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4 results on '"Maxime Cazes"'

1. D-Sorbitol Physical Properties Effects on Filaments Used by 3D Printing Process for Personalized Medicine

Author

Stéphane Roulon, Ian Soulairol, Maxime Cazes, Léna Lemierre, Nicolas Payre, Laurent Delbreilh, and Jean Alié

Subjects
3D printing, fused filament fabrication, hot melt extrusion, oral dosage forms, filament, personalized medicine, Organic chemistry, QD241-441
Abstract

Fused filament fabrication (FFF) is a process used to manufacture oral forms adapted to the needs of patients. Polyethylene oxide (PEO) filaments were produced by hot melt extrusion (HME) to obtain a filament suitable for the production of amiodarone hydrochloride oral forms by FFF 3D printing. In order to produce personalized oral forms adapted to the patient characteristics, filaments used by FFF must be controlled in terms of mass homogeneity along filament. This work highlights the relation between filament mass homogeneity and its diameter. This is why the impact of filler excipients physical properties was studied. It has been showed that the particle’s size distribution of the filler can modify the filament diameter variability which has had an impact on the mass of oral forms produced by FFF. Through this work it was shown that D-Sorbitol from Carlo Erba allows to obtain a diameter variability of less than 2% due to its unique particle’s size distribution. Using the filament produced by HME and an innovating calibration method based on the filament length, it has been possible to carry out three dosages of 125 mg, 750 mg and 1000 mg by 3D printing with acceptable mass uniformity.

Published
2021
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2. Production of Reproducible Filament Batches for the Fabrication of 3D Printed Oral Forms

Author

Stéphane Roulon, Ian Soulairol, Valérie Lavastre, Nicolas Payre, Maxime Cazes, Laurent Delbreilh, and Jean Alié

Subjects
3D printing, fused-filament fabrication, hot-melt extrusion, oral forms, filament, immediate release, Pharmacy and materia medica, RS1-441
Abstract

Patients need medications at a dosage suited to their physiological characteristics. Three-dimensional printing (3DP) technology by fused-filament fabrication (FFF) is a solution for manufacturing medication on demand. The aim of this work was to identify important parameters for the production of reproducible filament batches used by 3DP for oral formulations. Amiodarone hydrochloride, an antiarrhythmic and insoluble drug, was chosen as a model drug because of dosage adaptation need in children. Polyethylene oxide (PEO) filaments containing amiodarone hydrochloride were produced by hot-melt extrusion (HME). Different formulation storage conditions were investigated. For all formulations, the physical form of the drug following HME and fused-deposition modeling (FDM) 3D-printing processes were assessed using thermal analysis and X-ray powder diffraction (XRPD). Filament mechanical properties, linear mass density and surface roughness, were investigated by, respectively, 3-point bending, weighing, and scanning electron microscopy (SEM). Analysis results showed that the formulation storage condition before HME-modified filament linear mass density and, therefore, the oral forms masses from a batch to another. To obtain constant filament apparent density, it has been shown that a constant and reproducible drying condition is required to produce oral forms with constant mass.

Published
2021
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3. Production of Reproducible Filament Batches for the Fabrication of 3D Printed Oral Forms

Author

Nicolas Payre, Ian Soulairol, Laurent Delbreilh, Valérie Lavastre, Jean Alié, Maxime Cazes, Stéphane Roulon, Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU), Ecole Nationale Supérieure de Chimie de Montpellier (ENSCM), Sanofi-Aventis R&D, SANOFI Recherche, Groupe de physique des matériaux (GPM), Centre National de la Recherche Scientifique (CNRS)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche sur les Matériaux Avancés (IRMA), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), Normandie Université (NU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)-Université de Caen Normandie (UNICAEN), Normandie Université (NU)-École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), and Normandie Université (NU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Materials science, Scanning electron microscope, lcsh:RS1-441, Pharmaceutical Science, Fused filament fabrication, 02 engineering and technology, oral forms, 030226 pharmacology & pharmacy, Article, lcsh:Pharmacy and materia medica, Protein filament, 03 medical and health sciences, 0302 clinical medicine, Surface roughness, [SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering, Thermal analysis, Linear density, fused-filament fabrication, hot-melt extrusion, Amiodarone Hydrochloride, 3D printing, immediate release, 021001 nanoscience & nanotechnology, [SDV.SP.PG]Life Sciences [q-bio]/Pharmaceutical sciences/Galenic pharmacology, pediatric, Chemical engineering, filament, Extrusion, 0210 nano-technology
Abstract

International audience; Patients need medications at a dosage suited to their physiological characteristics. Three-dimensional printing (3DP) technology by fused-filament fabrication (FFF) is a solution for manufacturing medication on demand. The aim of this work was to identify important parameters for the production of reproducible filament batches used by 3DP for oral formulations. Amiodarone hydrochloride, an antiarrhythmic and insoluble drug, was chosen as a model drug because of dosage adaptation need in children. Polyethylene oxide (PEO) filaments containing amiodarone hydrochloride were produced by hot-melt extrusion (HME). Different formulation storage conditions were investigated. For all formulations, the physical form of the drug following HME and fused-deposition modeling (FDM) 3D-printing processes were assessed using thermal analysis and X-ray powder diffraction (XRPD). Filament mechanical properties, linear mass density and surface roughness, were investigated by, respectively, 3-point bending, weighing, and scanning electron microscopy (SEM). Analysis results showed that the formulation storage condition before HME-modified filament linear mass density and, therefore, the oral forms masses from a batch to another. To obtain constant filament apparent density, it has been shown that a constant and reproducible drying condition is required to produce oral forms with constant mass.

