Bambuterol Hydrochloride Research Articles

Stability indicating eco-friendly quantitation of terbutaline and its pro-drug bambuterol using quantitative proton nuclear magnetic spectroscopy

Quantitative 1H-NMR became an increasingly important issue in pharmaceutical analytical chemistry. This study used NMR spectroscopy to assay the bronchodilator drug terbutaline sulfate and its pro-drug bambuterol hydrochloride in pure form and pharmaceutical preparations. The technique proceeded using deuterium oxide (D2O) as an 1H-NMR solvent and phloroglucinol anhydrous as an internal standard (IS). Comparatively, to the phloroglucinol signal at 5.9 ppm, the resulting quantitative signals of the studied drugs were corrected. The terbutaline singlet signal at 6.3 ppm was chosen for quantification, while the bambuterol quantitative singlet signal was at 2.9 ppm. The two drugs were rectilinear over the concentration range of 1.0–16.0 mg/mL. LOD values were 0.19 and 0.21 mg/mL while LOQ values were 0.58 and 0.64 mg/mL for terbutaline and bambuterol respectively. The developed method has been validated according to the International Conference of Harmonization (ICH) regarding linearity, accuracy, precision, specificity, and robustness. A greenness profile assessment was applied, and the method proved to be green. The method enables the assay of the two drugs in pure drug and pharmaceutical preparations. The method also enables the assay of the two drugs in the presence of each other; thus, it is considered a stability-indicating method where terbutaline is an acid degradation product of bambuterol.

Development of Simple VU Spectrophotometric Method for the Estimation of Bambuterol Hydrochloride in Bulk and Its Formulations

A simple, rapid and highly sensitive spectrophotometric method has developed for the estimation of Bambuterol hydrochloride in bulk and marketed tablet dosage form. In distilled water, Bambuterol showed absorbance at 264nm. Linearity was observed in the conc range of 200-1000 μg/ml (r2 = 0.9990). The assay results were found to be in a good agreement with label claim. The recovery studies were carried at 3 different levels i.e, at 100%, 150%, 200%. The accuracy of the method was conformed by recovery studies of tablet dosage forms and was found to be 96.43% for bambuterol hydrochloride. The method was validated stastically and by good recovery with % RSD is less than 2Thus the proposed method was found to be rapid, specific, precise, accurate and cost-effective quality control tool for the routine analysis of bambuterol hydrochloride in bulk and combined dosage form.

Investigating the Effect of Silver Nanoparticles on the Fluorescence Intensity of Bambuterol and its Active Metabolite Terbutaline Using FRET

Silver nanoparticles (AgNPs) were found to significantly quench the fluorescence of bambuterol hydrochloride (BAM) and its active metabolite terbutaline sulfate (TER). The intrinsic fluorescence intensity of each of BAM (at 264/292 nm) and TER (at 276/306 nm) decreased by the gradual addition of AgNPs. Quenching of the steady state fluorescence of BAM and TER probably resulted from the energy transfer to the photo-excited state of AgNPs. The estimated Stern–Volmer quenching constant at several temperature settings proved that the quenching mechanism of the two drugs was dynamic quenching in case of BAM while it was static quenching in case of TER. The number of binding sites, binding constants, and corresponding thermodynamic parameters depending on the interaction system were estimated at 293, 313, and 333 °K and the results obtained were interpreted.

Eco-friendly chromatographic methods for concurrent estimation of Montelukast and Bambuterol with its pharmacopoeial related substance Terbutaline: Greenness appraisal using analytical Eco-scale, GAPI and AGREE metrics

