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At least 19 recordsLinked to original sources
PubMed1992

Interaction between polyethylene films and bromhexine HCl in solid dosage form. V. Effect of packaging materials on the sorption of bromhexine HCl.

A prevention method of the sorption of bromhexine HCl to plastic materials used in packaging was investigated. Four kinds of plastic packaging materials were used: Polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP) and polyacrylonitrile (PAN). Three polyethylenes having different densities were used. No effect of PE density on the sorption of bromhexine HCl from granules was observed. The effects of different kinds of plastics on the sorption of bromhexine HCl from solution and granules were studied. The sorption of bromhexine HCl to PAN, which had a high relative dielectric constant, was the most depressed among the four plastics. The sorption of meclizine HCl to PAN from the solution was also lowest, the same as bromhexine HCl.

Acrylic Resins↗
PubMed1980

Application of bromhexine metabolite VIII (NA 872) and bromhexine-glucose in treatment of adult respiratory distress syndrome; experimental and clinical results .

The authors study the changes in cardiopulmonary function after application of bromhexine metabolite VIII (NA 872) in an animal model of adult respiratory distress syndrome (ARDS) and bromhexine glucose solution (BGS) in ARDS patients. After damage of the lung alveolar surfactant by intratracheal atomization of 0.2 M HCl in LEWE Minipigs significant changes in lung compliance, dead space ventilation, venous admixture, alveolo-arterial oxygen tension difference, pulmonary vascular resistance, and oxygen uptake are present under application of NA 872 in comparison to untreated animals. In ARDS patients treated with BGS, pulmonary function is significantly ameliorated indicated by changes in static effective compliance, oxygen exchange ratio, and alveolo-arterial oxygen tension difference.

Animals↗
PubMed1977

[Prevention and therapy of respiratory distress syndrome in premature infants by means of bromhexine metabolite VIII. Animal experimental studies on the therapeutic efficacy of bromhexine metabolite VIII in premature respiratory distress syndrome].

In preparing a clinical study 14C-labelled bromhexine metabolite VIII was applied intraamnially in animal experiments. The distribution was measured in different maternal and fetal organs by thinlayer chromatography and autoradiography. A complete placental passage was found in both directions. An organspecific accumulation in the fetal lungs could not be demonstrated.

Ambroxol↗
PubMed1991

Characterization of bromhexine and ambroxol in equine urine: effect of furosemide on identification and confirmation.

The purpose of this study was two-fold: (1) to develop a simple and sensitive screening procedure for identifying and confirming bromhexine and ambroxol and, (2) to determine the effect of furosemide on the detection of bromhexine, ambroxol, or their metabolites in urine. Female horses (450-550 kg) treated with bromhexine or ambroxol (1 g, p.o.) were used. Urine samples were collected up to 48 h post-drug administration and analysed. Blind samples were used in evaluating the sensitivity of these methods and reproducibility of the results. Bromhexine and ambroxol were extensively metabolized in the horse. These agents and their respective metabolites were identified and confirmed using thin-layer chromatography (TLC) and gas chromatography-mass spectrometry (GC-MS), respectively. Hydroxy-bromhexine and desmethyl-bromhexine were major metabolites found to be unique to bromhexine-treated horses. These metabolites selectively absent from ambroxol-treated horse urine provide a chemical means to distinguish bromhexine from ambroxol administration in horses. These specific metabolites were similarly identified and confirmed in "blind" horse urine samples. The concomitant presence of furosemide (300 mg, i.v.) with bromhexine or ambroxol did not mask the presence of these agents or alter their metabolite profile. By application of the methods described in this study, bromhexine and ambroxol metabolites in horse urine can be easily identified and confirmed.

Ambroxol↗
PubMed1989

[Effects of inhaled bromhexine on the bronchomotor tone in rats and guinea pigs].

Bromhexine has been widely used as a mucolytic expectorant. Clinically, bromhexine is sometimes administered by inhalation. However, the effect of bromhexine by inhalation on bronchial musculature has not been documented. In the present study, the effect of inhaled bromhexine on bronchomotor tone in rats and guinea pigs was investigated. The bronchomotor tone was measured by a modified Konzett-Rössler method, and ventilation overflow (VO) was continuously recorded as an index of airway resistance. In rats, inhalation of bromhexine (0.1% and 0.2%, pH 5.3) caused no change in VO. At 0.2%, bromhexine slightly decreased systemic blood pressure (BP). In guinea pigs, bromhexine had no significant effect on VO at 0.2%, and it produced a significant but very slight increase at 0.1%. BP was slightly decreased by inhalation of bromhexine (0.1% and 0.2%, pH 5.3). N-Acetyl-L-cysteine, a cysteine-mucolytic (20%, pH 6.8), had no effect on VO and BP in either species. Inhalation of 0.1% bromhexine solution at pH 2.5, which was dissolved in tartaric acid solution, significantly increased VO, because of its acidity. From the above results, it is suggested that when the pH of the solution is considered, bromhexine has no or almost negligible effect on airway smooth muscles, and it may be useful as an effective mucolytic.

