Provenza Nora, Calpena Ana C, Mallandrich Mireia, Pueyo Blanca, Clares Beatriz
a Pharmacokinetics and Biopharmaceutics Unit , School of Pharmacy, University of Barcelona , Barcelona , Spain and.
b Department of Pharmacy and Pharmaceutical Technology , School of Pharmacy, University of Granada , Granada , Spain.
Pharm Dev Technol. 2016 Sep;21(6):755-62. doi: 10.3109/10837450.2015.1055765. Epub 2015 Jul 9.
Elaboration of oral liquid formulations is the best alternative when no marketed forms are available for pediatrics.
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).
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.
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.
A correct dosage for the treatment of NAS was guaranteed.
当没有适用于儿科的市售剂型时，制备口服液体制剂是最佳选择。
美沙酮（MI、MII、MIII）和苯巴比妥（PI、PII）的开发、表征及稳定性评估可用于治疗新生儿戒断综合征（NAS）。
制定了标准操作规程，并在三个温度下评估90天，包括外观、pH值、流变行为和药物含量等参数。
苯巴比妥颜色变化使得需在25°C以下储存。美沙酮溶液的pH值未改变，且能使苯巴比妥保持溶解状态。4°C下的降解数据符合高原方程并随后呈单相衰减。MI在三个温度下均稳定60天；MII在4°C和25°C下稳定90天，在40°C下稳定60天；MIII在4°C下稳定60天，在25°C下稳定15天，在40°C下稳定7天。PI在4°C下稳定60天，在25°C下稳定30天。PII在4°C和25°C下稳定7天。所有溶液均符合微生物标准。
保证了治疗NAS的正确剂量。
