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Biomarkers as Targeted Herbal Drug Discovery
CHAPTER 9
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Phytoconstituent-Based
Nanotherapeutics as Ocular Delivery
Systems
MOHAMMED JAFAR,1* SYED SARIM IMAM,2 and
SYED AZIZULLAH GHORI
1
2
3
Department Department of Pharmacy practice,
3
ABSTRACT
In the last few years, there has been a wide growth in the field of phytomedicine and gaining popularity all over the globe because of their natural
origin and lesser side effects. The applications of different phytoconstituents
loaded nanoformulations have been widely accepted as delivery systems
for various diseases. The application of nanoformulation opened the door
in a disease like glaucoma, eye cancer, and other anterior ocular diseases
by significantly modifying the properties of drugs and their carriers. It
utilized various nanoformulations like nanoparticle, nanoemulsion, nano
lipid structure, nano lipid vesicle to transport the different phytoconstituents
like curcumin, quercetin, forskolin to the site of action. The greater stability
of phytoconstituents loaded nanoformulation is due to the formation of
chemical links between lipid molecules and active agents. There are several
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phytoconstituents loaded nanoformulation have depicted a novel delivery
system to deliver active compounds to the target site of action, and at present,
several nanoformulations are in clinical use. This chapter summarizes the
latest research reports regarding the possible administration of phytoconstituents loaded nanoformulations for different ocular diseases.
The eye is considered as an essential part of the body that comprises of two
major anatomical parts: the anterior as well as the posterior region. The
posterior region mainly composed of choroid, vitreous chamber, macula, and
retina and importantly the posterior area of the sclera is located interior to
the lens (Janagam et al., 2017). The majority of eye-related illnesses seem
to be arisen from internal structures of the eye, hence raising the quantum
and intensity in a consistent manner (Thrimawithana et al., 2011). If left
untreated, these problems may cause permanent eye damage resulting in loss
of complete vision. According to the recent data reports it was revealed that
around 39 million people were affected because of age-associated macular
degeneration (AMD), Retinopathy due to diabetes, and disease of glaucoma
of the posterior region of the eye resulting in the complete visual loss (International Federation, 2013; McGrath et al., 2017).
Presently, the use of invasive procedures and topical administration of
drugs in the form of ocular gel, ointment, etc., to the posterior and anterior
regions of the eye is the only available option for managing these disorders. Yet, posterior side topical drug delivery abides a point of confronta-
tion because of diverse efuence systems and organic impediments, like
nasolacrimal drainage, tear clearance, the cornea, conjunctiva, and scleral
barriers. The current advancement in the eld of nanotechnology and nano
-
drug studies, laid down a great provision and access by overwhelming the
restrictions of the conventional treatments, due to their protecting capability
for encapsulated medications that ease their transport to a particular spot of
tissue (Weng et al., 2017; Kaur and Kakkar, 2014). Additionally, nanoparticles aids as a favorable vehicle for topical drug delivery systems due to
prolonged drug duration, higher drug absorbency beyond the barriers, and
posterior area drug delivery via restrained rate (Delplace et al., 2015). Varied
nano-vehicles such as lipid nanoparticles, liposomes, emulsions, spanlastics, micelles, polymeric nanoparticles, layered double hydroxides (LDH),
dendrimers, cyclodextrins, and pro-active medication with built-in quality
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has been employed in order to achieve and devise a novel formulation optimization designs in case of topical administration of posterior eye (Madni
et al., 2017).
As reported by World Health Organization (WHO), in southeast countries like India, China, and such other developing countries, the main health
needs of approximately 80% of the population are met and/or complemented
by traditional medicine (Robinson and Zhang, 2011). Since ancient times
herbal extracts have been used in treating various eye diseases. Macerated
fruit of Atropa belladonna was the plant-derived substance used by the
Egyptians rst time in the anterior region of the eye to treat ophthalmic
disease (Duncan and Collison, 2003). Several new phytoconstituents have
been studied exhaustively in order to nd out constituents with the capacity
to give greater advantages to eye tissue and the sight. Transpiring indications
of wound-healing, anti-inammatory, antioxidant, antimicrobial, antiangiogenic, and antineoplastic characteristics ascribed to herbal extracts has
advocated larger speculations in investigation in this eld. Regardless of
technological progress in the manufacture of synthetic drugs, the pharmaceutical industry still look for novel active constituents from natural origin,
moreover, often visiting previously accepted plant-derived compounds.
Considering the above facts, this chapter aims to report different nano-based
ocular drug delivery systems of phytoconstituents used in the effective treatment of vision-threatening posterior eye diseases.
