFast Dissolving Tablets

during Initial Studies.

Ingredients Concentration (%) Application Cefadroxil 250mg Active Pharmaceutical Ingredient Crosscarmillose 10-20 Super disintegrant Alovera powder 10-20 Super disintegrant Sago starch 10-20 Super disintegrant Dibasic calcium phosphate

2-40 Disintegrant

Starch 5-40 Binder, Disintegrant Magnesium stearate <1 Glidant Aerosil <1 Lubricant Flavour <0.1 Flavour

During preliminary studies, different formulations were prepared using various

concentrations of Superdisintegrants. This was done to aid in choosing the limits for

ingredients for further evaluation [6, 13]. Pre-optimized investigation containing different

concentration of superdisintegrants keeping the total tablet weight constant, are enlisted

in Table No. 2

Table 2:Different Concentration of Superdisintegrants employed during Initial Studies

for Tablets.

ING F1 F2 F3 F4 F5 F6 cefadroxil (mg) 250 250 250 250 250 250 Crosscarmellose 6% 12% Sago starch 6% 12% Aloe vera powder 6% 12% DCP 32% 26% 32% 26% 32% 26% Starch 11.2% 11.2% 11.2% 11.2% 11.2% 11.2% Mg. stearate 1mg 1mg 1mg 1mg 1mg 1mg Aerosil 1mg 1mg 1mg 1mg 1mg 1mg Pineapple flavor 0.1mg 0.1mg 0.1mg 0.1mg 0.1mg 0.1mg Total(mg) 375 375 375 375 375 375

*All ingredients are in mg.

EVALUATION OF POWDER BLEND

The blend was evaluated for following parameters.



Angle of repose

Angle of repose is defined as the maximum angle possible between the surface of pile of

powder and horizontal plane. The angle of repose was determined by the funnel method.

The accurately weighed powder was taken in a funnel. The height of the funnel was

adjusted in such a way that the tip of the funnel just touched the apex of the heap of the

powder. The powder was allowed to flow through the funnel freely onto the surface. The

diameter of the powder cone was measured. The angle of repose was calculated by

substituting the values of the base radius ‘r’ and pile height ‘h’ in the following equation

[5, 16]:

Therefore,

Where, = Angle of Repose

h = Pile height

r = Radius of pile

Table 3: Relationship between Angle of Repose () and Flowability

Angle of repose

() Flowability

< 20 Excellent

20-30 Good

30-34 Acceptable

> 40 Very poor

Bulk density

The powder sample, 25 g was accurately weighed and filled in a 100 ml graduated

cylinder and the powder was leveled and the unsettled volume was noted. The bulk

density was calculated by the formula [16]:



Tapped density

The tapped density was determined by mechanically tapping the measuring cylinder and

the volume was noted [5, 16]:

Compressibility Index

Percent compressibility can be determined from the formula [16]:

Table 4: Relationship between % Compressibility and Flowability.

% Compressibility Flowability

5-15 Excellent

12-16 Good

18-21 Fairly acceptable

23-35 Poor

33-38 Very poor

< 40 Very very poor

Hausner’s ratio

It provides an indication of degree densification which could result from vibration of feed

hopper. [16]

Lower Hausner’s ratio (<1.25) = Better flowability

Higher Hausner’s ratio (>1.25) = Poor flowability

PREPARATION OF FAST DISSOLVING TABLET

Fast dissolving tablets of Cefadroxilwere prepared using direct compression method

incorporating superdisintegrants. The Cefadroxil is passed through sieve no.80# & all

excipients are passed through sieve no.60# the Cefadroxilequivalent to 4 mg, &

excipients were mixed thoroughly in glass mortar using a pestle. Superdisintegrants, taste



masker & other excipients were incorporated in the powder mixture according to each

formulation in the table and finally magnesium stearate was added as lubricant. The

whole mixture is then passed through sieve no.60 twice. Tablets were prepared using 6.35

mm circular flat-beveled edge punch of the rotary tablet machine [CIP-

Machine12station]. Compression force was kept constant for all formulations & thickness

of the tablet was kept in 4.11±0.3mm. [10,15]

