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Health and Nutrition Product Guide - Anshul Life Sciences

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www.ispcorp.com<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong><strong>Product</strong> <strong>Guide</strong>Performance Enhancing <strong>Product</strong>s


Introduction..................................................................................... 3Table of ContentsApplication Selection <strong>Guide</strong>.................................................... 5Binders <strong>and</strong> Solubilizers.Plasdone® K Povidone............................................................................ 6.Plasdone® C Povidone............................................................................. 6.Plasdone® S-630 Copovidone............................................................... 7.CAVAMAX® Native Cyclodextrins......................................................... 8.CAVITRON® <strong>and</strong> CAVASOL® Derivative Cyclodextrins.................... 8.Pharmasolve® Drug Solubilizer............................................................ 9.2-Pyrol® Drug Solubilizer....................................................................... 9Disintegrants.Polyplasdone® Crospovidone..............................................................10Film Coating Systems.Advantia Prime Coating Systems.....................................................11.Advantia Performance Coating Systems........................................12solvents .THF Tetrahydrofuran Solvent.............................................................13Active Ingredients.Ferronyl® Carbonyl Iron Supplement................................................14.Polyplasdone® INF-10 Crospovidone.................................................14.PVP-Iodine Antiseptic..........................................................................15 .Allantoin Skin Protectant....................................................................15Topical Excipients.Ceraphyl® Emollients ...........................................................................16.Cerasynt® Emulsifiers............................................................................16.Prolipid® Lamellar Gel System............................................................17.Preservatives..........................................................................................17Biomedical Polymers.Gantrez® Copolymers............................................................................18ISP Pharma Techonologies......................................................19.CAVAMAX® <strong>and</strong> CAVASOL® are registered trademarks ofWacker-Chemie AG.<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


For over 50 years, ISP has been a leading supplier ofhigh quality products used to enhance performance inhealth <strong>and</strong> nutrition applications. Today, ISP producesmore than 30 products for use in oral solids, liquids <strong>and</strong>semi-solids; parenterals; topicals <strong>and</strong> ophthalmic dosageforms. This product guide can help you locate a productto meet your application needs.Plasdone® BindersISP offers a comprehensive range of binders for wetgranulation, dry granulation or direct compressiontablet manufacturing processes. Our Plasdone® Kpolymers are the premier high performance binders forwet granulation. Plasdone® S-630 polymer is a superior,high-performance dry binder in both direct compression<strong>and</strong> dry granulation.CAVAMAX®, CAVitron® <strong>and</strong> CAvasol®CyclodextrinsAs a result of their molecular structure <strong>and</strong>shape, cyclodextrins have a unique ability toact as molecular containers by entrappingguest molecules in their internal cavity. Theresulting inclusion complexes are used ina number of pharmaceutical applicationsincluding: increasing water solubility of poorlysoluble drugs to improve bioavailability; tastemasking bitter actives for use in chewable; <strong>and</strong>orally disintegrating tablet applications, <strong>and</strong>;stabilizing drug actives to inhibit light, thermal<strong>and</strong> oxidative degradation. ISP offers thebroadest range of cyclodextrin products to helpachieve specific formulation objectives.IntroductionPolyPlasdone® SuperDisintegrantsISP provides Polyplasdone® Crospovidone for rapiddisintegration <strong>and</strong> dissolution of oral solid dosageforms. A synthetic, cross-linked polymer, Polyplasdone®Crospovidone is available in two particle sizes toprovide formulation flexibility for small <strong>and</strong> largetablets or intragranular <strong>and</strong> extragranular applications.With its small particle size <strong>and</strong> rapid disintegration,Polyplasdone® XL-10 Crospovidone is preferred for orallydisintegrating tablet (ODT) formulations.Advantia Coating SystemsAdvantia Prime <strong>and</strong> Performance Coating Systemsare pre-blended, ready-to-use powders that are readilydispersed in water <strong>and</strong> applied to the substrate. ISP hasdeveloped Advantia Prime <strong>and</strong> Performance CoatingSystems utilizing a scientific approach for characterizingthe nature of the relationships between components<strong>and</strong> their use levels in film coating formulations forimmediate-release <strong>and</strong> enteric-release dosage forms.Each system is formulated <strong>and</strong> selected to provide theoptimum performance.Topical ExcipientsWith a wealth of experience in products forskin care, ISP offers a range of emollients<strong>and</strong> conditioners, to improve the aestheticsof topical creams <strong>and</strong> lotions. The Ceraphyl®product line contains a series of long chainfatty esters that provide a range of aestheticproperties. ISP offers a range of high qualityfatty esters, derived from vegetable sources,for use as primary <strong>and</strong> auxiliary oil-inwateremulsifiers for a variety of topicalpharmaceutical formulations.ISP’s preservative products deliver broadspectrum activity <strong>and</strong> compatibility protectingtopical formulations from antimicrobialcontamination.<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


