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Business Unit Performance Materials Innovative materials for the pharmaceutical industry Business Line Pharmaceutical Industry India Think Asia. Think DKSH. Ashland Inc., USA Products Generic name Characteristics Application Polyplasdone XL (Type A) Crospovidone Conventional particle size grade Used as a disintegrant for IR tablets Polyplasdone XL-10 (Type B) Fine particle size grade Used as a disintegrant for ODT and provides smooth mouth feel Polyplasdone INF-10 (Type B) Very fine particle size grade Used as a suspending agent in oral suspension and also used as a disintegrant for pellets and MUPS Polyplasdone Ultra (Type A) Low peroxide content grade with conventional particle size Used as a disintegrant for IR tablets containing oxidation sensitive API Polyplasdone Ultra-10 (Type B) Low peroxide content grade with fine particle size Used as a disintegrant for ODT containing oxidation sensitive API Grade differentiation based on viscosity and K value Used as binder and vehicle for soft gelatin capsules and for drug solubilization Plasdone K-12 Plasdone K-17 Povidone/PVP Used as a binder for wet/dry granulation in tablets, capsules, pellets and powders Plasdone K-25 Plasdone K-29/32 Plasdone K-90 Plasdone K-90D Plasdone C-12 Plasdone C-17 Plasdone C-30 Pyrogen free grade Used as solublizer and suspension stabilizer for parenterals and ophthalmic formulations Plasdone S-630 Copovidone – • Plasdone S-630 is a binder and matrix polymer for solid dispersion formulations • It is used to enhance solubility of poorly soluble drugs through melt extrusion or spray dried solid dispersion Klucel HF, HXF Pharm Hydroxypropyl cellulose (HPC) Grade differentiation based on Viscosity ‘X' stands for fine particle size Used as a release retardant in CR Tablets and thickener for semisolids Klucel MF, MXF Pharm Klucel GF, GXF Pharm Klucel JF, JXF Pharm Klucel LF, LXF Pharm Klucel EF, EXF Pharm Klucel ELF Pharm Used as a release retardant in CR Tablets and binder for solid oral formulations • 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 2 Ashland Inc., USA (Cont‘d) Products Generic name Characteristics Application Benecel E4M Pharm* Benecel E10M Pharm* Hydroxypropyl methylcellulose/ Hypromellose (2910 substitution/ E Type) – • These grades can be used as hydrophilic release retardant for CR tablets • Can also be used as a thickening agent to help prevent or minimize suspension settling without altering taste or mouth feel in liquid suspensions Benecel K100 LV PH PRM** Benecel K250 PH PRM** Benecel K750 PH PRM** Benecel K1500 PH PRM** Benecel K4M Pharm* Benecel K4M PH DC Benecel K15M Pharm* Benecel K15M PH DC Benecel K35M Pharm* Benecel K100M Pharm* Benecel K100M PH DC Benecel K200M Pharm* Hydroxypropyl methylcellulose/ Hypromellose (2208 substitution/ K Type) Differentiation based on viscosity 'DC' stands for direct compressible grade • These grades can be used in single or in combination intragranularly or extragranularly as hydrophilic release retardant for CR tablets • DC grades are used as direct compressible release retardant Methylcellulose Differentiation based on viscosity Benecel Methylcellulose used as granulating agent and thickener. Low viscosity Benecel A15 LV is commonly used in drug layering Benecel ME 233 P Pharm Methylhydroxyethyl cellulose – It can be used as binder in solid orals and as rheology modifier in liquid orals and topicals Aquarius Preferred HSC Ready-mix coating system – High-solids coatings based on cellulosic polymers * CR grades available, ** Only CR grades available Benecel A15 LV PH PRM Benecel A15C Pharm Benecel A4M Pharm Aquarius Preferred HSP High-solids coatings based on copovidone with cellulosic polymers for significant improvements in adhesion and sprayable solids Aquarius Prime Coatings based on traditional cellulosic polymers Aquarius Prime LS Coatings based on cellulosic polymer and lactose Aquarius Preferred MG This coating system reduces the moisture uptake 3 Ashland Inc., USA (Cont‘d) Products Generic name Characteristics Application Aquarius Preferred TG Ready-mix coating system – This coating system masks the unpleasant taste of tablet Aquarius Preferred OG This coating system masks the unpleasant odour of tablet Aquarius Control ENA Delayed-release (enteric) coatings based on methacrylic acid-ethyl acrylate copolymer Aquarius Control SRX Sustained release coatings based on ethylcellulose Blanose 7H4XF PH Blanose 7HF PH Blanose 7H3SF PH Blanose 7HOF PH