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Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.
Biol Pharm Bull. 2013; 36(9):1488-93.BP

Abstract

Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

Authors+Show Affiliations

Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

23995661

Citation

Yoshita, Tomohiro, et al. "Clinical Disintegration Time of Orally Disintegrating Tablets Clinically Available in Japan in Healthy Volunteers." Biological & Pharmaceutical Bulletin, vol. 36, no. 9, 2013, pp. 1488-93.
Yoshita T, Uchida S, Namiki N. Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers. Biol Pharm Bull. 2013;36(9):1488-93.
Yoshita, T., Uchida, S., & Namiki, N. (2013). Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers. Biological & Pharmaceutical Bulletin, 36(9), 1488-93.
Yoshita T, Uchida S, Namiki N. Clinical Disintegration Time of Orally Disintegrating Tablets Clinically Available in Japan in Healthy Volunteers. Biol Pharm Bull. 2013;36(9):1488-93. PubMed PMID: 23995661.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers. AU - Yoshita,Tomohiro, AU - Uchida,Shinya, AU - Namiki,Noriyuki, PY - 2013/9/3/entrez PY - 2013/9/3/pubmed PY - 2014/4/2/medline SP - 1488 EP - 93 JF - Biological & pharmaceutical bulletin JO - Biol Pharm Bull VL - 36 IS - 9 N2 - Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity. SN - 1347-5215 UR - https://www.unboundmedicine.com/medline/citation/23995661/Clinical_disintegration_time_of_orally_disintegrating_tablets_clinically_available_in_Japan_in_healthy_volunteers_ L2 - http://joi.jlc.jst.go.jp/DN/JST.JSTAGE/bpb/b13-00353?lang=en&amp;from=PubMed DB - PRIME DP - Unbound Medicine ER -