已入深夜,您辛苦了!由于当前在线用户较少,发布求助请尽量完整的填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!祝你早点完成任务,早点休息,好梦!

Effect of Packaging Materials and the Leached Iron on the Stability of Butorphanol Tartrate Injection

安瓿 布托啡诺 氧气 酒石酸盐 柠檬酸 化学 核化学 无机化学 有机化学 医学 外科
作者
Zijun Dai,Zhu Chang,Jinyuan Lyu,Chunfeng Liu,Jiajian Xu,Haoxiang Wu,Fuli Zhang
出处
期刊:Aaps Pharmscitech [Springer Nature]
卷期号:22 (5) 被引量:1
标识
DOI:10.1208/s12249-021-02060-4
摘要

The aim of this study was to investigate the effect of various parameters on the stability of butorphanol tartrate injection and to screen the optimal packaging material. The effect of the headspace oxygen levels, ampoule color, manufacturer, and size on the stability of butorphanol tartrate formulation were evaluated. The headspace oxygen levels controlled by nitrogen purging were found to be particularly effective in improving stability of the butorphanol formulation, especially below 2%. Although it is a photolabile drug, butorphanol tartrate was getting degraded at much higher extent in amber color ampoules in comparison to clear ampoules. The degradation by oxidation was found to be a free radical-mediated process catalyzed by the presence of iron ions leached from the amber ampoules. The ampoule manufacturers also had a significant effect on the stability of butorphanol. Two-milliliter ampoules provided a better stability of the butorphanol tartrate injection than 1mL ampoules as 2-mL ampoules had the lower headspace oxygen level at the same level of oxygen content. The oxidation mechanism of the butorphanol tartrate injection was investigated under various conditions, which include iron powder spiking, removal of excipients, exposure to oxygen/nitrogen, exposure to stainless steel and at different pH. Iron powder spiking, presence of citric acid, exposure to oxygen, exposure to stainless steel, and high pH accelerated the oxidative degradation. The effect of oxygen, iron ion and citric acid is in agreement with a metal-catalyzed oxidation mechanism called Udenfriend reaction. Based on the formulation test results, limiting headspace oxygen level, ampoule color, manufacturer, size, controlling iron ion contamination, and pH are recommended for formulation development. In conclusion, it can be suggested that this study can lead to a better understanding of the degradation mechanism of butorphanol tartrate; hence, it would contribute to the development of butorphanol tartrate injection with improved stability. Virous packaging materials have different effects on the stability of butorphanol tartrate injection, and the leached iron of packaging ampoules and stainless steel can trigger Udenfriend reaction with butorphanol tartrate and citric acid (CA), which lead to the oxydative degradation of butorphanol tartrate injection.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
minmi完成签到,获得积分20
刚刚
闲庭完成签到 ,获得积分10
刚刚
与月同行完成签到,获得积分10
1秒前
kjding发布了新的文献求助10
1秒前
勿昂完成签到 ,获得积分10
2秒前
WYJ完成签到,获得积分10
4秒前
Lucas应助科研通管家采纳,获得30
4秒前
科研通AI2S应助科研通管家采纳,获得10
4秒前
科研通AI2S应助科研通管家采纳,获得10
4秒前
4秒前
超级碧曼完成签到,获得积分20
5秒前
超级碧曼发布了新的文献求助10
9秒前
雪白问兰完成签到 ,获得积分10
11秒前
13秒前
mov完成签到,获得积分10
13秒前
紫色翡翠完成签到,获得积分10
15秒前
段祥发布了新的文献求助10
17秒前
九日橙完成签到 ,获得积分10
17秒前
这像话吗完成签到,获得积分20
18秒前
momo完成签到,获得积分10
20秒前
北方小镇完成签到 ,获得积分10
20秒前
月月鸟完成签到 ,获得积分10
20秒前
尤静柏完成签到,获得积分10
23秒前
科研通AI2S应助超级碧曼采纳,获得10
24秒前
claud完成签到 ,获得积分10
24秒前
梦璃完成签到,获得积分10
24秒前
B612小行星完成签到 ,获得积分10
24秒前
杨二锤完成签到 ,获得积分0
27秒前
完美世界应助拼搏妙竹采纳,获得10
27秒前
30秒前
33秒前
33秒前
郜雨寒完成签到,获得积分10
34秒前
该房地产个人的完成签到,获得积分10
35秒前
36秒前
dd发布了新的文献求助10
36秒前
Jasper应助大街小巷采纳,获得10
36秒前
迷路冰安完成签到 ,获得积分10
36秒前
宋泽艺完成签到 ,获得积分10
37秒前
lili完成签到 ,获得积分10
38秒前
高分求助中
Spray / Wall-interaction Modelling by Dimensionless Data Analysis 2000
Aspects of Babylonian celestial divination: the lunar eclipse tablets of Enūma Anu Enlil 500
Mathematics and Finite Element Discretizations of Incompressible Navier—Stokes Flows 500
India's foreign trade policy and its performance in the world economy 450
Dictionary of socialism 350
Mixed-anion Compounds 300
Geochemistry, 2nd Edition 地球化学经典教科书第二版 300
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3196557
求助须知:如何正确求助?哪些是违规求助? 2845245
关于积分的说明 8053685
捐赠科研通 2509895
什么是DOI,文献DOI怎么找? 1342090
科研通“疑难数据库(出版商)”最低求助积分说明 639304
邀请新用户注册赠送积分活动 608595