Cargando…

A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms

The aim of this work was to investigate the effect of process parameters on the printability of a formulation containing copovidone and paracetamol, and on the properties of solid oral forms 3D-printed through selective laser sintering. Firstly, the influence of the heating temperature was evaluated...

Descripción completa

Detalles Bibliográficos
Autores principales: Gueche, Yanis A., Sanchez-Ballester, Noelia M., Bataille, Bernard, Aubert, Adrien, Rossi, Jean-Christophe, Soulairol, Ian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8539463/
https://www.ncbi.nlm.nih.gov/pubmed/34683997
http://dx.doi.org/10.3390/pharmaceutics13101701
_version_ 1784588753011998720
author Gueche, Yanis A.
Sanchez-Ballester, Noelia M.
Bataille, Bernard
Aubert, Adrien
Rossi, Jean-Christophe
Soulairol, Ian
author_facet Gueche, Yanis A.
Sanchez-Ballester, Noelia M.
Bataille, Bernard
Aubert, Adrien
Rossi, Jean-Christophe
Soulairol, Ian
author_sort Gueche, Yanis A.
collection PubMed
description The aim of this work was to investigate the effect of process parameters on the printability of a formulation containing copovidone and paracetamol, and on the properties of solid oral forms 3D-printed through selective laser sintering. Firstly, the influence of the heating temperature was evaluated individually, and it was revealed that this parameter was critical for printability, as a sufficiently high temperature (100 °C) is necessary to avoid curling. Secondly, the effects of laser power, scan speed, and layer thickness were determined using a Box–Behnken design. The measured responses, printing yield, height, weight, hardness, disintegration time, and percentage of drug release at 10 min showed the following ranges of values: 55.6–100%, 2.92–3.96 mm, 98.2–187.2 mg, 9.2–83.4 N, 9.7–997.7 s, and 25.8–99.9%, respectively. Analysis of variance (ANOVA) proved that the generated quadratic models and the effect of the three–process parameters were significant (p < 0.05). Yield improved at high laser power, low scan speed, and increased layer thickness. Height was proportional to laser power, and inversely proportional to scan speed and layer thickness. Variations in the other responses were related to the porosity of the SOFs, which were dependent on the value of energy density. Low laser power, fast scan speed, and high layer thickness values favored a lower energy density, resulting in low weight and hardness, rapid disintegration, and a high percentage of drug release at 10 min. Finally, an optimization was performed, and an additional experiment validated the model. In conclusion, by applying a Quality by Design approach, this study demonstrates that process parameters are critical for printability, but also offer a way to personalize the properties of the SOFs.
format Online
Article
Text
id pubmed-8539463
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-85394632021-10-24 A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms Gueche, Yanis A. Sanchez-Ballester, Noelia M. Bataille, Bernard Aubert, Adrien Rossi, Jean-Christophe Soulairol, Ian Pharmaceutics Article The aim of this work was to investigate the effect of process parameters on the printability of a formulation containing copovidone and paracetamol, and on the properties of solid oral forms 3D-printed through selective laser sintering. Firstly, the influence of the heating temperature was evaluated individually, and it was revealed that this parameter was critical for printability, as a sufficiently high temperature (100 °C) is necessary to avoid curling. Secondly, the effects of laser power, scan speed, and layer thickness were determined using a Box–Behnken design. The measured responses, printing yield, height, weight, hardness, disintegration time, and percentage of drug release at 10 min showed the following ranges of values: 55.6–100%, 2.92–3.96 mm, 98.2–187.2 mg, 9.2–83.4 N, 9.7–997.7 s, and 25.8–99.9%, respectively. Analysis of variance (ANOVA) proved that the generated quadratic models and the effect of the three–process parameters were significant (p < 0.05). Yield improved at high laser power, low scan speed, and increased layer thickness. Height was proportional to laser power, and inversely proportional to scan speed and layer thickness. Variations in the other responses were related to the porosity of the SOFs, which were dependent on the value of energy density. Low laser power, fast scan speed, and high layer thickness values favored a lower energy density, resulting in low weight and hardness, rapid disintegration, and a high percentage of drug release at 10 min. Finally, an optimization was performed, and an additional experiment validated the model. In conclusion, by applying a Quality by Design approach, this study demonstrates that process parameters are critical for printability, but also offer a way to personalize the properties of the SOFs. MDPI 2021-10-15 /pmc/articles/PMC8539463/ /pubmed/34683997 http://dx.doi.org/10.3390/pharmaceutics13101701 Text en © 2021 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
Gueche, Yanis A.
Sanchez-Ballester, Noelia M.
Bataille, Bernard
Aubert, Adrien
Rossi, Jean-Christophe
Soulairol, Ian
A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
title A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
title_full A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
title_fullStr A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
title_full_unstemmed A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
title_short A QbD Approach for Evaluating the Effect of Selective Laser Sintering Parameters on Printability and Properties of Solid Oral Forms
title_sort qbd approach for evaluating the effect of selective laser sintering parameters on printability and properties of solid oral forms
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8539463/
https://www.ncbi.nlm.nih.gov/pubmed/34683997
http://dx.doi.org/10.3390/pharmaceutics13101701
work_keys_str_mv AT guecheyanisa aqbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT sanchezballesternoeliam aqbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT bataillebernard aqbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT aubertadrien aqbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT rossijeanchristophe aqbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT soulairolian aqbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT guecheyanisa qbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT sanchezballesternoeliam qbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT bataillebernard qbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT aubertadrien qbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT rossijeanchristophe qbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms
AT soulairolian qbdapproachforevaluatingtheeffectofselectivelasersinteringparametersonprintabilityandpropertiesofsolidoralforms