Antihypertensive Drug Telmisartan Hydrochlorothiazide Bilayer Tablet Formulation Research And Development

In recent years,with the increase in the number of hypertension,antihypertensive drugshave a broad market increasingly. Elderly patients with hypertension generally, mostaccompanied by a variety of other illnesses, such as hypertension associated with diabetes,hypertension accompanied by renal insufficiency.With a single antihypertensive drug is oftendifficult to control blood pressure in the safety enclosed.it’s often requires two or more speciesof drugs used in combination to achieve the ideal antihypertensive effect.It is easy to reducepatient compliance while taking several medications together.if you can not control bloodpressure in a safe range,a variety of complications caused by high blood pressure will ensued.If one or several drugs to be combined into a bilayer tablet, it can not only help to reducethe time of patients with medication but also be able to better control the drug release rate, makethe better control of blood pressure within the normal range.Telmisartan and hydrochlorothiazidein combination, can improve blood vessel function status, delay or reverse left ventricularhypertrophy, reduce the incidence of cardiovascular events and mortality, and also reduce theincidence of adverse drug alone and reduce the degree of adverse reactions.This paper aims to develop a double sheet of antihypertensive drugs----Telmisartanhydrochlorothiazide double sink. Basis on Patent ZL02827182.3, pharmacy, medical suppliesand the "Chinese Pharmacopoeia" tablet quality requirements as a guide for the bilayer tabletformulation and process improvements. The main contents are as follows:using wet granulation, the amount of disintegrator microcrystalline cellulose and theadhesives Starch were screened in Hydrochlorothiazide layer.The preparation is optimizedcontains hydrochlorothiazide12.5g(6.25%),Lactose129.66g(64.83%),Microcrystalline cellulosepH10140g(20%),Microcrystalline cellulosepH30212g(6%),Iron oxide red0.34g(0.17%),Magnesium stearate1g(0.5%),starch4.5g(2.25%) per1000tables.The ratio of rawmaterials and Accessories are suitable in this preparation,homemade tablets dissolution systemmeet the quality requirements.Double sheet for process optimization, establish a set of production telmisartanhydrochlorothiazide tablets bilayer process parameters.The results showed that when30meshaperture sieve granulation, drying temperature60℃, dry particles of less than2.5%moisturecontent in hydrochlorothiazide layer, when the produced temperature is in the range of18℃-25℃, humidity less than50%, spray drying air temperature about85℃,80%sorbitoldiameter greater than150um in telmisartan layer.It can produce a stable tablet weight, standardfriability and dissolution,the substances are in the range of the content which are required by two-layer tablet quality requirement.Double sheet for process optimization, establish a set of production telmisartanhydrochlorothiazide tablets bilayer process parameters.The results showed that when30meshaperture sieve granulation, drying temperature60℃, dry particles of less than2.5%moisturecontent in hydrochlorothiazide layer, when the produced temperature is in the range of18℃-25℃, humidity less than50%, spray drying air temperature about85℃,80%sorbitoldiameter greater than150um in telmisartan layer.It can produce a stable tablet weight, standardfriability and dissolution,the substances are in the range of the content which are required bytwo-layer tablet quality requirement.