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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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...
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Colloidal precipitates01:09

Colloidal precipitates

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The high insolubility of some precipitates can result in an unfavorable relative supersaturation. This can lead to colloidal particles with a large surface-to-mass ratio, where adsorption is promoted. For instance, in the precipitation of silver chloride, silver ions are adsorbed on the surface of the colloidal particles, forming a primary layer. This layer attracts ions of opposite charge (such as nitrate ions), forming a diffuse secondary layer of adsorbed ions. This electric double layer...
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Recrystallization: Solid–Solution Equilibria01:10

Recrystallization: Solid–Solution Equilibria

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Recrystallization is a purification technique used to separate impurities from solid compounds. In this technique, no chemical reactions occur. Instead, it exploits physical properties only, specifically, the solubility differences between the desired compound and impurities, either at a single temperature or at different temperatures, and under other selected conditions. The solid-solution equilibrium (solubility equilibrium) of each component in the solution represents a binary phase...
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Sublimation01:03

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Sublimation is the direct transformation of a solid to a gaseous state. For instance, at standard pressure and room temperature, solid carbon dioxide sublimes to gaseous carbon dioxide. The phase diagram depicts the conditions required for sublimation. This process occurs at the solid-gas phase boundary and is not observed above the triple point of the substance. The reverse of sublimation is called deposition, where a gaseous substance condenses directly into a solid. Sublimation and...
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Crystal Growth: Principles of Crystallization01:25

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Crystallization is a phase transformation process in which crystals are precipitated from a supersaturated solution or formed from other sources. During crystallization, atoms or molecules arrange themselves into a well-defined, rigid crystal lattice to minimize energy.
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Formulations for Freeze-drying of Bacteria and Their Influence on Cell Survival
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通过冷干燥生产的非盐基共形配方.

Mohammed Suleiman Alsalhi1, Paul G Royall2, Hisham Al-Obaidi3

  • 1Institute of Pharmaceutical Science, King's College London, SE1 9NH, UK; College of pharmacy, King Saud University, Riyadh, Saudi Arabia.

International journal of pharmaceutics
|September 15, 2023
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概括

这项研究开发了一种新型的非盐共同形态系统 (CAM),通过冷干燥使用酸盐和印米他辛. 优化的比率显著改善了药物的溶解和物理稳定性,为难溶性药物提供了可扩展的制造方法.

关键词:
同形态系统是同形态系统.解散 解散 解散 是一个过程.结干燥 这是一种冷干燥.非离子相互作用 非离子相互作用最好的比率是最好的比率.物理稳定性 物理稳定性

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科学领域:

  • 制药科学 制药科学
  • 材料科学 材料科学 材料科学
  • 药物运输 药物运输 药物运输

背景情况:

  • 同形系统 (CAMs) 提供了一个有前途的策略,以提高生物制药分类系统 (BCS) 类II药物的溶解.
  • 目前的CAM配方通常依赖于盐形成和机械激活,由于缺乏对非离子相互作用和可扩展过程的理解,限制了它们的应用.
  • 研究非盐基CAM和探索结干燥等替代制造方法对于更广泛的药物开发至关重要.

研究的目的:

  • 为了研究氨酸 (非离子氨基酸) 与印米他辛 (模型药物) 的比例对非盐基CAM的影响.
  • 开发和描述使用可扩展的冷干燥工艺的CAM,使用 tert-butyl酒精-水辅溶剂系统.
  • 评估开发的CAMs的溶解性能和物理稳定性.

主要方法:

  • 使用三乙醇-水辅溶剂系统的冷干燥来制备三乙醇-甲共形系统 (CAMs).
  • 使用差分扫描热量测量 (DSC),UV-Vis光谱,里埃变换红外 (FT-IR) 光谱,核磁共振 (NMR) 光谱,热重力测量分析 (TGA) 和X射线粉末衍射 (XRPD) 的CAM系统性表征.
  • 在定义的储存条件下评估溶解性能和物理稳定性.

主要成果:

  • 使用辅助溶剂系统的冷干燥成功地产生了托-甲CAMs.
  • 通过FT-IR和NMR证实了分子相互作用,包括键 (H键),H/π和π-π相互作用.
  • 药物释放率显著改善,与药物:氨基酸的摩尔比为1.5:1 (1:0.42重量比) 或更低的配方相比,与纯的印梅他辛相比.
  • 药物:氨基酸比为2.3:1 (1:0.25重量比) 或更低的配方在干燥条件下 (5%RH,25°C) 至少9个月表现出较低的物理稳定性,与纯无形印美不同.

结论:

  • 使用三乙醇水共溶剂系统的冷干燥是一种生产非盐基药物氨基酸共形系统 (CAMs) 的可行方法.
  • 优化药物对前者比率对于实现BCSII类药物的增强溶解和长期物理稳定性至关重要.
  • 这种方法表明了开发可扩展和有效配方的潜力,用于难以溶解的药物.