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, in April of 2007, the FDA Guidance for Industry regarding ODTs[2]. In this guidance, the FDA recommends that ODTs be kept to a minimum tablet size of 500mg. Many pharmaceutical companies with a vested interest in ODTs have responded to the FDA. None support the size limit and it will be interesting to watch this guidance develop, as there may be many ODT products in the pipiline that exceed 500mg. For those who subscribe to The Pink Sheet report a report of many pharmaceutical companies opinion on this can be found.

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 rigorous for ODTs due to their fast DT, ideally less than 30 seconds.

Current ODTs on the market

Product	Company	API	Indication	Market Age Group	Technology
Benadryl FastMelt	Pfizer	Diphenhydramine / Pseudoephedrine	Allergy
Calpol Fast Melts	Pfizer	Paracetamol	Analgesic	6+
Nurofen Meltlets	Crookes Healthcare	Ibuprofen		6+
Alavert	Wyeth	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		Zydis
Zofran Zydis	GlaxoSmithKline	Ondansetron	Nausea		Zydis
Zydis Selegiline		Selegiline
Orapred ODT(TM)	Alliant	Prednisolone Sodium Phosphate	Asthma		OraSolv®
FazaClo®	Avanir	Clozapine	Schizophrenia		OraSolv®
Zomig-ZMT/Rapimelt®	Astrazeneca	Zolmitriptan	Migraine		DuraSolv®
Tempra First Tabs®	Bristol-Meyers Squibb	Pediatric Analgesics			OraSolv®
Maxalt-MLT	Merck & Co.	Rizatriptan	Migraine