The data collection of the present work is carried out to prepare a document on SUPAC. We have incorporated the changes in base formulation and prepared documentation for Eplerenone-immediate release solid oral dosage form as per USFDA guideline. Scale up and post approval change (SUPAC) classified changes according to “LEVELS” and provided requirements to support each level. The reporting category for the change was determined by the “LEVELS” classification. Aldosterone Antagonists such as Eplerenone is used in immediate release for Batch level changes and composition level changes. Ac-Di-SolTM excipient is used as disintegrating agents which was able to decrease disintegration time upto 7 minutes while increasing the concentration of Ac-Di-SolTM excipients. These combinations of active compound and carrier material have been found to possess improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, safety, as well as other improved pharmacokinetic, chemical and/or physical properties.
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