Formulation of Piroxicam (20 mg /ml) (w/v) for Intramuscular Injection Only/تصييغ تركيبة بيروكسيكام (20mg/ ml) للحقن العضلي

Abstract

Piroxicam is a non – steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effects, used for the treatment of rheumatoid arthritis ,osteoarthritis and traumatic conditions . In the present study many formulas were prepared to develop a new pharmaceutical formula containing piroxicam (20mg /ml) (w/v) injectable solution with other materials. Practically piroxicam powder insoluble in water and very slightly soluble in alcohol, this difficult property does not allow to obtain aqueous solution complied for the preparation of injectable composition by few and simple steps ,therefore used mixed solvent system contains (propylene glycol,ethanol absolute and nicotinamide ) to obtain and maintain aqueous clear solution. Benzyl alcohol added as preservative and analgesic ,sodium EDTA as chelating and stabilizer agent and sodium phosphate monobasic was added as buffering agent.To avoid precipitation, aqueous solution was adjusted by sodium hydroxide to maintain alkaline solution at pH (9.5) according to pharmacopeial pH range ( 8 – 10 ). The sterilization was carried out by filtration system through (0.2 µm) membrane filter and by autoclave at (121°C) for (30min). The stability was studied after exposure the formula to different conditions temperatures and humidity at (25°C/60% RH, 30°C/65%RH, 40°C/75%RH) according to International Conference Harmonization ( ICH ) Guidelines. The results of stability study was indicated that, the studied formula was stable .No physico – chemical changes were observed and mixed solvent system was the appropriate method to dissolve poorly water soluble material like piroxicam .