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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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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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The flow table test is an established method used to assess the workability of concrete, particularly useful for evaluating highly flowable concrete mixes. This test employs an apparatus that consists of a wooden board topped with a steel plate, collectively weighing 35 pounds. The board is connected to a base via a hinge and measures 27.6 inches on each side.
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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Drug Dissolution: Requirements and Profile Comparison01:14

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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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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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Identifying Robust Parameters for Flowability Analysis of Pharmaceutical Powders Using the Shear Cell Method.

Tamaki Miyazaki1, Tatsuo Koide1, Ken-Ichi Izutsu2

  • 1Division of Drugs, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki 210-9501, Japan.

Chemical & Pharmaceutical Bulletin
|October 8, 2025
PubMed
Summary
This summary is machine-generated.

Powder flowability is crucial for pharmaceuticals. A new intrinsic parameter, the critical state line slope (ϕCSL), reliably predicts powder flowability across different conditions, aiding quality control and formulation design.

Keywords:
active pharmaceutical ingredientconstant-volume shear cell methodcritical state line angleflow functionflowability parameterparticle morphology

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Powder flowability is essential for pharmaceutical manufacturing, impacting robustness and content uniformity.
  • Shear cell measurements provide parameters for predicting powder behavior but often depend on consolidation conditions.
  • A need exists for an intrinsic flowability parameter independent of external factors for better quality control and formulation.

Purpose of the Study:

  • To investigate the relationship between shear cell parameters and consolidation conditions for pharmaceutical powders.
  • To identify a robust, intrinsic parameter that accurately reflects powder flowability.
  • To assess the influence of particle size and shape on powder flowability parameters.

Main Methods:

  • Performed constant-volume shear cell measurements on pharmaceutical powders with varying particle sizes and shapes.
  • Analyzed the relationship between shear cell parameters and different consolidation conditions (indentation load).
  • Identified and evaluated the critical state line slope (ϕCSL) as a potential intrinsic flowability parameter.

Main Results:

  • Preshear points aligned on a single straight line through the origin for a given powder substance, irrespective of indentation load, particle size, or shape.
  • The critical state line slope (ϕCSL) demonstrated robustness and insensitivity to particle size and shape variations.
  • Deviations in ϕCSL for fine powders (<10 µm) suggest the influence of interparticle cohesive forces.

Conclusions:

  • The critical state line slope (ϕCSL) can serve as a reliable intrinsic flowability parameter for pharmaceutical powders.
  • ϕCSL offers a robust measure for quality control of raw materials and efficient formulation design.
  • Interparticle cohesive forces become significant for fine powders (<10 µm), affecting their flowability characteristics.