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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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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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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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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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Explaining the underlying causes of different tabletability classifications of binary mixtures.

Pradeep Valekar1, Ira S Buckner1

  • 1Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15282, USA.

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Summary

Predicting tabletability of binary mixtures is possible by modeling component properties. Understanding compressibility and compactibility differences explains mixture behaviors, enabling accurate tablet formulation predictions.

Keywords:
CompactibilityCompressibilityIdeal behaviorNegative deviationsPositive deviationsTabletability classificationTensile strength

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • A tabletability classification system exists for binary mixtures.
  • Previous studies applied the system but did not explain the causes of observed behaviors.

Purpose of the Study:

  • Investigate the reasons behind different tabletability behaviors in binary mixtures.
  • Identify component attributes influencing specific mixture behaviors.
  • Develop predictive models for mixture tabletability.

Main Methods:

  • Characterized binary mixtures of components with varied compressibility and compactibility.
  • Compared individual component properties with observed mixture behaviors.
  • Developed and validated models to predict tabletability based on component attributes.

Main Results:

  • Accurate models of component compressibility and compactibility can predict mixture tabletability.
  • Similar component tabletability profiles result in linear mixture behavior.
  • Differences in compactibility/tabletability cause negative deviations; differences in compressibility/compactibility cause positive deviations.

Conclusions:

  • Component properties (compressibility, compactibility) are key determinants of binary mixture tabletability.
  • Predictive modeling based on component characteristics enhances formulation development.
  • Understanding deviation causes aids in optimizing tablet manufacturing processes.