DELIVERY SYSTEMS
Solid lipid nanoparticles (SLN), as well as nanostructured lipid carriers (NLC),
are considered to be regularly investigated lipid nanoparticles that are used
for the ocular drug delivery. These nano-drugs usually contain a solid lipid
core, which has potential in accumulating medications with hydrophilic and
lipophilic nature into lipid fabric (Figure 9.1). SLN are accurately embraced
with more than a single solid lipid, which shows a melting point of 40°C and
even higher. Subsequently in the beginning of 1990s the benefits of control
release property of SLNs has been emerged (Souto and Doktorovova, 2009),
including cellular toxicity, augmented compatibility, and high in vivo tolerance
(Doktorovova et al., 2014, 2016). Compared to SLN, NLCs which contain
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suitable blends of both liquid and solid lipids seem to possess the benefits
of elevated medication carrying potential, improved storage steadiness, and
efficient drug discharging characteristics (Das et al., 2012; Liu et al., 2017).
Several phytoconstituents based lipid nanomedicines were developed for the
effective treatment of vision-threatening diseases. Yu et al. (2018) designed
a new nanostructured lipid carrier (NLC) embedded double-receptive
hydrogel for ocular drug delivery of quercetin (QN). NLC loaded with quercetin (QN-NLC) was devised using melt emulsification combined with the
ultra-sonication method. A three-factor five-level central composite design
(CCD) was utilized to optimize the formulation of QN-NLC. The optimized
QN-NLC presented a particle size of 75.54 nm with narrow size distribution
and greater encapsulation efficiency (97.14%). QN-NLC was identified by
differential scanning calorimetry (DSC) and scanning electron microscopy
(SEM). Moreover, a pH and temperature double-receptive hydrogel consisting
of carboxymethyl chitosan (CMCS) and poloxamer 407 (F127) was fabricated
by a cross-linking reaction with a naturally occurring nontoxic crosslinking
agent genipin (GP). FT-IR was used to exhibit that F127/CMCS hydrogel was
successfully produced. The results of SEM analysis and swelling experiments
demonstrated that F127/CMCS hydrogel was both pH, as well as temperaturereceptive. Moreover, In vitro release studies exhibited dual temperature and
pH responsiveness of the hydrogel, and 80.52% of total quercetin was released
from the QN-NLC based hydrogel (QN-NLC-Gel) within 3 days, unfolding
QN-NLC-Gel released drug sustainability. Collectively speaking, the produced
NLC-based hydrogel was a promising drug delivery system for the application
to the ophthalmic region.
Lakhani et al. (2018) were conducted a new study on preparation, optimization, and evaluation of curcumin-incorporated NLCs for their in vitro
and ex vivo characteristics. A standard CCD was utilized in optimization of
NLCs, which are formulated using hot-melt emulsication and ultrasonication methods, these NLCs were evaluated for their in vitro physicochemical
characteristics. Their stability over an extended period of 3 months and transcorneal permeation across excised rabbit corneas (ex vivo) were examined for
the optimized NLCs. The optimized NLC, with polydispersity index of 0.17 ±
0.05, particle size of 66.8 ± 2 nm, drug loading (DL) of 3.1 ± 0.05% w/w, and
entrapment efciency of 96 ± 1.6%, was chosen using CCD. The optimized
NLCs showed optimum ex vivo stability at 4°C for the study period and showed
a signicant improvement in curcumin permeation (2.5-fold) across the rabbit
cornea in comparison to the control. Altogether, these studies demonstrated
the successful designing and development of NLCs utilizing the design of
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experiment approach; the formulation improved curcumin permeation across
excised corneas and did not show any harmful side effects.
Wang et al. (2017) prepared, optimized, and characterized a cationic lipid
nanoparticle (CLN) system containing fractioned drugs utilizing a molecular
dynamics model as a novel approach of optimizing and characterizing the
formulations. Puerarin (PUE) and scutellarin (SCU) were used as model
drugs. Melt-emulsion ultrasonication and low temperature-solidication
methods were used in the preparation of CLNs. The characteristics of CLNs
such as gross morphology, zeta potential, and particle size, DL, entrapment
efciency (EE), and in-vitro drug release performance were assessed. The
CLNs were also evaluated by corneal permeation, preocular retention time,
and pharmacokinetics (PKs) in the aqueous humor. Moreover, a molecular
dynamics model was employed to assess the formulation. SEM results
revealed that the nanoparticles were approximately spherical in shape. All
other physical parameters results of these nanoparticles were satisfactory and
most importantly the mathematical values calculated for these systems were
statistically signicant. The pharmacokinetic study performed collecting
samples from the aqueous humor demonstrated that compared with the PUE
and SCU solution, the area under the concentration-time curve (AUC) value
of PUE was increased by two folds for PUE-SCU CLNs, and the SCU AUC
was also enhanced by two folds. In the molecular dynamics model, PUE,
and SCU passed through the POPC bilayer, with a clear cut difference in the
free energy well depth. It was found that the maximum free energy required
for PUE and SCU transmembrane movement was ~15 and 88 kJmol
–1
,
respectively. These ndings indicated that compared with SCU, PUE easily
passed through the membrane. The diffusion coefcient values obtained for
PUE and SCU were also statistically signicant. Data obtained from the
molecular dynamics model were in accordance with the experimental data.
