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PubMed1977

Increased incorporation of fatty acids into phospholipids of lungs and livers of rabbits under the influence of bromhexine and ambroxol.

The incorporation of lauric acid, palmitic acid and oleic acid into phospholipids of lung and liver has been studied in tissue slices of control rabbits and of rabbits treated with bromhexine or ambroxol in doses of 10 mg/kg. A marked increase (up to 200% of the controls) of palmitic acid incorporation into phosphatidylcholine (lecithin) and phosphatidylethanolamine of the lung was found whereas the incorporation rate of palmitic acid into lecithin and phosphatidylethanolamine of the liver displayed no significant change. The incorporation of lauric acid and oleic acid into lung phospholipids was not accelerated. The observed effects were more marked in short time experiments (analysis 2 h after drug injection) than after treatements for 7 days. It is concluded that the phospholipid synthesis is stimulated by the drugs especially in the lungs. This seems to be of particular interest with respect to the surfactant system of the lung and might have some therapeutic relevance.

Ambroxol↗
PubMed1976

Studies on the formation of cyclohexylamine and N-methylcyclohexylamine from bromhexine in animals and man, and simultaneous determination of cyclohexylamine and N-methylcyclohexylamine by gas chromatography.

In order to detect cyclohexylamine and N-methylcyclohexylamine simultaneously in urine, a gas chromatographic method was developed in which Chromosorb 103 (porous polymer) was found to be suitable as the column packing. The detection limits were 0.1 mug/ml of cyclohexylamine and 0.4 mug/ml of N-methylcyclohexylamine in urine. In tests on animals administered bromhexine, which contains N-methylcyclohexylamine as part of its side-chain, neither cyclohexylamine nor N-methylcyclohexylamine was detected in the urine.

Animals↗
PubMed1978

Surfactant in the amniotic fluid and bromhexine metabolite VIII.

The effect of metabolite VIII of bromhexine on surfactant content in the amniotic fluid was investigated in a double blind study. Administration of 100 and 200 mg NA-872 daily for 5 days to pregnant women ranging in gestational age from 196 to 243 days was not followed by a significant rise in the L/S ratio.

Ambroxol↗
PubMed1996

Activity of bromhexine and ambroxol, semi-synthetic derivatives of vasicine from the Indian shrub Adhatoda vasica, against Mycobacterium tuberculosis in vitro.

The benzylamines, bromhexine and ambroxol, widely used as mucolytics, have a pH-dependent growth-inhibitory effect on Mycobacterium tuberculosis. As these compounds are concentrated in macrophages, they might exert a clinically useful effect on intracellular tubercle bacilli. This, combined with indirect effects including enhancement of lysozyme levels in bronchial secretions and levels of rifampicin in lung tissue and sputum, and possibly clearance of bacilli-laden mucus from cavities and bronchi, suggests a potentially useful adjunctive function for these agents in the therapy of tuberculosis, and adds credibility to early reports of the beneficial effect of benzylamines in this disease.

Ambroxol↗
PubMed1996

Simultaneous determination of bromhexine hydrochloride and methyl and propyl p-hydroxybenzoate and determination of dextromethorphan hydrobromide in cough-cold syrup by high-performance liquid chromatography.

Liquid chromatographic methods were developed for the determination of bromhexine hydrochloride, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate (method A) and dextromethorphan hydrobromide (method B) in cough-cold syrup formulations. Reversed-phase analytical columns (150 mm x 3.9 mm i.d.) were used with (A) C18 and (B) phenyl as stationary phases and mixtures of (A) acetonitrile and aqueous 15 mM triethylamine solution (43:57) and (B) methanol and aqueous 3% ammonium formate buffer solution (53:47) as mobile phases at a flow rate of 1.0 ml min-1. Both aqueous components were adjusted to pH 3.9. UV detection of analytes was at (A) 245 nm and (B) 278 nm. In both methods, the time required for an HPLC run giving good separations and recoveries was less than 8 min.