Table 5:Preparation of Final Formulation

ING

F1 F2 F3 F4 F5 F6

cefadroxil (mg) 250 250 250 250 250 250

Crosscarmellose 15 30

Aloe vera powder 15 30

Sago starch 15 30

DCP 80 65 80 65 80 65

Starch 28 28 28 28 28 28

Mg. stearate 1 1 1 1 1 1

Aerosil 1 1 1 1 1 1

Pineapple flavor 0.1. 0.1 0.1 0.1 0.1 0.1

Total(mg) 375 375 375 375 375 375

*All ingredients are in mg

EVALUATION OF TABLETS

Physical Evaluation of Tablets

I Dimension

The thickness and diameter of the tablets was determined using a Vernier caliper. Five

tablets from each type of formulation were used and average values were calculated [16].

II Hardness

Hardness was measured using the Monsanto hardness tester and measured the pressure

required to break diametrically placed matrix tablet, by a coiled spring.[13, 16]

III Friability



Roche Friabilator was used for the purpose, 10 tablets were weighed and placed in the

Roche friabilator test apparatus, the tablets were exposed to rolling and repeated shocks,

resulting from free falls within the apparatus. After 100 evolutions the tablet were de-

dusted and weighted again. The friability was determined as the percentage loss in weight

of tablets.[3, 16]

IV Weight variation test

According to method given in IP, weight variation test is done by 20 tablets were selected

randomly. By weighing tablets individually; calculating the average weight and

comparing the individual tablet weight to average weight variation tolerance. [4, 16]

Table 6: Specifications for Tablets as per IP

Sr No. Average Weight of Tablet % Deviation

1 80 mg or less 10

2 More than 80 mg but less that 250 mg 7.5

3 250 more 5

Wetting time

A piece of tissue paper folded twice containing amaranth powder on the upper surface

was placed in a small Petri dish (ID =6.5 cm) containing 6 ml of distilled water, a tablet

was put on the paper and the time required for formation of pink color was measured as

wetting time. Three trials for each batch were performed and standard deviation was also

determined. [8, 16]

Disintegration time

Initially, the disintegration time for fast dissolving tablets was measured using the

conventional test for tablets as described in the Pharmacopoeia. Tablets were placed in

the disintegration tubes and time required for complete disintegration, that is without

leaving any residues on the screen was recorded as disintegration time. [7, 16] A modified

method was also used to check the disintegration time. In about 3 tablets were tested from



each formulation. In disintegration time study tablet was put into the 100 ml distilled

water contained in beaker at the 37±2°C. Time required for complete dispersion of tablet

was measured as the disintegration time. [9, 16]

In-vitro dissolution studies

Following parameters were used for the dissolution study[16]:

1. Apparatus : IP dissolution apparatus (Type I)

2. Speed of the paddle : 50 rpm

3. Stirrer : Paddle type

4. Temperature : 37 °C + 0.5 °C

5. Dissolution medium : distilled water

6. Volume of medium : 900 ml

7. Sample withdraw at each time intervals : 1 ml

Sample volume of 1 ml was withdrawn at regular time intervals from a zone midway

between the surface of dissolution medium and the top of rotating paddle not less than 1

cm apart from the vessel wall. The volume withdrawn was replaced by fresh volume of

dissolution medium to maintain constant volume of medium. The filtered samples and

take second dilution from filter media withdraw make up volume up to 25 ml. and that

second dilution were analyzed spectrophotometrically at 263 nm using distilled water as a

blank. Drug content in dissolution sample was determined by calibration curve. [16]

HPLC METHOD FOR Cefadroxil

Prepare the following solutions freshly.

Test solution. Weigh and powder 20 tablets. Weigh accurately a quantity of the powder

containing about 0.2 g of cefadroxil, dissolve in phosphate buffer pH 5.0 by shaking for

30 minutes and dilute to 200.0 ml the same solvent. Filter the solution.

