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Related Concept Videos

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

Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model

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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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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 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 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 pKa, Lipophilicity and GI pH01:21

Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH

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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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An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules
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Statistical approaches to evaluate in vitro dissolution data against proposed dissolution specifications.

Fasheng Li1, Beverly Nickerson2, Les Van Alstine1

  • 1Pharmaceutical Sciences Statistics, Pfizer Research and Development, Groton, Connecticut, USA.

Pharmaceutical Statistics
|March 18, 2024
PubMed
Summary

Setting dissolution specifications for pharmaceutical products is crucial for regulatory approval. This paper outlines the statistical methods and scientific judgments involved in establishing these critical quality measures for drug release and stability.

Keywords:
bootstrappingcompendial criteriain vitro dissolutionprobabilityspecificationvisualization

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Product Quality

Background:

  • In vitro dissolution testing is a mandatory quality attribute for solid oral dosage forms.
  • Meeting compendial standards for dissolution is essential for regulatory submission and marketing approval.
  • Variability exists in statistical approaches for dissolution data analysis and specification setting.

Purpose of the Study:

  • To provide a general overview of the process for evaluating and establishing in vitro dissolution specifications.
  • To describe the steps involved in setting dissolution acceptance criteria for product release.
  • To outline the methodology for setting dissolution specifications for stability studies.

Main Methods:

  • Review of statistical approaches for analyzing dissolution data.
  • Description of methods for setting acceptance criteria based on product requirements and scientific judgment.
  • Explanation of procedures for visualizing dissolution results.

Main Results:

  • Outlined a systematic approach to evaluating and setting dissolution specifications.
  • Highlighted the importance of statistical analysis in defining release and stability criteria.
  • Emphasized the role of scientific judgment in adapting methods to specific product needs.

Conclusions:

  • Establishing robust in vitro dissolution specifications is critical for pharmaceutical product approval.
  • A combination of statistical methods, scientific judgment, and product-specific considerations is necessary.
  • Consistent evaluation and setting of specifications ensure product quality throughout its shelf life.