Stability of dilute oral morphine solution for neonatal abstinence syndrome.
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.


CONCLUSIONS
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.
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
Jason
J
Sauberan
Steven
S
Rossi
Jae H
JH
Kim
D000284:Administration, Oral; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004339:Drug Compounding / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D007231:Infant, Newborn; D009020:Morphine / Q000737:chemistry*; D009294:Narcotics / Q000737:chemistry*; D009357:Neonatal Abstinence Syndrome; D019999:Pharmaceutical Solutions; D014481:United States
D009294:Narcotics; D019999:Pharmaceutical Solutions; D009020:Morphine