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Stability of Dilute Oral Morphine Solution for Neonatal Abstinence Syndrome

Sauberan, Jason PharmD; Rossi, Steven PhD; Kim, Jae H. PhD

Journal of Addiction Medicine:
doi: 10.1097/ADM.0b013e318280f495
Original Research
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.

Author Information

From the University of California, San Diego (UCSD) Medical Center (JS), Department of Pharmacy and UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, San Diego, CA; UCSD School of Medicine (ST), Department of Anesthesiology, San Diego, CA; and UCSD School of Medicine (JHK), Department of Pediatrics, Division of Neonatology, San Diego, CA

Send correspondence and reprint requests to Jason B. Sauberan, PharmD, University of California, San Diego (UCSD) Medical Center, Department of Pharmacy and UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, 200 W. Arbor Dr, San Diego, CA. E-mail: jsauberan@ucsd.edu.

Supported by the UCSD School of Medicine, Department of Pediatrics.

The authors declare no conflicts of interest.

Received September 28, 2012

Accepted December 02, 2012

© 2013 American Society of Addiction Medicine