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TASTE MASKING OF ONDANSETRON HYDROCHLORIDE BY POLYMER CARRIER SYSTEM AND FORMULATION OF RAPID-DISINTEGRATING FILMS
Authors: Sumitha Ch., Karuna Sree N., Divya B., Madhavi K., Vimal Kumar Varma M., Charbe N.N.
Number of views: 342
The purpose of this research was to mask the intensely bitter taste of Ondansetron HCl and to
formulate rapid disintegrating films (RDFs) of the taste-masked drug using methocel E15. Taste masking
was done by complexing Ondansetron HCl with ion exchange resin (Polacriline Potassium) which also has
disintegrating property, in different ratios and by using sucralose as sweetening agent in very low
concentrations. Taste was further masked using vanilla flavor in combination with lychee and banana flavor.
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 RDFs. The complex with drug-polymer ratio of 2:1 did not show drug release in
SSF; therefore, it was selected. The properties of films such as hydration study, folding endurance and invitro
drug disintegration in the oral cavity were investigated. PEO N-10, 7% wt/wt gave the minimum
disintegration time and elegance to the final product. Films of batch F4 containing mannitol and sorbital in
the ratio 1:1 and 7% wt/wt PEO N-10 showed faster disintegration, within 12.5 seconds. Good correlation
between in-vitro disintegration behavior and in the oral cavity was recognized. Taste evaluation of RDF 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. Films of batch F4 also revealed rapid drug release (t90, 60 seconds) in SGF.
Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the
formulated films in the oral cavity.