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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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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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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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The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
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Mechanical Properties and Tableting Behavior of Amorphous Solid Dispersions.

Sarsvat Patel1, Xiang Kou1, Hao Helen Hou2

  • 1Pharmaceutical Materials Science & Engineering Laboratory, Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota 55455.

Journal of Pharmaceutical Sciences
|October 23, 2016
PubMed
Summary

Amorphous solid dispersions (ASDs) of acetaminophen and copovidone show mechanical properties are key to tablet quality. Moisture content significantly impacts hardness and glass transition temperature, affecting drug formulation performance.

Keywords:
amorphouscompactiondispersionglass transitionhardnessmechanical propertiesphysical characterizationsolid statetablet

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Area of Science:

  • Materials Science
  • Pharmaceutical Technology
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) are crucial for improving the solubility and bioavailability of poorly soluble drugs.
  • Acetaminophen (APAP) is a widely used analgesic, and its formulation into ASDs with copovidone is a common strategy.

Purpose of the Study:

  • To investigate the impact of drug loading and moisture content on the mechanical and thermal properties of acetaminophen-copovidone ASDs.
  • To understand how these properties influence the tableting behavior and final tablet quality.

Main Methods:

  • Preparation of ASDs using film casting with varying acetaminophen (APAP) loading.
  • Characterization via differential scanning calorimetry (DSC) and nanoindentation.
  • Assessment of tableting behavior and tablet quality.

Main Results:

  • Glass transition temperature (Tg) decreased with increasing APAP content.
  • ASDs hardness initially increased at low APAP loading then decreased at high APAP loading.
  • Moisture content reduced both hardness and Tg, lowering the softening transition threshold at higher relative humidity.

Conclusions:

  • Mechanical properties, specifically hardness, are more indicative of plasticization/antiplasticization effects in ASDs than thermal properties.
  • Understanding moisture effects is critical for controlling tablet quality and formulation performance.