With over a decade of experience in the formulation, characterisation and manufacture of stabilised amorphous dispersions, Pharmaterials are pleased to extend their capabilities in the field with the addition of a cGMP Leistritz Hot Melt Extruder.
Hot Melt Extrusion (HME) is a proven processing technology for the development of pharmaceutical products with improved performance and reduced manufacturing costs. It’s potential is reflected in the range of different dosage forms it is able to produce and application as a drug delivery processing technology for poorly soluble compounds and controlled release dosage forms.
Our equipment capabilities include:
- 16mm Leistritz Twin Screw Extruder
- 18mm Leistritz Twin Screw Extruder
- K-Tron Precision Powder Feeder
- Pelletizer, Calender & Chiller
The equipment allows for the production of granules, pellets, capsules, tablets and transmucosal dosage forms using HME. We can carry out feasibility studies, using just a few grams of API, through to cGMP production for Phase I and II clinical trials. The new equipment complements Pharmaterials existing capability for manufacturing spray dried dispersions. It also allows Pharmaterials to develop continuous manufacturing processes of both granulated products and solid dispersion products.
Please contact us to find out more about the exciting opportunities that this technology can provide for your drug product.