A Non-destructive Quantitative Transmission Raman Spectroscopy Method for Active Pharmaceutical Ingredient in Drug Product In-Use Samples Prepared in Dosing Vehicles.
AAPS PharmSciTech
; 23(5): 132, 2022 May 02.
Article
in En
| MEDLINE
| ID: mdl-35501618
ABSTRACT
Compatibility and in-use stability screening studies are required for dosing vehicle selection based on the FDA's guidance, "Use of Liquids and/or Soft Foods as Vehicles for Drug Administration General Considerations for Selection and In Vitro Methods for Product Quality Assessments." One of the major analytical challenges in these studies is sample preparation because extracting active pharmaceutical ingredient (API) from the drug product mixed into viscous soft-food matrices (e.g., yogurt or apple sauce) is laborious, prone to human errors, and time-consuming. Additionally, observed in-solution degradation caused by dosing vehicle ingredients causes analytical error. In our study, NIR- and Raman-based non-destructive tests have been explored and developed with drug product powder formulation prepared in dosing vehicles. A transmission Raman chemometrics model was developed and calibrated with samples varying in API content, water content, and milled extrudate particle size distribution. The method was proven to be accurate, linear, selective, and robust. Our work with non-destructive tests eases the laboratory burdens to perform in-use stability studies with dosing vehicles for all phases of development that need to cover all application scenarios of clinical preparation and usage.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Spectrum Analysis, Raman
/
Excipients
Type of study:
Guideline
Limits:
Humans
Language:
En
Journal:
AAPS PharmSciTech
Journal subject:
FARMACOLOGIA
Year:
2022
Document type:
Article
Affiliation country: