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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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 (l :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 (I: I) 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:S1 0 sec
and :S4%, 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-I0 (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%). Two specific and sensitive
isocratic HPLC methods for the determination of ondansetron and sumatriptan in
plasma were developed and validated separately. The 90% confidence interval results
of Cmax and AUCo-oo obtained from the bioavailability studies demonstrated that
Reference and Test formulations of ondansetron and sumatriptan succinate are
bioequivalent in their rate and extent of absorption. In conclusion, taste masked
ondansetron and sumatriptan succinate ODTs were successfully prepared and could
be useful alternatives to commercially available products.
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Keywords
DISINTEGRATING TABLETS , SOLUBLE DRUG