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RECENT TRENDS IN APPLICATIONS OF PULMONARY DRUG DELIVERY: A

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Publication Ref No.: IJPRD/2011/PUB/ARTI/VOV-2/ISSUE-12/FEB/018 ISSN 0974 – 9446

RECENT TRENDS IN APPLICATIONS OF PULMONARY DRUG DELIVERY: A REVIEW

Siraj Shaikh*1 Syed Nazim1, Afsar Shaikh1 ,

Tarique Khan1, Md.Zameeruddin1,
Quazi Majaz1, Shailesh Chalikwar 2
1
Ali-Allana college of pharmacy Akkalkuwa
Dist, Nandurbar, Maharashtra, India.
2
Siraj Shaikh R.C.Patel college of pharmacy,Shirpur
Dist Dhule, Maharashtra, India.
Email:[email protected]

ABSTRACT

Pulmonary drug delivery system is a needle free technique. The origin of inhaled therapies seen in
back 4000 years ago to India, where people smoked the leaves of the Atropa belladonna plant to
suppress cough. In the 19th and early 20th centuries, asthmatics smoked asthma cigarettes that
contained stramonium powder mixed with tobacco to treat the symptoms of their disease. Now a day’s
pulmonary drug delivery remains the preferred route for administration of various drugs. It is an
important research area which impacts the treatment of illnesses including asthma, chronic obstructive
pulmonary disease and various diseases. Drug is delivered directly to the conducting zone of the lungs.
In this article, we summarize recent advances in applications of pulmonary drug delivery system.
previously pulmonary drug delivery is used for management of Asthma and COPD only but due
advancement in application nowadays Pulmonary drug delivery is useful to treat Diabetes, angina
pectoris, cancer , bone disorders ,migraine,tuberculosis,acute lung injury and others. .

Key Words: Asthma, pulmonary route, application, bone disorders, inhalation therapy.

INTRODUCTION L of air that must be inhaled daily to accomplish

The development of an inhalation therapy that is gas exchange. It is a characteristic of the
effective and safe depends not only on a effectiveness of lung defense mechanisms that
pharmacologically active molecule, but also on in healthy people’s lungs are sterile below the
a delivery system and its applications. The larynx. 1
respiratory tract is exposed to a relatively large By pulmonary route drug goes gives direct to a
number of biological and non biological target organ. In the treatment of obstructive
particulates. These are contained in the 20,000 respiratory diseases, pulmonary delivery can

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minimize systemic side effects, provide rapid ADVANTAGES OF PULMONARY DRUG

response and minimize the required dose since DELIVERY.
the pulmonary route is better alternative to other
1) It is needle free pulmonary delivery.
routes because if we compare it with parental
2) It requires low and fraction of oral dose.
route injection is associated with pain.
3) Pulmonary drug delivery having very
Seconadly, chronic injection is an unpleasant
negligible side effects since rest of body is not
prospect with a host of hygiene issues and
exposed to drug.
potential side effects. At worst, it can create a
4) Onset of action is very quick with pulmonary
barrier to patient compliance with the particular
drug delivery.
drug regimen required to most effectively treat a
5) Degradation of drug by liver is avoided in
given disease, since some patients choose
pulmonary drug delivery.8,9,10
irregular treatment or no treatment at all when
faced with frequent injections. 2 CURRENT APPLICATIONS OF PULMONARY
While injecteble route is another option has DRUG DELIVERY
served as the primary means of delivering drug
but it is invasive in nature so, many non- 1) Application of pulmonary drug delivery
invasive routes have been explored as in Asthma and COPD.11,12
alternatives. Oral route remains the most
common method of delivery for most small Asthma is a chronic long term lung disease that
molecule drugs. However, oral delivery most is characterized by inflammation and narrowing
often does not work for macromolecules of airways. Asthma causes recurring periods of
because proteins are digested before they have wheezing, chest tightness, shortness of breath,
an opportunity to reach the bloodstream. As and coughing. The coughing often occurs at
compare to pulmonary route more dose is night or early in the morning. Asthma affects
required to show action by oral route. 3,4 people of all ages, but it most often starts in
Drug delivery by Nasal route is inefficient in childhood. In the United States, more than 22
terms of the amount of drug actually delivered million people are known to have asthma.
to the body and to improve its efficiency Nearly 6 million of these people are children.
penetration enhancers must be added that may Aerosol systems that deliver bronchodilators to
cause local irritation. But in case of pulmonary relax airways and corticosteroids to control
route research has shown that many molecules inflammation in asthma and COPD are widely
are absorbed through the deep lung into the used today and carry a proven track record.
bloodstream naturally with relatively high Today’s inhaled drug delivery market is
bioavailability and without the need for dominated by the three main classes of drug
enhancers used by other noninvasive routes. such as bronchodilators, corticosteroids, and
Intradermal route offers an even less naturally anticholinergic. Nowadays all above three
permeable boundary to macromolecules than classes of drugs given by pulmonary route. For
the gastrointestinal tract. The devices, which managment of asthma advances done in drugs
inject proteins like insulin, have been available such levosalbutamol inhalers which having
for years, however they have not very well superior efficacy as compare to
accepted by doctors as well as patients due to salbutamol.COPD means chronic obstructive
the discomfort and the potential for ‘‘splash pulmonary diseases. COPD is linked to
back’’ to transmit blood borne diseases smoking, comprises chronic bronchitis and
associated with it .Thus pulmonary route is emphysema and causes one million deaths
better route as compare to other routes,5,6,7,

