Pii Expands Formulation, Manufacturing Capabilities

Pharmaceutics International, Inc. (Pii) has added hot melt extrusion (HME) to its portfolio of formulation and process development solutions. The company has purchased a 16mm and an 18mm Leistritz twin screw extruders, an investment enabling Pii to carry out feasibility studies using just a few grams of API, to pilot scale cGMP productions for Phase I and II clinical trials using HME.

“Pii’s investment in hot melt extrusion is part of the company’s goal of providing our clients with a comprehensive package of bioavailability enhancement capabilities,” said Steve King, senior vice president of Pii. “This proven technology further enables us to meet the challenges of poorly soluble compounds and advance our client’s compounds through the development pipeline.”

HME offers a number of benefits to optimize drug formulation, including the development of solid dispersions for bioavailability enhancement of poorly soluble compounds and controlled release drug delivery. In addition to the new hot melt extrusion capability, Pii’s bioavailability enhancement portfolio includes spray drying, solvent-based fluid bed processing, soft gels and liquid filled hard capsules.