TABLETES MOLDADOS ORODISPERSÍVEIS DO EXTRATO SECO DE Camellia sinensis (L.): PADRONIZAÇÃO E CARACTERIZAÇÃO

Abstract

The soluble dry extract of Camellia sinensis (L.) (Matcha) is rich in phenolic compounds but presents significant oxidative instability, and few innovative pharmaceutical dosage forms are available on the market. This study aimed to develop, characterize, and evaluate the stability of molded orodispersible tablets containing Camellia sinensis (L.) dry extract. Two pharmaceutical bases were initially tested. Base I exhibited high friability and a 5.01% mass loss after 90 days, proving unsuitable for formulation. Base II showed superior physical and chemical performance, with only 0.60% mass loss in the same period. Extract concentrations ranging from 10 - 40% w/w were incorporated, with 40% identified as the maximum feasible level without compromising moldability or disintegration. Quality control tests included organoleptic assessment, average mass, disintegration, and quantification of gallic acid via UV-Vis spectrophotometry, employing a highly linear calibration curve (r = 0.9986). Thermal analyses (TGA and DSC) indicated enhanced thermal stability of the final product compared with the isolated extract, suggesting physicochemical interactions between the matrix and the phenolic compounds. Preliminary stability studies demonstrated overall maintenance of characteristics, with a slight loss of marker content under light exposure (– 7.5% over 90 days). The developed formulation is considered technologically viable and represents a promising alternative for delivering phenolic compounds from Camellia sinensis (L.) in a solid oral dosage form.