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A sensitive, heart-cutting, two-dimensional liquid chromatography–tandem mass spectrometry method for the determination of mometasone furoate in human plasma : application for a bioequivalence study in nasal spray formulations

100%

Yang L. , Yang H. , Xie H. , Liu H. , He G. , Zhong W. , Wang L.

Acta Chromatographica

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2024

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tom Vol. 36, no. 1

14--22

EN

We developed and validated a sensitive, heart-cutting, two-dimensional liquid chromatography–tandem mass spectrometry (2D-LC‒MS/MS) method to determine the concentration of mometasone furoate in human plasma after nasal spray administration. Isotopically labeled mometasone furoate-13¹³C,d₆ was used as an internal standard (IS). Plasma samples were prepared using a solid-phase extraction (SPE) method. With this 2D-LC strategy, the analytes were trapped in the first dimension (1D) column, and only judiciously selected portions of the 1D effluent were transferred to the second dimension (2D) column for further separation to obtain high-resolution information. MS/MS quantification was performed in positive ionization mode via multiple-reaction monitoring (MRM). This analytical method was fully validated according to related regulatory guidance, and the results showed that the method is robust and sensitive enough for pharmacokinetic investigation of mometasone furoate with satisfactory linearity from 0.25 to 30 pg mL⁻¹. This method was successfully applied to a bioequivalence (BE) study of mometasone furoate aqueous nasal sprays in healthy volunteers.

2

Bacteriotherapy for preventing recurrent upper respiratory infections in children: a real-world experience

86%

Tarantino V. , Savaia V. , D’Agostino R. , Silvestri M. , Ciprandi G.

Polish Journal of Otolaryngology

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2018

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tom 72

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nr 3

33-38

EN

Background: Recurrent upper respiratory infections (RURI) constitute a social problem for both their pharmaco-economic impact and the burden for the family. Bacteriotherapy could be an interesting preventive option. Objective: The aim of this study was to evaluate the preventive effects of RURI in children. Design: The study was designed as spontaneous and was conducted in real-life setting. Globally, 80 children (40 males, mean age 5.26 (2.52) years) with RURI were enrolled. Children were treated with Streptococcus salivarius 24SMB and Streptococcus oralis 89a: nasal spray 2 puffs per nostril twice/day for a week for 3 monthly courses. Number of URI, and school and work absences were evaluated and compared with the past year. Results: Bacteriotherapy significantly halved the mean number of URI episodes being 5.98 (2.30) in the past year and 2.75 (2.43) after the treatment (p<0.0001). Bacteriotherapy also induced an over 35% reduction both in the number of school days and in the number of working days missed per month from 4.50 (2.81) to 2.80 (3.42) and from 2.33 (2.36) to 1.48 (2.16), respectively (p<0.0001). Conclusions: This real-life study provides the first evidence that Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray could be effective in preventing RURI in children.

3

Bacteriotherapy for preventing recurrent upper respiratory infections in children: a real-world experience

86%

Tarantino V. , Savaia V. , D’Agostino, Roberto , Silvestri M. , Ciprandi G.

Otolaryngologia Polska

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2018

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tom 72(3)

33-38

EN

Background: Recurrent upper respiratory infections (RURI) constitute a social problem for both their pharmaco-economic impact and the burden for the family. Bacteriotherapy could be an interesting preventive option. Objective: The aim of this study was to evaluate the preventive effects of RURI in children. Design: The study was designed as spontaneous and was conducted in real-life setting. Globally, 80 children (40 males, mean age 5.26 (2.52) years) with RURI were enrolled. Children were treated with Streptococcus salivarius 24SMB and Streptococcus oralis 89a: nasal spray 2 puffs per nostril twice/day for a week for 3 monthly courses. Number of URI, and school and work absences were evaluated and compared with the past year. Results: Bacteriotherapy significantly halved the mean number of URI episodes being 5.98 (2.30) in the past year and 2.75 (2.43) after the treatment (p<0.0001). Bacteriotherapy also induced an over 35% reduction both in the number of school days and in the number of working days missed per month from 4.50 (2.81) to 2.80 (3.42) and from 2.33 (2.36) to 1.48 (2.16), respectively (p<0.0001). Conclusions: This real-life study provides the first evidence that Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray could be effective in preventing RURI in children.