Extended Release

Proportionality and Regulatory Considerations for Biowaivers in SR Dosage Forms

Proportionality and Regulatory Considerations for Biowaivers in SR Dosage Forms

ByPharma Lesson Reading Time: 2 minutes

For SR formulations, the rate-controlling polymer plays a crucial role in drug release. When seeking a biowaiver for a lower strength, regulatory agencies assess whether the polymer content is proportional or if adjustments impact drug release. Proportionality of Rate-Controlling Polymer Across Strengths Lower strengths may qualify for a biowaiver if the polymer-to-drug ratio remains the…

Extended Release Rates Technology for Injection Dosage Form

Extended Release Rates Technology for Injection Dosage Form

ByPharma Lesson Reading Time: 4 minutes

Extended-release injectable formulations are designed to release the active pharmaceutical ingredient (API) at a controlled rate over an extended period, from several hours to weeks. The primary goal of these formulations is to reduce the frequency of administration, minimize drug fluctuations, and maintain therapeutic drug levels, improving patient adherence and clinical efficacy. The development of…

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