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Data Acquisition and Sample Analysis
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A primary
consideration in fiber optic dissolution is the problem of excipient
particles present in the sample volume analyzed. The C Technologies IO™
system addresses this concern by employing an excipient correction
algorithm using a baseline correction method. This method corrects the
data collected from the spectral absorption band of the active by
subtracting the measured absorbance value of a reference wavelength
outside the drug’s absorption band. Since excipient spectra are
typically linear and easily validated, subtracting this offset value
from the measured in-band absorption therefore corrects that value for
the effects of the particles.
Although this baseline correction should be verified on a product-to-product basis, this method has enjoyed real-world success in the pharmaceutical research lab. One such study involved a developmental immediate-release pharmaceutical drug (*Pfizer, Morris Plains, New Jersey). This product comprised commonly used excipients and an active ingredient delivered in a capsule shell. The IO™ data presented illustrates the baseline uniformity of the excipient blend and capsule shell in relation to the UV/VIS spectra of the active ingredient. Also shown is the direct correlation of fiber optic dissolution results vis-ŕ-vis traditional off-line results on the same product. |
 Graph I: UV/VIS spectra of matrix interferences collected by fiber optic probe in vessel with paddles in motion. Insert: UV/VIS spectra of active ingredient.
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