Effect of Colour and Surface Properties of Solid Pharmaceutical Dosage Forms on Light Reflection in Solar Spectral Range.

IF 4.3 3区 医学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Pharmaceutical Research Pub Date : 2025-08-01 Epub Date: 2025-07-28 DOI:10.1007/s11095-025-03896-2
Elżbieta Mickoś, Anna Banyś, Magdalena Hartman-Petrycka, Żaneta Gortat-Stanisławska, Sławomir Wilczyński
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引用次数: 0

Abstract

Objective: The objective of the present study was to undertake a comparative analysis of the effect of colour, score line, embossing or printing on the surface of selected solid oral pharmaceutical dosage forms on the reflectance properties in the range of ultraviolet A, visible and near infrared radiation from 335 to 2500 nm. This analysis was carried out using the value of directional hemispherical reflectance as a parameter indicating the resistance of the pharmaceutical dosage form to solar radiation through reflection mechanism. Reflected radiation has no physical or chemical effects.

Methods: Directional hemispherical reflectance (DHR) was used in analysis. Quantitative assessment of the reflected radiation by the sample allows the determination of how much radiation is absorbed or transmitted by the tested object, thus allowing the assessment of the interaction strength of specific spectral ranges.

Results: External parameters of the pharmaceutical dosage form, such as colour, score lines, embossing, or imprints, can determine interactions of medicinal product with electromagnetic radiation.

Conclusions: These findings have practical implications for pharmaceutical formulation. The results suggest that colour and surface texture should be considered when developing photostable pharmaceutical products.

Highlights: • Electromagnetic radiation affect on stability of medicinal product. • Reflected radiation does not cause physical and chemical effects. • Colour and structural elements of solid pharmaceutical dosage form determine reflective properties. • Directional hemispherical reflectance (reflectance) as a measurer of exposure to radiation.

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固体药物剂型的颜色和表面性质对太阳光谱反射的影响。
目的:比较分析所选固体口服药物剂型表面颜色、划线、压花或印刷对其在335 ~ 2500 nm紫外光a、可见光和近红外波段反射特性的影响。本分析采用定向半球反射率值作为指示药物剂型通过反射机制对太阳辐射的抗性的参数。反射的辐射没有物理或化学效应。方法:采用定向半球反射法(DHR)进行分析。通过对样品反射辐射的定量评估,可以确定被测物体吸收或透射了多少辐射,从而可以评估特定光谱范围的相互作用强度。结果:药品剂型的外部参数,如颜色、划线、压花或印记等,可以确定药品与电磁辐射的相互作用。结论:这些发现对药物配方具有实际意义。结果表明,在开发光稳定性药品时应考虑颜色和表面纹理。•电磁辐射对药品稳定性的影响。•反射辐射不会引起物理和化学效应。•固体药物剂型的颜色和结构元素决定反射特性。•定向半球形反射率(反射率)作为辐射暴露的量度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pharmaceutical Research
Pharmaceutical Research 医学-化学综合
CiteScore
6.60
自引率
5.40%
发文量
276
审稿时长
3.4 months
期刊介绍: Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.
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