Application Function <strong>Product</strong>sOral SolidsOral liquids<strong>and</strong>semi-solidsParenteralsOphthalmicTopicalsBiomedicalPolymersActive StabilizationDirect Compression Binder Aid Plasdone® S-630DisintegrantEncapsulation/TastemaskingCAVAMAX®, CAVITRON® <strong>and</strong> CAVASOL® CyclodextrinsPolyplasdone® XL <strong>and</strong> XL-10CAVAMAX® CyclodextrinsFilm Coating Additives Plasdone® S-630Film Coating Systems (Aesthetic <strong>and</strong> Enteric Release)Advantia Coating SystemsGranulation Binder - Dry Plasdone® S-630Granulation Binder - WetIron SupplementSolubility EnhancementIron SupplementSolubility EnhancementSuspension AgentsThickening AgentsCrystal InhibitionSolubility EnhancementSolubilty EnhancementCrystal InhibitionViscosity ModifierLubricityAntisepticsEmollients <strong>and</strong> ConditionersPlasdone® K-25, K-29/32, K-90 <strong>and</strong> K-90DFerronyl® IronPlasdone® K, Plasdone® S-630, CAVAMAX®, CAVITRON® <strong>and</strong>CAVASOL® Cyclodextrins, Polyplasdone® XL <strong>and</strong> XL-10Ferronyl® IronPlasdone® K, Plasdone® S-630, CAVAMAX® <strong>and</strong> CAVASOL®CyclodextrinsPolyplasdone® INF-10Plasdone® CPlasdone® C, Pharmasolve®, 2-Pyrol®Plasdone® C, Pharmasolve®, 2-Pyrol®, CAVITRON CyclodextrinsPlasdone® CPVP-IodineCeraphyl®Emulsifiers Cerasynt® SD <strong>and</strong> 945Film Formers Gantrez®, Plasdone® S-630Lamellar Gels Systems Prolipid® 141PreservativesSkin ProtectionThickening AgentsBioadhesivesGermall 115 <strong>and</strong> II, Germall Plus <strong>and</strong> Liquid Germall Plus,Germaben II <strong>and</strong> II-E, LiquaPar Oil, PE <strong>and</strong> OptimaAllantoin USPPlasdone® KGantrez®, Plasdone® KFilm Formers Gantrez®, Plasdone® S-630Lubricious CoatingsPlasdone® CPore Formation Plasdone® K-90Wound CareGantrez®, PVP-IodineApplication Selection <strong>Guide</strong><strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


Oral Solids · Oral Liquids <strong>and</strong> Semi Solids · Topicals · Medical DevicesPlasdone® S-630 PolymerCopovidone USP/NF, Ph. Eur., JPE<strong>Product</strong>K-ValueWeight AverageMolecular WeightPlasdone® S-630 25-31 24,000-30,000Description60:40 copolymer of vinylpyrrolidone <strong>and</strong> .vinyl acetate (PVP/VA)AppearanceWhite to creamy white, free-flowing powderChemistryPropertiesCH 2CHNnOCH 2CH• Soluble in water <strong>and</strong> most pharmaceutically acceptable solvents• Lower glass transition temperature (Tg) than vinylpyrrolidonehomopolymers (106Plasdone o C comparedS-630to ~165 o C for Plasdone K-29/32CAS# 25086-89-9PVP)• Forms hard, glossy, transparent, air-permeable, water .removable films• More substantive <strong>and</strong> better film former than vinylpyrrolidonehomopolymers due to increased hydrophobicity <strong>and</strong> lower Tg• Lower hydroscopicity than PVP .mO CH 3COBinders <strong>and</strong> SolubilizersApplications <strong>and</strong> Benefits• Serves as tablet binder in wet <strong>and</strong> dry granulation <strong>and</strong> directcompression tablet processes• Improves compactability of other binders <strong>and</strong> fillers in directcompression tablet process• Improves solubility <strong>and</strong> enhances bioavailability of drug actives• Gives excellent performance as binder in moisture sensitiveformulations• Enhances appearance <strong>and</strong> color stability of tablet film coatings• Increases productivity of film coating process by increasingsuspension solids• Improves adhesion of tablet coatings to hydrophobic cores• Possesses excellent film forming properties <strong>and</strong> high .substantivity to skin<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