Administration, Inhalation↗
PubMedDate not supplied

Bioavailability of bromhexine tablets and preliminary pharmacokinetics in humans.

The absorption of bromhexine from Bromhexin tablets 8 mg, DAK has been compared with that from Bisolvon tablets 8 mg, Boehringer Ingelheim, in a two-way complete crossover study. Four tablets of each of the two bromhexine products, corresponding to a single dose of 32 mg of bromhexine hydrochloride (77.6 mumol), was administered to each of the 10 volunteers. The plasma concentration was followed over the 4-hour period following each administration. By means of Pratt's test for paired data no statistically significant difference (p greater than 0.10) between the two products was found with respect to maximum plasma concentration (89 and 84 nmol.1(-1), respectively), the times for their occurrence (1.3 and 1.0 h, respectively), and the area under the plasma concentration-time curves (140 and 132 nmol.1(-1).h, respectively). It is concluded that Bromhexin, DAK and Bisolvon are bioequivalent. Provisional pharmacokinetic data for bromhexine, after oral administration, in man were obtained. The first-pass effect and the biological half-life were estimated by combining plasma and 30 h urine data from four of the volunteers. The first-pass effect was estimated to be c. 75 per cent, the biological half-life to be c. 6 h, and c. 0.1 per cent of the dose was found as unmetabolized bromhexine in the urine. The data indicate that the pharmacokinetics of bromhexine may be described as a two-compartment open model.

Adult↗
PubMed1992

Interaction between polyethylene films and bromhexine HCl in solid dosage form. IV. Prevention of the sorption by addition of magnesium aluminum silicate.

The effects of magnesium aluminum silicate (MAS) addition on the sorption of bromhexine HCl to polyethylene film in tablets were studied. The addition of MAS prevented the sorption of bromhexine HCl to polyethylene film. In order to investigate the mechanism, the interaction between bromhexine HCl and MAS was studied by the powder X-ray diffraction method. It was observed that bromhexine HCl was preferentially adsorbed to the surface of MAS rather than to polyethylene film. The adsorption was accelerated at high temperature and reduced pressure conditions. The sorption of bromhexine base and bromhexine HCl to packaging material were compared using tablet dosage forms. The sorption of bromhexine base to polyethylene film was greater than that of bromhexine HCl.

Aluminum Compounds↗
PubMed1985

Influence of a fluidifying agent (bromhexine) on the penetration of antibiotics into respiratory secretions.

The authors report the results of a study designed to evaluate the possible increase of penetration into bronchial secretions of antibiotics when combined with a fluidifying agent: bromhexine. The study was carried out in a double-blind experiment: erythromycin in 22 patients (group I) or amoxycillin in 26 patients (group II) were administered orally; in both groups several patients were given a placebo, instead of bromhexine. Antibiotics were administered at the usual dosage: 0.5 g X 2 for erythromycin (3 days); 1 g X 2 for amoxycillin (7 days); with the latter, two different doses of bromhexine were administered simultaneously: 48 mg/day and 96 mg/day in ten and eight patients respectively. Samples of bronchial secretions were collected by means of fibreoptic bronchoscopy at the second hour for erythromycin and for amoxycillin; simultaneous serum samples were also collected. The results of the study showed in both groups a significant increase of the ratios between bronchial levels and simultaneous serum concentrations when combined with bromhexine; in patients receiving amoxycillin with 96 mg of bromhexine the percentage penetration was noticeably higher (7.5%) than in those treated with 48 mg bromhexine (4.3%). These results confirm the efficacy of bromhexine as a drug able to disrupt mucopolysaccharides of bronchial secretions and, as a result, to increase the bronchial penetration of antimicrobial drugs as evaluated on the basis of percentage penetration ratio.

Bromhexine↗
PubMed1978

Sjörgren's syndrome treated with bromhexine: a randomised clinical study.

