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4
Lipid-based particulate systems for
delivery of plant actives and
extracts: Extraction, prospective
carriers, and safety issues
Manju Rawat Singh
1
, Kusum Pradhan
1
,
Madhulika Pradhan
2
, Krishna Yadav
1, 3
,
Nagendra Singh Chauhan
4
, Shradha Devi Dwivedi
1
and
Deependra Singh
1
1
University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, Chhattisgarh,
India;
2
Rungta College of Pharmaceutical Sciences and Research, Bhilai, Chhattisgarh, India;
3
Raipur Institute of Pharmaceutical Education and Research, Raipur, Chhattisgarh, India;
4
Drugs Testing Laboratory, Avam Anusandhan Kendra (State Government Lab of AYUSH),
Raipur, Chhattisgarh, India
1. Introduction
Modern biotechnology and pharmacotherapy recently developed more interest in the pro-
duction of new therapeutic agents with a novel formulation originating from botanical sour-
ces [1]. Herbal medicines from natural sources share a major portion of traditional medicine
and come in naturopathy. WHO also estimates that 65%e80% of the world’s population
depend on traditional medicine as primary health care medication system and 85% of these
medicines involve the use of herbal preparations [2]. It is also estimated that about 25% of the
drugs prescri bed worldwide are derived from plants and application of these modern med-
icines directly correlate with their traditional use as herbal medicines [3].
Herbal drugs are gaining enhanced popularity in the modern world in curing various dis-
eases due to less toxic and better therapeutic effects [4]. It has been increasingly common in
recent years for herbals to be employed as the basis for new medicine development (Fig. 4.1).
CHAPTER
83
Phytopharmaceuticals and Herbal Drugs
https://doi.org/10.1016/B978-0-323-99125-4.00017-2 © 2023 Elsevier Inc. All rights reserved.
https://t.me/med1917
Over time, herbal medicines were not considered for new formulations because of the dif-
ficulty in extracting specific components from complicated polyherbal systems and the
absence of scientific rationale for their use. Further, active ingredients originated from plant
resources generally exhibit compromised desired effects limited by issues such as stab ility,
solubility, molecular size, bioavailability, and toxicity (Table 4.1).
FIGURE 4.1 Drug development based on traditional lead.
4. Lipid-based particulate systems for delivery of plant actives and extracts: Extraction, prospective carriers, and safety issues84
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TABLE 4.1 List of some general herbal ingredients, their nature, and limitations in clinical use.
S.N Active ingredients Nature of ingredients Clinical use limitation References
1. Vinorelbine Vinca alkaloids Neurotoxicity [5]
2. Silybin Flavonolignans Low bioavailability [6]
3. Docetaxel Taxanes Toxicity and low therapeutic effect [7]
4. Vinblastine Vinca alkaloids Neurotoxicity [8]
5. Puerarin Isoflavones Poor water solubility and low oral
bioavailability
[9]
6. Quercetin Flavonoid Low gastrointestinal absorption [10]
7. Ellagic acid Natural phenol
antioxidant
Short half-life [11]
8. Curcuminoids Natural phenol Low water solubility and half-life variation
at different pH
[12]
9. Vinpocetine Semisynthetic derivative
alkaloid of vincamine
Poorly water soluble [13]
10. Triptolide Active diterpene Poor water solubility and toxic effects
adverse drug reaction, hyper
susceptibility of skin
[14]
11. Catechins Poly phenol antioxidant Bioavailability <5% and the half-life
is short
[15]
12. Baicalin Flavones Stability problem [16]
13. Curcumin Natural phenol Low water solubility, low bioavailability,
and clinical efficacy
[17]
14. Podophyllotoxin Nonalkaloid toxin lignan Severe side effects after systemic
absorption; unpredictable in systemic
behavior
[18]
15. Etoposide Derives from
podophyllotoxin
Low oral bioavailability and poor water
solubility
[19]
16. Paclitaxel Taxanes Low aqueous solubility [20]
17. Dihydroartemisinin Glycoside sesquiterpene
lactone
Low bioavailability and water solubility [21]
18. Camptothecin Quinoline alkaloids Systemic toxicity [22]
19. Berberine Isoquinoline alkaloids Low oral bioavailability [23]
20. Naringenin Flavones Short half-life [24]
21. Rutin Glycoside between the
flavonol quercetin and
rutinose
Low water solubility [25]
22. Resveratrol Polyphenolic flavonoid Rapidly metabolized in the liver and
intestinal epithelial cells
[26]
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Numerous plant actives and extracts have been regularly tested by controlled, scientifi-
cally validated trials for their potential clinical applications like anticarcinogenic activity,
hypocholesterolemic effect, insulin enhancing effects, photoprotection effects, oral submuco-
sal fibrosis effects, toxicity assessment, etc. [27,28]. However, the identification of novel excip-
ients that are safe and perform specific tasks directly or indirectly impacting
pharmacokinetic, as well as pharmacodynamic, parameters has been encouraged by im-
provements in drug delivery [29e31]. Properties of plant actives and extracts influence the
selection of a suitable formulation to improve their retention time in the body [32].
