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LLAMIL RUIZ, PH.D., is Head of the Liquid and Freeze-Dried Formulations Laboratory; IGNACIO RODRIGUEZ, B.SC., is Specialist, Formulations Production; REYNIER BAEZ is Technician; and RAYMERSY ALDANA is Technician, Formulation Development, Center for Genetic Engineering and Biotechnology, Havana, Cuba.

Address correspondence to Dr. Ruiz at the Center for Genetic Engineering and Biotechnology, Avenue 31, Cubanan, Playa, Havana 11600, Cuba (llamil.ruiz{at}cigb.edu.cu).

Purpose. The stability of an extemporaneously prepared recombinant human interferon alfa-2b (rh-IFN-2b) eye drop formulation was studied. Methods. A volume of 3 x 106 International Units (IU) of rh-IFN-2b formulated in solution was diluted with 5 mL of a 0.01% benzalkonium chloride solution. The stability of the extemporaneous formulation was evaluated for 30 days at room temperature (5 ± 3 °C) and at 28 ± 2 °C. Solutions were periodically subjected to bioactivity assay (antiviral titration), enzyme-linked immunosorbent assay, preservative-efficacy and sterility testing, organoleptic evaluation, and pH testing. Preservative efficacy was tested against five microorganisms. The organoleptic characteristics were verified by checking for the transparency and absence of suspended solids against light and dark backgrounds. Statistical significance was determined using analysis of variance after a comparison of the homogeneity of variance (Bartlett’s test). Results. Results from this evaluation indicated that the formulation was stable for 15 days at 5 ± 3 C. During this storage period, the biological activity varied between 80 and 125% of the nominal value (0.5 x 106 IU/mL). The formulation was sterile and organoleptically acceptable. The pH ranged from 6.7 to 7.3, and the preservative was effective. The formulation was stable for 7 days when stored at 28 ± 2 °C. The formulation remained sterile, colorless, and without suspended solids. The pH range was 6.7–7.3. Conclusion. An extemporaneously pre -pared rh-IFN-2b eye drop formulation was stable at 5 ± 3 °C for 15 days and at 28 ± 2 °C for 7 days. Index terms: Antivirals; Benzalkonium chloride; Color; Compounding; Hydrogen ion concentration; Interferon alfa-2b; Preservatives; Solutions, ophthalmic; Stability; Sterility; Storage; Temperature