Tablets & Capsules

TC0719

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Tablets & Capsules July 2019 13 O ral controlled-release (OCR) drug products release the active pharmaceutical ingredient (API) into the patient's gastrointestinal (GI) tract either slowly or after a delay. This results in much of the API being released in an area of higher pH, over a wider range of GI location, and over time. The peak concentration (C max ) of API in the blood plasma for an OCR dosage form will typically be lower and delayed and will rise and fall more slowly than for an immediate-release dosage form, as shown in Figure 1. This article describes the various types of oral controlled-release (OCR) dosage forms and discusses the factors to consider when developing an OCR drug product. Developing oral controlled-release drug products Richard Sidwell Recro Gainesville formulation

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