Pediatric paracetamol incorporated into polymeric film: a new formulation

Abstract

The oral route of medication administration is the most acceptable and convenient when compared to other routes. However, pediatric patients may have limitations in swallowing solid formulations, this leads to the common and imprecise practice of dose modification. Thus, to overcome the problems related to conventional pharmaceutical forms, orodispersible films (FOD) were developed experimentally and incorporated into them, paracetamol with a pediatric concentration of 160 mg. For the formation of FOD, the following were applied as inputs: Polyethylene glycol, a plasticizer polymer and responsible for incorporating the drug; Carboxymethylcellulose, polymer which gave mechanical properties to the film; Sorbitol, a sweetener intended to mask the astringent taste; sodium benzoate as a preservative and distilled water as solvent. For the assay of the active in the FOD, a methodology was validated to assure the veracity of the analytical results obtained through the Ultraviolet-Visible spectrophotometry and its concentration was calculated using the equation of the line. The developed FOD presented an appropriate and differentiated form, being able to increase the speed of disintegration and dissolution for local action or systemic absorption. The versatility of FODs confirms its high value as a suitable technological platform for the extension and adjustment of different drug administration routes.