Process Validation of Solid Oral Dosage Form of Ethambutol.HCl and Isoniazid Combination Tablet
Abstract
The current study was designed to meet the current regulatory requirements and prove with assurance
that, the product meets the predetermined specifications and quality attributes. The objective of the study was to
systematically conduct the validation studies pertaining to the manufacturing activities of solid oral dosage form of
tablet and to confirm that the product manufactured with the present method consistently meets the predetermined
specifications and quality attributes. Concurrent process validation of manufacturing process of Ethambutol.HCl 800
mg and Isoniazid 300 mg combination tablet was being undertaken due to the addition of “Wet Milling” step for wet
granulation. The purpose is to develop a proper design and a robust process along with tests for appropriate quality
control checks which will lead to high quality product. Hence, the present work was carried out on the process
validation of solid oral dosage form of the tablets. Present work was carried out on the process validation of solid
oral dosage form of the tablets confirms that the observed sets of conditions are better suited for manufacturing.
Keywords
Validation, Ethambutol, Isoniazid, Oral dosage form, Tablet, Manufacturing
Thanks
Authors are thankful to Dayanand
Education Society Latur and SDMVM’s Dr.
Vedprakash Patil Pharmacy College Latur.
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