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Effective delivery of many of BCS class II compounds with low solubility can be enabled with amorphous dispersions made by hot-melt extrusion (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.
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 (SDDs) 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 extruders at a wide range of scales enables production of extrudates using current Good Manufacturing Practice (cGMP) and development (non-cGMP) processes for use in clinical studies and at small commercial levels.
|Type & model||Manufacturer||Scale||cGMP||Non cGMP|
|ZSE-18, 18 mm||Leistritz||0.1 - 10 kg/hr|
|MP-PH, 19 mm||Baker Perkins||0.1 - 10 kg/hr|
|ZSE-27, 27 mm||Leistritz||1 - 25 kg/hr|
|Additional accessories for all extruders:
K-Tron loss-in-weight powder feeders, liquid feeders and pelletizer, Sandvik chill roll, Leistritz side stuffer