Immunoglobulin G particles manufacturing by spray drying process for pressurised metered dose inhaler formulations
| Autor: | Laurence Benissan, Gérard Coquerel, Pascal Cardinael, Laurence Menu-Bouaouiche, Véronique Carli |
|---|---|
| Přispěvatelé: | iDD-Xpert Laboratoire pharmaceutique, Laboratoire de Glycobiologie et Matrice Extracellulaire Végétale (Glyco-MEV), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU), Sciences et Méthodes Séparatives (SMS), Propre |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Materials science
[SDV.BIO]Life Sciences [q-bio]/Biotechnology Drug Compounding Pharmaceutical Science Excipient 02 engineering and technology [SDV.BC.BC]Life Sciences [q-bio]/Cellular Biology/Subcellular Processes [q-bio.SC] 030226 pharmacology & pharmacy Immunoglobulin G Excipients 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine [SDV.BBM.GTP]Life Sciences [q-bio]/Biochemistry Molecular Biology/Genomics [q-bio.GN] [SDV.BC.IC]Life Sciences [q-bio]/Cellular Biology/Cell Behavior [q-bio.CB] medicine Metered Dose Inhalers Desiccation Particle Size [SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry Molecular Biology/Biochemistry [q-bio.BM] ComputingMilieux_MISCELLANEOUS [SDV.BDD.GAM]Life Sciences [q-bio]/Development Biology/Gametogenesis Pharmacology Chromatography Aqueous solution biology [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry Molecular Biology/Molecular biology [SDV.BBM.MN]Life Sciences [q-bio]/Biochemistry Molecular Biology/Molecular Networks [q-bio.MN] 021001 nanoscience & nanotechnology Metered-dose inhaler Trehalose [SDV.BV.PEP]Life Sciences [q-bio]/Vegetal Biology/Phytopathology and phytopharmacy [SDV.BV.AP]Life Sciences [q-bio]/Vegetal Biology/Plant breeding [CHIM.POLY]Chemical Sciences/Polymers chemistry Spray drying biology.protein Feasibility Studies Particle size Mannitol Powders 0210 nano-technology medicine.drug |
| Zdroj: | Annales Pharmaceutiques Françaises Annales Pharmaceutiques Françaises, Elsevier Masson, 2018, 76 (4), pp.291-298. ⟨10.1016/j.pharma.2018.03.003⟩ |
| ISSN: | 0003-4509 |
| Popis: | Summary Objective The objective of this work is to show the feasibility of manufacturing from a spray drying process particles containing immunoglobulin G capable of being administered by inhalation via a pressurized metered dose inhaler. Methods Spray drying were made from aqueous solutions containing IgG and two types of excipients, mannitol and trehalose, with two ratios: 25% w/w and 75%w/w. The physicochemical and aerodynamic properties of the powders obtained were characterized just after manufacturing and after 1 month of storage at 40 °C/75% RH according to criteria defined as needed to satisfy an inhaled formulation with a pressurized metered dose inhaler. Maintain of the biological activity and the structure of IgG after atomization was also tested by slot blot and circular dichroism. Results All spray-dried powders presented a median diameter lower than 5 μm. The powders atomized with trehalose showed a solid state more stable than those atomized with mannitol. All atomized powders were in the form of wrinkled particles regardless the nature and the ratios of excipients. The results showed that the aerosolisation properties were compliant with the target, independently of the excipient used at a ratio of 25% w/w IgG-excipient. Moreover, the addition of excipient during the atomization process the denaturation of IgG was limited. Conclusion This study showed that the use of trehalose as excipient could satisfy the requirements of an inhaled formulation with a pressurized metered dose inhaler. |
| Databáze: | OpenAIRE |
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