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Hot Melt Extrusion

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.

A continuous processing technology, HME combines multiple unit operations, such as granulation and blending, into a single process. More specifically, HME is the process of embedding drug in a thermoplastic carrier by forcing mixtures of API, functional excipients, and processing aids through a die under controlled conditions, including temperature, mixing, feed-rate and pressure.

Benefits & Advantages:

  • Improved bioavailability of poorly soluble compounds
  • Improved clinical profiles and patient compliance
  • Extended patent life and product differentiation
  • Continuous operation leading to reduced production time and cost

Applications of HME

HME has been shown to provide sustained, modified, and targeted drug delivery. Additionally, the application of the technology to produce solid solutions and dispersions demonstrate its value as a drug delivery processing tool for poorly soluble compounds. Improved bioavailability is achieved by modifying the physical state of the drug by dispersing the drug in the polymer matrix at the molecular level thus increasing drug release. HME has been applied to:

  • The Creation of Solid Dispersions
  • The Development of Controlled Release Formulations
  • Taste Masking
  • Life Cycle Management
  • Processing of Potent Compounds Under Protected Conditions

HME Equipment & Capabilities

Pii is able to produce granules, pellets, capsules, tablets and transmucosal dosage forms using HME. We can 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. Our equipment capabilities include:

  • 16mm Leistritz Twin Screw Extruder
  • 18mm Leistritz Twin Screw Extruder
  • K-Tron Precision Powder Feeder
  • Pelletizer & Chiller

An Experienced Provider

With more than 400 development programs completed, Pii has an extensive track record working with difficult to formulate drug substances and complex manufacturing processes. Building on this experience, Pii has added HME to its arsenal of tools to further meet the challenges of poorly soluble compounds.

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