Preface

The book series titled Expectations and Real-
ities of Multifunctional Drug Delivery Systems
covers several important topics on drug-delivery
systems, regulatory requirements, clinical studies,
intellectual properties trends, new advances,
manufacturing challenges, etc. written by leading
industry and academic experts. Overall, the
chapters published in this series reflect the broad-
ness of nanopharmaceuticals, microparticles,
other drug carriers and the importance of the
respective quality, regulatory, clinical, GMP scale
up, and regulatory registration aspects.
This series is destined to fill the knowledge
gap through information sharing and with orga-
nized research compilation between diverse
areas of pharma, medicine, clinical, regulatory
practices, and academics.
Expectations and Realities of Multifunctional Drug
Delivery Systems is divided into four volumes:
Volume 1: Nanopharmaceuticals
Volume 2: Delivery of Drugs
Volume 3: Drug Delivery Trends
Volume 4: Drug Delivery Aspects
The specific objectives of this book series are
to:
(1) provide a platform to discuss opportunities
and challenges in development of
nanomedicine and other drug-delivery
systems;
(2) discuss current and future market trends;
(3) facilitate insight sharing within various
areas of expertise; and
(4) establish collaborations between academic
scientists, and industrial and clinical
researchers.
Innovative cutting-edge developments in
micro-nanotechnology offer new ways of pre-
venting and treating diseases like cancer, ma-
laria, HIV/AIDS, tuberculosis, and many more.
The application of micro-nanoparticles in drug
delivery, diagnostics, and imaging is vast.
Hence, Volume 1: Nanopharmaceuticals, in
the book series mainly reviews advances in
drug delivery area via targeted therapy with
improved drug efficiency at a lower dose, trans-
portation of the drug across physiological bar-
riers as well as reduced drug-related toxicity.
One of the contributions by Campos et al.
(Chapter 1) discusses the influence of physico-
chemical factors affecting long-term stability,
release and toxicological profiles of solid lipid
nanoparticles. This chapter also reviews the
importance of composition and administration
routes studied for lipid nanocarrier systems.
In another manuscript by Rachmawati et al.
(Chapter 2), the authors highlight the current
status of drug delivery development for herbal
bioactives. Along with various mucosal bio-
carriers, the authors describe biokinetic and
clinical translation challenges with herbal deliv-
ery and limitations with regulatory procedures.
In this chapter herbal nanocarriers like lipid
nanoparticles, nanosuspensions etc. are
discussed in detail.

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Chapter 3 by Rostamizadeh et al. describes
the development of polymeric micelles for multi-
ple drug delivery in oncology. The co-loading of
two or more drugs is possible using polymeric
micelles. The authors describe the types of
polymers employed, preparation methods, and
characterization techniques for such carrier
systems. Furthermore, wider applications like
chemotherapeutic delivery, stimuli-responsive
drug delivery, and targeted-drug delivery via
such carriers is discussed in detail. On the other
hand, hyaluronic acid nanoparticles are being
widely explored in nanomedicines. The promising
nanocarriers to deliver drugs in conjugated, self-
assembled, or in nanocomplex form are discussed
in the book chapter by Nasr et al. in Chapter 4. The
authors confirm that the current research
shows impressive research findings in areas like
osteoarthritis, tissue engineering, cancer target-
ing, theranostic applications, and so on, which
are under further exploration by industry.
The work by Jadav and Paradkar (Chapter 5)
is aimed at discussing widely studied drug
delivery systems in academics and in industry,
i.e. solid dispersions. Various aspects like classi-
fication of solid dispersions, their formulation
optimization, processing and physicochemical
characterization are reviewed in this chapter.
Chapter 6 by Bueno highlights the impor-
tance of understanding nanotoxicity at early
stages of development. Although nanocarriers
have shown promising results in delivering
drugs at target sites or locations, the accumula-
tion of nanoparticles at cellular and tissue
levels in excess causes toxicity. Current literature
contains very limited information on this topic.
This chapter reviews various aspects of nanotox-
icity and provides information on key concepts
for evaluation of the toxicity.
The topic presented by Diaz-Arévalo et al.
(Chapter 7) describes the systemic review of
nanoparticles-based vaccine development. Initial
results of nanocarriers like liposomes, virus like
particles, metallic and nonmetallic particles, and
polymeric nanoparticles in vaccine therapy are
promising although some limitations like stability
and cytotoxicity needs to be overcome.
Chapter 8 by Kovacevic discusses delivery of
poorly soluble and low-permeable drugs via
lipid nanocarriers. An overview of available
mechanistic studies in model and in real cell
membranes for better understanding of cell
internalization processes is provided.
The chapter by Alexander et al. (Chapter 9)
reviews approaches for effective brain drug deliv-
ery using nasal mucosa. This route can deliver
drugs effectively at target sites with improved
therapeutic performance of drugs. In addition,
the authors explain limitations of this drug deliv-
ery route and regulatory market approval
challenges.
Starling-Windhof et al. (Chapter 10) address
industry and technology trends in the intellec-
tual property (IP) landscape of pharmaceutical
drug delivery over 3 decades. It is fascinating
to see the global picture; it makes scientists
aware of the trends and special interests of
specific geographical regions or markets.
This chapter provides information on IP trends
in oral, topical, and parenteral drug delivery
area. Guidance on emerging trends and
IP-monitoring strategies are also presented.
In summary, I am sure this book volume and
the complete book series will provide you great
insights in areas of micro-nanomedicines, drug
delivery sciences, new trends, and regulatory
aspects.
O. Farokhzad, R. Langer, and the National
Cancer Institute are gratefully acknowledged for
the book cover image, which represents the po-
tential of nanopharmaceuticals in targeting drug
molecules. This photograph presented on cover
page captures interactions of surface-modified
polymeric nanoparticles with prostate cancer
cellsdit is an ideal example for drug targeting.
All the efforts of experts, scientists, and
authors are highly acknowledged for sharing their
knowledge, ideas, and insights about the topic.
Ranjita Shegokar, PhD
Editor