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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

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Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Via Francesco Sforza, 28, 20122 Milan (MI), Italy
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Department of Veterinary Medicine, Università Degli Studi di Milano, Via Celoria 10, 20133 Milan (MI), Italy
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Department of Clinical and Community Sciences, University of Milan, Via della Commenda, 19, 20122 Milan (MI), Italy
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Bruttomesso Pharmacy, Galenic Laboratory, Piazza Guglielmo Marconi, 20, 26013 Crema (CR), Italy
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Department of Environmental Science and Policy, Università degli Studi di Milano, Via Mangiagalli 25, 20133 Milan (MI), Italy
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(4), 378; https://doi.org/10.3390/pharmaceutics12040378
Received: 29 February 2020 / Revised: 14 April 2020 / Accepted: 16 April 2020 / Published: 20 April 2020
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. View Full-Text
Keywords: cyclosporine A; tacrolimus; ophthalmic formulations; vernal keratoconjunctivitis cyclosporine A; tacrolimus; ophthalmic formulations; vernal keratoconjunctivitis
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MDPI and ACS Style

Ghiglioni, D.G.; Martino, P.A.; Bruschi, G.; Vitali, D.; Osnaghi, S.; Corti, M.G.; Beretta, G. 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. Pharmaceutics 2020, 12, 378. https://doi.org/10.3390/pharmaceutics12040378

AMA Style

Ghiglioni DG, Martino PA, Bruschi G, Vitali D, Osnaghi S, Corti MG, Beretta G. 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. Pharmaceutics. 2020; 12(4):378. https://doi.org/10.3390/pharmaceutics12040378

Chicago/Turabian Style

Ghiglioni, Daniele G., Piera A. Martino, Gaia Bruschi, Davide Vitali, Silvia Osnaghi, Maria G. Corti, and Giangiacomo Beretta. 2020. "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" Pharmaceutics 12, no. 4: 378. https://doi.org/10.3390/pharmaceutics12040378

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