business unit performance materials innovative excipients
TRANSCRIPT
Innovative excipients for the pharmaceutical industry
Business Unit
Performance Materials
Think Asia. Think DKSH.
Business LinePharmaceutical IndustryIndia
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Ashland Inc., USA
Products Characteristics Applications
Crospovidone
Polyplasdone XL (Type A) Conventional particle size with 110-140 microns
Used as a disintegrant for IR tablets
Polyplasdone XL-10 (Type B) Fine particle size with 25-40 microns Used as disintegrant for ODT and provides smooth mouth feel
Polyplasdone INF-10 (Type B) Very fine particle size grade Used as suspending agent in oral suspension and also used as disintegrant for pellets and MUPS
Polyplasdone Ultra (Type A) Low peroxide content 30 ppm with conventional particle size of 110-140 microns
Used as a disintegrant for IR tablets containing oxidation sensitive API
Polyplasdone Ultra-10 (Type B)
Low peroxide content 50 ppm with fine particle size of 25-40 microns
Used as a disintegrant for ODT containing oxidation sensitive API
Povidone/PVP
Grade K value viscosity Weight average molecular weight
Applications
Plasdone K-12 10.2-13.8 4,000 Used as binder and vehicle for soft gelatin capsules and for drug solubilization
Plasdone K-17 16.0-17.5 10,000
Plasdone K-25 24.0-26.0 34,000 Used as a binder for wet/dry granulation in tablets, capsules, pellets and powders
Plasdone K-29/32 29.0-32.0 58,000
Plasdone K-90 85.0-95.0 1,300,000
Plasdone C 12 10.2-13.8 4,000 Pyrogen free grade used as solubliser and suspension stabiliser for parenteral products
Plasdone C17 16.0-17.5 10,000
Plasdone C 30 29.0-32.0 58,000
Copovidone
Grade K value viscosity Weight average molecular weight
Applications
Plasdone S-630 25.0-31.0 47,000 • Used as a dry binder aid in granulation and matrix polymer for solid dispersion formulations• It is used to enhance solubility of poorly water soluble drugs through melt extrusion or spray dried solid dispersions
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Ashland Inc., USA
Products Characteristics Applications
Hydroxypropyl Cellulose (HPC)
Grade Typical Brookfield Viscosity (mPa.s)
Weight average molecular weight
Applications
Klucel HF, HXF Pharm 1500-3000 1,150,000 Used as a release retardant in CR tablets and thickener for semisolids
Klucel MF, MXF Pharm 4000-6500 850,000 Used as a release retardant in CR tablets and binder for solid oral formulations
Klucel GF, GXF Pharm 150-400 370,000
Klucel JF, JXF Pharm 150-400 140,000
Klucel LF, LXF Pharm 75-150 95,000 • Conventional grades used as binder for wet granulation and fine particle grade is used for dry granulation and direct compression• Used in film coating system• Low molecular weight Klucel used in melt extrusion
Klucel EF, EXF Pharm 300-600 80,000
Klucel ELF Pharm 150-225 40,000
X: Stands for fine particles sizes
Hydroxypropyl Methylcellulose/Hypromellose (2208 substitution/K Type)
Grade Nominal Viscosity (mPa.s)ª
Weight average molecular weight
Applications
Benecel K 100 LV PH PRM ** 80-120 164,000 • These grades can be used in single or in combination intragranularly or extrgranularly as hydrophilic release retardant for CR tablets• DC grades are used as direct compressible release retardant agent
Benecel K250 PH PRM ** 200-300 200,000
Benecel K750 PH PRM ** 562-1050 250,000
Benecel K1500 PH PRM ** 1125-2100 300,000
Benecel K4M Pharm * 2700-5040 400,000
Benecel K4M PH DC 2700-5040 400,000
Benecel K15 M Pharm* 13500-25200 575,000
BenecelK15 M PH DC 13500-25200 575,000
Benecel K35M Pharm* 26250-49000 675,000
Benecel K100M Pharm* 75000-140000 1,000,000
Benecel K100M PH DC 75000-140000 1,000,000
Benecel K200M Pharm* 150000-280000 1,200,000
