Biomedical Engineering Reference
In-Depth Information
Characterization of nanopharmaceuticals is an important point in nanopharmaceu-
ticals production. As characterization of a simple formulation is easier compared to
a more difficult constructed one, the complexity (structure and composition) of mar-
keted formulations so far has been generally simple. Although there are a couple of
characterization methods, nanoparticulate formulations can be challenging to char-
acterize (Oberdörster, Oberdörster, and Oberdörster 2005; Oberdörster et al. 2005;
Powers et al. 2006). Besides formal characterization techniques for size, size distri-
bution, and so on, there is a special need for characterizing the toxicological hazard,
which is difficult due to the wide range of different engineered nanomaterials. A
team of the International Life Sciences Institute Research Foundation/Risk Science
Institute developed a screening strategy for the hazard identification of nanomateri-
als for early stage risk assessment.
6.6 CONCLUSION
The first nanopharmaceuticals, which have already reached the market, demonstrate
that there is a chance of success for such products. But these relatively few positive
cases do not reflect the full potential of this technology yet. There are still many
unmet medical needs, where nanopharmaceuticals hold promises to either improve
efficiency and/or reduce toxicity, or even open pathways to entirely new therapeu-
tic modalities. With the rise of macromolecular biopharmaceuticals (i.e., peptide or
nucleotide based drugs), there is also a need for new delivery agents that not only
deliver the active pharmaceutical ingredient to its target but also preserve its stabil-
ity during preparation, storage, and circulation in the body. Sound knowledge of the
materials, their toxicity, biocompatibility, and biodegradability is a basis for suc-
cessful nanoparticulate formulations (Cleland, Daugherty, and Mrsny 2001; Miele
et al. 2009). Statements that simpler carrier systems are much easier in translation
to clinics do by no way implicate that more complicated systems may not have their
advantages. Scientists working on combinatorial systems, however, should also work
on methods for high precision fabrication and analytical methods, which are suitable
not only for elucidation of the exact structure but also for enabling a quality control.
There is no clear regulatory and safety guideline explicitly for nanopharmaceu-
ticals. At the moment, they are treated like every other medicinal product to get
approval for the market. Most likely, however, nanopharmaceuticals could get faster
in their translation, if we manage to identify rules helping in prediction of nanopar-
ticles risks based on the input parameters (materials, manufacturing methods, puri-
fication, etc.) and their resulting particle properties (size, zeta potential, surface
functionalities, etc.). In this scenario, we hopefully know the impact of the carrier
and thus have to characterize only for biokinetics (comparable to what we perform
now with tablets or capsules).
The multidisciplinary nature of the field cannot be reduced. Thus, it is vital for
scientists working in the field of nanopharmaceuticals to have a basic understanding
of the physicochemical behavior, nanotechnological methods as well as biological
targets, physiological environment, and toxicological possibilities—at least in such
an extent to manage communication to experts of the other subdisciplines. In addi-
tion, we may need communication/computer scientists to manage the organization of
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