Lessons Learned from Pharmaceutical Nanomaterials - Safety of Nanomaterials along Their Lifecycle - page 109

6

Lessons Learned
from Pharmaceutical
Nanomaterials

Emad Malaeksefat, Sarah Barthold,
Brigitta Loretz, and Claus-Michael Lehr

CONTENTS
6.1 What Are Pharmaceutical Nanomaterials? “Nanoparticles” from a
Pharmaceutical Point of View ...................................................................... 112
6.1.1 Designs of Nanopharmaceuticals ..................................................... 112
6.1.2 Into the Human Body, But Safely ..................................................... 113
6.2 Effect of the Route of Application: Chances and Risks of
Nanopharmaceuticals ................................................................................... 114
6.3 Get to Know Your Nanoparticles ................................................................. 116
6.3.1 Current Status of Nanoparticle Characterization ............................. 117
6.3.1.1 Size ..................................................................................... 117
6.3.1.2 Shape and Structure ........................................................... 118
6.3.1.3 Charge ................................................................................ 118
6.3.1.4 Chemical Identity ............................................................... 118
6.3.2 Particle-Cell/Tissue Interactions ..................................................... 119
6.3.2.1 Cytotoxicity or Cell Viability ............................................ 119
6.3.2.2 Immunotoxicity .................................................................. 120
6.3.2.3 Genotoxicity or Mutagenicity ............................................ 120
6.3.2.4 Alterations in Cell Function ............................................... 120
6.4 Safety and Quality by Design ....................................................................... 121
6.5 Nanopharmaceuticals State of the Art.......................................................... 123
6.5.1 Application Fields: Why to Use Nanopharmaceuticals .................... 123
6.5.2 Nanopharmaceuticals on the Market ................................................ 125
6.5.2.1 Rapamune ® (Sirolimus) ...................................................... 125
6.5.2.2 Abraxane ® (Paclitaxel) ....................................................... 127
6.5.2.3 AmBisome ® (Amphoter icin B) .......................................... 128
6.5.2.4 Doxil/Caelyx ® (Doxorubicin) ............................................ 128
6.5.2.5 First siRNA Carrier in Clinical Trials (CALAA-01) ......... 128
6.5.3 Requirements for Nanopharmaceuticals .......................................... 129
6.6 Conclusion .................................................................................................... 130
References .............................................................................................................. 131

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