Jason Sauberan1, Steven Rossi, Jae H Kim. 1. University of California, San Diego (UCSD) Medical Center, Department of Pharmacy and UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA, USA. jsauberan@ucsd.edu
Abstract
BACKGROUND: Oral morphine is a recommended option for the treatment of neonatal abstinence syndrome (NAS). Commercially available oral morphine solution products in the United States are not formulated in concentrations appropriate for use in neonates. OBJECTIVE: To test the stability of a diluted oral morphine solution for treatment of NAS. METHODS: Ethanol-free morphine 2 mg/mL oral solution was diluted to 0.4 mg/mL with sterile water and stored in a light protected container at room temperature (20°C-25°C). The change in morphine concentration over time was measured by liquid chromatography mass spectrometry with simultaneous ultraviolet diode array detection. RESULTS: : The test morphine solution retained 107% of its original concentration after 60 days. CONCLUSION: Extemporaneously prepared 0.4 mg/mL oral morphine solution is suitable for use in the treatment of NAS as a potentially safer alternative to opium-containing agents.
BACKGROUND: Oral morphine is a recommended option for the treatment of neonatal abstinence syndrome (NAS). Commercially available oral morphine solution products in the United States are not formulated in concentrations appropriate for use in neonates. OBJECTIVE: To test the stability of a diluted oral morphine solution for treatment of NAS. METHODS:Ethanol-free morphine 2 mg/mL oral solution was diluted to 0.4 mg/mL with sterile water and stored in a light protected container at room temperature (20°C-25°C). The change in morphine concentration over time was measured by liquid chromatography mass spectrometry with simultaneous ultraviolet diode array detection. RESULTS: : The test morphine solution retained 107% of its original concentration after 60 days. CONCLUSION: Extemporaneously prepared 0.4 mg/mL oral morphine solution is suitable for use in the treatment of NAS as a potentially safer alternative to opium-containing agents.
Authors: Walter K Kraft; Susan C Adeniyi-Jones; Inna Chervoneva; Jay S Greenspan; Diane Abatemarco; Karol Kaltenbach; Michelle E Ehrlich Journal: N Engl J Med Date: 2017-05-04 Impact factor: 91.245