Reference solution. A 0.1 per cent w/v solution of cefadroxil RS in phosphate buffer pH

5.0.

Chromatographic system

a stainless steel column 25 cm x 4 mm, packed withoctadecylsilyl silica gel (3 to 10

μm),



mobile phase: a mixture of 96 volumes of phosphatebuffer pH 5.0 and 4 volumes of

acetonitrile,

flow rate. 1.5 ml per minute,

spectrophotometer set at 230 nm,

a 20 μl loop injector.

Inject the reference solution. The test is not valid unless the relative standard deviation

for replicate injections is not more than 2.0 per cent.Inject alternately the test solution and

the reference solution. [16]

Stability studies

Stability testing can be as long as two years process, it is time consuming and expensive.

Therefore it is essential to devise a method that will help rapid prediction of long-term

stability of dosage form. The accelerated stability testing is defined as the validated

method by which the product stability may be predicted by storage of the product under

conditions that accelerate the change in defined and predictable manner [3, 14].

Stability studies of the formulated tablets were carried out at 40 ± 1°c and 75 % relative

humidity in stability chamber for one month. Tablets were withdrawn at 7th,14th, 21th and

28th days intervals and evaluated for hardness, drug content, wetting time, in-vitro

disintegration time and in-vitro dissolution studies[1,16]. (ICH-Guidelines)

Preformulation study-

Melting point-

Active pharmaceutical ingredient calculate melting point by filling capillaryand check

there result should be accepted.[6,10]

Meltinng point- 198-199 (uncorrect)

Physical appearance- off white colour

Odour-odourless

Compatibility study

FT-IR study-



Figure 1:cefadroxil drug

Table 7: Cefadroxil IR Interpritaton

Spectra functional Group 805.31 phenyl ring substitution band 817.85 phenyl ring substitution band

1258.59 C-O group stretching

1337.66 C-N amine group bending

1600.01 N-H amine group stretching 1608.69 C=C bond in aromatic ring 1738.89-1608.69

Finger print region gives phenyl ring substitution overtone

1754.08 C=O Carboxylic group

3018.7 N-H primary amine group bending

3031.23 aromatic ring substitution

Figure 2: cross carmellose



Table 8: Cross carmellose IR interpritation

Spectra functional Group

579.87 C-Br stretching

587.95 C-H alkyne bending

740.88 C-H phenyl ring substitution bending

953.83 C-H out of plane

1143.83 C-H stretching

1457.27 C-H deff. Alkyne Bending

1590.36 NH2 amine

2390.36 -NH- stretching

2356.06 -NH2- stretching

2963.13 C-H alkane Stretching

3025.45 C-H aromatic ring stretching

3178.79 N-H secondary amine Stretching

3367.22 O-H stretching alcohol

Figure 3: cefadroxil with crosscarmellose

Table 9: Cefadroxil With crosscarmellose IR interpretation

Spectra functional Group 579.87 C-Br stretching 587.95 C-H alkyne bending 740.88 C-H phenyl ring substitution bending 805.31 phenyl ring substitution band 817.85 phenyl ring substitution band 953.83 C-H out of plane 1143.83 C-H stretching 1258.59 C-O group stretching 1337.66 C-N amine group bending 1457.27 C-C stretching



1590.36 C-H deff. Alkyne Bending 1600.01 N-H amine group stretching 1608.69 C=C bond in aromatic ring

1738.89-1608.69 Finger print region gives phenyl ring substitution overtone

1754.08 C=O Carboxylic group 2356.06 NH2 amine 2963.13 C-H alkane Reaching 3018.7 N-H primary amine group bending 3031.23 aromatic ring substitution 3178.79 N-H secondary amine Stretching 3367.22 O-H stretching alcohol

