Raman Barcode for Counterfeit Drug Product Detection.

Area of Science:

• Analytical Chemistry
• Spectroscopy
• Pharmaceutical Analysis

Background:

• Counterfeit drugs containing incorrect or no active pharmaceutical ingredient (API) infiltrate global supply chains, endangering consumers.
• Traditional Raman spectroscopy identification methods struggle with complex drug formulations, limiting their screening capabilities.

Purpose of the Study:

• To introduce and validate a novel "Raman barcode" method for accurate identification of APIs in finished drug products.
• To overcome limitations of traditional spectral correlation methods in pharmaceutical analysis.

Main Methods:

• Developed a "Raman barcode" by transforming Raman spectra of APIs and drug products into binary representations based on peak frequencies.
• Quantified API identity by calculating the percentage of nonzero overlap between the expected API barcode and the drug product barcode.

Main Results:

• Successfully identified 18 approved drug products and nine simulated counterfeit products with 100% accuracy.
• The Raman barcode method demonstrated high accuracy in distinguishing between genuine and counterfeit drug products.

Conclusions:

• The Raman barcode approach offers a rapid, non-destructive, and highly accurate method for identifying APIs in drug products.
• This technique significantly enhances the ability to screen pharmaceutical supplies for counterfeit medications, improving consumer safety.