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472 C. Ginn et al.
https://t.me/med1917
2017)
2015)
El-Ridy et al.
Ma et al.
Hoy (2021)
Chokshi et al.
(2021)
(2021)
Booysen et al.
(2013)
Dineshkumar
et al. (
(
after 6 months treatment with amikacin liposome
suspension plus guideline-based therapy in compari-
son to no patient cured when treated with standard
guideline-based therapy alone
Inhalation In Phase III clinical trials; 55.4% patients were cured
cholesterol
Delivery system Drug Composition Route Biological activity Reference
Liposomes Amikacin Dipalmitoylphosphatidylcholine
Table 17.6 Examples of pre-clinical nanotherapy for the treatment of TB
ability (~17-folds) compared to unformulated drug
888, Poloxmer
®
188, Span 80
Campritol
Rifampicin Mannose-grated stearyl amine Oral Rifampicin nanoparticles showed enhanced bioavail-
Solid lipid
nanoparticles
mycobacterial burden (colony-forming unit) com-
pared to 60% decrease by unformulated isoniazid in
Palmityl palmitate
Isoniazid Mannose-grafted stearyl amine Inhalation Isoniazid lipid nanoparticles showed 83% decrease in
Mannose solid
lipid nanoparticles
Wistar rats
PLGA Oral Sustained drug release of over seven days following
Rifampicin
Polymeric
10 days in the liver and lungs
once-off oral administration of drug nanoparticles in
mice with subsequent drug distribution of up to
Oral Slow and prolonged release of rifampicin from the
and isoniazid
nanoparticles
Dendrimers Rifampicin Pegylated PAMAM dendrimer
dendrimer was observed in vivo (Wistar rats) with
(5 G)
longer half-life (66.3 h) and a higher area under curve
rifampicin (2.14 h and 1154 μg/L*h)
Niosomes Ethambutol Span 60 SC Ethambutol niosomes showed higher accumulation in
lungs for a prolonged period of time compared to
(71,451 μg/L*h) in comparison to unformulated
unformulated drug
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17.6 Acquired Immunodeficiency Syndrome (AIDS)
17.6.1 Pathology
Human immunodeficiency virus (HIV) is the retrovirus responsible for acquired
immunodeficiency syndrome (AIDS). A condition that causes progressive failure of
the immune system making those infected at risk of opportunistic infections and
cancers. The HIV virus targets cells expressing the CD4 and chemokine (CCR5/
CXCR4) receptors. These cells are: (i) CD4
phages (CD68
+
) in lymph nodes, spleen, liver, brain, lung, bone marrow, and (iii)
+
T cells, (ii) monocytes and macro-
dendritic cells in the lymphoid tissues (e.g. vagina, tonsil, rectum) (Lucas and
Nelson 2015). This RNA virus codes for the enzyme reverse transcriptase, which
transcribes the RNA genome into a DNA version and then integrates it into the host
cell genome (Hu and Hughes
2012). Immune dysfunction occurs as a result of low
levels of CD4+ T-cells due to the following mechanisms; (i) direct viral cell killing,
(ii) apoptosis of infected T cells, and (iii) indirect killing by CD8+ T cells (Lucas and
Nelson
2015). Without effective treatment, death from AIDS occurs rapidly
(2–4 years) from the initial time of diagnosis.
17.6.2 Conventional Therapy
Treatment involves the use of antiretroviral drugs which act by inhibiting different
stages in the virus lifecycle. These tend to fall into one of the following categories
(Daar
2017
): (i) reverse transcriptase inhibitors which inhibit viral DNA replication
either by incorporation and chain termination or by blocking enzyme binding
(e.g. zidovudine, etravirine, rilpivirine, lamivudine), (ii) protease inhibitors (PIs)
that prevent maturation of newly formed virions by preventing the cleavage of HIV’s
polyproteins (e.g. ritonavir, saquinavir, darunavir), (iii) CCR5 antagonists that block
the CCR5 receptor and prevent virus entry into host cells (e.g. maraviroc),
(iv) integrase inhibitors that block the incorporation of viral DNA into the host
cells (e.g. raltegravir), (v) fusion inhibitors that block the fusion of HIV virions with
the cell membrane and its subsequent entry into host cells (e.g. enfuvirtide),
(vi) attachment inhibitors that bind to HIV virions and inhibit their entry into host
cells (e.g. fostemsavir), and (vii) pharmacokinetic enhancers which inhibit CYP3A,
reduce the metabolism, and increase the concentration of antiretroviral drugs
(e.g. cobicistat). Treatment regimens using three or more of these drugs at the
same time are described as highly active antiretroviral therapy (HAART) and have
proved more effective.