Figure 4 : Aloe vera Powder

Table 10: Aloe vera Powder IR interpretation


1067.64 C-O stretching gives alcohol,ether,carboxylic group

1150.58 C-N stretching

1218.09 C-O stretching gives carboxylic group

1303.92 NO2 stretching

3256.91 C-H alkyne stretching



Figure 5: Cefadroxil with alovera

Table 11: Cefadroxil with alovera IR interpretation

Spectra functional Group 805.31 phenyl ring substitution band 817.85 phenyl ring substitution band 1067.64 C-O stretching gives alcohol,ether,carboxylicgroup 1150.58 C-N stretching 1218.09 C-O stretching gives carboxylic group 1258.59 C-O group stretching 1303.92 NO2 stretching 1337.66 C-N amine group bending 1600.01 N-H amine group stretching 1608.69 C=C bond in aromatic ring 1738.89-1608.69 Finger print region gives phenyl ring substitution overtone 1754.08 C=O Carboxylic group 3018.7 N-H primary amine group bending 3031.23 aromatic ring substitution 3256.91 C-H alkyne stretching

Figure 6: Sago Starch



Table 12: Sago Starch IR interpretation


832.71 C-H bending phenyl ring substitution

996.27 C-H alkene Bending

1075.35 C-N stretching Amine

1337.98 C-N Amines

1634.13 NO2 stretchingasymmetric

1662.09 O-H stretching alcohol, phenol

2885.6 C=O stretchingcarboxylic group

3250-3550 stretching Phenol

Figure 7: cefadroxil with sago starch

Table 13: cefadroxil with sago starch IR interpretation


805.31 phenyl ring substitution band

817.85 phenyl ring substitution band

832.71 C-H bending phenyl ring substitution

996.27 C-H alkene Bending

1075.35 C-N stretching Amine

1258.59 C-O group stretching

1337.66 C-N amine group bending

1337.98 C-N Amines

1600.01 N-H amine group stretching

1608.69 C=C bond in aromatic ring 1738.89-1608.69

Finger print region gives phenyl ring substitution overtone

1754.08 C=O Carboxylic group

2885.6 C=O stretchingcarboxylic group

3018.7 N-H primary amine group bending

3031.23 aromatic ring substitution

3250-3550 stretching Phenol



IR graph-from above IR spectrum shows that above polymer shows no inter action with

active drug. Cefadroxil was subjected to Drug- Excipient compatibility studies with

various excipients like croscarmellose sodium, aloe vera powder, sago starch, all tablet

excipient. The mixture has shown no colour change. Hence no interaction between drug

and excipient. [16]

Report

When FTIR spectrum of Cefadroxil (pureDrug), excipients and optimized

formulation of Cefadroxil tablets (F2) were compared, there were no major changes in the

position spectrum. It indicates the absence of physical and chemical interaction among

active component Cefadroxil and excipients. So, the orodispersible tablet of Cefadroxil

has no interaction with added excipients. [8, 16]

Calibration curve –

Table 14: Calibration curve

Figure 8: Calibration curve

Concentration Absorbance 00 0

10 0.287 20 0.571 30 0.847 40 1.095 50 1.365



Table 15: Calibration curve result

Parameter Result Calibration curve Cefadroxil 1mole/cm 263nm Eqn calibration curve Y=MX+C Regration eqn Y=0.027X Slope 0.027 Intercept 0.0

FORMULATION Evaluation-

Table 16: Evaluation of Blend

Formulation Code

Angle of repose (θ)

Bulk Density

(gm/cm3)

Tapped Density

(gm/cm3)

Carr’s Index (%)

