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16
Novel drug delivery approaches for
improving therapeutic applications
of berberine and berberine-rich
herbal preparations
Deependra Singh
1, 2
, Krishna Yadav
1, 4
, Manju Rawat Singh
1
,
Narayan D. Chaurasiya
3
and Babu L. Tekwani
3
1
University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, Chhattisgarh,
India;
2
NCNPR, School of Pharmacy, University of Mississippi, Olemiss, Oxford, MS, United
States;
3
Department of Infectious Diseases, Division of Drug Discovery, Southern Research,
Birmingham, AL, United States;
4
Raipur Institute of Pharmaceutical Education and Research,
Raipur, Chhattisgarh, India
1. Introduction
Herbs and herbal drugs have drawn immense interest among people due to their clinically
proven effects in curing a wide variety of communicable as well as noncommunicable dis-
eases [1]. Herbal drugs are popular due to their safety profiles under clinical settings [2,3 ].
However, the complex nature of herbal preparations poses significant challenges and limita-
tions regarding bioavailability, pharmacokinetics, and pharmacodynamics of principal active
constituents [4,5](Table 16.1). Conventional formulations have not been effective in avoiding
these limitations. Furthermore, due to a lack of scientific rationale and proces sing challenges,
such as standardization, extraction, and identification of specific medicinal components in
complicated poly-herbal preparations, herbal medicines were not taken into account for
development as new formulations [30]. However, the development of complex herbal med-
icine preparations as approved treatments requires scientific validation, development of stan-
dardized preparations, quality control, and systematic evaluations of the safety of herbal
drugs. These requirements have paved the pathway for the development of novel drug
CHAPTER
375
Phytopharmaceuticals and Herbal Drugs
https://doi.org/10.1016/B978-0-323-99125-4.00016-0 © 2023 Elsevier Inc. All rights reserved.
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delivery systems constituting various types of pharmaceutical preparations. The nature of the
individual drug delivery approach requires knowledge regarding routes of administration of
herbal preparations and the nature of principal active constituents.
The novel herbal drug carriers cure a particular disease by both spatial and temporal ap-
proaches (Table 16.2 and Fig. 16.1).
TABLE 16.1 List of some general herbal ingredients, their nature, and limitations in clinical use.
Active ingredients Nature of ingredients Clinical use limitation References
Vinorelbine Vinca alkaloids Neurotoxicity [6,7]
Silybin Flavonolignans Low bioavailability [8,9]
Docetaxel Taxanes Toxicity and low therapeutic effect [10,11]
Vinblastine Vinca alkaloids Neurotoxicity [7]
Puerarin Isoflavones Poor solubility in water and limited oral
bioavailability are two problems.
[12,13]
Quercetin Flavonoid Low gastrointestinal absorption [14,15]
Ellagic acid Natural phenol antioxidant Short half-life [16]
Curcuminoids Natural phenol Low water solubility and half-life variation at
different pH
[17,18]
Vinpocetine Semisynthetic derivative
alkaloid of vincamine
Poorly water soluble [19]
Triptolide Active diterpene Poor water solubility and toxic effects adverse
drug reaction, hypersusceptibility of skin
[20]
Catechins Poly phenol antioxidant The bioavailability is less than 5%, and the
half-life is minimal.
[21]
Baicalin Flavones Stability problem [22]
Curcumin Natural phenol Low water solubility, low bioavailability, and
clinical efficacy
[18]
Podophyllotoxin Nonalkaloid toxin lignan Severe side effects after systemic absorption;
unpredictable in systemic behavior
[23]
Etoposide Derived from podophyllotoxin Low oral bioavailability and poor water
solubility
[24]
Dihydroartemisinin Glycoside sesquiterpene
lactone
Low bioavailability and water solubility [25]
Camptothecin Quinoline alkaloids Systemic toxicity [26]
BER Isoquinoline alkaloids Low oral bioavailability [27]
Naringenin Flavones Short half-life [28]
Rutin Glycoside between the
flavonolquercetin and rutinose
Low water solubility [29]
16. Novel drug delivery approaches for improving therapeutic applications of berberine and berberine-rich herbal preparations376
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TABLE 16.2 Botanical sources, parts used, active constituents with their dose range, pharmacokinetics, and mechanism of action, essential
formulations, 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%
Primary neurons
were protected
from A-induced
cell death, and
caspase-3 activity
was decreased
when Ab-was
present
Crystalline
xanthine
alkaloids
Nanostructured
lipid carriers,
lipid
nanoparticles
Null toxicity for
cosmetics and
dermal
application
[31]
Cannabis
sativa
Leaves,
seed
Cannabinoids 15e20 mg
measured both
pain intensity and
pain relief
Bioavailability and
absorption are very
variable, ranging
from 4% to 12%,
and the drug is
processed in the
liver, particularly by
cytochrome P450
mixed-function
oxidases
THC antagonism
by CB1 blockers
resulted in CNS
and heart rate
implications
Lipophilic
alkamides
Micelles and
lipid bilayers
Produces less
tachycardia and
less euphoria
than others
[32]
Cocos
nucifera
Fruits,
seed
Lauric acid 2%e4% lauric
acid with vehicle
(water or ethanol
or water/ethanol)
In the rat, an
extremely
specialized probe
for CYP2E1 was
developed
Specific P-450
catalytic activity,
immunoblot
analyses, and
pharmacological
and immune
inhibitors
Component
of
triglycerides
Lipid emulsion Human liver
microsomes are
mediated by a
CYP4A isoform
in rat kidney
microsomes
[33]
Daucus
carota
Seed Anthocyanin 33 mg/kg orally Peak plasma
concentration after
30 min of
consumption was
100 ug/L
Suppression of LDL
cholesterol,
reduction of methyl
linoleate, or
inhibition of the oil
or oil-containing
system are all
possible outcomes
of this
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
10 ug/L
[34]
(Continued)
1. Introduction 377
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