The Study On Thiamazole Osmotic Pump Preparations

Thiamazole is commonly used thiourea antithyroid drugs, mainly used forclinical treatment of various types of hyperthyroidism. Thiamazole is one of the mainoral drug hyperthyroidism treatment taken in the world, The saled Thiamazole tabletsare taken more often, taking a large amount of inconvenience to the patient. Osmoticpump formulations is a representative of a controlled release formulation due to itssteady release rate and the unique releasing way. And it being more valued in thepharmaceutical industry because of its short development cycle, less investment need,low economic risk, technical content and added value.We used Thiamazole as a model drug to research the preparation of Soluble Drugsingle room three osmotic pump tablets. We make the tablet core with the main drugThiamazole and HPMC, mixed with ethyl cellulose and HPMC production wrappedup and down two floors, and optimizating the composition of the tablet core andcladding prescription proportion; The release in vitro was investigated by similarityfactor. The best combination of tablet core is Thiamazole10mg and HPMCk15m60mg, the upper and lower layers are all wrapped with HPMCk100m30mg andethylcellulose10mg.The preparation is simple, can better control8h uniform releaseof Thiamazole. This osmotic pump tablets eliminates the tedious process of coatingand drilling, reduced the number of processes, so that the preparation process issimplified.By using a full wavelength scanning UV spectrophotometer, the measurementwavelength was determined in252nm.Interference test of accessories have beentested and found no interference.We establish a standard curve and study the release, optimizing the prescription,and ultimately achieve a qualified release limits.We study the effects of the stirringrate and release medium using three different stirring speeds and three differentrelease media, in eight hours of the dissolution test, the rotational speed120,100and75r/min were almost overlap, which can explain the situation in vivo gastrointestinal motility will not affect the product’s release osmotic pump tablets.The pH4.5,6.8and7.4were compared respectively, we found the osmotic pump release curves werealmost overlap, indicating that pH has little effect on this drug release.We establishedquality standards of Thiamazole osmotic pump tablets, mainly including identification,related substances, determination, content uniformity and other tests.We examinedThiamazole osmotic pump tablets according to Chinese Pharmacopoeia2010editiontwo Appendices and relevant guidelines, the results of this osmotic pump tablets ofthe indicators are in line with regulations.