Formulation development of a recombinant Streptokinase suppository for hemorrhoids treatment

Recombinant Streptokinase (rSK) is a protein of bacterial origin currently used in the treatment of acute myocardial infarction. Its thrombolytic and anti-infl ammatory action makes it attractive for the treatment of hemorrhoids. In this work the infl uence of absorption enhancer, preservative and emulsifi ers on rSK stability was accessed by determin- ing its biological activity under stress conditions. According to the results obtained, were selected as excipients for the formulation: Sodium salicylate as enhancer and anti-infl ammatory agent, thimerosal as preservative, Span 60 as emulsifi er and Witepsol W25 as suppository base and 100 000 IU per gram of suppository for stability study. Afterwards, three lots at pilot scale were manufactured, packed in aluminum blister shell and stored at 5 ± 3 oC. Immediately after preparation, the samples were evaluated at months 0, 3, 6, 9, 12 and 18 having into account the physical, chemical and biological properties. The stability study demonstrated that the formulation containing rSK as active pharmaceutical ingredient was stable during 18 months under refrigerated conditions.