This study represents the development of new eco-friendly HPLC and HPTLC methods for simultaneous quantification of montelukast sodium (MLK), bambuterol hydrochloride (BAM) and terbutaline (TER) as the pharmacopeial related substance of BAM. The HPLC-DAD procedure employed Zorbax eclipse plus C8 column (4.6 × 250 mm, 5 µm particle size) as a stationary phase and a mobile phase consisting of a mixture of 0.003 M phosphate buffer pH 5.0 and acetonitrile eluted in a gradient mode at a constant flow rate of 1.1 mL/min. The chromatograms were recorded at 210 nm for the three analytes. The HPTLC employed precoated HPTLC silica gel aluminum plates 60 F254 as stationary phase with a mobile phase system consisting of ethyl acetate, ethanol and ammonia (78.9: 12: 9.1). The developed plates were scanned densitometrically at 210 nm for the three analytes. Analytical performance of the adopted methods was validated according to the ICH guidelines with respect to linearity, ranges, detection and quantification limits, precision, accuracy, specificity and robustness. The adopted methods were successfully applied for the concurrent analysis of MLK and BAM in their combined tablets. Finally, greenness assessment using various approaches; analytical Eco-Scale, green analytical procedure index (GAPI) and the more recent Analytical GREEnness metric (AGREE) was performed to confirm the greenness of the proposed HPLC and HPTLC methods and to compare them with previously published chromatographic methods.

FORMULATION, DEVELOPMENT AND IN-VITRO EVALUATION OF A BAMBUTEROL HYDROCHLORIDE IN-SITU GELLING SYSTEM FOR NASAL DELIVERY

The goal of this project was to design, develop, and in-vitro evaluation of an in-situ gelling system for nasal administration of Bambuterol hydrochloride. All of the batches were prepared using different concentration of pectin, given different doses of simulated nasal electrolyte solution (SNES) i.e., 0.1 ml to 2.0 ml. All batches and formulation batches with a composition of 0.8 percent low methoxyl pectin underwent an in vitro gelation testing. The pH of the formulation reduced as the pectin content increased due to the acidic nature of pectin. The drug concentration was greater than 95%, and the apparent viscosity of the sol and gel was measured using a Brookfield viscometer (Rotational Viscometer Model). When the concentration of gelling polymer was increased from 0.5 to 1.0 percent, the gel strength (SOL) increased from 0.6 to 1 sec. The gel strength (GEL) increased from 0.7 to 13 seconds as a result of gelation. In vitro drug release experiments showed that the resulting formulations could release the medication for up to 10 hours when Higuchi kinetics were applied to all of them. The gels were stable across the six-month test period, according to the accelerated stability studies. There was no drug-polymer interaction, according to DSC and XRD analyses. Based on these findings, in situ nasal gel could be a possible drug delivery strategy for bambuterol hydrochloride, allowing it to bypass first-pass metabolism and hence improve bioavailability.

FORMULATION, DEVELOPMENT AND IN-VITRO EVALUATION OF A BAMBUTEROL HYDROCHLORIDE IN-SITU GELLING SYSTEM FOR NASAL DELIVERY

The goal of this project was to design, develop, and in-vitro evaluation of an in-situ gelling system for nasal administration of Bambuterol hydrochloride. All of the batches were prepared using different concentration of pectin, given different doses of simulated nasal electrolyte solution (SNES) i.e., 0.1 ml to 2.0 ml. All batches and formulation batches with a composition of 0.8 percent low methoxyl pectin underwent an in vitro gelation testing. The pH of the formulation reduced as the pectin content increased due to the acidic nature of pectin. The drug concentration was greater than 95%, and the apparent viscosity of the sol and gel was measured using a Brookfield viscometer (Rotational Viscometer Model). When the concentration of gelling polymer was increased from 0.5 to 1.0 percent, the gel strength (SOL) increased from 0.6 to 1 sec. The gel strength (GEL) increased from 0.7 to 13 seconds as a result of gelation. In vitro drug release experiments showed that the resulting formulations could release the medication for up to 10 hours when Higuchi kinetics were applied to all of them. The gels were stable across the six-month test period, according to the accelerated stability studies. There was no drug-polymer interaction, according to DSC and XRD analyses. Based on these findings, in situ nasal gel could be a possible drug delivery strategy for bambuterol hydrochloride, allowing it to bypass first-pass metabolism and hence improve bioavailability.

