FORMULATION AND IN-VITRO EVALUATION OF NOVEL BUCCAL MUCOADHESIVE TABLETS OF FELODIPINE

Abstract

The objective of this work was formulation and in-vitro evaluation of novel buccal mucoadhesive tablets of felodipine as core in cup to release and permeate the drug unidirectionally towards the buccal mucosa and to enter directly in to systemic circulation. The carbopol, sodium alginate, sodium carboxy methyl cellulose, guar gum and HMPC were used in the development of buccal cups in various proportions. Core tablet of drug was prepared by direct compression method. Mucoadhesive properties of mucoadhesive cups includes shear strength, tensile strength and peel strength were measured on freshly collected porcine buccal mucosa as substrate. Force of Adhesion (N) in shear strength, peel strength and tensile strength results for the adhesive cups composed of carbopol and HPMC (3:1) were 0.0398, 0.0384 and 0.0394 respectively. The novel tablets were evaluated in terms of content uniformity, weight variation, thickness, diameter, hardness, friability, swelling index, surface pH, mucoadhesion strength and time and in vitro release. The adhesive cups had residence time above 5 h were selected for further placing of core tablet. In the final tablet formulations FBT3 which composed of carbopol and HPMC in the ratio of 3:1 and in core 20 mg of carbopol showed the satisfactory results of in-vitro studies. The permeability coefficient (kp) value for MC9 (3 parts of carbopol: 1 part of HPMC) was 0.055 cm/h and diffusion coefficient was 6.48 cm²/h. The maximum % of drug (99.9 %) was permeated in 6 h study from FBT3 formulation. Cumulative

% drug release from backing layer was also estimated and it observed that the drug releasing from back layer was not considerable (3.42 % for FBT3). Hence the results of this study signifying that the developed dosage form was a suitable alternative for delivery of felodipine in to blood circulation.