Platform Technologies

Hot Melt Extrusion for High Potent Drugs

Midas offers profound know-how and expertise available, based on hands-on working experience with HME and related  technologies since more than 10 years (from development to commercial manufacturing). The Manufacturing site has multiple GMP certifications (e.g. EU, FDA, ANVISA) and Controlled Drugs Licence.

Advantages of Hot Melt Extrusion

  • Well suitable for thermolabile products, as processing time is only minutes
    (advantage over bead coating or melt granulation)
  • Low dust formation (advantage over spray drying), safe handling of high potent drugs
  • Solvent free process (advantage over spray drying)
  • Relatively high drug load possible
  • Ability to incorporate taste masking and abuse deterrent technologies (“one-step-process”)
  • Allows many patent circumventing pathways as well as claiming own IP
  • Predictable and easy up-scale
  • 3D-Printing

Services:

Development

  • Screening of polymers
  • Proof of concept (suitability of HME)
  • Identification of lead formulation
  • Confirmation of desired properties (e.g. dissolution and stability)
  • QbD approach: control of critical parameters via DoE

Manufacturing

  • Definition of design space for commercial production
  • Production of registration batches
  • Commercial manufacturing in dedicated area for high potent drugs

Milestones

Grafik Hot Melt
  • HME enables substantially improved solubility/bioavailability of APIs and control of API release out of oral solid dosage forms [incl. abuse deterrent properties])
  • HME enables different pharmaceutical forms and broad production scale
  • HME can be easily applied to NCE´s, their life cycle management (e.g. improving risk-benefit profile) or to “generics plus”
  • HME offers high potential to create own IP
  • Manufacturing is performed in a dedicated area for handling of high potent drugs
  • HME can be used in combination with 3D-Printing

Your Contact

Dr.  Tanja Westphal-Mirzad

Dr. Tanja Westphal-Mirzad

Finished Products Development
Director

Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany
Prof. Dr.  Sigrid Saaler-Reinhardt

Prof. Dr. Sigrid Saaler-Reinhardt

Corporate Project Management
Director

Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany

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