Case Study 9
Replacement of a Proprietary Controlled Release Technology

Sponsor requested the replacement of expensive proprietary controlled release technology to conventional 24 hours controlled release dosage form.

A set excipient compatibility studies were conducted to evaluate 12 blends in both dry and wet environments.

Nine prototype formulas of direct compression matrix tablets were developed and manufactured for clinical trials.

To overcome any differences between fed and fasted states, polymer coatings were also applied to the matrix tablets

A pharmacokinetic study of the developed multiple dose weight proportional strengths was tested in human subjects and found to be near zero-order.

The new formulations allowed the sponsor to avoid using an elaborate and expensive manufacturing process. An application for a composition patent has been made by the sponsor.