在室温下在聚烯注射器中的吗啡 - 胺添加剂的长期物理化学稳定性
Luigi Devis1, Marie-Lise Colsoul1,2, Benoît Bihin2,3
1Department of Laboratory Medicine, CHU UCL Namur, UCLouvain, Belgium.
International journal of pharmaceutical compounding
|October 20, 2025
概括
吗啡和胺化合物添加剂在室温下在聚烯注射器中稳定49天. 这一发现支持这些解决方案的预先准备,增强患者护理和减少错误.
科学领域:
- 制药科学 制药科学
- 临床药房 临床药房
- 药物的稳定性 药物的稳定性
背景情况:
- 预先制备吗啡和胺溶液可以通过减少错误,成本和护理工作量来提高护理质量.
- 关于在室温下在聚烯注射器中的吗啡化物和胺化物添加剂的稳定性数据有限.
研究的目的:
- 评估吗啡化物 (2.0 mg/mL) 和胺 (3.3 mg/mL) 添加剂的物理和化学稳定性.
- 在室温下保存的聚烯注射器中评估稳定性,保护免受光照,长达49天.
主要方法:
- 五个混合剂注射器的无菌制备.
- 在49天的周期性分析.
- 物理稳定性通过视觉,显微镜和度进行评估;化学稳定性使用超高性能液态染色学 (UHPLC) 进行评估.
主要成果:
- 没有观察到视觉降水,颜色变化或明显的度增加.
- 在整个研究期间保持稳定的pH值.
- 通过UHPLC确认的吗啡和胺度在第49天仍然高于初始值的90%.
结论:
- 吗啡和胺化合物添加剂在特定的储存条件下,在物理和化学上至少49天稳定.
- 支持通过集中静脉注射添加剂服务预先制备这种添加剂.
- 提高效率,并可能减少临床实践中的药物错误.
相关概念视频
Drug Product Stability
223
The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
223
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
177
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
177
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
666
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
666
Bioavailability Enhancement: Drug Stability Enhancement and GI Retention
193
Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
193
Opioid Analgesics: Synthetic and Semisynthetic Opioids
908
Synthetic and semisynthetic opioids are pivotal in pain management and tackling opioid addiction. Semisynthetic opioids, including morphinans (morphine derivatives), oxycodone, oxymorphone, hydrocodone, and hydromorphone, have improved pharmacokinetic profiles compared to morphine. Additionally, heroin and 6-MAM (6-Monoacetylmorphine) show better CNS penetration than morphine due to heightened lipid solubility. Hydromorphone, a potent opioid, undergoes hepatic metabolism to form the active...
908
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
498
Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
498


