PP-015 Tacrolimus eye drops as a therapeutic alternative for paediatric patients with inflammatory ocular surface diseases

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Corticosteroids 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.


The 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 methods

Initially, 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.


Each 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.


The 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 acknowledgements

Acknowledgements: Fundación Mutua Madrileña and Fundación Española de Farmacia Hospitalaria.

References and/or acknowledgements

No conflict of interest

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