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Bromhexine:AComprehensiveReview
A R T I C L E I N F O A B S T R A C T
Keywords:
Reviewarticle
Asthma
Bromhexine
Chronic Bronchitis
Introduction
Natural molecules have been a boon in the field of medical science and therapeutics. With the
progress of latest technology and advancement in synthetic chemistry and computational
biology, it has now become possible to precisely decide the best possible fit inhibitor molecule
for the pathologically important target molecules in the human body. In recent history, many
naturally occurring molecules have been derivatized to improve the inhibitory potential.
Bromhexine is one such molecule that has been derivatized from the naturally occurring
molecule vasicine. Vasicine is obtained from Adhatodavasica, a very well known herb for
respiratory and other inflammatory diseases. The present review describes the importance
and uses of bromhexine in the area of therapeutics with a light on its mechanism of action and
its use in several diseases such as asthma and chronic bronchitis.
Bromhexine, a benzylamine derived cardiac depressant of
vasicine, is a quinazoline alkaloid obtained from the plant
Adhatoda vasica. It was developed in the research laboratory of
Boehringer Ingelheim in the late 1950s as an active ingredient for
pharmaceutical use. It was introduced in 1963 under the
trademark of Bisolvon® and is chemically known as N-
cyclohexly-N-methyl-(2-amino-3, 5-dibromobenzyl) ammonium
chloride. [1] The chemical structure of bromhexine is represented
in figure 1.
It is also known by the synonym as Bromhexine Hydrochloride.
Bromhexine is majorly used as a mucolytic agent for curing
respiratory disorders correlated with excessive or viscid mucus. It is
used as a secretolytic expectorant for the effective treatment of
cough with phlegm. [2, 3] In addition, bromhexine also has
antioxidant properties. It is mainly associated with upper as well as
lower respiratory tract infections [4] such as broncho-pneumonia
[5], bronchiectasis [6], acute and chronic bronchitis [7], sinusitis [8],
mixed respiratory conditions [9] & diseases like allergic asthma [10]
and obstructive airway diseases whose course is complicated by
infections. [11] This compound is accepted well as it has a low level
of toxicity. [12] It is generally well tolerated and can also be given to
children of different ages.
2.PhysicalProperties
Bromhexine exists as a white crystalline powder in solid state
and is insoluble in water but shows little solubility in alcohol. It is
also slightly soluble in chloroform and methylene chloride. [13]
3.Mechanismofaction
Bromhexine's intentional use is to support the body's activities
associated for clearing mucus from the respiratory tract. The
mechanism of action is based on phlegm degradation, thereby easing
coughs. [3] It helps in enhancing the production of serous mucus in
the respiratory tract and helps in the production of thinner and less
viscous phlegm. This produces a secretomotoric effect by helping the
cilia in expectoring the phlegm out of the lungs. Due to this reason, it
is often regarded as an important component of cough syrups. [14]
Bromhexine begins to act on the mucus at the formative stages in
the glands inside the mucus-secreting cells. [12] Through oral
administration in patients, the onset of action of bromhexine begins
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Volume 6, Issue 2, April 2015
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c
* Corresponding Author : Dr.Rachana
Copyright 2011. CurrentSciDirect Publications. IJBMR - All rights reserved.
c
Associate Professor, Department of Biotechnology,
Jaypee Institute of Information Technology,
A-10, Sector 62, Gautam Buddha Nagar, Noida, 201309,
Uttar Pradesh, India
Phone: +91 9315434437
Email ID: rachana.dr@gmail.com
a b
Ayushi Bhagat , and Rachana *
a
M.Tech Student, Department of Biotechnology, Jaypee Institute of Information Technology, Noida
b*Associate Professor, Department of Biotechnology, Jaypee Institute of Information Technology, Noida
Jaypee Institute of Information Technology,
A10, Sector 62, Gautam Buddha Nagar, Noida, 201309, Uttar Pradesh, India
Figure1representstheChemicalStructureofBromhexine.
