Friciu M Mihaela, Alarie Hugo, Beauchemin Mylène, Forest Jean-Marc, Leclair Grégoire
, MSc, is a Research Associate with the Faculty of Pharmacy, Université de Montréal, Montréal, Quebec, BSc, is a Master of Science candidate in the Faculty of Pharmacy, Université de Montréal, Montréal, Quebec, PharmD, MSc, is a Pharmacist with the Department of Pharmacy, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec, BPharm, DPH, MSc, is a Pharmacist with the Compounding Service (Fabrication) in the Department of Pharmacy, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec, BPharm, PhD, is an Associate Professor with the Faculty of Pharmacy, Université de Montréal, Montréal, Quebec.
Can J Hosp Pharm. 2020 Mar-Apr;73(2):141-144. Epub 2020 Apr 1.
Until October 2014, methadone hydrochloride for injection (10 mg/mL) was available in Canada through Health Canada's Special Access Programme. Diluted to 5 mg/mL in saline, it was used in pediatrics for acute and cancer-related pain. More recently, the department of pharmacy of the Centre hospitalier universitaire Sainte-Justine in Montréal, Quebec, proposed compounding a solution of methadone hydrochloride for injection (5 mg/mL) from bulk powder and saline solution for pediatric administration.
To assess the stability of the proposed compounded preparation.
Solutions of methadone hydrochloride in saline were prepared from bulk powder and stored in clear glass vials for up to 180 days at room temperature (25 °C) or with refrigeration (5 °C), with testing on days 0, 7, 14, 30, 60, 90, and 180. The appearance of the solutions and presence of particulate matter were assessed. A stability-indicating high-performance liquid chromatography (HPLC) method was developed to assay the concentration of methadone over time.
No notable changes in appearance of the methadone solution were observed, particle counts did not exceed limits specified by the , and no microbial growth was observed. The HPLC analysis showed that the concentration of methadone remained above 90% on all study days.
Methadone hydrochloride for injection prepared from bulk powder in saline solution at a concentration of 5 mg/mL remained chemically stable for at least 180 days when stored in clear glass vials at 5 °C and at 25 °C.
直到2014年10月，加拿大可通过加拿大卫生部的特殊准入计划获得注射用盐酸美沙酮（10毫克/毫升）。稀释至生理盐水中浓度为5毫克/毫升后，用于儿科治疗急性疼痛和与癌症相关的疼痛。最近，魁北克蒙特利尔圣贾斯汀大学中心医院药房提议将散装粉末和生理盐水混合配制成注射用盐酸美沙酮溶液（5毫克/毫升）用于儿科给药。
评估所提议的复方制剂的稳定性。
用散装粉末制备盐酸美沙酮生理盐水溶液，并储存在透明玻璃瓶中，在室温（25℃）或冷藏（5℃）条件下保存长达180天，分别在第0、7、14、30、60、90和180天进行检测。评估溶液的外观和颗粒物的存在情况。开发了一种稳定性指示高效液相色谱（HPLC）方法来测定随时间变化的美沙酮浓度。
未观察到美沙酮溶液外观有明显变化，颗粒计数未超过规定限度，也未观察到微生物生长。HPLC分析表明，在所有研究日美沙酮浓度均保持在90%以上。
由散装粉末在生理盐水中配制成浓度为5毫克/毫升 的注射用盐酸美沙酮，当储存在透明玻璃瓶中于5℃和25℃条件下时，化学稳定性至少保持180天。
