Patient-centric dose design

Published: 13-Sep-2016

The latest developments in orally disintegrating tablets

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If prescribed classic tablet formulations, compliance with dosing regimens can be challenging for many patients.

Elderly users frequently find them hard to swallow, and parents all too often experience great difficulty when persuading small children to take their tablets. Although liquid formulations can provide a solution, there is an alternative — the orally disintegrating tablet or ODT.

ODTs have significant benefits. As they dissolve in naturally produced saliva in the mouth, no further liquid is required, making them extremely convenient to take on-the-go. This dissolution and absorption in the oral cavity confers rapid onset of action too, which can be beneficial for conditions such as migraine and insomnia.

Catalent’s Zydis ODT is the world’s best-selling orally disintegrating tablet. The first product was launched more than 30 years ago and, today, at least 35 products formulated with Zydis technology are on the market in more than 60 countries. More than a billion doses are manufactured every year at Catalent.

The Zydis ODT typically disperses on the tongue in less than 3 seconds as a result of the lyophilisation technology used in its manufacture, and has a smooth mouthfeel (unlike other ODT products that can take longer than a minute to disperse and often leave a paste-like feel in the mouth).

Speed of dispersion is important. Rapid dissolution enables effective buccal and sublingual dispersion; pregastric absorption may also be achieved for certain APIs. This not only enables rapid onset of action, but also avoids first-pass metabolism in the liver and can therefore improve product safety.

Not all APIs can be formulated to give pregastric absorption though, the determining factors include the API dose, solubility, lipophilicity and molecular weight. However, if the API is suitable, then modifications to the formulation can be used to further enhance its absorption in this way.

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