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Bioavailability Enhancement: Drug Stability Enhancement and GI Retention01:05

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

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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...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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).
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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,...
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Updated: Jan 7, 2026

Combinatorial Synthesis of and High-throughput Protein Release from Polymer Film and Nanoparticle Libraries
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聚合物作为喷雾干燥蛋白质配方的稳定辅料.

Chanakya D Patil1, Yijing Huang1, Kinnari Santosh Arte1

  • 1Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN, 47907, USA.

Pharmaceutical research
|December 22, 2025
PubMed
概括

新的聚合物辅助剂 (2-基) -β-环氧 (HPβCD) 和水解凝增强了喷雾干燥牛血清白蛋白 (BSA) 的稳定性. 这些替代品比生物药物产品的传统糖稳定剂更有希望.

关键词:
聚合方式 聚合方式 聚合方式一个聚合物聚合物.蛋白质配方是一种蛋白质配方.复制 复制 复制喷雾干燥 喷雾干燥

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科学领域:

  • 制药科学 制药科学
  • 生物技术是生物技术.
  • 材料科学 材料科学 材料科学

背景情况:

  • 生物制药产品在储存期间需要稳定,通常通过干燥技术实现.
  • 喷雾干燥是一种高通量替代冷干燥的方法,可提高药物产品的稳定性.
  • 稳定辅助剂对于保护敏感蛋白质在加工和储存期间免受降解至关重要.

研究的目的:

  • 评估基于多糖和蛋白质酸盐的聚合物辅料作为替代传统稳定剂如三和曼尼托尔的替代品.
  • 评估 (2-hydroxypropyl) -β-cyclodextrin (HPβCD) 和水解凝对喷雾干燥牛血清白蛋白 (BSA) 的稳定潜力.
  • 为了比较新型辅助剂与传统的糖稳定剂在喷雾干燥和储存期间保护蛋白质的疗效.

主要方法:

  • 使用HPβCD,水解凝,20kDa的德克斯或碳糖甲基纤维素 (NaCMC) 制备喷雾干燥的BSA配方,含有或不含有三醇或曼尼托尔.
  • 通过监测在压力储存条件下 (40°C3个月) 的单体损失来评估蛋白质稳定性.
  • 分析结晶性 (PXRD),二次结构变化 (ssFTIR),粒子特征和复制时间.

主要成果:

  • 与单独的三糖或曼尼托尔相比,含有HPβCD或水解凝的配方表明BSA单体损失明显较低.
  • 德克斯特兰20 kDa和NaCMC配方表现出蛋白质稳定性较差.
  • 粉末X射线衍射揭示了盐结晶,固态里埃变换红外光谱学表明了随着时间的推移BSA的二次结构变化.

结论:

  • HPβCD和水解凝有效地提高了喷雾干燥的BSA的物理稳定性.
  • 这些聚合物辅料显示出与传统的基于糖的稳定剂相比,作为优质稳定剂添加剂的潜力.
  • 这些发现支持使用HPβCD和水解凝来增强蛋白质制药的稳定性.