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Related Concept Videos

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: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

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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 Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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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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Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH01:21

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Drug absorption within the gastrointestinal (GI) tract is a complex process influenced by several critical factors, including the site pH, the drug's dissociation constant (pKa), and the drug's lipophilicity. The GI tract exhibits a pH gradient, with an acidic environment in the stomach and a more alkaline environment in the small intestine. This pH variation directly affects the ionization state of drugs.
A drug's pKa and the pH of the gastrointestinal (GI) tract play crucial roles...
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Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

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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: Physicochemical Parameters01:22

Factors Influencing Drug Absorption: Physicochemical Parameters

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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.
Enhanced drug absorption can be achieved by reducing particle sizes and increasing surface areas, thereby facilitating...
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Drug Dissolution in Oral Drug Absorption: Workshop Report.

Kimberly Raines1, Payal Agarwal1, Patrick Augustijns2

  • 1Food and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.

The AAPS Journal
|November 7, 2023
PubMed
Summary
This summary is machine-generated.

This workshop explored challenges in drug dissolution for oral absorption, focusing on amorphous solid dispersions and in vitro methods. Key discussions involved defining "dissolved drug" and advancing non-compendial testing for better biopharmaceutical predictions.

Keywords:
absorptionamorphousdissolutionfoodpermeabilitysolubility

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Area of Science:

  • Pharmaceutical Sciences
  • Biopharmaceutics
  • Drug Delivery

Background:

  • The workshop
  • Drug Dissolution in Oral Drug Absorption
  • convened experts to discuss critical aspects of drug dissolution and its impact on oral drug absorption.
  • Key themes included amorphous solid dispersions (ASDs), the interplay between dissolution and permeation, and the development of in vitro methods for predicting in vivo performance.

Purpose of the Study:

  • To identify and discuss current challenges and emerging trends in drug dissolution science relevant to oral drug absorption.
  • To explore advancements in in vitro methodologies for assessing drug performance and predicting in vivo outcomes.
  • To address regulatory considerations and potential obstacles for novel dissolution testing approaches.

Main Methods:

  • The workshop featured lectures and breakout sessions, facilitating in-depth discussions on specific topics.
  • Key areas of focus included the characterization of dissolved drug in complex media, limitations of standard dissolution tests, and the application of non-compendial methods.
  • Discussions also covered specialized conditions and the potential benefits of biopredictive methods.

Main Results:

  • Recurring topics highlighted the complexity of defining and measuring "dissolved drug," especially for poorly soluble drugs in colloidal systems.
  • Limitations of traditional sink conditions in dissolution testing were identified, prompting exploration of non-compendial methods and conditions.
  • The potential utility of biopredictive dissolution methods for regulatory purposes, such as biowaivers, was recognized.

Conclusions:

  • Accurate assessment of dissolved drug, particularly for poorly soluble compounds in challenging media, remains a critical area for development.
  • Non-compendial dissolution methods and conditions offer promise for improved biopharmaceutical predictions but face regulatory acceptance hurdles.
  • A balanced approach, potentially integrating quality control and biopredictive methods, may be necessary for comprehensive drug product evaluation.