Modern pharmaceu tical research solves the scientific need for herbal medicines, as it paves
the pathway for development of novel drug delivery systems constituting various types of
delivery systems, through different routes of adm inistration. These novel herbal drug carriers
cure a particular disease by both spatial and temporal approach. They can be targeted specif-
ically to the affected zone inside a patient’s body and can transport the drug to a particular
area at specified time [33,34]. It is necessary to select medicinal properties of herbal therapeu-
tics depending on their mechanism of action, to prepare a novel formulation with desirable
pharmacokinetics and clinical trial (Table 4.2).
Lipid solubility and molecular size have been reported as the major limiting factors that
inhibit these plant-based drugs to pass through biological membrane, due to which the sys-
temic absorption following oral or topical administration of drugs is hindered [43e45]. The
efficient applications of some plant actives are also restricted due to low bioavailability after
oral and parenteral administration. Recent trends toward the use of plant-based natural prod-
ucts demands the replacement of natural additives and many plant-derived products like
polysaccharides, resins, tannins, glycosides, anthraquinones, flavonoids, and terpenoids
with synthetic drugs. Thus, increasing demand of herbal product requires focus in terms
of purity of the extract; novel methodology of extraction; novel herbal formulation, safety,
and efficacy. The bulk of these plant-derived chemicals are discussed in this review, along
with their chemical components, applications, and some new studi es as excipients in lipid-
based systems [45].
To address the issue of medication formulation where limited solubility in the gastrointes-
tinal tract (GIT) fluids restricts exposure, our lab has showed that lipid-based drug delivery
systems can be a viable and practical opti on [46,47]. Lipids are preferred as they are the main
components of the cell membrane, can effectively incorporate lipophilic compounds, and
facilitate the delivery of bioactives into cells. Lipid-based systems show properties of
improved bioavailability, reduced toxicity, solubility enhancement, enhanced pharmacolog-
ical activity, improved tissue macrophage distribution, protection from chemical and physical
distribution, sustained release and suitability for lipophilic drugs [29,30,45,48,49](Table 4.3).
There have been various motivational grounds for the increasing interest in lipid-based
systems, which include.
• Lipid-base d system enhances bioavailability and reduces plasma profile variability of
active constituents.
• Improved understanding of the lipid excipients used.
• Formulatio n versatility and choice of different lipid-based delivery systems.
• Scale-up and transfer of technologies.
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TABLE 4.2 Botanical sources, parts used, active constituents with their dose range, pharmacokinetics, and mechanism of action, essential formula-
tions, and clinical trials of various herbal drugs.
Botanical
sources
Part
used
Active
constituents
Dose range and
route
Pharmacokinetics
parameter
Possible
mechanism of
action Properties
Essential
formulation Clinical trials References
Camellia
sinensis
Leaves
and leaf
bud
Caffeine Typically used
doses (less than
500 mg), IV 1
e20 mg/kg
Nonlinear mixed
effect modeling
(jack-knife
procedure),
bioavailability
approx.60%
Protected primary
neurons from
Ab-induced cell
death and
suppressed
Ab-induced
caspase-3 activity
Crystalline
xanthine
alkaloids
Nanostructured
lipid carriers,
lipid
nanoparticles
Null toxicity for
cosmetics and dermal
application
[35]
Cannabis
sativa
Leaves,
seed
Cannabinoids 15e20 mg
measured both
pain intensity
and pain relief
4%e12%
bioavailability and
absorption highly
variable,
metabolized in the
liver, especially by
cytochrome P450
mixed-function
oxidases
CB1 blocker
antagonism of
THC-induced CNS
and heart rate
effects
Lipophilic
Alkamides
Micelles and
lipid bilayers
Produces less
tachycardia and less
euphoria than others
[36]
Cocos
nucifera
Fruits,
seed
Lauric acid 2%e4% lauric
acid with vehicle
(water or ethanol
or water/
ethanol)
Highly specific
probe for CYP2E1
in rat
Specific P-450
catalytic activities,
immunoblot
analysis, and
chemical and
immunoinhibitions
Component
of
triglycerides
Lipid emulsion Human liver
microsomes are
mediated by a CYP4A
isoform in rat kidney
microsomes
[37]
Daucus
carota
Seed Anthocyanin 33 mg/kg orally Peak plasma
concentration after
30 min of
consumption was
100ug/L
Inhibition of LDL
cholesterol,
inhibition of
methyl linoleate or
inhibition of oil or
oil-containing
system
Water-
soluble
vacuolar
pigments
(flavonoids)
Lipid
microemulsion
Sorption of
anthocyanins in their
glycosidic form in
humans after ingestion
of 25 g of elderberry,
peak plasma
concentration after
30 min of consumption
was 100 ug/L
[38]
(Continued)
1. Introduction 87
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