| Melt pelletization in a high speed mixer has its unique character, one of the techniques which manufacture pelletized products. Pellets are of great interest to the people more and more. It is one of the common and effective methods in producing sustained-release pellets. In its simplest form, melt pelletization proceeds by mixing the starting materials with a binder which is solid at ambient temperature and melts or softens at relative low temperatures. By operation of the mixture, the temperature is raised because of the development of heat caused by friction. The binder melts and acts like a liquid binder. By further agigation wet agglomerates are formed. Melt pelletization in a high shear mixer has been reported before, to provide basis for pharmaceutical industry and raising the level of pharmaceutical products, the process variable and effects of these parameters on the performance of the end products were investigated using self-made high shear mixer in the article.Based on previous experiments,a laboratory scale high speed mixer was self-made. It is convenient to operate the mixer and control the mixing process. It is easy to clean this equipment. The purpose of the present work was about the studies on the compound recipe Propranolol sustained-release pellets. Because of some reasons we preparedPropranolol sustained-release pellets and Hydrochlorothiazide conventional tables not pellets.Drugs have different micromeritics property for example crystal state, flowbility, binding force, if they are manufactured based on the same formulation or the same process technology, the performance of the pellet is different. The different types, amounts and properties of the experients affect the possibility of the pellets and the quality of the pellets. Based on the property of the model drug, we selected Calcium Sulfate as dilute, Hydrogenated Castor Oil as binder.There were three phases in the process. The first phase: the variables (the different kinds of binder, the impeller speed, product load, and massing time) 100g product load, 87centigrade product temperature, 350rpm impeller speed, the massing time was 7min.The results showed that pellets made had advantages of good sphericity, high strength and high bulk density.The second phase was used combing melt pelletization in the same high-shear mixer with coating technique to obtain pellets with high drug content inside. The mixer containing Propranolol and binder was sprayed on the surface. The variables were investigated and the optimal parameters of process were found under certain condition. They were 86.5 centigrade coating temperature, 350rpm impeller speed. The amount radio of pellets and Propranolol and binder was 50:40:15.The last phase was the coating process which was performed by coating hydrophobic and hydrophilic materials to obtain 12 hour sustained-release pellets. The results indicated that the ideal sustain-release behavior and good release reproductivity were achieved using coating formulation .The amount radio of Calcium Sulfate and Hydrogenated Castor Oil was 1:1, the total amount of coating materials was 50 percent of the amount of the drug pellets.The stability of Propranolol sustained-release pellets were studiedABSTRACTusing the method of fit factor. The drug content and release stability of sustained-release pellets were good under the condition of high temperature, high humidity and strong light. The pharmacokinetics of pellets in dogs indicated that the Tmax was 3.54h, t1/2 was 3.2h, and relative bioavaility was 235.1%.The second part of this paper was about the preparation of Hydrochlorothiazide. The formulation variables were optimizated by orthogonal design. The release of Hydrochlorothiazide in 30min was 80 percent of the total amount and this formulation was equivalent to the standard. HPLC method were used to detect Propranolol and Hydrochlorothiazide.This article discussed the form mechanism of pellet and adopted a process that was applicable to the model drug. The results in t...
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