Kutty Raman G, Bevry Mackenzie, Hoffmann Paul, Abourashed Ehab A
Transitional Year Residency, Medical College of Wisconsin Affiliated Hospitals at Ascension St. Joseph Hospital, Milwaukee, Wisconsin, United States.
Department of Internal Medicine, White River Health System, Batesville, Arkansas, United States.
Heliyon. 2022 Aug 5;8(8):e10104. doi: 10.1016/j.heliyon.2022.e10104. eCollection 2022 Aug.
Knowing the level of active ingredients in an expired drug is a matter of concern irrespective of its final disposition. This is also a matter of national security and defense as it has important implications on the nation's stockpile of prescription medications. Current literature has limited information about the strength of expired medications and any relevant trends.
To utilize high performance liquid chromatography (HPLC) to determine the strength of selected drugs for asthma and chronic obstructive pulmonary disease (COPD) as a class of therapeutic agents commonly used in free clinics.
Samples from expired lots of montelukast and albuterol pharmaceutical products were analyzed for their levels of their respective active ingredients. Two HPLC methods were developed, validated, and applied to achieve this goal. Quantitative analysis of each drug was performed using two different reversed phase C18 columns with a linear gradient of acetonitrile in 0.1% aqueous formic acid at a flow rate of 1 mL/min for both methods. Detection wavelength for montelukast and albuterol was 280 and 277 nm, respectively.
Expiry dates of analyzed batches ranged from 2003 to 2019. Despite the extended time range beyond expiry dates, levels of both drugs were relatively consistent and exceeded 90% of the listed strength in most analyzed lots.
Our results introduce a new perspective towards reducing the financial burden resulting from disposal of expired medications with retained strength. They also offer supporting evidence to extend the use of out-of-date montelukast and albuterol preparations at home and in free clinics.
了解过期药物中活性成分的含量是一个值得关注的问题，无论其最终处置方式如何。这也是一个国家安全和国防问题，因为它对国家处方药储备有重要影响。目前的文献中关于过期药物效力及任何相关趋势的信息有限。
利用高效液相色谱法（HPLC）测定作为免费诊所常用治疗药物类别的哮喘和慢性阻塞性肺疾病（COPD）所选药物的效力。
对过期批次的孟鲁司特和沙丁胺醇药品样本进行分析，以确定其各自活性成分的含量。开发、验证并应用了两种HPLC方法来实现这一目标。两种方法均使用两根不同的反相C18柱，以乙腈在0.1%甲酸水溶液中的线性梯度，流速为1 mL/min对每种药物进行定量分析。孟鲁司特和沙丁胺醇的检测波长分别为280和277 nm。
分析批次的过期日期从2003年到2019年。尽管超出过期日期的时间范围较长，但在大多数分析批次中，两种药物的含量相对一致，且超过所列效力的90%。
我们的结果为减轻因处置仍有药效的过期药物而产生的经济负担引入了新的视角。它们还为在家中和免费诊所延长使用过期的孟鲁司特和沙丁胺醇制剂提供了支持性证据。
