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Considerations for developing modified release versions of an immediate release product.
Released By Bend Bioscience
June 24, 2022
Developing a modified release (MR) formulation of an existing immediate release (IR) dosage form is a frequent request. There are a number of therapeutic and business advantages for why a company would modify the release of a drug and expand development beyond the IR predecessor including patient compliance, extended duration of action, and extension of product lifecycles. On the therapeutic front, modified release drug products enable drug release over a defined period of time or at specific locations within the gastrointestinal (GI) tract for prolonged or targeted drug delivery. “This allows for less frequent dosing, which can increase patient compliance and result in fewer side effects by reducing peaks and troughs in blood levels,” said Brittany L. Hayes, Ph.D., applied technology director at Societal CDMO, a pioneer in modified release technology. “This is a huge therapeutic advantage for patients if the debilitating effects of a disease appear quickly once the drug concentration falls out of the therapeutic window.” Other therapeutic advantages of MR drugs include improved efficacy, optimized clinical performance, a greater selectivity of activity, or possibly new indications. From a business advantage perspective, a successful MR drug product can provide a company with market expansion, intellectual property, and extension of exclusivity as pharma companies face patent loss. Reformulated drugs can have improved characteristics that will attract patients and they may help the innovator company to ward off generic competition and maintain market share for as long as possible. Modifying Dosage Forms Modified release formulation development and manufacturing are notoriously challenging. According to the experts at contract development and manufacturing organization (CDMO) Societal CDMO, achieving an effective formulation requires a holistic, well-researched view of:
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