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Hot Melt Extrusion
Solutions for poorly soluble compounds
Hot Melt Extrusion (HME) is a widely applied technology in the plastics industry. Although a relatively new technology in the pharmaceutical industry, HME has proven to be a robust and viable method for pharmaceutical applications and has exciting prospects for the future.
HME is the process of embedding drug in a polymeric carrier. Specifically, HME dosage forms are complex mixtures of API, functional excipients, and processing aids. The mixture is processed at elevated temperature and pressure, which disperses the drug in the matrix at a molecular level through the formation of a solid solution. Extruded material can be further processed into a variety of dosage forms, including capsules, tablets and transmucosal systems.
Not only is HME an efficient manufacturing process, it has also been shown 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.
HME Advantages
HME offers several advantages over traditional pharmaceutical processing techniques including:
- Enhanced bioavailability of poorly soluble compounds
- Processing in the absence of solvents and water
- 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
PharmaForm’s extensive experience applying HME techniques to drug delivery has made PharmaForm a recognized world-leader in formulating molecules using HME. PharmaForm’s scientists have authored several peer-reviewed articles, presentations and book chapters on the topic and are listed as co-inventors on approved US patents related to HME.
PharmaForm has been involved in over twenty HME projects, including feasibility assessment, phase I, II, and III formulation development, and reformulation and life-cycle management projects.
PharmaForm is one of a few contract development organizations capable of taking a drug candidate from formulation development to GMP manufacturing utilizing HME.
HME Dosage Forms Developed at PharmaForm include:
- Orally dissolving thin films
- Bioadhesive films for transmucosal delivery
- Tablets and capsules with improved bioavailability
PharmaForm HME Processing Equipment
- Twin Screw Co-rotating Extruders
- Single Screw Extruder
- Developmental-scale Melt Mixer (process as little as 0.5 g of material)
Contact Us
If you would like more information about our hot melt extrusion capabilities, contact Elizabeth Hickman at 512 834-0449 x264.
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