Benecel K100 M XR 75000-140000 1,000,000 Enhanced powder flow and tablet compaction at high speed tableting operations
*CR grades available, ** Only CR grades available, DC: Direct compressible grade, a: NF/EP/JP viscosity method
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Ashland Inc., USA
Products Characteristics Applications
Methyl Cellulose
Grade Nominal Viscosity (mPa.s)ª Applications
Benecel A15 LV PH PRM 13-18 Used as granulating agent and thickener. Low viscosity Benecel A15-LV is commonly used in drug layeringBenecel A15C Pharm 1312-2450
Benecel A4 M Pharm 2700-5040
a: NF/EP/JP viscosity method
Methylhydroxyethyl Cellulose
Grade Nominal Viscosity (mPa.s)ª Applications
Benecel ME 233 P Pharm 3100-5700 Used as a binder in solid orals and as rheology modifier in liquid orals and topicals
a: NF/EP/JP viscosity method
Ready-Mix Coating System
Aesthetic
Aquarius Preferred HSC Cellulose polymers High-solids coatings
Aquarius Preferred HSP Copovidone with cellulosic polymers High-solids coatings for significant improvements in adhesion and sprayable solids
Aquarius Prime Cellulosic polymers (HPMC & HPC), sprayable at 10-15%w/w solids
Good film strength and moderate film adhesion
Aquarius Prime LS HPMC and lactose based film coating systems, sprayable at up to 20%w/w solids
Significant improvement in film adhesion
Functional
Aquarius Preferred MG A label friendly composition consists of natural wax, water based coating systems, sprayable up to 17.5%w/w solids, non tacky perforamce
The coating system reduces moisture uptake (moisture guard)
Aquarius Preferred TG Coating system masks the unpleasant taste of tablet
Aquarius Preferred OG Coating system masks the unpleasant odour of tablet
Aquarius Control ENA Methacrylic acid-ethyl acrylate copolymer Delayed-release (enteric) coatings, stable release profiles over a wide pH range
Aquarius Control SRX Solvent dispersible ethylcellulose coatings potentially modified with HPMC as a pore former
Sustained release coatings with no curing required
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Ashland Inc., USA
Products Characteristics Applications
Sodium CMC/Carmellose Sodium
Grade Viscosity (mPa.s) Degree of substitution
Applications
Blanose 7H4XF PH 2500-4500 0.7 • Used as a thickener/ viscosity modifier in liquid orals/semi-solids• Also used as a binder and release retardant for CR tablets
Blanose 7HF PH 1500-2500
Blanose 7H3SF PH 1000-2800
Blanose 7HOF PH 1000-2800
Blanose 7M31F PH 1500-3100
Blanose 7M8SF PH 200-800
Blanose 7MF PH 400-600
Blanose 7M1F PH 50-100
Blnaose 7LP EP 25-50
Blanose 9H4XF PH 2500-4500 0.9
Blanose 9M31F PH 1500-3100
Blanose 9M20F PH 1200-1800
Blanose 12M31P 1500-3100 1.2
Blanose 12M8P 400-800
Sodium CMC/Carmellose Sodium
Grade Viscosity (mPa.s) Degree of substitution
Applications
Aqualon 7HF PH 1500-3000 0.7 • Used as a thickener/ viscosity modifier in liquid orals/semi-solids• Also used as a binder and release retardant for CR tablets
Aqualon 7H3SF PH 1000-2800
Aqualon 7HOF PH 1000-2800
Aqualon 7MF PH 400-800
Aqualon 7M8SF PH 400-800
Aqualon 7LF PH 25-50
Aqualon 7L2P 50-200
Aqualon 9M31F PH 1500-3100 0.9
Aqualon 9M8F PH 400-800
Aqualon 12M31P 800-3100 1.2
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Ashland Inc., USA
Products Characteristics Applications
Sodium CMC For parenteral and ophthalmic application
Grade Viscosity (mPa.s) Degree of substitution
Applications
Aqualon 7MF PH BET 400-800 0.7 High purity grade of sodium CMC, produced and tested to meet low levels of bioburden and endotoxinAqualon 7LF PH BET 25-50
Aqualon 7L2P BET 50-200
Ethyl Cellulose
Grade Viscosity (mPa.s)ª Weight average molecular weight
Applications
