Formulation Development of Extended Release Capsule for the Treatment of Parkinson's Disease

Abstract

Extended release formulations are gaining high importance in the field of solid oral dosage form as they are extending the effect of drug release. The marketed immediate release product showed many side effects and was not able to achieve a proper plasma concentration profile and hence there was a need of developing a multiparticulate system which can provide a uniform dosing which can reduce the intra-subject variability. The multi-unit particulate system including the pellets, minitablets are preferred where the drug-excipient or the physicochemical interaction interferes with the drug release. The present work aims in developing an extended release dosage form which can decrease the dosage frequency and help in achieving peak plasma concentration. The concentration of the pore former like povidone k-90 and the plasticizer medium chain triglyceride were optimized in order to sustain the release of the drug. Various polymers like ethyl cellulose and surelease have been optimized to achieve a prolong effect of drug. The batch is processed in fluidized bed processor by maintaining various process parameters and the final optimized batch has been filled in to capsules and various parameters like assay, water content, dissolution, particle size distribution, % yield have been evaluated. So, it can be concluded that the optimized batch shows no major change in the dissolution profile as of the reference product and hence multiparticulate system can be considered as a valuable approach for the development of extended release delivery of the drug.