Application of QbD Principles to METHOCEL™ Extended Release Matrices
Quality by Design (QbD) has been defined as a scientific and risk-based approach to product and process development, which targets continuous improvement and cost reduction as major outcomes. Understanding the influence of excipient variability and functionality on drug-product formulations within the QbD framework has been challenging. Therefore, it is imperative to engage the excipient suppliers early in development for effective implementation.
In this webinar, Controlled Release Alliance partners, Colorcon and Dow Wolff Cellulosics, will provide insight for:
A case study will be presented on the influence of hydroxypropoxyl (HP) substitution, viscosity, and particle size on performance of a hydrophilic matrix using METHOCEL K15M premium CR. In addition, formulation recommendations and The Alliance’s approach to QbD and available support will also be outlined to help the formulators and process engineers realize continuous improvements, cost savings and regulatory flexibility.
Sandip B. Tiwari, PhD; Tim D. Cabelka, PhD
Sandip B. Tiwari, PhD
Sr. Manager, Product Development
Ph.D. in Pharmaceutical Sciences from
Mangalore University, India
Sandip holds a PhD in Pharmaceutical Sciences from Mangalore University, India. In his current role, he is responsible for the development of the extended release matrix system portfolio including development of METHOCEL™ QbD, osmotic drug delivery technologies, and strategies for avoiding food effect with matrix formulations. Sandip has over 15 years experience in the pharmaceutical field and has participated in various stages of drug development during his career.
Tim D. Cabelka, PhD
Senior Product Research Specialist
Dow Wolff Cellulosics
PhD in Analytical Chemistry from Iowa State University, Ames, IA
Tim holds a PhD in Analytical Chemistry from Iowa State University. In his current role he is responsible for pharmaceutical product application development for METHOCEL™ (methylcellulose and hypromellose/HPMC), and is conducting research on the formulation performance of hydrophilic matrix tablets, application of QbD principles to excipients used in sustained-release, polymer structure-property relationships, and the interaction of polymeric excipients with solvents.