An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets

Orally disintegrating tablets (ODTs) are designed to dissolve or disintegrate rapidly upon contact with saliva to eliminate some common problems for oral solid-dosage forms such as difficulty in swallowing (dysphagia), the need for chewing a tablet, and the need for water intake (1). The Center for Drug Evaluation and Research's (CDER's) Data Standards Manual for Dosage Forms provides the original definition of an ODT as "a solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue (2)." Ideally, an ODT dissolves or disintegrates quickly in a few seconds it is placed on the tongue without the intake of water. ODTs can be used for incorporating additional clinical benefits such as enhancing oral absorption and bioavailability, improving patient compliance, and for business purposes such as extending patent life, product life cycle, and product differentiation (3).

Recently, increasing numbers of active pharmaceutical ingredients (APIs) have been formulated into orally disintegrating dosage forms. The current market consists of more than 145 launched products (both branded and generic) for 92 molecules (and combinations), which is an increase of 10 molecules and more than 15 brands from 2004, including prescription and over-the-counter (OTC) segments. ODT therapies for central nervous system disorders (depression, mood disorders, migraine headaches, Alzheimer's disease, insomnia, anxiety) still dominate the market, accounting for more than 40% of the market value. Gastrointestinal (GI) ODTs increased in share to 34% by value, oncology to 10%, and diabetes to 7%. In 2005–2006, brand companies learned that patients perceived a faster onset of action with an ODT, and caregivers welcomed the ease of administration of ODTs to patients who are reluctant to comply with medical orders or who became combatant when administered their medicine. These are likely the contributing factors to the high growth in the ODT market (4).