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Dissolution testing of orally disintegrating tablets.
J Pharm Pharmacol. 2012 Jul; 64(7):911-8.JP

Abstract

For industrially manufactured pharmaceutical dosage forms, product quality tests and performance tests are required to ascertain the quality of the final product. Current compendial requirements specify a disintegration and/or a dissolution test to check the quality of oral solid dosage forms. These requirements led to a number of compendial monographs for individual products and, at times, the results obtained may not be reflective of the dosage form performance. Although a general product performance test is desirable for orally disintegrating tablets (ODTs), the complexity of the release controlling mechanisms and short time-frame of release make such tests difficult to establish. For conventional oral solid dosage forms (COSDFs), disintegration is often considered to be the prerequisite for subsequent dissolution. Hence, disintegration testing is usually insufficient to judge product performance of COSDFs. Given the very fast disintegration of ODTs, the relationship between disintegration and dissolution is worthy of closer scrutiny. This article reviews the current status of dissolution testing of ODTs to establish the product quality standards. Based on experimental results, it appears that it may be feasible to rely on the dissolution test without a need for disintegration studies for selected ODTs on the market.

Authors+Show Affiliations

PHAST GmbH, Homburg, Germany. jkraemer@phast.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

22686339

Citation

Kraemer, Johannes, et al. "Dissolution Testing of Orally Disintegrating Tablets." The Journal of Pharmacy and Pharmacology, vol. 64, no. 7, 2012, pp. 911-8.
Kraemer J, Gajendran J, Guillot A, et al. Dissolution testing of orally disintegrating tablets. J Pharm Pharmacol. 2012;64(7):911-8.
Kraemer, J., Gajendran, J., Guillot, A., Schichtel, J., & Tuereli, A. (2012). Dissolution testing of orally disintegrating tablets. The Journal of Pharmacy and Pharmacology, 64(7), 911-8. https://doi.org/10.1111/j.2042-7158.2012.01473.x
Kraemer J, et al. Dissolution Testing of Orally Disintegrating Tablets. J Pharm Pharmacol. 2012;64(7):911-8. PubMed PMID: 22686339.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dissolution testing of orally disintegrating tablets. AU - Kraemer,Johannes, AU - Gajendran,Jayachandar, AU - Guillot,Alexis, AU - Schichtel,Julian, AU - Tuereli,Akif, Y1 - 2012/04/08/ PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2012/10/6/medline SP - 911 EP - 8 JF - The Journal of pharmacy and pharmacology JO - J. Pharm. Pharmacol. VL - 64 IS - 7 N2 - For industrially manufactured pharmaceutical dosage forms, product quality tests and performance tests are required to ascertain the quality of the final product. Current compendial requirements specify a disintegration and/or a dissolution test to check the quality of oral solid dosage forms. These requirements led to a number of compendial monographs for individual products and, at times, the results obtained may not be reflective of the dosage form performance. Although a general product performance test is desirable for orally disintegrating tablets (ODTs), the complexity of the release controlling mechanisms and short time-frame of release make such tests difficult to establish. For conventional oral solid dosage forms (COSDFs), disintegration is often considered to be the prerequisite for subsequent dissolution. Hence, disintegration testing is usually insufficient to judge product performance of COSDFs. Given the very fast disintegration of ODTs, the relationship between disintegration and dissolution is worthy of closer scrutiny. This article reviews the current status of dissolution testing of ODTs to establish the product quality standards. Based on experimental results, it appears that it may be feasible to rely on the dissolution test without a need for disintegration studies for selected ODTs on the market. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/22686339/Dissolution_testing_of_orally_disintegrating_tablets_ L2 - https://doi.org/10.1111/j.2042-7158.2012.01473.x DB - PRIME DP - Unbound Medicine ER -