Abstract
Disintegration time is the key critical quality attribute for a tablet classed as an Orally Disintegrating Tablet (ODT). The currently accepted in vitro testing regimen for ODTs is the standard United States Pharmacopeia (USP) test for disintegration of immediate release tablets, which requires a large volume along with repeated submergence of the dosage form within the disintegration medium. The aim of this study was to develop an in vivo relevant ODT disintegration test that mimicked the environment of the oral cavity, including lower volume of disintegration medium, with relevant temperature and humidity that represent the conditions of the mouth. The results showed that the newly developed Aston test was able to differentiate between different ODTs with small disintegration time windows, as well as between immediate release tablets and ODTs. The Aston test provided higher correlations between ODT properties and disintegration time compared to the USP test method and most significantly, resulted in a linear in vitro/in vivo correlation (IVIVC) (R2 value of 0.98) compared with a “hockey stick” profile of the USP test. This study therefore concluded that the newly developed Aston test is an accurate, repeatable, relevant and robust test method for assessing ODT disintegration time which will provide the pharmaceutical industry and regulatory authorities across the world with a pragmatic ODT testing regime.
Highlights
IntroductionThis method consists of a basket rack attached to a rod which oscillates vertically within a beaker filled within approximately 800 ml disintegration medium, which is placed beneath the basket assembly and kept at 37 °C
The standard test uses a large volume of disintegration medium, and the dosage form disintegrates within the oscillating vessel, which simulates the disintegration of a conventional tablet that is swallowed with water and disintegrates within the gastrointestinal (GI) tract
The Aston test was conceptualised and developed as there is currently no validated test that broadly mimics the oral in vivo conditions encountered by an Orally Disintegrating Tablet (ODT) during disintegration
Summary
This method consists of a basket rack attached to a rod which oscillates vertically within a beaker filled within approximately 800 ml disintegration medium, which is placed beneath the basket assembly and kept at 37 °C. Previous efforts have been made at conducting an in vivo relevant/correlating test, with methods ranging from the fabrication of tailored equipment[5,6,7,8], to improvised methods that were developed using currently available lab equipment[9,10,11,12,13,14,15,16] These different tests suffer from various limitations including absence of controlled conditions such as temperature and humidity as well as limited data for demonstrating in vitro/in vivo correlation (IVIVC). The results from the final design were compared to an in vivo ODT disintegration time study
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