All data showed that CLNs have a high capability for ocular administration
and can be used as an ocular delivery system for multi-component drugs.
Moreover, the molecular dynamics model can also be used as a novel method
for assessing new formulations.
Li et al. (2014) prepared employing emulsion evaporation-solidication at
low temperature method tetrandrine-loaded cationic solid lipid nanoparticles
(TET-CNP) and solid lipid nanoparticles (TET-NP). The particle size, zeta
potential, entrapment efciency of TET-CNP, and TET-NP were determined.
The results revealed that the TET-CNP and TET-NP had acceptable sizes
with optimum zeta potentials and high entrapment efciencies respectively.
In vitro drug release studies showed that both the TET-CNP and TET-NP
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perpetuated the drug entity much better than tetrandrineoccular solutions
(TET-SOL). In the PKs investigations, the AUC values of TET-CNP and
TET-NP were almost two-fold greater than that of TET-SOL; the Cmax values
of TET-CNP and TET-NP were also almost two and a half fold greater than
that of the TET-SOL respectively. Cytotoxicity study revealed that TET-CNP
and TET-NP had no signicant cytotoxicity at minimum amounts. Flow
cytometry studies and confocal microscopy analysis showed that calcein
labeled NP (CA-NP) uptake by SRA 01/04 cells was much greater than those
of calcein labeled CNP (CA-CNP) and calcein solution (CA-SOL).
Liu et al. (2011) prepared and evaluated the solid lipid nanoparticles of
baicalin (BA-SLN) for ocular delivery. The method used to prepare BA-SLN
was also an emulsication/ultrasonication technique. The advent of BA-SLN
was assessed by the negative stain technique. The key physical parameters mean diameter and zeta potential of BA-SLN were evaluated using a
Zetasizer. Another key feature entrapment efciency of BA-SLN was also
measured by using Sephadex-G50 column. Solid-state characterization of
BA-SLN was performed by DSC and X-ray studies. The in-vitro drug release
from BA-SLN was estimated using dialysis bag diffusion method. Isolated
rabbit corneas were used to assess the effects of SLN on corneal permeability of baicalin. The in-vivo ocular irritation test for prepared BA-SLN
was carried out on rabbits and the intensity of irritation to rabbit eye after
application of the above nanoparticles was examined observing pathological
sections of rabbit eye. The PKs studies were performed by microdialysis
in the rabbit aqueous humors. The results revealed that the BA-SLN had a
good particle size distribution with a positive zeta potential and the good
entrapment efciency. In vitro drug release studies clearly showed that
the BA-SLN retained the drug entity better than the baicalin ophthalmic
solutions (BA-SOL). In the PKs studies, the AUC value of BA-SLN was
four-fold versus the BA-SOL, and the Cmax value of BA-SLN versus the
BA-SOL was vefold with very low p values. Thus, SLN can be used as a
carrier to enhance the ocular bioavailability of baicalin.
Liposomes are colloidal vesicular transporters, which are produced by the
hydration of phospholipids. The nanosized liposomes are made up of phospholipids composed of the polar head as well as nonpolar fatty acid chains
(Figure 9.1), which aids them accommodated in individual minor structural
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phospholipid units both the hydrophilic and hydrophobic drug molecules
accessing their delivery to the targeted sites (Peptu et al., 2015). Phosphatidylcholine (PC), phosphatidylserine (PS), Soya phosphatidylcholine, and
Phosphatidylethanolamine, containing indistinguishable nature with the lipid
present on the surface of the cell membrane, generally opted for liposomal
preparations that lead to enhance pre-corneal absorption (Agarwal et al.,
2016). The newer generation surface-modified liposomes possessing both
mucoadhesive and improved penetration properties, not only capable of
entrapping the therapeutic agent but can also aims to specific sites through
corneal binding (Fangueiro et al., 2016).
Ocular delivery of phytoconstituents through various nanocarriers.
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