BackgroundEnsuring the safety of products made in pharmacy departments is an essential parameter in the development of any ophthalmic formulation.PurposeThe aim of this study was to show the cytotoxic effect of tacrolimus 0.03 mg/mL eye drops on human primary corneal epithelial cells using real time monitoring of dynamic changes based on bioimpedance measurements induced by cell–toxicant interactions.Material and methodsInitially, tacrolimus 0.03 mg/mL eye drops (TED) were prepared as a pharmaceutical compound in the department of pharmacy. The effect of the TED on the viability of cells was studied on ATCC normal human primary corneal epithelial cells. We used the xCELLigence real time cell analyser system (ACEA Biosciences, San Diego, California, USA) for monitoring the growth of cell cultures in real time. The cell index, based on the measured electric impedance across the cell culture, was used to represent the number of cells. 3000 cells/well (16 wells E-plates) were incubated for 20 hours. Subsequently, the original culture medium was aspirated and different TED concentrations (7.5 µg/mL, 15 µg/mL, 22 µg/mL, 30 µg/mL, 37 µg/mL and 45 µg/mL) were added to different wells. The results are represented as dose response curves versus time, and IC50 was calculated in different times.ResultsSurviving rate kinetic curves showed that TED induced a gradual decline in the cell surviving rate over a 20 hour exposure period. This behaviour suggests that TED cause significant corneal cellular toxicity. An analysis of the kinetic curve of the cell surviving rate showed that these effects were time and dose dependent. The IC50 at 30 min was 0.0139 mg/mL, at 4 hours 0.0125 mg/mL and at 16 hours 0.00836 mg/mL.ConclusionThese results may be particularly relevant to estimate the optimal TED concentration in clinical situations to avoid a toxic effect.References and/or acknowledgementsAcknowledgements: Fundación Mutua Madrileña and Fundación Española Farmacia Hospitalaria.No conflict of interest
BackgroundCorticosteroids and cyclosporine eye drops are common treatments in inflammatory ocular surface diseases. In some cases, patients do not respond to standard therapy and therefore it is necessary to search for new alternative formulations.PurposeThe aim of this study was to present an ophthalmic compounded alternative to common therapy for inflammatory ocular surface diseases and to evaluate the efficacy in three paediatric patients.Material and methodsInitially, a bibliographic research was conducted to find active ingredients and compatible excipients that could potentially be included in an ophthalmic formula (Martindale, Pubmed and Micromedex). Subsequently, tacrolimus eye drops (TED) were formulated and then its pH (pHmeter, WTW Inolab) and osmolality (VAPRO 5520) were measured. Finally, an ophthalmologist assessed the efficacy of the treatment over 3 months in 3 paediatric patients with inflammatory ocular surface disease in which previous treatments had failed.ResultsEach 1 mL of TED pharmaceutical compound contained 0.3 mg of tacrolimus, obtained from the intravenous presentation (Prograf). This ophthalmic formulation contained the following excipients: polyvinyl alcohol, benzalkonium chloride, sodium phosphate dibasic, sodium chloride, sodium phosphate monobasic, disodium edetate, hydrochloric acid or sodium hydroxide and purified water, all from the commercial presentation Liquifilm tears. The TED were developed in a horizontal laminar flow cabin, filtered through a 0.22 micron filter and packed into 5 mL sterile amber glass bottles. The osmolality of TED was 451.3±12.5 mmol/kg and the pH was 7. The ophthalmologist noticed a dramatic improvement in the evolution of the pathology in these 3 patients during the follow-up period; however, he noted that ocular tolerance should be improved as ocular itching was found after instillation of the eye drops.ConclusionThe TED, presented as an ophthalmic pharmaceutical compounding alternative, were safe and effective for paediatric patients with inflammatory ocular surface diseases who did not respond to cyclosporine eye drops.References and/or acknowledgementsAcknowledgements: Fundación Mutua Madrileña and Fundación Española de Farmacia Hospitalaria.No conflict of interest
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