Antitussive Agents↗
PubMed2005

Simultaneous spectrophotometric determination of salbutamol and bromhexine in tablets.

Typical anti-mucolytic drugs called salbutamol hydrochloride and bromhexine sulfate encountered in tablets were determined simultaneously either by using linear regression at zero-crossing wavelengths of the first derivation of UV-spectra or by application of multiple linear partial least squares regression method. The results obtained by the two proposed mathematical methods were compared with those obtained by the HPLC technique.

Albuterol↗
PubMed1979

Determination of bromhexine as its trifluoroacetyl derivative by gas-liquid chromatography with electron-capture detection.

A specific gas-liquid chromatographic method with electron-capture detection is described for the determination of bromhexine at the nanogram level. Structurally analogous internal standards were synthesized and their suitability was investigated, based on their chromatographic properties on different stationary liquid phases. The electron-capture activity of the compounds is increased by trifluoroacetylation. Reaction conditions for this derivatization were studied. Calibration graphs in the range 0-57 ng (in a total of 100 microliters of reaction mixture) showed good linearity.

Bromhexine↗
PubMed2001

Determination of ambroxol or bromhexine in pharmaceuticals by capillary isotachophoresis.

Expectorant drugs ambroxol (AX) and bromhexine (BX) were determined by capillary isotachophoresis (ITP) with conductimetric detection. The leading electrolyte (LE) was a buffer solution that contained 5 mM picolinic acid and 5 mM potassium picolinate (pH 5.2). The terminating electrolyte (TE) was 10 mM formic acid. The driving current was 80 microA (for approximately 200 s) or 50 microA (for approximately 350 s) and the detection current was 20 microA (a single analysis took about 8 min). The effective mobilities of AX and BX (evaluated with tetraethylammonium as the mobility standard) were 18.8 x 10(-9) m2 V(-1) s(-1) and 14.3 x 10(-9) m2 V(-1) s(-1) respectively. The calibration graphs relating the ITP zone length to the concentration of the analytes were rectilinear (r = 0.9993-0.9999) in the range 10 mg L(-1) (20 mg L(-1) for BX) to 200 mg l(-1) of the drug standard. The relative standard deviations (RSD) were 1.2 1.6% (n = 6) when determining 100 mg l(-1) of the analytes in pure test solutions. The method has been applied to the assay of AX or BX in seven commercial mass-produced pharmaceutical preparations. According to the validation procedure based on the standard addition technique the recoveries were 97.5-102.7% of the drug and the RSD values were 0.11-2.20% (n = 6).

Ambroxol↗
PubMed1984

[Bromhexine in symptomatic treatment of Sjögren syndrome].

In a group of 11 patients with Sjögren's syndrome bromhexine improved tear secretion in 7 cases and salivary secretion in 4. The efficacy of the drug, in particular in patients in whom the syndrome has been present for a short time, was thus confirmed.

Adult↗
PubMed1987

The effects of bromhexine hydrochloride and S-carboxymethyl-L-cysteine on guinea-pig uterine microflora.

This study used guinea-pigs as a mammalian model to investigate the effects of bromhexine hydrochloride and S-carboxymethyl-L-cysteine on the integrity of the cervical mucus plug. It was shown that under normal circumstances the uterus is sterile, but following drug administration microorganisms began to appear in the uterus with no significant effect on the vaginal microbial population. It therefore appears that these two mucolytic agents may reduce cervical mucus viscoelasticity. After the animals had been mated, microorganisms were isolated from the uterus even in the absence of drug treatment.

Animals↗
PubMed1993

Bromhexine plus oxytetracycline: the effect of combined administration upon the rheological properties of mucus from the mini-pig.

