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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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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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Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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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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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

697
Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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Microscope-enabled disc dissolution system: Concordance between drug and polymer dissolution from an amorphous solid

Shuaiqian Men1, James E Polli1

  • 1Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.

Journal of Pharmaceutical Sciences
|October 25, 2024
PubMed
Summary

A new microscope-enabled disc dissolution system (MeDDiS) accurately predicts drug and polymer release from amorphous solid dispersions (ASD). Imaging of dissolving ASD discs correlated with measured release profiles, identifying critical drug load limits.

Keywords:
AmorphousDissolutionImagingMicroscopePVPVAReleaseRitonavir

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery Systems

Background:

  • Amorphous solid dispersions (ASD) are crucial for enhancing drug solubility.
  • Predicting the drug load dispersibility limit in ASDs is essential for formulation development.
  • Existing methods for assessing ASD performance often lack real-time visual feedback.

Purpose of the Study:

  • To develop a novel microscope-enabled disc dissolution system (MeDDiS) with a larger dissolution volume (900 mL).
  • To evaluate the concordance between imaging data from MeDDiS and traditional dissolution measurements.
  • To assess MeDDiS's ability to predict drug and polymer release profiles across varying drug loads in ASDs.

Main Methods:

  • Fabrication of ASD discs containing ritonavir and PVPVA at different drug loads (5-50%).
  • Utilizing a digital microscope integrated into a 1-liter dissolution vessel (MeDDiS) for real-time imaging.
  • Quantifying changes in disc diameter over time and measuring ritonavir and PVPVA release.

Main Results:

  • MeDDiS imaging demonstrated strong concordance with measured drug and polymer dissolution profiles.
  • A critical drug load 'cliff' was identified around 30% ritonavir load, below which release significantly decreased.
  • MeDDiS successfully predicted both high and low release profiles above and below this identified drug load limit.

Conclusions:

  • The developed MeDDiS provides a promising tool for real-time assessment of ASD dissolution behavior.
  • MeDDiS imaging can accurately predict drug and polymer release, aiding in the determination of optimal ASD drug loads.
  • This method offers valuable insights into ASD performance, particularly around critical formulation limits.