Tropical Journal of Pharmaceutical Research

Review Article | OPEN ACCESS

Disintegration testing for orally disintegrating tablets (ODTs): An overview

Rawan SM Bafail

Department of Pharmaceutics and Pharmaceutical Technology, College of Pharmacy, Taibah University, Madinah Munawara, Saudi Arabia;

For correspondence:- Email: rawanpharma56@yahoo.com

Accepted: 02 November 2023 Published: 30 November 2023

Citation: Bafail RS. Disintegration testing for orally disintegrating tablets (ODTs): An overview. Trop J Pharm Res 2023; 22(11):2399-2406 doi: 10.4314/tjpr.v22i11.21

© 2023 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Prescribing orally disintegrating tablet (ODT) dosage form is a common practice. For several populations, including geriatrics and pediatrics, ODTs are one of the most desired dosage forms. They are solid dosage forms designed to disintegrate or dissolve very quickly in contact with saliva as soon as they are placed in oral cavity of a patient. According to United States Pharmacopeia (USP), every dosage form has to pass some quality control tests to ensure uniformity and performance of this dosage form. For ODTs, disintegration test is fundamental to ascertain time required for tablets to break down and release their contents for dissolution and absorption. Additionally, it is a crucial predictive test for determining in vitro/in vivo association. There are no mandatory universal disintegration testing standards for ODTs, however, as stated in the USP. Instead, recent USP refers to individual manufacturer monograph specifications which may vary from one monograph to another. This article discusses several developed disintegration tests and methods for ODTs such as OD-mate testing, basket rack assembly, CCD camera, texture analyzer (TA), special disintegration equipment, prototype disintegration tester (PDT), simple approach, and modified wetting test and elaborates on their advantages and disadvantages.

Keywords: Orally disintegrating tablets (ODTs), USP physical test, Disintegration test, super disintegrants