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Development of an Automated Digital Spray Pattern Measurement System

Conference Paper · January 2002

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Cindy Weinstein
Merck & Co.
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Respiratory Drug Delivery VIII, 2002 – Weinstein et al.

DEVELOPMENT OF AN AUTOMATED
DIGITAL SPRAY PATTERN
MEASUREMENT SYSTEM
Cindy L. J. Weinstein, David Christopher, Barbara Hudson, Grace Kwok,
Patience Ajongwen, and Navdeep Boparai

Pharmaceutical Development & Statistics Department,

Schering-Plough Research Institute (SPRI), Kenilworth, NJ, USA

Spray pattern testing used to characterize the performance of components in spray delivery
devices has been a manual, labor intensive process requiring highly skilled technicians for
over two decades. In the traditional TLC plate method for aerosol metered dose inhaler
drug products, the silica gel is illuminated under UV light causing the spray pattern to be
darker than the background. The difference in intensities between the background and spray
pattern (i.e., contrast) determines the ease with which the spray pattern can be measured.
The current SPRI technique employs Polaroid photography to capture spray pattern images
on TLC plates that are manually generated as a composite of five sprays at a one-inch (.
cm) target distance. This combination of test parameters generates spray patterns that are
of high contrast and have borders that are generally distinct, allowing trained operators to
reproducibly define the spray pattern boundary using circular templates of known diameter.
The spray pattern’s ratio and longest diameter are used to characterize the size and shape
of the pattern.

1 inch 1.5 inches

Figure 1 Spray pattern Polaroid photographs of a representative aerosol drug product generated manually
with a single actuation at 1 (2.5 cm) and 1.5 inches (3.8 cm) from the TLC plate. ese low contrast
images illustrate the limitations of using the traditional manual Polaroid spray pattern technology.

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582 Development of an Automated Digital Spray Pattern Measurement System – Weinstein et al.

A digital automated spray pattern measurement system (ASPMS) was developed for
spray pattern generation and analysis to provide objective data in an organized electronic format.
In order to discern product differences, the spray pattern method was changed from five sprays
to a single actuation at multiple test distances. is change in test parameters, in conjunction
with the TLC plate and Polaroid photography, greatly reduces the image intensity, and the
contrast becomes too low to manually measure with the transparent circular template method
(Figure ). Similarly, the digital system, although improved by the higher resolution of the digital
camera, did not provide an adequate distinction between the spray pattern and the TLC plate
background. is lack of discrimination was manifested as spray patterns that decreased with
increasing target distance, counter to prior experience with aerosol products, indicating that the
areas of lowest density at the edges of the spray pattern could not be resolved against the broad
intensity distribution of the TLC background.

2 cm 5 cm

Figure 2 Spray pattern digital photographs of a representative aerosol drug product generated using a device to
automate actuation with a single actuation at 2 and 5 centimeters from an alternate (i.e., non-TLC)
target medium. Notice the clarity of the images and the visibility of intensity gradations within the
spray pattern distinct from the background.

Numerous aerosol spray pattern images, generated using a proprietary automated actua-
tor device that controls for actuation force and velocity, were evaluated under the high resolution
provided by the digital camera. Analysis of their gray scale histograms revealed that the spray
image exponentially decreases in intensity from some maximum intensity at the center of the
pattern until the background intensity (i.e., target medium) is reached. With this knowledge,
several digital techniques and target media were explored. Ultimately, a method utilizing a pro-
prietary algorithm and alternate target medium to detect the spray pattern outline was identified.
Together with the device to automate actuation and other proprietary system elements, the new
automated digital method yields spray patterns produced from a single actuation that are visually
clear and follow the expected trend of increasing diameter with target distance (Figures  and ).
Furthermore, these images are larger than the spray patterns detected from TLC plates, indicat-
ing that more of the spray can be distinguished from the background. (Figure  shows the tight
intensity distribution of the alternate target medium in comparison to the former TLC plate
medium). Collectively, this novel system has the ability to characterize the performance of spray
delivery devices with greater discrimination.
Respiratory Drug Delivery VIII, 2002 – Weinstein et al. 583

Figure 3 is plot contains long diameter data as a function of spray distance from the alternate target
media for 4 representative aerosol products. Note the increase in diameter with increasing
distance for all aerosol products. In addition, the two nasal aerosol products (A and C) have a
different rate of increase compared to the two oral aerosol products (B and D), demonstrating the
product discrimination capability of the system.

Figure 4 Histogram comparison of the traditional TLC plate target medium to an alternate medium.
Both plots contain the same number of pixels (640 x 480). e distribution in intensity on the
TLC plate is significantly wider and contains fewer pixels in each bin. Conversely, the alternate
media demonstrates high uniformity in pixel intensity, which will be shifted away from the mean
of the spray pattern image intensity.

ACKNOWLEDGEMENTS

e authors recognize significant technical contributions of Mr. Kaufman, Mr. Curbishley, and Mr.
Bjorndal, and wish to thank Drs. Lusty and Hart for their editorial suggestions.
 Notes

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