after 30 minutes. Its complete effect is visualized by an increased
production of respiratory tract fluid after 2-3 days of the
commencement of treatment. Following oral administration,
bromhexine has been shown to increase the volume of sputum
and to decrease the viscosity of bronchial secretions in chronic
bronchitis patients. [15-17] The drug induces the hydrolytic
depolymerization of mucous protein fibers of high molecular
weight and stimulates the activity of the ciliated epithelium. [18-
19] It has been shown to reduce the viscosity of bronchial
secretions in both animals [2] and men. [20]
Anon in 1971 postulated an increase in the lysosomal activity
which was associated with bromhexine. [15] There were
significant improvements in the pulmonary function besides an
ease in expectoration, in bronchitis patients. Several other
pharmacological effects of bromhexine have also been posited
such as an increment of secretion from exocrine glands (eg, tear
production) and an upsurge in pulmonary surfactant production.
[17-18] Bromhexine also has clinical efficacy to increase sputum
concentrations in combination with various antibiotics such as
oxytetracycline, erythromycin, ampicillin and amoxicillin. [13, 16,
17, 21] However, some of these effects reported (exocrine
stimulation and increased sputum concentrations etc.) have not
yet been confirmed in the studies. [22-24]
It has been suggested that, Ambroxol (NA-872) which is a
metabolite of bromhexine, can also contribute to an increased
sec reti on f rom e xoc ri ne g land s dur in g b romh exin e
administration. [25-26] Asthmatic and chronic bronchitis
patients have sputum comprising of fibre systems characterized
with mucoproteins and mucopolysaccharides. The nuclei of cells
lining the mucosal wall of the bronchial track disintegrate leading
to the formation of purulent fibres of deoxyribonucleic acid. This
leads to the formation of sputum viscosity due to an increase in
the mucopolysaccharide and DNA fibre systems. Although,
antibiotics effectively decrease the DNA contribution, it has been
seen under the microscope that bromhexine helps in breaking
down the mucopolysaccharide fragments and thus cause a
reduction in sputum viscosity. Therefore, it is now more easily
removed through coughing. Bromhexine therapy often amends
the sputum immunoglobulins and causes changes in the secretory
granules of bronchial and nasal mucosa glands as seen through
electron microscopic studies. [1] Although there is a decline in the
sputum volume, its viscosity remains low until the bromhexine
treatment is maintained. This causes an increased response to
bronchodilator drugs by our body. It is preferable in some cough
medication as it does not include any sedatives which can
otherwise make the users feel drowsy. [27]
4.UseofBromhexineinpathologicalconditions
4.1Asthma
Various studies have been performed to analyse the
therapeutic applications for bromhexine for Asthma. Forty seven
patients, who were experiencing symptoms of respiratory disease
such as, the production of mucopurulent sputum were given a
dosage of 8 mg of bromhexine thrice daily for one week in a double
blind controlled crossover clinical study. An increase in the
ventilatory capacity leading to significant clinical improvement
was seen in a greater number of patients than those who were
administered placebo. However, there was a difference in the
results in different parts of the trial which was carried out in
winters and summers. [28] On the other hand, in another double
blind crossover technique, thirty four patients were given the oral
treatment with two drugs and placebo for three consecutive times
with a gap of 12 days. These people suffered from chronic asthma
and persistent mucoid expectoration. There was no significant
enhancement in the sputum viscosity, clinical state, PEF or airway
resistance. Th ough, patients' ow n preference regardi ng
bromhexine as a mucolytic agent increased by 0.1%. [29]
Similarly in another study of a double blind therapeutic
regimen, fourteen patients received oral or intravenous treatment
of bromhexine or placebo in conjunction with the regular
standard therapy for acute severe asthma. There was no
prominent recovery seen for bromhexine group of patients. [30]
In the next decade, twenty children in the range of ages from 3 to
14 years were nebulized with 2 ml of saline or bromhexine (2
mg/ml) for two weeks. They had been suffering from bronchial
asthma in combination with chronic sinusitis. Both treatments
had shown compelling improvements but saline nebulization was
more significant than bromhexine. [31] Hence, it can be seen that
although there are several studies related to asthma that have
been performed with bromhexine, some have shown positive
effects while the others have shown nil effect.
