Disintegration property of ODTs with co-processed excipients – Application note

Performance of orally disintegrating tablets (ODTs) with GRANFILLER-D was investigated by the real-time X-ray observation of water penetration into ODTs.

Orally disintegrating tablets (ODTs) have gotten attention as they improve medication adherence for patients who have issues in swallowing, such as geriatric and pediatric patients.　In the course of ODTs development, co-processed excipients for ODTs are available as time-saving tools for manufacturers. They consist of several excipients that have already been chosen and processed for those applications. The use of co-processed excipients in ODT is gradually becoming common, and has boosted the popularity of them. At present, many kinds of co-processed excipients are applied to marketed ODTs. GRANFILLER-D is one of such co-processed excipients, containing four ingredients listed in the USP, EP, and JP: mannitol, crospovidone, carmellose and microcrystalline cellulose. In this study, the performance of the co-processed excipient GRANFILLER-D was investigated by the real-time observation of water penetration into ODTs utilizing a synchrotron radiation X-ray.

Although X-ray imaging studies on tablets have been reported, most of them involved observation using static imaging techniques, for instance, observation of tablet inner density distribution and analysis of the internal structure of coated API particles in the tablet. In this study, we utilized a synchrotron radiation X-ray and high-speed image acquisition system at SPring-8, the world’s largest synchrotron radiation facility, to perform real-time observation of water penetration into ODTs and to acquire X-ray computed tomography (CT) of their initial disintegration behavior.
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Authors

Yukiko Suganuma
Yukiko Suganuma is in charge of technical support and marketing in Daicel Corporation in Japan. She earned her PhD in Physics at Ochanomizu University working in the field of soft matter. After a career in R&D for personal care products, she joined Pharma Solutions, Daicel Corporation in 2018. More on DAICEL Corporation

Dr. Helene Wall
Helene Wall is a Technical Sales Manager at HARKE Pharma GmbH. She received her PhD in organometallic Chemistry at the Technical University of Dortmund working in the field of (Aminomethyl)ferrocenes. After a career at the University she joined HARKE Pharma GmbH in 2019. More on HARKE Pharma GmbH