The demand for more patient-friendly and compliant dosage forms has increased over the past ten years, which has led to an annual increase in the need for developing new technologies1. Because it is very expensive to develop a new drug molecule, pharmaceutical companies are now concentrating their efforts on developing new drug dosage forms for existing drugs that have improved safety and efficacy along with reduced dosing frequency, as well as the production of more cost-effective dosage forms. For the majority of therapeutic agents used to produce systemic effects, the oral route still represents the preferred means of administration due to its many benefits and high patient compliance when compared to many other routes. The population is impacted by this issue, which ultimately raises the risk of therapy noncompliance and inefficiency. These factors have led to a great deal of interest in tablets that break down in the mouth [3]. Among all pharmaceutical formulations. NS, oral tablets with solid dosage have the most prominence [4] The ODT formulation is described as “a solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds when placed upon the tongue” by the Food and Drug Administration (FDA). The Zydis ODT formulation of Claritin (loratadine) was authorized by the US Food and Drug Administration in December 1996. The Zydis ODT formulation of Klonopin (clonazepam) and the Zydis ODT formulation of Maxalt (rizatriptan) came after it in December 1997 and June 1998, respectively. Moreover, a handful of medications have received regulatory authority approval for ODT formulations [5]
Mechanisms of Disintegration:
Unless the tablet is made for rapid surface erosion, it must first disintegrate before dissolving. Starches, agar, amylose, cellulose and its derivatives, gum and its derivatives, gelatin, resins, and silicone compounds are among the substances used as dissolves. Several mechanisms of action have been proposed for disintegration. The first mechanism involves the development of gas from an effervescent pair, such as citric acid and sodium bicarbonate, when water is absorbed. The disintegration of the pill may occur due to the expansion of gas. Another mechanism involves the disintegration of the tablet structure by swelling caused by the absorption of water [6].
Shruti Deshpande
10.5281/zenodo.16274270