Stable isotope-labeled excipients for drug product identification and counterfeit detection.
OBJECTIVE
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
(2)H- and (13)C-glucose were used as model excipients and incorporated in wet granulated formulations at a variety of different isotopic ratios. The ratios of (2)H/(1)H and (13)C/(12)C 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.
Felton
Linda A
LA
Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico, Albuquerque, NM, USA. lfelton@unm.edu
Shah
Punit P
PP
Sharp
Zachary
Z
Atudorei
Viorel
V
Timmins
Graham S
GS
D002626:Chemistry, Pharmaceutical / Q000379:methods; D058110:Counterfeit Drugs / Q000032:analysis*; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000032:analysis* / Q000737:chemistry*; D007553:Isotope Labeling / Q000379:methods*; D013058:Mass Spectrometry / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry*; D013607:Tablets / Q000032:analysis / Q000737:chemistry
D058110:Counterfeit Drugs; D005079:Excipients; D004364:Pharmaceutical Preparations; D013607:Tablets