Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating films

The purpose of this research was to mask the intensely bitter taste of Ondansetron HCl and toformulate rapid disintegrating films (RDFs) of the taste-masked drug using methocel E15. Taste maskingwas done by complexing Ondansetron HCl with ion exchange resin (Polacriline Potassium) which also hasdisintegrating property, in different ratios and by using sucralose as sweetening agent in very lowconcentrations. 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-maskedand selected for formulation RDFs. The complex with drug-polymer ratio of 2:1 did not show drug release inSSF; therefore, it was selected. The properties of films such as hydration study, folding endurance and invitrodrug disintegration in the oral cavity were investigated. PEO N-10, 7% wt/wt gave the minimumdisintegration time and elegance to the final product. Films of batch F4 containing mannitol and sorbital inthe ratio 1:1 and 7% wt/wt PEO N-10 showed faster disintegration, within 12.5 seconds. Good correlationbetween in-vitro disintegration behavior and in the oral cavity was recognized. Taste evaluation of RDF inhuman 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 ascore 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 theformulated films in the oral cavity.