Non- steroidal anti- inflammatory effects solid dosage formulation development and evaluation of quality parameters

Aceclofenac (AC), anti-inflammatory, a steroidal anti-inflammatory drug which is effective analgesic and antipyretic properties. Compared to other NSAIDs AC associated with significantly fewer adverse events. It is a narrow therapeutic index and a short biological half-life of a drug. This study aims to use the non-steroidal anti-inflammatory effective Aceclofenac tablets by wet granulation method for manufacturing a stable formulation developed to upgrade the quality. To achieve this goal, Aceclofenac 100 mg Tablet has been investigated direct compression and wet granulation technique in process development for tablets. It doesn't take place in the literature and because it is more economical method in terms of cost, wet granulation technique is selected and is intended to create originality on the product's method of production. Also solubility studies carried out and the evaluation results of pharmacokinetic data is decided to be used in pH 6.8 phosphate buffer solutions. Three pilot series produced by the selected final formulation, the quantification of the critical quality parameters, validation study of the analytical method development and method for improved dissolution and impurities are made. To decide whether or not stable of the formulation, manufactured pilot serieshave been followed in accelerated stability conditions in 40 ° C ± 2 ° C / 75% RH ± 5% for 6 months. At the end of our study; formulation development, method validation, pilot production and stability studies have been performed and all quality parameters data of Aceclofenac 100 mg Tablet has proven that manufactured products by the wet granulation technique are an economical stable product to use in pharmaceutical industry. Keywords: aceclofenac tablets, dissolution, stability study, quality parameters