Managing Risk and Opportunity for Immediate- and Modified-Release Drug Formulations

Formulators modify the release profiles of drugs for multiple reasons: to target delivery of the API, enhance bioavailability, provide dosage convenience, improve patient adherence, and extend the patentable life cycle of an existing drug.Whether the desired profile is for immediate or modified release, formulators must overcome the development hurdles of poorly soluble APIs. Modified-release drugs may require more excipients and more complex formulations and manufacturing steps, resulting in longer, and more expensive, development processes. Proven formulation methods and careful excipient selection, however, can be employed to develop formulations for modified release drugs that offer value to the patient.