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Inventi Rapid - Pharmaceutical Process Development

Articles

  • Inventi:ppd/28658/19
    PROCESS VALIDATION OF RIFAMPICIN AND ISONIAZID FILM COATED TABLETS
    Salunkhe Suchitra Sunil*, Jaymin G Patel, Bhumi Patel

    The purpose of research was to study the “process validation of rifampicin and isoniazid film coated tablets” in tablet dosage form was carried out at Sunij Pharma Pvt. Ltd., Vatva, G.I.D.C, Ahmedabad, Gujarat. The study involves validating the process variables of this product to show that the process was under control. The study was conducted on a batch size of 3,00,000 tablets, manufactured by wet granulation method. Various critical parameters at various stages which involve sifting, dry mixing, wet granulation, drying, dry milling (sizing of dried granules), lubrication, compression of granules and coating stages were identified and evaluated. The process parameters were evaluated by validating parameters. During granulation stage various parameters such as loads of chopper and impeller, LOD (Loss on Drying) during drying, Assay, particle size analysis at blending and lubrication stage. During compression stage tablets were evaluated at different speeds at regular intervals of time for appearance, dimensions, thickness, hardness, disintegration, friability, dissolution etc. Tablets were also evaluated at coating stage. The process validation data provides you the high degree of assurance and meets its pre-determined specifications.

    How to Cite this Article
    Salunkhe Suchitra Sunil, Jaymin G Patel, Bhumi Patel. Process Validation of Rifampicin and Isoniazid Film Coated Tablets. Inventi Rapid: Pharmaceutical Process Development, 2019(3):1-8, 2019.
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