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

Mark E. Lobatto, Claudia Calcagno, Maarten J. Otten, Antoine Millon, Sarayu Ramachandran, Maarten P.M. Paridaans, Fleur M. van der Valk, Gerrit Storm, Erik S.G. Stroes, Zahi A. Fayad, Willem J.M. Mulder, Josbert Maarten Metselaar

Research output: Contribution to journalArticleAcademicpeer-review

32 Citations (Scopus)


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.
Original languageEnglish
Pages (from-to)1133-1140
Issue number5
Publication statusPublished - 2015


  • METIS-315196
  • IR-99924


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