Orally disintegrating tablet

Orally disintegrating tablets (ODTs), also known as orodispersible tablets, are a type of dosage form that disintegrate and dissolve in the mouth, without the need for water. They are designed to provide an alternative to traditional tablets, especially for patients who have difficulty swallowing.

History

The concept of ODTs was first introduced in the 1980s, with the aim of improving patient compliance. The first ODT, a migraine medication called Maxalt-MLT, was approved by the FDA in 1998.

Formulation

ODTs are formulated using unique technologies to achieve rapid disintegration and dissolution. They typically contain a disintegrant, which helps the tablet to break apart, and a superdisintegrant, which promotes rapid water uptake. Commonly used superdisintegrants include crospovidone, sodium starch glycolate, and croscarmellose sodium.

Advantages

ODTs offer several advantages over traditional tablets. They can be taken without water, making them convenient for on-the-go use. They also provide rapid drug absorption, which can lead to faster onset of action. In addition, they can be beneficial for patients who have difficulty swallowing, such as children and elderly adults.

Disadvantages

Despite their advantages, ODTs also have some limitations. They can be more expensive to manufacture than traditional tablets, due to the need for specialized equipment and processes. They may also have a shorter shelf life, due to their increased sensitivity to moisture.

Regulatory considerations

In the United States, ODTs are regulated by the FDA. The agency has established guidelines for the development and approval of ODTs, including requirements for disintegration and dissolution testing.

Future directions

Research is ongoing to further improve the properties of ODTs, such as their taste and texture, and to expand their use to a wider range of drugs.