Continuer?

La page que vous recherchez est disponible en anglais.sur notre site global www.capsugel.com

Pour visiter cette page sélectioner continuer.

Continuer
Annuler

Bioavailability Enhancement Suite: Hot-Melt Extrusion (HME)

For drugs with low solubility or bioavailability, Capsugel Dosage Form Solutions offers a wide range of formulation options and technologies that maximize the opportunity for development and commercial success of drug candidates.

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.

HME Formulation Selection & Process Development

Formulation & Process Development flow chart

HME

Capability Highlights

Available Equipment

Twin Screw Mixers / Hot-Melt Extruders

Twin Screw Mixer

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

Related Links

Health and Nutrition

Additional Resources

Amorphous Solid Dispersions Using Hot-Melt Extrusion Technology


Powered by Translations.com GlobalLink OneLink SoftwarePowered By OneLink