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An estimated 35% of the general population suffers from dysphagia (i.e., difficulty in swallowing), including 30–40% of the
elderly and 18–22% of patients in long-term care (1). Moreover, solid-dosage forms that are easy to swallow may be necessary
for specific patient groups such as geriatric, pediatric, and traveling patients who may not have ready access to water (2).
Orally disintegrating tablets (ODTs) were developed to target these special patient populations who may suffer from difficulties
when swallowing a solid-dosage form. The US Food and Drug Administration guidance for industry defines ODTs as solid-dosage
forms that disintegrate rapidly, usually within a matter of seconds when placed upon the tongue. It also recommends the in vitro disintegration time be measured by means of a United States Pharmacopeia (USP) disintegration apparatus and be equal or less
than 30 s (3).
Benefits of ODTs
Accurate dosing, ease of manufacture, good stability, small size for packaging, and easy handling by patients are characteristics
of solid-dosage forms (4, 5). On the other hand, liquid-dosage form's advantages include: reduced risk of suffocation, ease
of swallowing, and simplified administration (6). Since OTDs are dosed as a solid and dissolve quickly into a liquid in the
mouth, this dosage form exhibits the advantages of both solid and liquid preparations (7). ODTs also do not require additional
water intake and provide more rapid availability of drug for absorption and circulation starting in the buccal mucosa. Buccal
mucosa absorption translates into bypass of first pass metabolism and more rapid onset of drug action. Even though most of
the research published so far has mainly focused on shortening disintegration times, some authors have reported formulations
that modify the release of the drug while preserving a fast disintegration time (8, 9). The many advantages of ODTs make them
an interesting dosage form with many research and development opportunities.
Over the years, several technologies and manufacturing processes have been developed for the production of ODTs. Technologies
such as Zydis (Cardinal Health, Dublin, OH) and Quicksolv (Janssen Pharmaceutica, Beerse, Belgium) rely on lyophilization
for the manufacture of the ODT (7, 10). WOWTAB (Yamanouchi Pharma Technologies, Norman, OK), OraSolv, and DuraSolv (Cima Labs,
Eden Prairie, MN) are some examples of technologies that are based on compaction processes (11–13). However, most of these
processes face the challenge of achieving rapid disintegration times, while obtaining final dosage forms that can withstand
subsequent packaging and shipping. Different approaches have been used to overcome this major problem in the development of
ODTs. Some include the development of special packaging devices that reduce the mechanical impact on the dosage form. Other
strategies include developing granules suitable for compaction of ODTs, or tableting at low-compression forces and applying
after-treatments to the resulting tablets (14). These solutions frequently lead to multistep processes that may require additional
equipment, resulting in high cost of production.
The research presented in this article details the development of a suitable direct compression method for the manufacture
of ODTs, incurring no further processing or the use of additional equipment. The proper combination of excipients tableted
at determined compression forces allowed us to successfully obtain ODTs.
Jason T. McConville is an assistant professor at the College of Pharmacy, Division of Pharmaceutics, University of Texas at Austin, Austin, TX 787120231, tel. 512.471.0942.
Articles by Jason T. McConville
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