4.2ChronicBronchitis
Similar to asthma, in the case of chronic bronchitis, either
types of reports were available in which positive or none effects
were seen. Bromhexine has been shown to change the sputum
characteristics in vitro but, it has produced varying results in
several clinical trials. [32] Here is a brief scenario highlighting
both the positive and nil effects observed by the bromhexine
therapy in chronic bronchitis patients.
4.2.1 Positive effects of bromhexine for chronic bronchitis
studies
Hamilton et al. reported that, when 16 mg bromhexine was
administered orally for three times daily for 11 days in twenty five
patients in a double blind clinical trial, it resulted in a prominent
increment in sputum volume along with a reduction in the
viscosity of sputum. No change in the ventilatory capacity or in the
respiratory state of the patients was visualized. There was a
change in the yield values with no possible side effects seen
amongst patients. [20] In agreement to Hamilton, Seventy-five
patients diagnosed with chronic bronchitis were administered a
daily dosage of 24 mg bromhexine and a placebo. Sixty one
patients produced suitable results for evaluation. Out of these, a
significant group felt better after consumption of bromhexine and
showed fewer side effects as compared to the placebo group. [33]
It has been seen that intra-alveolar haemorrhage and
sustained intermittent positive pressure ventilation therapy
leads to an increase in the viscosity of bronchial secretions in
chest injuries. To stop this kind of injuries an appropriate
mucolytic drug can be used to break the mucopolysaccharide
complex along with the moistening of inhaled air. When
bromhexine was used 12 mg daily along with ventilation therapy
in a patient with chronic bronchitis, it showed significant results.
[14] In yet another controlled double blind cross over clinical
study of twenty one patients suffering from severe chronic
bronchitis, 24 mg or 48 mg bromhexine was significantly
correlated with a placebo for 14 weeks daily. Sodium fluorescein
was utilized as a drug marker. Sufficient data was obtained from
eighteen patients with no change or enhancement in the
ventilatory capacity or sputum properties. No side effects were
Ayushi Bhagat & Rachana/Int J Biol Med Res.9(3):6455-6459
6456
6457
bronchitis exacerbations and those having mucoid sputum for
14 days. There was no change in the volume, yield value and
viscosity of the sputum. The ventilatory capacity of the lungs
remained unaffected after treatment with no shift in the ease of
breathing. [41] In another study, eleven out of twenty two patients
were asked to take bromhexine along with 1 g of erythromycin
ethyl succinate twice daily for a period of 10 days. The other half
group were administered with placebo along with the antibiotic.
These people had acute exacerbations of chronic bronchitis.
There was no clinical improvement seen in both these groups.
[42] .
4.3DiabeticNephropathy
Bromhexine has also been tested for the treatment of
nephropathy. Male wistar rats were given single intravenous
injections of streptozotocin (40 mg/kg) for the onset of diabetes.
They were treated with bromhexine at two different dose levels
for the subsequent 13 months. Renal analysis of these rats along
with non diabetic controls and untreated diabetic rats showed a
prominent increase in the glomerular volume. It led to an increase
in the thickness of the basement membrane in untreated diabetic
animals. Diabetic rats treated with bromhexine showed a
reduction in the glomerular volume as compared to animals that
were not given bromhexine therapy. This proved that bromhexine
effectively enhanced one of the changes in vitro diabetic
nephropathy. [43] On the other hand, in a study performed by
Marshall et al. in 1991, the activity of 72 mg of bromhexine daily
was observed in nine insulin dependent diabetes melitus patients
with normal albumin excretion in a randomised cross over double
blind clinical trial. There was no change in the albumin excretion
after bromhexine treatment in all the three groups tested with no
change in blood pressure, blood glucose levels or creatinine
clearance. Thus, they concluded that bromhexine had no effect in
insulin dependent diabetes mellitus patients. [44]
4.4RadiotherapyinducedXerostomia
Twenty five patients suffering from xerostomia after head and
neck radiotherapy were given a treatment of pilocarpine and
bromhexine in a randomized crossover single blind clinical trial.
Initially, they were given pilocarpine for a period of 2 weeks
followed by a wash out period of one week. Then, they were given
bromhexine for the subsequent 2 weeks. In the second part of the
clinical trial, patients were first asked to consume bromhexine
and then pilocarpine for a period of 2 weeks each along with a gap
of one week wash out period in between. The results were
analyzed based on the saliva secretion rates of patients.
