The Investigation Of Telmisartan Tablets' Preparation Technics And Quality

Telmesatan is a non-peptin ACH receptor, which is used as an antihepertensive drug in the treatment of all kinds of hepertension. Besides the Telmesatan tablet imported, there is no home made dosage-forms available. In this paper, the Telmesatan tablet (40 mg) was made and its qaulity-control standards and manufacturing technology was established.The optimum formulation was designed by the organal design method by the following compositions: For preparing 1000 Telmisatan tablets, telmisatan 40 g as the main drug, sorbitol 95 g as filler, 12 g as surfance activant, CMS-Na 15 g as disintegrant, Mg-St 2.0 g as lubricant. 3.36 g NaOH was added to adjust the pH and the mixture was dried by spraying. The powder obtained was pressed to tablet. The tablet cores were film-coated with Opadry (Y-1-7000) at the following parameters: Opadry concentration 16%, spraying speed 160 g/ min and the tablet temperature 60℃. The weight increase was within 1.5%～3.0%.The maximum UV absorbance of the Telmisatan is at 296 nm. The analysis method of the related substance was established by HPLC and the assay was established by UV method.The stablity test showed that: within the range of 6~24 months, the appearance, disintegration time, weight variance and the content was not affected and the the film coating was of no influence on the in vitro dissolution of the Telmisatan tablet.The manufacturing technology established in this paper was reasonable and of good repeatability. The tablet manufactured can be an alternative to the product imported. The data and and parameters in the paper can be used as references in the industrial scale manufacture of the Telmisatan tablet.