Effects of Ambroxol Hydrochloride on Lung Tissue Cell Apoptosis and Vascular Remodeling in Rats with Smoke Induced Chronic Obstructive Pulmonary Disease

To evaluate the effects of ambroxol hydrochloride on lung tissue cell apoptosis and vascular remodeling in rats with smoke induced chronic obstructive pulmonary disease. Sprague Dawley rats were randomly divided into normal, model, experimental and control groups (n=20). The rat model of chronic obstructive pulmonary disease was established by fumigation using Yan’an Cigarettes for 64 d. After fumigation, the experimental and control groups were subcutaneously injected with 5 mL of Ambroxol hydrochloride (20 mg/kg) and 5 mL of Bambuterol hydrochloride (20 mg/kg) respectively, while the normal and model groups were intraperitoneally injected with an equal dose of normal saline. Following drug intervention for 28 d, the pathological changes in lung tissues, vascular remodeling, lung tissue cell apoptosis, expressions of alpha-smooth muscle actin and vascular endothelial growth factor, as well as levels of caspase-3, B-cell lymphoma-2 and B-cell lymphoma-2 associated X protein were detected by hematoxylin and eosin staining, elastic Van Gieson staining, terminal deoxynucleotidyl transferase dUTP nick end labeling staining, immunohistochemical staining and western blotting, respectively. Compared with normal group, the damage of lung tissues was obvious, the medial thickness of pulmonary arterioles significantly increased, the degree of vascular muscularization, apoptosis rate and expressions of alpha-smooth muscle actin, vascular endothelial growth factor, caspase-3 and B-cell lymphoma-2 associated X protein rose and the expression of B-cell lymphoma-2 decreased in model group (p<0.05). Compared with model group, the damage of lung tissues was significantly improved, the medial thickness of pulmonary arterioles decreased, the degree of vascular muscularization, apoptosis rate and expressions of alpha-smooth muscle actin, vascular endothelial growth factor, caspase-3 and B-cell lymphoma-2 associated X protein reduced and the expression of B-cell lymphoma-2 rose in experimental and control groups (p<0.05). Ambroxol hydrochloride can inhibit the apoptosis of lung tissue cells and improve vascular remodeling, thereby protecting the lung tissues of chronic obstructive pulmonary disease rats.

A simple and economic chromatographic method for simultaneous determination of six bronchodilator drugs in pharmaceutical dosage forms

Chronic obstructive pulmonary disease is a major cause of morbidity and mortality worldwide. Combining an inhaled anticholinergic and a β2-agonist are a convenient way of delivering treatment, obtaining better lung function and improved symptoms. We aimed to develop and validate a reliable HPLC method for the simultaneous determination of the anticholinergics; ipratropium bromide, glycopyrronium bromide and tiotropium bromide in addition to the β2-agonists; bambuterol hydrochloride, formoterol fumarate and indacaterol maleate. The chromatographic separation was achieved on a Phenomenex Luna phenyl-hexyl (250 × 4.6 mm i.d., 5 μm) column and a mobile phase composed of 0.2% phosphoric acid (pH 3.0)/methanol/acetonitrile (66:12:22, v/v/v). The analysis was performed at a flow rate of 1 mL/min with UV detection at 210 nm. Method validation showed that calibration curves were linear within the range from 0.5 to 30.0 μg/mL with a correlation coefficient > 0.998. Intraday and interday precision and accuracy evaluated by relative standard deviation were lower than 2%. The limits of detection were in the ranges of 0.037–0.152 μg/mL. The developed method which is rapid, sensitive and highly efficient was applied for the analysis of the six bronchodilators in single and combined formulations saving money, solvents and chemicals. In addition, the environmental impact of the proposed method was evaluated using a suitable analytical Eco-Scale.

