We provide flexible end-to-end solutions for bioavailability challenged compounds from concept to commercial, and from API to finished drug products. Effective delivery of many BCS class II compounds with low solubility can be enabled with amorphous dispersions made by hot melt extrusion technology (HME).
Functional excipients, such as surfactants, may be added to aid in the extrusion process or to improve dissolution performance upon administration. When cooled, the extrudate generally consists of a single-phase amorphous glassy matrix that can be milled to the desired particle size and incorporated into traditional tablet or capsule dosage forms.
The resultant extrudate is typically milled and directly filled into capsules, or formulated with excipients and compressed into tablet formats.
Our breadth of solubilization technologies and depth of fundamental understanding allows the use of a creative, fit-for-purpose, drug development approach. This means we may focus on low-risk, drug-sparing spray-dried dispersions in early development and transition to HME formulations when and where appropriate based on considerations such as drug properties, dose and cost of goods.
The use of extrudates at a wide range of scales enables the production of extrudates using current cGMP and development processes for use in clinical studies and at small commercial levels. HME capabilities are in place for the development or cGMP production of extrudate for use in clinical studies or small commercial levels.