Oral Solids · Oral Liquids <strong>and</strong> Semi-SolidsCAVAMAX ® CyclodextrinsUSP/NF, Ph. Eur., JP selected productsOral Solids · Oral Liquids <strong>and</strong> Semi-Solids · ParenteralsCAVITRON ® <strong>and</strong> CAVASOL ® CyclodextrinsUSP/NF, Ph. Eur., selected productsBinders <strong>and</strong> Solubilizers<strong>Product</strong>sCyclodextrinTypeNumber of Glucose UnitsCAVAMAX® W6 Pharma a 6CAVAMAX® W7 Pharma ß 7CAVAMAX® W8 Pharma g 8DescriptionBucket-shaped, cyclic, oligo-saccharides produced .from starchAppearanceWhite, free-flowing powderChemistryHydrophobic Cavity<strong>Product</strong>sCAVITRON® W7 HP5PharmaCAVITRON® W7 HP7PharmaCAVASOL® W7 HP PharmaCAVASOL® W8 HP PharmaCyclodextrin TypeHydroxypropyl-bcyclodextrinHydroxypropyl-bcyclodextrinHydroxypropyl-bcyclodextrinHydroxypropyl-gcyclodextrinTypical Degree ofSubstitution4.1-5.16.0-8.04.1-5.13.5-4.9The CAVITRON grades of hydroxypropyl-b-cyclodextrin are manufactured to control endotoxin levels.DescriptionHydroxypropyl substituted, bucket-shaped, cyclic, .oligo-saccharides produced from starchAppearanceWhite to off-white powderChemistryHydrophilic ExteriorProperties• Water soluble• Very stable at alkaline pH; stable in acidic solutions above pH 3• Hydrophobic interior cavity; hydrophilic exterior• Cavity size depends on number of glucose units in .cyclodextrin ring• Can form complexes with drug activesApplications <strong>and</strong> Benefits• Enhances bioavailability by increasing water solubility of .poorly-soluble drug actives• Improves the light, thermal <strong>and</strong> oxidative stability of drug activesthrough formation of inclusion complexes• Reduces dermal, gastrointestinal or ocular irritation throughcomplex formation• Masks unpleasant tastes <strong>and</strong> odors of drug actives to improvepatient compliance• Prevents drug-drug <strong>and</strong> drug additive interactions• Simplifies product h<strong>and</strong>ling by reducing volatility of actives orconverting liquids to powdersProperties• Water soluble• Stable in base <strong>and</strong> weak organic acids, but are hydrolyzed .by strong acids• Hydrophobic interior cavity; hydrophilic exterior• Can form complexes with drug activesApplications <strong>and</strong> Benefits• Enhances bioavailability by increasing water solubility of .poorly-soluble drug actives• Improves the light, thermal <strong>and</strong> oxidative stability of drug activesthrough formation of inclusion complexes• Reduces dermal, gastrointestinal or ocular irritation throughcomplex formation• Prevents drug-drug <strong>and</strong> drug additive interactions• Simplifies product h<strong>and</strong>ling by reducing volatility of actives orconverting liquids to powders<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


Oral SolidsAdvantia Prime Coating SystemsAdvantia Prime Coating Systems are pre-blended, ready-to-use powders that are readily dispersed in water <strong>and</strong> applied to immediaterelease dosage forms. Based on existing pharmaceutically-acceptable polymers, for example hydroxypropylmethyl cellulose (HPMC),Advantia Prime Coating Systems are available pigmented or unpigmented. The products listed below are st<strong>and</strong>ard concept samples thatcontain ingredients acceptable in North America, European Union <strong>and</strong> Japan for use on pharmaceutical products. The products listed areonly a sampling of the formulations available.<strong>Product</strong> Name Color Suggested Suspension Solids (%) Suggested Weight Gain (%)Advantia Prime 199900BA01 Clear 10-12% 1%Advantia Prime 190100BA01 White 12-15% 3%Advantia Prime 144900BA01 Yellow 12-15% 3-4%Advantia Prime 171900BA01 Pink 12-15% 3-4%Film Coating SystemsPharmaceuticals <strong>Product</strong> <strong>Guide</strong> 11


