OptiMelt™ Hot Melt Extrusion

OptiMelt™ hot melt extrusion can enhance bioavailability of your poorly soluble API, leading to better treatments for your patients

In the past decade, hot melt extrusion has increased in prominence for the pharmaceutical industry as an approach to develop solid dispersion dosage forms that enhance solubility/bioavailability of poorly soluble drugs. 

The main drivers of increased hot melt extrusion use in the pharmaceutical and OTC industry are:

• Enhances solubility/bioavailability for poorly soluble drugs
• Continuous processing allows for good process control & scalability
• Solvent-free (unlike some alternative solid dispersion approaches)
• Extrudate is versatile in its end use, including potential incorporation in controlled release delivery formulations
• Ability to incorporate taste masking

Hot melt extrusion is typically co-located with downstream processing and solid dose form manufacturing.

Benefits:

• GMP Bench to Pilot to Commercial scale, with global capabilities
  • Schorndorf, Germany and Somerset, NJ
• Broadest selection of downstream processing technologies, co-located with OptiMelt™ hot melt extrusion
• Integrated solutions provider, with over 75 years of industry experience
  • Development, formulation, scale-up, manufacturing, packaging
• Formulation acceleration and optimization with open Catalent-BASF bioavailability alliance
  • Broad range of excipients designed specifically to enhance solubility, particularly with hot melt extrusion
  • Non-exclusive arrangement to increase development efficiency and deliver better treatments for your molecules
• Global regulatory support and expertise

How It Works

OptiMelt™ hot melt extrusion enhances solubility by producing an increased-energy form of the drug through a combination of the process and the chemical properties of the excipient. The resulting product, called the extrudate, is then further processed and converted into a final dose form to achieve the final drug delivery profile desired.

Catalent Services

Through expert analysis and interpretation of data, our OptiMelt™ hot melt extrusion team will fully characterize your API and associated formulations throughout the development process to provide a robust data package in support of regulatory filings.

• Feasibility and Development programs
  • Tailored to meet your product requirements
  • Consideration of the relevant API characteristics identified during the technical evaluation of preformulation data 
  • A range of prototype formulations prepared under different processing conditions (bench-scale); analytical techniques applied as appropriate to determine optimum formulation and process parameters 
  • Short-term accelerated physical stability studies typically undertaken before recommendations for a full development program are made
• Full in-house analytical and regulatory services  
  • Full characterization of your API and associated formulations via expert analysis and interpretation of data throughout the development and scale-up process to provide a robust data package in support of regulatory filings
• Full-lifecycle management from molecule to market - with Lean efficiency standards 
• Expert handling and maximization of potent and controlled drugs
• Bench, pilot, and full-scale cGMP manufacturing in the U.S. and Europe

Facilities

We currently have two OptiMelt™ hot melt extrusion facilities.

• Schorndorf, Germany
  • OptiMelt™ Hot Melt Extrusion:
    • Bench, Pilot, and Commercial Scale GMP capability
  • Fluid Bed granulation, including Wurster technology:
    • Bench, Pilot, and Commercial Scale GMP capability
  • Notable standards of compliance 
    • Passed three FDA pre-approval inspections (PAI) and numerous inspections by national and international regulatory authorities
  • Additional Capabilities 
    • Category I-IV and solvent-based processing
    • Commercial high-shear granulation
    • Blending
    • Dry granulation
    • Spheronization
    • Tablet compression
    • Hardshell-capsule filling
    • Pan-coating

• Somerset, New Jersey, U.S.A.
  • OptiMelt™Hot Melt Extrusion:
    • Bench and Pilot GMP capacity
    • Potent drug capabilities
    • FDA audited
  • Strong compliance 
    • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
  • Services 
    • Commercial and development