Hausner’s ratio

H1 28.94±0.93 1.21±0.09 1.39±0.10 13.15±1.00 1.15±0.01

H2 26.70±0.87 1.29±0.04 1.50±0.06 13.78±1.22 1.16±0.02

H3 29.03±0.33 1.30±0.05 1.49±0.07 12.75±1.18 1.15±0.02

H4 29.53±1.33 1.19±0.06 1.38±0.06 13.99±0.63 1.16±0.01

H5 28.28±0.88 1.37±0.06 1.57±0.07 12.76±0.82 1.15±0.01

H6 27.03±0.38 1.25±0.09 1.45±0.10 13.99±0.31 1.16±0.00

The prepared blend were evaluated for the blend property like angle of repose, bulk

density, tapped density, Carr’s index, Hausner’s ratio. Results obtained are shown in

above table 16

The below results predict that, angle of repose less than 30° gives the excellent flow

property to the powder blend. Carr’s index is in the range of 10-20% which is considered

as excellent compression property. Hausner’s ratio value is also lower. Similarly, the bulk

density and tapped values was found to be near to one. Hence, have good flow property.

All these results indicated that, the powder blends possess satisfactory flow and

compressibility properties. [8,16]

Preparation of tablets

Fast dispersible tablets containing 250 mg of Cefadroxil were prepared by direct

Compression method and the various formulae used in the study are shown in Table. All

the ingredients without magnesium stearate and aerosil were mixed uniformly followed

by addition of magnesium stearate and Aerosil. The prepared powder blend was



evaluated for various parameters like bulk density, tapped density, angle of repose,

compressibility index and Hausner ratio. After evaluation of powder blend the tablets

were compressed with a sixteen‐station rotary punch‐tableting machine (clit single rotary

compression machine.) using 9 mm oval shape punches set. [16]

In-Vitro Evaluation Of Tablet

Tablet 17: Evaluation of tablet

Parameter F1 F2 F3 F4 F5 F6

Thickness 4.12±0.01 4.12±0.00 4.13±0.01 4.12±0.02 4.10±0.02 4.22±0.16

Weight variation passes passes passes Passes passes Passes

Friability 0.54±0.00 0.50±0.07 0.67±0.14 0.54±0.00 0.58±0.08 0.63±0.08

Hardness(kg\cm2) 5±0.0 5±0.6 6±1.2 7±0.6 6±1.2 5±0.6

Disintegration time(sec.)

30.67±0.5 17.67±2.52 31.00±2.65 25.33±8.08 24.00±2.00 23.67±4.5

Dispersion time(sec.)

47.00±6.2 28.00±8.00 47.33±7.02 42.33±7.23 39.67±3.06 46.00±2.0

% drug release 101.48 103.9 102.22 103.33 103.07 103.33

% Assay 100.68 96.30 96.81 101.59 101.57 97.51

From the above formulation prepared six batches are prepared which shows respective

thickness was found to be 4.10-4.22 ranges, friability was ranges to be 0.5.-0.7,hardness

was found to be 5-7 kg/cm2,disintegration time was found to be 15-40 sec.,dispersion

time was 25-50 sec.,% drug release found to be 100-104%,%assay was found to be 95-

102% from the above result we can select F2 formulation as optimize batch so good

result than other formulation.[13]



