Orally disintegrating tablet

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.

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