Products in Excipients

POLYSORB® 85/70/00 Partially dehydrated sorbitol liquid is a plasticizer in soft capsules and orally dissolving films. It can be used in pharmaceutical dosage forms.POLYSORB® 85/70/00 is an aqueous solution of D-sorbitol and 1.4- sorbitans that has been developed by Roquette as a plasticizer for soft gelatine capsule applications. The advantage of this product in soft gels relates to its remarkable compatibility with gelatin that ensures no migration over time thereby preventing any defects like graining when crystallizing plasticizers are used or leaching phenomena either into the filler media or at the surface of the soft gel.

PEARLITOL® CR-H - HYPROMELLOSE – MANNITOL is a combination of hypromellose (HPMC) and mannitol that offers excipient functional properties for tablet formulations. It serves as a binder while also providing controlled release characteristics. Specifically designed for direct compression formulations, Pearlitol® CR-H is suitable for use in oral tablets for both pharmaceutical and nutraceutical applications that require controlled properties.

GLYCOLYS® Low Solvent Sodium Starch Glycolate is a superdisintegrant for pharmaceutical and nutraceutical swallowable tablets, orally dispersible tablets and hard capsules. Features Different grades designed to meet specific needs: Withstanding high shear granulation Acidic conditions Low organic solvent content

LYCATAB® C partially pregelatinized starch is used in pharmaceutical and nutraceutical applications as a multifunctional for oral dosage forms. Applications gelatin capsules as a filler direct compression applications as a filler/binder swallowable tablets and hard capsules as a filler/binder/disintegrant Features Combines the disintegration power of starch granules with the high cohesion and good compressibility of pregelatinized starch Due to limited flow properties, often requires the use of additional excipients and production steps such as granulation or partial pregelatinization

LYCADEX® PF is a pyrogen-free dextrose monohydrate that can be used: as isotonic agent in Rx excipients and in injectable applications including large volume parenteral, total parenteral nutrition as a carbohydrate source and osmotic agent for hemodialysis and peritoneal dialysis

NEOSORB® BioPharma Low endotoxin grade sorbitol provides protein stabilization in your biopharmaceutical downstream applications. Known for its high water solubility, it is a proven formulation aid for biopharmaceuticals. Sorbitol is used as an excipient in over 35 commercial mAbs, therapeutic proteins and vaccines. Roquette's in process quality controls ensure a consistent supply of raw materials and excipients to help bring your biologics to life. Through our integrated supply chain and rigorous quality systems, we reduce the risks associated in biopharmaceutical manufacturing. NEOSORB® BioPharma is suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Contact us today to talk about our multi-compendial materials - EP, JP, and USP.

LYCASIN® Maltitol liquids are used as vehicle and humectant for syrups, suspensions and as sweetener in lozenges and medicated confectionary. LYCASIN® has taste and sweetness properties ideal for the preparation of sugar-free syrups made for pediatric and diabetic population.

StarLac® Co-processed lactose starch is a filler/binder with strong disintegrant properties. The co-processing offers superior benefit compared to a blend of lactose and starch. It allows to improve the performance (hardness, friability, disintegration time) of your formulation. Specifically designed for direct compression applications, StarLac® is also an excellent filler/binder in dry granulation processes. StarLac® can be used in various oral dosage forms in pharmaceutical applications including granules, swallowable tablets, orally dispersible tablets and hard capsules.

SweetPearl® P90 - MALTITOL powder is used as a filler and filler/binder. SweetPearl® provides stability to your formulation due to its chemical stability and low hygroscopicity. The SweetPearl® range offers you a choice between various particle sizes and densities to meet your formulation needs. It can be used in pharmaceutical applications such as swallowable tablets, chewable tablets, effervescent tablets, coatings, and medicated confectionery. As a patient-friendly excipient, it allows you to formulate non-cariogenic, non-acidogenic, and sugar-free formulations to address the widest patient population.