Oral SolidsAdvantia Performance Coating SystemsFilm Coating SystemsAdvantia Performance Coating Systems are pre-blended, ready-to-use powders based on methacrylic acid ethyl acrylate copolymer .for delayed release (enteric release) film coating of pharmaceutical oral solid dosage forms, including:• Tablets• Multiparticulates• Two-piece gelatin capsules• SoftgelsAvailable pigmented or unpigmented, Advantia Performance Coating Systems are easy-to-use powders that can be readily dispersed .in water <strong>and</strong> applied.With an Advantia Performance Coating Systems, suspension preparation is simple. The more traditional procedure for preparing .enteric-coating suspensions often requires three steps. In the traditional process, the first step is to homogenize the plasticizer, .detackifier <strong>and</strong> optionally, an antifoam agent in water to form a suspension. After a suitable mixing time, this suspension is then added,with mixing, to an acrylic polymer dispersion. This combined suspension is passed through a sieve. For a colored enteric-coatingformulation, a colorant must also be added using an additional processing step.With Advantia Performance Coating Systems, the Advantia Performance powder is added to water (stirred in a suitable mixing tank .to create a vortex) <strong>and</strong> mixed. There are fewer processing steps involved, <strong>and</strong> fewer ingredients to inventory <strong>and</strong> submit to quality .control testing compared to a traditional system, thus saving time <strong>and</strong> money.Advantia Performance 190024HA49Advantia Performance 190024HA49, a white coating formulation, has been selected as our st<strong>and</strong>ard concept sample as it provides .an overall excellent combination of properties for coating tablets. It is recommended to use Advantia Performance Coating Systems .at 20% solids in water. The maximum solids level will depend on the particular spray gun, pump <strong>and</strong> coating equipment used.In cases where a different coating system is required <strong>and</strong> acheive desired performance, ISP scientists utilize the design of experiments(D.o.E.) software in combination with responses generated from the design of experiments, to produce a coating formulation more suitable .for any given application.When a colored tablet is required, a colored Advantia Performance coating can be formulated to meet individual color needs, limited onlyby specific color regulations. ISP maintains strict color control to ensure lot-to-lot consistency.12 <strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


THF SolventDescriptionTetrahydrofuranAppearanceLiquidChemistrySolventsProperties• Purity: 99.9%• Boiling Point: 66 o C• Melting Point: -108.5 o C• Viscosity (25 o C): 0.47 cP• Flash Point (Tag Closed Cup): -14.4 o C• Completely miscible with water, most organic solvents, includingalcohols, diethylether, esters, ketones, aliphatic aromatic <strong>and</strong>chlorinated hydrocarbons• Highly volatile, flammable liquid• Noncorrosive to ordinary metals used for storage <strong>and</strong> processingequipment• Sterically unhindered oxygen with two unshared pairs of electronswhich favor formation of coordination complexesApplications <strong>and</strong> Benefits• Extraction solvent. In combination with water, effectivelyextracts physiologically active alkaloids such as caffeine• Excellent medium for chemical reactions involving Gringard <strong>and</strong>organometalic reagents• Steroid hormone production for use in birth control pills• Offers new routes for many syntheses<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong> 13


