Interaction between Polyethylene Films and Brombexine HCl in Solid Dosage Form. II. Effects of Moisture Property on the Sorption of the Drug

Abstract

The interaction between bromhexine HCl and polyethylene containers was studied in solutions and in tablet packaging systems. Various bromhexine HCl aqueous solutions of different pHs were stored in polyethylene containers at 25°C. The remaining amount of bromhexine HCl was determined by high performance liquid chromatography. It was observed that the transition of bromhexine HCl to polyethylene was inhibited by the addition of some surfactants into the solution, and by lowering the solution pH. In the solid dosage forms, influences of the additives were also studied. It was observed that the decrease of the content of bromhexine HCl in the solid dosage form was inhibited by the addition of acids (citric acid, tartaric acid) and surfuctant (sodium dodecyl sulfate) and accelerated by the addition of sodium bicarbonate, similarly to those in solutions. The results indicated that the transition to polyethylene films was influenced by the molecular state of bromhexine HCl.