Hot Melt Extrusion

Hot Melt Extrusion (HME) is a unique technology that enhances the bioavailability of poorly soluble APIs. AbbVie Contract Manufacturing offers proprietary hot melt extrusion (HME) technology in both the US and Europe.

Hero_Wave2.png

Scroll

Performance Perfected

A unique technology improving solubility

As the global leader and pioneer with more than thirty-five years of HME extrusion development experience, AbbVie has launched the most commercial products utilizing this technology. HME is widely recognized as an effective technology to transform poorly soluble APIs into amorphous solid dispersions ultimately improving patient compliance and making the manufacturing process more efficient.

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 APIs. The extrudate is then converted into granules or pellets in preparation for downstream processing into tablets, capsules or powder filled sachets.

Our unparalleled leadership in formulation and manufacturing, with more than 35 years of expertise, combined with academic collaborations that drive innovation, has resulted in the highest rate of HME technical publications, more than one hundred developed products and more than eight commercial products launched.

AbbVie Contract Manufacturing offers proprietary hot melt extrusion (HME) technology development, clinical and commercial manufacturing 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 6 stages:

Stage 1:

Assess technical feasibility for ASD formulation & HME process by evaluating small quantities of API.

Stage 2:

Develop prototypes and clinical formulations.

Stage 3:

Clinical manufacturing in Lake County, IL or Germany.

Stage 4:

Define final dosage form & commercial process train, CMPs & CPPs.

Stage 5:

Scale up and optimize process at commercial scale and define design space.

Stage 6:

Commercial manufacturing in Germany or Puerto Rico.

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.