Study Of Bezafibrate Sustained Release Tablets

Bezafibrate is the lipid-lowering drug belonged to phenoxy aromatic acid.It hasbeen used for long time and has sure curative effect.It can lower the level of LDL-Cand rise the level of HDL-C.It is generally used with the common tablets of0.2g inthe domestic and be administrated three times one day,but the sustained-releasetablets is usually used in foreign,which is administrated only one time one day,it isvery convenient to patient and it can improve the compliance of patient so thatimprove the effection of drug and reduce the event of cardiovascular.There are some research mechanism who have developed the BezafibrateSustained-release Preparation,but have not been agreed to produce.Tianjin TaslyGroup is the main factory of row material and common tablets,which occupy the90%market.In order to improve the competition,prolong the life of product,improve theeffection and reduce the cost of patient,we develop the Bezafibrate Sustained-releaseTablet with the product of SANDOZ as the reference preparation. The study take f2asthe evaluation quota, select the model and proportion of sustained-release material,thekinds and amount of adhesives,the hardness and so on.,fanally we take PEO N80andPEO1105as the sustained-release material,ethanol as the adhesives.The finalformulation is Bezafibrate400g,PEO110570g, PEO N8030g,lactose25g,magnesiumstearate5.25g.In order to evaluate the reproducibility,we produce three batchproduct,the quality meet the standard..During the quality study,we develop UV to determine the release, verify themethod such as linearity,precision,recovery,durability and so on.In the durability,wefound the release is sensitive to pH of medium,which should be controlled in7.2±0.02.We develop the HPLC in the study of content and related substance andestablish rational quality standard. The method can control the quality accurately andconveniently.In the study of influence factors of high temperature,we found that release slow.In the accelerated contion for six months,release have the tendency of slow,butcontent and related substance did not change in all test.According to the result ofstability, the sample should be stored at cool temperature, dry place,seal.