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Submission: On March 04 via api from US — Scanned from DE
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Droplet Size Analysis of Pharmaceutical Emulsions: Lab and In-Process Testing
Added:02/06/2024 17:11
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Emulsions are two phase systems composed of a dispersed phase (the droplets or
particles) and a continuous phase (liquid diluent such as water). The size of
the droplets in the dispersed phase is critically important. There are several
ways of measuring the size of emulsion droplets, including dynamic light
scattering (DLS), zeta potential, laser diffraction, and single particle optical
sizing (SPOS) in the laboratory. This talk will discuss their advantages and
disadvantages of each.
The only official test for testing emulsion droplet size is USP <729>. The talk
will review Methods I and II for measuring the mean size and tail of the droplet
distribution using dynamic light scattering or laser diffraction and single
particle optical sizing. This same approach can be applied to other emulsions
beyond lipids. An example of a CBD oil emulsion will demonstrate how the USP 729
method can be expanded beyond lipid emulsions.
While almost all emulsion droplet size analysis is currently performed in the
laboratory, online analysis by DLS is also an option. How to perform in-process
measurements and example results for several pharmaceutical emulsions will be
covered including Intralipid, Propofol, and Lipomed.
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ABOUT THIS ITEM
Emulsions are two phase systems composed of a dispersed phase (the droplets or
particles) and a continuous phase (liquid diluent such as water). The size of
the droplets in the dispersed phase is critically important. There are several
ways of measuring the size of emulsion droplets, including dynamic light
scattering (DLS), zeta potential, laser diffraction, and single particle optical
sizing (SPOS) in the laboratory. This talk will discuss their advantages and
disadvantages of each.
The only official test for testing emulsion droplet size is USP <729>. The talk
will review Methods I and II for measuring the mean size and tail of the droplet
distribution using dynamic light scattering or laser diffraction and single
particle optical sizing. This same approach can be applied to other emulsions
beyond lipids. An example of a CBD oil emulsion will demonstrate how the USP 729
method can be expanded beyond lipid emulsions.
While almost all emulsion droplet size analysis is currently performed in the
laboratory, online analysis by DLS is also an option. How to perform in-process
measurements and example results for several pharmaceutical emulsions will be
covered including Intralipid, Propofol, and Lipomed.
SPEAKER INFORMATION
Mark Bumiller
Mark is Technology Manager for the instrumentation group (formerly Particle
Sizing Systems) at Entegris, Inc. Mark has worked in the field of particle size
analysis for over thirty five years. He has served as a member of the expert
committee for USP 788, the executive committee of the International Fine
Particle Research Institute, and the executive committee of Particle Technology
Forum of the American Institute of Chemical Engineers. Mark is an active member
of ISO Technical Committee 24, SC4 helping to write standards for particle size
and zeta potential analysis.
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