Investigating the effect of alkaline amino acids on the solubility of piroxicam

Abstract

Introduction : The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to both the pharmaceutical industry and the regulatory bodies. In the present study a dissolution medium was developed for piroxicam which is a class ӀӀ BCS and non-steroidal anti-inflammatory drug (NSAID) that is widely used for the treatment of medium pains ، fever and inflammation. Aim : The aim of this study was to evaluate the effects of alkaline amino acids on piroxicam solubility. Material and methods : Solubility of piroxicam in different concentrations of Arginine –Lysine alkaline amino acids and glucosamine ، included in environments of phosphate buffer with pH = 7.4 ، citrate buffer with pH = 4.2 - 6 and water with pH = 6.5 were studied. To measure the solubility of piroxicam in different dissolution environment, the classic method of saturation shake-flask was used. Results : Based on the obtained data, glucosamine has a greater role in increasing the piroxicam solubility to alkaline amino acids. The highest solubility of the drug can be seen in media consisting less concentration of glucosamine along with citrate buffer with pH = 6. There was no solubility increase in the water environment, and we needed more concentrations of amino acids in phosphate buffer to increased the solubility of the drug. Also Arginine increased the solubility in the phosphate buffer to a limited extent.

Discussion and conclusion : Considering the results of the dissolution medium worked in this thesis, it can be concluded that the most suitable environment for increasing the dissolution of the drug is Arginine along with phosphat buffer with pH = 7.4