Vendor Watch

Vendor Watch

Roquette announces continuous commitment to mannitol

Roquette, a world leader in polyols (sugar alcohols) and one of Europe’s largest and most advanced starch producers, has announced an investment to increase its mannitol production with a new capacity in its US facilities. Roquette processes nature’s products, adapting them to needs of the industry. With starch derived from corn, wheat, potato and pea, the company produces an extensive range of high-quality ingredients for the food, fermentation, pharmaceutical, paper and corrugated board, chemical, and feed industries.

This expansion of capabilities adds mannitol to Roquette’s US manufacturing facility which is already producing maltitol, sorbitol and other new products, to meet continued growth needs of the health food and pharmaceutical excipient markets. The increasing demand for mannitol in these applications is behind Roquette’s decision to invest further in this product line, not only in terms of manufacturing capacity to ensure continuous supply and reliability, but also in terms of product development.

Roquette’s commitment to the development of mannitol comes at a time of increased focus for the company around innovation and development of products for the healthcare industry. M Edouard Roquette, Global Marketing Director for the Group, says, “It is clear that mannitol is a sophisticated polyol with exceptional application potential for the pharma and health areas. This product line falls within Roquette’s core development and know-how where the company has a wealth of experience. We will continue to play to this strength in developing mannitol, making it one of the cornerstones of the excipient’s industry.”

Roquette’s production and quality investment reaffirms the company’s willingness to maintain its leadership in the mannitol business. A major GMP quality assurance programme has just been concluded on the endotoxin controlled pyrogen-free mannitol line, making this product the only mannitol PF to be GMP certified according to the new ICH Q7A rules. M Ph Olivier, Corporate QA Director says, “This GMP upgrade has been a major investment for our QA group. This was started as a voluntary upgrade to satisfy our healthcare customers. It is satisfying to see that it is now becoming the industry’s standard and it is gratifying to be able to guarantee full compliance to the new rules. The upgrade concerns formally the API mannitol grade, but in terms of quality safety it also benefits the mannitol grade excipients produced on the line. “

What is mannitol?

Mannitol is one of the sugar alcohols or polyols available and has been used in diverse applications for a number of years. Roquette pioneered the industrial production of mannitol in the 1970’s and has assured a constant high quality grade independent of seasonal variations.

Mannitol has many virtues and numerous uses in the food industry, but it has been in the pharmaceutical and health industry that this product has excelled. The availability of a consistent and reliable quality grade has made mannitol a particularly suitable excipient for the pharma and health industries. In terms of excipient profile, mannitol has a share of the most desirable qualities that formulators seek in mineral, sugar or even polymeric excipients, notably a characteristic low chemical reactivity, an extraordinarily low level hygroscopicity making it one of the “driest” products for moisture sensitive formulation, coupled with a pleasant taste and mouthfeel.

Such remarkable intrinsic properties have been further developed over the years by Roquette’s technical teams leading to the creation of the largest mannitol range for the pharma and health industries. The mannitol range (Pearlitol) which includes filler-diluents with different particle sizes, innovative and patent protected filler-binders for direct compression and also an endotoxin controlled grade as an active diuretic ingredient.

The inescapable chemical and technical virtues of mannitol, coupled with the finely tuned properties of the Roquette’s Pearlitol range have brought this product from a relatively elite and exotic status firmly into the frame for pharmaceutical and nutraceutical formulations. Today mannitol is becoming a centrepiece excipient in the formulators toolbox.