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annually.Titropium inhalers are present in liquefy secretions in CF patient.

market to teat COPD. III). Tobramycin-spray dried.
Tobramycin powders containing Nanoparticles
2) Recent role pulmonary delivery in for pulmonary delivery.Tobramycin is widely
patients on ventilators used to treat patients with CF. Overall, evidence
suggests improved lung function and probably
Aerosols to patients on ventilators have
reduced hospitalization when tobramycin is part
received much accepted by doctors as well as
of maintenance therapy in CF .13
patient in 1990. Some studies of early delivery
techniques documented low (2.2%) deposition
4) New use of pulmonary delivery in
in the lung with half retained in the nebulizer,
diabetes
and considerable intersubject variability.
Diabetes is a syndrome of disordered
Recently to improve inhalation coordination of
patient devices like Baby mask are mostly metabolism and inappropriate hyperglycemia
used.This mask is attached to spacer for small resulting from a deficiency of insulin secretion or
tidal volumes and low inspiratory flow rates resistance. Diabetes can cause a heart attack,
infant and young Childers..By using baby mask stroke, blindness, kidney disease, nerve
we can easily give medication to child up to 2 damage and other serious health problems. The
most common form of this therapy is twice-daily
years this is recent advancements in
subcutaneous injections of insulin. This type of
applications of pulmonary drug delivery.
treatment is painful and as a result encourages
3) Pulmonary delivery in cystic fibrosis noncompliance by up to half of the diabetics.
Peptides and/or proteins are becoming more
important in medication. When taken orally,
Nowadays cystic fibrosis is very common
peptides and/or proteins are degraded by the
disease .Pulmonary delivery played an
proteolytic enzymes in the gastrointestinal tract,
important role in the management of CF for
and might be impermeable to the intestinal
decades. The main aim of aerosol system is to
mucosa due to their hydrophilicity and large
deliver drugs to infants and chidrens.
Recentallly following drugs are given by molecular size. As a result, systemic delivery of
pulmonary route for cystic fibrosis. these macromolecular drugs and other
therapeutic and diagnostic agents has been
I) N-Acetylcysteine limited to the parenteral route. Repeated
N-acetylcysteine (NAC) is Mucolytic agents injections are required due to the short half-lives
of peptide/protein drugs.14
have been used by pulmonary route to help in
The first attempts at
sputum clearance. It will help to liquefy
intrapulmonary delivery were made in the
tenacious secretions and make their clearance
1920s . However, almost 50 years feasibility
easier. Recently newer mucolytic agent,
of arolosied insiulinwas demonstrated Initial
nacystelyn, has been developed for delivery via
observations were soon confirmed by
a dry powder inhaler.
others revealing a more rapid absorption
II) Recombinant human deoxyribonuclease and clearance compared to
aerosol subcutaneous administered insulin.
Several companies are working on insulin
Rerecentallly deoxyribonuclease is given by
pulmonary route .Recombinant human inhalers than any other insulin delivery option.
deoxyribonuclease aerosol mainy used to Insulin inhalers would work much like asthma
inhalers.