MICROCEL® Microcrystalline cellulose is used in pharmaceutical and nutraceutical applications as a filler/binder and fiber source in various oral dosage forms. Applications Swallowable tablets Hard capsules Blends Granules Pellets premix Features Available in a large range to meet different formulation, process and dosage form requirements Large surface area allows adsorption of particles or liquids and a certain capacity to act as a disintegrant Spray dried and offered from EXCiPACT (International Pharmaceutical Excipients Certification) certified plant

KLEPTOSE® HPB Hydroxypropyl Betadex Cyclodextrin is a modified beta-cyclodextrin parenteral grade material that can be used as an encapsulating agent for Rx injectables. Benefits Improves stabilization of active substances against light and oxidation Enhances solubilization of active pharmaceutical ingredients Features White, amorphous powder Molecule is a torus-shaped ring with a polar hydrophilic outside and an apolar hydrophobic cavity

Maize Starch 5% native acts as a thickener, humectant and bulking agent for cakes, pastries, custards, fillings, sauces and other food applications. Benefits Shelf-life extension Texturizing Water retention

NEOSORB® XTAB 300S is a directly compressible sorbitol powder that can be used for very hard, sugar-free tablets with high flavor load. Benefits Delivers a smooth, hard and uniform colored surface Provides a clean, cooling effect Does not produce acids or cause dental plaque or tooth decay Nutritional benefits (maintenance of tooth mineralization, tooth-friendly generic EU claims) recognized by European regulations Features Non-cariogenic Sugar-free

Roquette Pea Starch N735 is a versatile ingredient that serves as an anti-caking agent, binder, carbohydrate source, and texturizing agent. Available in powder form, this neutral-scented, white to off-white powder effortlessly enhances your formulations. It offers alcohol solubility and a neutral taste.

SOLUTAB® Croscarmellose sodium is used in pharmaceutical and nutraceutical applications as a superdisintegrant for various oral dosage forms. Applications Swallowable tablets Orally dispersible tablets Hard capsules Blends Granules Pellets premix Benefit Efficient disintegration at low use level Features Crosslinked carboxymethyl cellulose sodium Three grades are available Disintegration performance is obtained through the wicking and swelling capacity that can be maximized via the selection of its origin (wood or cotton) Can be adapted to wet and dry granulation or direct compression processes

TACKIDEX® Potato dextrins provide a variety of benefits to the manufacturer and consumer as both an excipient and a nutrient. They are white to yellow powders obtained from maize, tapioca, and potato starch by heat treatment. These are ingredients for clinical nutrition and nutraceuticals. Dextrins are starch polymers derived through solid-state heating from partially hydrolysed starch. Dextrinization is a classical starch processing technology that makes partial or complete solubility possible. As an excipient, dextrins are a binder, filler, stabilizer,  suspending agent, and viscosifier. As a nutrient, it is a carbohydrate and fiber source. TACKIDEX® can be used in various oral dosage forms in both pharmaceutical and nutraceutical applications, including swallowable tablets, chewable tablets, effervescent tablets, lozenges, hard capsules, soft capsules, coatings, orally dissolving films, blends, granules, pellet premix, medicated confectionary, syrups, suspensions, and liquids.

KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex Cyclodextrin is a low endotoxin grade materials that provides protein stabilization for biopharmaceutical downstream applications. With a hydrophobic internal cavity and hydrophilic exterior, KLEPTOSE® HPB BioPharma can encapsulate molecules, forming inclusion complexes where lipophilic compounds are non-covalently bound within the cavity. It is suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Benefits Unique ability to encapsulate and shield water insoluble materials can be utilized to shield exposed hydrophobic residues on aggregation-prone proteins, thereby modulating protein aggregation Shows promise as a multifunctional excipient suitable for biopharma applications Can serve as a tool to synergistically complement biotherapeutic formulations Multicompendial material (EP, USP, JP) Features Starch derivative Cyclic oligosaccharide with a bucket-like structure

PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical applications as a filler, filler/binder and bulk sweetener for various oral dosage forms. Applications Swallowable, orally dispersible, chewable and effervescent tablets, Lozenges Blends Granules Pellets premix Medicated confectionery Benefit Suitable for use in formulations addressing all types of patient populations, including pediatric and diabetic Features Directly compressible Unique blend of exceptional physical and chemical stability No hygroscopicity Organoleptic, non-cariogenic and sugar-free properties

SWEETPEARL® P35 is a product with the chemical name maltitol, serving as a sweetener, nutritive sweetener, and sugar substitute. It falls under food ingredient functions, specifically as a nutritive sweetener and sugar substitute. The labelling claims for this product include being biodegradable. SWEETPEARL® P35 is primarily targeted at the food and nutrition markets and is commonly used in chewing gum applications. It is water-soluble and presents as a white crystalline powder with no discernible odor, offering a cool and sweet taste.

PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in oral dosage form applications. Applications Swallowable, orally dispersible, chewable and effervescent tablets Lozenges Blends Granules Pellets premix Medicated confectionery Features Unique blend of exceptional physical and chemical stability and no hygroscopicity Directly compressible crystalline range with various particle sizes Great organoleptic, non-cariogenic and sugar-free properties Suitable for use in formulations addressing pediatric and diabetic patient populations

GLYCOLYS® Sodium Starch Glycolate is a superdisintegrant for pharmaceutical applicationbs such as swallowable tablets, orally dispersible tablets and hard capsules. Benefits BSE-free Halal and Kosher certified Melamine-free Non-GMO Non-hazardous TSE-free Vegan Features Free of off-odors Low ethanol content

PEARLITOL® Flash is used in nutraceutical and pharma oral dosage forms as a filler/binder for orally dispersable tablets. Applications Fast disintegrating tablets Orally dispersible tablets Benefits Excipient functional properties Disintegrant benefit Simplifies tablet formulation Features Compound of mannitol and starch adapted to direct compression formulation Excellent chemical inertness Consistent rapid disintegration under any compression force

KLEPTOSE® LINECAPS Pea Maltodextrin Cyclodextrin can be used as a solubilizer, stabilizer and taste-making agent in pharma oral dosage applications. Applications Swallowable, chewable and effervescent tablets Lozenges Hard and soft capsules Orally dissolving films Blends Granules Pellets premix Medicated confectionery Syrups Suspensions Liquids Cream Paste Semi-solids

CLEARGUM® CO 03 is a pregelatinized, low-viscosity octenyl succinate starch that can be used as an emulsifier and solubilizer in pharmaceutical and nutraceutical formulations including encapsulation of vitamins or APIs. and as a binder in wet granulation. Benefits BSE-free Halal and Kosher certified Melamine-free Non-GMO Non-hazardous TSE-free Vegan Features Food modified starch (E1450) Free of off-odors Low viscosity Tasteless

NEOSORB®70/70 B Sorbitol liquid crystallizing and non-crystallizing products are widely used excipients as vehicle in liquid dosage forms and as a humectant in semi solids. They can be used in various pharmaceutical and nutraceutical applications including lozenges, medicated confectionary, syrups, suspensions, creams and pastes. These NEOSORB® 70/70 B brand materials are part of a large family of Roquette polyol compounds containing sorbitol and other hydrogenated long chain oligomers and polymers. NEOSORB®70/70 B solutions can be used as substitutes for sucrose and meet organoleptic (natural sweetness) and health requirements (i.e they are sugar-free, low-calorie, do not induce dental caries, and may be advised for diabetics). These grades will differ by a difference of composition and concentration in sorbitol and other polyols.

