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An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole.
To measure the disintegration time of the tablet coating and the tablet core, automatic disintegration testers are used which are able to determine the complete disintegration process of a tablet by measuring the rest height of the thickness with every upward stroke of the disintegration tester basket.
The hardness value of a tablet gives an early indication of the tablet's disintegration time. Further measured parameters are weight, thickness, diameter, disintegration time, friability, and abrasion. Friability and abrasion testing is performed in rotating testing drums, designed according to the pharmacopeia.
The dosage should have a uniform appearance, with an acceptable taste, tablet hardness, and capsule disintegration. It is unlikely that formulation studies will be complete by the time clinical trials commence. This means that simple preparations are developed initially for use in phase I clinical trials.
A Zydis tablet is produced by lyophilizing or freeze-drying the drug in a matrix usually consisting of gelatin. The resulting product is very lightweight and fragile, and must be dispensed in a special blister pack. Amipara et al., in their article "Oral disintirating tablet of antihypertensive drug" explain the technology's limitations:
Individuals with unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets bearing the above lot numbers have been advised to discontinue use of the product.
Some time release formulations do not work properly if split, such as controlled-release tablet coatings, while other formulations such as micro-encapsulation still work if the microcapsules inside are swallowed whole. [25] [26] Among the health information technology (HIT) that pharmacists use are medication safety tools to help manage this ...
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