Study On The Manufacturing Process Of Compound Levodopa Microcapsule Floating Tablets

Objective: To prepare compound levodopa microcapsule floating tablets which can float,sustained-release and used by dosage apart. Methods:1) The drug-loading rate andentrapment rate were selected as indexes, the preparing of levodopa microcapsules ofintra-liquid desiccation and emulsion-solvent evaporation were separately optimized bythe orthogonal design. And according to compare the quality inspection results ofmicrocapsules made by two methods, finding out a final microcapsulated method.2)According to the in vitro release behavior of levodopa microcapsules, the data which wereanalyzed by the statistical method-similar factor method were selected as indexes, theuniform design was used to optimize the process of benserazide solid dispersion.3)Thefloating tablets were prepared by powder direct compression. The floating capability andsustained-release in vitro were used as evaluation indexes, the preparing of powderfloating tablets and microcapsule floating tablets was optimized by the orthogonal design.According to compare the floating capability, sustained-release capability and whether canused by dosage apart, the final process of floating tablets was be established.4) Thequality standard of the floating tablets was studied. Result:1) The levodopamicrocapsules made by the method of emulsion-solvent evaporation had smaller particlesize and can sustained-release.2) The release behavior of benserazide solid dispersionwhich was prepared by optimized method was similar with levodopa microcapsules.3)According to the abilities of float, sustained-release and used by dosage apart, themicrocapsule floating tablets was selected as the final dosageform.4) The quality standardof the floating tablets was established. Conclusion: The optimized formulation of thecompound levodopa microcapsule floating tablets is proper, and the production process issteady, scientific and feasible. The release test showed the compound levodopa microcapsule floating tablets have an obvious sustained release effect and can be used bydosage apart.