European Regulatory Perspective on Super-Generics: Antacid Orally Disintegrating Tablets (ODT)

Abstract

Abstract

Super-generic is the general form of nomenclature for hybrid medicinal product in European Union (EU). The super-generic form of the medicinal product is one that considers changes in the form of active substance, therapeutic indications, strength, pharmaceutical form or route of administration. They rely partly on results of preclinical tests and clinical trials of an innovator product and also on new data with appropriate bioavailability and bioequivalence studies. Marketing authorization for super-generics in EU can be obtained by any of the four registration processes, i.e., centralized, decentralized, mutual recognition and national procedure. Additional studies such as pharmacokinetics, preclinical and clinical studies are conducted as required by the changes that are made in the super-generic product as compared to the innovator product. Antacid orally disintegrating tablets (ODTs) as a part of super-generics have gained considerable attention since last decade. This mode of administration is expected to be beneficial to pediatric, geriatric patients or people with impaired swallowing especially psychiatric patients. These products have a significant impact on exhausting marketing authorization trend of conventional dosage forms. In an effort to develop drug products that are more convenient to use and address potential issues of patient compliance, super-generics have gained importance.

Keywords: super-generic, orally disintegrating tablet (ODT), antacid, patient compliance

Cite this Article

Jain A, Dixit M, Samaga V et al. European regulatory perspective on super-generics: Antacid orally disintegrating tablets (ODT). Trends in Drug Delivery. 2016; 3(1): 31–37p.