Shimoda H, Taniguchi K, Nishimura M, Matsuura K, Tsukioka T, Yamashita H, Inagaki N, Hirano K, Yamamoto M, Kinosada Y, Itoh Y
Preparation of a fast dissolving oral thin film containing dexamethasone: a possible application to antiemesis during cancer chemotherapy. [JOURNAL ARTICLE]
Eur J Pharm Biopharm 2009 Sep 4.
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 second 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 Cmax (h), Tmax (mug/mL), AUC (mug/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.
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