Drug Delivery Aspects: Expectations and Realities of Multifunctional Drug Delivery Systems: Volume 4: Expectations and Realities of Multifunctional Drug Delivery Systems

258 Pages·2020·14.759 MB·English

by  Ranjita Shegokar (editor)

DRUG DELIVERY ASPECTS
DRUG DELIVERY ASPECTS
EXPECTATIONS AND REALITIES OF
MULTIFUNCTIONAL DRUG
DELIVERY SYSTEMS
VOLUME 4
Editedby
R S , P D
ANJITA HEGOKAR H
CapnomedGmbH,Zimmern,Germany
Elsevier
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Contributors
Hend Abd-Allah Department of Pharmaceutics Riham I. El-Gogary Department of Pharmaceutics
and Industrial Pharmacy, Faculty of Pharmacy, and Industrial Pharmacy, Faculty of Pharmacy,
AinShamsUniversity,Cairo,Egypt AinShamsUniversity,Cairo,Egypt
SaraM.AbdelSamie DepartmentofPharmaceutics Muhammad Irfan Department of Pharmaceutics,
andIndustrialPharmacy,FacultyofPharmacy,Ain FacultyofPharmaceuticalSciences,GCUniversity
ShamsUniversity,Cairo,Egypt Faisalabad,Faisalabad,Pakistan
Mona M.A. Abdel-Mottaleb Department of Phar- Nirmal Jayabalan Department of Pharmacy, Birla
maceutics and Industrial Pharmacy, Faculty of Institute of Technology and Science, Pilani,
Pharmacy, Ain Shams University, Cairo, Egypt; Hyderabad,India
PEPITEEA4267,Univ.BourgogneFranche-Comt(cid:1)e, AnđelkaB.Kova(cid:3)cevi(cid:1)c DepartmentofPharmaceuti-
Besanc¸on,France cal Technology, Faculty of Biological Sciences,
Abid Riaz Ahmed Merck Healthcare KGaA, InstituteofPharmacy,Friedrich-SchillerUniversity
Darmstadt,Germany Jena,Jena,Germany
Akash Chavrasiya Department of Pharmacy, Birla DharmeshMehta BusinessDevelopment,Gangwal
Institute of Technology and Science, Pilani, Chemicals,Mumbai,India
Hyderabad,India Joana Portugal Mota Lecifarma—Laborato´rio
Yanping Chen Center of Emphasis in Infectious Farmac^eutico, Lda, Va´rzea do Andrade—Cabec¸o
Diseases, Department of Molecular and Transla- de Montachique, Lousa; CBIOS-Research Center
tionalMedicine,PaulL.FosterSchoolofMedicine, forBiosciencesandHealthTechnologies,Luso´fona
Texas Tech University Health Sciences Center El University,Lisbon,Portugal
Paso,ElPaso,TX,UnitedStates Mostafa Nakach Sanofi R&D, Vitry sur Seine,
Joa˜o Dias-Ferreira Department of Pharmaceutical France
Technology, Faculty of Pharmacy, University of Maha Nasr Department of Pharmaceutics and
Coimbra,Coimbra,Portugal Industrial Pharmacy, Faculty of Pharmacy, Ain
Diana Diaz-Ar(cid:1)evalo Immunology Functional ShamsUniversity,Cairo,Egypt
Group, Foundation Institute of Immunology of Ridahunlang Nongkhlaw Department of Phar-
Colombia-FIDIC, School of Medicine and Health
macy, Birla Institute of Technology and Science,
Sciences, Universidad del Rosario, Bogota, D.C., Pilani,Hyderabad,India
Colombia
Parameswar Patra Department of Pharmacy, Birla
Sachin Dubey Formulation, Analytical and Drug
Institute of Technology and Science, Pilani,
ProductDevelopment,GlenmarkPharmaceuticals,
Hyderabad,India
LaChauxdeFonds,Switzerland
Antonello Santini Department of Pharmacy,
Alessandra Durazzo CREA-Research Centre for UniversityofNapoli“FedericoII”,Napoli,Italy
FoodandNutrition,Rome,Italy
Ahmad Abdul-Wahhab Shahba Kayyali Chair for
