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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

404
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...
404

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Preparation and evaluation of stable amorphous flurbiprofen complexes using two different cyclodextrins.

Hiroto Ito1, Fumitoshi Hirayama2, Daisuke Iohara3

  • 1Graduate School of Pharmaceutical Sciences, Sojo University, 4-22-1 Ikeda, Nishi-ku, Kumamoto 860-0082, Japan.

Journal of Pharmaceutical Sciences
|July 27, 2025
PubMed
Summary

This study developed stable amorphous inclusion complexes using flurbiprofen (FP) and cyclodextrins (CDs). The addition of gamma-cyclodextrin (γ-CD) significantly improved drug stability and enhanced oral absorption, offering a promising approach for poorly soluble drugs.

Keywords:
AmorphousComplexationCyclodextrinOral absorptionPhysical stabilityPowder technology

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery Systems

Background:

  • Poorly water-soluble drugs often exhibit low oral bioavailability.
  • Amorphous solid dispersions are a strategy to enhance drug solubility and absorption.
  • Cyclodextrins (CDs) are widely used to form inclusion complexes with drugs.

Purpose of the Study:

  • To develop stable amorphous inclusion complexes of flurbiprofen (FP) with cyclodextrins (CDs).
  • To investigate the stabilizing effect of different cyclodextrins, particularly gamma-cyclodextrin (γ-CD), on amorphous drug-CD systems.
  • To evaluate the impact of these complexes on drug dissolution and in vivo oral absorption.

Main Methods:

  • Co-grinding of crystalline flurbiprofen/beta-cyclodextrin (β-CD) complexes with alpha-cyclodextrin (α-CD) or gamma-cyclodextrin (γ-CD) to form ternary amorphous systems.
  • Assessment of physical stability under accelerated humid conditions.
  • In vitro dissolution studies to evaluate supersaturation.
  • In vivo pharmacokinetic studies in rats to determine oral absorption parameters (Cmax, AUC).

Main Results:

  • The ternary amorphous FP/β-CD/γ-CD system demonstrated superior physical stability compared to binary amorphous FP/β-CD.
  • A small molar ratio of γ-CD (1:0.1) was sufficient to inhibit crystallization of the FP/β-CD complex.
  • The FP/β-CD/γ-CD complex maintained a supersaturated state longer in vitro.
  • In vivo studies showed a significant enhancement in FP oral absorption (2.4-fold Cmax, 2.1-fold AUC) with the ternary complex.

Conclusions:

  • Gamma-cyclodextrin (γ-CD) is an effective stabilizer for amorphous cyclodextrin-based drug complexes.
  • Combining two different cyclodextrins can enhance both physical stability and oral bioavailability of poorly water-soluble drugs.
  • Ternary amorphous systems offer a promising strategy for improving drug delivery.