ANIL KANE
Global Head of Technical & Scientific Affairs, Thermo Fisher Scientific, Canada

Abstract

As a leading CDMO supporting the pharmaceutical industry, Thermo Fisher Scientific’s pharma services team is involved in problem solving for clinical candidates with respect to solubility enhancement, improving exposure and bioavailability, improving stability and optimizing manufacturing parameters in late clinical stage for oral solid dosage forms such as tablets, capsules, softgels or sterile injectables as liquid or lyophilized products. This paper will highlight some examples of problems and solutions that have helped in bringing effective medications & drug products to approval and to patients.

Innovative drugs and therapies can significantly improve outcomes for patients, but they must first make it through the several stages of clinical studies before they’re approved for the market. These clinical trials are key to ensuring safety and efficacy of new treatments and cures. Drug development can be a daunting process for pharmaceutical companies and researchers as they dedicate significant time, money, and resources to developing a new prescription drug.

The investigational drug candidate must go through the screening, preclinical candidate selection, and early phase development challenges followed by many processes to ensure that it is safe and effective. And with all the intensive and complex steps—such as screening, selection, and development—that need to be done, projects can cost pharmaceutical companies a lot more than initially planned, particularly in the absence of a systematic scientific development strategy.

This article explores the challenges of oral solid dosage (OSD) forms in development and timely critical considerations to bring success in proof of concept studies as well as late stage clinical phase ...