Combined system of sinomenine hydrochloride sustained-release pellets

Aim:To establish a linear additive model for the predication of in vitro sinomenine hydrochloride release from the combination of immediate release,enteric-coated and sustained-release pellets based on the release profiles of each pellet type.Methods:Immediate release pellets were manufactured by extrusion/spheronization technology.The operation of bottom-spraying in the fluid-bed equipment was conducted to enteric-coating using Eudragit L-30D-55 and sustained-release coating using Surelease.In vitro sinomenine hydrochloride release profiles of both uncoated and coated pellets were fitted to the chosen mathematical equations offered by the curve fitting toolbox of Matlab before a linear additive model was created based upon the best-to-fitting equations.The proportion of each pellet type in the combined format to generate the desired 24 h sinomenine hydrochloride release profile was solved by Matlab.The predicted and assayed sinomenine hydrochloride release from the polled pellets was compared.Results:It was shown that the actual sinomenine hydrochloride release profiles of each pellet type were approximate to those of predicted ones.A linear additive model of the appropriate mathematical equations of each pellet was proven to be capable of controlling in vitro release of sinomenine hydrochloride multiple-unit pellets.Conclusion:A multiple-unit combined system of the selected pellets,as a novel sustained-release system,was successfully prepared.In vitro release performance of the calculated combination of each pellet type could be guaranteed by this approach in designing sustained-release drug delivery system.