Article ID Journal Published Year Pages File Type
5551011 Journal of Food and Drug Analysis 2017 8 Pages PDF
Abstract

•Ethyl anthranilate-loaded polymeric patch remained stable for 6 months.•Lower limit of residual solvent confirms the suitability and applicability of patch.•This report outlined the stability parameters to be evaluated of a certain device.

Compromised stability of pharmaceutical formulations loaded with volatiles is a serious problem associated with devices designed to deliver volatile compounds. The present study has been focused to evaluate the stability potential of matrix-type polymeric patches composed of volatile ethyl anthranilate for prophylaxis against vector-borne diseases. Ethyl anthranilate-loaded matrix-type polymeric patches were fabricated by solvent evaporation method on an impermeable backing membrane and attached to temporary release liners. Stability testing of the polymeric patches was performed as per the International Conference on Harmonization (ICH) guidelines for 6 months under accelerated conditions. In addition, the quantification of residual solvents was also performed as per the ICH guidelines. After conducting the stability studies for 6 months, the optimized patches showed the best possible results with respect to uniformity of drug content, physical appearance, and other analytical parameters. Furthermore, the amount of residual solvent was found well below the accepted limit. Thus, the present report outlined the analytical parameters to be evaluated to ensure the stability of a certain devices consisting of volatile compounds.

Graphical abstractStability testing of insect repellent prophylactic patch as per the International Conference on Harmonization (ICH) guidelines for 6 months.Download high-res image (251KB)Download full-size image

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Life Sciences Agricultural and Biological Sciences Food Science
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