Three adult mini-pigs were employed to assess the effects of a twice daily dosage (40 mg kg-1) of oxytetracycline hydrochloride (OTC) and a combination of OTC with (0.5 mg kg-1) bromhexine hydrochloride (BHC) on the rheological properties and wet weight of secreted tracheal mucus. Mucus was collected daily from open-ended tracheal pouches established surgically in the mini-pigs. After a five day control period, either OTC or OTC plus BHC was administered twice daily with the normal diet. Each study period was followed by a five day washout period when mucus was collected but no drug given. The viscoelastic properties of each mucus sample were determined using creep compliance analysis. OTC was shown to increase the residual shear viscosity IP < 0.01) and increase the instantaneous compliance (P < 0.01). An increase in the wet weight of the collected mucus occurred in one pig only (P < 0.01). When BHC was co-administered with OTC, all of these changes were abolished. Evidence was obtained to suggest that BHC increased the concentration of OTC within the secreted mucus. BHC appeared to reverse the mucospissic activity of OTC in-vivo.

Animals↗
PubMed1979

Biochemical modifications of pulmonary surfactant after bromhexine derivate injection.

The authors study the influence of bromhexine metabolite VIII on phospholipid and fatty acid composition comparatively to controls. The subcutaneous injection of NA 872 produces on pulmonary surfactant an increase of 43% of total phospholipids. This change in the distribution of phospholipids is shown by the increase of 53% of phosphatidylcholines. A rise of 61.9--74.4% of palmitic acid appears in the phosphatidylcholines of the pulmonary surfactant. It can be noticed that the specific activity of the phosphatidylcholines rises by 31%.

Animals↗
PubMed1990

Pharmacokinetics and first-pass effect of bromhexine in rats.

The pharmacokinetics and first-pass effect of bromhexine (BH) were studied in rats. Upon i.v. administration of 0.3 and 1 mg/kg of BH hydrochloride to normal rats, the plasma concentrations followed a biexponential curve, with slower terminal elimination (t1/2 beta = 8.9-11 h). In bile duct cannulated rats, the plasma concentration-time profile was similar to that of normal rats and the bile excreted within 30 h contained only 1.5 +/- 1.2% of the dose as intact and conjugated BH. These results suggest that a slower terminal elimination of BH after i.v. injection is due to a relatively small plasma clearance and large distribution volume rather than the enterohepatic recycling of the drug. Renal clearance of BH was negligible since urinary excretion of intact BH for 24 h after i.v. injection did not exceed 1% of the dose. After oral administration of BH, the systemic availability ranged only 1.8-3.9% based on i.v. and oral data, showing the poor bioavailability of oral BH. The first-pass effect of BH was measured by comparing the area under plasma concentration-time curve (AUC) after i.v., oral or hepatic portal (h.p.v.) administration of the drug. The AUC following h.p.v. dosing was only one-tenth of that obtained following i.v. administration and the AUC after oral dose was a quarter of that after h.p.v. administration. The hepatic extraction ratio was estimated to be 0.92. A low bioavailability after oral BH was explained by both hepatic and intestinal first-pass clearance, but mainly due to hepatic extraction.

Administration, Oral↗
PubMed1991

Percutaneous absorption of bromhexine in rats.

The percutaneous absorption of bromhexine (BH), an expectorant drug, through rat skin was examined in vitro and in vivo. BH in free base form penetrated better than the hydrochloride through the skin. When the in vitro penetration of BH was compared using Plastibase, macrogol and sucrose ester of fatty acid F-160 (DK-ester) formulations, the DK-ester formulation showed the best penetration of BH of the three. The addition of Azone (3%) or lauric acid (BH: lauric acid molar ratio, 1:1) considerably increased BH penetration to a relatively large penetration rate. The plasma levels of BH after in vivo application of the DK-ester formulation with Azone or lauric acid (0.6 g/3.8 cm2) were also higher than those after the formulation without an enhancer, and a constant plasma level (20-50 ng/ml) was obtained during the application for 48 h. However, the bioavailability was low, 2.5 and 2.7% respectively. When the amount of BH remaining in DK-ester ointment and the skin after an 18-h application was measured, the BH content in the ointment was 88.6 +/- 8.0% for the formulation without Azone and 93.7 +/- 6.9% for that with Azone. The low penetration and low bioavailability observed will thus be due to the high drug retention of the base.

