Orally disintegrating tablet
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The Food and Drug Administration's (FDA) definition of an orally disintegrating tablet (ODT) is: "A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue." [1]
The United States Pharmacopeia (USP) does not have a published definition for ODT. However, ODTs fall under the general guidance of the USP method 701 for Disintegration, which is the current regulatory condition for meeting the "definition" of ODT. This is currently under review by the FDA, since this dissolution test is too rigourous for ODTs due to their fast DT, ideally less than 30 seconds.
[edit] Current ODTs on the market
Product | Company | API | Indication | Market Age Group |
---|---|---|---|---|
Calpol Fast Melts | Pfizer | Analgesic | 6+ | |
Benadryl FastMelt | Pfizer | Diphenhydramine / Pseudoephedrine | Allergy | 6+ |
Nurofen Meltlets | Crookes Healthcare | Ibuprofen | 6+ | |
Alavert | Loratadine | Allergy | 6+ | |
Clarinex Redi-Tabs | Pfizer | Desloratadine | Allergy | 6+ |
Prevacid | Tap Pharmaceuticals | Lansoprazole | Ulcer | |
Zomig-ZMT | AstraZeneca | Zolmitriptan | Migraine | |
Zyprexa Zydis | Eli Lilly and Company | Olanzapine | Schizophrenia | |
Zofran Zydis | GlaxoSmithKline | Ondansetron | Nausea | |
Zydis Selegiline | Selegiline |