How To Achieve Different Release Profiles And Select Excipients For Formulation Development Of Modified Release Oral Solid Dosage Forms

By Myke Scoggins, Ph.D., Director, Product Development, Societal™ CDMO

Modified release oral solid dosage forms are highly specialized formulations. These dosage forms enable drug release over a defined period or at specific locations within the gastrointestinal (GI) tract for prolonged or targeted drug delivery. At the same time, they allow for less frequent dosing, which can increase patient adherence and result in fewer side effects by reducing peaks and troughs in blood levels.

However, modified release formulation and manufacturing are challenging. To obtain the desired release profile — or release profiles if there are more than one active pharmaceutical ingredient (API) — a holistic approach is necessary. Knowledge of the API, inclusion of appropriate excipients, and selection of dosage form and manufacturing techniques all play a role. These considerations, along with the desired pharmacokinetic (PK) profile, help build a robust system that delivers the therapeutic in a fashion that best benefits the patient. As this article will explain, numerous considerations, in addition to those listed above, enter into the planning and execution of a successful modified release oral solid dosage formulation.