Roquette - Enabling Excipients and Actives: Diluent-Binders, Binders and Disintegrants

Roquette is a global manufacturer of pharmaceutical excipients and actives, and has been supplying the pharmaceutical industry with enabling excipients including binders, diluent-binders and disintegrants for more than thirty years.

LEADING ROLE IN INJECTABLES AND DIALYSIS SOLUTIONS

This dedication has made Roquette a leading supplier of excipients and actives for injectables and dialysis solutions, (LYCADEX® PF dextrose monohydrate, PEARLITOL® PF mannitol, NEOSORB® PF sorbitol, and XYLISORB® PF xylitol).

Thanks to its leadership in polyols, Roquette offers the broadest range combining chemical stability with good taste characteristics, sugar-free sweetness and oral health benefits suitable for numerous pharmaceutical applications. This includes:

• PEARLITOL® C crystalline mannitol
• PEARLITOL® SD and DC granulated mannitol
• NEOSORB® sorbitol
• MALTISORB® maltitol
• XYLISORB® xylitol
• LYCASIN® hydrogenated glucose syrups

PHARMACEUTICAL FORMULATION INNOVATION

The Roquette team has a long track record of helping design pharmaceutical formulations with an in-house team of scientists who are able to investigate chemical, biotechnological microbiological, toxicological and formulation issues.

Thanks to its R&D team at the research, control and application laboratories, Roquette is able to contribute to its customers’ developments, notably in the areas of:

• Injectables (enteral and parenteral solutions)
• Tablets obtained by direct compression or wet granulation
• Syrups, suspensions, Granules and sachets
• OTC and nutraceuticals
• Toothpastes and mouthwashes

Let us share with you our expertise and facilities to create outstanding new formulations!

PYROGEN-FREE RAW MATERIALS

Roquette is the leading specialist of raw materials for injectables and dialysis solutions. Produced for more than 20 years, pyrogen free dextrose monohydrate LYCADEX^® PF is used by a majority of pharmaceutical companies involved in the production of solutions for infusions.

The established range also includes pyrogen free polyols and KLEPTOSE^® HPB, pyrogen free HPBCD. Committed to providing the most complete range of safe and reliable products for dialysis and parenteral applications, Roquette most recently introduced Sodium Lactate Pharma and Sodium Gluconate Pharma. These highly purified pharmaceutical organic salts act as physiological buffers in dialysis and injectable solutions.

EXCIPIENTS AS DILUENT-BINDERS, BINDERS AND DISINTEGRANTS

Roquette proposes a remarkable varied range of diluent-binders such as PEARLITOL® SD and DC mannitol, a comprehensive range of granulated mannitol. The range is particularly useful in challenging or unstable formulations and appropriate for all types of tablets including chewable / oral dispersible or effervescent tablets.

STANDARD DISINTEGRATION EXCIPIENTS

Roquette has also developed a versatile range of standard disintegration excipients ranging from native starches to the innovative starch compound STARLAC®. We also offer the partially pregelatinized starch LYCATAB® C, and GLYCOLYS® sodium starch glycolate superdisintegrant.

WET GRANULATION AND PHARMACEUTICAL BINDERS

Wet granulation can be achieved through different processes, the wetting and granulation having a marked impact on the quality of the final granules. Roquette has developed specific pharmaceutical binders with different degrees of water solubility or dispersibility:

LYCATAB® PGS, a pregelatinized dispersible starch, is ideally used in dry blends.

LYCATAB® DSH, a water-soluble maltodextrin binder, is suitable for preparation of granulation solutions or use in dry blends.

FORMULATION CHALLENGES - CUSTOM-DESIGNED EXCIPIENTS

By understanding the formulation challenges of its customers, Roquette lead the development of purpose designed excipients. These excipients are designed for applications including:

• PEARLITOL® and STARLAC® diluent-binders for direct compression
• LYCATAB® binders for wet granulation
• KLEPTOSE® cyclodextrines for molecular encapsulation
• GLYCOLYS® superdisintegrants
• STARLAC® filler binder
• NUTRIOSE® soluble fibers

ENSURING QUALITY IN OUR EXCIPIENTS AND ACTIVES

Roquette's commitment to excellence in the field of enabling excipients for the pharma industry can be measure through its attitude to quality issues with its production conforming to the world's highest quality standards. Our manufacturing plants are regularly audited by international regulatory bodies, such as the US FDA and European authorities, to further ensure that quality.