Design of pediatric oral formulations with a low proportion of methadone or phenobarbital for the treatment of neonatal abstinence syndrome.

Abstract

CONTEXT:

Elaboration of oral liquid formulations is the best alternative when no marketed forms are available for pediatrics.

OBJECTIVE:

The development, characterization and stability evaluation of methadone (MI, MII, MIII) and phenobarbital (PI, PII) can be used for the treatment of neonatal abstinence syndrome (NAS).

MATERIAL AND METHODS:

A standard operating procedure was established and parameters such as appearance, pH, rheological behavior and drug content were evaluated at three temperatures for 90 days.

RESULTS AND DISCUSSION:

Changes in color of phenobarbital made necessary the storage below 25 °C. pH did not change in methadone solutions and was able to maintain phenobarbital solubilized. Degradation data at 4 °C fitted to Plateau equation followed by one phase decay. MI was stable for 60 days at the three temperatures; MII for 90 days at 4 and 25 °C and 60 days at 40 °C; MIII for 60 days at 4 °C, 15 days at 25 °C and 7 days at 4 °C. PI was stable for 60 days at 4 °C and 30 days at 25 °C. PII was stable for 7 days at 4 and 25 °C. All solutions met microbial specifications.

CONCLUSION:

A correct dosage for the treatment of NAS was guaranteed.

• Authors: Nora Provenza, Ana C Calpena, Mireia Mallandrich, Blanca Pueyo, Beatriz Clares
• Journal: Pharmaceutical development and technology (Pharm Dev Technol) Vol. 21 Issue 6 Pg. 755-62 (Sep 2016) ISSN: 1097-9867 [Electronic] England
• PMID: 26155877 (Publication Type: Journal Article)

Chemical References

• Methadone
• Phenobarbital

Topics

• Administration, Oral
• Chemistry, Pharmaceutical (methods, standards)
• Drug Design
• Drug Packaging
• Drug Stability
• Humans
• Infant, Newborn
• Methadone (administration & dosage, chemical synthesis)
• Neonatal Abstinence Syndrome (drug therapy)
• Phenobarbital (administration & dosage, chemical synthesis)
• Rheology (methods, standards)
• Treatment Outcome