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Related Concept Videos

Measurement of Bioavailability: Pharmacodynamic Methods01:20

Measurement of Bioavailability: Pharmacodynamic Methods

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Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
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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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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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Measurement of Bioavailability: Pharmacokinetic Methods01:30

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Pharmacokinetics is a vital branch of pharmacology that examines how drugs are absorbed, distributed, metabolized, and excreted by the body. Two key methodologies in pharmacokinetics are plasma drug concentration studies and urinary drug excretion analyses, both of which provide critical insights into a drug's therapeutic efficacy and bioavailability.Plasma Drug Concentration-Time StudiesPlasma drug concentration-time studies involve analyzing blood samples at specific intervals to quantify...
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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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Measuring biotherapeutic viscosity and degradation on-chip with particle diffusometry.

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  • 1School of Mechanical Engineering and Birck Nanotechnology Center, Purdue University, West Lafayette, 47907, USA.

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Summary

Particle diffusometry (PD) offers a novel, accessible method to assess biotherapeutic stability by measuring solution viscosity. This technique can detect drug degradation, ensuring pharmaceutical quality across the supply chain.

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Area of Science:

  • Biotechnology
  • Pharmaceutical Science
  • Analytical Chemistry

Background:

  • Drug degradation due to improper storage conditions, especially for temperature-sensitive biotherapeutics, leads to significant economic losses.
  • Current high-throughput, low-volume stability testing platforms are limited to R&D, hindering quality control and clinical applications.
  • Microanalysis platforms offer potential for efficient biotherapeutic characterization in diverse settings.

Purpose of the Study:

  • To introduce particle diffusometry (PD) as a new technique for analyzing biotherapeutic degradation.
  • To demonstrate PD's capability in assessing solution viscosity for stability determination.
  • To validate PD's applicability for critical biotherapeutics like insulin and monoclonal antibodies.

Main Methods:

  • Particle diffusometry (PD) utilizes a microfluidic chip and microscope setup.
  • PD calculates Brownian motion of particles in quiescent solutions, adapting particle image velocimetry (PIV) principles.
  • Viscosity measurements are performed on protein solutions to assess degradation and concentration effects.

Main Results:

  • PD successfully measures solution viscosity, distinguishing native proteins from degraded samples.
  • The technique accurately determines viscosity changes relative to biotherapeutic concentration.
  • PD analysis was applied to insulin and monoclonal antibody solutions, demonstrating its practical utility.

Conclusions:

  • Particle diffusometry provides a novel, user-friendly tool for biotherapeutic stability analysis.
  • Its simple setup allows for implementation in production, quality control, distribution, and clinical settings.
  • PD enhances the ability to ensure the quality and efficacy of biopharmaceuticals throughout their lifecycle.