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Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography

Aim: The study aimed to analyze the weight and homogeneity of the parts of tablets containing carbamazepine and tablets with trazodone hydrochloride, obtained after subdivision with a kitchen knife. X-ray microtomography was used for homogeneity analysis. Methods: 30 tablets with carbamazepine and 3...

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Autores principales: Meisner, Michał, Kuśnierz, Piotr, Duda, Piotr, Wilczyński, Sławomir, Sarecka-Hujar, Beata
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9506467/
https://www.ncbi.nlm.nih.gov/pubmed/36145598
http://dx.doi.org/10.3390/pharmaceutics14091850
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author Meisner, Michał
Kuśnierz, Piotr
Duda, Piotr
Wilczyński, Sławomir
Sarecka-Hujar, Beata
author_facet Meisner, Michał
Kuśnierz, Piotr
Duda, Piotr
Wilczyński, Sławomir
Sarecka-Hujar, Beata
author_sort Meisner, Michał
collection PubMed
description Aim: The study aimed to analyze the weight and homogeneity of the parts of tablets containing carbamazepine and tablets with trazodone hydrochloride, obtained after subdivision with a kitchen knife. X-ray microtomography was used for homogeneity analysis. Methods: 30 tablets with carbamazepine and 30 tablets with trazodone hydrochloride were analyzed in terms of weight uniformity after subdivision. Then, seven tablets of each type were analyzed using an X-ray microtomography (Phoenix vǀtomeǀx, General Electric). The absorption of X-rays by an object is proportional to its density. In turn, measurement of the density of the analyzed object in a microtomographic image is the grayscale level. Based on the correlation between the grayscale value and the reference density, from the calibration phantom, we were able to determine the density of any area of the tablet’s scan. Results: During the subdivision, the weight loss exceeded 3% for two carbamazepine tablets, while for trazodone tablets, none lost more than 3%, which is the limit recommended by Food and Drug Administration (FDA). As to the density of the tablets resulting from the microtomographic analysis, two of the whole tablets containing trazodone hydrochloride had a significantly higher density than the remainder (p < 0.001). Similarly, some differences in density were observed in the analysis of the density of tablets of carbamazepine (p = 0.008). Parts of one of the analyzed tablets with trazodone obtained after subdivision differed in terms of pixel brightness, thus density. On the other hand, the uniform density was observed for parts of the split tablets containing carbamazepine. Conclusions: Parts of the trazodone hydrochloride tablets obtained after subdivision differed in terms of homogeneity and weight. Microtomographic methods may be an interesting and useful method for evaluating the uniformity of compounds in solid dosage forms.
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spelling pubmed-95064672022-09-24 Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography Meisner, Michał Kuśnierz, Piotr Duda, Piotr Wilczyński, Sławomir Sarecka-Hujar, Beata Pharmaceutics Article Aim: The study aimed to analyze the weight and homogeneity of the parts of tablets containing carbamazepine and tablets with trazodone hydrochloride, obtained after subdivision with a kitchen knife. X-ray microtomography was used for homogeneity analysis. Methods: 30 tablets with carbamazepine and 30 tablets with trazodone hydrochloride were analyzed in terms of weight uniformity after subdivision. Then, seven tablets of each type were analyzed using an X-ray microtomography (Phoenix vǀtomeǀx, General Electric). The absorption of X-rays by an object is proportional to its density. In turn, measurement of the density of the analyzed object in a microtomographic image is the grayscale level. Based on the correlation between the grayscale value and the reference density, from the calibration phantom, we were able to determine the density of any area of the tablet’s scan. Results: During the subdivision, the weight loss exceeded 3% for two carbamazepine tablets, while for trazodone tablets, none lost more than 3%, which is the limit recommended by Food and Drug Administration (FDA). As to the density of the tablets resulting from the microtomographic analysis, two of the whole tablets containing trazodone hydrochloride had a significantly higher density than the remainder (p < 0.001). Similarly, some differences in density were observed in the analysis of the density of tablets of carbamazepine (p = 0.008). Parts of one of the analyzed tablets with trazodone obtained after subdivision differed in terms of pixel brightness, thus density. On the other hand, the uniform density was observed for parts of the split tablets containing carbamazepine. Conclusions: Parts of the trazodone hydrochloride tablets obtained after subdivision differed in terms of homogeneity and weight. Microtomographic methods may be an interesting and useful method for evaluating the uniformity of compounds in solid dosage forms. MDPI 2022-09-01 /pmc/articles/PMC9506467/ /pubmed/36145598 http://dx.doi.org/10.3390/pharmaceutics14091850 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Meisner, Michał
Kuśnierz, Piotr
Duda, Piotr
Wilczyński, Sławomir
Sarecka-Hujar, Beata
Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography
title Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography
title_full Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography
title_fullStr Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography
title_full_unstemmed Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography
title_short Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?—A Preliminary Assessment Using an X-ray Microtomography
title_sort are there differences in the homogeneity of the parts of tablets obtained after subdivision?—a preliminary assessment using an x-ray microtomography
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9506467/
https://www.ncbi.nlm.nih.gov/pubmed/36145598
http://dx.doi.org/10.3390/pharmaceutics14091850
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