Microsoft powerpoint - aaps 2004 furosemide poster v3
Influence of manufacturing changes and formulation excipients on the Influence of manufacturing changes and formulation excipients on the AAPS 2004 direct determination of furosemide in solid oral dosage forms using Poster T3053 direct determination of furosemide in solid oral dosage forms using laser-induced breakdown spectroscopy (LIBS) laser-induced breakdown spectroscopy (LIBS) L. St-Onge1,*, P. Faustino2, M. Tourigny3, M. Sabsabi1 L. St-Onge1,*, P. Faustino2, M. Tourigny3, M. Sabsabi1 1National Research Council of Canada (IMI), Boucherville (QC), Canada; 2Food & Drug Administration (CDER), Silver Spring (MD), U.S.A.; 3Pharma Laser, Boucherville (QC), Canada1National Research Council of Canada (IMI), Boucherville (QC),Spring (MD), U.S.A.; 3Pharma Laser, Boucherville (QC), Canada* Corresponding author: [email protected]LIBS spectra Internal standardization To investigate the influence of Influence of magnesium stearate content and
z This study was carried out using a PharmaLIBS™ Model 200
manufacturing changes and formulation
instrument (Pharma Laser, Boucherville, Canada)
compression strength (in direct compression tablets) excipients on the direct determination of furosemide by LIBS in solid dosage forms.
z A pulsed Nd:YAG laser (λ=1064 nm, 7 ns, 200 mJ/pulse)
produced a gaseous plasma directly at the surface of the
Approach: Various furosemide formulations with the same drug concentration were analyzed to identify possible matrix effects
z The optical emission spectrum was resolved, and furosemide
was identified unambiguously through emission of atomic
z Each tablet analysis was based on a total of 60 laser pulses
(6 sites, 10 pulses/site), with a one minute duration
Background
In LIBS, a laser pulse is focused directly on the
sample, in ambient air, leading to the vaporization of
Joulemeter
some material and the formation of a transient
Steering Nd:YAG Laser
luminous plasma. Elemental components of the
sample are detected from the plasma emission,
F ib e r O p tic
through optical emission spectroscopy.
LIBS has been used in a variety of applications
Influence of manufacturing changes Detector
involving solid, liquid or gas analysis.1
(for lactose-matrix tablets) Spectrograph Sample Tray Influence of lactose/Avicel ratio (in direct compression tablets)
Pharmaceutical applications of LIBS include the
For similar formulations, the LIBS signal
analysis of active pharmaceutical ingredients (API)
XY-Rot Stage
1 DA Rusak et al., Crit Rev Anal Chem 27 (1997) 257-90. S Béchard, Pharm Formul Qual 3 (2001) 37-40. MD Mowery et al., J Pharm Biomed Anal 28 (2002) 935-43. L St-Onge et al., Spectrochim Acta B 57 (2002) 1131-40.
5 Other publications available at http://www.pharmalaser.comWorking principle of the PharmaLIBS™ 200 instrument
Using the Cl or S emission provides similar
intensities, and therefore sensitivity, for
80-mg furosemide tablets (320-mg total weight) were manufactured by direct compression or wet granulation. Ten
quantitation of furosemide. The intensities are
experimental furosemide formulations were investigated, with the same furosemide content, but differing mainly in
systematically lower in a lactose matrix.
their relative excipient content of Avicel, lactose and magnesium stearate. Conclusions Conclusions Direct Compression formulations Wet Granulation formulations
• Either of chlorine or sulfur signals could be used for quantitating
Formulation Furosemide MgStearate Formulation Furosemide MgStearate Povidone
ependence on the formulation and manufacturing than the
o. ctose/Avicel ratio was the parameter of the formulation that
The Mg signal is more affected than the C signal
by the matrix, which explains why the Mg/C ratio
S and Cl are specific to
still depends on the matrix (as with Cl/C and S/C).
furosemide (in this
In the present case, using internal standardization
The Mg/C ratio is seen to decrease gradually up to
does not compensate for the change in matrix. On
formulation) and can be used
60% lactose in the mixture, and is approximately
average, the Cl/C ratio in lactose is 74% that in
constant thereafter. The overall decrease in signal
for quantitation.
Avicel. For S/C, the decrease is somewhat greater,
going from Avicel to lactose is the same as
monitoring of pharmaceuticals during manufacturing changes. We acknowledge the involvement of Yves Mouget, Ph.D., in early phases of this work.
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