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Related Concept Videos

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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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).
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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Recent Techniques to Improve Amorphous Dispersion Performance with Quality Design, Physicochemical Monitoring,

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Summary
This summary is machine-generated.

Amorphous solid dispersions (ASDs) enhance drug solubility. Advanced computational tools and manufacturing techniques improve ASD stability and predict drug-polymer interactions, accelerating pharmaceutical development.

Keywords:
amorphous solid dispersiondrug releasedrug–polymer interactionmachine learningsimulationstabilitythermodynamics

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Physical Chemistry

Background:

  • Poorly water-soluble drugs present significant bioavailability challenges in pharmaceutical development.
  • Amorphous solid dispersions (ASDs) offer a promising formulation strategy to overcome these solubility limitations.

Purpose of the Study:

  • To provide a comprehensive review of the physicochemical principles governing ASD stability.
  • To discuss manufacturing techniques, advanced design approaches, and characterization methods for ASDs.
  • To highlight challenges and future directions in ASD formulation development.

Main Methods:

  • Review of literature on ASD physicochemical principles, manufacturing techniques (hot-melt extrusion, spray drying, KinetiSol®), and advanced characterization (solid-state NMR, IR, dielectric spectroscopy).
  • Analysis of computational approaches including molecular modeling, in silico prediction, machine learning (ML), and artificial intelligence (AI).
  • Discussion of integrated formulation design frameworks like physiologically based pharmacokinetic (PBPK) modeling and accelerated stability testing.

Main Results:

  • Physicochemical principles like drug-polymer miscibility, molecular mobility, and thermodynamics are crucial for ASD stability.
  • Manufacturing methods significantly impact formulation homogeneity and scalability.
  • ML/AI platforms enable accurate prediction of drug-polymer interactions and physical stability, reducing trial-and-error.
  • Advanced characterization provides insights into phase separation and recrystallization dynamics.

Conclusions:

  • Ensuring long-term ASD stability and maintaining supersaturation remain key challenges.
  • Integrated formulation design and computational advancements are vital for refining ASD strategies.
  • Interdisciplinary collaboration and data-driven approaches are essential for accelerating clinical translation and unlocking the therapeutic potential of ASDs.