Stability of 10-mg/mL and 50-mg/mL ketamine oral solutions.

Summary

Ketamine oral solutions at 10 mg/mL and 50 mg/mL, prepared in a flavored suspending excipient and stored in amber plastic bottles, remain chemically stable for at least 90 days at both refrigeration (2°C-8°C) and ambient (22°C-25°C) temperatures. Over 90 days, at least 98% of the initial ketamine concentration was retained under all conditions tested. Solution pH, color, and odor also remained unchanged throughout the study period. These results indicate that extemporaneously compounded oral ketamine solutions can be stored for up to 90 days without significant degradation.

Study at a glance

Abstract

Ketamine is an anesthetic agent commonly used for the induction of anesthesia. Ketamine is also given to control pain, for treatment of posttraumatic stress disorder, and to induce bronchodilation in refractory asthma. Moreover, ketamine therapy is gaining ground as an intervention for patients with treatment-resistant depression and individuals who have depression with serious suicidal ideation. Recently, the drug has been used to disrupt maladaptive reward memories in individuals with harmful alcohol consumption behaviors. The stability of 10-mg/mL and 50-mg/mL ketamine solutions stored at ambient and refrigeration temperatures was assessed over 90 days. Three batches of 10-mg/mL and 50-mg/mL ketamine solutions were stored for 90 days under two temperature conditions (2°C-8°C and 22°C-25°C) in amber plastic bottles. Chemical stability was assessed using a stability-indicating high-performance liquid chromatography assay. At each study time, visual inspection and pH assessments of ketamine concentration and pH were conducted. For all solutions tested at each condition, the ketamine concentration remaining was at least 98% of the initial concentration over 90 days of storage. Throughout the study period, solution pH remained stable and the color and odor of the suspensions remained unchanged. Extemporaneously compounded 10-mg/mL and 50-mg/mL oral solutions of ketamine prepared in a flavored suspending excipient and stored in amber polypropylene plastic bottles were stable for at least 90 days at both ambient and refrigeration temperatures.