Modified release formulations: extending drug commercial lifecycle

April 30, 2024

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The text discusses the evolving landscape of drug release systems, emphasizing the shift from immediate release formulations to modified dosage forms. These modifications aim to enhance patient compliance, achieve therapeutic goals, reduce dosing frequency, and improve safety. One strategy to extend a drug's market exclusivity and delay patent expiration is through the 505(b)(2) pathway, which allows substantial modifications to approved drugs.

There's a growing demand for customized drug delivery solutions due to competition, evolving dosage forms, and the complexities of launching novel drugs. Pharma companies prioritize creating dosage forms that are both effective and promote patient adherence.

Learn more about modified release (MR) formulations: Extended Release, Targeted Release, Delayed Release, & Orally Disintegrating Tablets (ODTs).