Preparation And Investigate Drug Release Of Venlafaxine Hydrochloride Extended Release Capsules

Extrusion-spheronization was used to prepare uncoated pellets, the pellets were coated with fluid bed technique in this study. Based on preliminary study of the prescription, QC method for sustained release capsules of venlafaxine hydrochloride was established. UV was used to determine the content and the release, and HPLC was used to determine the related substances. All pilot-test samples from3lots were analyzed with the established QC method and the release curves of the samples made by us and the original samples in various solvents were compared. Single-factor method was used to investigate the several factors affecting the pellets properties in prescription factors and the technology factors. The drug stability and release were set as observation parameters to decide coating layer prescription and coating parameter.In vitro release study results have revealed that the release of sustained release capsules of venlafaxine hydrochloride made with extrusion-spheronization is consistent with that of original preparation (怡诺斯(?)). Single-factor observation on the pellets containing drug shows that the process variables including spheronization disk speed, spheronization residence time and wetting fluids were the most critical factors in influencing the physical characteristics of the resulting products; The final preparation technology:∮0.8mm spherical surface screen radial extrude, extrude speed35r/min/min, spheronization speed800r/min/min, materials/binding agent (W/V) is1:0.8. The final Prescription is made of venlafaxine hydrochloride84.9g, microcrystalline cellulose100g, and Starch12g, with1%sodium cellulose glycolate in10%ethanol as bond. Eudragit NE30D was used as film-former of sustained release coat and weight gain is22%-30%.The method for preparing sustained release capsules of venlafaxine hydrochloride was reliable and repeatable.