Studies On The Preparation And Quality Of Simvastatin Orally Disintegrating Tablets

Simvastatin is a kind of important drug for curing heart and blood tube disease, and it is mainly used for the prevention and treatment of high blood fat and coronary heart disease. Nowadays, the preparations of Simvastatin have common tablets, film coated tablets and capsules.Orally disintegrating tablet is a special solid form. After meeting with saliva, the tablet can be promptly disintegrated and dispersed within one minute, and patients can easily administrate the drug only with swallow actions without the help of water. Compared with general preparations, it owns series of advantages such as administration convenience, assimilation promptly, high bioavailability and low stimulate to alimentary tract mucous membrane. For above reasons, this kind of oral solid preparation attracts much attention since it was put into market. The research to this solid preparation in abroad has been developed promptly and huge economic benefit to enterprises has been taken. The domestic research on oral disintegrating tablets is later than foreign countries, and related researches are gradually paid more and more attention in recent years.For the reason that Simvastatin has the characters of insipid and small dosage, it is suit to make orally disintegrating tablets, and is convenient to patients administration. Hence, this kind of preparation has splendid market foreground or anticipation. Whereas, there has no report of Simvastatin orally disintegrating tablets successfully put into market both in domestic and foreign market ,and either there has no reference to manufacturing composition process as well as quality standard. So, it is very important to study the manufacturing process and quality of Simvastatin orally disintegrating tablets.The article has made detailed studies on Simvastatin orally disintegrating tablets composition process, and on optimizing excipients volume with the method of composition Uniform Design. The optimum composition was got, and double-aluminum packaging was used as the packaging form of this product through experiments.The analysis methods of this product including assay, relative substance test and dissolution test were also systemically studied. Especially it is the first time to conduct comparison study of several test methods of disintegrating time, and the point of view that use existing disintegrator only changing its operation method was clearly given. Based on the above studies, the integrated quality standard of Simvastatin orally disintegrating tablets has been established. In addition, Accelerating test and long term stability test to three consecutive batches of pilot manufacturing products were also investigated. The results of stability tests show that the quality of Simvastatin orally disintegrating tablets is stable.The development of Simvastatin orally disintegrating tablets contributes to a new dosage form for Simvastatin. The studies on the preparation and quality of Simvastatin orally disintegrating tablets in this article will supply precious experience to domestic orally disintegrating tablets research.