Oral Solids · Oral LiquidsFerronyl® Iron SupplementDescriptionUltra-fine, elemental iron with greater than 98% pure iron;Carbonyl iron powderOral Solids · Oral LiquidsPolyplasdone® INF-10Crospovidone USP/NF, Ph. Eur., JPE<strong>Product</strong>sTypical Average Particle Size (µm)Polyplasdone® INF-10 10Active IngredientsAppearanceGray powderChemistryProperties• Lower acute toxicity compared to ferrous saltsDescriptionNon-ionic, crosslinked polyvinylpyrrolidone (PVP), PVPPAppearanceWhite, free-flowing powderChemistry• Excellent bioavailability due to fine, spherical particlemorphology• High iron dose per unit weight compared to ferrous salts• Very stable• Easy to formulateApplications <strong>and</strong> Benefits• Provides source high in bioavailable iron for multivitamins, ironsupplements <strong>and</strong> chewable children’s multivitamins• Fortifies food with iron, an essential nutrient for humans <strong>and</strong>animalsProperties• Insoluble in water <strong>and</strong> all other common solvents• Large specific surface area• Non-ionicApplications <strong>and</strong> Benefits• Approved for use in some countries as an active to treatgastrointestinal disorders <strong>and</strong> as an anti-diarrheal agent inhuman <strong>and</strong> veterinary applications. ** Subject to local regulatory approval.14 <strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


TopicalsPVP-Iodine AntisepticPovidone iodine USP/NF, Ph. Eur., JPTopicalsAllantoin USPAllantoin USP/NF, Ph. Eur.DescriptionStable complex of iodine <strong>and</strong> polyvinylpyrrolidone (PVP)DescriptionGlyoxylidiureideAppearanceReddish-brown powderChemistryONCHCH 2I 3HCH 2ONCHCH 2NCHOAppearanceWhite, odorless crystalline powderChemistryOHN NOHNH C NH 2Active IngredientsProperties• Antiseptic agent• Available iodine of 11-12%• Releases iodine at levels balancing microbiocidal efficacy withreduced potential for irritation <strong>and</strong> sensitization often caused byhigher levels of free iodine on the site of application• No permanent staining of skin, natural fibers or hard surfaces• Virtually no vapor pressure or iodine sublimation• Water soluble• Compatible with most surfacesProperties• Classified “Safe <strong>and</strong> Effective” (Category 1) by the United StatesFood <strong>and</strong> Drug Administration (FDA) as a skin protectant at uselevels of 0.5-2.0%Applications <strong>and</strong> Benefits• Enhances the desirability of creams <strong>and</strong> lotions by its action as askin protectant• Approved by US FDA for many applications including minor cuts,scrapes, burns, sunburn, fever blisters, diaper rash <strong>and</strong> chaffed,chapped, cracked or wind-burned skin or lipsOApplications <strong>and</strong> Benefits• Safer <strong>and</strong> easier to use than classic iodine preparations• Disinfects skin for wound treatment, presurgical skinpreparation, <strong>and</strong> treatment of burn abrasions <strong>and</strong> infections onthe skin• Adheres to treated surfaces for prolonged activity• Forms films that protect wounds• Imparts effective antimicrobial activity to a wide range offormulations including powders, tablets, lotions, gels, ointments,creams <strong>and</strong> sprays• Reported effective in douches <strong>and</strong> vaginal suppositories fortreatment of vaginal infections• Produces effective gargles <strong>and</strong> presurgical oral washes <strong>and</strong> rinses• Reduces microbial levels in veterinary applications includingpresurgical scrubs, skin infection treatments <strong>and</strong> teat dips toprevent bovine mastitis<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong> 15


