Back to Search
Start Over
Pharmaceutical development and preclinical evaluation of a GMP-grade anti-inflammatory nanotherapy
- Source :
- Nanomedicine: Nanotechnology, Biology and Medicine, Nanomedicine: Nanotechnology, Biology and Medicine, Elsevier, 2015, 11 (5), pp.1133-40. ⟨10.1016/j.nano.2015.02.020⟩, Nanomedicine: nanotechnology, biology and medicine, 11(5), 1133-1140. Elsevier Inc., Nanomedicine, 11(5), 1133-1140. Future Medicine Ltd., Nanomedicine : nanotechnology, biology and medicine, 11(5), 1133. Elsevier
- Publication Year :
- 2015
- Publisher :
- Elsevier BV, 2015.
-
Abstract
- International audience; 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. 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.
- Subjects :
- Male
Chemistry, Pharmaceutical
[SDV]Life Sciences [q-bio]
Anti-Inflammatory Agents
Wistar
Pharmaceutical Science
Medicine (miscellaneous)
use/toxicity
Pharmacology
GMP-grade
Rats, Sprague-Dawley
General Materials Science
Clinical imaging
Pharmaceutical sciences
Prednisolone/administration & dosage/*analogs &
Aorta
Liposome
Prednisolone phosphate
Anti-Inflammatory Agents/*administration & dosage/pharmacokinetics/therapeutic
METIS-315196
Pharmaceutical/*methods
IR-99924
3. Good health
Chemistry
Nanomedicine
Aorta/drug effects/pathology
Molecular Medicine
Rabbits
Half-Life
medicine.drug_class
Prednisolone
Biomedical Engineering
Bioengineering
Article
Anti-inflammatory
derivatives/pharmacokinetics/therapeutic use/toxicity
Materials Science(all)
Pharmacokinetics
medicine
Humans
Animals
Toxicokinetics
Glucocorticoids/*administration & dosage/pharmacokinetics/therapeutic
Rats, Wistar
Glucocorticoids
business.industry
Atherosclerosis
Rats
Clinical trial
Formulation design
Liposomes
Sprague-Dawley
Atherosclerosis/*drug therapy/pathology
business
Subjects
Details
- ISSN :
- 15499634 and 17435889
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Nanomedicine: Nanotechnology, Biology and Medicine
- Accession number :
- edsair.doi.dedup.....e79ed09ed8f998ca03ede8ef7ef7a4a7