Blanose 7M31F PH Blanose 7M8SF PH Blanose 7MF PH Blanose 7M1F PH Blnaose 7LF PH Blanose 9H4XF PH Blanose 9M31F PH Blanose 12M31P Blanose 12M8P Sodium CMC/ Carmellose sodium Differentiation based on viscosity and degree of substitution • Used as a thickener/viscosity modifier in liquid orals/semi-solids • Also used as a binder and release retardant for CR tablets Aqualon 7HF PH Aqualon 7H3SF PH Aqualon 7MF PH Aqualon 7M8SF PH Aqualon 7LF Aqualon 7L2P Aqualon 9M31F PH Aqualon 9M8F PH Aqualon 12M31P Sodium CMC/ Carmellose sodium Differentiation based on viscosity and degree of substitution • Used as a thickener/viscosity modifier in liquid orals/semi-solids • Also used as a binder and release retardant for CR tablets Aqualon EC T10 Pharm Ethyl cellulose Differentiation based on viscosity Used as a binder in direct compression due to its good flow and compactability Aqualon EC N7 Pharm Aqualon EC N10 Pharm Aqualon EC N14 Pharm Aqualon EC N22 Pharm Aqualon EC N50 Pharm Aqualon EC N100 Pharm Used for coating powder, granules and pellets to control drug release. Also used in seal coating 4 Ashland Inc., USA (Cont‘d) Products Generic name Characteristics Application Natrosol 250 HHX/HHW Pharm Natrosol 250 HX Pharm, H Pharm Natrosol 250 M Pharm Natrosol 250 G Pharm Natrosol 250 L Pharm Hydroxyethyl cellulose Differentiation based on viscosity 'X' stands for fine particle size • Used as a viscosity modifier in liquid orals and semi-solids • Also used as release retardant in CR tablets Aquasolve L Hypromellose acetate succinate/HPMCAS Dissolves at pH more than 5.8 Used as an enteric coating agent and as a solublizer for poorly soluble API in spray dried solid dispersions and hot melt extrusion Aquasolve M Aquasolve H Dissolves at pH more than 6.0 Dissolves at pH more than 6.8 Cavamax W6 Pharma a-cyclodextrin Oral grade • Used to enhance solubility of poorly soluble drugs in solid dispersions • Used to mask unpleasant odour/ taste of API and to stabilize the same Cavamax W7 Pharma b-cyclodextrin Cavamax W8 Pharma g-cyclodextrin Cavasol W7 HP Pharma Hydroxypropyl b-cyclodextrin Cavasol W8 HP Pharma Hydroxypropyl g-cyclodextrin Cavitron W7 HP5 Pharma Cavitron W7 HP7 Pharma Hydroxypropyl b-cyclodextrin Parenteral grade Used to increase solubility of drug in Parenterals Pharmasolve N-methyl-2pyrrolidone – Used as solubilizer and penetration enhancer in parenterals and topicals Products Generic name Characteristics Application Cellucrest 101 Microcrystalline cellulose Conventional particle size grade Conventional grade for wet and dry granulation Cellucrest 102 Coarser particle size Filler for direct compression. Improves flow property and compressibility Cellucrest 112 Low moisture, coarser particle size Filler for direct compression of moisture sensitive product Cellucrest 113 Low moisture, fine particle size Improves stability of moisture sensitive product Crest Cellulose Pvt. Ltd., India 5 Crest Cellulose Pvt. Ltd., India (Cont‘d) Products Generic name Characteristics Application Cellucrest 200 Microcrystalline cellulose Largest particle size Improves flow of blend for direct compression and dry granulation. Also reduces weight variation and variation in content uniformity Cellucrest 301 High bulk density grade To achieve efficient mixing of blend to manufacture small tablets and reduces weight variation and variation in content uniformity Cellucrest 302 High bulk density grade with coarser particle size To achieve efficient mixing of blend to manufacture small tablets and reduces weight variation and variation in content uniformity Rapigel Sodium starch glycolate – Used as a disintegrant for IR tablets, capsules and ODT Lubricrest Magnesium stearate – Lubricant Crestcross Croscarmellose sodium – Used as a disintegrant for IR tablets, capsules and ODT Crestadd Dicalcium phosphate anhydrous/ Dicalcium phosphate dihydrate – Used as a filler in wet granulation Gelmac Pregelatinized maize starch – Used as a binder Products Generic name Characteristics Application Flavor (Liquid form) Natural flavor Nature identical flavor Synthetic flavor – Flavoring agent for liquid orals Symega Flavours, India Spray Dried Flavor (Powder form) Flavoring agent for ODT, effervescent powder, granules and tablets Unique combinations for bitter taste masking Bitter Taste Masker Functional Flavor – – Delivery of nutraceutical actives for gut health 6 Stepan, USA Products Generic name Characteristics Application Stepanol WA 100 Sodium lauryl sulphate Oral grade, needle like crystals