pH effect on paraben stability for parenteral drug formulation

Year 2025, Volume: 29 Issue: 1, 280 - 286

Süleyman Özakın

Abstract

The pH optimization and EDTA are widely used in pharmaceutical formulations. The aim of the research
work was to evaluate the pH effect and develop a including stable paraben pharmaceutical product. pH of final product
is most important critical quality attributes (CQA). Variability pH of formulation is affecting paraben stability. Therefore,
chemical stability may affect paraben assay, so this CQA was be evaluated throughout parenteral formulation. A total of
four formulations were designed to the stability study. To improve the stability of paraben formulations (T1-T4) were
evaluated with different pH ranges and EDTA during stability period. Stability studies were performed to assay analysis
of methyl paraben and propyl paraben. The rate of assay results was compared to T1-T4 formulations. As a result of
paraben assay analysis for T2 formulation was found to be within in specification limit. The one of them were
determined to the best formulations for paraben stability during stability periods. The research proposes a novel stable
formulation and proper storage conditions for paraben parenteral solutions. The instability problem of paraben
formulation was optimized with targeted pH modification.

Keywords

Drug stability, excipient, methyl paraben, parenteral formulation, propyl paraben

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