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February 8, 2012
Applied Drug Delivery: Hot Melt Extrusion and Optidose Technology
Speakers for this Event:
  • Abu T. M. Serajuddin, Ph.D., Professor, Department of Pharmaceutical Sciences, College of
        Pharmacy & Allied Health Professions, St. John's University  Learn More
  • Hans Maier, Head Formulation Scientist, Modified Release Technologies, Catalent Pharma
        Solutions, Schorndorf
     Learn More
  • Michael Valazza, Vice President, Global Business Development, Controlled Release Technologies,
        Catalent Pharma Solutions  Learn More
  • Irena McGuffy, Manager, Softgel Formulation, Catalent Pharma Solutions  Learn More
  • Applied Drug Delivery: Hot Melt Extrusion and Optidose Technology

    There has been much interest during the past decade in melt extrusion using twin-screw extruders for the development of drug products. The technology is especially promising in the development and stabilization of high-energy (e.g., amorphous) forms of poorly water-soluble APIs by solid dispersion in polymeric carriers to enhance their dissolution rates and bioavailability.

    In this presentation, the principles of applying the melt extrusion technology in the development of high-energy materials and solid dispersion systems will be discussed. Some of the issues in the successful development of melt-extruded products include the lack of miscibility of API with polymers used and the possible degradation of the API, the polymer or both, if excessively high temperature is needed in the melt extrusion process. We will discuss strategies to overcome such issues, as well as issues related to in vitro-in vivo correlation of melt extruded solid dispersions and novel melt granulation technology for 90% or higher drug load. Case histories will be cited.

    Our panel will also examine some predictive tools for saving API, time and costs. In hot-melt extrusion a number of formulation, equipment and process factors influence the performance of the resulting product including carrier selection, polymer to API ratio, screw and configuration, and temperature profile along the process section.

    Additional topics include:

    • New advancements in modified controlled release technologies, including novel OSDrC® OPTIDOSETM optimized dose delivery technology
    • Drug delivery technologies and strategies for improved oral delivery for poorly soluble and permeable drugs

    An audience Q&A session is included at the end of the presentation.

    THIS PROGRAM IS INTENDED FOR:
    • Chief Scientific Officers
    • Vice Presidents, Directors of Research & Development
    • Drug Development Scientists
    • Process Development Scientists
    • Process Engineer Development Scientists
    • Directors, Managers of Technical Development, Upstream Development, Technology Assessment

    From pharmaceutical companies working in product development of all dosage forms

    ABOUT OUR SPEAKERS:

    Abu T. M. Serajuddin, Ph.D., Professor, Department of Pharmaceutical Sciences, College of Pharmacy & Allied Health Professions, St. John's University

    Abu Serajuddin, Ph.D., joined St. John’s University, Queens, NY, as Professor of Industrial Pharmacy in September 2008 after a distinguished career of three decades in the pharmaceutical industry. In his latest positions in the industry, Dr. Serajuddin served as the Executive Director and US Head of Drug Product Development (1999-2003) and the Global Head of Science and Technology Development within Technical R&D (2003-2008) for Novartis Pharmaceuticals Corp.

    Dr. Serajuddin has authored over 80 research papers and book chapters and made over 90 invited presentations in scientific conferences. He is a co-inventor in 12 patents. Among his professional recognitions, he attained Fellow status in American Association of Pharmaceutical Scientists (AAPS), American Pharmacists Association (APhA), International Union of Pure and Applied Chemistry (IUPAC), and American Association of Indian Pharmaceutical Scientists (AAiPS).

    For his scientific achievements, Dr. Serajuddin was named Novartis Leading Scientist in 2005 and received the AAPS Research Achievement Award in Formulation Design and Development (FDD) in 2010. He serves in the Editorial Advisory Boards of Journal of Pharmaceutical Sciences and Journal of Excipients and Food Chemicals. Among many professional contributions, he chaired AAPS Pharmaceutics and Drug Delivery Section (2001) and AAPS Preformulation Focus Group (1994-1996). A graduate in pharmacy from Dhaka University, Bangladesh, Serajuddin received his M.S. in Pharmaceutics from Columbia University and Ph.D. in Industrial Pharmacy from St. John's University, both in New York.

    Hans Maier, Head Formulation Scientist, Modified Release Technologies, Catalent Pharma Solutions, Schorndorf

    Dr. Maier received a Degree in Chemistry and Chemical Engineering from the University of Stuttgart/Germany 1981 and a PhD in Inorganic and Analytical Chemistry 1986 from the University of Hohenheim/Germany. With more than 20 years experience in pharmaceutical development Hans provides technical and scientific leadership for the development of modified release technologies of solid dosage forms. His expertise includes polymer processing machinery (i.e. extruders, rotational molding machines), polymer rheology and chemical modification of polymers. Hans holds patents in engineering and design of biodegradable polymer systems.

    Michael Valazza, Vice President, Global Business Development, Controlled Release Technologies, Catalent Pharma Solutions

    Throughout his 30 year career, Mr. Valazza has held various executive positions in product development and technical services with a focus on modified and controlled release solid dosage form applications. He is a recognized leader in the field of controlled release technology, having published articles in several scientific journals, and presented at numerous industry conferences. He currently leads Catalent’s Controlled Release Technologies global team, and is based at their Somerset, NJ headquarters. Mr. Valazza is a registered pharmacist in New Jersey and Kentucky, with a Bachelor’s degree in Pharmacy from Rutgers University, College of Pharmacy. He is a member of the Controlled Release Society (CRS) and American Association of Pharmaceutical Scientists (AAPS).

    Irena McGuffy, Manager, Softgel Formulation, Catalent Pharma Solutions

    Throughout her career, Ms. McGuffy has held various positions in product development & technical services, as well as analytical services, with a focus on formulation of poorly soluble compounds, bioavailability enhancement, and immediate and controlled release solid dosage form development. In 2007, Ms. McGuffy joined Catalent Pharma Solutions and has expanded her expertise to softgel formulation and process development, scale up, technology transfer and validation. She currently leads the Softgel Formulation team at Catalent Pharma Solutions, Somerset, NJ site. Ms. McGuffy is a registered pharmacist with a Bachelor’s degree in Pharmacy and Master’s degree in Pharmaceutical Sciences from the University of Zagreb, Croatia. She is a member of the AAPS.

    OUR XTALKS PARTNER FOR THIS EVENT:

    Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most unique technologies to help you get more molecules to market faster, enhance product performance and provide superior, reliable manufacturing and packaging results.

    Catalent develops. With our broad range of expert services we drive faster, more efficient development timelines to help you take more molecules to market and create more effective products.

    Catalent delivers. As the world leader in drug delivery innovations, we have a proven record of enhancing bioavailability, solubility and permeability, improving ease and route of administration, and strengthening patient compliance for better treatments.

    Catalent supplies. Globally positioned to serve all your manufacturing and commercial packaging needs, we are the largest, most reliable supplier in pharmaceutical outsourcing.

    Catalent. More products. Better treatments. Reliably supplied.™

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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