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Shoults CC
Shoults CC
Tanzania
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Research Article
Pharmacokinetics of a Taste-Masked Prednisone Oral Microsphere Powder
Author(s): Shoults CC, Kearns GL, Meyer AR, Moran J, D’Ann Pierce, Abdel-Rahman SM, Berkland CJ and Dormer NH Shoults CC, Kearns GL, Meyer AR, Moran J, D’Ann Pierce, Abdel-Rahman SM, Berkland CJ and Dormer NH
Many active pharmaceutical ingredients (APIs) face the challenge of palatability when administered orally. Taste-masking technologies often utilize coatings to help palatability but these coatings or agglomerations can negatively impact bioavailability. Orbis Biosciences, Inc. (Orbis) has developed a novel taste-masking technology that has previously been demonstrated to have virtually complete taste-masking of the extremely bitter API, prednisone. The next facet of development was to assess the pharmacokinetics (PK) and relative bioequivalence (BE) of prednisone from this new formulation. Presented here is a randomized, open-label, two products, two period and crossover study in fasted adults comparing 10 mg prednisone taste-masked microspheres to a 10 mg prednisone tablet. Fourteen (14) post-dose plasma concentrations obtained over a 12 h period were analyzed for prednisone and its .. View More»
DOI: 10.4172/jbb.1000360