Aqualon EC T10 Pharm 8-11 75,000 Used as binder in direct compression due to its good flow and compactibility
Aqualon EC N7 Pharm 6-8 65,000 Used for coating powder, granules and pellet to control drug release also used in seal coating
Aqualon EC N 10 Pharm 8-11 75,000
Aqualon EC N14 Pharm 12-16 120,000
Aqualon EC N 22 Pharm 18-24 140,000
Aqualon EC N 50 Pharm 40-52 160,000
Aqualon EC N 100 Pharm 80-105 215,000
a: Viscosity measured in 80:20 mixture of toluene/ethanol at 5% solution concentration
Hydroxyethyl Cellulose
Grade Typical Brookfield Viscosity (mPa.s)
Weight average molecular weight
Applications
Natrosol 250 HHX/HHW Pharm
3500-5500 1,300,000 • Used as a viscosity modifier in liquid orals and semi-solids• Also used as release retardant in CR tablet
Natrosol 250 HX Pharm, H Pharm
1500-2500 1,000,000
Natrosol 250 M Pharm 4500-6500 720,000
Natrosol 250 G Pharm 250-400 300,000
Natrosol 250 L Pharm 75-150 90,000
X: Fine particle size and W: Superfine particle size
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Ashland Inc., USA
Products Characteristics Applications
Hypromellose Acetate Succinate/HPMCAS
Grade Nominal Viscosity (mPa.s)ª
Weight average molecular weight
Applications
Aquasolve L 2.4-3.6 114,700 Used as an enteric coating agent and as a solubliser for poorly soluble API in spray dried solid dispersions and hot melt extrusionAquasolve M 2.4-3.6 103,200
Aquasolve H 2.4-3.6 75,000
a: NF/EP/JP viscosity method
Native Cyclodextrin
Cavamax W6 Pharma a-cyclodextrin with molecular weight 973 • Grade for oral application • Used to enhance solubility of poorly soluble drugs in solid dispersions • Used to mask unpleasant odour/taste of API and its stabilization
Cavamax W7 Pharma b-cyclodextrin with molecular weight 1135
Cavamax W8 Pharma g-cyclodextrin with molecular weight 1297
Hydroxypropyl-b and Hydroxypropyl-g-Cyclodextrins
Cavasol W7 HP Pharma Hydroxypropyl b-cyclodextrin with molecular weight 1410 and typical degree of substitution 4.1-5.1
• Grade for oral application• Used to enhance solubility of poorly soluble drugs in solid dispersions • Used to mask unpleasant odour/taste of API and its stabilizationCavasol W8 HP Pharma Hydroxypropyl g-cyclodextrin with molecular
weight 1574 and typical degree of substitution 3.5-4.9
Cavitron W7 HP5 Pharma Hydroxypropyl b-cyclodextrin with molecular weight 1410 and typical degree of substitution 4.1-5.1
• Grade for Parenteral application• Used to increase solubility of drug in parenterals
Cavitron W7 HP7 Pharma Hydroxypropyl b-cyclodextrin with molecular weight 1520 and typical degree of substitution 6.0-8.0
N-Methyl-2 Pyrrolidone (NMP)
Pharmasolve Viscosity 1.7 Cp, crystal inhibitor Used as a solubility enhancer in parenteral applications and veterinary medicine
Macco, Canada
Products Characteristics Applications
Organic mineral salts ofCalcium, potassium, ammonium, magnesium, sodium, zinc
Organic mineral salts Pharma, biopharma, infusion and dialysis solutions, chemical specialities
Glycerophosphates, glucohep-tonates, lactates, gluconates, citrates, citric acid
Organic mineral salts Pharma and nutrition
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Grace davison Chemicals, USA
Products Characteristics Applications
Silicon Dioxide
Syloid G 156 FP Large internal surface area, intra particle porosity with a medium pore volume. Particle size 4.6-5.8 µm, pore volume 1.2 ml/g
Exclusively as a glidant in solid oral dosage forms, highly adsorptive as carrier for liquids
Syloid XDP 3150 Large internal surface area with a high pore volume. Particle size 120-170 µm, Pore
2volume 1.7.ml/g, BET 320 m /g, oil adsorption 300 g/100g
Superior adsorptive capacity as carrier for liquids and liquid pharmaceutical actives
