Journal
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
Volume 73, Issue 3, Pages 361-365Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejpb.2009.08.010
Keywords
Fast dissolving oral thin film; Dexamethasone; Antiemesis; Dissolution test; Pharmacokinetic parameters; Rat
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We prepared fast dissolving oral thin film that contains dexamethasone and base materials, including microcrystalline cellulose, polyethylene glycol, hydroxypropylmethyl cellulose, polysorbate 80 and low-substituted hydroxypropyl cellulose. This preparation showed excellent uniformity and stability, when stored at 40 degrees C and 75% in humidity for up to 24 weeks. The film was disintegrated within 15 s after immersion into distilled water. The dissolution test showed that approximately 90% of dexamethasone was dissolved within 5 min. Subsequently, pharmacokinetic properties of dexamethasone were compared in rats with oral administration of 4 mg dexamethasone suspension or topical application of the film preparation containing 4 mg dexamethasone to the oral cavity. Pharmacokinetic parameters were similar between the two groups in which C-max (h), T-max (mu g/mL), AUC (mu g/mL/h) and half-life (h) were 12.7 +/- 6.6 (mean +/- SD, N = 10). 3.4 +/- 1.4, 93.6 +/- 37.8 and 1.66 +/- 0.07, respectively, for oral suspension and 13.3 +/- 4.0, 3.2 +/- 1.0, 98.0 +/- 22.3 and 1.65 +/- 0.06, respectively, for film preparation. These findings suggest that the fast dissolving oral thin film containing dexamethasone is likely to become one of choices of dexamethasone preparations for antiemesis during cancer chemotherapy. (C) 2009 Elsevier B.V. All rights reserved.
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