Salbutamol Sulphate Research Articles

Development and validation of HPLC method for simultaneous determination of Ketotifen Fumarate and Salbutamol Sulfate in bulk and tablets dosage forms

The aim of the study was to develop and validate a new, rapid, sensitive, simple, accurate and reproducible HPLC method for simultaneous determination of ketotifen fumarate and salbutamol sulfate. Simultaneous HPLC method was developed using RP-C18 stainless steel analytical column 4.6×150 mm C18.Acetonitrile and phosphate buffer pH 4 (30 : 70) were used as mobile phase and wavelength was adjusted to 276 nm for detection of drugs. Developed method was validated for its specificity, accuracy, precision, linearity and robustness. Method was also applied to quantify drugs in commercial tablets. Chromatogram obtained by newly developed method for simultaneous determination of two anti-asthmatic drugs, having well distinguished peaks for both drugs. Retention time of ketotifen fumarate and salbutamol sulfate were 2.69 minutes and 9.47 minutes respectively. Total run time for both anti-asthmatic drugs was 12 minutes. Limit of quantification for ketotifen fumarate and salbutamol sulfate was 1 ng/ml and 1.50 ng/ml respectively. Limit of detection of ketotifen fumarate and salbutamol sulfate was 3.03 and 4.54 respectively. A simple, easy, precise and new method was developed for simultaneous quantification of frequently used anti-asthmatic drugs. Developed method may prove effective and beneficial in determination of ketotifen fumarate and salbutamol sulfate in bulk and other pharmaceutical dosage forms.

Development and validation of stability indicating UV-visible spectrophotometric method for simultaneous determination of salbutamol sulphate and ambroxol hydrochloridein liquid dosage form

Purpose: A new, simple, precise and validated UV spectrophotometric method has been developed for simultaneous estimation of salbutamol sulphate and ambroxol hydrochloride in liquid dosage form. Method: The method employed was simultaneous equation method which involves solving simultaneous equations based on measurement of absorbance at two wavelengths 224 nm and 244 nm, the λmax of salbutamol sulphate and ambroxol hydrochloride, respectively. Specificity of the method was determined by subjecting the drugs to various stress conditions like acid, alkali, thermal and photolytic degradation. Results: The linearity was obtained in the concentration range of 0.1-0.6 μg/mL for salbutamol sulphateand 1.5-09 μg/mL for ambroxol hydrochloride. The proposed method was effectively applied to liquid dosage form for estimation of both drugs. The accuracy and reproducibility results are close to 100% with ≤2% RSD. The results of proposed method have been validated as per ICH guidelines. Conclusion: A novel, precise and accurate stability indicating spectrophotometric method has been developed for the estimation of salbutamol sulphate and ambroxol hydrochloride in pharmaceutical syrup formulation.

Effect of Salbutamol Sulfate Combined with Budesonide on Asthma and Effects of RR, HR, PaCO2 and PO2

Effect of Salbutamol Sulfate Combined with Budesonide on Asthma and Effects of RR, HR, PaCO2 and PO2

DESIGN AND EVALUATION OF FAST DISSOLVING GRANULES OF SALBUTAMOL SULFATE

Objective: Appropriateness of administration and patient complaints are important factors in developing dosage forms, especially for children and elderly people. The goal of this research was to develop salbutamol sulfate granules that dissolve quickly to improve patient compliance. Methods: Five formulas (F1-F5) were prepared by wet granulation methods. Different type of excipients was used in the formulation like banana powder as super disinterring, mannitol, hydroxyl propyl methylcellulose; etc. The formulas were evaluated for flow properties, drug compatibility study by FTIR, drug content, and drug release profile. Results: The result revealed that the flowability of the five formulas has accepted flow properties; The FTIR studies of the formula F2 showed no drug-excipients interaction. All of the prepared formulas show an acceptable range of drug content, a rapid release of drug of about 95.2% within 10 min. These results indicate good and rapid release properties of salbutamol sulfate from fast dissolving granules. Conclusion: Salbutamol sulfate was successfully formulated as fast-dissolving granules by using banana powder.

Influence of surface interaction between drug and excipient in binary mixture for dry powder inhaler applications

The present study documents the drug-excipient incompatibility in the physical mixtures and its influence on bulk homogeneity and flowability for dry powder inhalers (DPI) applications. Binary mixtures with the model drugs (aceclofenac; salbutamol sulphate) and lactose monohydrate were prepared separately at varied drug loading (1–33 wt.%), and their physicochemical properties were assessed using various characterization techniques. The DSC, P-XRD and FT-IR studies show a significant shift in the signature peak of drug and excipient while ss-NMR, LC-MS show the absence of peaks. In contrast, new peaks are observed in LC-MS and GC studies. The insights are comprehended through a series of XPS studies. The findings indicated the formation of condensed or addition compound. This is attributed to an interaction between polar protic groups (-NH-, -COOH, -OH) and hemiacetal carbon (HO-C-OR) of drug and excipient in the solid-state. It induces crystal strain and alters bulk properties related to mixing (relative standard deviation, %RSD), cohesion and flow function coefficient (FFC). However, surface modification of excipient using MgSt and aerosil R972 (model nano-particle) eliminates such inter-particle interactions, crystal level changes. It improves the bulk properties of binary mixtures pivotal for DPI performance.

