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Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs

To overcome difficulties in splitting, uneven breaking and inconsistent dosing frequently reported with scored tablets, a novel punch was proposed for the manufacturing of easy breakable tablets (EBTs). In this work, the performance of the EBT punch was investigated vs. a ridged one for traditional...

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Autores principales: Palugan, Luca, Moutaharrik, Saliha, Maroni, Alessandra, Foppoli, Anastasia Anna, Melocchi, Alice, Vecchio, Carlo, Gazzaniga, Andrea, Cerea, Matteo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607861/
https://www.ncbi.nlm.nih.gov/pubmed/36297490
http://dx.doi.org/10.3390/pharmaceutics14102054
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author Palugan, Luca
Moutaharrik, Saliha
Maroni, Alessandra
Foppoli, Anastasia Anna
Melocchi, Alice
Vecchio, Carlo
Gazzaniga, Andrea
Cerea, Matteo
author_facet Palugan, Luca
Moutaharrik, Saliha
Maroni, Alessandra
Foppoli, Anastasia Anna
Melocchi, Alice
Vecchio, Carlo
Gazzaniga, Andrea
Cerea, Matteo
author_sort Palugan, Luca
collection PubMed
description To overcome difficulties in splitting, uneven breaking and inconsistent dosing frequently reported with scored tablets, a novel punch was proposed for the manufacturing of easy breakable tablets (EBTs). In this work, the performance of the EBT punch was investigated vs. a ridged one for traditional breakable tablets (TBTs) using a furosemide powder formulation for orally disintegrating tablets (ODTs). A Face Centered Central Composite Design was applied to investigate the influence of punch type, compaction force, tablet weight and press rotation speed on the mechanical properties of ODTs, their behavior in aqueous fluids and aptitude for splitting. Mass uniformity and adequate crushing strength, friability, water uptake, disintegration and wetting times were obtained from both TBTs and EBTs. Interestingly, more favorable splitting behavior was shown by tablets manufactured by the novel punch, in view of lower mass loss and portion mass variability after breaking. The ease of breaking, accuracy of subdivision and mass loss of ODTs were also evaluated by a volunteer (n = 20) panel test. Less difficulty was found in splitting EBTs than TBTs (p < 0.05), and a larger number of tablets were properly broken into four parts. Thus, this study proved the usefulness of the EBT punch in overcoming drawbacks associated with divisible tablets.
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spelling pubmed-96078612022-10-28 Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs Palugan, Luca Moutaharrik, Saliha Maroni, Alessandra Foppoli, Anastasia Anna Melocchi, Alice Vecchio, Carlo Gazzaniga, Andrea Cerea, Matteo Pharmaceutics Article To overcome difficulties in splitting, uneven breaking and inconsistent dosing frequently reported with scored tablets, a novel punch was proposed for the manufacturing of easy breakable tablets (EBTs). In this work, the performance of the EBT punch was investigated vs. a ridged one for traditional breakable tablets (TBTs) using a furosemide powder formulation for orally disintegrating tablets (ODTs). A Face Centered Central Composite Design was applied to investigate the influence of punch type, compaction force, tablet weight and press rotation speed on the mechanical properties of ODTs, their behavior in aqueous fluids and aptitude for splitting. Mass uniformity and adequate crushing strength, friability, water uptake, disintegration and wetting times were obtained from both TBTs and EBTs. Interestingly, more favorable splitting behavior was shown by tablets manufactured by the novel punch, in view of lower mass loss and portion mass variability after breaking. The ease of breaking, accuracy of subdivision and mass loss of ODTs were also evaluated by a volunteer (n = 20) panel test. Less difficulty was found in splitting EBTs than TBTs (p < 0.05), and a larger number of tablets were properly broken into four parts. Thus, this study proved the usefulness of the EBT punch in overcoming drawbacks associated with divisible tablets. MDPI 2022-09-27 /pmc/articles/PMC9607861/ /pubmed/36297490 http://dx.doi.org/10.3390/pharmaceutics14102054 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
Palugan, Luca
Moutaharrik, Saliha
Maroni, Alessandra
Foppoli, Anastasia Anna
Melocchi, Alice
Vecchio, Carlo
Gazzaniga, Andrea
Cerea, Matteo
Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs
title Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs
title_full Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs
title_fullStr Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs
title_full_unstemmed Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs
title_short Evaluation of Newly Designed and Traditional Punches in Manufacturing of Scored ODTs
title_sort evaluation of newly designed and traditional punches in manufacturing of scored odts
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607861/
https://www.ncbi.nlm.nih.gov/pubmed/36297490
http://dx.doi.org/10.3390/pharmaceutics14102054
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