Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets |
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Authors: | Shagufta Khan Prashant Kataria Premchand Nakhat Pramod Yeole |
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Institution: | (1) Department of Pharmaceutics, Institute of Pharmaceutical Education and Research (IPER), Borgaon (Meghe), 442001 Wardha, Maharashtra, India |
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Abstract: | The purpose of this research was to mask the intensely bitter taste of ondansetron HCl and to formulate a rapiddisintegrating
tablet (RDT) of the taste-maske drug. Taste masking was done by complexing ondansetron HCl with aminoalkyl methacrylate copolymer
(Eudragit EPO) in different ratios by the precipitation method. Drug-polymer complexes (DPCs) were tested for drug content,
in vitro taste in simulated salivary fluid (SSF) of pH 6.2, and molecular property. Complex that did not release drug in SSF
was considered taste-masked and selected for formulation RDTs. The complex with drug-polymer ratio of 8∶2 did not show drug
release in SSF; therefore, it was selected. The properties of tablets such as tensile strength, wetting time, water absorption
ratio, in vitro disintegration time, and disintegration in the oral cavity were investigated to elucidate the wetting and
disintegration characteristics of tablets. Polyplasdone XL-10 7% wt/wt gave the minimum disintegration time. Tablets of batch
F4 containing spray-dried mannitol and microcrystalline cellulose in the ratio 1∶1 and 7% wt/wt Polyplasdone XL-10 showed
faster disintegration, within 12.5 seconds, than the marketed tablet (112 seconds). Good correlation between in vitro disintegration
behavior and in the oral cavity was recognized. Taste evaluation of RDT in human volunteers revealed considerable taste masking
with the degree of bitterness below threshold value (0.5) ultimately reaching to 0 within 15 minutes, whereas ondansetron
HCl was rated intensely bitter with a score of 3 for 10 minutes. Tablets of batch F4 also revealed rapid drug release (t90, 60 seconds) in SGF compared with marketed formulation (t90, 240 seconds;P<.01). Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated tablets
in the oral cavity.
Published: June 22, 2007 |
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Keywords: | Taste masking rapid-disintegrating tablets ondansetron HCl Eudragit EPO superdisintegrants |
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