Abstract
The detection of counterfeit pharmaceuticals is always a major challenge, but the early detection of counterfeit medicine in a country will reduce the fatal risk among consumers. Technically, fast laboratory testing is vital to develop an effective surveillance and monitoring system of counterfeit medicines. This study proposed the combination of Attenuated Total Reflectance Fourier Transform Infrared (ATR-FTIR) and Differential Scanning Calorimetry (DSC) for the quick detection of counterfeit medicines, through the polymer analysis of blister packaging materials. A sample set containing three sets of original and counterfeit medicine was analyzed using ATR-FTIR and DSC, while the spectra from ATR-FTIR were employed as a fingerprint for the polymer characterization. Intending to analyze the polymeric material of each sample, DSC was set at a heating rate of 10 °C min−l and within a temperature range of 0–400 °C, with nitrogen as a purge gas at a flow rate of 20 mL min−1. The ATR-FTIR spectra revealed the chemical characteristics of the plastic packaging of fake and original medicines. Further analysis of the counterfeit medicine’s packaging with DSC exhibited a distinct difference from the original due to the composition of polymers in the packaging material used. Overall, this study confirmed that the rapid analysis of polymeric materials through ATR-FTIR and comparing DSC thermograms of the plastic in their packaging effectively distinguished counterfeit drug products.
Highlights
Pharmaceutical packaging is a USD 70 billion global industry with an estimated 6%year-over-year CAGR [1]
The Differential Scanning Calorimetry (DSC) thermogram for the counterfeit A1 sample blister pack showed a higher melting point at 267.48 ± 1.23 ◦C and a higher exothermic peak at 308.03 ± 2.11 ◦C. These results suggest that the polymer used in counterfeit A1 s plastic blisters was made of a different quality polyvinyl chloride (PVC) than the original blister (Sample A)
This work substantiated that Attenuated Total Reflectance (ATR)-FTIR and DSC are powerful analytical tools for polymer identification
Summary
Pharmaceutical packaging is a USD 70 billion global industry with an estimated 6%. year-over-year CAGR [1]. Counterfeit medicine is an alarming global problem that affects developing and developed countries with strong regulatory and market regulation structures This is supported by conservative figures from the last decade, in which 10% of all pharmaceutical products consumed worldwide are counterfeit. The majority of techniques are time consuming and require extensive pattern planning or sample destruction On this account, improving an analytical approach to simultaneously distinguish legitimate and counterfeit medicine samples from blister packaging tests is critical, as it enables the tablet to remain intact in its physical form [13]. Combining the benefits of DSC and ATR-FTIR indicates a promising possibility to quickly identify counterfeit drugs in the market, by investigating their polymer material in drug packaging using spectroscopy and thermal analysis. The combination technique will expand the analysis field and minimize errors to detect and identify counterfeit medicine in the market
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