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17.6.3 Rationale of Using Nano-delivery Systems
for Anti-HIV Drugs
The main challenges of anti-HIV drugs are toxicity, inability to reach site of viral
infection, and drug resistance. Various types of nanocarrier-based drug delivery
systems have already been investigated for the treatment of HIV including liposomes, nanoparticles, dendrimers, and bioconjugates (Khan et al.
et al. 2014;Oti 2020) (Table 17.7). Nanocarrier-based drug delivery approaches
offer the following benefits in the treatment of HIV: (i) the specific recognition of
HIV-infected cells (e.g. targeting of anti-HIV to macrophages), (ii) the ability to
deliver drug payload to viral reservoirs and cross physiological barriers (e.g. BBB,
blood-cerebrospinal fluid barrier), and (iii) as well as the capacity to deliver multiple
drugs simultaneously (Khan et al.
high effective drug concentrations at the sites of viral replication (e.g. liver, spleen,
and lymph nodes) should result in enhanced viral killing and minimise the production of resistant strains (Oti
of anti-HV are shown in Table
2020; Ramana et al. 2014). The maintenance of
2020). Examples of nanocarrier system used in delivery
17.7.
2020; Ramana
17.7 Conclusion
Infectious diseases are major health problem worldwide. The overall burden of
infectious diseases continues to rise with an increasing risk and difficulty to treat
in resource limited countries. The main challenges facing the development of antiinfective treatments are: (i) overcoming drug toxicity, (ii) improving drug ef ficacy,
and (iii) formulating stable, easy to use, and affordable anti-infective medicines.
Over the last few decades, intensive research has focused on developing antiinfective medicines that can target the pathogen at infection sites with minimal
effect on the non-target tissues. Lipid-based and polymer-based nano-delivery
systems have been the main focus of the research beside more complex drug delivery
systems such as dendrimers and nanotubes. Although, most of these nano-delivery
systems still face challenges of scaling up production and high cost, and with many
strategies presented still in pre-clinical stages of development, there are notable
nanomedicines that have made the full journey through development and into
clinical use.
Acknowledgements AMA and MB are grateful for funding from Welcome Trust.
17 Anti-infective Drug Nanosystems 475
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2016)
Godbole et al. (2020)
Lamivudine liposomes showed rapid clearance from the plasma and
higher tissue accumulation (10.97 ± 0.72-fold in liver and
biodistribution following subcutaneous injection showed that the
Cheng et al. (
drug-nanoparticles accumulated in the lymph nodes, liver and spleen
in vitro and a tenfold higher elimination half-life in rats following
subcutaneous injection in comparison to unformulated enfuvirtide
Pargoo et al. (2021)
¼ 94 nm) compared to
50
Lamivudine-conjugated to G2 dendrimer showed higher viral repli-
rats
cation suppression in vitro (IC
1.38 ± 0.52-fold in spleen) compared to unformulated lamivudine in
Surve et al. (2020)
¼ 960 nM). Also conjugating
50
Efavirenz nanoparticles showed reduced toxicity in U937 macro-
Lamivudine to G2 dendrimer reduced its toxicity in vitro
unformulated lamivudine (IC
phage cells in vitro compared to unformulated efavirenz. In vivo
phospholipid
Delivery
system Drug Composition Biological activity Reference
Table 17.7 Example of nanocarrier systems for delivery of anti-HIV drugs
Liposomes Lamivudine Cholesterol and
generation PEGylated
Dendrimer Lamivudine Negatively charged second
dendrimer (G2)
PLGA
Efavirenz Stearic acid, soy lecithin,
Polymer-lipid
hybrid
nanoparticles
Enfuvirtide Polyethylene glycol Enfuvirtide-PEG conjugates showed similar anti-HIV activity
Polymer
conjugate
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Questions
Q 1. There is problem of drug resistance in treatment of tuberculosis. Taking into
consideration all the benefits that nanocarriers can offer, what is the best way to
treat a possible resistant pathogen?
A 1. Nanocarriers such as polymeric nanoparticles can be designed to deliver a
combination of anti-TB drugs this might overcome the problem of treating
resistant pathogens. For example, PLGA has been investigated for delivering a
combination of rifampicin and isoniazid in the form of polymeric nanoparticles.
Furthermore, more advanced nanocarriers such as dendrimers offer the advantage
of their ability to deliver high load of the drug and more than one drug which
might offer a potential carrier for combination of anti-TB drugs.
Q 2. Amphotericin B (AmB) is an example of an active drug substance used to treat
fungal and parasitic diseases that has shown little documented resistance. Unfortunately, AmB has a narrow therapeutic window and is poorly soluble. Briefly
describe how it has been possible to improve the properties of AmB through drug
delivery.
A 2. AmB was initially discovered in the 1950s and shortly afterwards registered for
use as a micellar deoxycholic acid formulation which solubilised AmB but did
not improve its narrow therapeutic window. Several new classes of antifungal
drugs have continued to be developed, but AmB continued to be used in spite of
its toxicity. Then in the 1990s, several new lipid-based formulations of AmB
were registered for use, particularly liposomal AmB. Liposomal AmB is a
vesicular formulation that: (i) helps to mask the AmB to minimise toxicity and,
(ii) alters the biodistribution of AmB so that it is not systemically distributed.
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