Laboratory of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya 464-8650, Japan.
Micro Process Engineering Laboratory, Department of Micro Engineering, Kyoto University, Kyoto Daigaku-Katsura, Nishikyo-ku, Kyoto 615-8540, Japan.
Int J Pharm. 2022 Aug 25;624:121980. doi: 10.1016/j.ijpharm.2022.121980. Epub 2022 Jul 2.
Microtaggant technologies can encode individual numbers on coating tablet to authenticate pharmaceutical products and, therefore, combat the global spread of falsified medicine. In this study, a novel microtaggant, stealth nanobeacon (NB), with surface-enhanced Raman scattering (SERS) activity was applied to various coating tablets and its physical stability was evaluated. The NBs were composed of a reporter molecule (AH, adenine hydrochloride) and prepared with different sizes of gold nanoparticles (AuNPs). The NBs were directly deposited on the surface of various model coatings (e.g., hydroxypropyl cellulose, hydroxypropyl methyl cellulose, Eudragit® RS30D, ethyl cellulose). To investigate physical stability of the NB on the coating tablets, SERS spectra of the NB after friability test and acceleration test (store at 75% RH, 40 °C) were evaluated using a portable Raman spectrometer. After the friability test, there was no significant decrease in the peak intensity of the SERS signal (P) for authentication in all samples. In the acceleration test, the SERS signals of the samples were attenuated, but sufficient SERS signal intensity (P > 70) was maintained in the seven types of coating for authentication. These results demonstrate that the microtaggant NB has the potential to be used for a wide range of coating tablets.
微标记技术可以在涂层片剂上编码单个数字,以验证药品的真伪,从而打击假药在全球范围内的传播。在这项研究中,一种新型的具有表面增强拉曼散射(SERS)活性的微标记物,即隐形纳米信标(NB),被应用于各种涂层片剂,并对其物理稳定性进行了评估。NB 由报告分子(AH,盐酸腺嘌呤)和不同大小的金纳米粒子(AuNP)组成。NB 直接沉积在各种模型涂层(如羟丙基纤维素、羟丙基甲基纤维素、Eudragit® RS30D、乙基纤维素)的表面。为了研究 NB 在涂层片剂上的物理稳定性,使用便携式拉曼光谱仪评估了脆性试验和加速试验(在 75% RH、40°C 下储存)后 NB 的 SERS 光谱。脆性试验后,所有样品的 SERS 信号(用于鉴定的 P)的峰强度均无明显下降。在加速试验中,样品的 SERS 信号衰减,但七种用于鉴定的涂层仍保持足够的 SERS 信号强度(P>70)。这些结果表明,微标记物 NB 具有广泛应用于各种涂层片剂的潜力。