Ambroxol HCl Research Articles

Case Study: Open Pyometra in a Pomeranian Dog at INI Veterinary Service Clinic

A five-year-old female Pomeranian dog presented with vomiting, restlessness, decreased appetite, and vaginal discharge. The physical examination revealed yellowish to brownish purulent vaginal discharge with an unpleasant smell. The X-ray image showed an enlarged uterus, while the hematology results revealed hypochromic normocytic anemia, neutrophilia, lymphopenia, and thrombocytopenia. The blood chemistry test results showed abnormalities, including elevated levels of alkaline phosphatase levels (ALP) and cholesterol as well as decreased amylase levels. Based on the anamnesis, clinical findings, physical examination, and supporting examinations, it was concluded that the dog was diagnosed with open cervix pyometra. The dog was treated with oxytocin hormone at a dose of 0.5 IU/kg BW, methylergometrine at a dose of 0.125 mg/dog, enrofloxacin at a dose of 5 mg/kg BW, carprofen at a dose of 2.5 mg/kg BW, cyproheptadine at a dose of 0.5 mg/kg BW, ranitidine at a dose of 3.5 mg/kg BW, ondansetron at a dose of 1 mg/kg BW, glyseryl guaiacolate at a dose of 20 mg/kg BW, ambroxol HCl at a dose of 2 mg/kg BW, Fufang® at adose of 1 ml, Sangobion® at a dose of 100 mg/dog, Maxbiotik® at a dose of 66 mg, and Transfer Factor Plus® at a dose of 20 mg. The treatment resulted in an improvement in the animal's condition as evidenced by the absence of nasal and vaginal discharges and vomiting, as well as a stool consistency of two out of five.

Beyond Use Date (BUD) Determination of Ambroxol Hydrochloride Syrup by High-Performance Liquid Chromatography – UV/VIS Detector

Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. The retention time for ambroxol HCl was 4.62 minutes. In the validation, ambroxol HCl showed good linearity with r = 0.99985 in the 6 to 36 µg/ml. LOD and LOQ for ambroxol HCl were 0.74 µg/ml and 2.25 µg/ml, respectively. It is also fulfilled the accuracy and precision parameters with a % recovery from 99.04% to 100.94% and CV<2%. This method meets the requirements according to the ICH Q2(R1) guidelines and can be used for the assay of ambroxol HCl syrup. The ambroxol HCl level on all samples was still higher than 90% (until the 36th day). Normality test data result indicated that data must be divided into two groups that are sample A and B, and sample C, D, and E. In conclusion, the extrapolation result showed that the BUD ambroxol HCl syrup was 83 days for sample A and B, and 49 days for sample C, D, and E.

Comprehensive evaluation of extemporaneous preparation containing ambroxol HCl and salbutamol sulfate: Compatibility, chemometrics, and stability study

Sustained release solid dispersion of Metoclopramide HCL: formulation, evaluation and pharmacokinetic studiesS. L. Neha, Neelam Singh, Mohd Yasir

Chemometrics-assisted content uniformity evaluation of extemporaneous preparation containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl

Chemometrics-assisted content uniformity evaluation of extemporaneous preparation containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl

Chemometrics-assisted content uniformity evaluation of extemporaneous preparation containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl

Chemometrics-assisted content uniformity evaluation of extemporaneous preparation containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl

DOMINATED RP-HPLC METHOD FOR QUALITY CONTROL OF TERNARY PHARMACEUTICAL FORMULATION: GUAIFENESIN/LEVOCETIRIZINE/ AMBROXOL HCL AND STABILITY STUDIES

