化学的手法で盗難・偽造医薬品を特定、同定技術が解決の糸口に(Chemical detective work could be the solution to stolen and repackaged medicine)

2025-08-08

2025-08-07 コペンハーゲン大学(UCPH)

EUでは薬品窃盗や偽造が増加し、2024年には違法医薬品42万件超が押収された。コペンハーゲン大学とスタンフォード大学の研究チームは、医薬品固有の「化学的指紋」を利用して出所を特定する新手法を開発。原料や製造過程に由来する炭素・酸素・水素の安定同位体比のわずかな差を解析し、製造元を識別できる。市販イブプロフェンを例に検証した結果、見た目が同一でも同位体パターンで識別可能だった。安定同位体は長期間変化せず、なりすましが困難で、特別な機器も不要。約24時間で50試料を解析でき、盗難やリパッケージ薬品の追跡に有効とされる。

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イブプロフェン製剤および一般的に使用される医薬品添加物の安定したδ2H、δ13C、およびδ18O同位体パターンの解明 Revealing the Stable δ2H, δ13C, and δ18O Isotopic Patterns of Ibuprofen Drug Products and Commonly Used Pharmaceutical Excipients

Else Holmfred,Page Chamberlain,and Stefan Stürup
Molecular Pharmaceutics Published: July 1, 2025
DOI:https://doi.org/10.1021/acs.molpharmaceut.5c00522

Abstract

This study explored the use of stable light δ²H, δ¹³C, and δ¹⁸O isotope ratio mass spectrometry (IRMS) to identify unique isotopic signatures in 27 ibuprofen drug products and pharmaceutical 27 commonly used excipients. The 27 ibuprofen drug products were collected from six different countries containing active pharmaceutical ingredient varying from 20% to 82% of the total tablet mass and 6–18 excipients. The drug products were homogenized by ball milling, but no other sample preparation was required prior to analysis. Approximately 150 μg of sample material was encapsulated (n = 3) and analyzed through TC/EA IRMS calibrated against certified reference materials. The isotopic analyses were conducted over consecutive weeks with high data reproducibility, and the ibuprofen drug products and excipients presented the lowest isotopic variation by mass for the δ¹³C signal, followed by δ²H and δ¹⁸O. The isotopic standard deviations for the drug products (δ²H ≤ 5.29%, δ¹³C ≤ 0.37%, and δ¹⁸O ≤ 1.75%) were expectedly higher compared to monoingredient excipients but generally considered low. Unique isotopic signatures were determined for the drug products and excipients, and through the isotopic separation, it was possible to differentiate across pharmaceutical manufacturers and between drug products produced by the same manufacturer. The isotopic signal stability across pharmaceutical batches was determined through analysis (n = 3) of 9 drug products obtained from the same manufacturer having different batch numbers, expiration dates, and packaging material. The isotopic variation (δ²H = -44.78 ± 3.51‰, δ¹³C = -22.11 ± 0.46‰, and δ¹⁸O = 34.18 ± 1.73‰) within batches from a pharmaceutical manufacturer was lower than the isotopic variation across the different drug products making stable light isotopic analysis a powerful tool for unique identification and for health authorities and pharmaceutical manufacturers to detect falsified and substandard drug products, protect against patent infringement, and ensure high-quality drug products.