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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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In Vitro Drug Dissolution: Compendial Testing Models II01:09

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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The Fluid Mosaic Model01:34

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The fluid mosaic model was first proposed as a visual representation of research observations. The model comprises the composition and dynamics of membranes and serves as a foundation for future membrane-related studies. The model depicts the structure of the plasma membrane with a variety of components, which include phospholipids, proteins, and carbohydrates. These integral molecules are loosely bound, defining the cell’s border and providing fluidity for optimal function.
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Theories of Dissolution: Diffusion Layer Model01:15

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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.
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Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model01:09

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Various dissolution theories provide insight into the factors that influence the dissolution rate. Danckwerts' Model suggests that turbulence, rather than a stagnant layer, characterizes the dissolution medium at the solid-liquid interface. In this model, the agitated solvent contains macroscopic packets that move to the interface via eddy currents, facilitating the absorption and delivery of the drug to the bulk solution. The regular replenishment of solvent packets maintains the...
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In vitro Digestion of Emulsions in a Single Droplet via Multi Subphase Exchange of Simulated Gastrointestinal Fluids
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Developing a predictive in vitro dissolution model based on gastrointestinal fluid characterisation in rats.

Juliane Fjelrad Christfort1, Sophie Strindberg2, Jakob Plum3

  • 1Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, DK-2100 Copenhagen, Denmark; Department of Health Technology, Technical University of Denmark, DK-2800 Lyngby, Denmark.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|July 10, 2019
PubMed
Summary
This summary is machine-generated.

This study developed a new in vitro dissolution model simulating rat gastrointestinal fluids. This biorelevant model improves prediction of drug performance in vivo, advancing preclinical drug development.

Keywords:
Biorelevant mediaGastrointestinal fluidsIn vitro in vivo correlationRats

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Area of Science:

  • Pharmacokinetics
  • Drug Discovery
  • Preclinical Research

Background:

  • Physiological factors affecting drug solubility vary across species.
  • Existing in vitro models struggle to accurately predict in vivo drug behavior in rats due to species-specific gastrointestinal (GI) fluid differences.
  • Accurate in vitro-in vivo correlation is crucial for efficient drug development.

Purpose of the Study:

  • To develop a physiologically relevant in vitro dissolution model that simulates the gastrointestinal fluids of fasted rats.
  • To compare the predictive performance of this new model against existing in vitro and in vivo data.
  • To enhance the accuracy of preclinical drug absorption and solubility studies.

Main Methods:

  • In situ measurement of pH, osmolality, bile acid, and phospholipid concentrations in six segments of the rat GI tract.
  • Collection and characterization of rat stomach and small intestine fluids.
  • Matrix-assisted laser desorption ionization mass spectrometry imaging to identify bile acids and phospholipids.
  • Development of biorelevant media simulating rat gastric and proximal small intestinal fluids.
  • Implementation in a two-step in vitro dissolution model.

Main Results:

  • pH and osmolality increase along the rat GI tract.
  • High concentrations of bile acids and phospholipids found in the proximal small intestine, with increased bile acids and decreased phospholipids distally.
  • Specific bile acids (cholic, taurocholic, glycocholic acid) and phospholipid classes (phosphatidylcholine, lysophosphatidylcholine) identified.
  • The developed biorelevant media and two-step model showed improved prediction of furosemide in vivo performance.

Conclusions:

  • A novel biorelevant in vitro dissolution model for fasted rats was successfully developed.
  • The model accurately simulates key physiological parameters of the rat gastrointestinal tract.
  • This advanced in vitro model offers superior prediction of in vivo drug performance compared to previous methods.