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A new modified wetting test and an alternative disintegration test for orally disintegrating tablets.
J Pharm Biomed Anal. 2016 Feb 20; 120:391-6.JP

Abstract

Industrial manufacturing of solid oral dosage forms require quality tests, such as friability, hardness, and disintegration. The United States Pharmacopeia (USP) disintegration test uses 900mL of water. However, recent studies of orally disintegrating tablets (ODTs) have shown that this volume does not accurately portray the oral environment. In our study, various tests were conducted with a more moderate amount of water that accurately resembles the oral environment. A simulated wetting test was performed to calculate the water absorption ratio. Results showed that wetting was comparable to disintegration. Although the wetting test worked for most types of ODTs, it had limitations that produced inaccurate results. This led to the use of a modified shaking water bath test. This test was found to work for all types of ODT products and was not subject to the limitations of the wetting test. The shake test could provide disintegration times rather than water permeation times; however, it could not be used to calculate the water absorption ratio. A strong correlation was observed between the standardized shake test and the USP disintegration times for the tablets. This shake test could be used during the development stages and quality tests for ODTs with relative ease.

Authors+Show Affiliations

University of Toledo, College of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, 3000 Arlington Ave., Toledo, OH 43614, USA.University of Toledo, College of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, 3000 Arlington Ave., Toledo, OH 43614, USA.University of Toledo, College of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, 3000 Arlington Ave., Toledo, OH 43614, USA.University of Toledo, College of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, 3000 Arlington Ave., Toledo, OH 43614, USA. Electronic address: Gabriella.Baki@utoledo.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26774944

Citation

Hooper, Patrick, et al. "A New Modified Wetting Test and an Alternative Disintegration Test for Orally Disintegrating Tablets." Journal of Pharmaceutical and Biomedical Analysis, vol. 120, 2016, pp. 391-6.
Hooper P, Lasher J, Alexander KS, et al. A new modified wetting test and an alternative disintegration test for orally disintegrating tablets. J Pharm Biomed Anal. 2016;120:391-6.
Hooper, P., Lasher, J., Alexander, K. S., & Baki, G. (2016). A new modified wetting test and an alternative disintegration test for orally disintegrating tablets. Journal of Pharmaceutical and Biomedical Analysis, 120, 391-6. https://doi.org/10.1016/j.jpba.2015.12.046
Hooper P, et al. A New Modified Wetting Test and an Alternative Disintegration Test for Orally Disintegrating Tablets. J Pharm Biomed Anal. 2016 Feb 20;120:391-6. PubMed PMID: 26774944.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A new modified wetting test and an alternative disintegration test for orally disintegrating tablets. AU - Hooper,Patrick, AU - Lasher,Jason, AU - Alexander,Kenneth S, AU - Baki,Gabriella, Y1 - 2015/12/29/ PY - 2015/10/06/received PY - 2015/12/21/revised PY - 2015/12/23/accepted PY - 2016/1/18/entrez PY - 2016/1/18/pubmed PY - 2016/12/15/medline KW - Disintegration KW - ODT KW - Oral disintegration KW - Orally disintegrating tablet KW - Water absorption KW - Wetting test SP - 391 EP - 6 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 120 N2 - Industrial manufacturing of solid oral dosage forms require quality tests, such as friability, hardness, and disintegration. The United States Pharmacopeia (USP) disintegration test uses 900mL of water. However, recent studies of orally disintegrating tablets (ODTs) have shown that this volume does not accurately portray the oral environment. In our study, various tests were conducted with a more moderate amount of water that accurately resembles the oral environment. A simulated wetting test was performed to calculate the water absorption ratio. Results showed that wetting was comparable to disintegration. Although the wetting test worked for most types of ODTs, it had limitations that produced inaccurate results. This led to the use of a modified shaking water bath test. This test was found to work for all types of ODT products and was not subject to the limitations of the wetting test. The shake test could provide disintegration times rather than water permeation times; however, it could not be used to calculate the water absorption ratio. A strong correlation was observed between the standardized shake test and the USP disintegration times for the tablets. This shake test could be used during the development stages and quality tests for ODTs with relative ease. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/26774944/A_new_modified_wetting_test_and_an_alternative_disintegration_test_for_orally_disintegrating_tablets_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(15)30311-3 DB - PRIME DP - Unbound Medicine ER -