Determinants of response to bronchodilator in patients with cough variant asthma- A randomized, single-blinded, placebo-controlled study

BackgroundNot all patients with cough variant asthma (CVA) show responsiveness to bronchodilators (RB) in clinic. Whether there are specific clinical and pathophysiological features can indicate RB in patients with CVA needs further investigation. Thus, we aimed to investigate the RB in patients with CVA and associated factors. MethodsForty-two CVA patients were randomized in a 2:1 ratio to receive oral bambuterol hydrochloride (10 mg, once daily, for 3 days) or matched placebo, 36 patients (24 with bronchodilator and 12 with placebo) completed the study eventually. RB was considered when cough visual analogue scale (VAS) score decreased 30% or more after 3 days treatment. The baseline clinical and pathophysiological characteristics between patients with RB and patients without RB were compared. CRS was presented with the lowest concentration of capsaicin inducing at least 5 coughing (C5). ResultsThe responsive rate of patients with bronchodilator was significantly higher than that with placebo (62.5% vs 16.7%, p < 0.01). Patients with RB showed a significant greater mean decline of FEV1% predicted after bronchial provocation (26.7% vs 22.4%, p < 0.05) and higher geometric mean of sputum eosinophils (1.37 vs 0.69, p < 0.05) as compared with these without RB. No significant differences in sputum neutrophil, Log C5 were found between patients with RB and patients without RB. There was a moderate correlation between the decline of FEV1% pred and RB (rs = 0.443, p < 0.05). The regression analysis showed that nocturnal cough was a predictor of RB (OR, 7.33, 95% CI: 1.11–48.26, p = 0.038). No adverse events were reported by all of the patients after the study. ConclusionMore than one-third of patients with CVA do not respond to bronchodilator treatment, indicating that the response to bronchodilator should not be a diagnostic requirement of CVA. CVA patients with higher airway responsiveness will more likely respond to bronchodilator. Cough of CVA might be elicited by different mechanisms, which suggests that CVA could be divided into two phenotypes according to the response to bronchodilators.

Preparation of graphene oxide and its application for improving the properties of an electrochemical sensor for the determination of bambuterol hydrochloride in real samples

In this study, an ion-selective electrode modified with graphene oxide (GO) was developed to determine bambuterol hydrochloride (BAM)viaan electrochemical method.

Response to bronchodilator and clinical, pathophysiological features in patients with nonasthmatic eosinophilic bronchitis.

Whether nonasthmatic eosinophilic bronchitis (NAEB) shows response to bronchodilator (RB) remains unclear. To investigate the RB and its relationship with clinical and pathophysiological features in NAEB. Fifty-one patients with NAEB were assigned in a 2:1 ratio to receive oral bambuterol hydrochloride (n=34, 10mg, once daily, for 3days) or matched placebo (n=17) randomly, of whom 48 patients (32 with bronchodilator and 16 with placebo) completed the study. Sputum induction, spirometry and cough reflex sensitivity were measured. RB was considered when cough Visual analogue scale (VAS) score decreased 30% or more after treatment. Cough reflex sensitivity was defined as the lowest concentration of capsaicin inducing five coughings or more (C5), and presented as Log C5. The responsive rate of patients with bronchodilator was significantly higher than that with placebo (34.4% vs 6.3%, P<0.05). The VAS score decreased significantly in patients with bronchodilator (median: 6.0-3.0, P<0.01). There was a significantly higher median Log C5 (2.7 vs 1.3, P<0.05), and a higher trend of decline in FEV1 % predicted and MMEF% predicted after bronchial provocation in patients with RB as compared with patients without RB. No significant differences in baseline percentages of sputum eosinophil were found between patients with RB and that without RB. One third of patients with NAEB respond well to bronchodilator treatment, which are related with lower cough reflex sensitivity and increased airway responsiveness. The relationship between NAEB and asthma needs to be investigated further.

