Chemical Distribution Uniformity Assessment of "Intra-Tablet" by Hyperspectral Raman Imaging Analysis.

Ningyun Sun, Jing Zhang, Mingtao Guo, Yibin Mao, Wei Wu, Yi Lu

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Article in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

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6 authors.

Ningyun SunKey Laboratory of Smart Drug Delivery of MOE, School of Pharmacy, Fudan University, Shanghai, 201203, China.

Jing ZhangSPH Sine Pharmaceutical Laboratories Co., Ltd, Shanghai, 201206, China.

Mingtao GuoNational Key Laboratory of Fundamental Science On Synthetic Vision, Sichuan University, Chengdu, 610065, China.

Yibin MaoSPH Sine Pharmaceutical Laboratories Co., Ltd, Shanghai, 201206, China. maoyibin@sphsine.com.

Wei WuKey Laboratory of Smart Drug Delivery of MOE, School of Pharmacy, Fudan University, Shanghai, 201203, China. wuwei@shmu.edu.cn.

Yi LuKey Laboratory of Smart Drug Delivery of MOE, School of Pharmacy, Fudan University, Shanghai, 201203, China. fd_luyi@fudan.edu.cn.ORCID http://orcid.org/0000-0002-9655-7510

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to develop a new index, Distribution Uniformity Index (DUI), to assess the "intra-tablet" homogeneity.

methodsHigh-resolution hyperspectral Raman imaging was adopted to scan a tablet to get the components' distribution. The heuristic algorithm was applied to generate a Raman heatmap with RGB colors quantitatively correlated with the concentrations of each component. DUI is defined as the ratio of the area under the uniformity curve of the sample image to that of the randomized image. The accuracy and applicability of DUI were verified by constructing model images with controlled uniformity and random regions. The effects of "intra-tablet" homogeneity on the disintegration and dissolution of spironolactone tablets were investigated.

resultsDUI value was directly obtained from heuristic visual analysis of macro-pixel from hyperspectral Raman images. A good linear relationship and good repeatability were confirmed between DUI and the uniformity of model images. The size of CaSO

conclusionsDUI represents a novel index to evaluate the "intra-tablet" homogeneity and is beneficial for formulation research and development.

Indexed as

Spectrum Analysis, RamanSpironolactoneTabletsAlgorithmsChemistry, PharmaceuticalDrug CompoundingDrug LiberationExcipientsSolubilityExcipientsSpironolactoneTabletsdistribution uniformity indexheuristic visual analysishyperspectral raman imaging“intra-tablet” homogeneityspironolactone tablet

Identifiers

PMID39505780

DOI10.1007/s11095-024-03778-z

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.