FORMULATION AND EVALUATION OF SOLUBILITY ENHANCED FAST DISINTEGRATING TABLETS OF TELMISARTAN USING NATURAL SUPERDISINTIGRANTS

Abstract

Telmi sartan (TLM) is an angiotensin II receptor antagonist used in the treatment of hypertension. According to biopharmaceutical classification system , telmisartan belongs to class II drug. It is practically insoluble in water and it shows low dissolution profi le and poor absorption. In ord er to improve the solubility and dissolution rate of telmisartan, 6 inclusion complexes were prepared by both physical mixing and kneading methods in 1:1, 1:2 and 1:3 molar ratios of telmisartan and β - cyclodextrin. The complexes were tested for dug content and in - vitro drug release studies. Based on these parameters formulation KM3 was selected as best one for further studies as % drug content was 98.47% and in - vitro drug release was 76.991% in 45min. The tablets were formulated for the inclusion complex KM 3 using two natural super disintegrants gum karaya and soy polysaccharides in three concentrations and were evaluated for % weight variation, hardness and disintegration time and in - vitro drug release studies. The % weight variation range was found to be b etween 508±0.57 to 524±0.34, the hardness range was found to be between 3.4±0.29 to 4.2±0.18 kg/cm2, the disintegration time ranges between 5min 20sec to 7min 25sec, in - vitro drug release shows that as concentration of super disintegrant increases rate of drug release increases. Among all the formulations, F3 shows best result with a disintegration time of 5min 30sec and drug release up to 92.555% in 45min.