DESIGN, PREPARATION, AND EVALUATION OF SELF-MICROEMULSIFYING DRUG DELIVERY SYSTEM OF BAMBUTEROL HYDROCHLORIDE

Objective: The self-micro-emulsifying drug delivery system (SMEDDS) of bambuterol hydrochloride was designed, prepared, and evaluated to overcome the problem of poor bioavailability.&#x0D; Methods: The designing of the formulation included the selection of oil phase, surfactant, and cosolvent/cosurfactant based on the saturated solubility studies. Psuedoternary phase diagram was constructed using aqueous titration method, to identify the self-emulsifying region. Different ratios of the selected surfactant and cosolvent/cosurfactant (Smix) were also studied and used to construct the ternary phase diagram. The prepared formulations of the SMEDDS were evaluated for drug content, morphology, globule size, robustness to dilution, emulsification time, optical clarity, and stability.&#x0D; Results: The formulation containing 10 mg bambuterol hydrochloride, triacetin (12.50% w/w), Tween 80 (43.75% w/w), and ethanol (43.75% w/w) was concluded to be optimized. The optimized SMEDDS not only showed optimum globule size, zeta potential, and drug content but was also found to be robust to dilution, formed emulsion spontaneously, and was stable. The optimized SMEDDS showed increased permeability of the drug across the intestinal membrane in ex vivo studies.&#x0D; Conclusion: The results suggest that bambuterol hydrochloride can be formulated as self-microemulsifying drug delivery system, and further, SMEDDS can be used to improve the oral bioavailability of bambuterol hydrochloride.

Novel chemo-fluorimetric methods for determination of bambuterol hydrochloride in presence of the active metabolite terbutaline

Three novel, simple, rapid and sensitive spectrofluorimetric methods were developed for the simultaneous determination of bambuterol hydrochloride (BAM) in presence of its active metabolite and acidic degradation product; terbutaline (TER). Method I based upon calculating the first derivative values (D1) of the previously stored conventional emission spectra of both drugs. BAM and TER were measured at 302 and 286 nm respectively. Methods II & III built upon estimating the sum amount of both drugs at the isosbestic points (287.5 nm in the conventional emission method and 229.5, 247.5 nm in synchronous emission method). TER was determined using the previously mentioned D1 methods while BAM concentrations were considered by subtraction. All the optimization parameters were carefully optimized such as Δ λ and diluting solvents. The calibration curves were rectilinear over the range of 0.4 – 8.0 µg mL-1 with quantitation limits ranged from 0.246 – 0.273 µg mL-1. The proposed methods were successfully applied to the assay of synthetic laboratory mixtures, commercially available tablets as well as forced acidic stability testing.

Potentiometric sensor based on novel flowered-like Mg-Al layered double hydroxides/multiwalled carbon nanotubes nanocomposite for bambuterol hydrochloride determination

Nowadays, development of highly efficient potentiometric sensors attracts the attention of many researchers over the world; due to the great expansion of portable analytical devices. This study aims to apply a current development to the construction and sense of carbon paste sensors based on flowered-like Mg-Al layered double hydroxides/multiwalled carbon nanotubes (FLLDH/MWCNTs) (sensor І), FLLDH/titanate nanotubes (TNTs) (sensor ІІ) and MWCNTs/TNTs (sensor ІІІ) nanocomposites for bambuterol hydrochloride analysis; to enhance the potentiometric response towards determination of the drug. The sensors exhibited excellent Nernstian slopes 58.8 ± 0.5, 58.5 ± 0.8 and 57.4 ± 0.7 mV/decade with linear working ranges of 1.0 × 10−7–1.0 × 10−2, 1.0 × 10−6–1.0 × 10−2 and 1.0 × 10−7–1.0 × 10−2 mol L−1, detection limits 2.3 × 10−8, 2.5 × 10−7and 7.5 × 10−8 mol L−1 and quantification limits of 7.6 × 10−8, 8.3 × 10−7and 2.5 × 10−7 mol L−1 for sensor І, ІІ and ІІІ, respectively. The selectivity behaviour of the investigated sensors was tested against biologically important blood electrolytes (Na+, K+, Mg2+, Ca2+). The proposed analytical method was successfully applied for BAM determination in pure drug, pharmaceutical products, surface water, human plasma and urine samples with excellent recovery data (99.62, 99.10 and 98.95%) for the three sensors, respectively.

