TY - JOUR
T1 - Novel plasminogen and hyaluronate sodium eye drop formulation for a patient with ligneous conjunctivitis
AU - Conforti, Franca Manganelli
AU - Di Felice, Giovina
AU - Bernaschi, Paola
AU - Bartuli, Andrea
AU - Bianco, Giuseppe
AU - Simonetti, Alessandra
AU - Buzzonetti, Luca
AU - Valente, Paola
AU - Corsetti, Tiziana
PY - 2016/4/15
Y1 - 2016/4/15
N2 - Purpose. The development, analysis, and first clinical use of a novel eye drop formulation of plasminogen and hyaluronate sodium for the treatment of a patient with ligneous conjunctivitis (LC) are described. Summary. LC is a chronic inflammatory disorder of the eye that can in rare cases lead to corneal involvement and subsequent blindness. Topically administered plasminogen is an effective treatment for LC; however, the lack of a specific and validated formulation of plasminogen for topical treatment can constitute a gap in the quality of care. A novel formulation of plasminogen and hyaluronate sodium for the treatment of LC was developed by combining commercially available products. Through a series of tests, including microbiological, viscosity, and pH analyses, the novel eye drop formulation was demonstrated to have constant activity (3.3 IU/mL or greater), to be microbiologically stable (i.e., sterile), and to be safe enough for daily administration. The first clinical application of the novel eye drop formulation was in the case of a nine-year-old girl with LC affecting both eyes. Initially, the girl's parents administered two drops every three hours to the left eye each day while the girl was awake. On examination after 30 days of daily use of the eye drop formulation, the patient was found to have a clear cornea and no membrane development on the conjunctiva; the formulation was subsequently administered in both eyes, with positive results. Conclusion. A new formulation of plasminogen plus hyaluronate sodium was developed, tested, and used successfully in a girl with LC.
AB - Purpose. The development, analysis, and first clinical use of a novel eye drop formulation of plasminogen and hyaluronate sodium for the treatment of a patient with ligneous conjunctivitis (LC) are described. Summary. LC is a chronic inflammatory disorder of the eye that can in rare cases lead to corneal involvement and subsequent blindness. Topically administered plasminogen is an effective treatment for LC; however, the lack of a specific and validated formulation of plasminogen for topical treatment can constitute a gap in the quality of care. A novel formulation of plasminogen and hyaluronate sodium for the treatment of LC was developed by combining commercially available products. Through a series of tests, including microbiological, viscosity, and pH analyses, the novel eye drop formulation was demonstrated to have constant activity (3.3 IU/mL or greater), to be microbiologically stable (i.e., sterile), and to be safe enough for daily administration. The first clinical application of the novel eye drop formulation was in the case of a nine-year-old girl with LC affecting both eyes. Initially, the girl's parents administered two drops every three hours to the left eye each day while the girl was awake. On examination after 30 days of daily use of the eye drop formulation, the patient was found to have a clear cornea and no membrane development on the conjunctiva; the formulation was subsequently administered in both eyes, with positive results. Conclusion. A new formulation of plasminogen plus hyaluronate sodium was developed, tested, and used successfully in a girl with LC.
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U2 - 10.2146/ajhp150395
DO - 10.2146/ajhp150395
M3 - Article
AN - SCOPUS:84964033701
VL - 73
SP - 556
EP - 561
JO - Bulletin. American Society of Hospital Pharmacists
JF - Bulletin. American Society of Hospital Pharmacists
SN - 1079-2082
IS - 8
ER -