Existing treatment for Sjögren's syndrome is unsatisfactory, and uncontrolled observations have suggested that bromhexine may be effective. Twenty-nine patients with Sjögren's syndrome were therefore assigned to two randomised double-blind crossover trials with bromhexine and placebo, each comprising two two-week periods. In the first trial bromhexine 24 mg/day was given by mouth; in the second the dose was increased to 48 mg/day. After each treatment period the Schirmer test response, break-up time, Bijsterveld score, and the time taken for the patient to eat a dry biscuit were recorded, as well as the patient's estimate of moistness in the eyes and mouth. In the second (higher-dose) trial values on the Schirmer test were significantly higher after bromhexine than after placebo and the break-up time was also increased after bromhexine, which suggested that the drug has a dose-dependent effect on lacrimal gland secretion in Sjögren's syndrome. It had no effect on salivary gland function. Bromhexine is therefore valuable in the treatment of Sjögren's syndrome.

Bromhexine↗
PubMed1983

A role of lysosomal enzymes in the mechanism of mucolytic action of bromhexine.

The effect of bromhexine on behaviors of lysosomal enzymes in the submucosal gland was investigated using canine tracheal slice preparations, with reference to the histochemical changes in acid glycoproteins (AGP) in the gland. Incubation of tracheal slices with 1% Triton X-100 or 0.0004-0.04% bromhexine for 30 min decreased the number of stained lysosomes in the glandular cells. The decrease in stained lysosomes after treatment with 1% Triton X-100 or 0.04% bromhexine was effectively prevented by addition of 5% lecithin. The number of glandular cells that were stained red (stain index R) in the combined alcian blue at pH 2.5 and periodic acid-Schiff procedure markedly increased by treatment with 1% Triton X-100 or 0.0004-0.04% bromhexine. In the bromhexine treated groups, there was a close correlation (r=0.932, P less than 0.01) between the increase in the number of glandular cells showing the stain index R and the decrease in the number of stained lysosomes in the cells. These findings suggest that the enzymes which are liberated from lysosomes into the cytoplasm by bromhexine may, at least in a part, be involved in the mucolytic action of the agent on AGP contained in mucus granules of the submucosal gland.

Animals↗
PubMed1985

Effects of bromhexine on the secretions of saliva and tears.

Effects of bromhexine and pilocarpine on the secretions of submaxillary saliva in dogs and of tears in rabbits were investigated including their effects on lysozyme activity in an attempt to elucidate the efficacy of bromhexine on Sjögren's syndrome. Pilocarpine (0.3 mg/kg, p.o.) significantly increased spontaneous salivary flow rate, but bromhexine (20 and 40 mg/kg, p.o.) had almost no influence on spontaneous salivary flow rate. Pilocarpine increased total protein, saccharide, lysozyme and IgA secretions in saliva under electrical stimulation of the chorda tympani. Bromhexine did more markedly increase total lysozyme and IgA secretions in saliva, with minor increases in total protein and saccharide secretions. Pilocarpine (0.4 mg/kg, i.v.) had almost no influence on lysozyme concentration in tears, whereas it markedly increased tear secretion volume leading to an increase in total lysozyme secretion. On the other hand, bromhexine (4 and 8 mg/kg, i.v.) significantly increased both lysozyme concentration and total lysozyme secretion in tears from 50 min after injection, without influencing tear secretion volume. From these findings, it is suggested that bromhexine may work effectively on Sjögren's syndrome by acting to accelerate the secretions of lysozyme and IgA in saliva and tears, which are known to have antiinflammatory and bacteriocidal effects.

Animals↗
PubMed2000

[Determination of bromhexine in plasma by gas chromatography-electron capture detection and pharmacokinetic studies].

This paper reports a gas chromatography-electron capture detection(GC-ECD) method for the study of pharmacokinetics of bromhexine in healthy human body. A2 m x 3 mm i.d. silanized glass column packed with 5% SE-30 was used. The carrier gas was nitrogen. The internal standard was 5-chloro-2-amino-diphenyl ketone. After NaH2PO4-Na2HPO4 buffer (pH 6.0) being added, the plasma was extracted with n-hexane-dichloromethane (9:1, V/V). A good linearity was obtained from 1.0 microgram/L to 50.0 micrograms/L of bromhexine in human plasma, r = 0.9994. The detection limit of bromhexine in plasma was 0.5 microgram/L. The average recovery was 97.5%. The pharmacokinetics of bromhexine was determined by this method after a single oral dose of 8 mg bromhexine capsule given to each of 8 volunteers. The results showed that the plasma concentration-time courses conformed to one compartment model. The established GC-ECD method is a good method for the determination of bromhexine in human plasma. The method is rapid, simple, precise and sensitive.

Bromhexine↗
PubMed1985

Bromhexine in the treatment of otitis media with effusion.

