Hot-Melt Extrusion (HME)
An estimated 60 percent of compounds in early development have poor solubility. Effective delivery of many of these compounds can be enabled with amorphous dispersions made by hot-melt extrusion (HME). Amorphous dispersions made by hot-melt extrusion involve co-melting of the drug substance and 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. Upon cooling, 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.
Our breadth of solubilization technologies and depth of fundamental understanding allow use of a creative, fit-for-purpose, drug development approach. This means focusing on low risk, drug substance-sparing spray-dried dispersions (SDDs) in early development, and transitioning to HME when appropriate based on considerations such as drug substance properties, dose, and cost of goods. Bend Research is the partner of choice for development and clinical manufacturing of HME formulations.
- Over a decade of experience in amorphous dispersion and extruded formulation development.
- R&D and cGMP extrusion capabilities (18 mm and 27 mm twin-screw extruders).
- Rational selection of technology based on physicochemical properties of drug substance, development stage, and cost of goods implications.
- Predictive model-based approach to performance and stability assessment, and process definition to minimize development time and risk to clients' programs.
- Extensive experience formulating solid dosage forms incorporating extruded intermediates.