Published
2021

4. First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities

Author

Madeleine Hill, Philippe Hubert, Katerina Plachka, Abhijit Tarafder, Adrien Raimbault, Benjamin Wuyts, Manish Grangrade, Niranjan Desphande, Andrew J. Aubin, Fabien Mauge, Vincent Desfontaine, Lucie Nováková, Erik L. Regalado, Mengling Wong, Sophie Bertin, Alexandre Grand-Guillaume Perrenoud, Julien Lefevre, Estelle Corbel, Caroline West, Elise Lemasson, Santosh Sadaphule, Dorina Kotoni, Brandon M. Jocher, Adrian Clarke, Marion Iguiniz, Eric Lesellier, Tomas Leek, Davy Guillarme, Debby Mangelings, Yvan Vander Heyden, Loic Villemet, Ravi Yadav, Nicolas Roques, Sabine Heinisch, Philippe Hennig, Luca Gioacchino Losacco, Isabelle François, Maxime Cazes, Nathalie Da Costa, Claudio Brunelli, Jean-Luc Veuthey, William Farrell, Kelly Zhang, Roland Djang’eing’a Marini, Christophe Desvignes, Shankar Shringare, Charlene Galea, Michael J. Gray, Amandine Dispas, Sandesh Rane, Lulu Dai, Morgan Sarrut, School of Pharmaceutical Science, University of Geneva [Switzerland]-Université de Lausanne (UNIL), Laboratoire De Chimie Analytique Pharmaceutique, Université de Genève (UNIGE)-Ecole de pharmacie Genève-Lausanne (EPGL), Special Pathogens, Public Health Agency of Canada-National Microbiology Laboratory, Chromatography & Hyphenated Techniques - Chromatographie et techniques couplées, Institut des Sciences Analytiques (ISA), Institut de Chimie du CNRS (INC)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Sanofi R&D, Analyt Sci, Institut de Chimie Organique et Analytique (ICOA), Université d'Orléans (UO)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut de Chimie du CNRS (INC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Tampere University of Technology [Tampere] (TUT), NASA Goddard Space Flight Center (GSFC), Oril Industrie, Laboratoire des Sciences de l'Information et des Systèmes (LSIS), Centre National de la Recherche Scientifique (CNRS)-Arts et Métiers Paristech ENSAM Aix-en-Provence-Université de Toulon (UTLN)-Aix Marseille Université (AMU), Institut National de l'Environnement Industriel et des Risques (INERIS), Research grants from Walloon Region of Belgium and EU Commission (project FEDER-PHARE) to Amandine DISPAS are gratefully acknowledged. Waters (Milford, MA, USA) is acknowledged for supplying all columns used in this study. Novartis (Basel, Switzerland) is acknowledged for funding the EDQM standards sent to the participating laboratories. The author wants to thank M. Heptia and B. Dahmen for technical assistance and F. Bonivert for logistic help. K. Plachka and L. Novakova wish to gratefully acknowledge the grant project SVV No. 260412/2018 and the STARSS project (Reg. No. CZ.02.1.01/0.0/0.0/15_003/0000465) co-funded by ERDF. L. Montis (Waters) is acknowledged., Faculty of Medicine and Pharmacy, Pharmaceutical and Pharmacological Sciences, Chemical Engineering and Industrial Chemistry, Department of Analytical Chemistry, Applied Chemometrics and Molecular Modelling, Université de Lausanne = University of Lausanne (UNIL)-Université de Genève = University of Geneva (UNIGE), Université de Genève = University of Geneva (UNIGE)-Ecole de pharmacie Genève-Lausanne (EPGL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université d'Orléans (UO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), and Aix Marseille Université (AMU)-Université de Toulon (UTLN)-Arts et Métiers Paristech ENSAM Aix-en-Provence-Centre National de la Recherche Scientifique (CNRS)

Subjects
Quality Control, spectroscopy, Salbutamol sulfate, International Cooperation, Transferability, Clinical Biochemistry, Pharmaceutical Science, Context (language use), Food company, 01 natural sciences, Analytical Chemistry, [CHIM.ANAL]Chemical Sciences/Analytical chemistry, Drug Discovery, Supercritical Fluid Chromatography (SFC), Inter-laboratory, Process engineering, Pharmaceutical impurities, Collaborative study, ddc:615, Reproducibility, 010405 organic chemistry, business.industry, Chemistry, 010401 analytical chemistry, Reproducibility of Results, Chromatography, Supercritical Fluid, Repeatability, 0104 chemical sciences, Supercritical fluid chromatography, Drug Contamination, business, Inter-laboratory study, Chromatography, Liquid
Abstract

International audience; Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques.

Published
2018

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