Fixed dose combination

Most of the patients in current scenario are treated with more than one anti-hypertensives and most often with fixed dose combinations. Hence the use and efficacy of fixed dose combination are controversial and is the most debated issue in Indian perspective  The aim of this randomized pilot study was to evaluate the rationality and side effect profile of fixed dose anti-hypertensive combinations used in our hospital. A total of 25 hypertensive patients prescribed with anti-hypertensive FDCs were randomly selected and their outpatient record were monitored and recorded for a period of 2 weeks. The data was then suitably analyzed. Out of the 13 FDCs, only one FDC (7.69%) have its APIs present in both EML of WHO and NLEM of India. There was no established evidence in terms of therapeutic efficacy and safety for the 3 combinations (23.07%).76.92% of FDCs were cost effective when compared with their individual components. 11 FDCs (84.61%) provide published literature on the reduction of either dose of individual drugs or their adverse effects. Only one FDC was found to be irrational in this study. Giddiness (33.33%) was the most frequently seen side effect among the prescribed FDCs. During this limited study period with only 13 anti-hypertensive FDCs, we were able to find an irrational FDC, which clearly show an urgent need to conduct further studies on evaluating the rationality of FDCs as a whole. As a clinical pharmacist, our immense role in evaluating the rationality of FDCs could enable the DCGI to withdraw irrational FDCs from the market.   

The emerging new fixed dose combination of Glipizide (GLZ) as sustained release and Telmisartan (TEL) as immediate release were formulated as a bilayer matrix tablet using guggul. Guggul used as a binding agent with three different concentrations (70%, 80%, and 90%; F1-F6) was used for the preparation of first layer of tablet containing glipizide. The conventional tablet of telmisartan was prepared as a second layer. Prepared bilayer tablets were studied for the in vitro release study carried out at pH 1.2 for first two hours and then at pH 6.8 for 6 hours using USP dissolution apparatus II (Basket). All the evaluation tests were found to be within the acceptance limits specified in Indian Pharmacopeia. The assay and dissolution study of tablets were done by HPLC which was developed and validated according to the ICH Q2 (B) guidelines. The contents of assay of the tablets were found to be 90.92% - 103.84% for F2-F5. The release of glipizide from the tablet was extended up to 8 h. Tablet containing 2.5 mg of glipizide with 80% of guggul release of drug after 8 h was found to be 82.36% and tablet containing 5 mg of glipizide with 90% guggul release of glipizide after 8 h was found to be 74.67%. The release pattern of each formulation (F2-F5) was fitted into the dissolution kinetics models and all the formulations were best fitted in the Higuchi model kinetic. From the results, we have concluded that the guggul act as a binding agent as well as rate retarding agent.