Formulation and stability evaluation of bromhexine hydrochloride for veterinary use

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Formulation and stability evaluation of 1% w/v oral solution of Bromhexine hydrochloride for veterinary use

Purpose: The aim of this study is to develop bromhexine hydrochloride 1 %w/v oral solution for veterinary use and to evaluate its stability.

Methods: Solutions of Bromhexine hydrochloride (1%w/v) were prepared by dissolving bromhexine hydrochloride in benzyl alcohol at 50 °C then alcohol 96 % v/v; Tween 80 and purified water were added. The obtained solution was filled in amber glass bottles, and the solution was stored at 25 °C/60 % relative humidity (RH) and at 40 °C /75% RH. The strengths of bromhexine hydrochloride were determined by High performance liquid chromatographic assay at 0, 2, 4, 6, 8, 10, 12, 16, 20 and 24 months. The concentrations of the drug were directly related to the peak area. pH, odor, color and crystal formation was also monitored.

Results: The degradation of bromhexine hydrochloride 1% w/v oral solution was faster at 40 °C/75% RH than at 25 °C /60% RH. No significant differences were found between the initial and final pH value for the solution at the studied conditions. No detectable changes in color, odor or precipitations were observed for the solutions stored at the upper conditions.

Conclusions: Bromhexine hydrochloride 1% w/v oral solution could be formulated and remains stable for at least 2 years when is stored at 25°C /60% RH and for 16 months when stored at 40 °C /75% RH.

Reference: The Islamic University Journal (Series of Natural Studies and Engineering), Vol.15, No. 1, pp 13 -22 , 2007