Silsol 6035 Engineered advanced silica technologies generate high pore volume which facilitates voids for entrapment. Avg. particle size 37 µm with bulk density 420 g/l
Formulate a large class of poorly soluble acive ingredients and compounds (solubility enhancer)
Symega Flavours, India
Products Characteristics Applications
Natural flavor, nature identical flavor, synthetic flavor
Flavor (Liquid Form) Equipped process capacity for generation of customized flavors
Flavoring agent for liquid orals
Spray Dried Flavor (Powder Form)
Flavoring agent for ODT, effervescent powder, granules and tablets
Bitter Taste Masker Unique combinations for bitter taste masking
Functional Flavor Delivery of nutraceutical actives for gut health
Stepan, USA
Products Characteristics Applications
Sodium Lauryl Sulphate
Stepanol WA 100 Oral grade, Needle like crystals Used as a wetting agent in tablets, liquid orals and semisolids
Stepan Mild SL3-BA
Disodium Laureth Sulfosuccinate
Stepan Mild SL3-BA • Viscosity 200 CPS• pH 6.0
Cleansing agent used in manufacturing of creams and lotions
Stepl CS 270C
Sodium Lawveth Sulfate
Steol CS-270C pH 7.0-9.0 Foaming property, used in manufacturing of skin care formulations
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Solvay, (France and Thailand)
Products Characteristics Applications
Sodium Carbonate IPH
Sodium Carbonate IPH Particle size less than 500 µm Alkalizing property, used in solid oral and liquid oral formulations
Sodium Bicarbonate
BICAR EXC-0/13 Particle size less than 200 µm Alkalizing property, used in solid oral and liquid oral formulations
BICAR EXC-27/50 Particle size less than 500 µm
Kimica Corporation, Japan
Products Characteristics Applications
Alginic acid
Kimica Acid SN Complying NF Used as dis-integrants in anti-reflux and effervescent tablets
Kimica Acid SEB Complying EP and BP
Sodium Alginate Ultra low viscosity type
Grade Viscosity at 10% solution (mPa.s) Applications
Kimica Algin ULV-L3 20-50 • Used as gelling agent in anti-reflux suspensions and effervescent tablets• Gastric reflux preventionKimica Algin ULV-L5 30-60
Kimica Algin ULV-1 100-200
Kimica Algin ULV-3 300-400
Kimica Algin ULV-5 500-600
Sodium Alginate standard type
Grade Viscosity at 1% solution (mPa.s) Applications
Kimica Algin IL-2 20-50 • Used in controlled release formulations• Gastric coating agent
Kimica Algin IL-6 40-80
Kimica Algin I-1 100-200
Kimica Algin I-3 300-400
Kimica Algin I-5 500-600
Kimica Algin I-8 800-900
Kimica Algin I-S 900-1000
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Kimica Corporation, Japan
Products Characteristics Applications
Sodium Alginate Ultra high viscosity type
Grade Viscosity (mPa.s) Applications
Kimica Algin LZ-2 1000-1500 Used in controlled release formulations
Sodium Alginate high stiffness gelation type
Grade Viscosity (mPa.s) Applications
Kimica Algin ULV-1G 100-200 (10%) Used in controlled release formulations
Kimica Algin ULV-5G 300-700 (10%)
Kimica Algin IL-6G 30-60 (1%)
Kimica Algin I-1G 100-200 (1%)
Kimica Algin I-3G 300-400 (1%)
Propylene Glycol Alginate
Standard Type Propylene Glycol
Grade Viscosity at 1% solution (mPa.s) Applications
Kimiloid LVC 70-170 Used as a suspending agent, emulsion stabilizer, plasticizer and binder
Kimiloid HVC 200-600
High Esterification Type Propylene Glycol Alginate
Grade Viscosity (mPa.s) Applications
Kimiloid AB 13-40 Used as a suspending agent, emulsion stabilizer, plasticizer and binder
Kimiloid LLV 15-35
Kimiloid NLS-K 30-60
Kimiloid LV 60-100
Kimiloid MV 100-150
Kimiloid HV 150-250
Potassium Alginate
Kimica Algin K – Dental impression material
Calcium Alginate
Kimica Algin Ca – Wound dressing
Ammonium Alginate
Kimica Algin NH – Dental impression material
Magnesium Alginate
