Process Validation of Solid Antioxidant Skin Supplement Tablets

Abstract

Antioxidants, protects the skin from cell damage and harmful rays. So, there is a need to kill the skin problems. The Aim of this present work is to study about oral antioxidants and its benefits for our skin and body hence this formulation can be used as health supplements. The purpose of this work is to prepare and perform process validation of antioxidant tablet formulation.  The study consists of manufacturing of the three batches of 1 lakh tablets each of solid  Antioxidant tablets. Each batch of Antioxidant tablets consists of Reduced L-Glutathione,  Pycnogenol, Alpha Lipoic Acid, Vitamin C Coated and Grape Seed Extract as active  antioxidant components. The results demonstrate that the manufacturing process was under  control throughout all stage between batches. The process validation of, the all three batches were conducted, for a batch size at dry mixing, Blending, Compression, Coating and Packing stage. The three validation batches of tablets, containing all active components complies with the approved in-process and raw materials and finished product specifications defined for the formulation. Finished product reports of all the  three batches shows that product meets the in-house specifications.  The overall review of results shows consistency and reproducibility within and between all  three batches. Hence it was concluded that the manufacturing process and the equipments adopted were strong enough and produce product meets pre-determined standards and quality attributes, therefore the process stands validated.

Keywords: Validation, Process validation, Antioxidant, Quality, Tablet, manufacturing, Solid dosage form.