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Related Concept Videos

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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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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...
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Related Experiment Video

Updated: Nov 29, 2025

Preparation and Characterization of Nanoliposomes for the Entrapment of Bioactive Hydrophilic Globular Proteins
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Characterization and stabilization in process development and product formulation for super large proteinaceous

Yanli Yang1, Zhiguo Su1, Guanghui Ma1

  • 1State Key Laboratory of Biochemical Engineering Institute of Process Engineering Chinese Academy of Sciences Beijing P. R. China.

Engineering in Life Sciences
|November 18, 2020
PubMed
Summary

Analytical techniques are crucial for understanding and stabilizing super large proteinaceous particles (SLPPs) like viruses and extracellular vesicles. This review details methods to ensure the quality, safety, and efficacy of SLPP-based therapeutics.

Keywords:
characterizationdenaturationrational designsuper large proteinaceous particles

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Area of Science:

  • Biotechnology
  • Biophysics
  • Analytical Chemistry

Background:

  • Super large proteinaceous particles (SLPPs), including viruses, virus-like particles, and extracellular vesicles, show significant promise in therapeutic applications like vaccination, gene therapy, and cancer treatment.
  • Challenges in manufacturing and application stem from the inherent instability and complex structure/composition of these bio-particles.
  • A thorough understanding of SLPP characteristics is essential for rational process design and formulation development.

Purpose of the Study:

  • To review and highlight analytical techniques for the characterization and stabilization of SLPPs.
  • To provide insights into mechanisms of SLPP denaturation and strategies for preserving biological function.
  • To guide process development and product formulation for high-quality SLPP-based products.

Main Methods:

  • High-performance size exclusion chromatography (HPSEC)
  • Multi-angle laser light scattering (MALLS)
  • Asymmetrical flow field-flow fractionation (AF4)
  • Nanoparticle tracking analysis (NTA)
  • Capillary Zone Electrophoresis (CZE)
  • Differential scanning calorimetry (DSC)
  • Differential scanning fluorescence (DSF)
  • Isothermal titration calorimetry (ITC)
  • Dual polarization interferometry (DPI)

Main Results:

  • These advanced analytical techniques offer deep insights into SLPP denaturation mechanisms.
  • They aid in identifying solutions to prevent deactivation or denaturation, thereby preserving biological functions.
  • The application of these methods supports the development of stable and effective SLPP formulations.

Conclusions:

  • Combining various physicochemical techniques with in vitro/in vivo biological activity analyses is the future trend for SLPP development.
  • This integrated approach is crucial for guaranteeing the high quality, safety, and efficacy of SLPPs.
  • Effective characterization and stabilization are key to unlocking the full therapeutic potential of SLPPs.