Dataset Information

Stability and Safety Traits of Novel Cyclosporine A and Tacrolimus Ophthalmic Galenic Formulations Involved in Vernal Keratoconjunctivitis Treatment by a High-Resolution Mass Spectrometry Approach.

ABSTRACT: In this study, a sensitive quantitative method based on high performance liquid chromatography combined with high-resolution mass spectrometry, Q ExactiveTM-Orbitrap® was set up and applied for the determination of the immunosuppressor agents cyclosporine A and tacrolimus in novel ethanol-free ophthalmic formulations for the treatment of Vernal keratoconjunctivitis. Different storage parameters in terms of storage temperatures and practical usage conditions were investigated to assess the stability of all formulations during shelf life simulating the real conditions as well to confirm the feasibility of use of ethanol-free products. The methodology was linear (r2 = 0.995) over the concentration range 0-200?ng/mL, and its selectivity, precision, accuracy and recovery were all within the required limits. Under different conditions (storage period 0-90 days, 5-25 °C, unopened/usage simulated conditions), our results revealed that both active pharmaceutical ingredients (API) show satisfactory stability up to 30 days of storage/usage, with a significant and consistent concentration decline of cyclosporine A after this time point when its hydroalcoholic formulation was kept at 25 °C.

SUBMITTER: Ghiglioni DG

PROVIDER: S-EPMC7238033 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Stability and Safety Traits of Novel Cyclosporine A and Tacrolimus Ophthalmic Galenic Formulations Involved in Vernal Keratoconjunctivitis Treatment by a High-Resolution Mass Spectrometry Approach.

Ghiglioni Daniele Giovanni DG Martino Piera Anna PA Bruschi Gaia G Vitali Davide D Osnaghi Silvia S Corti Maria Grazia MG Beretta Giangiacomo G

Pharmaceutics 20200420 4

In this study, a sensitive quantitative method based on high performance liquid chromatography combined with high-resolution mass spectrometry, Q Exactive<sup>TM</sup>-Orbitrap<sup>®</sup> was set up and applied for the determination of the immunosuppressor agents cyclosporine A and tacrolimus in novel ethanol-free ophthalmic formulations for the treatment of Vernal keratoconjunctivitis. Different storage parameters in terms of storage temperatures and practical usage conditions were investigate ...[more]

PMID: 32326044

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Project description:PurposeVernal keratoconjunctivitis (VKC) is a severe chronic allergic inflammation of the ocular surface with episodes of acute exacerbations, that primarily affects children and young adults. Although the etiology and pathogenesis of VKC remain unclear, studies have suggested that environmental factors may be involved. This study aims to investigate the association between exposure to meteorological and environmental factors and the incidence of VKC exacerbations.MethodsThis study was conducted in southern Israel, which is a semi-arid, hot, and dry climate with frequent dust storms. Patients diagnosed with VKC were recruited for the study. VKC exacerbations were identified as the need for medical intervention. Pollutants measured included nitrogen dioxide (NO2), ozone (O3), particulate matter (PM10 and PM2.5), sulfur dioxide (SO2), relative humidity (RH), temperature, and solar radiation (SR). To assess the association between VKC exacerbations and exposure to different pollutants, a case-crossover analysis was conducted. We also stratified the analysis by sex, age, ethnicity, immigration status, and social state score.ResultsOur results demonstrated that the pollutants NO2, O3, and PM10 were associated with VKC exacerbations with odds ratio (OR) = 2.17 (95% confidence interval [CI] =1.40 to 3.04), OR = 2.28 (95% CI = 1.30 to 3.39), and OR = 1.89 (95% CI = 1.06 to 2.74). Other pollutants PM2.5, temperature, and solar radiation were also independently associated with incidence of exacerbations with OR = 1.15 (95% CI = 0.87 to 1.50), OR = 1.75 (95% CI = 1.16 to 2.65), and OR = 1.37 (95% CI = 1.01 to 1.63) and had varying effects in different demographic strata.ConclusionsThe environmental parameters, NO2, O3, PM10, PM2.5, temperature, and solar radiation were found to be significantly associated with VKC exacerbations, with NO2, O3, and PM10 showing the strongest associations. Our findings suggest that environmental factors should be considered when developing strategies to prevent and manage VKC exacerbations.

Project description:IntroductionVernal keratoconjunctivitis is a chronic bilateral severe form of allergic conjunctivitis which affects normal activities in school/work. It is a severe form of allergies in warm and dry tropical and sub-tropical countries. Its prevalence in Ethiopia ranges from 5.2% to7.3%. Most studies are institution based and do not address specific factors associated with vernal keratoconjunctivitis. There is no a study that shows the magnitude of vernal keratoconjunctivitis in the study area.ObjectiveTo assess the prevalence of vernal keratoconjunctivitis and its associated factors among children in Gambella town, Southwest Ethiopia, 2018.Methods and materialsA community based cross-sectional study was conducted from April 25 to May 12, 2018, in Gambella town. A total of 578 study participants were selected using a systematic random sampling technique. A pre-tested semi-structured questionnaire, torch, and magnifying loop were used to collect data. The data was entered into epidemiological information 7.1 and exported to statistical package for social science for analysis. Binary logistic regression analysis model was fitted to identify factors associated with vernal keratoconjunctivitis. Odds ratio with respected 95% CI was used to identify the direction and strength of association.ResultsA total of 574 children participated in this study representing a response rate of 99.30%. The mean age of the participants was 9.74±4.0 years. The prevalence of vernal keratoconjunctivitis was 11.10% (95% CI: 8.70, 13.90). Male sex (adjusted odds ratio = 4.12(95% CI: 1.42, 11.91)), close animal contact (adjusted odds ratio = 3.45(95% CI: 1.14, 10.41)), dust exposure (adjusted odds ratio = 3.38(95% CI: 1.31, 10.04)), and personal systemic allergy history (adjusted odds ratio = 4.82(1.40, 16.72) were independently associated with vernal keratoconjunctivitis.ConclusionThe prevalence of VKC was high among children in Gambella town. Sex being male, close animal contact, personal systemic allergy history, and dust exposure were positively associated with vernal keratoconjunctivitis independently.

Dataset Information

Stability and Safety Traits of Novel Cyclosporine A and Tacrolimus Ophthalmic Galenic Formulations Involved in Vernal Keratoconjunctivitis Treatment by a High-Resolution Mass Spectrometry Approach.

Publications

Stability and Safety Traits of Novel Cyclosporine A and Tacrolimus Ophthalmic Galenic Formulations Involved in Vernal Keratoconjunctivitis Treatment by a High-Resolution Mass Spectrometry Approach.

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