Formulation and Evaluation of Solid Self-emulsifying Drug Delivery System of Bambuterol Hydrochloride

The solid self-emulsifying drug delivery system of bambuterol hydrochloride was designed, prepared and evaluated to overcome poor bioavailability. The designing process included selection of oil phase, surfactant and co-solvent/co-surfactant based on saturated solubility studies. Psuedoternary phase diagram was constructed using dilution method to identify the self-emulsifying region. Liquid self-emulsifying drug delivery formulations were prepared from components obtained from these studies and were converted to solid self-emulsifying drug delivery systems by adsorption technique using microcrystalline cellulose:aerosil mixture as the adsorbent. The prepared solid self-emulsifying drug delivery system-based formulations were evaluated for drug content, morphology, globule size, micromeritic properties, ex vivo permeability and stability. Formulation F1 containing 10 mg bambuterol hydrochloride, triacetin (12.50 % w/w), Tween 80 (43.75 % w/w) and ethanol (43.75 % w/w) was concluded to be optimal. These results suggested that bambuterol hydrochloride can be formulated as a solid self-emulsifying drug delivery system, which could be used to improve oral bioavailability of bambuterol hydrochloride.

DESIGN, PREPARATION, AND EVALUATION OF SELF-MICROEMULSIFYING DRUG DELIVERY SYSTEM OF BAMBUTEROL HYDROCHLORIDE

Objective: The self-micro-emulsifying drug delivery system (SMEDDS) of bambuterol hydrochloride was designed, prepared, and evaluated to overcome the problem of poor bioavailability.Methods: The designing of the formulation included the selection of oil phase, surfactant, and cosolvent/cosurfactant based on the saturated solubility studies. Psuedoternary phase diagram was constructed using aqueous titration method, to identify the self-emulsifying region. Different ratios of the selected surfactant and cosolvent/cosurfactant (Smix) were also studied and used to construct the ternary phase diagram. The prepared formulations of the SMEDDS were evaluated for drug content, morphology, globule size, robustness to dilution, emulsification time, optical clarity, and stability.Results: The formulation containing 10 mg bambuterol hydrochloride, triacetin (12.50% w/w), Tween 80 (43.75% w/w), and ethanol (43.75% w/w) was concluded to be optimized. The optimized SMEDDS not only showed optimum globule size, zeta potential, and drug content but was also found to be robust to dilution, formed emulsion spontaneously, and was stable. The optimized SMEDDS showed increased permeability of the drug across the intestinal membrane in ex vivo studies.Conclusion: The results suggest that bambuterol hydrochloride can be formulated as self-microemulsifying drug delivery system, and further, SMEDDS can be used to improve the oral bioavailability of bambuterol hydrochloride.

Carbon nanotubes based potentiometric sensor for determination of bambuterol hydrochloride: Electrochemical and morphology study

A novel carbon paste sensor based on carbon nanotubes (CNTs) was successfully developed for the sensitive and selective determination of bambuterol hydrochloride (BAM). The sensor is based on bambuterol-tetraphenyl borate (BAM-TPB) as a recognition ion-pair, dibutyl phthalate (DBP) as plasticizer and incorporation of sodium tetraphenyl borate (NaTPB) as lipophilic anionic additive and CNTs. The morphology and surface properties of sensors were characterized by HRTEM and electrochemical impedance spectroscopy (EIS), respectively. The characteristics of the sensors, BAM-TPB/ NaTPB (CPE) and BAM-TPB/ NaTPB/ CNTs (CNT-CPE), were measured, showing notable features as they provided measurements of the potential with near-Nernstian slopes of 56.2 ± 0.8 and 59.3 ± 0.5 mV/decade over the concentration ranges of 1 × 10−6−10-2 and 1 × 10-7−10-2 mol L-1. The sensors were found to be precise and usable within wide pH ranges in short response times. Attractively, CNT-CPE showed lower detection limit reaching to 3.2 × 10-8 mol L-1, higher thermal stability (0.00024 mV °C-1) and longer lifetime (more than 4 months).