Thomas Du€rig R&D and Innovation, Ashland
PharmaceuticalIndustries,DepartmentofPharma-
PharmaandHealth&Wellness,AshlandSpecialty
ceutics, College of Pharmacy, King Saud Univer-
IngredientsG.P.,Wilmington,DE,UnitedStates sity,Riyadh,SaudiArabia
vii
viii
Contributors
Ranjita Shegokar Capnomed GmbH, Zimmern, DepartmentofMolecularandTranslationalMedi-
Germany cine,PaulL.FosterSchoolofMedicine,TexasTech
VaibhavSihorkar Formulations,NCEandInnova- UniversityHealthSciencesCenterElPaso,ElPaso,
TX,UnitedStates
tion, Sai Life Sciences Limited, ICICI Knowledge
Park, Genome Valley, Hyderabad, Telangana, Yongyong Yan Key Laboratory of Oral Medicine,
India GuangzhouInstituteofOralDisease,Stomatology
Sarabjit Singh Formulation Research, CIPLA, Hospital of Guangzhou Medical University,
Guangzhou, Guangdong, People’s Republic of
Mumbai,India
China; Center of Emphasis in Infectious Diseases,
Eliana B. Souto Department of Pharmaceutical
DepartmentofMolecularandTranslationalMedi-
Technology, Faculty of Pharmacy, University of
cine,PaulL.FosterSchoolofMedicine,TexasTech
Coimbra, Coimbra; CEB—Centre of Biological
UniversityHealthSciencesCenterElPaso,ElPaso,
Engineering, University of Minho, Gualtar Cam-
TX,UnitedStates
pus,Braga,Portugal
Mingtao Zeng Center of Emphasis in Infectious
Haiyan Wang Key Laboratory of Oral Medicine,
Diseases, Department of Molecular and Transla-
GuangzhouInstituteofOralDisease,Stomatology
tionalMedicine,PaulL.FosterSchoolofMedicine,
Hospital of Guangzhou Medical University,
Texas Tech University Health Sciences Center El
Guangzhou, Guangdong, People’s Republic of
Paso,ElPaso,TX,UnitedStates
China; Center of Emphasis in Infectious Diseases,
Preface
ThebookseriestitledExpectationsandReal- 3. facilitate insight sharing within various
itiesofMultifunctionalDrugDeliverySystems areas of expertise;and
covers several important topics on drug-deliv- 4. establish collaborations between academic
ery systems, regulatory requirements, clinical scientists, andindustrial and clinical
studies, intellectual properties trends, new researchers.
advances, manufacturing challenges, etc., writ-
Innovative cutting-edge developments in
ten by leading industry and academic experts.
micro–nanotechnology offer new ways of pre-
Overall, the chapters published in this series
venting and treating diseases like cancer,
reflect the broadness of nanopharmaceuticals,
malaria, HIV/AIDS, tuberculosis, and many
microparticles, other drug carriers, and the
more. The applications of micro–nanoparticles
importanceoftherespectivequality,regulatory,
in drug delivery, diagnostics, and imaging are
clinical,GMPscale-up, andregulatoryregistra-
vast.Hence,Volume4:DrugDeliveryAspects
tion aspects.
in the book series mainly reviews advances in
This series is destined to fill the knowledge
drug delivery areas via targeted therapy with
gapthroughinformationsharingandwithorga-
improveddrugefficiencyatalowerdose,trans-
nized research compilation between diverse
portation of the drug across physiological bar-
areas of pharma, medicine, clinical, regulatory
riers, as well as reduced drug-related toxicity.
practices, and academics.