Table 18: Cumulative Percentage of Drug Release

Cumulative percentage drug release

Time F1 F2 F3 F4 F5 F6

2 87.04±0.37 88.02±0.77 86.79±0.56 87.78±0.37 87.04±0.9 87.28±0.21

4 88.02±0.77 90.74±1.34 87.65±0.77 88.77±0.56 88.52±1.43 88.52±0.00

6 87.65±0.57 93.46±4.13 88.27±0.56 90.25±0.56 89.88±0.21 90.37±0.00

8 89.01±0.57 95.93±5.53 89.01±0.5 91.36±0.42 91.60±0.42 93.09±0.43

10 90.12±0.57 97.28±4.97 90.86±1.82 93.95±1.71 93.33±0 94.44±0.64

12 91.48±1.34 98.40±4.06 93.09±3.74 96.05±2.1 94.81±1.74 96.30±0.64

14 91.60±2.14 100.12±2.63 93.83±4.76 97.78±3.20 97.53±1.49 98.27±1.71

16 92.59±1.96 101.85±1.92 94.69±5.57 99.01±2.87 98.89±0.61 100.25±2.14

18 93.58±1.86 102.96±0.00 95.93±5.14 101.11±1.3 100.37±0.6 101.23±1.7

20 95.43±2.2 103.52±0.7 96.79±4.4 101.60±1.8 100.62±0.9 101.60±1.0

22 97.04±1.9 103.89±0.2 98.02±3.6 101.73±1.9 101.11±1.6 101.98±1.5

24 98.15±2.2 103.89±0.2 99.26±2.6 101.73±1.9 101.48±2.3 101.98±1.5

26 99.01±2.2 99.38±2.5 101.48±2.31 101.98±1.5

28 99.01±2.26 101.48±2.31

30 99.01±2.26

Figure 9:Percentage of drug release



Percentage Assay by HPLC method

As Per IP prepare solution of phosphate buffer 5,and prepare a Reference solution as well

as test solution and calculate area peak by the HPLC software brown, Japan. For that first

take 3 reference solution peak ,calculate their average and used for al bathes. HPLC peak

area as well as graph shown below from that we can calculate percentage assay[12]

Figure 10: HPLC For Standard 1

Figure 11: HPLC For Standard 2



Figure 12 :HPLC For Standard 3

Reference solution area peak

Average area was found to be 7914591.444

Figure 13: HPLC For F1 batch

% Assay =100.68



Figure 14:HPLC for F2 Batch

% Assay = 96.30

Figure 15:HPLC For F3 Batch

%Assay = 96.81

Figure 16:HPLC For F4 Batch

% Assay =101.59

Figure 17: HPLC For F5 Batch

% Assay = 101.57



Figure 18: HPLC For F6 Batch

% Assay = 97.51

Stability study-

This result was noted after 45 days of formulation and shows good result of formulation.

Table 19: Stability study

Parameter F1 F2 F3 F4 F5 F6 Thickness 4.13±0.01 4.11±0.00 4.12±0.01 4.12±0.02 4.10±0.02 4.14±0.16

Weight variation passes passes passes Passes passes Passes

Friability 0.4±0.00 0.5±0.07 0.76±0.14 0.5±0.00 0.7±0.08 0.5±0.08

Hardness(kg\cm2) 5±0.0 5±0.6 6±1.2 7±0.6 5±1.2 5±0.6

Disintegration time(sec.)

29.58±0.5 19.67±2.52 36.00±2.65 40.33±8.08 27.00±2.00 26.67±4.5

Dispersion time(sec.)

51.00±6.2 28.09±8.00 54.33±7.02 52.03±7.23 36.67±3.06 46.00±2.0

% drug release 99.48 101.04 96.22 98.24 97.07 98.96

CONCLUSION

The present work led to the development of dispersible tablets for oral administration

comparing a therapeutically effective amount of cefadroxil by direct compression method

using various super disintegrating agents that disperse in oral cavity up to 20 seconds

with or without the drinking water, had a pleasant mouth feel and this and improved

patient compliance, particularly for those who have difficulty in swallowing (such as

pediatric and geriatric patient). Formulation F2 containing crosscarmellose (12%) with

appropriate amount of other excipients was considered to be the optimized formulation

with desired drug release (104.07%) within 20 minutes. Dispersible tablet shows all



parameter like hardness,friability,disintegration time, dispersion time,thickness as5,

0.50sec., 17.67, 28.00, 4.12respectively.

The stability study was done for 3 months all parameters such as hardness, weight

variation, thickness, friability, disintegration time, and in-vitro dissolution studied at the

end of every month, the results shows that no significant changes in that parameters.

ACKNOWLEDGEMENT

The authors acknowledge the P.S.G.V.P. Mandala’s College of Pharmacy, Shahabadfor

support to carry out the research work and Adora Pharma manufacturer,

Aurangabadproviding facilities to carry out the research work andprovide theall research

project help.

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For Correspondence: Bhupendra R. Tiwari Email: [email protected]

vol - 4, issue - 4, supl – 1, sept 2013 issn: 0976-7908 tiwari et al

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