Study On Sustained-Release Pellets Prepared By Melt Agglomeration In High Speed Mixers

Preparation of sustained-release pellets by melt agglomeration in high-speed mixers is a new method for the production of pellets, in recent years more and more people begin to pay attention to this method for its efficient. This material mixed with the easiest way and supplemented by heating, solid binders melt into a liquid, and finally by the full hybrid and collide to form pellets. Melt agglomeration in high-speed mixers have been reported by foreign literatures, to provide basis for pharmaceutical industry and raising the level of pharmaceutical products, the process variable and prescription were investigated using self-made high-speed mixer with heating jacket.Select soluble drug metformin hydrochloride as a model drug, drug-containing skeleton pill was prepared, wax coating layer was pack, finally get the sustained-release pellets. Preparation and prescriptions was optimized, as follows,20% of the amount of the binder, the coating material is stearic acid, the coating amount is 15%, pill time 25min, a pellet temperature of 49 ℃, to prepare a good release of sustained release pellets. The pharmacokinetic model release curve fitting results showed that the drug release mechanism for non-Fickian diffusion,so the drug release mechanism is diffusion and erosion. The stability of Metformin hydrochloride sustained-release pellets were studied, the drug content and release stability of sustained-release pellets were good under the condition of high temperature,high humidity and strong light.Selected Gliclazide as a model drug, according to the nature of the drug, blank pill was prepared first and coating drug-contained layer, packet waxy layer last. Inspect the influencing factors, the amount of 40% lactose finalized, the coating material is stearic acid and calcium sulfate, a ratio of 1:1, the coating amount of 40%, stirring paddle speed 200rpm, mixing time 25min, water temperature 50℃,heating rate of 0.5 ℃/min.Reproducible experimental results showed that the above prescription, technology is feasible and reliable.Reference to the findings of the first two chapters, prepared Metoproiol tartrate sustained-release pellets, prescription and process was optimized by orthogonal design. Best main parameters are as follows:15% of the amount of the coating, the coating ratio of 2:1, pill temperature 48℃, pill timel5min. By verifying that the method of preparation of metoprolol tartrate sustained-release pellets is reliable and controllable quality.The subject were prepared by three different sustained-release pellets, many experimental results showed that to achieve the desired requirements. The results in this paper showed that the performance of sustained-release pellets made by this method was good,and it was a practical basis for the pharmaceutical industry in the future.