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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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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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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.
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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.
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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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In vitro experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
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Challenges in Permeability Assessment for Oral Drug Product Development.

Mirko Koziolek1, Patrick Augustijns2, Constantin Berger3

  • 1NCE Drug Product Development, Development Sciences, AbbVie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany.

Pharmaceutics
|October 28, 2023
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Summary

Understanding drug permeation is crucial for oral drug delivery. This review covers methods to assess drug permeability in the human gut, aiding drug development.

Keywords:
drug absorptionin silicoin vitroin vivooral drug deliverypermeability

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Area of Science:

  • Pharmacology
  • Drug Delivery
  • Gastroenterology

Background:

  • Intestinal drug permeation is essential for oral drug delivery success.
  • Increasing interest in oral peptides and poorly permeable drugs highlights the importance of permeability.
  • Permeability is a critical parameter in oral drug product development.

Purpose of the Study:

  • To review methodologies for determining drug permeability in the human gastrointestinal tract.
  • To identify the application of these methods across different drug development stages.
  • To focus on novel techniques and their impact on drug development.

Main Methods:

  • In silico (computational) approaches.
  • In vitro models (e.g., cell cultures, gut-on-chip).
  • In vivo studies (animal and human models).

Main Results:

  • Discussion of advantages, limitations, and applications of various permeability assessment methods.
  • Highlighting advancements in computational, gut-on-chip, and human tissue-based models.
  • Addressing the impact of permeability on pharmacokinetic predictions and excipient effects.

Conclusions:

  • A comprehensive overview of drug permeability assessment methods is provided.
  • Novel techniques offer improved prediction and understanding of intestinal drug permeation.
  • Accurate permeability data is vital for successful oral drug product development.