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Non-destructive Raman Method Development for Quantifying Active Pharmaceutical Ingredient in an Oral Suspension
Jacquelyn North1, Raaidah Saari-Nordhaus1, Gregory Doddridge2
1Research & Development, AbbVie Inc, 1 N Waukegan Road, North Chicago, IL, 60064, USA.
AAPS Pharmscitech
|April 5, 2024
Summary
Non-destructive Raman spectroscopy techniques, transmission Raman (TRS) and non-contact optic (NCO) probes, offer efficient alternatives for quantifying active pharmaceutical ingredients (APIs) in liquid drug products within dosing syringes, improving stability testing.
Area of Science:
- Pharmaceutical analysis
- Analytical chemistry
- Spectroscopy
Background:
- Stability testing of liquid drug products is crucial for quality assurance, adhering to International Conference on Harmonisation (ICH) and European Agency for the Evaluation of Medicinal Products (EMEA) guidelines.
- Current in-use stability testing involves laborious, time-consuming, and error-prone traditional chromatography methods.
- Non-destructive analysis methods are needed to enhance the efficiency of stability testing for liquid drug products.
Purpose of the Study:
- To investigate transmission Raman (TRS) and non-contact optic (NCO) probe Raman techniques as non-destructive alternatives for quantifying active pharmaceutical ingredients (APIs) in liquid drug samples within dosing syringes.
- To compare the performance of these Raman techniques against traditional UHPLC methods for in-use stability testing.
Main Methods:
- Utilized transmission Raman (TRS) and back scatter Raman with a non-contact optic (NCO) probe.
- Employed chemometric methods for API quantitation in liquid samples within plastic oral dosing syringes.
- Validated linearity and accuracy using cross-validation and independent pilot plant batch samples.
Main Results:
- Both TRS and NCO techniques successfully measured signals through plastic oral dosing syringes.
- Chemometric models demonstrated linearity across a 60 to 80 mg/mL API concentration range.
- API concentrations were predicted within 4% accuracy compared to UHPLC-measured values for independent samples.
Conclusions:
- Transmission Raman (TRS) and non-contact optic (NCO) probe Raman spectroscopy are viable non-destructive methods for API quantitation in in-use liquid drug samples.
- These techniques offer significant improvements in efficiency over traditional chromatography for stability testing.
- Future work can explore enhanced probes and broader applications for different formulations and sample presentations.
Keywords:
Chemometrics; Transmission Raman Spectroscopy; Back Scatter RamanDosing SyringeNon-destructiveOral SuspensionMore Related Videos
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