Stable preservative-free mydriatic and anti-inflammatory solutions for injection

摘要

STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION 5OF THE DISCLOSURE The present invention relates to stable, preservative- and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection. F1, G1 5mM Ketor/5mM Phen NaPhosphate, pH 7.4 No Excipients or Additives Related Substance Assay Results for F1, G1 pH7.4 Phenylephrine % Related Time (months) Substances 2-8* C 25* C 400 C 60* C Pre Filtered 0.00 Post Filtered 0.00 0.5 0.00 0.00 0.00 0.00 1 0.00 0.00 0.00 0.21 2 0.00 0.00 0.00 2.26 3 0.00 0.00 0.25 1.74 4 0.00 0.00 0.40 2.68 6 0.00 0.21 1.22 5.64 9 0.00 0.00 0.29 8.85 12 2.09 1.36 1.90 16.97 Related Substance Assay Results for F1, G1 pH7.4 Ketorolac % Related Time (months) Substances 2-8 0 C 250 C 400 C 60* C Pre Filtered 0.09 Post Filtered 0.00 0.5 0.08 0.08 0.00 0.00 1 0.00 0.00 0.00 0.09 2 0.00 0.00 0.00 0.67 3 0.00 0.00 0.00 0.74 4 0.00 0.00 0.23 1.12 6 0.00 0.21 0.66 3.51 9 0.00 0.05 0.36 2.65 12 0.00 0.00 0.64 3.30