TopicalsCeraphyl® EmollientsTopicalsCerasynt® EmulsifiersTopical ExcipientsPatient compliance <strong>and</strong> consumer acceptance of pharmaceuticaltopical preparations may depend on their tactile properties. Manycommon formulations have poor product aesthetics which lead tolow patient compliance. Typically, combinations of emollients areutilized to provide a cascading sensory effect in which emollientswith various spreading rates are employed to eliminate sensorygaps from initial product application to residual after-feel. ISPoffers an extensive line of emollients to meet your formulationneeds. Below is a sampling of the products available <strong>and</strong> theirtypical applications. For additional information or for assistancein selecting the emollients to meet your formulation needs, pleasecontact your ISP sales office.<strong>Product</strong> Name Description Applications <strong>and</strong> BenefitsEsters Based on Alpha Hydroxy AcidsCeraphyl® 31 Lauryl lactate Lactate esters that deliver propertiesCsimilar to AHA derivatives withoutCeraphyl® 4112-15Alkyl lactatecausing irritation on the skinReduces tackiness <strong>and</strong> oiliness ofother components. Imparts non-oilyCeraphyl® 45 Dioctyl malatelubricity to hydro-alcoholic products.Easy to emulsify <strong>and</strong> works best atneutral pHLight Dry Feeling EstersISP offers oil-in-water emulsifiers for topical creams <strong>and</strong> lotions.<strong>Product</strong>NameCerasynt®SDCerasynt®945Description Appearance HLBGlycerylStearateGlycerylStearate<strong>and</strong>Laureth-23MeltingPoint(ºC)Flake 3 55-57.5Flake 7-8 53-55ApplicationsNonionicstabilizer <strong>and</strong>emulsifier.Effectivenonionic acidstabilizedemulsifier fortopicalpreparations.Forms opaquegels withmineral oil.Ceraphyl® 140ACeraphyl® 230Isodecyl oleateDiisopropyladipateVery dry, non-greasy estersImparts a transient feel during rubout but leaves minimal residueafter-feelFrequently used to reduce thetackiness or light feel of heavieremollientsGeneral Purpose EstersCeraphyl® 368Esters that Impart BodyEmulsynt GDLEthylhexylpalmitateGlyceryldilaurateImparts “mild feel” to emulsionsduring rub-out <strong>and</strong> reducesintermediate tackiness.Less oily than mineral oil <strong>and</strong> has aricher feel than isopropyl myristateSolid emollient esters withmelting points slightly abovebody temperatureImparts dry, non-greasy after-feelUseful for adding “body” <strong>and</strong>viscosity to emulsions <strong>and</strong>increasing eleganceEsters for Maximum After-FeelCeraphyl® 791Isocetyl stearoylStearateHighly branched di-esters that donot penetrate the skinDelivers a cushiony after-feel <strong>and</strong>provides a long playtime16 <strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


TopicalsProlipid® 141 Lamellar Gel SystemTopicalsPreservativesDescriptionContains glyceryl stearate, behenyl alcohol, palmitic acid, stearicacid, lecithin, lauryl alcohol, myristyl alcohol <strong>and</strong> cetyl alcoholAppearanceCream-to-beige waxy flakesChemistryProperties• Lamellar gel formers that moisturize <strong>and</strong> promote healthy skin bystrengthening the skin’s natural barrier function• Possible to develop stable lamellar gel networks with a wide rangeof rheological <strong>and</strong> sensory properties• Compatible over wide pH range• Resistant to rinse-offApplications• Masks undesirable sensory properties, such as oily feel in topicalformulations• Overcomes poor patient compliance of topical formulations withoily ingredients by entrapping the oil phase within the bilayermatrix producing silky smooth feel• Provides excellent feel properties to medicated creams <strong>and</strong> bodywashesBased on a wealth of preservative expertise, ISP offers a range ofbroad-spectrum preservatives to meet the challenges of today’stopical formulations. Selecting the right preservative for yourproduct formulation is just as important as the other ingredients<strong>and</strong> many factors will need to be considered. The guide belowwill aid in the selection of the ISP preservative. For additionalassistance, contact your local ISP sales office.<strong>Product</strong> Name Description Appearance ApplicationsGermall® 115Germall IIGermall PlusLiquidGermall PlusGermaben® IIGermaben II-ELiquaPar® OilLiquaPar PELiquaParOptimaImidazolidinylUreaImidurea, NFDiazolidinyl UreaDiazolidinylurea <strong>and</strong>IodopropynylButylcarbamatePropyleneGlycol <strong>and</strong>DiazolidinylUrea <strong>and</strong>IodopropynylButylcarbamatePropylene Glycol<strong>and</strong> DiazolidinylUrea <strong>and</strong>Methylparaben<strong>and</strong>PropylparabenPropylene Glycol<strong>and</strong> DiazolidinylUrea <strong>and</strong>Methylparaben<strong>and</strong>PropylparabenIsopropylparaben<strong>and</strong>Isobutylparaben<strong>and</strong> ButylparabenPhenoxyethanol<strong>and</strong>Isopropylparaben<strong>and</strong>Isobutylparaben<strong>and</strong> ButylparabenPhenoxyethanol<strong>and</strong>Methylparaben<strong>and</strong> Isopropylparaben<strong>and</strong>Isobutylparaben<strong>and</strong> ButylparabenWhitepowderWhitepowderWhitepowderClear liquidClear liquidClear liquidClear,viscousliquidClear,viscousliquidClear,viscousliquidLargelyanionicwater-solublesystemsLargelyanionicwater-solublesystemsLargelycationic <strong>and</strong>nonionicwater-solublesystems; Oilin wateremulsionsLargelycationic <strong>and</strong>nonionicwater-solublesystems;Oil in wateremulsionsOil in wateremulsionswith oil phase25%AnhydroussystemsAnhydroussystemsAnhydrousSystemsbased onmineral <strong>and</strong>natural oilsTypicalUseLevel0.2-0.6%0.1-0.3%0.05-0.2%0.1%-0.5%0.5-1.0%0.5-1.0%0.4-0.8%0.5-1.0%0.5-1.0%Topical Excipients<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong> 17


