在0.2和3.33毫克/毫升的弹性体器件内内福的物理化学稳定性
Aline Daval1, Elise D'Huart2,3, Franck Blaise2
1CHRU de Nancy Pôle Pharmacie, Nancy, Grand Est, France aline.daval88@gmail.com.
European journal of hospital pharmacy : science and practice
|December 4, 2025
概括
在elastomeric输液装置中,nefopam溶液在32°C下24小时内在化学和物理上都稳定. 这种稳定性支持在家用作术后疼痛管理,当口服很难时.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 尼福帕姆是一种非阿片类止痛药,对术后疼痛管理至关重要.
- 便携式弹性体输液装置是首选的家庭管理,需要药物稳定性在体温 (32°C).
研究的目的:
- 为了评估nefopam溶液 (0.2和3.33毫克/毫升) 在0.9%NaCl中的物理化学稳定性.
- 为了评估便携式弹性体器件的稳定性,在32°C保存长达24小时.
主要方法:
- 通过HPLC和pH测量评估的化学稳定性,根据ICH Q2 (R1) 进行验证.
- 通过视觉和潜视觉颗粒检查评估的物理稳定性 (欧洲药典指南).
- 在准备后的0,6小时和24小时测试了稳定性.
主要成果:
- 尼福帕姆溶液在32°C保持超过93%的初始度24小时.
- 没有观察到显著的pH值变化 (>1单位) 或降解产物,证实了化学稳定性.
- 视觉和潜视觉检查证实了整个24小时期间的物理稳定性.
结论:
- 尼福帕姆溶液 (0.2和3.33毫克/毫升) 的物理化学稳定性在弹性体输液装置中在32°C下24小时内得到证实.
- 这种稳定性使得在家中持续使用,有利于患有难以口服或试图最大限度地减少副作用的患者.
相关概念视频
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
167
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...
167
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
647
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...
647
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
135
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
135
Drug Product Stability
217
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...
217
Factors Influencing Drug Absorption: Pharmaceutical Parameters
382
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
382
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
480
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...
480


