Residual Solvents in Nanomedicine and Lipid-Based Drug Delivery Systems: a Case Study to Better Understand Processes
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RESEARCH PAPER
Residual Solvents in Nanomedicine and Lipid-Based Drug Delivery Systems: a Case Study to Better Understand Processes Amrita Dikpati 1 , 2 & Farzad Mohammadi 2 , 3 & Karine Greffard 2 & Caroline Quéant 2 & Philippe Arnaud 4 & Guillaume Bastiat 5 & Iwona Rudkowska 2,3 & Nicolas Bertrand 1,2
Received: 29 February 2020 / Accepted: 8 July 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
ABSTRACT Purpose Complexities surrounding the manufacture and quality control of nanomedicines become increasingly apparent. This research article offers a case study to investigate how, at the laboratory scale, various stages of liposome and nanoparticle synthesis affect the amount of residual solvent found in the formulations. The objective is to bring insights on the reliability of each of these processes to provide final products which meet regulatory standards and facilitate identifying possible bottleneck early during the development process. Methods The residual solvent at various stages of preparation and purification was measured by headspace gas chromatography. Liposomes were prepared by two different methods with and without solvent. Polymer nanoparticles prepared via nanoprecipitation and purified by ultrafiltration were Amrita Dikpati, Farzad Mohammadi and Karine Greffard contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11095-020-02877-x) contains supplementary material, which is available to authorized users. * Nicolas Bertrand [email protected] 1
Faculty of Pharmacy, Université Laval, Pavillon Ferdinand-Vandry, 1050, avenue de la Médecine, Québec G1V 0A6, Canada
2
Endocrinology and Nephrology Unit, CHU de Québec - Université Laval Research Center, 2705 Laurier Blvd, Québec City G1V 4G2, Canada
3
Department of Kinesiology, Faculty of Medicine, Université Laval, 2300 rue de la Terrasse, Québec G1V 0A6, Canada
4
Faculté de Pharmacie de Paris, Université de Paris, 4 avenue de l’Observatoire, 75006 Paris, France
5
Micro et Nanomédecines Translationnelles, MINT, UNIV Angers, UMR INSERM 1066, UMR CNRS 6021, 4 rue Larrey, 49933 Angers, Cedex 9, France
studied. The effects of purification by size exclusion chromatography and dialysis were also investigated. Results The complete removal of residual solvent requires processes which go beyond usual preparation methods. Conclusions This work might prove valuable as a reference for scientists of different fields to compare their own practices and streamline the translation of nanomedicines into efficacious and safe drug products.
KEY WORDS liposomes . nanoparticles . nanomedicine manufacturing . residual solvent . gas chromatography . quality control Pharmacopoeias define residual solvents as organic volatile impurities found in final drug products [1]. Solvents can originate from the manufacturing and purification of active drug substances and excipients, but also from the cleaning and maintenance of equipment. Importantly, in complex drug p
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