AbbVie Contract Manufacturing offers proprietary hot melt extrusion (HME) technology in both the US and Europe. AbbVie is the global leader with more than thirty years of HME extrusion development experience and the most commercial products launched utilizing this unique technology. HME is a robust process that effectively addresses the need to enhance bioavailability of a poorly soluble and potent APIs.

Hot melt extrusion (HME) is a solvent-free technology that enhances the bioavailability of poorly soluble and potent APIs. Through continuous processing, HME is more economical than other formulation options and can be used for abuse deterrence and taste masking. This can ultimately deliver a higher quality, more marketable product in line with your commercial strategy.

During HME, a powder blend consisting of crystalline API and polymer(s) is transformed into an extrudate, which contains molecularly dispersed API in a polymer matrix.  The extrudate can be directly shaped or subsequently converted into granules or pellets for downstream processing.  Rationally designed ASDs can achieve higher apparent solubility and improved bioavailability.

Our unparalleled leadership in formulation and manufacturing, with more than 30 years of expertise, combined with academic collaborations that drive innovation, has resulted in the highest rate of HME technical publications and more than seven commercial products launched

AbbVie advances your science like we would our own, with customized pharmaceutical hot melt extrusion services that include:

  • Optimized amorphous solid dispersion (ASD) and enhanced solubility for poorly soluble APIs
  • Bioavailability enhancement expertise
  • Solvent-free and continuous processingSupport for good process control and scalability
  • Taste masking and abuse deterrence capabilities
  • End-to-end manufacturing from extrudate to packaged drug product
  • Proven expertise in drug delivery

PRODUCT DEVELOPMENT

AbbVie can support you in both the development and commercialization of products utilizing Hot Melt Extrusion. Our approach to development and commercialization of amorphous solid dispersions (ASD) consists of 4 stages:

processmap

 

COMMERCIAL MANUFACTURING

10+ extruders in network

  • 18 mm – 70 mm screw size
  • Multiple OEMs (Liestritz, Coperion, Bosch)
  • Potent capability (<1 μg/m3)
  • Extensive experience in various equipmentmanufacturers, screw size, block and exit die configurations
  • Scale-up and technical transfer from site to site
  • Melt granulation (continuous)

Manufacturing sites in US and Europe

  • Barceloneta, Puerto Rico
  • Ludwigshaven, Germany

Downstream Manufacturing Options

  • Controlled Release
  • Modified Release
  • Tablets (including multi-layer)
  • Capsules

Packaging Options

  • Blisters
  • Bottles
  • Sachets/Sticks
  • Wallets