Hot Melt Extrusion

Hot melt extrusion (HME) is a unique technology that enhances bioavailability of poorly soluble, but potent active pharmaceutical ingredients (API). HME is more economical than other formulation options and excels in abuse deterrence and taste-masking applications, resulting in higher quality, more marketable products. And AbbVie CMO is the leader in hot melt contract manufacturing.

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Performance Perfected

A unique technology improving potency.

In this process, a powder of crystalline API and polymers is heated and extruded into a matrix with the API dispersed evenly throughout in the polymer matrix.  HME is a robust process that effectively addresses the need to enhance bioavailability of a poorly soluble and potent APIs. 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 Contract Manufacturing offers proprietary hot melt extrusion (HME) technology in both the US and Europe. 

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

Product Development

AbbVie supports the development and commercialization of Hot Melt Extrusion and amorphous solid dispersions (ASD) consists of 4 stages:

Stage1 Stage 2

API Characterization                                                                      

Formulation Screening                                                                       

 

  • Assess Technical feasibility for define ASD formulation & HME process
  • Identify prototype and clinical formulations
  • Utilize small quantities of API for available physicochemical analysis
  • Prototype & clinical formulations: dissolution and stability characterization
  • Establish rational ASD for formulation/process design and characterization
  • Analytical methods development
Stage 3 Stage 4

Formulation & Process Development                                         

Process Scale-Up                                                                

 

  • Define commercial formulation, process train, process conditions
  • Scale up and optimize process at commercial scale and define design space
  • Small-pilot scale runs
  • Formulation & process development finalization
  • Finalized/optimized formulation; process characterization
  • Process development finalization (design space, CMA, CPP. IPC justification)
  • 11 mm - 26 mm screwsize
 

Commercial Manufacturing

10+ Extruders in Network


  • 18 mm – 70 mm screw size
  • Multiple OEMs (Liestritz, Coperion, Bosch)
  • Potent capability (<1 μg/m3)
  • Continuous melt granulation
  • Sites in US and Europe
    • Barceloneta, Puerto Rico
    • Ludwigshaven, Germany

Downstream Manufacturing Options


  • Controlled Release
  • Modified Release
  • Tablets
  • Capsules

Packaging Options


 
  • Blister
  • Bottle
  • Sachet/Stick
  • Wallet

An AbbVie CMO representative is eager to talk to you.

AbbVie CMO is a seasoned partner for all your contract manufacturing needs. Let’s start a conversation today. The future is a click away.

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