Orally disintegrating tablet
The Federal 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"
The United States Pharmacopeia's (USP) does not have a published definition for ODT. However, ODT's fall under the general guidance of the USP method 701 for Disintegration, whic 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 disintegration time; ideally <30 seconds.
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+ |
| Zomig-ZMT | AstraZeneca | Zolmitriptan | Migrane | |
| Zyprexia Zydis | Eli Lilly & Co. | Olanzapine | Schizophrenia | |
| Zofran Zydis | GSK | Odansetron | Nausea | |
| Zydis Selegiline | Selegiline |