Hot Melt Extrusion (HME) is a widely applied technology in the plastics industry. An increasingly explored technology in the pharmaceutical industry, HME has proven to be a robust and viable method for pharmaceutical applications capable of creating a diverse range of dosage forms with clinical benefits.

HME is the process of embedding drug in a thermoplastic carrier. The mixture is processed at elevated temperatures and pressures, which disperses the drug in the matrix at a molecular level to form a solid solution. Extruded material can be further processed into a variety of dosage forms, including capsules, tablets and transmucosal systems. HME is an efficient platform for the production of amorphous solid dispersions to enhance the bioavailability of poorly soluble compounds. HME is suitable for both low and high-potent compounds and has been demonstrated to provide sustained, modified and immediate release profiles. These applications demonstrate the potential of HME as a drug delivery processing technology.

Hot Melt Extrusion Advantages

HME offers several advantages over conventional pharmaceutical processing techniques including:

  • Enhanced bioavailability of poorly soluble compounds
  • Economical process with reduced production time, fewer processing steps, and a continuous operation
  • Clinically advantaged dosage forms, such as drug abuse and dose dumping deterrent technology
  • Sustained, modified and targeted release capabilities
  • Life cycle management / Intellectual property positioning

Hot Melt Extrusion Expertise

Formex’s extensive experience applying HME techniques to drug delivery has made Formex a recognized world-leader in formulating molecules using HME. Formex’s scientists have authored numerous peer reviewed articles, presentations and book chapters on the topic and are listed as co-inventors on approved US patents related to HME. Formex is one of a few contract development organizations capable of taking a drug candidate from formulation development to GMP manufacturing utilizing HME. Formex’s experience with and integrated approach to HME formulation and process development ensures the most rapid and cost effective route to the clinic.

HME Dosage Forms Developed at Formex include:

  • Orally dissolving thin films
  • Molded tablets
  • Bioadhesive films for transmucosal delivery
  • Tablets, granules and capsules with improved bioavailability

Hot Melt Extrusion Processing Equipment

  • 18mm Leistritz Twin Screw Co-rotating Extruder
  • 16mm Leistritz Twin Screw Co-rotating Extruder

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