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September 19, 2012
Using Amorphous Spray-Dried Dispersions to Develop Oral Solid Dosage Forms
SPEAKERS FOR THIS EVENT:
  • Randy Wald, R.Ph., Senior Research Fellow, Bend Research Inc.  Learn More
  • Chris Craig, Research Fellow, Bend Research Inc.  Learn More
  • Using Amorphous Spray-Dried Dispersions to Develop Oral Solid Dosage Forms

    Current estimates are that more than 30% of orally delivered new medicines need solubilization technology to achieve efficacy. Selecting the appropriate technology can result in non-crystalline, physically stable intermediates that will then be incorporated into immediate-release or modified‑release dosage forms.

    This webinar will encompass key spray-dried dispersion (SDD) aspects that enhance and sustain in vivo drug solubility, and how these attributes are preserved during downstream solid dosage form formulation and process development. Discussions will include bulk-sparing tablet formulation and process development for pre­clinical studies, process development and scale-up strategies for clinical trial material manufacturing, and
    incorporation of SDD formulations into select modified-release dosage forms.

    Case studies will be presented.

    THIS PROGRAM IS INTENDED FOR:

    People in the Pharmaceutical Industry interested in learning more about the benefits of spray-dried dispersions, solid dosage form formulation and process development

    ABOUT OUR SPEAKERS:

    Randy Wald, R.Ph., Senior Research Fellow, Bend Research Inc.

    Randy Wald is the director of oral drug delivery technology at bend research Inc., He oversees formulation and process development for laboratory, pilot and commercial scales of immediate released, modified released, and enhanced solubility oral solid dosage forms, including those incorporating Bend Research’s spray‑dried dispersion intermediates. In this capacity, he also supervises the technical transfer to cGMP manufacturing sites such as Bend Research Manufacturing, and client, and partner CMO/CDMO sites. Unit operations commonly used include fluid‑bed processing, wet and dry granulation for immediate and controlled-release tablets, wet-milling and /dry-particle size reduction techniques, twin-screw melt extrusion, encapsulation, single and multilayer tabletting, and both aqueous and solvent film‑coating.

    Mr. Wald holds a B.S. degree in pharmacy from the University of Minnesota. He holds two patents, has written five articles and given more than 20 external presentations.

    Chris Craig, Research Fellow, Bend Research Inc.

    Chris Craig is a research fellow at Bend Research Inc. His expertise spans physical chemistry, process and pharmacokinetic modeling, engineering design, formulation and process development and scale up. His knowledge in the areas of spray-dried dispersion fundamentals and dosage forms supports a variety of client projects. He has developed immediate and modified release dosage forms, involving dry granulation, direct compression, particle size reduction, cosmetic and functional pan coating, and laser-drilling. He had also supported the installation qualification and performance qualification (IQ/OQ) on site in a cGMP manufacturing site.

    Mr. Craig holds a B.S. in chemical engineering from the University of Rochester.

    OUR XTALKS PARTNER FOR THIS EVENT:

    For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding.

    Bend Research provides several capabilities, including formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including spray-dried dispersions and hot-melt extrusion formulations, as well as controlled-release, inhalation, and biotherapeutics technologies.

    Bend Research has more than 285 employees based in six state-of-the-art facilities in Bend, Ore., USA.

    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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