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Merck

Degradation of parabens by Pseudomonas beteli and Burkholderia latens.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V (2010-03-09)
Aeshna Amin, Sateesh Chauhan, Manish Dare, Arvind Kumar Bansal
要旨

p-Hydroxybenzoic acid esters (parabens) are commonly used antimicrobial preservatives in pharmaceutical formulations. Two microorganisms, isolated from non-sterile methyl paraben (MP) and propyl paraben (PP) solutions, were found to degrade the respective parabens. Identification by 16S rRNA partial gene sequencing revealed them to be Pseudomonas beteli and Burkholderia latens, respectively. The present work describes a previously unreported interaction of the parabens with P. beteli and B. latens. Degradation of MP at various concentrations by P. beteli, followed a logarithmic pattern, while that of PP by B. latens was found to be linear. It was subsequently observed that P. beteli could degrade only MP, while B. latens could degrade both the parabens. Absence of HPLC chromatogram peaks of expected degradation products indicated that the parabens were used up as a carbon source. The behaviour of pathogens (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus niger) of the pharmacopoeial preservative effectiveness test (PET), towards MP, showed that none had the ability to degrade the paraben. It was concluded that, for a paraben-preserved multi-dose ophthalmic formulation, the sole use of the four pathogens that are recommended by the pharmacopoeia for PET can falsely indicate the formulation to be effective against 'in-use' contamination.

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製品内容

Supelco
プロピルパラベン, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
4-ヒドロキシ安息香酸プロピル, ≥99%
Sigma-Aldrich
4-ヒドロキシ安息香酸プロピル, BioXtra
プロピルパラヒドロキシ安息香酸塩, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
4-ヒドロキシ安息香酸プロピル, tested according to Ph. Eur.