Used as a wetting agent in tablets, liquid orals and semi-solids Mondo Minerals B.V., Netherlands Products Generic name Characteristics Application Microtalc Pharma 50 Talc/Hydrated Magnesium Silicate Standard Particle Size grade Used as an antiadherant for tablets Fine particle size grade Very fine particle size grade Used for drug layering in pellets and also used as anti tacking agent in film coating system Microtalc Pharma 30 Microtalc Pharma 8 JMC Corporation, Korea Products Generic name Characteristics Application Sodium saccharin, 15% moisture Sodium saccharin, 6% moisture Sodium saccharin – Used as a sweetner in powder, granules, ODT and liquid orals Products Generic name Characteristics Application Pretiox AV 01 PhG Titanium dioxide – Used as an opacifier in capsule shell and color coating system Precheza A.S., Czech Republic 7 Freund Corporation, Japan Products Generic name Characteristics Application Dilactose R Dilactose F Dilactose S Lactose monohydrate (Granulated) Grade differentiation based on particle size Used in direct compression formulations to provide good flow and superior compressibility. Tablets manufactured with Dilactose provides quick disintegration Products Generic name Characteristics Application GNF-D211 GNF-D215 Co-Processed excipient (D-Mannitol, Microcrystalline cellulose, Crospovidone, Carboxymethyl cellulose) – Co-processed excipient for ODT Products Generic name Characteristics Application Kimica Acid SN Alginic acid Complying NF (National Formulary) Complying to EP and BP Used as a disintegrant in anti-reflux and effervescent tablets Kimica Algin ULV-L3 Kimica Algin ULV-L5 Kimica Algin ULV-1 Kimica Algin ULV-3 Kimica Algin ULV-5 Sodium alginate Ultra low viscosity sodium alginate Used as a gelling agent in anti-reflux suspensions and effervescent tablets Kimica Algin IL-2 Kimica Algin IL-6 Kimica Algin I-1 Kimica Algin I-3 Kimica Algin I-5 Kimica Algin I-8 Kimica Algin I-S Sodium alginate Standard type sodium alginate Used in controlled release formulations Daicel Corporation, Japan Kimica Corporation, Japan Kimica Acid SEB 8 Kimica Corporation, Japan (Cont‘d) Products Generic name Characteristics Application Kimica Algin LZ-2 Sodium alginate Ultra high viscosity sodium alginate Used in controlled release formulations Kimica Algin ULV-1G Kimica Algin ULV-5G Kimica Algin IL-6G Kimica Algin I-1G Kimica Algin I-3G Sodium alginate High stiffness gelation type Sodium Alginate Kimiloid LVC Kimiloid HVC Propylene glycol alginate Standard Type Propylene Glycol Alginate Kimiloid AB Kimiloid LLV Kimiloid NLS-K Kimiloid LV Kimiloid MV Kimiloid HV Used as a suspending agent, emulsion stabilizer, plasticiser and binder High esterification type Propylene Glycol Alginate Kimica Algin K Potassium alginate – Kimica Algin Ca Calcium alginate Gelling agent Kimica Algin NH Ammonium alginate Dental impression material Kimica Algin Mag Magnesium alginate Anti reflux suspensions for infants Dental impression material NOF Corporation, Japan NOF CORPORATION Products Generic name Characteristics Application Polysorbate 20 Polyoxyethylene sorbitan monolaurate/Polysorbate 20 – Used as a solublizer in parenterals Polysorbate 80 GS Polyyoxyethylene Sorbitan monooleate/Polysorbate 80 Polysorbate 80 HX2 Sunbright DKH-02HB PEG 200 Sunbright DKH-03HB PEG 300 Sunbright DKH-04HB PEG 400 Activated PEGs Methoxy-polyethylene glycols (mPEGs) Used as a solublizer in parenterals High purity solubilizer for parenterals Parenteral grade Used as a solublizer in parenterals – Used for targeted drug delivery system 9 NOF Corporation, Japan (Cont‘d) NOF CORPORATION Products Generic name Characteristics Application Phospholipids from Natural Sources HSPC (Hydrogenated soyabean phosphatidylcholine EPC (Egg phosphatidylcholine) HEPC (Hydrogenated egg phosphatidylcholine) Egg sphingomyelin/ Milk sphingomyelin – Used in liposomes 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 – Used in liposomes Products Generic name Characteristics Application Purified Egg Phospholipids PL 90 Purified egg phospholipids Parenteral grade Used as an emulsifier in injectables Products Generic name Characteristics Application Cavamax W8 - CoQ10 complex Highly bioavailable CoQ10 – Cardiovascular health Fresenius Kabi, Germany Wacker Chemie AG, Germany 10 Wacker Chemie AG, Germany (Cont‘d) Products Generic name Characteristics Application Cavacurcumin Highly bioavailable curcumin – Anticancer/antiinflammatory HTEssence Hydroxytyrosol – Antioxidant for Cardiovascular health/ skin lightening Horphag Research, Switzerland Products Generic name Characteristics Application Pycnogenol French maritime pine bark extract – • Cardiovascular health – Improves endothelial function – Normalises high blood pressure • Diabetes • Joint health • Oral skin care/topical skin care • Sports nutrition • Erectile dysfunction Robuvit French oak extract – Chronic fatigue syndrome Products Generic name Characteristics Application Polyglykol 300 Polyglykol 400 Polyglykol 600 Polyethylene glycols/ Macrogols Brand name followed by numbers indicate the average molecular weight The high solvent power leads to a broad use of low molecular weight PEGs in liquid preparations such as drops, parenterals or fillings for gelatin capsules Polyglykol 1000 Polyethylene glycols/ Macrogols – Used to make ointment base Lanogen 1500 Polyethylene glycols/ Macrogols Ointment base (JP) containing Polyglykol® 300 and 1500 in a ratio of 1:1. Used as an ointment base Clariant, Switzerland 11 Clariant, Switzerland (Cont‘d) Products Generic name Characteristics Application Polyglykol 1500 S Polyglykol 2000 S Polyglykol 3000 S/P Polyglykol 3350 S/P/PS Polyglykol 4000 S/P/PF/ PS Polyglykol 6000 S/P/PF Polyglykol 8000 S/P/PF Polyglykol 10000 S/P Polyglykol 12000 S/P Polyglykol 20000 S/P Polyglykol 35000 S Polyethylene glycols/ Macrogols Brand name followed by numbers indicate the average molecular weight ‘S' stands for flakes 'P' stands for powder 'PF' stands for fine powder 'PS' stands for spray dried powder • Solid PEGs are preferred bases for suppository masses. PEGs can be used as carriers, solubilizers and absorption improvers for active substances, usually processed in the form of a melt (melt granulation) • They also act as lubricants and binders during tablet processing • PEGs also has a plasticizing effect which facilitates the shaping of the tablet mass in the compression process and may counteract capping • Solid PEGs are also frequently used in tablet coatings as a plasticizer. The flexibility of sugar-coated tablets is increased by PEGs The USP/NF describes a blend in the monograph ‘PEG 3350 and Electrolytes for Oral Solution’ as a laxative preparations which contains a detailed description of all potential individual salt components to be used in addition to the polyglycol with a mean molecular weight of 3350 Products Generic name Characteristics Application Farmal MN 5000 Mannitol Standard oral grade Used as a diluent for ODT and also used in sugar free tablets Injectable grade Vehicle for lyophilised products – Used as a sweetner in powder, granules, ODT and liquid orals Ingredion, USA Farmal MN 5010 Dulcent Aspartame Aspartame Dulcent Sucralose Sucralose Used as a sweetner in powder, granules, ODT and liquid orals 12 Our core business Pharmaceutical industry We source and supply a wide range of innovative, high-performance chemicals, intermediates, API and formulations for the pharmaceutical industry. Sourcing We source APIs, excipients, and intermediates from India as well as globally. We provide • Regulatory support • Technical assistance • Logistics, warehousing and distribution • Custom manufacturing • Development services • Quality assurance Strengthen service offerings We continually strengthen and expand our range of service offerings across the entire value chain. To ensure the long-term success of our business partners, we constantly deliver more value-added solutions that give them a competitive advantage. Your preferred partner for sourcing • Comprehensive sourcing network in Asia, Europe and the Americas • Proven track record • Early trend scout • Global technology transfers • Highly dedicated team of sourcing specialists Increase operational efficiency We continuously improve the efficiency of our processes. The quality of our services is based on best practices and standards throughout our entire 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. Our key sourcing offices • Japan • Korea • China • India • Europe 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. 13 Notes 14 15 Pharmaceutical industry Branch locations Ahmedabad Phone +91 79 6543 9950 [email protected] Kolkata Phone +91 33 4060 5527 [email protected] Delhi Phone +91 11 2691 6320/21 [email protected] Mumbai Phone +91 22 6157 7000 [email protected] DKSH India Private Limited Fantree Building, Sarla Park, Andheri East, Mumbai 400059, India Phone +91 22 6157 7000, Fax +91 22 2920 0210 [email protected], www.dksh.in Secunderabad Phone +91 40 6649 1011 [email protected]
