Webinar: Strategic Approach for Manufacturing Solid Dosage Forms

Sponsored by: Catalent Pharma Solutions

Focused on:

  • Solid Dosage Forms
  • Roller Compaction

Date: 21 February

154

Time: 11AM New York / 4PM London

Roller Compaction: new trends, challenges and solutions

When driving compounds from development to clinic and commercial, it is important to provide a customized plan to achieve clinical and commercial success. A key aspect to this is selecting which process you will use to manufacture your product. Roller Compaction has become an important manufacturing process when addressing the unique needs of API. OptiPact™ is a platform offered by Catalent Pharma Solutions designed for dry granulation processes.

One of the most popular approaches to improving solubility is to develop a spray dried amorphous co-polymer dispersion. Although this approach has a high probability of success, it also introduces some unique challenges. Amorphous co-polymer dispersions commonly exhibit extremely poor flow, low bulk density and can be sensitive to moisture. Dry granulation by roller compaction significantly improves the manufacturability of these amorphous dispersions while avoiding moisture- and heat-induced degradation; however, OptiPact can be applied to any oral solid development program.

The core foundation of OptiPact is that it includes angled, horizontal, and vertical feed roller compaction technologies, and the optimal process selection is based upon the physical characteristics of the materials. OptiPact provides a systematic approach during which the materials undergo rigorous physical characterization using the Johanson Indicizers and other instruments to select the optimum roller compaction process.

During this webinar, industry oral solid drug development experts will discuss why roller compaction is gaining popularity across the industry and why you should consider OptiPact for your program as well as the advantages of using roller compaction after spray dried dispersions. Real case studies will be presented in order to show how OptiPact can provide a solution and path forward for some of the more challenging programs.

Presented by

Todd Stutzman, Pharm.D.,

Director of Pharmaceutics

Todd started his career at Sandoz Pharmaceuticals and worked on the formulation development of several OTC products, both liquids and solids. He also worked at Marion Merrell Dow developing oral solid IR and SR formulations. He has spent his last 10 years at Catalent, overseeing and working on over 150 different compounds, spanning a broad range of therapeutic areas.

Sarah Pyszczynski, PhD,

Principle Scientist

Sarah is a Principal Scientist with Catalent Pharma Solutions in Kansas City, Missouri. She has nine years of experience in the pharmaceutical industry in both analytical and process development functions. She earned her Ph.D. in Pharmaceutical Chemistry from the University of Kansas.

Key Learning Objectives

  • Learn how a dry granulation process improves the manufacturability of spray dried dispersion
  • Learn about the different roller compaction feed systems and the benefits of utilizing each
  • Learn how rigorous physical characterization including the Johanson Indicizer assists in selection of a roller compaction technology
  • Advantages of scalability from development to commercial batches utilizing roller compaction

Audience

  • Heads of Research and Development
  • Heads of Manufacturing
  • Operations
  • Outsourcing
  • Project Managers