Process for the preparation of a stable fixed dose pharmaceutical composition comprising one or more anti-infective drugs and microorganisms as active ingredients

摘要

Micro organisms are useful in management of diseases including diarrhoea and gastro intestinal diseases like pseudomembranous colitis, megacolon etc. They are also useful in prevention of gastro intestinal disturbances and diseases caused by anti-infective agents like ampicillin, amoxycillin, cloxacillin, clauvanic acid, cefuroxime axetel, cephalixin, erythromycin etc. For prevention micro organisms are to be taken along with anti infective agents. When micro organisms are combined with anti-infective agents for ease of administration and improving compliance and therapeutic effect, the combination is not found to be stable at room temperature as micro organisms are sensitive to anti-infective agents and are destroyed by effect of anti-infective agent in composition. The present invention relates to the process of preparing a stable fixed dose composition of anti-infective agent with micro organism as active ingredient. The process includes preparation of various dosage forms for oral route like capsule, tablet and liquid formulation. The process comprises of providing an appropriate barrier by way of selected coating procedure to one of the active ingredients in such a way that micro organisms are not affected by anti-infective agents. This results in a stable composition. By using an appropriate coating technique composition is made to remain stable over a period of 3-36 months at ambient/room temperature. The ratio of micro organism to anti-infective agents in a composition can be 1:2 to 1:25 by weight. The ratio of 1:5 by weight is found to be optimal for the purpose. The amount of coating is dependent on the type of coating technique, dosage form i.e. capsule, tablet or liquid and desired self life. The micro organisms of the composition were found to be active after variable time period. They also provided therapeutic effect and eliminated gastro intestinal disturbances associated with anti-infective agents when evaluated in humans.