Insights into the Impact of Nanostructural Properties on Powder Tribocharging: The Case of Milled Salbutamol Sulfate.

The impact of the crystallinity of organic solid materials on their tribocharging propensity is well reported. However, no unequivocal explanation about the potential underlying mechanism(s) could be found so far in the literature. This study reports the effect that different degrees of crystalline disorder has on the tribocharging propensity of a small molecular organic material, salbutamol sulfate (SS). Ball-milling was used to induce structural transformations in the crystalline structure of SS. Particles with different nanostructures were produced and analyzed for their solid-state, particle properties, and tribocharging. It was found that differences in the amorphous content among the processed particles and related moisture levels had an impact on powder tribocharging. A correlation between the latter and the nanostructural properties of the particles was also established. The presence of interfaces between nanodomains of different densities and shorter average lengths within the phases seems to lead to a mitigation of charge. This suggests that undetected, subtle nanostructural differences of materials can affect powder handling and processability by altering their tribocharging. The present findings demonstrate the nanostructural implications of powder triboelectrification, which can help toward the rational design of a wide variety of organic solids.

A Case-Control of Patients with COVID-19 to Explore the Association of Previous Hospitalisation Use of Medication on the Mortality of COVID-19 Disease: A Propensity Score Matching Analysis.

Data from several cohorts of coronavirus disease 2019 (COVID-19) suggest that the most common comorbidities for severe COVID-19 disease are the elderly, high blood pressure, and diabetes; however, it is not currently known whether the previous use of certain drugs help or hinder recovery. This study aims to explore the association of previous hospitalisation use of medication on the mortality of COVID-19 disease. A retrospective case-control from two hospitals in Madrid, Spain, included all patients aged 18 years or above hospitalised with a diagnosis of COVID-19. A Propensity Score matching (PSM) analysis was performed. Confounding variables were considered to be age, sex, and the number of comorbidities. Finally, 3712 patients were included. Of these, 687 (18.5%) patients died (cases). The 22,446 medicine trademarks used previous to admission were classified according to the ATC, obtaining 689 final drugs; all of them were included in PSM analysis. Eleven drugs displayed a reduction in mortality: azithromycin, bemiparine, budesonide-formoterol fumarate, cefuroxime, colchicine, enoxaparin, ipratropium bromide, loratadine, mepyramine theophylline acetate, oral rehydration salts, and salbutamol sulphate. Eight final drugs displayed an increase in mortality: acetylsalicylic acid, digoxin, folic acid, mirtazapine, linagliptin, enalapril, atorvastatin, and allopurinol. Medication associated with survival (anticoagulants, antihistamines, azithromycin, bronchodilators, cefuroxime, colchicine, and inhaled corticosteroids) may be candidates for future clinical trials. Drugs associated with mortality show an interaction with the underlying conditions.

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

Formulation, Optimization and In Vitro Evaluation of Fast Disintegrating Tablets of Salbutamol Sulphate using a Combination of Superdisintegrant and Subliming Agent.

The present research work was aimed to formulate fast disintegrating tablets (FDTs) of salbutamol sulphate (SBS) using a combination of a superdisintegrant and a subliming agent, optimize the formulation and evaluate the in vitro performance of the developed FDTs. A formulation of SBS FDT was developed using a combination of superdisintegrant - crospovidone and subliming agent - Ammonium Bicarbonate (AB) in which formulation variables, namely levels of crospovidone and Microcrystalline Cellulose (MCC):Mannitol (MNTL) ratio, were evaluated for their effects on the response variables, disintegration time, hardness, friability and wetting time, of the resulting FDTs. By employing Central Composite Design (CCD) methodology, the FDTs were optimized to achieve optimum levels of the formulation factors. The desired optimum condition was obtained at 7.82% crospovidone and 70% of 1.56:1 MCC: MNTL ratio, while maintaining AB at 5% level for aesthetic reasons. Under the optimized conditions, the disintegration time, hardness, friability, and wetting time were 14.57 ± 0.53 sec, 7.17 ± 0.82 kg/cm2, 0.311% and 13.14 ± 0.69 sec, respectively. The experimentally observed responses were found to be in close agreement with the predicted values for the optimized formulation. Moreover, the validity of the obtained optimal point was confirmed by the low magnitude of percent prediction error (< 5%). FDTs of SBS were successfully formulated and optimized using CCD employing a combination of a superdisintegrant and a subliming agent.

