Preparation and Evaluation of Fixed Combination of Ketoprofen Enteric Coated and Famotidine Floating Mini Tablets by Single Unit Encapsulation System

The present study was based on the FDA suggested system for humans, according to the Center for Drug Evaluation and Research (CDER) regulates the combination of products has been divided based on the dosage form preparation, that include a product contained two or more drugs that is known as fixed combination according to the section 21 CFR 300.50 [1]. The final product contains two more regulated components like drug/device, drug/biologic, device/biologic and drug/ device/biologic called as combination product and without biologic/ device that is not a combination product according to the act 21 CFR 3.2 (e) [2]. The present work was developed according to the act 21 CFR 300.50, There is evidence that fixedcombination medicines has shown greater therapeutic outcomes in patients with communicable diseases such as HIV [3] or tuberculosis [4] (TB), other chronic diseases, such as hypercholesterolaemia [5] and rheumatoid and osteo arthritis [6]. The system fixed combination is not only provide the therapeutic out come and also reduce the drug related side effects upon the addition of another drug and reduce the cost effect on the final product according to the budget impact model [6].