Designing Amorphous Formulations and Manufacturing Processes for Challenging Compounds

12:10 - 12:45

Lonza provides design, development and manufacturing services for active pharmaceutical ingredients, drug product intermediates and finished dosage forms.  Specialized capabilities are in place for improving low solubility / bioavailability (BA) and modulating pharmacokinetics (PK) to meet target product profiles.  Dr. Michael Grass will provide the following overview with representative case studies:

  • The range of enabling technologies utilized to improve solubility and BA
  • Key criteria for matching enabling technologies to API / formulation problem statements
  • Case study #1 - Improving the BA of Itraconazole over the amorphous reference listed drug utilizing a dissolution-permeation in vitro test
  • Case study #2 - Manufacturing amorphous dispersions with methacrylic acid/methyl methacrylate copolymer for improved performance and stability
  • Summary and Q&A

Michael Grass, Principal Scientist Product Development, Lonza Bend