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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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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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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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Recrystallization is a purification technique used to separate impurities from solid compounds. In this technique, no chemical reactions occur. Instead, it exploits physical properties only, specifically, the solubility differences between the desired compound and impurities, either at a single temperature or at different temperatures, and under other selected conditions. The solid-solution equilibrium (solubility equilibrium) of each component in the solution represents a binary phase...
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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Enhanced Dissolution of Naproxen by Combining Cocrystallization and Eutectic Formation.

Hakyeong Kim1, Soeun Jang1, Il Won Kim1

  • 1Department of Chemical Engineering, Soongsil University, Seoul 06978, Korea.

Pharmaceutics
|April 30, 2021
PubMed
Summary

Combining cocrystallization with eutectic formation significantly enhances drug dissolution rates for sparingly soluble active pharmaceutical ingredients (APIs). This dual strategy improves early drug release in biorelevant media, maximizing API utility in drug development.

Keywords:
active pharmaceutical ingredientcocrystaldissolutioneutecticnaproxen

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Drug Delivery

Background:

  • Improving dissolution of sparingly soluble active pharmaceutical ingredients (APIs) is crucial for drug development.
  • Cocrystal formation is a known method to modify API physicochemical properties.
  • Dissolution behavior of cocrystals in biorelevant media requires further investigation.

Purpose of the Study:

  • To investigate the combined strategy of cocrystallization and eutectic formation for enhancing drug dissolution.
  • To evaluate the dissolution behavior of naproxen cocrystals and eutectics in biorelevant media.
  • To compare the dissolution rates of melt-crystallized eutectics and cocrystals against neat naproxen.

Main Methods:

  • Construction of binary melting diagrams to identify eutectic compositions.
  • Utilizing a model system of naproxen and three pyridinecarboxamide isomers.
  • Comparative dissolution testing of eutectics, cocrystals, and neat naproxen in simulated biorelevant media.

Main Results:

  • Eutectics demonstrated enhanced early dissolution rates for cocrystals.
  • This enhancement was observed both with and without bile salt and phospholipid components.
  • Cocrystal dissolution was expedited in the absence and delayed in the presence of these components.

Conclusions:

  • The combined strategy of cocrystallization and eutectic formation offers significant advantages for improving drug dissolution.
  • This approach is beneficial for maximizing the pharmaceutical utility of cocrystals, especially for poorly soluble APIs.
  • The findings support the application of this combined strategy in advanced drug formulation development.