Roquette, a global leader in plant-based ingredients and pharmaceutical excipients for the health and nutrition sectors, today, celebrates the launch of its latest novel pharmaceutical excipient: KLEPTOSE® Crysmeb methyl-beta-cyclodextrin (MßCD). This unique solution harnesses the high encapsulating performance of specifically modified MßCD to enhance the solubility and stability of a wide range of active (bio)pharmaceutical ingredients (APIs). In contrast to DIMEB or RAMEB forms of methylated cyclodextrin, KLEPTOSE® Crysmeb is suitable for both oral and parenteral delivery methods, allowing drug manufacturers greater freedom to adapt for therapeutic efficacy and patient preference. This flexibility makes KLEPTOSE® Crysmeb an ideal solution for drug development and optimization, blending safety and formulation performance.

Stable, soluble and encapsulated

KLEPTOSE® Crysmeb is a unique MßCD in which most of the methyl groups are attached at the C2 position on the glucose chains that make up cyclodextrins’ distinctive ring-shaped molecules. This specific substitution pattern significantly increases the aqueous solubility of the modified cyclodextrin, allowing it to form soluble inclusion complexes with poorly soluble APIs such as those used in Class II and IV drugs. The excellent encapsulation capacity of KLEPTOSE® Crysmeb makes it an equally powerful stabilizer, protecting sensitive actives from degradation due to temperature fluctuations encountered during production and supply chain.

“Thousands of hours of study, experimentation and optimization have gone into the creation of KLEPTOSE® Crysmeb,” said Elham Blouet, Regional Head of Biopharma Technology at Roquette. “Apart from its exceptional solubility, stability and bioavailability-enhancing properties, what truly sets this solution apart is its suitability for both liquid and solid dispersions, meaning it is as powerful in innovative oral formulations, as it is in parenteral formulations.”

Assured safety from the excipient experts

In addition to offering unmatched functional properties, pharmaceutical producers can rest assured that KLEPTOSE® Crysmeb meets the same high standards of quality, safety, and traceability demanded of all Roquette excipients. The new solution is manufactured in accordance with recognized quality systems, including ISO 9001 and GMP for pharmaceutical excipients, relevant ICH guidelines for elemental impurities and residual solvents, and major nitrosamine regulations. US Drug Master Files Type IV can also be made available to formulators to help streamline regulatory file submissions.

Thanks to its uniquely robust and transparent, vertically integrated supply chain, Roquette is able to offer drug manufacturers the comprehensive sourcing information they need for complete peace of mind. In addition, the company’s expert formulation teams are always ready to provide technical data and guidelines, helping partners accelerate early-stage drug development and launch new therapies to market faster.