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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 Quantification of Injectability by Mechanical Testing
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The Quantification of Injectability by Mechanical Testing.

Thomas E Robinson1, Erik A B Hughes2, Neil M Eisenstein2

  • 1School of Chemical Engineering, University of Birmingham; TER281@bham.ac.uk.

Journal of Visualized Experiments : Jove
|June 2, 2020
PubMed
Summary
This summary is machine-generated.

This study presents a mechanical testing method to objectively measure the injectability of viscous biomaterials for drug and cell delivery. The protocol quantifies force to ensure formulation and delivery system compatibility.

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Area of Science:

  • Biomaterials Science
  • Drug Delivery
  • Mechanical Engineering

Background:

  • Injectable biomaterials are crucial for minimally invasive drug and cell delivery.
  • Their high viscosity and semi-solid nature challenge traditional injectability assessments.
  • Objective characterization of injectability is needed for reliable formulation and delivery.

Purpose of the Study:

  • To describe a standardized protocol for objectively assessing the injectability of injectable biomaterials.
  • To provide a method for comparing different biomaterial formulations and delivery systems.
  • To enable early-stage decision-making in the translational process for biomaterials.

Main Methods:

  • Utilizes a standard mechanical tester to compress syringe plungers at a controlled rate.
  • Measures the force exerted during injection.
  • Applies the protocol to various materials, syringes, and needle geometries.

Main Results:

  • Establishes a quantifiable force value (maximum or plateau) for assessing injectability.
  • Allows for direct comparison between different samples and against absolute force limits.
  • Demonstrates applicability across diverse materials and delivery configurations.

Conclusions:

  • The described mechanical testing protocol offers a faster, more direct, and reproducible method for evaluating biomaterial injectability compared to rotational rheology.
  • Results aid in optimizing formulations, selecting appropriate syringe and needle sizes, and understanding injection-induced material changes.
  • This objective assessment is vital for advancing the development and clinical translation of injectable biomaterials.