The focus of this volume is on GMP scale-up,
Expectations and Realities of Multifunctional
regulatory, functional, and preclinical aspects
Drug Delivery Systems is divided into four
of drug delivery systems.
volumes:
One of the contributions by Abdel-Mottaleb
Volume 1: Nanopharmaceuticals et al. (Chapter 1) discusses new trends in drug
Volume 2: Delivery of Drugs deliveryareausinghyaluronicacid,asaningre-
Volume 3: Drug Delivery Trends dientaswellasanactive.Thepharmaindustryis
Volume 4: Drug Delivery Aspects always in search ofnew and functional ingredi-
ents. Hyaluronic represents one such example,
The specific objectives of this book series
and iscurrently beingexplored asa drug deliv-
are to:
ery agent for a wide range of routes like nasal,
1. provide aplatform to discussopportunities pulmonary, ophthalmic, topical, and parenteral.
andchallenges in development of The authors review its potential in wound
nanomedicine and other drug-delivery healing,osteoarthritis,tissueengineering,cancer
systems; targeting, atherosclerosis, diabetes treatment,
2. discuss current and future market trends; theranostic,imagingapplications,andsoon.
ix
x
Preface
Chapter 2, by Shegokar, highlights basic generation excipients, especially polymers and
understandingsonpreclinicaltesting.Thistopic processing techniques like HME. This chapter
hasrecentlybeenseriouslypickedupbyindus- provides readers an in-depth understanding
try and regulatory bodies. However, it is not of key parameters in formulating stable solid
easytogetaclearviewonwhattypesofpreclin- amorphousdispersionsfromanindustrialpoint
ical strategy one must select for specific drug of view.
delivery types. Multiple CROs (contract Chapter 6 by Nongkhlaw et al. highlights
research organizations) exist to support indus- opportunitiesandchallengesinformulatingbio-
try/academics on this, but it is a time- pharmaceuticals. It is another trend spotted in
consuming and costly discussion. Therefore, pharmaceutical drug delivery in addition to
thefocusofthischapteristogivereadersabasic nanotechnology. The authors describe in detail
understanding of preclinical phase and desired technological potential, industrial advantages,
testings, guidelines available, and an overview technologies available, and limitations of the
of regulatory requirements, and upcoming sameforlocal(targetingbrain,pulmonary,ocu-
trends inthe field. lar,oral,etc.)andintravenousdrugadministra-
The contribution by Ahmed et al. in tion of biopharmaceuticals. At the end of the
Chapter3describestheimportanceofaqueous chapter, an overview of formulation strategies
filmcoatings.Themainaimofthischapteristo and ingredient choice isprovided.
provideanoverviewonthecuring(postthermal Nanotechnology is good, but to what
treatment) and storage stability of aqueous extent? It is slowly posing health hazards not
coated dosage forms. In this chapter, a novel onlythoughautomobilesbutalsothoughfood,
approachofaqueouscoating—solidificationof medicine, cosmetics, and detergents. The
Self-NanoEmulsifying Drug Delivery Systems topic presented by Souto et al., in Chapter 7
(SNEDDS)—is discussed, which can signifi- describes the regulatory and ethical issues in
cantly enhance the solubility and stability of nanoparticles, materials, and particles (NMP)
poorlysolubledrugs. research. The chapter further outlines the pre-
A chapter by Shegokar and Nakach sent and future of nanotechnology, and its
(Chapter 4) reviews industrial scale-up aspects applicationsalongtheaxisofsocialandethical
ofthemostemployedtechniqueinnanoparticle concerns.
production, milling. Very few reports are pub- Chapter8bySinghandMehtareviewssteril-
lished in literature; however, they describe the ization opportunities and challenges for drug
scale-upofoneparticulardrugdeliverysystem. deliverysystems.Theteamofauthorshighlights
Thefocusofthischapteristogivereadersanin- keypointsliketheroleofformulations,physical
depth understanding of the milling technique forms,choiceofsterilizationtechnique,andreg-
for production of nanoparticles, GMP settings, ulatoryrequirements.Anindustrialperspective
regulations associated with it, and anoverview is given on this topic by discussing common
of industrial challenges. mistakes and ways to overcome these.
