Study On The Seratrodast Orally Disintegrating Tablet

Seratrodast is the thromboxane A2(TXA2) receptor antagonist, and is often administrated orally to treat asthma. It had high therapeutic effects and low side effects . To make it convenient for the patients' use , we studied the preparation of Seratrodast orally disintegrating tablets in this article.Firstly, the physico-chemistry properties such as dissolubility, apparent oil/water distribution ratio were investigated in order to take the following work of prescription design and pharmaceutical research.Seratrodast was slightly soluble in water . To promote its solubility and rheokinesis, we optimized the condition of microballoons silicage which could absorb the medicine, on the basis of single factor investigation. The silicagel's capacity of absorbing the drug was increased by using in the technology of solution lamination.The manitol, cellulose ,microcrystallisate and crospolyvinylpyrrolidone were chosen as the main adjuvants of the orally disintegrating tablet after the investigating of the solubility and the compress formability of several kinds of adjuvants. And the optimal proportion of the four adjuvants was determined through orthogonal experiments. Finally, the orally disintegrating tablet was prepared using direct compression method ,that the procedure was simple and the cost was low. It was showed that the solution velocity of orally disintegration tablets was faster than commom tablets according to in vitro experiment.The quality standards was established by the preliminary research: 0.8% Tw-80 as solvent, applying the spectrophotometry to determine the dissolution rate and employing HPLC to detect the content and related substance. It was showed that the methodology was feasible and accurate.The stability tests indicated that this preparation could be preserved for 6 months in the accelerated condition of 40±2℃, RH75%±5% and in the condition of 25±2℃, RH60%±10%after a 18-month's long-term observation, we found that the character of the sample,disintegration time,content and so on did not change obviously, and confirmed our conclusion that the Seratrodast orally disintegrating tablet was stable.