Orodispersible Tablets: from Concept to Data Analysis of Valid Records in Brazil

Abstract

Orodispersible tablets (ODT) are fast-disintegrating dosage forms for oral administration that do not require swallowing or the intake of water. Despite their convenience, ODT are rarely prescribed in Brazil. This study surveys data on valid ODT in the country, focusing on pharmacological classes and target populations. Additionally, it examines the composition and use instructions in package inserts to clarify their peculiarities. Registrations were obtained from online research on the Brazilian Health Regulatory Agency (ANVISA) website, with further information provided in the package insert available on the Bulário Eletrônico of ANVISA. A total of 50 valid ODT registrations were found in Brazil. The antiemetic and antidepressant classes, represented by ondansetron hydrochloride and mirtazapine, are the main drugs available as ODT. Descriptive and illustrative instructions on correct drug administration on the tongue were found. In excipient analysis, microcrystalline cellulose, croscarmellose, crospovidone, or sodium starch glycolate were frequently used as superdisintegrants. Mannitol is also present as a diluent and sweetener, which helps mask the unpleasant flavor of the ODT. In general, ODT registered in Brazil combine a simple composition with practical use, making them an excellent option for patients with special needs and with potential for growth in the Brazilian pharmaceutical market.