Pilocarpine proved more effective in treating xerostomia as
correlated with bromhexine. However, bromhexine also showed
effective results alone but was more productive in reducing
radiotherapy associated problems when used in combination
with pilocarpine. [45]
5.Conclusion
On the basis of the above mentioned descriptive studies
highlighting the role of bromhexine in various clinical conditions,
it can be stated that bromhexine has been effective in most of the
cases when administered to people. It has been proven to be a
suitable molecule that alters the mucus properties and has been
helpful in easing many clinical conditions like asthma, bronchitis,
nephropathy and xerostomia. The trend of research on this
observed in these patients. [34] As put forward by Lal and Bhalla,
forty one patients with chronic bronchitis were given 16 mg
bromhexine or placebo thrice daily for 3 weeks along with 500 mg
oxytetracycline twice daily. These patients also had symptoms of
irreversible airways obstruction. Thirty six patients showed
reduction in stickiness of phlegm whereas five patients had
developed influenza. There was no significant change in other
respiratory illnesses such as cough, sputum volume and ease of
breathing. [35]
As reported by Aylward, bromhexine was compared with S-
carboxymethylcysteine in a clinical study in patients having
mucoid sputum for 10 days. Both the drugs were given orally as
syr up fo rm ulat io ns t hr ice d aily a s 7 50 mg f or S-
carboxymethylcysteine and 16 mg for bromhexine. There was a
prominent change in cough severity, consistency of sputum and
expectoration ease. However, bromhexine didn't show any overall
benefits in the respiratory states and thus was not prefered by
clinicians. One person had also shown side effects of severe
nausea after receiving bromhexine. [36] Armstrong posited that
there were beneficial results after consuming bromhexine
(Bisolvon) which was used for the treatment of chronic
bronchitis. There were prominent amendments in the sputum
volume, consistency, peak expiratory flow rate and ascultatory
findings. This proved that bromhexine was effective for most
people with thick sputum. [37] In a double cross blind clinical
trial, thirty patients were randomized for 36 mg of bromhexine
and 45 mg of ambroxol (metabolite VIII of bromhexine). Several
parameters of mean bronchial flow resistance, arterial blood
gases, forced expiratory volume, static lung volumes and
laboratory results were analyzed. However, bromhexine didn't
cause a change in any of the lung parameters. [38]
In Greek medicine several early remedies such as cinnamon,
garlic, pepper, turpentine etc. have been replaced with the
modern mucokine tic re medies o f ephedr ine, a tropine ,
theophylline and bromhexine. [39] The efficacy of bromhexine
therapy was observed in the treatment of eighty eight patients
who were diagnosed with bronchiectasis, by administering them
with 30 mg capsules of bromhexine or placebo thrice daily in
conjunction with ceftazine for one week. Bromhexine produced
effective results and improved the respiratory conditions of
patients. [19] In a one-week, multicentric and randomised
double-blind clinical study, four hundred twenty six patients with
progressive coughing were tested for the efficacy and tolerability
of three expectorant formulations for three times per day for 7
days. Group A were given a fixed dose concentration of 2 mg
salbutamol, 100 mg guaiphenesin and 8 mg of bromhexine HCl.
There was a significant improvement in the reduction of cough
frequency and several sputum characteristics. Group B were
administered with a combination of 100 mg guaiphenesin and 2
mg salbutamol. Group C were given a combined dosage of 8 mg
bromhexine HCl and 2 mg salbutamol. Both groups B and C didn't
produce effective results as compared to group A. [40] This
further affirmed that the combination of salbutamol, bromhexine
and guaiphenesin over bromhexine or guaiphenesin given alone,
could be used effectively as a cough expectorant for alienating the
cough produced.
4.2.1 Nil effects of bromhexine for chronic bronchitis studies
Langlands in 1970 reported that 8 mg Bromhexine or identical
placebo tablets were administered in patients with chronic
Ayushi Bhagat & Rachana/Int J Biol Med Res.9(3):6455-6459
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