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The products fall into two main groups the dry Measles infects 30 to 40 million children
powder formulations and solution, which are in underdeveloped nations. Recently inhaled
delivered through different patented inhaler measles vaccine given by nebulizer. As far
systems. E.g. Novel pMDI formulations for back as the 1960s, influenza experts tested
pulmonary delivery of proteins.15, 16,17,18.19,20. aerosol flu vaccines.
(Refer Table No. 01) 8) In emphysema
Emphysema is most popular respiratory
5) In migraine
disorder due to deficiency of Alpha 1 antitrypsin
Ergotamine is drug of choice for migraine. Many uncontrolled neutrophil elastase deficiency
years ago, ergotamine via metered dose inhaler formed which leads to lung destruction and the
was used successfully to treat migraine formation of emphysema. Nowadays
headache.13 recombinant AAT (rAAT) given intravenously
6) Angina pectoris (IV) is very well accepted treatment. Early
evaluation of aerosolized AAT documented
Angina pectoris is not a disease itself it is adequate alveolar fluid AAT and penetration
symptoms of myocardial ischemia it is arises as into the lung interstitum. Neutrophil elastics’
a result of imbalance between oxygen supply inhibitor, secretory leukocyte protease inhibitor,
and demand of myocardium.Nitroglycerine. is has also been considered for protection against
drug of choice for angina pectoris has been elastase in CF and patients with AAT
given generally by sublingual route .It is well deficiency.
known as is a known coronary vasodilator, the
9) Recent use of pulmonary drug delivery in
rapid relief of angina is probably caused by a
transplantation
reduced demand on the heart and the
consequent reduced cardiac work. An aerosol Inhalation route play a role very important role
form has been tested in Europe and has in transplantation. Legion is problems of
been found comparable to sublingual transplanted organs and lung transplantation is
nitroglycerine. In particular, its efficacy has been one of the most difficult transplants to maintain.
found better than nitroglycerine tablets in During lung transplantation, pulmonary vascular
patients with dry mouth. Isosorbide aerosol has pressure and an intrapulmonary shunt have
also been reported useful in hypertensive crisis. been shown to respond to inhaled nitric oxide
In United States inhalation therapy for angina and inhaled aerosolized prostacyclin
pectoris is very well accepted.13 .prostacyclin which is given by pulmonary route
7) Role of pulmonary delivery in vaccination has also been described as an alternative to
21 nitric oxide in the management of reperfusion
injury after lung transplantation. Acute and
While there was moderate interest in chronic rejections are major problems
aerosol vaccination 15–20 years ago, progress compromising transplant and patient survival.
toward application has been modest Aerosolized cyclosporine a is useful for
seen.Nearly 100 vaccines are approved in the reducing the risk of acute rejection. 13
U. S. About half of these prevent respiratory
infections, yet all are currently injected. As
compare to injectable they remove needle fears, 10) In Pulmonary arterial hypertension22
especially in children, but they could also
This is new use of pulmonary route in
generate more potent local immune responses
2004, the FDA approved Ventavis (iloprost), an
than when they are injected into muscles.

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inhaled treatment for pulmonary arterial maintenance of expression over time, and
hypertension, made by CoTherix (South San efficacy of expression.
Francisco, CA, U. S. A.). In pulmonary arterial 14) Application of pulmonary drug delivery
hypertension, severe restriction of blood vessels in cancer chemotherapy
results in early death.
11) In acute lung injury13 Cancer is one of major disease which
takes death of people. Lung cancer is the
Drug given by pulmonary route plays very
leading cause of cancer deaths globally, and
important role in acute lung injury. Major inhaled chemotherapy seems a logical
complication of acute lung injury is Hypoxemia approach to treat lung cancer.
and it is often difficult to manage. Mediators
such as nitric oxide and prostacyclin can A multicenter Phase I clinical trial is
improve oxygenation by increasing blood flow evaluating doxorubicin HCI inhalation solution in
through ventilated areas. Prostaglandin E1 lung cancer patients. As many as 400 000 lung
(PGE1) by continuous aerosol via a ventilator cancer patients could benefit from inhaled
has also been shown to improve oxygenation. chemotherapy; a study is going on aerosolized
paclitaxel solution to mice with lung tumors. The
12) Application of pulmonary drug delivery
treatment significantly reduced lung tumors and
as a surfactant aerosol
prolonged survival. Aerosol delivery of the anti-
In respiratory distress of premature infants and cancer agent’s difluoro methylornithine and 5-
neonatal surfactant plays important role. In fluorouracil reduced lung tumors in mice 50 %
adults loss of surfactant is probably a and 60 %, respectively. Interleukin-2 stimulates
contributing factor in pathogenesis of acute immune function in cancer patients, but
respiratory distress syndrome. A recent study injections cause fever, malaise, and local
showed no difference in outcome for swelling. 24
spontaneously breathing newborns who inhaled
either surfactant or placebo via a CPAP mask. 15) Delivery of pentamidine by pulmonary
There continues to be great appeal for the use route25
of surfactant in adults because of the apparent protozoan Pneumocystis carinii(PCP) is
success in neonates, but its use should not major cause of Pneumonia in Patients with
become practice until well controlled trials acquired immunodeficiency syndrome . Aerosol
document clinically meaningful efficacy. pentamidine is not only useful in treating mild
13) Gene therapy via pulmonary route23 PCP and, but also for prophylaxis against PCP.
This is new research in application of Pentamidine aerosol is delivered to the alveolar
space, where the P. carinii organisms are
pulmonary drug delivery .Main aim Gene
found. The deposition fraction of pentamidine is
therapy given by pulmonary route is treatment
relatively low, around 2–3% of total dose in the
of cystic fibrosis. Cationic-lipid-mediated CFTR
nebulizer but as a fraction of total lung capacity,
gene transfer can significantly influence the
it is greater in children, and so there is need to
underlying chloride defect in the lungs of
reduce the dose in children.
patients with CFC. There are many problems to
16) Delivery of Amphotericin by pulmonary
be overcome before clinical applications are
route26
practical. Some of these are safety, successful
transfer of sufficient genetic material to Now days Amphotericin aerosol has been
appropriate tissue, adequate gene expression, successfully used to treat various infections.

