Our breadth of solubilization technologies and depth of fundamental understanding facilitates the use of a creative, fit-for-purpose, drug development approach.
Hot-melt extrusion (HME) technology is an established solid dispersion technology for improving dissolution rate and solubility, and a component of our premier bioavailability enhancement services. HME has broad applicability across poorly soluble (BCS II and IV) compounds and the resultant extrudate can be readily formulated in either tablets or capsules. We offer our customers 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 HME. HME manufacture of amorphous dispersion involves the melting of a drug substance with an appropriate polymeric excipient in a co-rotating twin-screw extruder. 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.
Resultant extrudate is typically milled and directly filled into capsules, or formulated with excipients and compressed into tablet formats. We are fully equipped to produce the hot-melt extrudate and finished dosage form for feasibility assessments, clinical trials and commercial scale applications.
Formulation & Process Development Flow Chart