Antimicrobial safety of a preservative-free nasal multiple-dose drug administration system

Klöcker, Norbert; Krämer, Axel; Verse, Thomas; Sikora, Claudia; Rudolph, P.; Daeschlein, Georg

doi:10.1016/j.ejpb.2003.12.005

Cited by 6 publications

(5 citation statements)

References 10 publications

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“…2º Anais do Programa de Mestrado Profissional do Instituto de Química da USP 9º Workshop do Programa -13/12/2021 Figura 1 -Sistema de embalagem do spray nasal, adaptado 7 Os frascos para análise de headspace foram previamente descontaminados por aquecimento em estufa à 300°C. Os componentes foram então pesados e acondicionados, sendo 1 componente inteiro por frasco, exceto para o frasco de PE, com massas que variam de 0,016g até 3,0g, em triplicata, conforme Figura 2: Figura 2 -Acondicionamento dos componentes individuais para análise por headspace em cromatógrafo a gás acoplado à espectrometria de massas Os componentes foram analisados individualmente por Headspace 7697A em Cromatógrafo a gás Agilent 7890B Series GC (Agilent Santa Clara, CA, USA) acoplado a detector de massas 5977B Quadrupolo (Agilent Santa Clara, CA, USA) e equipado com coluna HP-5MS (30m x 0.25mm x 0.25µm) (Agilent, Santa Clara, CA, USA).…”

Section: Methodsunclassified

Identificação De Extraíveis Voláteis Presentes Na Embalagem Primária De Um Spray Nasal

Francisco¹,

Blatt²,

Freitas³

et al. 2021

9° Workshop Do Mestrado Profissional Instituto De Química Universidade De São Paulo

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Resumo: Extraíveis são substâncias químicas orgânicas e inorgânicas, liberadas de um sistema de embalagem utilizado para acondicionar um medicamento, em condições de laboratório. Essas substâncias têm o potencial de lixiviar para um produto farmacêutico nas condições normais de armazenamento durante seu período de validade, sendo portanto, denominadas de lixiviáveis. Este trabalho investigou a composição química de origem volátil presente nos componentes individuais do material de embalagem de um spray nasal em análise por headspace em cromatógrafo a gás acoplado à espectrometria de massas (CG-EM). A identificação destes compostos foi obtida através da comparação dos índices de retenção linear, dos espectros de massa obtidos com as bibliotecas instaladas no equipamento e da literatura, utilizando uma série homóloga de n-alcanos, analisada nas mesmas condições experimentais. Os principais compostos presentes em todos os componentes foram dodecano e tetradecano, seguidos de decano e 2, 2, 4, 6, 6-pentametil-heptano. Estes resultados possibilitam uma correlação com os potenciais lixiviáveis, para estabelecer um protocolo de controle de qualidade para o acompanhamento destas substâncias no medicamento, aumentando sua segurança e eficácia, através da avaliação da sua toxicidade, se presentes no medicamento.

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Section: Methodsunclassified

Identificação De Extraíveis Voláteis Presentes Na Embalagem Primária De Um Spray Nasal

Francisco¹,

Blatt²,

Freitas³

et al. 2021

9° Workshop Do Mestrado Profissional Instituto De Química Universidade De São Paulo

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“…But no acceptable daily intake has been attributed to propyl parabens. PBM and PBP are generally used in combination because they possess synergistic activity, however an overuse of these preservatives can cause allergic reactions (Klöcker et al, 2004).…”

Section: Introductionmentioning

confidence: 99%

Preservatives Stability: Stability Study of Parabens under Different Conditions of Stress Degradation

Bennani¹,

Chentoufi²,

Karbane³

et al. 2020

ijrps

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Preservatives are used in a wide field of application to maintain the quality of products. They are used to deal with the chemical, physical and microbiological problems and the constraints of the development of several formulations. In this work, we tested the stability of antimicrobial preservatives which are the parabens under different stress degradation conditions to evaluate their degree of effectiveness. The tested parabens were incubated in different solutions at different pH, Temperatures, light conditions, and presence or absence of sucrose in solution (create a medium similar of syrups). The HPLC was used for the assay, by a validated method for the parabens assay and the statistical analysis of the data is carried out by JMP software. The results show a direct influence of temperature and pH on the level of parabens, while the influence of light remains negligible. The increase in temperature gives a degree of immunity of parabens levels, especially with the extreme values of pH. This study is one of the first studies of forced decomposition of parabens carried out under the various conditions suggested. The results give an idea of the stability profile of the tested parabens and suggest a model of the conditions of conservation and use of these products in different domains and under different conditions.

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“…are usually used in combination as they possess a synergistic activity when used together. However, overuse of preservatives may cause allergic reactions hence, they should be shown not to be cytotoxic or sensitizing 6,7 . p-Hydroxybenzoic esters (parabens) have been used as preservatives for over 70 years 8 .…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Determination of Preservatives (Methyl Paraben and Propyl Paraben) in Sucralfate Suspension Using High Performance Liquid Chromatography

Kashid

Singh

2010

Journal of Chemistry

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A reversed phase HPLC method that allows the separation and simultaneous determination of the preservatives methyl paraben (M.P.) and propyl paraben (P.P.) is described. The separations were effected by using an initial mobile phase of water: acetonitrile (50:50) on Inertsil C18 to elute P.P. and M.P. The detector wavelength was set at 205 nm. Under these conditions, separation of the two components was achieved in less than 10 min. Analytical characteristics of the separation such as precision, specificity, linear range and reproducibility were evaluated. The developed method was applied for the determination of preservative M.P. and P.P. at concentration of 0.01 mg/mL and 0.1 mg/mL respectively. The method was successfully used for determining both compounds in sucralfate suspension.

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Antimicrobial safety of a preservative-free nasal multiple-dose drug administration system

Cited by 6 publications

References 10 publications

Identificação De Extraíveis Voláteis Presentes Na Embalagem Primária De Um Spray Nasal

Identificação De Extraíveis Voláteis Presentes Na Embalagem Primária De Um Spray Nasal

Preservatives Stability: Stability Study of Parabens under Different Conditions of Stress Degradation

Simultaneous Determination of Preservatives (Methyl Paraben and Propyl Paraben) in Sucralfate Suspension Using High Performance Liquid Chromatography

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