Abstract

DESIGN AND CHARACTERIZATION OF BUCCAL TABLET OF MONTELUKAST SODIUM

Shivkumar Kalyani*, Ramchandra N. Chilkawar, Dr. Basavaraj. K. Nanjwade, Renuka Sangondi Giriyappa and Pramod Ganechari

ABSTRACT

Mucoadhesive buccal tablets of Montelukast sodium were prepared with an objective of enhancing the bioavailability by minimizing first pass metabolism. The buccal tablet were prepared by using Carbopol 934P and HPMC K4M as primary polymers alone and in combination with secondary polymers like Chitosan, Sodium alginate in varying concentration by direct compression method. Estimation of Montelukast sodium was carried out spectrophotometrically at 248 nm. The tablets were evaluated for hardness, thickness, weight variation, friability, drug content, surface pH, swelling index, In-vitro drug release, mucoadhesive strength and also the effect of secondary polymer concentration on these parameters was studied. Short-term stability studies (40±2o C/75±5% RH for 3 months) indicated that the buccal tablets are stable with respect to drug content and dissolution. All the tablets showed good mucoadhesive strength of 4.00 to 8.00 gm and force of adhesion increased with increase in polymer concentration and drug release reduced consequently. The surface pH of the tablet was in the range of 6.6 to 6.9 which does not irritate mucosa. The formulations CP1 (containing 30% carbopol 934P) and HP1 (containing 30% HPMC K4M) were found to be promising, which showed t50%, t70% and t90% values of 3.41h, 6.17 h, 7.34h & 3.20 h, 5.48h, 7.16 h and drug released 95.36 and 99.00% within 8 h respectively. These formulations have displayed good bioadhesion strength (5.1 and 4.0 gm respectively).

Keywords: Montelukast sodium; Carbopol 934P; HPMC K4M; Sodium alginate; Chitosan.