Pharmaceutical development and preclinical evaluation of a GMP-grade anti-inflammatory nanotherapy

Nanomedicine : Nanotechnology, Biology, and Medicine
Mark E LobattoJosbert M Metselaar

Abstract

The present study describes the development of a good manufacturing practice (GMP)-grade liposomal nanotherapy containing prednisolone phosphate for the treatment of inflammatory diseases. After formulation design, GMP production was commenced which yielded consistent, stable liposomes sized 100nm±10nm, with a prednisolone phosphate (PLP) incorporation efficiency of 3%-5%. Pharmacokinetics and toxicokinetics of GMP-grade liposomal nanoparticles were evaluated in healthy rats, which were compared to daily and weekly administration of free prednisolone phosphate, revealing a long circulatory half-life with minimal side effects. Subsequently, non-invasive multimodal clinical imaging after liposomal nanotherapy's intravenous administration revealed anti-inflammatory effects on the vessel wall of atherosclerotic rabbits. The present program led to institutional review board approval for two clinical trials with patients with atherosclerosis. In drug discovery, bringing production to industrial scale is an essential process. In this article the authors describe the development of an anti-inflammatory nanoparticle according to good manufacturing practice. As a result, this paves the way for translating laboratory studies to clinical t...Continue Reading

References

Mar 13, 2002·Circulation·Johann W AuerBernd Eber
Apr 25, 2006·Journal of the American College of Cardiology·Erling Falk
Jan 1, 1986·Journal of Pharmaceutical and Biomedical Analysis·H DerendorfH Möllmann
Oct 13, 2006·Nature Biotechnology·Volker WagnerAxel Zweck
Feb 29, 2008·Magnetic Resonance in Medicine : Official Journal of the Society of Magnetic Resonance in Medicine·W S KerwinT S Hatsukami
Mar 19, 2008·Journal of Liposome Research·Manuela BanciuGert Storm
May 17, 2008·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·James H F RuddZahi A Fayad
Feb 12, 2009·ACS Nano·Omid C Farokhzad, Robert Langer
Jul 10, 2010·Nature Reviews. Drug Discovery·Robby A Petros, Joseph M DeSimone
Jun 4, 2011·Molecular Pharmaceutics·Jolanda M van den HovenGert Storm
Oct 22, 2011·Nature Reviews. Drug Discovery·Mark E LobattoWillem J M Mulder
Jan 12, 2013·Science·Ira Tabas, Christopher K Glass
Feb 26, 2013·Current Topics in Medicinal Chemistry·Yongmin ChangKwon-Seok Chae
Jun 6, 2014·Science Translational Medicine·Willem J M MulderMatthias Nahrendorf

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Citations

Nov 20, 2015·Nanomedicine·Cédric Chauvierre, Didier Letourneur
Mar 27, 2016·Nanomedicine : Nanotechnology, Biology, and Medicine·Fleur M van der ValkAnouk A J Hamers
Jun 1, 2016·Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology·Jia ZhangShu Wang
Dec 21, 2017·Expert Opinion on Drug Delivery·Hanan Al-LawatiAfsaneh Lavasanifar
Aug 31, 2018·Cardiovascular Research·Iwona CichaDidier Letourneur
Nov 8, 2018·Physics in Medicine and Biology·Timothy Sowers, Stanislav Emelianov
Mar 29, 2019·Arteriosclerosis, Thrombosis, and Vascular Biology·Rob C I WüstGustav J Strijkers
Apr 3, 2020·Arteriosclerosis, Thrombosis, and Vascular Biology·Claudia CalcagnoZahi A Fayad
Jun 17, 2020·Advanced Healthcare Materials·Anastasia DarwitanSubbu Venkatraman
Oct 11, 2017·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Carla M A van AlemJoris I Rotmans
Feb 23, 2019·Arteriosclerosis, Thrombosis, and Vascular Biology·Alyssa M FloresNicholas J Leeper
Sep 27, 2018·Molecular Imaging and Biology : MIB : the Official Publication of the Academy of Molecular Imaging·Jonathan VigneUNKNOWN Cardiovascular study group of the European Society of Molecular Imaging
Dec 7, 2018·Frontiers in Pharmacology·Hannah A StrobelMarsha W Rolle
Nov 11, 2019·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Jana KubackovaOndrej Holas
Feb 12, 2021·Drug Delivery and Translational Research·Chee Wai WongTina T Wong
Jun 27, 2021·Advanced Drug Delivery Reviews·Marc-Phillip MastMatthias G Wacker

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