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Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach

Significant improvements in the wettability and dissolution rate of celecoxib (CEL), a poorly soluble selective cyclooxygenase-2 (COX-2) inhibitor, have been shown by Huyn et al., 2019 by combining the binary pharmaceutical compositions including CEL and one of the two co-formers, adipic acid (ADI)...

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Autores principales: Hong, Seung-Hyeon, Dinh, Linh, Abuzar, Sharif Md, Lee, Eun Seok, Hwang, Sung-Joo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9331714/
https://www.ncbi.nlm.nih.gov/pubmed/35893805
http://dx.doi.org/10.3390/pharmaceutics14081549
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author Hong, Seung-Hyeon
Dinh, Linh
Abuzar, Sharif Md
Lee, Eun Seok
Hwang, Sung-Joo
author_facet Hong, Seung-Hyeon
Dinh, Linh
Abuzar, Sharif Md
Lee, Eun Seok
Hwang, Sung-Joo
author_sort Hong, Seung-Hyeon
collection PubMed
description Significant improvements in the wettability and dissolution rate of celecoxib (CEL), a poorly soluble selective cyclooxygenase-2 (COX-2) inhibitor, have been shown by Huyn et al., 2019 by combining the binary pharmaceutical compositions including CEL and one of the two co-formers, adipic acid (ADI) and saccharin (SAC), into eutectic mixtures (EM). Purpose: In this study, we developed a therapeutic eutectic system for CEL which is a promising approach for oral delivery to enhance bioavailability. CEL EM were synthesized by novel techniques including supercritical CO(2) techniques and new tablet formulations were purposed. Methods: CEL EM were synthesized by evaporation crystallization method, spray drying, supercritical fluid (SCF) techniques. The CEL EM particles were then characterized by differential scanning calorimetry, powder X-ray diffraction, Fourier-transform infrared spectroscopy, scanning electron microscope, and particle size analysis. Dissolution studies were carried out. With a quality by design approach, a statistical method through design of experiment and data analysis by JMP(®) (SAS institute) was applied to CEL EM immediate release tablet formulation development. Results: CEL EM produced by spray drying technique, supercritical fluid (SCF) techniques were identified and characterized. The enhancement of dissolution was observed for SCF processed samples. The design space for CEL-ADI EM IR tablet and control limits for individual parameters were determined.
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spelling pubmed-93317142022-07-29 Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach Hong, Seung-Hyeon Dinh, Linh Abuzar, Sharif Md Lee, Eun Seok Hwang, Sung-Joo Pharmaceutics Article Significant improvements in the wettability and dissolution rate of celecoxib (CEL), a poorly soluble selective cyclooxygenase-2 (COX-2) inhibitor, have been shown by Huyn et al., 2019 by combining the binary pharmaceutical compositions including CEL and one of the two co-formers, adipic acid (ADI) and saccharin (SAC), into eutectic mixtures (EM). Purpose: In this study, we developed a therapeutic eutectic system for CEL which is a promising approach for oral delivery to enhance bioavailability. CEL EM were synthesized by novel techniques including supercritical CO(2) techniques and new tablet formulations were purposed. Methods: CEL EM were synthesized by evaporation crystallization method, spray drying, supercritical fluid (SCF) techniques. The CEL EM particles were then characterized by differential scanning calorimetry, powder X-ray diffraction, Fourier-transform infrared spectroscopy, scanning electron microscope, and particle size analysis. Dissolution studies were carried out. With a quality by design approach, a statistical method through design of experiment and data analysis by JMP(®) (SAS institute) was applied to CEL EM immediate release tablet formulation development. Results: CEL EM produced by spray drying technique, supercritical fluid (SCF) techniques were identified and characterized. The enhancement of dissolution was observed for SCF processed samples. The design space for CEL-ADI EM IR tablet and control limits for individual parameters were determined. MDPI 2022-07-26 /pmc/articles/PMC9331714/ /pubmed/35893805 http://dx.doi.org/10.3390/pharmaceutics14081549 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
Hong, Seung-Hyeon
Dinh, Linh
Abuzar, Sharif Md
Lee, Eun Seok
Hwang, Sung-Joo
Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach
title Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach
title_full Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach
title_fullStr Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach
title_full_unstemmed Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach
title_short Synthesis of Celecoxib-Eutectic Mixture Particles via Supercritical CO(2) Process and Celecoxib Immediate Release Tablet Formulation by Quality by Design Approach
title_sort synthesis of celecoxib-eutectic mixture particles via supercritical co(2) process and celecoxib immediate release tablet formulation by quality by design approach
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9331714/
https://www.ncbi.nlm.nih.gov/pubmed/35893805
http://dx.doi.org/10.3390/pharmaceutics14081549
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