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orally disintegrating tablet
An orally disintegrating 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.〔〔〔〔〔〔〔〔〔〔〔 The ODT serves as an alternative dosage form for patients who experience dysphagia (difficulty in swallowing) or for where compliance is a known issue and therefore an easier dosage form to take ensures that medication is taken. Common among all age groups, dysphagia is observed in about 35% of the general population, as well as up to 60% of the elderly institutionalized population 〔Sastry, S. et al., Pharm. Sci. & Tech. Today 3: 138-145, 2000.〕〔Groher ME, Bukatman MS. The prevalence of swallowing disorders in two teaching hospitals. Dysphagia. 1: 3-6, 1986.〕 and 18-22% of all patients in long-term care facilities
〔Layne KA, Losinski DS, Zenner PM, Ament JA. Using the Fleming index of dysphagia to establish prevalence. Dysphagia. 4: 39-42, 1989.〕 During the last decade, ODTs have become available in a variety of therapeutic markets, both OTC and by prescription. An additional reason to use an ODTs is the convenience of a tablet that can be taken without water.
==History==
Tablets designed to dissolve on the buccal (cheek) mucous membrane were a precursor to the ODT. This dosage form was intended for drugs that yield low bioavailability through the digestive tract but are inconvenient to administer parenterally, such as steroids and narcotic analgesics. Absorption through the cheek allows the drug to bypass the digestive tract for rapid systemic distribution. Not all ODTs have buccal absorption and many have similar absorption and bioavailability to standard oral dosage forms with the primary route remaining GI absorption. However, a fast disintegration time and a small tablet weight can enhance absorption in the buccal area. The first ODTs disintegrated through effervescence rather than dissolution, and were designed to make taking vitamins more pleasant for children. This method was adapted to pharmaceutical use with the invention of microparticles containing a drug, which would be released upon effervescence of the tablet and swallowed by the patient. Dissolution became more effective than effervescence through improved manufacturing processes and ingredients (such as the addition of mannitol to increase binding and decrease dissolution time). Catalent Pharma Solutions (formerly Scherer DDS) in the U.K., Cima Labs and Fuisz Technologies (whose founder Richard Fuisz went on to pioneer orally soluble films, a separate but related dosage form) in the U.S. and Takeda Pharmaceutical Company in Japan led the development of ODTs.
The first ODT form of a drug to get approval from the U.S. Food and Drug Administration (FDA) was a Zydis ODT formation of Claritin (loratadine) in December 1996.〔(FDA Drug Details for Claritin RediTabs )〕 It was followed by a Zydis ODT formulation of Klonopin (clonazepam) in December 1997,〔(FDA Drug Details for Klonopin Wafer )〕 and a Zydis ODT formulation of Maxalt (rizatriptan) in June 1998.〔(FDA Drug Details for Maxalt-MLT )〕 The regulatory condition for meeting the definition of an orally disintegrating tablet is USP method 701 for Disintegration. FDA guidance issued in Dec 2008 is that ODT drugs should disintegrate in less than 30 seconds.〔(FDA Guidance for Industry Orally Disintegrating Tablets )〕 This practice is under review by the FDA as the fast disintegration time of ODTs makes the Disintegration test too rigorous for some of the ODT formulations that are commercially available.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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