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Sustained-release or extended-release tablet formulations are designed to release the active pharmaceutical ingredient at a slower rate and over an extended period compared to conventional immediate-release dosage forms. This controlled drug delivery approach offers several advantages including improved patient compliance, maintenance of therapeutic drug levels, reduced side effects, and protection of drug molecules from degradation. 1,2 Various formulation approaches have been explored for achieving sustained drug release from tablet matrices. This review discusses key formulation aspects like rate-controlling polymers, factors influencing drug release, manufacturing techniques, and recent advances aided by quality-by-design principles and mathematical modeling for optimizing sustained-release profiles. Regulatory considerations for evaluation and approval are also highlighted
Shinde et al. (Thu,) studied this question.