Division of Pharmaceutical Analysis. Lucinda F. Buhse, Ph.D., Director. Research in support of the Critical Path Dimensions Ensuring Safety Demonstrating Medical Utility Industrialization Process. Division of Pharmaceutical Analysis Critical Path Initiatives.
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Division of Pharmaceutical Analysis
Lucinda F. Buhse, Ph.D., Director
Research in support of the Critical Path Dimensions
Demonstrating Medical Utility
Monitoring Liposomal Drug Products (LDPs) Under Manufacturing Stress Conditions
LDPs (PEGylated Doxil ®, Conventional DaunoXome®)
Acid and Base
Analytical methods for Monitoring quality
Drug Substance (HPLC-UV)
Encapsulation Efficiency (fluorescence)
Lipid Composition (HPLC-ELS)
Several sizes of patches, types of drug delivery, application periods, and shapes.
Transdermal Drug Delivery Systems: Adhesive Strength
Example of drug-in-adhesive
Example of reservoir
Test method development variables and constants:
Test panelRollsRolling time Test panel cleaning
Angle of pullPull speedDwell time Environment
Measuring API Particle Size in the Presence of Particulate Excipients
Drug Authenticity and Anti-counterfeiting
IRMS- Isotope Ratio Mass Spectrometry
IRMS can provide the source of active pharmaceutical ingredients (APIs). In the bivariate isotope ratio graph shown, the typical clustering of the data is consistent with manufacturer-based isotopic provenance.
Terahertz Absorption Spectra
Partial Least Squares Fit
THz Predicted Content (mg)
Content (mg) by NIR PLS Calibration from HPLC
Energy (5 - 45cm-1)
Acetaminophen tablet content: 65 – 135 mg scanned by NIR and Terahertz Absorbance.
Uncoated Acetaminophen tablets in 9 dosage levels 65 – 135mg.
Critical Path - Chemometrics
Tablet Reflectance – full range
Tablet Transmittance – limited spectral range
Data Range: 4000 – 10000cm-1
Data Range: 8600 – 10000cm-1
Near Infrared Reflectance and Transmittance of formulated tablets
Multivariate models in PAT – Partial Least Squares (PLS) analysis
PLS – Mean Centered, 2nd Derivative, 3 Factors
PLS – Mean Centered, Direct Spectra, 3 Factors
Content Measured by HPLC
Content Measured by HPLC