Overcoming challenges in early-stage formulation development of solid oral dose

Solutions for tablet development to accelerate your clinical journey

21

May

  • 3pm London | 10am New York
  • Free
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Why attend?

Successful solid oral drug development results in uniform, high-quality tablets that are safe and effective for the intended patients.  However, tablet formulation must also be able address numerous other challenges in order to progress to the next stage of a clinical trial, such as: mask undesirable tablet tastes and odors, protect the drug’s ingredients from contamination, prevent the drug from being dissolved in stomach acid, improve overall drug appearance and implement a delayed drug release.

This webinar will focus on the drug development path starting from pre-formulation through to clinical studies. We will discuss how to overcome the day-to-day challenges that can occur during tablet development and manufacturing.

Drug design is the most advanced approach for drug discovery and development. It utilizes the innovations in science and technology and includes them in its wide-ranging arsenal of methods and tools to achieve the main goal: Discovery of effective, specific, safe, and well tolerated drug which can improve patients’ lives.

Learning Objectives:

  • Understanding the importance of drug- excipient compatibility studies
  • Development approach considerations for small molecule NDA and ANDA programs
  • Overcoming challenges during manufacturing process
  • How to achieve optimal shelf life for your tablet

Speakers

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Rob Feltz
Director of Analytical & Formulation Services

 

As the Director of Analytical and Formulation Services, Robert is responsible for leadership of product development, GMP manufacturing, and analytical laboratory personnel. Robert has over 18 years of QC and R&D experience in the pharmaceutical industry as a subject matter expert in CMC sections of regulatory submissions. He also serves as a primary scientific reviewer on third-party research and development projects and provides expert guidance on identifying chemical degradation pathways, impurity purification, and qualification.

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Vinay Patil
Manager, Product development

As Manager of Product development Services at Sharp, Vinay is responsible for supporting R&D formulations by leading a team of scientists and product development leading to CTM manufacturing of products for clinical studies and subsequent regulatory filings. Vinay has over 7 years of R&D experience and clinical trials. He has started his career as Formulation Scientists and worked over more than 50 projects which includes NDAs and ANDAs throughout his career journey over the course of his career and has expertise in oral solid dosage form.

Vinay holds master’s degree in industrial pharmacy from University of Long Island, NY and a bachelor’s degree in Pharmaceutics from Pune University, India.

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