Abstract

PROCESS VALIDATION OF ETORICOXIB TABLETS

Jasvir Kaur*, Amritpal Singh and Satvinder Kaur

ABSTRACT

The object of this work was to validate the process of manufacture of solid oral dosage form of Etoricoxib film coated tablets in order to meet the current regulatory requirements and to prove with assurance that, the product meets predetermined specifications and quality attributes. The Etoricoxib tablet was manufactured by dry granulation method and involves dry mixing, wet mixing, granulation, drying, diminution (size reduction), sifting of lubricants, lubrication, compression, coating and strip packing. Three consecutive batches were taken for the validation of following parameters at regular intervals viz Weight variation, Hardness, Friability, Width, Length, Thickness, Disintegration and Dissolution. Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor belonging to the class of NSAIDs (Non Steroidal Anti- inflammatory Drugs).

Keywords: Etoricoxib, Validation.