Kimica Algin Mag – Anti reflux suspensions for infants
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Precheza A.S., Czech Republic
Products Characteristics Applications
Titanium Dioxide
Pretiox AV 01 PhG Gluten free, Melamine free, Genotoxic free, water soluble substances 0.25-0.50%
Used as an opacifier in capsul shell and Color coating System
Elementis, United Kingdom
Products Characteristics Applications
Talc/Hydrated Magnesium Silicate
Microtalc Pharma 50 Standard particle size grade 12-50 µm Used as a anti-adherant for tablets
Microtalc Pharma 30 Fine particle size with 8-26 µm
Microtalc Pharma 8 Very fine particle with 2.2-9 µm Used for drug layering in pellets and also used as antitacking agent in film coating system
JMC Corporation, Korea
Products Characteristics Applications
Sodium Saccharin
Sodium Saccharin, 15% moisture
Use of high purity raw material OTSA (Ortho-Toluene sulfonamide) facilitates for efficient control on generation of impurities
Used as a sweetner in powder, granules, ODT and liquid orals
Sodium Saccharin, 6% moisture
Daicel Corporation, Japan
Products Characteristics Applications
Co-Processed Excipient
GNF D 211 • Co-processed excipient: D-Mannitol, Microcrystalline Cellulose, Crospovidone, Carboxymethyl Cellulose • Differentiation based on particle size 100 µm and 150 µm
• Co-processed excipient for ODT (direct compression) • Used in troubleshooting of content uniformity issue • Used in low dose API's formulations
GNF D 215
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NOF Corporation, Japan
Products Characteristics Applications
Polysorbates, PEGs, Phospholipids
Polysorbate 20 Polyoxyethylene sorbitan monolaurate/ Polysorbate 20
Used as a solublizer in parenterals
Polysorbate 80 GS Polyoxyethylene Sorbitan mono-oleate/Polysorbate 80, low oxidation and degradation potential, low incidence of allergy
Used as a solublizer in parenterals
Polysorbate 80 HX2 High purity solubilizer for parenterals
PEGs
Activated PEGs Methoxy-polyethylene glycols (mPEGs), low diol contents, molecular weights ranging from 2kDa to 80kDa, PEG functional derivatives based on chemical conjugation
• Used for targeted drug delivery system• Gene and nucleic acid delivery • pH trigger release dependent drug delivery systems
Phospholipids Lipids
Phospholipids from natural sources
HSPC (Hydrogenated Soyabean Phosphatidylcholine)
• Used in liposomes • Use in lipid based drug delivery systems for onco (anti-cancer) molecules • pH responsive gene delivery and nucleic acid delivery systems • Tumor targeted gene delivery
EPC (Egg Phosphatidylcholine)
HEPC (Hydrogenated Egg Phosphatidylcholine)
Egg Sphingomyelin/Milk Sphingomyelin
Synthetic Phospholipids Different Derivatives of Phosphocholine
Different Derivatives of Phosphatidylglycerol
Different Derivatives of Phosphatidic acid, Sodium Salts
Different Derivatives of Phosphotidylethanolamine
Different Derivatives of Phosphatidylserine
Lipidure • Methacryloyloxyethyl Phosphoryl Choline• Ulta high hydrophilicity• Suppressing adhering proteins, suppressing adhering cells• Decreases the level of lactate dehydrogenase (LDH), Biocompatible material
• Dry eye score improvement • Protective effect against preservatives • Prevention of tear film breakup • Stabilization of tear film • Moisturizing effect
NOF CORPORATION
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Tata Chemicals Ltd, India
Products Characteristics Applications
Mannitol
Mannitol DC (100 SD) Standard oral grade, spray dried powder, differentiation based on particle size
Used as a diluent in solid orals and also used in sugar free tablets
Mannitol DC (200 SD)
Fresenius Kabi, Germany
Products Characteristics Applications
