Roquette has announced the launch of its latest novel pharmaceutical excipient, KLEPTOSE Crysmeb methyl-beta-cyclodextrin (MßCD).
The 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).
Unlike DIMEB or RAMEB forms of methylated cyclodextrin, KLEPTOSE Crysmeb is suitable for both oral and parenteral delivery methods.
This then allows drug manufacturers greater freedom to adapt for therapeutic efficacy and patient preference.
This flexibility makes KLEPTOSE Crysmeb an ideal solution for drug development and optimisation, blending safety and formulation performance.
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 stabiliser, able to protect sensitive actives from degradation caused by temperature fluctuations encountered during production and supply chain.
"Thousands of hours of study, experimentation and optimisation 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 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."
Pharmaceutical producers can also be sure 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 recognised 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.