Abstract:
OBJECTIVE To prepare telmisartan hydrochlorothiazide tablets by the methods of fluidized bed particles coating and assess its stability. METHODS Telmisartan particles were prepared by the fluidized bed one step granulation. Telmisartan particles of different coating weight, hydrochlorothiazide and pharmaceutical excipients were mixed. Then telmisartan hydrochlorothiazide tablets were prepared by rotary tablet machine. The optimization formulation were selected by orthogonal experiment. The assay and impurty were assayed by HPLC. The stability and dissolution study were conducted in an accelerated testing and long-term testing. RESULTS The optimal method of preparing telmisartan hydrochlorothiazide tablets showed a good stability. The formulation contained, external additional sodium carboxymethyl starch 20.4 mg and sodium hydroxide 8.5 mg showed the best dissolution. The final optimized prescription had similar dissolution behavior to brand drug. CONCLUSION The telmisartan hydrochlorothiazide tablets produced by fluidized bed particles coating show a good quality, and the process is more simple than two-layered tablets, the optimal method is feasible.