Topicals · Medical DevicesGantrez® CopolymersBiomedical Polymers<strong>Product</strong> Name Form AppearanceGantrez® S-96BF Solution STGantrez® S-97BFGantrez® S-97BF SolutionGantrez® MS-955Gantrez® ES-225Gantrez® ES-425Free acidof Gantrez®ANFree acidof Gantrez®ANFree acidof Gantrez®ANMixedsodium/calciumsaltHalf-esterderivativeHalf-esterderivativeSlightly hazy,viscousliquid(13% solids)Approx.MolecularWeightPowder 1,200,000Slightly hazy,viscousliquid(13% solids)White tooff-whitepowderViscousliquidViscousliquidBrookfieldViscosity(mPa. S)700,000 1501,500,0001,000,000100,000-150,00090,000-150,00070 (5%)340 (10%)1,000-1,600700-3,000(11.1%aqueoussolution)18,80014,400DescriptonCopolymers of polymethyl vinyl ether <strong>and</strong> maleic .anhydride (Gantrez AN) <strong>and</strong> derivativesProperties• Soluble in water <strong>and</strong>/or alcohol depending on the product form• Forms highly polar, tack-free films• Excellent wet adhesive strengths• BioadhesiveApplications <strong>and</strong> Benefits• Delivers excellent film-forming <strong>and</strong> adhesion properties to sprayb<strong>and</strong>ages <strong>and</strong> ostomy adhesives18 <strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong>


ISP Pharma TechnologiesISP Pharma Technologies (IPT) provides cGMP spray drying solutions to your drug solubility challenges.SolventAPIDispersant SystemMix/HomogenizeMixing Vessel(1)PumpPowderCollectionSpray DryBioavailability is enhanced by (1) dissolving the drug <strong>and</strong> a polymeric dispersant system in a suitable solvent, .(2) spray drying the resulting solution <strong>and</strong> (3) collecting the powder containing the drug either (A) molecularly .dispersed in the polymer matrix to form a solid solution or (B) dispersed as submicron particles to form a .solid suspension.In close collaboration, the ISP team will work with you through the entire commercialization process to enhance .the performance of your drug product:(2)(3)(a)Solid SolutionDrug Particle orDrug Rich LiquidSolid SuspensionSolid Emulsion(b)ISP Pharma Technologies• Feasibility Studies• Formulation/Process Development <strong>and</strong> Optimization• Scale-up• cGMP Clinical Supply Manufacturing• cGMP Commercial <strong>Product</strong>ion, the result is:—Enhanced bioavailability <strong>and</strong> therapeutic benefits—Reduced time to market—Improved life-cycle managementGetting StartedPlease contact your local ISP sales office or visit www.ispcorp.com to arrange a presentation to further describe .ISP Pharma technologies for drug solubilization.<strong>Health</strong> <strong>and</strong> <strong>Nutrition</strong> <strong>Product</strong> <strong>Guide</strong> 19


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While the information herein is believed to be reliable, we do not guarantee its accuracy <strong>and</strong> a purchaser must make its owndetermination of a product’s suitability for purchaser’s use, for the protection of the environment, <strong>and</strong> for the health <strong>and</strong> safety of its employees <strong>and</strong> the purchasers of its products. Neither ISP nor its affiliates shallbe responsible for the use of this information, or of any product, method, formulation, or apparatus described in this brochure. Nothing herein waives any of ISP’s or its affiliates’ conditions of sale, <strong>and</strong> WE MAKE NOWARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS OF ANY PRODUCT FOR A PARTICULAR USE OR PURPOSE. We also make no warranty against infringement of any patents by reason of purchaser’suse of any information, product, method or apparatus described in this brochure.

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