Development in Formulation and Evaluation of Levodopa- Tolcapone Orally Disintegrating Tablets

Abstract

Levodopa-Tolcapone oral disintegration tablet used in the treatment of Parkinsonism was formulated and prepared by direct compression method and evaluated. Increasing demand for more patient compliant dosage form and a novel method end up in developing orally disintegrating tablets which dissolve or disintegrates instantly on placing on buccal mucosa. It is suited for tablets undergoing high first pass metabolism in improving bioavailability with reducing dosing frequency to minimize side effect and make it more cost effective. Orally disintegrating tablets (ODTs) provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. The various formulation aspects, disintegrants employed along with various excipient developed for ODTs which include maximizing the porous structure of the tablet matrix, incorporating the appropriate disintegrating agent and use of highly water soluble excipients. Evaluation, palatability studies was done for all formulation (F1-F6). Effect of superdisintegrants (such as microcrystalline cellulose, sodium starch glycolate and crospovidone) on wetting time, disintegration time, drug content, in vitro release and taste evaluation (palatability studies) was done for the formulation with the peppermint oil and evaluated for its better compliance than the other flavors used in the formulation. Taste and disintegration of optimized formulation for (F4&F5) were found to be better than the marketed product.