Journal
NANOMEDICINE-NANOTECHNOLOGY BIOLOGY AND MEDICINE
Volume 11, Issue 5, Pages 1133-1140Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.nano.2015.02.020
Keywords
Nanomedicine; GMP-grade; Formulation design; Prednisolone phosphate; Atherosclerosis
Funding
- European Framework Program 7 [FP7-Health 309820]
- Dutch network for Nanotechnology NanoNext NL, in the subprogram Drug Delivery
- National Heart, Lung, and Blood Institute, National Institutes of Health, as a Program of Excellence in Nanotechnology (PEN) Award [HHSN268201000045C]
- NIH [R01 HL118440, R01 HL125703, R01 EB009638]
- NWO [Vidi 91713324]
- Enceladus Pharmaceuticals (Amsterdam, The Netherlands)
- International Atherosclerosis Society (USA)
- Foundation De Drie Lichten (The Netherlands)
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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 100 nm +/- 10 nm, 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. From the Clinical Editor: 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 trials in humans. (C) 2015 Elsevier Inc. All rights reserved.
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