Tamper-proof tablets for distinction between counterfeit and originator drugs through PEG coding

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Drug Delivery

Background:

• Counterfeit drugs pose a significant global public health risk.
• Existing drug serialization methods often fail to track individual units, limiting their effectiveness.
• A need exists for robust methods to authenticate and trace single pharmaceutical dosage forms.

Purpose of the Study:

• To develop and validate a proof-of-concept method for unambiguous identification and coding of individual drug tablets.
• To investigate the feasibility of using monodisperse polyethylene glycols (PEGs) for tablet-level drug product authentication.

Main Methods:

• Incorporation of varying qualities and amounts of monodisperse PEGs into tablet coating solutions at low concentrations (as low as 3 ppm).
• Analysis of coded tablets using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for code detection and verification.
• Evaluation of the method's performance and limitations, particularly concerning excipient interference.

Main Results:

• Successfully "wrote" a unique code into each tablet film using spiked PEGs.
• Demonstrated the ability to readily read and interpret these codes via LC-MS/MS analysis upon tablet isolation.
• Confirmed that different qualities and quantities of monodisperse PEGs are suitable for coding solid drug products.

Conclusions:

• Spiking monodisperse PEGs into tablet coatings offers a viable strategy for individual tablet authentication and traceability.
• This method provides a high level of specificity for identifying single drug units.
• The approach is currently limited to formulations where PEGs are not used as excipients due to potential interference.