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首页> 外文期刊>The Canadian journal of hospital pharmacy. >Stability of Generic Formulations of Bortezomib 1.0 and 2.5 mg/mL in Vials and Syringes Stored at 4°C and Room Temperature (23°C or 25°C)
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Stability of Generic Formulations of Bortezomib 1.0 and 2.5 mg/mL in Vials and Syringes Stored at 4°C and Room Temperature (23°C or 25°C)

机译：在小瓶和2.5mg / ml在4℃和室温（23°C或25°C）中储存的硼脲1.0和2.5mg / ml的通用配方的稳定性

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Background: The availability of generic versions of bortezomib raises questions about the reliability of extrapolating stability data from one brand to another. Objective: To evaluate the stability of bortezomib formulations available from Janssen, Teva Canada, Actavis Pharma, Dr. Reddy’s Laboratories, Apotex, and MDA, reconstituted with 0.9% sodium chloride (normal saline) to produce solutions of either 1.0 or 2.5 mg/mL and stored over at least 21 days under refrigeration (4°C) or at room temperature (either 23°C or 25°C) in the manufacturer’s original glass vials or in polypropylene syringes. Methods: On study day 0, solutions with concentration 1.0 mg/mL or 2.5 mg/mL of the Teva, Actavis, Dr. Reddy’s, Apotex, and MDA generic formulations were prepared. Three units of each type of container (glass vials and syringes) were stored at 4°C and 3 units at room temperature. Concentration and physical inspection were completed on at least 8 study days (including day 0) over a 21- to 84-day study period. Bortezomib concentrations were determined by a validated stability-indicating liquid chromatographic method with ultraviolet detection. The end point of these studies was the time to reach 90% of the initial concentration (T-90) with 95% confidence, which is expressed as “T-9095%CI”, where CI refers to the confidence interval. In addition to estimating the T-9095%CI, differences in stability among products from all manufacturers were compared using multiple linear regression. Previously published data for the Janssen product were included in the overall comparisons. Results: In all of the studies, the analytical method separated degradation products from bortezomib, such that the concentration of bortezomib was measured specifically, accurately (deviations < 2.5%), and reproducibly (average replicate error 2.5%). During all studies, solutions retained more than 94% of the initial concentration at 4°C. The T-9095%CI exceeded the study period for all formulations under all combinations of concentration, container, and temperature, except the 84-day study for the MDA product. Multiple linear regression showed no significant differences among manufacturers (p = 0.57). Conclusions: In this study, formulations of bortezomib currently marketed in Canada (by Janssen, Teva Canada, Actavis Pharma, Dr. Reddy’s Laboratories, Apotex, and MDA) were pharmaceutically equivalent and interchangeable. Given that there was no difference in stability related to manufacturer, nominal concentration, or container, we conclude that these formulations are physically and chemically stable for at least 35 days under refrigeration and at least 25 days at room temperature.
机译：背景：硼替佐米的通用版本的可用性引发了关于从一个品牌到另一个品牌推断稳定性数据的可靠性问题。目的：评估硼替佐米制剂的稳定性，该制剂可从杨森、加拿大Teva、Actavis制药公司、Reddy博士实验室、Apotex和MDA获得，用0.9%氯化钠（生理盐水）重新配制成1.0或2.5 mg/mL的溶液，并在冷冻（4°C）或室温（23°C或25°C）下，在制造商的原装玻璃瓶或聚丙烯注射器中储存至少21天。方法：在研究第0天，制备浓度为1.0 mg/mL或2.5 mg/mL的Teva、Actavis、Dr.Reddy's、Apotex和MDA通用配方溶液。每种容器（玻璃瓶和注射器）的三个单元在4°C下储存，三个单元在室温下储存。在21至84天的研究期间，至少在8个研究日（包括第0天）完成浓度和身体检查。硼替佐米的浓度通过经验证的稳定性指示液相色谱法和紫外检测进行测定。这些研究的终点是达到90%初始浓度（T-90）的时间，置信度为95%，用“T-9095%CI”表示，其中CI指置信区间。除了估计T-9095%置信区间外，还使用多元线性回归法比较了所有制造商产品的稳定性差异。之前公布的杨森产品数据包括在整体比较中。结果：在所有研究中，该分析方法分离了硼替佐米的降解产物，因此硼替佐米的浓度得到了专门、准确（偏差<2.5%）和重复性（平均重复误差2.5%）的测量。在所有研究中，溶液在4°C下保留超过初始浓度的94%。在所有浓度、容器和温度组合下，所有配方的T-9095%CI超过了研究期，但MDA产品的84天研究除外。多元线性回归显示制造商之间没有显著差异（p=0.57）。结论：在这项研究中，目前在加拿大市场上销售的硼替佐米制剂（由杨森、加拿大特瓦、阿塔维斯制药、雷迪博士实验室、Apotex和MDA）在药学上是等效的和可互换的。考虑到与制造商、标称浓度或容器相关的稳定性没有差异，我们得出结论，这些配方在制冷条件下至少在物理和化学上稳定35天，在室温下至少在25天。

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