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; Gert Storm; Erik S.G. Stroes; Zahi A. Fayad; Willem J.M. Mulder; Josbert M. Metselaar

doi:10.1016/j.nano.2015.02.020

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, Gert Storm, Erik S.G. Stroes, Zahi A. Fayad, Willem J.M. Mulder, Josbert M. Metselaar

Biomaterials Science and Technology

Research output: Contribution to journal › Article › Academic › peer-review

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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 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 language	English
Pages (from-to)	1133-1140
Journal	Nanomedicine
Volume	11
Issue number	5
DOIs	https://doi.org/10.1016/j.nano.2015.02.020
Publication status	Published - 2015

Keywords

2024 OA procedure

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Lobatto, M. E., Calcagno, C., Otten, M. J., Millon, A., Ramachandran, S., Paridaans, M. P. M., van der Valk, F. M., Storm, G., Stroes, E. S. G., Fayad, Z. A., Mulder, W. J. M., & Metselaar, J. M. (2015). Pharmaceutical development and preclinical evaluation of a GMP-grade anti-inflammatory nanotherapy. Nanomedicine, 11(5), 1133-1140. https://doi.org/10.1016/j.nano.2015.02.020

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title = "Pharmaceutical development and preclinical evaluation of a GMP-grade anti-inflammatory nanotherapy",

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 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{\textquoteright}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.",

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

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doi = "10.1016/j.nano.2015.02.020",

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AU - Lobatto, Mark E.

AU - Calcagno, Claudia

AU - Otten, Maarten J.

AU - Millon, Antoine

AU - Ramachandran, Sarayu

AU - Paridaans, Maarten P.M.

AU - van der Valk, Fleur M.

AU - Storm, Gert

AU - Stroes, Erik S.G.

AU - Fayad, Zahi A.

AU - Mulder, Willem J.M.

AU - Metselaar, Josbert M.

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AB - 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.

KW - 2024 OA procedure

U2 - 10.1016/j.nano.2015.02.020

DO - 10.1016/j.nano.2015.02.020

M3 - Article

SN - 1743-5889

VL - 11

SP - 1133

EP - 1140

JO - Nanomedicine

JF - Nanomedicine

IS - 5

ER -

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

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