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Characterization of the buccal and gastric transit of orally disintegrating tablets in humans using gamma scintigraphy.
Int J Pharm. 2020 Feb 25; 576:118937.IJ

Abstract

The present study characterized the buccal cavity-emptying and gastric-emptying kinetics of orally disintegrating tablets (ODTs) in fasted humans using gamma scintigraphy. 111Indium-diethylenetriaminepentaacetic acid and technetium-99 m-labeled ion exchange resin were used as a model soluble drug and insoluble pellet-type drug, respectively, and housed in ODTs. These ODTs were then administered to human subjects with or without ingestion of water, after which scintigraphic images were collected in order to characterize the buccal and gastric transit of the radioactivity. The oral disintegration of the ODTs was extremely rapid, with a mean time of ≤1 min. The buccal emptying of the radioactivity was most rapid for the ODT with a water-soluble radiolabel; however, the ODTs with water-insoluble radiolabels showed buccal emptying with median half-times of ≤2.5 min. The ODT with the soluble radiolabel in subjects without water ingestion showed the most rapid gastric emptying compared with the ODTs with the insoluble radiolabels, the gastric-emptying time of which was highly variable. Further, water ingestion did not markedly affect the gastric-emptying time of the tablets with the water-soluble model drug. The observations in the present clinical study will help clarify the in vivo performance of ODTs in humans.

Authors+Show Affiliations

Pharmaceutical Research and Technology Labs, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka 425-0072, Japan; School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.Astellas Ireland Co., Ltd., Damastown Road, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland.School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan. Electronic address: hkondo@u-shizuoka-ken.ac.jp.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31816352

Citation

Kambayashi, Atsushi, et al. "Characterization of the Buccal and Gastric Transit of Orally Disintegrating Tablets in Humans Using Gamma Scintigraphy." International Journal of Pharmaceutics, vol. 576, 2020, p. 118937.
Kambayashi A, Sako K, Kondo H. Characterization of the buccal and gastric transit of orally disintegrating tablets in humans using gamma scintigraphy. Int J Pharm. 2020;576:118937.
Kambayashi, A., Sako, K., & Kondo, H. (2020). Characterization of the buccal and gastric transit of orally disintegrating tablets in humans using gamma scintigraphy. International Journal of Pharmaceutics, 576, 118937. https://doi.org/10.1016/j.ijpharm.2019.118937
Kambayashi A, Sako K, Kondo H. Characterization of the Buccal and Gastric Transit of Orally Disintegrating Tablets in Humans Using Gamma Scintigraphy. Int J Pharm. 2020 Feb 25;576:118937. PubMed PMID: 31816352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Characterization of the buccal and gastric transit of orally disintegrating tablets in humans using gamma scintigraphy. AU - Kambayashi,Atsushi, AU - Sako,Kazuhiro, AU - Kondo,Hiromu, Y1 - 2019/12/06/ PY - 2019/07/11/received PY - 2019/11/15/revised PY - 2019/12/02/accepted PY - 2019/12/10/pubmed PY - 2019/12/10/medline PY - 2019/12/10/entrez KW - Buccal emptying KW - Gamma scintigraphy KW - Gastric emptying KW - Orally disintegrating tablets KW - Orodispersible tablets SP - 118937 EP - 118937 JF - International journal of pharmaceutics JO - Int J Pharm VL - 576 N2 - The present study characterized the buccal cavity-emptying and gastric-emptying kinetics of orally disintegrating tablets (ODTs) in fasted humans using gamma scintigraphy. 111Indium-diethylenetriaminepentaacetic acid and technetium-99 m-labeled ion exchange resin were used as a model soluble drug and insoluble pellet-type drug, respectively, and housed in ODTs. These ODTs were then administered to human subjects with or without ingestion of water, after which scintigraphic images were collected in order to characterize the buccal and gastric transit of the radioactivity. The oral disintegration of the ODTs was extremely rapid, with a mean time of ≤1 min. The buccal emptying of the radioactivity was most rapid for the ODT with a water-soluble radiolabel; however, the ODTs with water-insoluble radiolabels showed buccal emptying with median half-times of ≤2.5 min. The ODT with the soluble radiolabel in subjects without water ingestion showed the most rapid gastric emptying compared with the ODTs with the insoluble radiolabels, the gastric-emptying time of which was highly variable. Further, water ingestion did not markedly affect the gastric-emptying time of the tablets with the water-soluble model drug. The observations in the present clinical study will help clarify the in vivo performance of ODTs in humans. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/31816352/Characterization_of_the_buccal_and_gastric_transit_of_orally_disintegrating_tablets_in_humans_using_gamma_scintigraphy L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(19)30982-2 DB - PRIME DP - Unbound Medicine ER -
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