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UNI-PURE™ DW and DW-L Specialty Starches - Anshul Life Sciences

UNI-PURE™ DW and DW-L Specialty Starches - Anshul Life Sciences

UNI-PURE™ DW and DW-L Specialty Starches - Anshul Life Sciences

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<strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>DW</strong>-L <strong>Specialty</strong> <strong>Starches</strong>Improve solid oral dosage processing <strong>and</strong> appearance


<strong>UNI</strong>-PURE <strong>DW</strong>/<strong>DW</strong>-LPremium pharmaceutical excipients for use in drug deliveryIf moisture, easier preparation, <strong>and</strong> whiter color<strong>and</strong> cleaner taste are critical excipient factors in yoursolid oral dosage formulation, then you should evaluate<strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>DW</strong>-L corn starches. Theyare specially-processed, partially-pregelatinizedcorn starches prepared under carefully controlledcGMP conditions to optimize performance in soliddosage forms.<strong>UNI</strong>-PURE <strong>DW</strong>-L is carefully dried undercontrolled conditions to meet a moisture specificationthat is lower than that found in conventionalstarches.These multi-functional starches provide bindingfunctionality, act as filler/diluents for both capsule<strong>and</strong> tablet dosage forms <strong>and</strong> also can be used as disintegrantsin tablet systems.These starches can help improve the aesthetics ofyour formulations because they are whiter in color<strong>and</strong> have cleaner taste than conventional starches.Regulatory compliance is not an issue because<strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>UNI</strong>-PURE <strong>DW</strong>-L are carefullyprocessed to meet the specifications of the NF,PhEur, <strong>and</strong> JPE.Wet Granulation Binder<strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>UNI</strong>-PURE <strong>DW</strong>-L provideexcellent binding properties in wet granulationapplications. Since <strong>UNI</strong>-PURE <strong>DW</strong> is a partiallypregelatinized corn starch (10-20% soluble fraction),it swells in cold water <strong>and</strong> develops strong bindingor adhesive properties, thereby eliminating the needfor preparing starch pastes in the traditional manner.So <strong>UNI</strong>-PURE <strong>DW</strong>/<strong>DW</strong>-L reduce processing costsby eliminating the time <strong>and</strong> expense of preparingtraditional binder solutions. When <strong>UNI</strong>-PURE <strong>DW</strong>is used as a wet granulation binder, the optimumconcentration depends on the level of solvent, shearconditions of the granulator, <strong>and</strong> the temperature ofthe granulation. Furthermore, the binding propertiesof <strong>UNI</strong>-PURE <strong>DW</strong> are retained after conventional,fluid-bed, <strong>and</strong> high-shear granulations.Direct Compression BinderWith their superior compression profiles,<strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>UNI</strong>-PURE <strong>DW</strong>-L are extremelyuseful as binders in direct compression applications.The effect of <strong>UNI</strong>-PURE <strong>DW</strong> incorporation onthe compression profile of a poorly compressibledrug is shown in the figure below.Improves CompressibilityBinder Selection ProcessThe optimum performance of <strong>UNI</strong>-PURE <strong>DW</strong>depends on various factors including the physicochemicalproperties of the drug, type of filler <strong>and</strong> theprocess used to make granules <strong>and</strong> tablet. In a givenformulation, tablet performance is determined bythe processing conditions.ADirect CompressionPROCESSBWet GranulationMixing withother ingredientsCompressionBinder Addition (powder)Binder Addition (solution/paste)Granulate withwater/moistureHigh/Low shear or fluid-bed processDrying (tray/fluid bed)Screening


Enhanced Tablet PropertiesFast Disintegration TimeDrug Release PredictabilityImproved Crushing StrengthWho we areNational Starch <strong>and</strong> Chemical Company is an experienced participant in the world of pharmaceuticals, health <strong>and</strong>nutrition. For decades, our starches have been key ingredients, as binders, disintegrants, encapsulants, <strong>and</strong> viscosifyingagents, in medications <strong>and</strong> vitamins. We’re an experienced global supplier you can count on – one with world classmanufacturing facilities that will continue to supply consistent products year after year.We operate complete analytical <strong>and</strong> pilot plant facilities around the world, including a state-of-the-art solid oral dosagelaboratory at our research headquarters in Bridgewater, New Jersey, to help you select, test, <strong>and</strong> scale up your formulation.As a global leader in specialty starch research <strong>and</strong> manufacturing, we maintain manufacturing, technical service,<strong>and</strong> sales centers in key business centers on six continents. We are ready to service your account in any part of theworld. For more information, visit our web site at www.nationalstarch.com or www.excipients.com or contact yourlocal National Starch <strong>and</strong> Chemical representative.


