Paper Title
TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.
Article Identifiers
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Keywords
Con-current validation, Metformin Hydrochloride, Sustained Released , critical parameters, process validation
Abstract
Validation is the process of establishment of documented evidence that the process, methods and procedure that are carried out will leads ti the expected results. Sustained release are the type of solid dosages form that is designed to release the drugs over an extended period of time to achieve the therapeutic levels. The aim of the present study is to perform concurrent process validation metformin Sustained release tablet to ensure optimization and reproducibility.to conduct the validation three consecutive batches were selected. All instruments required to carry out con-current validation were calibrated as per SOPs. All raw materials used in the manufacturing of the product were verified for the release status. Tablet was manufactured by wet granulation method. Granulation was excellent at 10 minutes .Drying was excellent at temperature of 50 ± 50C because %LOD was in limit . Blending was excellent at 8 minutes . For compression parameters like Average weight, Weight of 20 tablets, Hardness, Thickness, Diameter, Friability and Assay were according to specification.. All parameters at various stages of tablet manufacturing were as per specifications, so the process was validated properly along with the hold time studies.All parameters at various stages of tablet manufacturing were as per specifications, so the process was validated properly.
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How To Cite (APA)
Priyanka Jha, Sunita Arya, & Gulbahar (August-2022). TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 7(8), 592-612. https://ijnrd.org/papers/IJNRD2208066.pdf
Issue
Volume 7 Issue 8, August-2022
Pages : 592-612
Other Publication Details
Paper Reg. ID: IJNRD_182452
Published Paper Id: IJNRD2208066
Downloads: 000122019
Research Area: Pharmacy
Author Type: Indian Author
Country: Dehardun, Uttarakhand, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2208066.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2208066
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