Dextrose Anhydrous is a sugar carbohydrate used for as a filler and a carbohydrate source in pharma oral dosage and nutraceutical forms, including swallowable tablets, chewable tablets, effervescent tablets and medicated confectionaries. Features Monomer of natural starch polymer that is also the natural physiological sugar in the human body Provides key excipient and nutrient benefits Natural low water content compared to dextrose monohydrate t High stability Available as a range of products to meet application requirements of manufacturers

NEOSORB® Sorbitol pharma is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener for oral dose applications. It can also be used as a plasticizing agent well-adapted to starches in coating/film forming applications. Applications Powder blends Premixes Granules Pellets Swallowable, chewableand effervescent tablets Medicated confectionary Features Excellent tableting properties Non-cariogenic Non-acidogenic Sugar-free Suitable for use in formulations addressing pediatric and diabetic patient populations

XYLISORB® Xylitol powders are used in coatings for pharmaceutical and nutraceutical formulations, and as a filler, filler/binder and bulk sweetener that provides nutrient benefits. Applications Swallowable tablets Medicated confectionery Features Five-carbon polyol with a characteristic crystalline shape Low-calorie, sugar-free ingredient with high natural sweetness Suitable for use in formulations addressing pediatric and diabetic patient populations

LYCATAB® PGS is used in pharmaceutical and nutraceutical applications as a binder for wet granulation. Features Natural pregelatinized maize starch resulting from a combination of the natural binding properties of pregels starches and a controlled manufacturing process Dispersible and partially soluble in cold water and ready for use High-stability reproducible binding properties during granulation and dissolution profile of actives in final forms Can be used in granules and swallowable forms

PEARLITOL® PF is a pyrogen-free mannitol that is used for parenteral preparations and Rx injectables. Applications Osmotic diuretic agent in small and large volume parenteral injectables Isotonic agent and bulking agent for freeze-dried powder for Rx injection or infusion Pharmaceutical API used to reduce elevated pressure in the brain (cerebral oedema) and in the eyes (note: production has to comply with the internationally accepted GMP standards)

NEOSORB® PF pyrogen-free sorbitol is used: as a carbohydrate source and osmotic diuretic agent in large-volume parenteral injectables as an isotonic agent for Rx injectables as an irrigating fluid for surgical procedures, to prevent intra- and extra-cellular dehydration

Roquette powdered NF corn starch is used in pharmaceutical and nutraceutical formulations as a disintegrant, filler and binder (once cooked). Applications Swallowable tablets Hard capsules Blends Granules Pellets premix

Roquette Dextrose Monohydrate acts as a sweetener, pigment and flavor enhancer in various pet food and feed specialties. It has a sweet flavor (approximately 0.75 times greater than that of sucrose) and therefore improves the palatability of finished products.

KLEPTOSE® HPB Oral Grade is a solubilizer and stabilizer for pharmaceutical and nutraceutical oral dosage applications. Applications Swallowable, chewable and effervescent tablets Lozenges Hard and soft capsules Orally dissolving films Blends Granules Pellets premix Medicated confectionary Syrups Suspensions Liquids Cream Paste Semi-solids Benefits Improves the solubility of poorly soluble compounds Can be used for taste masking of bitter or unpleasant active ingredients

XYLISORB® Xylitol powders can be used in pharmaceutical and nutraceutical applications as a filler, filler/binder and bulk sweetener that provides nutrient benefits. Applications Swallowable tablets Medicated confectionaries Features Five-carbon polyol with a characteristic crystalline shape Low calorie sugar-free ingredient with high natural sweetness Suitable for use in formulations addressing pediatric and diabetic patient populations

XYLISORB® Xylitol powders can be used as a low calorie, sugar-free ingredient that provides high natural sweetness. A five-carbon polyol with a characteristic crystalline shape, it provides excipient benefits as a coating, filler and filler/binder and nutrient benefits as a bulk sweetener. It can be used: in pharmaceutical and nutraceutical oral dosage applications, including swallowable tablets and medicated confectioneries in formulations addressing all types of patient populations, including pediatric and diabetic