Hot-Melt Extrusion

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

hot-melt extrusion highlights

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 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  development or cGMP production of extrudate for use in clinical studies or small commercial levels.

Capability Highlights:

• Rational selection of technology based on physicochemical properties of drug, development stage, and cost of goods implications
• Extensive experience formulating solid dosage forms incorporating HME intermediates
• Development and cGMP extrusion manufacturing capabilities (18-, 19- and 27mm twin-screw extruders) with a large selection of prefabricated dies
• Full selection of ancillary feeding, cooling, pelletizing and milling equipment
• Predictive model-based approach to performance evaluation, stability assessment and process definition to minimize development time and risk to clients’ programs.