Development and Stability Assessment of Alternative Sugar-Free Pediatric Solution Containing Losartan Potassium

Abstract

Purpose:

Losartan potassium is an antihypertensive drug commercialized only as tablets. As an alternative to the hospital pediatric extemporaneous preparations, it was developed a sugar-free oral liquid formulation containing this drug (2.0 mg/mL) in order to allow the dose adjustment, accuracy and easy administration.

Methodology:

The stability of formulation was evaluated at room temperature (15-30°C), refrigerated (2-8°C) and oven (40°C), during 56 days in amber glass bottles (n = 3). A stability-indicating analytical method by high performance liquid chromatography (HPLC) was used for drug determination weekly. The acceptance criterion was between 95.0% and 105.0%. Organoleptic characteristics, pH, viscosity, and microbiological content were also evaluated.

Results:

All samples under room and refrigerated conditions kept their pH values and microbiological content in accordance during all the period tested. However, for those at room temperature, the drug amount, formulation appearance and viscosity were adequate until the 42nd day of analysis, indicating that this was the recommended beyond-use date for the proposed solution.

Conclusion:

A simple and economical solution was obtained with the advantage to be sugar-free, without the cariogenic effect, and without the disadvantages of pharmaceutical suspensions, contributing to pediatric patients during hospital treatments.