Particle Properties And CharacteristicsBulk <strong>and</strong> tap density (typical values)Bulk densityTap densitySEM (500x)0.57 ± 0.01 g/mL0.67 ± 0.01 g/ mLPhysical <strong>and</strong> Chemical Characteristics (cont.)SULFUR DIOXIDE 0.001% maximumORGANIC VOLATILEIMPURITIES Complies to NF st<strong>and</strong>ardsHEAVY METALS 20 PPM maximumARSENIC2 PPM maximumFOREIGNComplies to PhEurMATERIAL st<strong>and</strong>ardsMicrobiological SpecificationsE. Coli NegativeSalmonellaNegativeKlebsiellaNegativeS. Aureus NegativeP. Aeruginosa NegativeProduct SpecificationsPhysical <strong>and</strong> Chemical CharacteristicsCOLORWhite to off-whiteFORMFine powderMOISTURE<strong>UNI</strong>-PURE <strong>DW</strong> 13% maximum<strong>UNI</strong>-PURE <strong>DW</strong>-L 6% maximumSULFATED ASH 0.5% maximumIRON0.002% maximumpH 4.5 - 7.0OXIDIZINGComplies toSUBSTANCES NF/PhEur/JPE st<strong>and</strong>ardsLabel DeclarationPregelatinized Corn Starch NF, PhEurPartly Pregelatinized Starch JPEChemical DescriptionCAS Registry Number: 9005-25-8CAS Registry Name: StarchStorage And H<strong>and</strong>ling<strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>UNI</strong>-PURE <strong>DW</strong>-L are packagedin four-ply, kraft paper bags <strong>and</strong> fiber drums.It is recommended that <strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong><strong>UNI</strong>-PURE <strong>DW</strong>-L be stored in a clean, dry area atambient temperature <strong>and</strong> away from aromatic material.The shelf life for <strong>UNI</strong>-PURE <strong>DW</strong> <strong>and</strong> <strong>UNI</strong>-PURE<strong>DW</strong>-L is 24 months from the date of receipt.North America – Bridgewater, NJ+1 908 685-5303Fax +1 908-685-5489Regional Technical CentersEurope – Hamburg, Germany+49 (0) 40-23915-0Fax +49 (0) 40-23915-170Asia/Pacific – Singapore+65 872-5335Fax +65 872-5988National Starch <strong>and</strong> Chemical Company, 10 Finderne Avenue, Bridgewater, NJ 08807-3300 U.S.A.National Starch <strong>and</strong> Chemical Information Center Tel: 1-800-797-4992 Fax: 1-609-409-5699 Internet: www.excipients.comThe information given <strong>and</strong> the recommendations made herein are based on our research <strong>and</strong> are believed to be accurate but no guarantee of their accuracy is made. In every case we urge <strong>and</strong> recommend that purchasers beforeusing any product in full scale production make their own tests to determine to their own satisfaction whether the product is of acceptable quality <strong>and</strong> is suitable for their particular purposes under their own operating conditions.No representative of ours has any authority to waive or change the foregoing provisions but, subject to such provisions, our engineers are available to assist purchasers in adapting our products to their needs <strong>and</strong> to the circumstancesprevailing in their business. Nothing contained herein shall be construed to imply the nonexistence of any relevant patents or to constitute a permission, inducement or recommendation to practice any invention covered by anypatent, without the authority from the owner of this patent. We also expect purchasers to use our products in accordance with the guiding principles of the Chemical Manufacturers Association’s Responsible Care® program.5201-00-0609-2M© 2000 National Starch <strong>and</strong> Chemical Company

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