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Related Concept Videos

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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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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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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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...
373
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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...
820
Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

2.0K
Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

544
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...
544

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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Introducing diffusing wave spectroscopy as a process analytical tool for pharmaceutical emulsion manufacturing.

Mathias Reufer1, Alexandra H E Machado2, Andreas Niederquell2

  • 1University of Applied Sciences and Arts Northwestern Switzerland, Institute of Pharma Technology, Muttenz CH-4132 Switzerland; LS Instruments, Fribourg CH-1700, Switzerland.

Journal of Pharmaceutical Sciences
|October 11, 2014
PubMed
Summary
This summary is machine-generated.

Diffusing wave spectroscopy (DWS) monitors pharmaceutical emulsion manufacturing. This light scattering technique tracks droplet size and dynamics, correlating well with quality attributes for process optimization.

Keywords:
diffusing wave spectroscopy (DWS)emulsionsgellight scatteringmanufacturingmicrorheologyphysical characterizationpolymerprocess analytical technology (PAT)

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Area of Science:

  • Materials Science
  • Chemical Engineering
  • Biophysics

Background:

  • Emulsions are vital in pharmaceuticals, food, and cosmetics, requiring precise manufacturing control.
  • Monitoring emulsion quality during production is crucial but challenging due to a lack of suitable analytical tools.

Purpose of the Study:

  • To evaluate diffusing wave spectroscopy (DWS) as an at-line process analytical technology for pharmaceutical emulsion manufacturing.
  • To correlate DWS measurements with traditional methods like rheology and microscopy.

Main Methods:

  • Utilized diffusing wave spectroscopy (DWS) to analyze a model oil-in-water emulsion.
  • Complemented DWS with mechanical rheology, microscopy, and stability testing.
  • Measured microrheology and static properties (transport mean free path).

Main Results:

  • DWS microrheology results aligned well with bulk rheology measurements.
  • Intensity correlation functions provided insights into emulsion dynamics during homogenization.
  • Static DWS measurements correlated strongly with changes in droplet size distribution.

Conclusions:

  • Diffusing wave spectroscopy (DWS) shows significant promise as a process analytical technology for pharmaceutical emulsion development and manufacturing.
  • DWS offers valuable insights into emulsion dynamics and droplet size evolution.
  • This technique can aid in ensuring critical quality attributes are met during production.