Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 359, Issue 1-2, Pages 63-69Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2008.03.019
Keywords
taste masking; orally disintegrating tablet; microspheres; spray drying
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The purpose of this study was to evaluate the potential of microspheres for taste masking when incorporated into orally disintegrating tablets. The microspheres were produced by spray drying a mixture of the model compound (famotidine) with taste masking material. The spray process was optimized using a central composite design for two variables to obtain microspheres with desirable characteristics. Then the microspheres were mixed with other excipients to form orally disintegrating tablets. The optimal spray-drying process parameters were 34 mg/ml for solid concentration and 7 ml/min for feed rate. The drug encapsulation efficiency of the spray-dried microspheres ranges from of 37.59 to 61.56%, with a mean diameter of less than 10 mu m size and low moisture content (less than 4%). Results from an evaluation by a panel of six human volunteers demonstrated that the orally disintegrating tablets with taste masking microspheres improved the taste significantly. Furthermore, an in vivo study in rats showed that the microspheres neither decrease the bioavailability nor retard the release of famotidine significantly. In conclusion, spray-dried microspheres can effectively mask the bitter taste of the active pharmaceutical ingredients in combination with the orally disintegrating tablets. (C) 2008 Elsevier B.V. All rights reserved.
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