在液态溶液中因物理压力引起的粒子形成的整体评估
Patrick Schlossbauer1, Stefanie Schopf1, Katrin Lindner1
1Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.
概括
开发稳定的液体治疗药物至关重要. 这项研究表明,像和摇这样的物理压力会导致聚,形成可见微粒 (SVP) 并影响药物的稳定性.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 药物运输 药物运输 药物运输
背景情况:
- 液体疗法面临着物理稳定性的挑战,导致药物聚合和降解.
- 这些问题可能会引起患者安全问题,包括增加免疫性和降低药物的效力.
研究的目的:
- 开发和测试用于诱导液体配方的物理应力方法.
- 研究各种压力对聚和颗粒形成的影响.
主要方法:
- 开发了通过,,和冷-解周期来施加物理压力的方法.
- 利用缓冲解决方案来优化应力参数,而不会损坏材料.
- 在工具配方中测试了治疗活性.
主要成果:
- 环静脉引发了依赖时间的可见粒子 (SVP) 在溶液中的形成.
- 动实验揭示了特异性的聚合模式.
- 高速动增加了界面应力和样品的区分能力.
- 冷和解导致SVP,可能是由于玻璃脱层.
结论:
- 物理压力显著影响液体疗法的稳定性.
- 不同的应力方法会导致不同程度的聚合和粒子形成.
- 了解这些由压力引起的变化对于确保药物的安全性和有效性至关重要.
相关概念视频
Solution Formation
37.6K
There is no one solvent that can dissolve every type of solute. Some substances that readily dissolve in a certain solvent might be insoluble in a different solvent. A simple way to predict which substances dissolve in which solvent is the phrase "like dissolves like". This means that polar substances, such as salt and sugar, dissolve in a polar substance like water. In contrast, non-polar substances are more soluble in non-polar solvents such as carbon tetrachloride.
This selective...
This selective...
37.6K
Energetics of Solution Formation
7.4K
The formation of a solution is an example of a spontaneous process, which is a process that occurs under specified conditions without energy from some external source.
When the strengths of the intermolecular forces of attraction between solute and solvent species in a solution are no different than those present in the separated components, the solution is formed with no accompanying energy change. Formation of the solution requires the solute–solute and solvent–solvent...
When the strengths of the intermolecular forces of attraction between solute and solvent species in a solution are no different than those present in the separated components, the solution is formed with no accompanying energy change. Formation of the solution requires the solute–solute and solvent–solvent...
7.4K
Enthalpy of Solution
30.5K
There are two criteria that favor, but do not guarantee, the spontaneous formation of a solution:
30.5K
Peptide Bonds
82.9K
A peptide bond covalently attaches amino acids through a dehydration reaction. One amino acid's carboxyl group and another amino acid's amino group combine, releasing a water molecule. The resulting bond is the peptide bond. The products that such linkages form are peptides. As more amino acids join this growing chain, the resulting chain is a polypeptide. Each polypeptide has a free amino group at one end. This end has the N-terminal, or the amino-terminal, and the other end has a free...
82.9K
Precipitate Formation and Particle Size Control
6.8K
In precipitation gravimetry, the precipitating agent should react specifically or selectively with the analyte. While a specific reagent reacts with the analyte alone, a selective reagent can react with a limited number of chemical species.
The obtained precipitate should be either a pure substance of known composition or easily converted to one by a simple process, such as ignition or drying. In addition, the precipitate should be insoluble and easily filterable. In general, filterability...
The obtained precipitate should be either a pure substance of known composition or easily converted to one by a simple process, such as ignition or drying. In addition, the precipitate should be insoluble and easily filterable. In general, filterability...
6.8K
General Properties of Solutions
35.8K
Many common substances around us exist as a solution, such as ocean water, air, and gasoline. All solutions are mixtures of substances that are composed of varying amounts of two or more types of atoms or molecules. A mixture with a non-uniform composition is a heterogeneous mixture, whereas a mixture with a uniform composition is a homogeneous mixture. The components that make the homogeneous mixture are evenly spread out and thoroughly mixed.
35.8K


