Orally Disintegrating Tablets Using Starch and Fructose - Pharmaceutical Technology

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Orally Disintegrating Tablets Using Starch and Fructose
The authors demonstrated that ODTs can be obtained by direct compression of a mixture of starch, fructose, and SMCC.


Pharmaceutical Technology
pp. 92-99


PHIL ASHLEY, DIGITAL VISION, GETTY IMAGES
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.


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