Study On Compound Metformin Hydrochloride Sustained Release Tablets

Compound metformin hydrochloride sustained-release tablets is compound preparation consisting of pioglitazone hydrochloride (immediate release) and metformin hydrochloride (sustained release), a long-acting oral used to treat non-insulin-dependent diabetes mellitus (NIDDM), the two main ingredients are clinically widely used hypoglycemic agents.Although the price of the same dose of sustained-release tablet formulation is higher than normal tablet, taking normal tablets cause plasma concentrations increased rapidly then causing hypoglycemia and other adverse reactions.But sustained-release formulations can maintain relatively stable blood drug level,meanwhile can avoid adverse reactions due to the quickly raise of our blood concentration.The specifications of Metformin hydrochloride sustained-release tablets oversea listing is more diversified,each tablet contain1000mg,850mg,500mg mainly,while the domestic market nearly are all 500mg.Because of the maximum dose daily taking of metformin hydrochloride sustained-release tablets is high,and diabetes is a chronic progressive disease which require long-term medication,if the medication more frequently daily for the patients with higher blood concentration,it will bring a lot of inconvenience to the patients.In order to further improve the compliance of patients,the compound sustained-release preparation developed in this paper,take the pioglitazone hydrochloride and metformin hydrochloride compound preparation ACTOPLUS MET(?) XR of Takeda Pharmaceutical Corporation as the reference reagent(specification is 15mg/1000mg),At present, there is not the same specification in the market.Foreign commercial product adopts single chamber osmotic pump preparation technology, the manufacturing cost is high,so we want to develop a new preparation can let the drug release completely,In order to reduce the cost of production,aimed at reduce the cost of production,reduce the number of times of take medicine,reduce adverse reactions and so on,moreover, to improve the compliance of some patients,thereby to obtain a better therapeutic effect.The main research as follow:1.The prescription and technology optimization of Compound metformin hydrochloride sustained-release tabletsObjective:The prescription for screening and optimization, this part is the key point of the study. Method:Taking release rate of PH and MH as index,the suitable fillers, adhesive,film formers and porogen were optimized. Result:Compound Metformin Hydrochloride Sustained Release Tablets prescription and preparation process were determined,it showed a similar release rate as the reference samples. Conclusion:The prescription is reasonable, process is feasible and stable,and low production cost,achieved the design requirements.2.The research of sustained-release tablets quality criteriaObjective:In order to control the quality of sustained-release tablets. Method:To establish reliable methods,to mensurate the release, related substances, content of the sustained-release tablets. At the same time conduct methodology study on these methods. Result:The method is sensitive and accurate, the degradation product and excipients have no interference in the determination of the main drug. Conclusion:Establish sustained-release tablets quality criteria for preparation production and go on sale.3.The research of sustained-release tablets’stabilityObjective:Research the stability of compound metformin hydrochloride sustained-release tablets. Method:Stability investigation contain influencing factor experiment,amplification test. Rusult:All results display the index appearance, dissolution, drug content, relative substances of the preparation do not 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.