Drug content determination of amorphous solid dispersion containing tablets using a non-destructive and rapid UV...

Area of Science:

• Pharmaceutical Technology
• Analytical Chemistry
• Process Analytical Technology

Background:

• Amorphous solid dispersions (ASD) are crucial for enhancing drug solubility and bioavailability.
• Effective quality control methods are needed for ASD-based pharmaceuticals, especially those manufactured via continuous processes.

Purpose of the Study:

• To evaluate UV imaging as a rapid, non-destructive process analytical technology (PAT) tool for quantifying drug content in ASD tablets.
• To assess the capability of UV imaging to differentiate between batch and continuous manufacturing processes for ASD tablets.

Main Methods:

• ASD fibers were produced by electrospinning and blended with excipients using batch and continuous methods.
• Tablets were compressed, and UV imaging was employed to capture drug fluorescence.
• Partial least squares regression models were developed using image data for active pharmaceutical ingredient (API) quantification.

Main Results:

• UV imaging successfully quantified API content in ASD tablets with high accuracy (RMSEP 0.381 w/w%, 4.59% relative error).
• Principal component analysis of UV images distinguished between tablets from batch and continuous blending processes.
• The developed models demonstrated reliability through external validation.

Conclusions:

• UV imaging is a viable, cost-effective PAT tool for real-time monitoring and quality control in pharmaceutical manufacturing of ASD tablets.
• The method supports both batch and continuous manufacturing paradigms, offering significant advantages for process understanding and control.
• UV imaging's ability to detect process variations highlights its potential for ensuring product consistency and preventing counterfeit drugs.