Development And Evaluation Of Taste Masked Orally Disintegrating Tablets Of A Water Soluble Drug, Sumatriptan Succinate And A Water Insoluble Drug, Ondansetron

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Date
2010-12
Authors
Ravi, Sheshala
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Publisher
Universiti Sains Malaysia
Abstract
The aim of the present research was to formulate taste masked orally disintegrating tablets (ODTs) of ondansetron (water insoluble) and sumatriptan succinate (water soluble) using different available technologies namely Orasolv, freeze drying and Wowtab. In Wowtab and freeze drying techniques, the bitter taste of ondansetron was masked by the addition of a sweetener (aspartame), whereas in the Orasolv technique by complexing the drug with Eudragit EPO (1:0.5). In all the techniques used to prepare sumatriptan succinate ODTs, the intensely bitter taste of the drug was masked by coating it with Eudragit EPO (1:1) using spray dryer. In Wowtab technique, ondansetron and sumatriptan succinate formulations were prepared using different types and concentrations of superdisintegrants. The Wowtab and freeze drying techniques produced optimized formulations of ondansetron tablets with an in vitro disintegration time and water content within the USP requirement of ≤10 sec and ≤4%, respectively. However, none of the ondansetron formulations prepared by Orasolv technique met the official requirements for in vitro disintegration time. On the other hand, the three techniques (Orasolv, freeze drying and Wowtab) produced optimized formulations of sumatriptan succinate that fulfilled the USFDA official requirements for in vitro disintegration time of <60 sec. The in vitro release profiles of the optimized formulations for the two drugs were comparable with the commercial products. The optimized formulations of ondansetron and sumatriptan succinate prepared by Wowtab technique were selected for the evaluation of taste, mouth feel and in vivo disintegration time using human volunteers. The optimized formulations of ondansetron and sumatriptan succinate had a pleasant taste with good mouth feel and disintegrated in the mouth within 12 and 41 sec, respectively. In addition, both optimized formulations were stable for at least 6 months at 40 °C/75% RH and 25 °C/65% RH. The optimized formulation of ondansetron consisted of Polyplasdone XL-10 (15%), aspartame (7%) and strawberry flavour (1%) whereas sumatriptan succinate consisted of Kollidon CL-SF (5%), ammonium bicarbonate (10%), aspartame (2%) and pineapple flavour (0.75%).
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Keywords
Formulate taste masked orally disintegrating tablets of ondansetron , and sumatriptan succinate using different available technologies namely Orasolv
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