DEVELOPMENT AND CHARACTERIZATION OF ORODISPERSIBLE TABLETS CONTAINING PARACETAMOL GRANULES COATED WITH TASTE-MASKING TECHNOLOGY

Orodispersible tablet technology allows tablets to be administered without the need for additional water, which would increase pediatric patient compliance. In this paper, an orodispersible paracetamol tablet formulation with flavor masking technology was developed. For this purpose, the methacrylic acid-derived polymer, Eudragit^® E100, has the ability to form films on particles, which are insoluble at pH higher than 5.0 and soluble lower than it. The coated granules were obtained by coating the paracetamol with the Eudragit^® E100 polymer (20% w/w) in Hüttlin Oystar fluidized bed. The tablets were obtained by direct compression with 800 mg as average weight, and the formulations were differentiated by the used disintegrant: Pharmaburst^® 500, Prosolv^® ODT G2 or Starlac^®. Characterization of the granules and afterward of the obtained tablets were carried out. All formulations reached average weight, hardness, friability, disintegration in accordance with the proposed specifications. The mean disintegration time of the tablets was 20 seconds. Taste masking was evaluated in-vitro from a dissolution method adapted from the 41^st United States Pharmacopeia, where the dissolution profile in simulated saliva and simulated gastric fluid was assessed in order to mimic the passage through the oral cavity and posterior passage through the stomach. When at basic pH (6.8), after 30 seconds of the trial the dissolved amount of paracetamol was less than 20%, evidencing that all tested formulations have the potential for taste masking.