€
The compilation by Sihorkar and Durig in Botulismisaparalyticdiseasecausedbyintox-
Chapter 5 aims at discussing amorphous solid icationwithneurotoxinsproducedbyClostridium
dispersionasaformulationenablingtechnology botulinum.Currently,vaccinesandantibodiesare
to a commercially viable technology with a theonlytwoprimarymeansoftreatingbotulism.
plethoraofmarketedproductsacrosstheglobal TheworkbyYanetal.(Chapter9)highlightsthe
pharmaceutical space. The authors discuss the vaccinedevelopmentstrategiesforbotulism.This
industrial perspective of ASD technology, chapterprovidesanoverviewofnewvaccineand
which has benefited immensely from newer- immunotherapeutic developments like vaccine
xi
Preface
vector updates, immune sequence optimization, nutraceuticals have limitations like high dose,
andrecombinantantibodies. poor bioavailability, and toxicity and stability
Chapter10byKova(cid:2)cevi(cid:3)cdiscusseschallenges problems. In maximizing their therapeutic
in the delivery of nonsteroidal antiinflamma- potential to their full extent, nanotechnology
tory drugs (NSAIDs), and highlights the recent plays a key role. The last contribution by
advancesontheuseofpolymericnanoparticles, Abdel Samie and Nasr (Chapter 11) describes
nanoemulsions, and nanosuspensions/nano- food to medicine transformation of stilbenoid
crystals, intended for oral, topical, parenteral, via vesicular and lipid-based nanocarriers.
andocularadministrationtoovercometheasso- In summary, I am sure this book volume
ciated challenges. These new strategies can and the complete book series will provide you
increase drug-associatedpooraqueoussolubility great insights in areas of micro-nanomedicines,
and thereby reduce the dose-associated adverse drug delivery sciences, new trends, and regu-
effects.Anoverviewofvariousnanotechnological latory aspects.
approaches for delivery of antiinflammatory Alltheeffortsofexperts,scientists,andauthors
drugsisprovidedinthischapter. arehighlyacknowledgedforsharingtheirknowl-
Nowadays, patients and consumers demand edge,ideas,andinsightsaboutthetopic.
safer and more natural products for regular
infections. This resulted in the evolution of Ranjita Shegokar,PhD
the nutraceutical market. However, many Editor
C H A P T E R
1
Versatile hyaluronic acid nanoparticles
for improved drug delivery
a,b a
Mona M.A. Abdel-Mottaleb , Hend Abd-Allah ,
a a
Riham I. El-Gogary , Maha Nasr
aDepartment ofPharmaceuticsand Industrial Pharmacy, Facultyof Pharmacy, AinShams University,
Cairo, Egypt
bPEPITE EA4267,Univ.Bourgogne Franche-Comt(cid:1)e, Besanc¸on,France
1 Introduction
severalthousandrepeatingdisaccharidesmole-
cules in the backbone. The molecular weight of
Althoughmorethan80yearshavepassedsince HA molecules differs owing to the variable
thediscoveryofhyaluronicacid(HA),itstillsur- number of these repeating disaccharide units
prisesresearcherswithitsuniquephysicochemical in each molecule, its molecular weight ranges
properties and physiological roles in the human from 1 to 10,000 kDa [3]. HA has an unusual
body. HA was first discovered by Karl Meyer mechanism of biosynthesis and exceptional
and John Palmer in 1954 [1]. They isolated an physical properties. Sodium hyaluronate is the
unknown material from the vitreous bodyof a predominant form of HA at physiological pH.
bovine eye, containing two sugar molecules Sodium hyaluronate and HA are collectively
including“uronicacid.”So,byconnectingthesub- referred to as hyaluronan. Due to the fact that
stitute name for the vitreous—“hyaloid”—with HA exists as a polyanion, it can self-associate
the name of a component of that polysac- and can also bind water molecules giving it a
charide—“uronic acid”—the name of HA was stiff, viscous quality with jelly-like consistency
adoptedforthismaterial.HAwasfirstusedcom- that causesit to behave like alubricant [2].
mercially as a substitute for egg white in bakery HA was found to be abundantly distributed
products. Later on, its first medical application in cellular surfaces, in the basic extracellular
forhumanswasinitiatedasavitreousreplacement substances of the connective tissues of verte-
duringeyesurgeryinthelate1950s[2]. brates,inthesynovialfluidofjoints,inthevitre-
HA belongs to a group of substances called ous humor of the eye, and in the tissue of the
mucopolysaccharides belonging to the glycos- umbilical cord; all this attracted significant
aminoglycans(GAGs)family[1,2].HAincludes attention regarding its medical applications
1
DrugDeliveryAspects #2020ElsevierInc.Allrightsreserved.
https://doi.org/10.1016/B978-0-12-821222-6.00001-4