PII Expands Drug Formulation and Manufacturing Capabilities With Hot Melt Extrusion Technology

Pharmaceutics International, Inc. (Pii), has announced that it 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.

This investment enables Pii to carry out feasibility studies, using just a few grams of active pharmaceutical ingredient, to pilot scale cGMP productions for Phase I and II clinical trials using HME.

A well known processing technology, hot melt extrusion 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.

“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.

King continued, “This proven technology further enables us to meet the challenges of poorly soluble compounds and advance our client’s compounds through the development pipeline.”

In addition to the new hot melt extrusion capability, Pii’s solutions for bioavailability enhancement include spray drying, solvent‐based fluid bed processing, soft gels and liquid filled hard capsules.