Rethinking Thin-Layer Chromatography for Screening Technetium-99m Radiolabeled Polymer Nanoparticles

Kathrin Schorr, Xinyu Chen, Takanori Sasaki, Anahi Paula Arias-Loza, Johannes Lang, Takahiro Higuchi* and Achim Goepferich*, 
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Abstract

Thin-layer chromatography (TLC) is commonly employed to screen technetium-99m labeled polymer nanoparticle batches for unreduced pertechnetate and radio-colloidal impurities. Although this method is widely accepted, our findings applying radiolabeled PLGA/PLA–PEG nanoparticles underscore its lack of transferability between different settings and its limitations as a standalone quality control tool. While TLC profiles may appear similar for purified and radiocolloid containing nanoparticle formulations, their in vivo behavior can vary significantly, as demonstrated by discrepancies between TLC results and single-photon emission computed tomography (SPECT) and biodistribution data. This highlights the urgent need for a case-by-case evaluation of TLC methods for each specific nanoparticle type. Our study revealed that polymeric nanoparticles cannot be considered analytically uniform entities in the context of TLC analysis, emphasizing the complex interplay between nanoparticle composition, radiolabeling conditions, and subsequent biological behavior.

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重新思考用薄层色谱法筛选锝-99m 放射性标记聚合物纳米粒子
薄层色谱法(TLC)通常用于筛选锝-99m 标记的聚合物纳米粒子批次,以确定是否存在未还原的过硫酸盐和放射性胶体杂质。虽然这种方法已被广泛接受,但我们在应用放射性标记的 PLGA/PLA-PEG 纳米粒子时发现,这种方法缺乏在不同环境下的可移植性,而且作为一种独立的质量控制工具存在局限性。虽然纯化的和含有放射性胶体的纳米粒子制剂的TLC图谱可能看起来相似,但它们在体内的表现可能会有很大不同,TLC结果与单光子发射计算机断层扫描(SPECT)和生物分布数据之间的差异就证明了这一点。这凸显了对每种特定纳米粒子类型的 TLC 方法进行个案评估的迫切需要。我们的研究表明,在 TLC 分析中,聚合物纳米粒子不能被视为分析上统一的实体,这强调了纳米粒子组成、放射性标记条件和后续生物行为之间复杂的相互作用。
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来源期刊
ACS Pharmacology and Translational Science
ACS Pharmacology and Translational Science Medicine-Pharmacology (medical)
CiteScore
10.00
自引率
3.30%
发文量
133
期刊介绍: ACS Pharmacology & Translational Science publishes high quality, innovative, and impactful research across the broad spectrum of biological sciences, covering basic and molecular sciences through to translational preclinical studies. Clinical studies that address novel mechanisms of action, and methodological papers that provide innovation, and advance translation, will also be considered. We give priority to studies that fully integrate basic pharmacological and/or biochemical findings into physiological processes that have translational potential in a broad range of biomedical disciplines. Therefore, studies that employ a complementary blend of in vitro and in vivo systems are of particular interest to the journal. Nonetheless, all innovative and impactful research that has an articulated translational relevance will be considered. ACS Pharmacology & Translational Science does not publish research on biological extracts that have unknown concentration or unknown chemical composition. Authors are encouraged to use the pre-submission inquiry mechanism to ensure relevance and appropriateness of research.
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