FORMULATION AND EVALUATION OF CONTROLLED RELEASE MUCOADHESSIVE MATRIX TABLETS OF LEVAMISOLE: ASSEMENT OF PURIFIED FRUIT PULP POLYSACCHARIDE ISOLATED FROM AEGLE MARMELOS AS MUCOADHESIVE EXCIPIENT
Abstract
ABSTRACT
Objective: Mucoadhesive tablets have been developed for Levamisole using natural mucoadhesive material such as purified polysaccharide isolated from
the ripe fruit pulp of Aegle marmelos. Lin (AMPS) and evaluate in-vitro, in-vivo mucoadhesive properties to assess its efficacy as mucoadhesive agent.
Method: The tablets were formulated with AMPS in different concentration employing wet granulation method. Pre-compression tests, tablet
parametric tests, swelling index and In-vitro drug release kinetics were performed. Optimization of formulation was done on the basis of controlled
and maximum amount of drug release with respect to time. In-vitro, ex-vivo evaluation of mucoadhesion was performed with all prepared formulation
but in-vivo evaluation was done by X-ray with optimized formulation (F40) in rabbit. Stability studies were carried out according to ICH guide line
with optimized formulation.
Results: The tensile strength, mucoadhesive strength and swelling index increase as the natural polymer concentration increase. The release
Kinetics and mechanism of release were calculated by fitting in-vitro release data in various models demonstrating that release. In vitro drug release
of the optimized batch (F40) was best fitted and explained by Korsemeyer–Peppas and zero order drug release; (Rp=0.9891) and (Ro=0.9842)
showed highest linearity and n value 0.97>0.5<1. Hence, pattern of drug release by non-Fickian erosion controlled release. Studies of the optimized
formulation demonstrate no significant change in the tensile strength, mucoadhesive strength and drug assay.
Conclusion: These research outcomes clearly specify the potential of the AMPS to be used as mucoadhesive, release retardent natural material in
tablet formulation
Keywords: Polysaccharide, Acrylamidopropylmethane sulfonic acid, Aegle marmelos, Levamisole, Mucoadhessive.
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