Journal de bioéquivalence et de biodisponibilité

Abstrait

Comparison of Multidrug Formulations for Anti-Hypertensive Treatment

Drashti Desai, Pravin Shende and Gaud RS

The multidrug therapy in the form of Orally Disintegrating Tablets (ODTs) is superior to control and treat high blood pressure and to decrease cardiovascular events in hypertensive patients than individual drug telmisartan, hydrochlorothiazide and amlodipine besylate to provide quick onset of action and improve drug adherence. ODT formulations of telmisartan and amlodipine besylate (F1), telmisartan and hydrochlorothiazide (F2), amlodipine besylate and hydrochlorothiazide (F3) were prepared by direct compression method and evaluated for precompression parameters and post-compression parameters. Formulation F1 showed the highest release of the drug, i.e., 80.7 ± 0.5%, whereas F2 and F3 showed 66.285 ± 0.3% and 65.182 ± 0.7% respectively for 15 min. All three formulations (F1, F2 and F3) passed the tests with disintegrating time within the limit of 20 s. The hardness of formulations was in the range of 4.33 to 5.33 kg/cm2 and the friability of all the formulations were found to be within limit of 1%. The thickness and diameter of all the formulations were found to be 0.2-0.3 cm and 0.8 cm respectively. The % dissolution efficiencies were found in the order of F1>F3>F2. All formulations were found to be stable when were maintained at 40 ± 2°C/75 ± 5% RH and 50 ± 2°C/75 ± 5% RH for 6 months. This multidrug combination therapy may serve as an alternative for conventional single pill dosage form to treat hypertension.