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Such use should not become clinical practice cessation. Nicotine for inhalation and for nasal
without good randomized controlled trials. delivery is available, and studies indicate some
improvement in the success of cessation efforts
Ribavirin aerosol has also been used for
beyond placebo. Inhaled nicotine substitution
treatment or prophylaxis following bone marrow
for cigarettes has much potential because it
transplantation but controlled trials are needed
most mimics delivery by smoking, giving a rapid
to better clarify efficacy.
rise in blood nicotine level.

17) Delivery of Gentamycin by pulmonary 20) Inhaled drug delivery for tuberculosis
route therapy28
Tuberculosis is most infectious diseases
For chronic Pseudomonas aeruginosa
because One third of the world population is
(PA) infections in CF gentamycin given by
infected with tuberculosis and new infections
pulmonary route plyas important role.It was
occur at a rate of one per second. The urgency
observed daily inhalations of gentamicin delays
to treat TB may be addressed with approaches
the acquisition of chronic PA infections and
consisting of newer drugs and delivery systems
decreases disease progression in children with
The recent increase in the emergence of drug-
zanamivir, made by GSK, was the first inhaled
resistant strains of Mycobacterium tuberculosis
anti-viral medication approved by the FDA in
1999. For treatment of flue dose of dry powder and the dearth of anti-TB drugs is threatening
inhalers is twice daily for 5 days. 27 the future containment of TB. Administering
drugs by the pulmonary route to the lungs
allows higher drug concentrations in the vicinity
8) Diagnostic application pulmonary drug of these lesions. Supplementing conventional
delivery 27 therapy with inhaled antiTB therapy may allow
therapeutic concentrations of drug to penetrate
Pulmonary drug delivery is not only effectively into lung lesions and treat the
useful for therapeutic purpose but also for resident mycobacterium. Drugs Used
diagnosis purpose. Several diagnostic tests Experimentally to Treat TB by the Pulmonary
utilizing specific-size nonradioactive aerosols Route is as rifampicin, ionized and
and also radioactive aerosols with standard pyrazinamide.
nuclear medicine technology are practiced in
respiratory medicine. For example, inhalation of As we know that drug resistance is major
aerosols of methacholine and histamine is hurdle in treatment of tuberculosis if drugs given
widely used to assess nonspecific bronchial by pulmonary route for management of TB
responsiveness in asthma. reduces chances of drug resistance TB.Various
drug delivery systems such as micro particles,
nanoparticles and Liposomes can be delivered
19) Nicotine aerosol for smoking cessation to the periphery of the lungs for instantaneous
As we know that smoking is injurious to health and targeted or controlled release. This may
.It is very difficult to cess such habit. From lead to therapeutically effective drug
ancient times people smokes cigarette and get concentrations in regions of the lungs
addicted with smoking. Primary reason for containing large burdens of bacteria. Aerosol
cigarette smoking is Nicotine addiction, and delivery to the lungs as an adjunct to
nicotine replacement is appealing as a means conventional therapy has the potential to
of reducing cigarette use to ultimately achieve decrease the dosing frequency and the duration