Animals↗
PubMed1986

Estimation of a drug effect by a simplified radioaerosol inhalation lung cine-scintigraphy: bromhexine on mucociliary clearance mechanisms.

A proposed simplification of radioaerosol inhalation lung cine-scintigraphy, namely 60 min measurement of radioactivity without repeating measurement at 24 hr later and calculation of alveolar deposition ratio (ALDR) by the regression formula of ALDR = -48.08 + 0.47 X FEV1.0% + 0.59 X LRR60, was found useful and applicable even to the evaluation of a drug on mucociliary clearance mechanisms. The simplified method indicated a very similar evaluation of the effect of bromhexine on airway clearance efficiency with those actually revealed by the original method.

Aerosols↗
PubMed2001

Solubilization of bromhexine hydrochloride in aqueous lecithin dispersions. Physicochemical characterization of interactions between drug and carrier.

In aqueous systems bromhexine hydrochloride (Br-HCl) has a poor solubility (4.54 mg/g) and displays no amphiphilic character e.g. self association. Therefore the drug is molecularly dispersed in water until the solubility product of Br-HCl is exceeded. Solubilization of Br-HCl is linearly increased on addition of lecithin; calculations show that 10 mg Phospholipon 90G (P 90G) enable solubilization of additional 1.25 mg Br-HCl after the solubility product of Br-HCl has been exceeded. This means that four to five phospholipid molecules are needed for the solubilization of one drug molecule. Ternary systems with P 90G concentrations up to 20% have a lamellar microstructure. The systems are multilamellar vesicle dispersions as polarisation microscopy, transmission electron microscopy and small-angle X-ray diffractometry suggest. Furthermore, Br-HCl solubilization leads to a significant reduction of the interlamellar distance d and increases the elastic properties of the systems. 31P NMR data provide evidence that Br-HCl is solubilized within the lipophilic part of the phospholipid bilayer.

Bromhexine↗
PubMed1975

[Bromhexine residues in calves, pigs, and in the milk of cows].

After several oral applications of N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)-aminehydrochloride (bromhexine, Bisolvon-R) to various calves and pigs the residue behaviour was examined. In animals slaughtered immediately after the final application significant amounts of Bisolvon were found. The substance showed a greater affinity to liver and fat tissue whilst, in general, in the muscle tissue, the lungs and kidneys only very small amounts were traceable. In the liver and lungs 3 different metabolites appeared in small quantities. They were partly in conjugated and partly in free form. Within 2 days the amounts greatly decreased and after 7 days at the latest, no residues were traceable; only in the fat of both animal species and in the kidneys of the calves were small quantities of Bisolvon still to be found. Excretion by the milk following oral and parenteral application was also studied. Only traces of Bisolvon were found, which rapidly decreased. Results of the studies show that, neither at a later date of slaughtering nor immediately after the final application, the residues in the animal tissues and in the milk examined present a danger to the health of the human consumer.

Adipose Tissue↗
PubMed2002

Stevens-Johnson syndrome presumably induced by bromhexine. A case report.

The Stevens-Johnson syndrome is a serious form of erythema multiforme, an acute inflammatory pathology with an autoimmune pathogenesis. Its etiology is unknown, although it is thought to have multifactorial causes; nonetheless, many drugs are thought to induce such an immune response. The clinical symptomatology is mainly muco-cutaneous, with a remarkable oral involvement. The authors describe here a case of Stevens-Johnson syndrome involving the ocular, oral, and genital areas, presumably induced by the bromhexine administered to the patient for a viral syndrome.

Adult↗