Background Children of opioid-dependent mothers often suffer from withdrawal symptoms after birth. In the neonatal unit of our hospital children were treated with diluted opium tincture if clinically necessary.
Purpose Application problems led to the question how the rarely needed treatment could be improved to be safer and more efficient.
Materials and Methods A more suitable formulation to treat the neonatal abstinence syndrome was found by screening current treatment guidelines. The pharmaceutical product with an acceptable shelf-life was compounded by separating the solvent from the ingredients. Three batches have been verified by quantitative analysis.
Results Morphine hydrochloride solution 0.5 mg/ml (NRF 29.3) is a standardised formula for the therapy of neonatal abstinence syndrome.1 In contrast to the use of opium tincture, the safety profile is more favourable, particularly due to the absence of alcohol and the use of a single substance instead of the alkaloid mixture. As the preservative-free solution has a limited shelf-life of 7 days at room temperature, it does not allow for pre-production. Furthermore, due to the moderate demand, a weekly production cycle in the pharmacy would lead to the discarding of the narcotic substance, including extensive documentation in most of the cases.
The problem was solved by separating the solvent from the ingredients and preparing a reconstitution kit.
The reconstitution kit contains a bottle with the undissolved ingredients, all materials required for reconstitution and an illustrated instruction for preparation on the ward to reduce the risk of errors within the process.
Photometric analysis of three reconstituted batches showed that the morphine hydrochloride concentrations were within specifications.2
Conclusion The kit for reconstitution of a morphine hydrochloride solution including step-by-step instruction is simple and safe. It is economic by avoiding the discarding of opioids and allows the treatment of neonatal abstinence syndrome even outside of the hospital pharmacy’s working hours.
. Morphinhydrochlorid-Lösung 0,5 mg/ml (NRF 29. 3. ). DAC/NRF 2015/1.
. Bracher F, et al. (Hrsg.). Monographie Morphinhydrochlorid. Arzneibuch-Kommentar. Wissenschaftliche Erläuterungen zum Europäischen und Deutschen Arzneibuch. 31. Lieferung 2009. WVG Stuttgart/Govi-Verlag Pharmazeutischer Verlag GmbH Eschborn.