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Paper Details


Harendra Prasad* and Navneet Kumar Verma

Journal Title:World Journal of Pharmaceutical Research

New drug-delivery technologies are often championed by contract manufacturing organizations. For new technologies that provide significant clinical as well as financial value, research and innovation in the contract manufacturing and pharmaceutical segments lead to the emergence of numerous competing versions of the technologies. Such a technology evolution has been evident for orally disintegrating tablets (ODTs). Designed to disintegrate rapidly on contact with saliva and enable oral administration without water or chewing, these formulations offer increased convenience and ease of administration with the potential to improve compliance, particularly in certain populations where swallowing conventional solid oral-dosage forms presents difficulties. The Zydis lyophilization technology provided the first approved ODT in the United States in 1996. The earliest US regulatory definition for an ODT reflected the lyophilized ODTs that prevailed at the time. An ODT was defined as a solid-dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed on the tongue (1). The emergence of multiple ODT technology platforms created some regulatory challenges due to increasing variance in the critical product attributes of ODTs, notably disintegration time and tablet size. It can be assumed that the regulatory challenge was most acute for generic product applications. Hypothetically, in an abbreviated new drug application, the disintegration time of a generic product could be 3045 s, and the disintegration time of a reference product 010 s. Prolonged disintegration times may result in failure to meet the defining performance characteristics of the ODT dosage form, such that the product might require water for administration or chewing to facilitate swallowing. Where the patient or caregiver?s expectation is for rapid dispersion in the mouth, larger units with slower disintegration times could result in confusion regarding the product quality and even present a choking hazard. Thus, in addition to product definition, patient safety is also a significant consideration.