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of therapy. This may ultimately lead to less delivered by inhalation route of using
severe side effects, improved patient aerosolized insulin encapsulated liposomes.
compliance and reduced emergence of drug Liposomes, as a pulmonary drug
resistant strains of TB. delivery vehicle, have been studied for years
21) Pulmonary delivery of lower molecular and used as a means of delivering
weight Heparin29 phospholipids to the alveolar surface for
treatment of neonatal respiratory distress
Now days , low molecular weight syndrome. More recently, they have been
heparins is better as an alternative to investigated as a vehicle for sustained-release
unfractionated heparin because of improved therapy in the treatment of lung disease, gene
pharmacokinetic profiles and reduced cost of therapy and as a method of delivering
therapy in the treatment of deep vein therapeutic agents to the alveolar surface for
thrombosis and pulmonary embolism . Low the treatment of systemic diseases.
molecular weight heparins are given by Liposomes can be produced from a variety of
subcutaneous and intravenous routes. phospholipids from natural sources, that are
Administration of an anticoagulant drug directly endogenous to the lungs and that carry either
to the pulmonary circulation would be ideal for no charge or net negative or positive
the treatment of pulmonary embolism. A charges.30,31,32. 33
pulmonary formulation of LMWH will allow direct
23) Recent use of pulmonary delivery for
administration of the drug into the lungs, and
bone disorders34
consequently this formulation is likely to reduce
the mortality from an attack of pulmonary Disease such as osteoporosis and
embolism. This pulmonary therapy is non Paget’s disease of bones can be treated by
invasive because it is needle free. pulmonary delivery. The predicted increase in
22) Controlled delivery of drugs to lungs by the number of patients with osteoporosis and
pulmonary route the lack of ideal therapies dictates the need for
better treatments. Clinical evidence from a
Recent application of pulmonary drug
variety of other peptides and proteins indicates
delivery is controlled delivery by lungs. Most
that pulmonary delivery is safe, efficient, well
Drugs in inhalation required to be take 3-4 times
tolerated and preferred by patients so
in day because of its short duration action so
pulmonary route is better option to treat bone
sustained release of drugs in lungs prolong
disorders.
action in lung for that Liposomes, microsphere
Nanoparticles carriers are used Sustained Following are drugs used to treat osteoporosis
release from a therapeutic aerosol can prolong are the naturally occurring peptides calcitonin
the residence of an administered drug in the and parathyroid hormone, which regulate bone
airways or alveolar region, minimize the risk of metabolism. For the peptides to become viable
adverse effects by decreasing its systemic therapies, formulations must be developed that
absorption rate, and increase patient bypass the need for injection. Pulmonary
compliance by reducing dosing frequency. E.g. delivery of calcitonin and parathyroid hormone
ribavirin aerosol, novel sustained released appears likely in the near future.
microspheres for pulmonary drug delivery,
The recent introduction of a nasal
studies showed that plasma glucose level was
formulation of calcitonin points to the feasibility
effectively reduced when liposomal insulin was
of lung delivery. A pulmonary formulation
inhaled through the mouth that delivers

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calcitonin or PTH into the deep lung should day’s pulmonary drug delivery remains the
improve the bioavailability and efficacy of the preferred route for administration of various
drugs. drugs. Pulmonary drug delivery is an important
24) Current use of pulmonary delivery of research area which impacts the treatment of
opioids as pain therapeutics35 illnesses including asthma, chronic obstructive
pulmonary disease and various diseases.
For pain management painful inject able
Inhalation gives the most direct access to drug
are given. To avoid pain associated with inject
target. In the treatment of obstructive respiratory
able pain killer Pulmonary opioid delivery is
diseases, pulmonary delivery can minimize
better alternative. Early clinical studies involving
systemic side effects, provide rapid response
inhaled opioids were focused on treatment of
and minimize the required dose since the drug
dyspnoea and not pain management, but they
is delivered directly to the conducting zone of
showed that inhalation of various opioid
compounds is safe, even in severely ill patients. the lungs .It is a needle free several techniques
The advent of specialized and efficient have been developed in the recent past, to
pulmonary drug delivery systems has facilitated improve the Quality of pulmonary drug delivery
the evaluation of inhaled opioids, such as system without affecting their integrity.
morphine and fentanyl, for management of Because of advancement in applications of
pulmonary drug delivery it is useful for multiple
severe pain associated with surgery or
diseases. So pulmonary drug delivery is best
malignant disease. In the past, the few studies
route of administration as compare to other
evaluating pulmonary delivery of opioids for the
routes.
management of severe pain has with limited
success. Earlier attempts at systemic delivery of
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applications, limitations

TABLES

Table no.1. Characteristics of devices for intrapulmonary delivery of insulin.

Name of Device Formulation Requirement Dose Battery size
organization of Insulin of adjustment
breath
activation
Alkemes/Eli AIR Dry Yes coarse No Small
Lilly powders
Aerogun/Becton Aero Dose Liquid Yes Fine Yes Small
Dickinson
Elmsford Med Tone Dry No coarse No small
powders,
Pfizer/Aventis Inhance/Exubera Dry No coarse No Large
powders,
Aradigm/Novo AERX idms Liquid Yes Fine Yes Large
Nordisk

…End…

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