The global burden of coexistent Type Two Diabetes Mellitus (TTDM) and hypertension is rising and it is emerging as a severe threat to world health and well being. This twin epidemic of coexistent TTDM and hypertension exposes patients to severe co-morbidities like cardiovascular diseases, lower limb amputations, diabetic nephropathy, diabetic retinopathy if not treated in time and with appropriate regimen. Guidelines established by various international organizations suggest multiple drug therapy for the safe and effective management of coexistent TTDM and hypertension. Such a polypharmacy with complex drug regimen leads to increased pill burden and often reflects into decreased patient compliance. This poor adherence to prescribed regimen, then gets translated into worsening of conditions and increases the hospitalization and all cause mortality to a significant extent. Use of FDCwill be one of the promising solution in the treatment of coexistent TTDM and hypertension where patients have to take 4-5 tablets on an average per day and thus show poor compliance to therapy. Use of FDC leads to the decrease in pill burden and thus helps in improving patient compliance. Along with these facts formulations of FDC also leads to simplification of complex drug regimen, synergistic effect produced by dugs in combination and reduction in cost of product. Present review describes the role of FDC in the treatment of coexistent TTDM and hypertension.

Objective: Coexistent Type Two Diabetes Mellitus (TTDM) and hypertension exposes patients to severe co-morbidities. Complex polypharmacy suggested by international organizations leads to the increased pill burden and decreased patient compliance which leads to worsening of conditions. Materials and Methods: Present research aims at the formulation and development of fixed dose combination (FDC) for treatment of coexistent hypertension and TTDM as it will help in increasing patient compliance. Literature survey and patient survey facilitated the selection of metformin HCl, telmisartan, atorvastatin and aspirin for the formulation of FDC. Formulation and development of enteric coated aspirin tablet and the bilayer tablet of metformin HCl, telmisartan & atorvastatin calcium were two major parts of this research.Aspirin was enteric coated by compression coating technique to avoid gastric irritation. Bilayer tablet separating metformin HCl layer from the layer of a mixture of telmisartan and atorvastatin calcium was prepared to avoid the physical incompatibility problem between metformin HCl and telmisartan.The final FDC formulation was prepared by encapsulating, enteric coated aspirin tablet and bilayer tablet in a size 00 capsule and subjected to accelerated stability studies. Results: Batch F2 of bilayer tablet containing one layer of metformin HCl and the other layer having a mixture of telmisartan& atorvastatin calcium releases more than 80% of metformin HCl, telmisartan and atorvastatin calcium within 1 hour. Batch A2E of enteric coated aspirin tablet was found to show delayed and complete drug release as compared to A2D within 3.5 hours. Similarity factor f2 was found to be 69.33. After long term storage of formulation at 40 o C/75% RH, stability of drug components remained unaffected. Conclusion: FDC of antihypertensive and antidiabetic agent will be revolutionary in the treatment of coexistent TTDM and hypertension as it will be a cheaper alternative to current therapy.