Preparation of radioiodinated bambuterol hydrochloride as beta receptors imaging agent

Bambuterol·HCl was successfully labeled with 125I via direct electrophilic substitution at ambient temperature. The effect of reaction parameters such as Bambuterol amount, CAT amount, pH of the reaction mixture, reaction temperature, and reaction time and the in vitro stability of 125I-Bambuterol·HCl were studied. The maximum yield of 125I-Bambuterol·HCl was 92.5 ± 1.9%. The yield was determined by paper electrophoresis. In vitro stability study showed that it is preferred to use the freshly prepared agent. Biodistribution studies showed high uptake of 125I-Bambuterol·HCl in liver and lungs (16 ± 0.15 and 4.3 ± 0.08% injected dose/g tissue, respectively, at 5 min post injection). The uptake in liver and lung remained high up to 1 h, as β2-receptors are located mainly at the liver and lungs (bronchial smooth muscles). The clearance of 125I-Bambuterol·HCl from mice appeared to be mainly via the renal pathway. Radioiodinated Bambuterol·HCl shows promise as novel selective β2-adrenoceptor imaging agent.

Spectrophotometric determination and thermodynamic studies of the charge transfer complexes of bambuterol–HCl

ObjectiveThe aim of the present work was to develop simple spectrophotometric methods for the simultaneous determination of bambuterol hydrochloride. MethodSpectrophotometric method for determination of bambuterol hydrochloride after its conversion to bambuterol base by formation of charge transfer complexes as n-donor with π-acceptors, dichlorodicyanobenzoquinone (DDQ) and tetracyanobenzoquinodimethane (TCNQ) which were prepared in acetonitrile. They yield radical anions measured at 461 and 842 nm within concentration ranges of 36.7–183.7, 4.59–36.7 μg ml−1 with a good correlation coefficients (r2 = 0.9999–0.9998) respectively. The nature of the formed complexes was studied via determination of the association constant and the molar absorptivity using Bensi–Hildebrand equation. The free energy change (ΔG) and the enthalpy of formation (ΔH) as well as the entropy (ΔS) were determined for the reaction product with TCNQ. The method was successfully applied for the analysis of bambuterol hydrochloride in its pharmaceutical preparation where no interference could be observed from the additives commonly present as proven by good mean recoveries of 99.74% and 100.014%. There was no significant difference observed when the method was statistically compared with the pharmacopeial official method used for determination. ConclusionThe proposed charge transfer complexation methods are rapid and simple and from the economical point of view, the analytical reagents used are inexpensive, have excellent shelf life and are available in any analytical laboratory. The suggested methods could be successfully applied for quality control and routine analysis.

A Novel Approach to Formulate and Optimize Orally Disintegrating Tablets of Bambuterol Hydrochloride

The aim of this article was to choose the optimal ingredients for oral disintegrating tablets of bambuterol hydrochloride (BBH) and use a novel approach to measure disintegration time. The disintegration time measured by a new approach was compared with disintegration time measured in oral cavity and conventional disintegration test. The result shows that the new apparatus is suitable for measuring the disintegration time. The effect of ingredients (diluents, disintegrants and adhesives) on the characteristics of the tablets was investigated. The orally disintegrating tablets of BBH were prepared by wet granulation. The results showed that the optimum proportion was 10 mg BBH, 100 mg lactose, 80 mg MCC, 10 mg crospovidone (PVPP), 2 mg aspartame, 2 mg DL-malic acid. The orally disintegrating tablet disintegrated rapidly, tasted good and could be taken convenient.