Formulation And Evaluation Of Pulsatile Drug Delivery System Of Tolterodine Core In Cup Tablets
Objective:The aim of the present study to prepare Pulsatile release tablets of Tolterodine tartarate for the treatment of over active bladder.
Methods:The drug delivery system was designed to deliver the drug at time when it could be most needful for the patient. Tolterodine Tartarate Pulsatile core-in-cup tablet was designed to deliver a rapid or transient and quantified drug after a predetermined lag period. This type of tablet was prepared by direct compression method and is used to prepare a set of core-in-cup tablets with Swellable and Rupturable polymers like Pectin, Locust bean gum and HPMCK15M respectively with different proportions with impermeable cup ethyl cellulose. Tablets were evaluated for Precompression, Post compression and in vitro dissolution studies. Results: The drug polymer interaction was studied by FTIR. The Precompression and post compression parameters are with in the limits.The Data of core-in-cup tablet were within the acceptable limit and they can be compressed directly into tablets. The hardness, friability and uniformity in weight and disintegration time results were in accordance with the standard limit. The lag time is dependent on rupturing property of Ethylcellulose and swelling property of the polymers. In the Optimized formulation the best fit model was found to be Korsmeyer peppas with exponential ‘n’ value is > 1 indicates the drug release follows super case II transport mechanism. The initial burst release was observed after lag time and drug release of 9was extended up to 11hrs for the optimized formulation. The in vitro drug release studies suggest that core-in-cup tablet prepared with ethyl cellulose and HPMC K 15 M shows a lag time of 4hrs due to more swelling and delayed rupturing properties of HPMC K15M and ethyl cellulose. Comparitive Dissolution studies were conducted for optimized formulation TT9 & Marketed preparation. Short Term Stability studies indicate no significant changes in Drug content and Dissolution rates.