Limited aqueous solubility remains a critical challenge in the development of therapeutic agents, particularly for Biopharmaceutics Classification System (BCS) Class II and IV compounds, where dissolution and permeability constraints significantly impact oral bioavailability and parenteral formulation feasibility.

This work presents KLEPTOSE® Crysmeb, a methylated β-cyclodextrin derivative engineered to enhance drug solubility through inclusion complex formation. The physicochemical basis of drug–cyclodextrin interactions is discussed, with emphasis on how complexation modulates apparent solubility, dissolution kinetics, and formulation performance.

Representative formulation strategies incorporating KLEPTOSE® CRYSMEB are evaluated for both oral and parenteral delivery routes, highlighting its utility in overcoming solubility-limited bioavailability. Particular attention is given to its compatibility with diverse active pharmaceutical ingredients (APIs) and its role within contemporary formulation design frameworks.

Steve Amoussou-Guenou, Customer Solutions Manager, Roquette