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Process Validation of Remogliflozin Etabonate Sustained Release Formulation

Authors: Aveek Datta1, Dr. Subhasis Maity*2, Miltu Kumar Ghosh3, Kuntal Hazra4;

Process Validation of Remogliflozin Etabonate Sustained Release Formulation

Abstract

Failure in developing an effective process for the manufacturing of drug products may lead to severe consequences like product recalls and plant closure. As a result, process validation has gained a prime focus as an essential product development activity. In the limelight of this notion, the research goal of current work was to carry out prospective process validation for the manufacture of Remogliflozin Etabonate sustained release tablets along with a tablet containing them. Remogliflozin Etabonate mini tablets production was trialed and tested for results. The Formulation that gave promising results was considered and concluded for process validation. Protocol and batch manufacturing record (BMR) were prepared for three consecutive batches of the same size, method, equipment, and validation criteria. The critical process parameters were identified; mini-tablets were compressed by using the direct compression method and evaluated. The results of three consecutive batches were compiled with specifications. It indicated that the process employed here offers a high degree of assurance to produce quality products meeting pre-determined specification limits and quality attributes. Three process validation batches of same size, manufacturing process, equipment & validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication and compression stages were identified and evaluated. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.

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