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

Sumitha Ch.¹, Karuna Sree N.², Divya B.³, Madhavi K.⁴, Vimal Kumar Varma M.⁵, Charbe N.N.^6
1Dept of Pharmaceutics, Mother Teresa College of Pharmacy, Ghatkeser, R.R. Dist 501301, AP, India
²Dept of Pharmaceutics, Mother Teresa College of Pharmacy, Ghatkeser, R.R. Dist 501301, AP, India
³Dept of Pharmaceutics, Mother Teresa College of Pharmacy, Ghatkeser, R.R. Dist 501301, AP, India
⁴Dept of Pharmaceutics, Mother Teresa College of Pharmacy, Ghatkeser, R.R. Dist 501301, AP, India
⁵Dept of Pharmaceutics, Mother Teresa College of Pharmacy, Ghatkeser, R.R. Dist 501301, AP, India
⁶Dept of Pharmaceutics, Mother Teresa College of Pharmacy, Ghatkeser, R.R. Dist 501301, AP, India

Received : -     Accepted : -     Published : 21-12-2009
Volume : 1     Issue : 2       Pages : 24 - 27
Int J Chem Res 1.2 (2009):24-27
DOI : http://dx.doi.org/10.9735/0975-3699.1.2.24-27

Keywords : Ondansetron hydrochloride, Methocel E15, Polacriline Potassium, Poly ethylene oxide N-10, Rapid disintegrating films RDF, Simulated salivary fluid, Drug-polymer complexes, Hydration studies
Conflict of Interest : None declared

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.

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