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Printable version |
Impact of deep-freezing on stability of 40 mg/ml pefloxazine eye drops |
Journal de Pharmacie Clinique. Volume 18, Number 1, 88-9, Mars 1999, 4es ATELIERS DU SNPHPU
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Résumé
Article gratuit
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Author(s) : C. GELLIS, V. SAUTOU-MIRANDA, V. PINON, F. PICQ, J. CHOPINEAU |
Summary : The purpose of this work was to evaluate the impact of deep-freezing on the stability of « fortified » 40 mg/ml pefloxazine eye drops. We studied the physical and chemical stability and the maintenance of sterility of the eye drops after deep-freezing at – 20 °C followed by refrigeration for 48 h. We found that 40 mg/ml pefloxazine eye drops in 5 % glucose showed high stability when deep-frozen for 3 months at – 20 °C. The pH and osmolality were stable and compatible with intra-ocular administration. No particles or germs were detected. The eye drops also remained stable and sterile when kept refrigerated for 48 h at + 4 °C after thawing. Deep-freeze storage at 40 mg/ml pefloxazine eye drops for 3 months allows (i) stocks of chemically and microbiologically safe preparations to be made up before administration to solutions (ii) prompter dispensing to patients from stock through not having to made up solutions extemporaneously, and (iii) better production management. |
Keywords : eye drops, pefloxazine, stability, deep-freezing. |
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