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San Piero Patti, Italy

Spatafora C.,University of Catania | Daquino C.,SIFI SpA | Tringali C.,University of Catania | Amorati R.,University of Bologna
Organic and Biomolecular Chemistry | Year: 2013

Benzo[kl]xanthene lignans, promising bioactive polyphenols obtained by biomimetic oxidative coupling of caffeic acid derivatives, react efficiently with peroxyl radicals in both polar and non-polar solvents, thanks to the simultaneous presence of guaiacol-like and catechol-like OH-groups. This journal is © The Royal Society of Chemistry 2013. Source

McCann L.C.,Glasgow Caledonian University | Tomlinson A.,Glasgow Caledonian University | Pearce E.I.,Glasgow Caledonian University | Papa V.,SIFI SpA
Cornea | Year: 2012

Purpose: To compare the efficacies of sodium hyaluronate, hydroxypropyl methylcellulose (HPMC), and a new oil-in-water emulsion (Emustil unidose; SIFI) in the management of lipiddeficient dry eye.Methods: Seventy-five subjects with dry eye were randomly divided into 3 groups. Each was allocated sodium hyaluronate, HPMC, or emulsion eyedrops to be used four times daily for 90 days. Parameters were measured at baseline, 30 days, and 90 days. A compliance visit was performed at days 7 and 60.Results: Significant reduction (P < 0.05) in evaporation and improvement in symptoms in all groups were found. No statistically significant increase in tear turnover rate (TTR) was found with any solution. A significant difference in tear stability and noninvasive tear break-up time (NITBUT) was found in the emulsion and sodium hyaluronate groups but not in the HPMC group (P > 0.05). There was a significant decrease in osmolarity and corneal staining in the emulsion group (P< 0.001) but not in the sodium hyaluronate or HPMC group (P > 0.05).Conclusions: A significant reduction in evaporation and improvement in symptoms in all therapy groups were found from baseline to 90 days. However, no significant effect was seen on TTR for any group. The emulsion drops were shown to perform best, improving tear stability, and decreasing osmolarity and corneal staining. These results are consistent with improvements in the lipid layer of the tear film as a result of prolonged use of emulsion drops. Copyright © 2011 by Lippincott Williams & Wilkins. Source

Faraldi F.,Presidio | Papa V.,SIFI SpA | Rasa D.,SIFI SpA | Santoro D.,SIFI SpA | Russo S.,SIFI SpA
Clinical Ophthalmology | Year: 2013

Purpose: To compare the effcacy and safety of 0.1% dexamethasone/0.3% netilmicin (Netil-dex), with that of 0.1% dexamethasone/0.3% tobramycin (Tobradex) in the treatment of external ocular infammation requiring antibiotic therapy. Methods: In this randomized, double-blind study, 139 subjects with conjunctival infammation associated with signs of ocular infection were treated with Netildex (n = 71) or Tobradex (n = 68) four times daily for 6 days. The primary effcacy analysis was based on the percentage of patients with at least a 50% decrease in conjunctival hyperemia at the endpoint visit (Day 6 [+ 1]) with respect to baseline (responder rate). An equivalence margin of 20% was set for this study. A follow-up visit was performed at Day 14 (+ 1). Other effcacy parameters were: conjunctival edema, conjunctival discharge, lid hyperemia, lid edema, presence of ocular infection, and symptoms of ocular discomfort. Safety evaluations included intraocular pressure, visual acuity, and adverse events. Results: At Day 6, a decrease of conjunctival hyperemia was observed in 87.3% and 90.9% of the patients treated with Netildex and Tobradex, respectively. The 95% confdence interval for the difference between groups (-15.3 ÷ 8.0) satisfed the equivalence hypothesis. Subjects treated with Netildex had a better control of lid hyperemia (P = 0.016), tearing (P = 0.001), burning (P = 0.007), and stinging (P = 0.004). No adverse reactions were observed during the study except one case of keratitis in the Tobradex group. Conclusion: Netildex was as effective and safe as Tobradex in reducing signs and symptoms in patients with conjunctival infammation when ocular infection was suspected. © 2013 Faraldi et al. Source

Zammataro A.,SIFI SpA | Civiale C.,SIFI SpA | Saletti R.,University of Catania | Foti S.,University of Catania
Journal of Mass Spectrometry | Year: 2011

A rapid, selective and sensitive method for quantification of latanoprost free acid in rabbit aqueous humor (AH) and ciliary body (CB) using reverse phase-high performance liquid chromatography coupled with electrospray ionization (ESI)-mass spectrometry/mass spectrometry has been developed and validated. Quantification in AH and CB was achieved by stable isotope dilution employing tetra-deuterated analog of latanoprost free acid, used as internal standard. Sample preparation was based on protein precipitation with methanol in AH, and on liquid extraction with a mixture of ethyl acetate and isopropanol 60:40 (v/v) in CB. Elution was achieved on an octylsilica (C8) column, using an isocratic elution method. Detection was performed on a triple quadrupole mass spectrometer, using ESI in positive ion selected reaction monitoring mode. Calibration curves were linear in the validated concentration ranges of 10-160 ng/mL in AH and 80-1280 ng/g in CB. The accuracy and precision values, obtained from three different sets of quality control samples, each analyzed in triplicate on three different days, were within the generally accepted criteria for analytical methods (< 15%). The limit of detection was 30.66 pg/mL in AH and 237.75 pg/g in CB. The assay proved to be accurate and precise when applied to the in vivo study of latanoprost free acid in rabbit AH and CB after single administration of an eye drops containing latanoprost. Copyright © 2011 John Wiley & Sons, Ltd. Source

Zammataro A.,SIFI SpA | Saletti R.,University of Catania | Civiale C.,SIFI SpA | Muccilli V.,University of Catania | And 2 more authors.
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2010

A rapid, sensitive and selective method for the simultaneous quantification of carteolol and dorzolamide in rabbit aqueous humor (AH) and ciliary body (CB) has been developed and validated using reversed phase-high performance liquid chromatography (RP-HPLC) with isocratic elution coupled with atmospheric pressure chemical ionization mass spectrometry/mass spectrometry (APCI-MS/MS). The analytes and nadolol (used as internal standard, IS) were purified from AH by protein precipitation. The sample preparation from CB was based on a two steps extraction procedure at different pH, utilizing a liquid-liquid extraction with a mixture of ethyl acetate, toluene and isopropanol 50:40:10 (v/v) at pH 8, followed by a second extraction with ethyl acetate at pH 11. The combined organic extracts were then back extracted into 0.1% aqueous trifluoroacetic acid (TFA). The accuracy and precision values, calculated from three different sets of quality control samples analyzed in sestuplicate on three different days, were within the generally accepted criteria for analytical methods (<15%). The assay proved to be accurate and precise when applied to the in vivo study of carteolol and dorzolamide in rabbit AH and CB after single administration of an eye drops containing both drugs. © 2010 Elsevier B.V. All rights reserved. Source

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