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Children at play often make suspensions such as mixtures of mud and water, flour and water, or a suspension of solid pigments in water known as tempera paint. These suspensions are heterogeneous mixtures composed of relatively large particles that are visible to the naked eye or can be seen with a magnifying glass. They are cloudy, and the suspended particles settle out after mixing. On the other hand, a solution is a homogeneous mixture in which no settling occurs and in which the dissolved...

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Using Dry Dispersion Laser Diffraction to Assess Dispersibility in Spheronized Agglomerate Formulations.

Faustin Arevalo¹, Steven Tignor², Andrew Brunskill³

¹Merck & Co., Inc., Sterile and Specialty Products, Rahway, New Jersey, USA. faustin.arevalo@merck.com.

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|February 23, 2024

Summary

This summary is machine-generated.

Laser diffraction effectively predicts aerodynamic particle size distribution (APSD) in agglomerates, correlating well with impactor-sized mass and fine particle fraction. This method streamlines product development by saving time and labor compared to cascade impaction.

Keywords:

agglomerate strength cascade impaction dry powder inhaler (DPI)laser diffraction spheronized agglomerates

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Area of Science:

Pharmaceutical Sciences
Materials Science
Analytical Chemistry

Background:

Accurate particle size distribution (PSD) is crucial for drug delivery and formulation performance.
Cascade impaction is a standard but labor-intensive method for assessing aerodynamic particle size distribution (APSD).
Laser diffraction offers a potentially faster alternative for particle size analysis.

Purpose of the Study:

To evaluate dry dispersion laser diffraction as a surrogate for cascade impaction in characterizing agglomerate formulations.
To identify geometric particle size metrics from laser diffraction that correlate with APSD.
To assess the potential of laser diffraction to streamline product development.

Main Methods:

Dry dispersion laser diffraction was employed to measure particle size distribution (PSD) of eleven agglomerate batches.
Cascade impaction was used to determine the aerodynamic particle size distribution (APSD) for the same batches.
Semi-empirical analysis was performed to correlate PSD and APSD metrics.

Main Results:

A strong correlation was found between impactor-sized mass (%ISM) and cumulative PSD fraction <14.5 µm.
The fine particle fraction (FPF) showed a high correlation (R-squared = 0.974) with the cumulative PSD fraction <0.99 µm.
Mass median aerodynamic diameter (MMAD) did not correlate well with cumulative PSD fractions.

Conclusions:

Laser diffraction can serve as a viable surrogate for cascade impaction in assessing agglomerate dispersibility.
This approach offers significant savings in labor and turnaround time, facilitating efficient product development.
Geometric particle size metrics from laser diffraction can predict key APSD parameters relevant to inhalation products.