Design of an acetaminophen syrup formulation for pediatric use

Abstract

In the present work, a formulation of acetaminophen syrup was developed, with a dose of 160 mg / 5 ml, aimed at forming part of the basic table of medicines of the University School Hospital of the National Autonomous University of Honduras. An experimental statistical design of D-optimal mixture was carried out to determine the combination of cosolvents that allows solubilizing the dose of acetaminophen. The independent variables were the content of: water, ethanol, glycerin, sorbitol 70% and propylene glycol; while the responses were pH and dissolved drug content. All the variables influenced the dissolution of the pharmaceutically active ingredient (IFA); with a higher incidence of ethanol and propylene glycol. The optimal mixtures were able to initially dissolve the IFA dose, but after fifteen days the recrystallization of the drug occurred. Given this situation, 7% of polyvinylpyrrolidone (K-30) was incorporated, this guaranteed the solubility of acetaminophen, achieving an adequate appearance. Subsequently, sensory tests evaluated by untrained judges 60 were performed, which allowed to select the strawberry flavor (0.2%) and the red color FD & C 40 (0.4%) as the flavor and color correctors, respectively. In addition, the analytical method was validated by High Resolution Liquid Chromatography established in USP 35. The method was linear, precise and selective for the analysis of acetaminophen in the proposed formulation, but did not comply with the accuracy parameter. Finally, the chemical and technological quality control of the elaborated preparations was carried out, at 0 and 90 days and the preliminary microbiological analysis fulfilling the established
specifications.