Study On Gliclazide Modified Release Tablets

Gliclazide is a new generation oral hypoglycemic drug of sulfonylurea. It hypoglycemic activity main to stimulate secreting of endogenous insulin, partly elevate the sensitivity of circa-texture to insulin, alone be used to the patients whose blood glucose levels were not well controlled by diet and exercise, and can be used with other hypoglycemic drug or insulin, it has some advantages such as high performance,prolonged action,security, low dose, hypotoxicity, junior drug adverse reaction. The existing specification all of solid are80mg,30mg, and40mg.In early stage, there is ordinary tablet in the market. The modified tablet, which is research and development in2000, is approved and spread in our country in2003. As the price of the same dose of the modified release tablets is several times higher than ordinary preparation and glucose increased rapidly when taking ordinary tablets that can cause hypoglycemia and other adverse reactions, while modified-release formulations can maintain a more stable blood concentration and avoid adverse reactions, the major domestic pharmaceutical companies competing for imitation, in order to reduce the costs and meet the needs of patients. Diabetes is a chronic progressive disease and require long-term medication, which will give patients a lot of inconvenience. So Servier has developed a new dosage forms (60mg)---gliclazide MR, but it is not in domestic market now. Consequently, gliclazide MR (60mg) is developed according to the requirements of the physicochemical properties and modified release formulation, and this can reduce production costs, to solve some problems of the number of patients, so that patient get best interests. The main research as follow:1.The prescription and technology optimization of Gliclazide Modified Release TabletsObjective:The prescription for screening and optimization,the part of work is the key point of the study. Method:According to dissolution of the drug, I conducted a series of adjuvant screening, optimum prescription by crosscut. Result:finally I determine the best prescription of gliclazide MR and preparation technology. Conclusion:The prescription is reasonable, the prescription technology is stable, and reduce the production costs greatly.2.The research of gliclazide quality criteriaObjective:In order to control the quality of gliclazide modified release tablets. Method:To establish a reliable HPLC assaying method, dissolution method and stability analysis method. Result:The method is accurate, sensitive, the adjuvant and degradation product don’t interfere principal agent was established. Conclusion: Establish gliclazide quality criteria for preparation production and go on sale.3.The research of gliclazide’s stabilityObjective:Research the stability of gliclazide modified release tablets. Method:Stability investigation contain influencing factor experiment,acceleration experiment, sample experimental long-term stay. Rusult:All results display the index appearance, dissolution, drug content, relative substances of the preparation not to have marked change during the stability study. Conclusion:testify the preparation has good stability, and provide a basis for package selection and quality specification setting.