Purified Egg Phospholipids
Purified Egg Phospholipids PL 90
Parenteral grade Used as an emulsifier in injectables
Ingredion, USA
Products Characteristics Applications
Aspartame
Dulcent Aspartame Artificial non-saccharide sweetener Used as a sweetener in powder, granules, ODT and liquid orals
Sucralose
Dulcent Sucralose Calorie free artificial sweetener Used as a sweetener in powder, granules, ODT and liquid orals
Diaonj Technologies, India
Products Characteristics Applications
Dissolution media
Dissomed Biorelevant dissolution media (fasted and fed state)
Bioequivalence testing in-vivo and in-vitro correlation of formulation
We can source any product/s of your requirement, which may not be listed above
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Our core business
Disclaimer The information in this brochure is to our best knowledge true and accurate but, all instructions, recommendations or suggestions are made without guarantee. Since the conditions of use are beyond their control, DKSH disclaims any liability for loss or damage suffered for use of this data or suggestions. Furthermore, no liability is accepted if use of any product in accordance with this data or suggestions infringes any patent.
Fully compliant• Regulatory• Customs• FDA and audit complaint warehouses• Dedicated sample facility
Easy to work with• Market insights and intelligence• Warehousing/logistic support• Market development • Technical support/ troubleshooting• Sampling and regulatory documentation
Deliver value• High service level• Provide solution• Global company with local approach• Strong network and relationship in industry
DKSH – ideal partner for Pharmaceutical IndustryWe supply a wide range of innovative, high-performance excipients, interme-diates, solvents, key raw materials, actives for the pharmaceutical and nutraceutical industry. To ensure the long-term success of our business partners, we constantly deliver solutions that give them a compe-titive advantage. We provide, regulatory
support, technical assistance, logistics, warehousing, distribution and periodic market intelligence amongst a range of value added services.
Proven operational efficiencyWe continuously improve the efficiency of our processes. The quality of our services is based on best practices and standards throughout our organization. An efficient
supply chain coupled with synergies across all business units and countries allow us to fulfill the diverse requirements of the business we serve.
SourcingWe source ingredients for pharma and nutra industry from across the world.
Your preferred partner for sourcing• Comprehensive global sourcing
network • Highly dedicated team of sourcing specialists
Our key sourcing offices• China• Europe• India• Japan• Korea
DKSH Group• Leading provider of Market Expansion Services• Total Sales CHF 11.3 billion (2018)• 33,000 employees in 35 markets and 825 business locations• More than 150 years in Asia
Business Unit Performance Materials• We source, develop, market and distribute a wide range of specialty chemicals and ingredients• Focus on industries and applications• Over 1,080 specialized staff in 31 markets• 29 innovation centers• 100 business locations
Business Lines• Pharmaceutical Industry• Food & Beverage Industry• Personal Care Industry• Specialty Chemicals Industry
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Notes
DKSH India Private LimitedFantree Building, Sarla Park, Andheri East, Mumbai 400059, IndiaPhone +91 22 6157 7000, Fax +91 22 2920 0210 www.dksh.in
AhmedabadPhone +91 79 6543 9950
DelhiPhone +91 11 2691 6320/21
KolkataPhone +91 33 4060 5527
MumbaiPhone +91 22 6157 7000
SecunderabadPhone +91 40 6649 1011
Version: Pharmaceuticals; April, 2019