In a double blind randomised trial of 95 children aged 3-8 years with otitis media with effusion (OME), the efficacy of the mucolytic agent bromhexine hydrochloride (Bisolvon) was compared with a placebo. Each child received two 4 week courses of either bromhexine or placebo in a random fashion. One hundred and ninety ears were available for analysis, i.e. 380 'ear treatments'. There were 198 ears in the placebo group and 182 ears in the bromhexine group. The resolution rate in the placebo treated group was 19% and in the bromhexine treated group 16%. Bromhexine does not appear to be a useful drug for the treatment of OME in children.

Bromhexine↗
PubMed1989

[Interaction between polyethylene films and bromhexine HCl in solid dosage forms. I. Effects of moisture contents in the solid dosage forms on the sorption of the drug].

The decrease of bromhexine HCl contents in granules and tablets was determined when the preparations were stored in polyethylene film package. Effects of temperature, contact area with film, excipients and moisture contents in the preparation on the remaining amount of bromhexin HCl were studied in order to investigate the interaction mechanism between bromhexine HCl and polyethylene film. It was observed that the decrease of bromhexine HCl was due to the sorption to the polyethylene film. The results indicated that the moisture contents of the dosage forms determined the rate of sorption predominantly, and that removal of adsorbed water from dosage forms was effective to prevent bromhexine HCl content decrease.

Adsorption↗
PubMed1984

The role of vagal reflex in mechanism of secretagogic action of bromhexine.

The in vivo effect of bromhexine on secretory activities of tracheal submucosal glands was investigated with a histological/histochemical technique with reference to a role of the vagal reflex. When bromhexine was given at 5, 10 or 20 mg/kg into the stomach of anesthetized dogs, the ratio of acinar inner diameter of the submucosal gland to wall thickness (AIWR) markedly increased in a biphasic manner; the early transient increase was seen 0.5 hr after administration, and the second prolonged increased occurred during 2 to 6 hr after administration. The early stimulant phase was almost abolished by atropine, 1 mg/kg i.v., or bilateral cervical vagotomy, whereas the second stimulant phase was not affected by these treatments. Emetine also induced a similar early increase in AIWR at 0.5 hr after administration, the change also being abolished by atropine or surgical vagotomy in this case. The number of submucosal glandular cells which stained blue and purple with a combination of alcian blue at pH 2.5 and periodic acid-Schiff was decreased by bromhexine, but the cell number which stained red was markedly increased. These histochemical changes in glandular cells were not influenced by treatment with atropine or surgical vagotomy. In the present study, it was found that bromhexine exerts both a secretagogic action on submucosal glands and a mucolytic action toward acid glycoproteins inside the cells in vivo. Also, the secretagogic action of bromhexine occurs biphasically; the first phase results from the vagal reflex probably through a gastrointestinal irritation, and the second phase results from a direct action on the glands.

Animals↗
PubMed1988

Lack of detectable N-nitroso-N-methyl-N-cyclohexylamine in humans after administration of bromhexine.

The possible formation of N-nitroso-N-methyl-N-cyclohexylamine (NMCA) from the drug bromhexine (N-methyl-N-cyclohexyl-(2-amino-3,5-dibromobenzyl)-ammonium hydrochloride) and nitrite was investigated in humans using three different approaches: 1. analysis on metabolites of NMCA in human urine; 2. analysis on NMCA in human gastric juice; 3. in vitro incubation of human gastric juice with therapeutic bromhexine doses. Diet given to volunteers was varied during these investigations with respect to nitrate content. Experiments with a maximum load of 200 mg nitrate to stimulate nitrite formation were performed. Results of in vivo experiments did not indicate any formation of NMCA. In one out of 39 ex-vivo/in-vitro experiments (with a load of 100 mg nitrate in drinking water) 0.5 ng NMCA/ml gastric juice could be detected which is near the detection limit. Finally, this study showed that bromhexine is not secreted by saliva. This allows to conclude that nitrite and bromhexine do not reach the stomach simultaneously over a longer period of time. In consequence, medication with bromhexine is not regarded to represent a risk due to nitrosamine formation.

Bromhexine↗
PubMed1981

Clinical trial of bromhexine in Sjögren's syndrome.

Tear secretion and lysozyme tear content were measured in 30 patients with Sjögren's syndrome after treatment with oral bromhexine, 32 mg/day. In 21 patients (70%) there was a marked increase in tear secretion and in lysozyme content. In patients with keratoconjunctivitis sicca (KCS) good results in clarifying the mucoid eye discharge were obtained. A remarkable amelioration of xerostomia was also noted. Six other patients, serving as controls, were given a placebo and bromhexine. The placebo had no influence on the rate of tear secretion, while bromhexine caused it to increase in 70% of the controls. This side effects of bromhexine treatment encountered in the present study were negligible and transient. We consider bromhexine to be the drug of choice in the treatment of Sjögren's syndrome.

Bromhexine↗