Paper Title

TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.

Article Identifiers

Registration ID: IJNRD_182452

Published ID: IJNRD2208066

DOI: Click Here to Get

Authors

Priyanka Jha , Sunita Arya , Gulbahar

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.

How To Cite

"TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.7, Issue 8, page no.592-612, August-2022, Available :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: 000121156

Research Area: Pharmacy

Country: Dehardun, Uttarakhand, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2208066.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2208066

About Publisher

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

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Call For Paper - Volume 10 | Issue 8 | August 2025

IJNRD is Scholarly open access journals, Peer-reviewed, and Refereed Journals, High Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool), Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) with Open-Access Publications.

INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (IJNRD) aims to explore advances in research pertaining to applied, theoretical and experimental Technological studies. The goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in and around the world. IJNRD will provide an opportunity for practitioners and educators of engineering field to exchange research evidence, models of best practice and innovative ideas.

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