Robust and Facile Platform to Enhance the Solubility of Drugs and Dietary Supplements

Poor solubility of therapeutic molecules is a common problem within drug formulation. Nearly 90% of all drug candidates are poorly soluble which increases the time and required resources for R&D to bring the desired product to the market. The problem of poor solubility is also ubiquitous for a wide range of bioactive dietary supplements.

A Swedish company has developed a proprietary technology platform for oral drug delivery formulations (directly compressed tablets) based on a high surface area microcrystalline cellulose analogue that allows for increased bioavailability and rapid onset of poorly soluble substances from highly diverse pharmacological classes. The platform is very robust and suitable for formulation of substances from a wide variety of pharmacological classes. 

• Reformulation of existing problem drugs;
• Formulation of poorly soluble problem drug candidates;
• Formulation of poorly soluble dietary supplements;
• Establishment of maximum toxicity dose in pre-clinical product development.

Possible clinical indications include OTC drugs; pain management; Ca-channel blockers; anti-cancer drugs; anti-viral drugs; poorly soluble peptides; dietary supplements.

The platform has clear clinical and process-economic benefits. The clinical benefits are related to enhanced bioavailability, reduced fasted-fed state variability, and rapid onset of action. Process-economic benefits include facile manufacturing using widely available industrial equipment; dry powder processing, which eliminates the need for solvents and spray/freeze-drying processes; no need for formulating drug in the form of soft gel capsules; direct compression tableting is based on an excipient which acts both as a drug carrier and tablet binder, i.e. minimum number of additives; overall cost-efficiency and scalability.