Choosing A Formulation And Process Approach To Oral Controlled Release Products

By Richard Sidwell, Ph.D., Senior Director of Product Development, Societal™ CDMO

Choosing the wrong approach to developing and manufacturing your extended release (ER) product can leave you in a blind alley. With no path forward, will you have the money and time to start over? Or will your product simply fall by the wayside?

Developing controlled release formulations may require more time, funds and effort than expected. Enlisting the help of an experienced OCR formulator can quicken the process and ensure your project’s success, especially for complicated formulations requiring multiple active pharmaceutical ingredients (APIs) or complex release patterns. Choosing the best technology and approach for your product can save a lot of frustration and cost on the road to approval.

This article offers some considerations, a framework, and some guiding questions to help you make informed decisions as you work toward a solution.