Study On Prescription And Process Parameters Of Sustained Release Coated Tablet

In this paper, central composite design-response surface method and orthogonal design are two different methods on the membrane control metformin hydrochloride sustained release tablets and controlled release of metoprolol tartrate tablets membrane process was quantified; The use of coating pot, the pot temperature, compressor pressure, peristaltic pump speed, coating pan speed and other parameters of the quantitative study, which composite design response surface to predict the best coating efficiency parameter range, orthogonal designed on the basis of the value of experience in office settings to achieve the best efficiency and the film coating and controlled release purposes. So the study of the paper provides a theoretical basis to explore and solve a sustained-release preparation process parameter control problem.Pre-selection of prescription of model tablet was done by testing hardness and friability of the tablet. Weight gained experiment of coated tablet was applied to select the final prescription. And the final prescription was selected as follow:the microcrystalline cellulose, starch fillers do,2% HPMCE30D solution as binder, magnesium stearate lubricant prescription.The coating solutions which were prepared by OpadryⅡ,Eudragit NE30D or Eudragit RS PO and Eudragit RL PO were tested predominately and separately. The suitable prescriptions were determined though quality test of coated tablet which was including exterior release rate and the Coating efficiency. On the basis of pre-experiment, using CCD to select the best process parameters, and to get the ideal coating process parameter finally. After that, verification experiment was required to test the accuracy of the parameters expected.The ideal coating process parameter was resulted as follow. Coating temperature=45℃, pressure of compressed air=kg/cm2, speed of pump=1.0-1.2mL/min, speed of rotation=45 r/min.In which membrane-bound type model of Metoprolol tartrate experiments, sustained-release film clothes by screening a prescription to be Eudragit RS PO and Eudragit RL PO dosage of 4%, the ratio of 1:1, while orthogonal to be coated by process parameters for the package clothing temperature 45℃, compressor pressure of 3.7 kg/cm2, peristaltic pump speed of 1.2mL/min, coating pan speed 45r/min. And, through experimental screening tests confirm the stability of the best prescription process quality and stability.