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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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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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Factors Influencing Drug Absorption: Drug Dissolution01:27

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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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

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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: Alternative Methods01:17

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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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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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Is equilibrium slurry pH a good surrogate for solid surface pH during drug dissolution?

Taiga Uekusa1, Alex Avdeef2, Kiyohiko Sugano1

  • 1Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|October 12, 2021
PubMed
Summary

Equilibrium slurry pH (pHeq) can accurately predict solid surface pH (pH0) during drug dissolution for small molecules in concentrated buffers, provided no precipitation occurs. This finding simplifies dissolution modeling.

Keywords:
Computer simulationEquilibrium slurry pHOral drug absorptionSolid surface pH

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Area of Science:

  • Pharmaceutical Sciences
  • Physical Chemistry
  • Chemical Engineering

Background:

  • Accurate measurement of solid surface pH (pH0) during drug dissolution is crucial for understanding drug behavior.
  • Equilibrium slurry pH (pHeq) is a commonly used surrogate, but its validity requires rigorous investigation.
  • Existing methods lack a comprehensive framework for evaluating the pH0 ≈ pHeq approximation.

Purpose of the Study:

  • To investigate the suitability of equilibrium slurry pH (pHeq) as a surrogate for solid surface pH (pH0) during drug dissolution.
  • To develop and validate a comprehensive calculation scheme for both pHeq and pH0.
  • To determine the conditions under which the pH0 ≈ pHeq approximation is accurate.

Main Methods:

  • Formalized a calculation scheme for pHeq and pH0 based on charge neutrality principles (equilibrium charge neutrality and charge flux neutrality).
  • Investigated the validity of the pH0 ≈ pHeq approximation using the developed scheme.
  • Assessed the impact of molecular properties (e.g., molecular weight) and buffer characteristics (e.g., buffer capacity) on the approximation.

Main Results:

  • The approximation pH0 ≈ pHeq is accurate for small molecules (approx. MW = 150) in high concentration buffer media (approx. buffer capacity = 30 mM/ΔpH).
  • The approximation holds true if no precipitation of the drug's free or salt form occurs during slurry pH measurement and at the dissolving drug surface.
  • The calculation scheme is applicable to both free and salt forms of drugs in unbuffered and buffered media, including bicarbonate buffers.

Conclusions:

  • Equilibrium slurry pH (pHeq) can serve as a reliable surrogate for solid surface pH (pH0) under specific conditions, simplifying dissolution studies.
  • The developed calculation scheme provides a robust framework for assessing the validity of the pH0 ≈ pHeq approximation.
  • The low computational expense of the scheme makes it suitable for integration into various computer simulations, including biopharmaceutics modeling and simulation.