The present investigation was aimed to establish a liquid chromatographic method for simultaneous quantification of guaifenesin, levocetirizine and ambroxol HCl in ternary fixed dosage form. The three drugs were swiftly resolved using ODS C18 reverse phase column with mobile phase consisting of ammonium phosphate buffer, pH 4.5: acetonitrile (60:40, v/v) at a flow rate of 1.0 mL/min and UV detection at 236 nm. The retention time values were 2.231, 2.772 and 6.309 min, respectively, for guaifenesin, levocetirizine and ambroxol HCl. The response was a linear function of analyte over the concentration range of 12.5-75 µg/mL, 0.625-3.750 µg/mL and 3.75-22.5 µg/mL with correlation co-efficient value of 0.999. Maximum recovery (99.12-101.2 %) was obtained in ternary liquid oral formulation (Leoriv plus syrup). Three drugs were well resolved from their degradation products and net degradation was calculated in acid hydrolysis, base hydrolysis, oxidation, thermal and UV conditions. The proposed method enables the simultaneous quantification of guaifenesin, levocetirizine and ambroxol HCl in routine QC laboratories.

Ion Transport Modulators Differentially Modulate Inflammatory Responses in THP-1-Derived Macrophages.

Ion transport modulators are most commonly used to treat various noncommunicable diseases including diabetes and hypertension. They are also known to bind to receptors on various immune cells, but the immunomodulatory properties of most ion transport modulators have not been fully elucidated. We assessed the effects of thirteen FDA-approved ion transport modulators, namely, ambroxol HCl, amiloride HCl, diazoxide, digoxin, furosemide, hydrochlorothiazide, metformin, omeprazole, pantoprazole, phenytoin, verapamil, drug X, and drug Y on superoxide production, nitric oxide production, and cytokine expression by THP-1-derived macrophages that had been stimulated with ethanol-inactivated Mycobacterium bovis BCG. Ambroxol HCl, diazoxide, digoxin, furosemide, hydrochlorothiazide, metformin, pantoprazole, phenytoin, verapamil, and drug Y had an inhibitory effect on nitric oxide production, while all the test drugs had an inhibitory effect on superoxide production. Amiloride HCl, diazoxide, digoxin, furosemide, phenytoin, verapamil, drug X, and drug Y enhanced the expression of IL-1β and TNF-α. Unlike most immunomodulatory compounds currently in clinical use, most of the test drugs inhibited some inflammatory processes while promoting others. Ion pumps and ion channels could therefore serve as targets for more selective immunomodulatory agents which do not cause overt immunosuppression.

First-order derivative spectrophotometric estimation of gemifloxacin mesylate and ambroxol HCl in tablet dosage form

Aim of present work was to develop and validate a simple, precise and accurate uv-vis spectrophotometric method for the simultaneous estimation of gemifloxacin mesylate (GEMI) and ambroxol HCl (AMB) in their combined tablet dosage form. The method is based on first-order derivative spectroscopy. For determination of sampling wavelengths, each of GEMI and AMB were scanned in the wavelength range of 200–400 nm in the spectrum mode and sampling wavelengths were selected at 360 nm (zero crossing of GEMI) where AMB showed considerable absorbance and at 221.6 nm (zero crossing of AMB) where GEMI showed considerable absorbance. The linearity was obtained in the concentration range of 32-192 µg/ml for GEMI and 7.5-45 µg/ml for AMB. The correlation coefficients were found to be 0.9987 and 0.9992 for GEMI and AMB, respectively. The method was validated as per ICH guidelines. Mean recoveries were found satisfactory. All the data of validation study was found to be satisfactorily. The proposed method can be applied for simultaneous estimation of both the drugs

First-order derivative spectrophotometric estimation of gemifloxacin mesylate and ambroxol HCl in tablet dosage form

First-order derivative spectrophotometric estimation of gemifloxacin mesylate and ambroxol HCl in tablet dosage form

Simultaneous estimation of salbutamol sulphate and ambroxol HCl from their combined dosage form by UV-VIS spectroscopy using simultaneous equation method

A simple UV-Vis Spectrophometric method was developed for the simultaneous determination of salbutamol sulphate and ambroxol HCl (AMB) from their combined dosage form. The method employs formation and solving of simultaneous equation using 242 nm and 272 nm as two analytical wavelengths (λMax of the drugs) of detection. Both the drugs obeyed Beer-Lambert’s law over the concentration range 1-50 μg/mL for salbutamol sulphate and 10-50 μg/mL for ambroxol HCl, respectively. The developed method was validated for Accuracy, Precision, Limit of Detection and Limit of Quantification as per ICH guidelines and results of analysis were validated statistically.

Concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation by RP-HPLC

RP-HPLC method was developed for concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation. Analytes were separated with mobile phase consisting of mixture of methanol and water (0.1% triethylamine) in the ratio 50: 50 at a flow rate of 0.7 ml/min with Nucleosil (4.6 mm I.D x 250 mm) C18 column. The retention time of ambroxol HCl and salbutamol sulphate was found to be 3.61 and 6.20 min, respectively. The detection was carried out at 224 nm. The dynamic range for ambroxol HCl and salbutamol sulphate observed was 15-75 µg/ml and 1-5 µg/ml, respectively. The percent recovery obtained for ambroxol HCl and salbutamol sulphate were close to 100%. Obtained statistical data of results was found to satisfactorily.

Simultaneous estimation of salbutamol sulphate and ambroxol HCl from their combined dosage form by UV-VIS spectroscopy using simultaneous equation method

Simultaneous estimation of salbutamol sulphate and ambroxol HCl from their combined dosage form by UV-VIS spectroscopy using simultaneous equation method

Concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation by RP-HPLC

Concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation by RP-HPLC

Ion Transport Modulators as Antimycobacterial Agents

There is an urgent need for better and safer therapeutic interventions for tuberculosis (TB). We assessed the effects of FDA-approved ion transport modulators, namely, ambroxol HCl, amiloride HCl, diazoxide, digoxin, furosemide, hydrochlorothiazide (HCTZ), metformin, omeprazole, pantoprazole, phenytoin, verapamil, and drug X and Y on the growth of free and intracellular Mycobacterium bovis BCG. Free and intracellular M. bovis BCG were cultured in the presence or absence of the test drugs for 3 to 9 days and then quantified. For both free and intracellular bacteria, cultures that were exposed to furosemide, phenytoin, or drug Y yielded lower bacteria counts compared to drug-free controls (p < 0.05). The same was observed with diazoxide, HCTZ, verapamil, and drug X, but only for intracellular M. bovis BCG (p < 0.05). To assess the effects of the drugs on bactericidal activity of rifampicin, free and intracellular M. bovis BCG were treated with rifampicin alone or in combination with each of the thirteen test drugs for 3 to 9 days. For extracellular bacteria, higher bacteria clearance rates were observed in cultures exposed to rifampicin in combination with amiloride HCl, diazoxide, digoxin, furosemide, HCTZ, metformin, pantoprazole, phenytoin, drug X, or drug Y than those exposed to rifampicin alone, indicating that rifampicin had a synergistic effect with these test drugs. Rifampicin was also synergistic with ambroxol HCl, diazoxide, digoxin, furosemide, HCTZ, omeprazole, pantoprazole, phenytoin, verapamil, and drug X against intracellular M. bovis BCG. The antimycobacterial properties exhibited by the ion transport modulators in this study make them viable candidates as adjuncts to the current anti-TB regimens.

Quality by Design Strategy for Simultaneous HPLC Determination of Bromhexine HCl and Its Metabolite Ambroxol HCl in Dosage Forms and Plasma

The quality by design strategy was applied for the simultaneous chromatographic quantification of a binary mixture of bromhexine HCl and its pharmacologically active metabolite ambroxol HCl in dosage forms as well as in human plasma. In this study, five independent parameters were screened by fractional factorial design to specify the critical ones. The optimal conditions were determined by a response surface methodology using a central composite design. Response surface methodology enabled the best separation in minimal run time, as well as, prediction of separation and retention parameters with minimum error. Separation and quantitation were carried out on BDS Hypersil C8 (250 × 4.6 mm, 5 μm) RP-column at 1.1 mL min−1 flow rate, 25 mM of KH2PO4 (pH 3.5) in aqueous mobile phase, 65% MeOH, 210 nm wavelength of detection and 10 µL injection volume. After optimization of the chromatographic parameters, validation of the method was achieved according to ICH guidelines. Linearity ranged from 0.195 to 100 µg mL−1 ambroxol HCl, and 0.391–100 µg mL−1 bromhexine HCl, with R2 values of 0.9998 and 0.9999 and limits of detection of 0.098 and 0.195 µg mL−1, respectively. Recovery results ranged from 98.06 to 100.18 and 97.88 to 100.68 for bromhexine HCl and ambroxol HCl, respectively, with RSD less than 1.80.

