Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, McGuire Claire, Lodder Robert A
Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506.
Contact Context. 2023;2023. doi: 10.6084/m9.figshare.23317136. Epub 2023 Jun 7.
Dantrolene sodium is a direct-acting skeletal muscle relaxant. Dantrolene sodium for injection is indicated, along with suitable supportive measures, for the management of sudden, severe hypermetabolism of skeletal muscle typical of malignant hyperthermia crises in patients of any age. The formulation scanned in this work was designed to be injected intravenously. Intra-lot and inter-lot variability in the spectra of REVONTO (dantrolene sodium) was measured in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Spectra of 69 vials from lot 20REV01A contained two groups (n=56 vials, n=13 vials) when scanned with an FTNIR. The two groups of spectra in lot 20REV01A were found to be 66.7 SDs apart using a subcluster detection test, suggesting that the two groups were manufactured differently. As a result, all available samples of dantrolene were examined. A library of spectra of 141 vials of dantrolene from 4 lots were found to contain 3 separate groups, also suggesting that different vials contain different materials.
丹曲林钠是一种直接作用的骨骼肌松弛剂。注射用丹曲林钠，连同适当的支持措施，适用于治疗任何年龄患者典型的恶性高热危象中突然发生的严重骨骼肌代谢亢进。本研究中扫描的制剂设计为静脉注射。在药物质量研究（DQS）中，使用傅里叶变换近红外光谱法（FTNIR）测量了瑞凡托（丹曲林钠）批次内和批次间光谱的变异性。用FTNIR扫描时，来自20REV01A批次的69个小瓶的光谱包含两组（n = 56个小瓶，n = 13个小瓶）。使用子聚类检测测试发现，20REV01A批次的两组光谱相差66.7个标准差，这表明两组的生产方式不同。因此，对所有可用的丹曲林样品进行了检查。发现来自4个批次的141个丹曲林小瓶的光谱库包含3个不同的组，这也表明不同的小瓶含有不同的物质。
