Abstract
The present work aims at developing mucoahesive tablets of ondansetron hydrochloride using bioadhesive polymers like carbopol-934, sodium alginate and gelatin. Tablets prepared by direct compression using different polymer with varying ratio were evaluated for hardness, friability, uniformity of weight, disintegration time, microenvironmental pH, bioadhesion and in vitro release. Hardness, friability disintegration time and drug release were found within pharmacopoeial limit. Microenvironmental pH decreased whereas bioadhesive strength, water uptake, and in vitro release increased with increase in carbopol-934. Increasing sodium alginate and gelatin increased the microenviromental pH and decreased bioadhesive strength, water uptake and in vitro release. With a view to investigate the modulation of drug release from formulation by addition of pH modifiers viz. citric acid and sodium bicarbonate, the tablets with carbopol-934 (2.0), sodium alginate (0.5) and gelatin (6.5) were used and the effect of pH modifiers on microenvironmental pH, bioadhesion, water uptake, in vitro permeation and in vitro release was studied. Microenvironmental pH, bioadhesive strength, water uptake, in vitro release and permeation decreased with increasing concentration of citric acid whereas microenvironmental pH, water uptake and release were enhanced and bioadhesive strength was lowered with increase in sodium bicarbonate. Present study demonstrates carbopol-934, sodium alginate, gelatin polymer system with added pH modifier can be successfully formulated for buccal delivery of ondansetron with desired release profile.
Highlights
The present work aims at developing mucoahesive tablets of ondansetron hydrochloride using bioadhesive polymers like carbopol-934, sodium alginate and gelatin
Tablets of ondansetron HCl prepared with different polymer combinations were evaluated for friability, drug content, hardness, disintegration time, thickness, weight uniformity and their values complied with pharmacopoeial limit ranging from 0.12 to 0.40%, 7.25±0.40 to 8.06±0.32 mg/tablet, 5.00±0.50 to 7.33±0.76 kg/cm2, 130 to 170 min., 5.0 to 5.5 mm, 96.50±3.73 to 100.10±1.94 g, respectively
Hardness of buccal adhesive tablets of ondensetron HCl prepared by using different polymer proportions of C, sodium alginate (SA) and G in combination was found to increase with increase in the concentration of all three polymers but the effect of polymer concentration on hardness was found to be more pronounced with gelatin (5.50±0.50 to 7.33±0.76 kg/cm2; F=3.38, P=0.053) and least affected by carbopol-934 (5.50±0.50 to 5.65±0.29 kg/cm2; F=1.308, P=0.331) (Table 1)
Summary
Ondansetron HCl was received as a generous gift from commercial suppliers In addition to the above properties prepared tablets, formulations were evaluated for microenvironmental pH, in vitro release, bioadhesion, water uptake and in vitro permeation. Twentyfour tablets divided into six groups, each group consisting of four tablets were weighed and average weight of four tablets was calculated These tablets were placed on the gel surface in six Petri dishes, each containing four tablets and kept in an incubator at 37 1o. Citric acid and sodium bicarbonate sieved (Sieve No 200) and incorporated in concentrations 1-5% w/w mixed intimately and compressed These prepared tablets were evaluated for microenvironment pH, bioadhesive strength, water uptake, in vitro release and permeation. [32,33] In vitro permeation of ondansetron HCl from tablets through the excised porcine buccal membrane was studied[5,30]. Statistical analysis of the data obtained from the studies was carried out with either one way analysis of variance (ANOVA) and post hoc Dunnett test or two way ANOVA followed by post hoc Bonferroni comparisons
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