DISSOLUTION PROFILE OF AMBROXOL HCl TABLET WITH ADDITIONAL VARIATIONS OF LUDIPRESS® AND LACTOSE USING THE DIRECT PRESS METHOD

Objective: The drug will provide a therapeutic effect when dissolved so that it is easily absorbed. The process of dissolving drugs is called dissolution. Additional substances contained in pharmaceutical preparations, one of which serves to accelerate the solubility of active substances. The aim of this study was to obtain a comparative composition of Ludipress® and lactose additives suitable for producing ambroxol HCl tablets that met the ambroxol acceleration ambroxol in the body.&#x0D; Methods: Ambroxol HCl tablets were made by direct pressing method. For research purposes, 4 formulas with variations of Ludipress® and Lactose were designed. The tablet was then evaluated, which includes uniformity in weight, diameter, thickness, hardness, friability, disintegration time, and dissolution. Data obtained in the analysis using the perfect random block design method (DBAS) with α = 0.05 where blocks and groups were used.&#x0D; Results: From the results of the Mass Printing Evaluation of Tablets, it was found that the four formulas that were designed met the resting angle, flow rate, real density, compressed density, and compressibility met existing requirements. The results of evaluation tablets, which included uniformity of weight, uniformity of size, hardness, friability, disintegration time, and dissolution test, were found that only F1 formula did not meet uniformity requirements. All four formulas meet the Indonesian pharmacopeia requirements for time of violence, fragility and disintegration. The dissolution test results showed that in the 45-minute test each percent dissolved concentration of the active substance for F1, F2, F3, and F4 was 58.77974, 66.91104, 80.09946, and 64.02293 suggesting only the F3 formula fulfilled the dissolution requirements according to European Pharmacopoeia which stated that the concentration of dissolved active tablets should not be less than 75% during the 45-minute test.&#x0D; Conclusion: The formula that met the solubility requirements consisted of an additional 69% Ludipress® and 10% lactose with a solubility value of 80.09%.

Simultaneous determination of guaifenesin enantiomers and ambroxol HCl using 50-mm chiral column for a negligible environmental impact.

Chiral stationary phases are conveniently used for enantiomeric separation of drugs by liquid chromatography. Consumption of large volumes of hazardous solvents is considered as a common challenge for the sustainability of this technique. To this end, a columnar chromatography has been adopted using 50-mm-length stationary phases. The study comprised five Phenomenex Lux cellulose- and amylose-based columns for the separation of guaifenesin (GUA) enantiomers. In addition, an experimental design was used to optimize the gradient profile for the separation of racemic GUA and ambroxol HCl (AMB) binary mixture. The chromatographic method was achieved using Lux Cellulose-1 (50×4.6mm) as a chiral stationary phase and ethanol/water as a mobile phase with linear gradient elution of 20% to 70% ethanol in 6minutes at a flow rate of 1.0mLmin-1 and UV detection at 270nm. Linearity ranges were found to be 50 to 1000μgmL-1 and 15 to 450μgmL-1 for each GUA enantiomer and AMB, respectively. Environmental, health and safety tool was used to assess and compare greenness of the proposed and reported methods. Short column indeed reduces the environmental impact by decreasing waste by about 60% and utilizing only 1-mL ethanol in the mobile phase. The proposed method is a safer alternative for the simultaneous determination of drugs in their combined pharmaceutical formulation. The method has been validated and compared favorably with a reported one.

RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms

The objective of the present work was to develop and validate a simple, sensitive, rapid and stable reverse-phase high performance liquid chromatography (RP-HPLC) method for a combination of Terbutaline sulphate (TSL), Ambroxol hydrochloride (AML) and Guaifenesin (GFN). The combination of these drugs was analyzed by using Shimadzu LC 2010 CHT high performance liquid chromatography (HPLC). Successful separation was achieved by isocratic elution on a reverse-phase C18 column (sun fire) (250mm, 4.6mm, 5μ), using a mobile phase consisting of buffer: acetonitrile in the ratio 80: 20 (buffer - 0.1% v/v triethyleamine pH-3.0) followed by 1.0mL/min flow rate. The wavelength of detection was at 220nm. The chromatographic retention times were consistent at 3.0, 10.5 and 13.8minutes for TSL, AML and GFN respectively. For these three compounds, the lower limit of detection was 1.0, 1.25, and 1.5μg/mL and lower limit of quantification was 3.3, 4.1 and 5.0μg/mL respectively. The linearity concentrations established for TSL, AML and GFN were 1.0-7.0, 1.5-7.5 and 4.0-14.0μg/mL respectively. The correlation coefficients for all the drugs were found to be greater than 0.999. The relative standard deviation of inter- and intra-day were less than 2.0%. This method provides a necessary tool for quantification of the selected drugs for their assay. The proposed method is simple, accurate, reproducible and applied successfully to analyze three compounds in pure as well dosage form.

RP-HPLC Method Development and Validation for Estimation of Acebrophylline

Acebrophylline is an anti-inflammatory and airway mucus regulator. It had ambroxol and theophylline-7-acetic acid, the former facilitates the biosynthesis of pulmonary surfactant which raises blood levels of ambroxol, by stimulating surfactant production. Chemical structure of acebrophylline is 1, 2, 3, 6- tetrahydro-1, 3-dimethyl-2, 6-dioxo-7H-purine-7-aceticacidwithtrans-4-[(2-amino-3, 5 dibromophenyl) methyl] aminio] cyclohexanol. Survey revealed that various analytical methods like spectrophotometric, HPLC, and RP-HPLC, have been reported for the determination of Ambroxol HCl and Theophylline-7-acetic acid, individually and in combination with some other drugs. The aim of present study was to develop and validate stability indicating HPLC method for the analyses of acebrophylline. High performance liquid chromatographic method has been developed for the estimation of Acebrophylline. Reported methods also include RP-HPLC method for determination of Acebrophylline. The developed UV spectrophotometric method is simple and requires less time for the analysis. It is also rapid and economic method.

Development and in-vitro evaluation of candy based medicated lollipops: a novel system of drug delivery

Lollipops or lozenges are defined as the flavored medicated dosage forms intended to be sucked and held in the mouth or pharynx containing one or more medicaments usually in the sweetened base. Lollipops are commonly used for the purpose of local or systemic effects through the buccal mucosa. Advantages of the lollipop as dosage forms include increase in bioavailability, reduction in dose size, gastric irritation and bypass first metabolism1. Lollipop is designed to improve patient compliance, acceptability, transportation etc2The lollipops were prepared by heating and congealing method in a candy based industry with sucrose base. All the formulations prepared were subjected to various physicochemical parameters like hardness, content uniformity, friability, weight variation etc. Thickness of lollipop ranges from 12-13.2 mm. The hardness of these lollipops ranges between 10-11.5 kg/cm... Results of in-vitro release profile indicated that formulation L3, L6, and L10 were the most promising formulations as the extent of drug release from this formulation was high as compare to other formulations up to 30 mins. The in vitro release of medicated lollipop of ambroxol hcl was found in the release of drug from the lollipop depends on the type and concentration of polymer used. As per all satisfactory evaluation parameters, the batch L3 is found to be optimized batch. The stability studies showed that there was no change in the formulation after 90 days. The medicated lollipops can provide an attractive alternative formulation in the treatment of mucolytics in pediatric patients. Keywords: Amboxol HCl, Lollipops, mucolytic and mucokinetics.