Stable isotope-labeled excipients for drug product identification and counterfeit detection

Abstract

Purpose: Counterfeit drug products have become a major problem worldwide and a number of techniques to detect counterfeit products or reduce the potential for counterfeiting have been investigated. This study examined the use of stable isotope-labeled excipients in solid dosage forms as a method to identify drug products and to detect counterfeits. Methods: ²H- and ¹³C-glucose were used as model excipients and incorporated in wet granulated formulations at a variety of different isotopic ratios. The ratios of ²H/¹H and ¹³C/¹²C in each product were then determined by isotope ratio mass spectrometry. Results: Results demonstrated the ability to detect the isotope-labeled glucose in both granules and tablets. Conclusions: It was possible to use the isotope ratios to differentiate between specific batches of granules, demonstrating the potential of this technique for in-product, batch-specific identification.

• Anticounterfeiting method
• in-product identification
• labeled excipients
• stable isotopes