FORMULATION & DEVELOPMENT OF PELLETS OF TOLTERODINE TARTRATE: A QUALITATIVE STUDY ON WURSTER BASED FLUIDIZED BED COATING TECHNOLOGY

Abstract

In recent pharmaceutical applications, multiparticulate dosage forms are gaining much importance over single-unit dosage forms. The purpose of designing multiparticulate dosage form is to develop a reliable formulation that has all the advantages of a single unit formulation and yet devoid of the danger of alteration in drug release profile and formulation behavior due to unit to unit variation. The aim of present work is qualitative study on formulation of multiparticulate modified release pellets of Tolterodine Tartrate, by “Wurster Based Fluidized Bed Coating Process”(layering technique).The main purpose of the present study was to investigate the feasibility of the wurster process for preparing extended release pellets and subsequently comparing the release profile of the pellets so prepared with a marketed reference product in various media. Additionally, the effects of some independent process variables were evaluated. The effect of the various process parameters i.e. inlet air temperature, product temperature, exhaust temperature, atomization speed, spray pump speed, atomization air volume and air flow on the wurster process was studied. The results suggested that the values of process parameters greatly vary with the physical properties of the drug, polymers and solvents used in process for layering of pellets. Key Words: non-pariel-seeds (N.P.S), E.R coating (extended release coating), Wurster technology, process parameters