Formulation, Optimization and In Vitro Evaluation of Fast Disintegrating Tablets of Salbutamol Sulphate using a Combination of Superdisintegrant and Subliming Agent

Formulation, Optimization and In Vitro Evaluation of Fast Disintegrating Tablets of Salbutamol Sulphate using a Combination of Superdisintegrant and Subliming Agent

Spectrophotometric Determination of Salbutamol Sulphate and Isoxsuprine Hydrochloride in Pharmaceutical Formulations

A simple, sensitive and accurate spectrophotometric method has been developed for the determination of salbutamol sulphate (SAB) and isoxsuprine hydrochloride (ISX) in pure and pharmaceutical dosage. The method involved oxidation of (SAB) and (ISX) with a known excess of N-bromosuccinamid in acidic medium, and subsequent occupation of unreacted oxidant in decolorization of Evans blue dye (EB). This, in the presence of SAB or ISX was rectilinear over the ranges 1.0-12.0, 1.0-11.0 µg/mL, with molar absorptivity 4.21×104 and 2.58×104 l.mol-1.cm-1 respectively. The developed method had been successfully applied for the determination of the studied drugs in their pharmaceutical dosage resulting in a good agreement with certified value and standard addition procedure.

Novel spherical lactose produced by solid state crystallisation as a carrier for aerosolised salbutamol sulphate, beclomethasone dipropionate and fluticasone propionate

The purpose of the present work was to engineer lactose carrier particles for inhalation using a solid-state crystallisation of amorphous spray dried lactose approach. A suspension of spray dried lactose was contacted with hot ethanol for 10 and 30 s to produce spherical particles (ESDL10) and (ESDL30) with different degrees of crystallinity, particle size, and controlled surface rugosity. Lactohale® (control) and engineered spray dried lactose (ESDL) particles were characterised by Scanning Electron Microscopy, X-ray Powder Diffraction and Tribo-electrification. Lactohale® and engineered lactose particles were mixed separately with salbutamol sulphate (SS), beclomethasone dipropionate (BDP) and fluticasone propionate (FP) and each formulation was assessed for drug content uniformity, drug segregation after tribo-electrification and drug deposition using Andersen Cascade Impactor (ACI). Lactohale® showed the highest but opposite affinity for electrical surface charges compared to engineered lactose. Lactohale® showed the greatest variation in drug content uniformity with SS but to a lesser extent with BDP and FP, whereas the ESDL carriers produced an acceptable uniform mix with all drugs. SS-Lactohale® formulation showed the highest segregation after tribo-electrification up to 119-fold in comparison to that observed with SS-engineered lactose. ESDL10 carrier promoted a better drug deposition for both BDP and FP and showed the least variation in both content uniformity and FPD with all three drugs. Therefore, production of crystalline spherical lactose carrier with controlled surface texture, size and crystallinity is achievable using solid state crystallisation for DPIs, whilst providing less variation in drug content uniformity and consistent fine particle dose to the lungs in-vitro for both hydrophilic and hydrophobic drugs.

Comparison of efficacies of full and abbreviated cascade impactors in aerosol characterization of nebulized salbutamol sulfate produced by a jet nebulizer

The properties of aerosols generated from salbutamol sulfate solution (1 mg/mL) using an air-jet nebulizer were evaluated using Next Generation Impactor (NGI), a full cascade impactor, and Fast Screening Impactor (FSI), an abbreviated impactor measurement (AIM). Both impactors were operated under the same experimental conditions. The samples were recovered and assayed using validated high performance liquid chromatography (HPLC). The study investigated AIM-Human Respiratory Tract (HRT) concept by comparing key parameters of aerosolization i.e. fine particle dose (FPD) and fine particle fraction (FPF) measured using FSI, with NGI as baseline. The results showed that FSI yielded different but comparable values for FPD and FPF, indicating that it is alternative impactor to NGI. Despite the fact that FSI could not replace NGI, it may be used as an alternative impactor for simple and rapid aerosol characterization of formulations in some pharmaceutical development and quality control processes.

A REVIEW OF THE COMBINATION OF XANTHINE AND BRONCHODILATOR DRUG IN MOUTH‑DISSOLVING FILM FOR ASTHMA TREATMENT”

There has been an increase in demand for caregiver dosage forms over the past two decades. In the oral cavity, mouth dissolving film dissolves swiftly. Oral films that dissolve in your mouth function best when combined with medications that act quickly, such as Xanthine category drugs (Salbutamol Sulphate) and Xanthene Derivative Theophylline. According to the World Health Organization (WHO), asthma affects one in six adults and a quarter of all children, according to the WHO. A child’s admission to the hospital is often due to asthma, which is one of the most prevalent reasons for admission. During an asthma attack, quick-relief or rescue drugs are used to relax and open the airways, as well as ease symptoms. If prescribed, these medications can also be administered prior to exercise. To treat asthma, a combination of Salbutamol Sulfate and Theophylline is available in tablet form under the brand name “Theo-Asthalin.” Oral films seem to be the most efficacious formulation. As a consequence, children with asthma should receive support from drugs given in the form of mouth-dissolving films, since they provide better patient compliance and an appropriate treatment method.

Comparison between Salbutamol and Salbutamol with Magnesium Sulphate by nebulization in Treatment of Acute Asthma in Asthmatic Patient

Abstract Background Asthma exacerbations are acute or subacute episodes of breathlessness, cough, wheezing, and chest tightness, or any combination of these symptoms. Exacerbations are associated with airways obstruction that should be documented and quantified by PEF or FEVI measurement. Early treatment of asthma exacerbations should be the best strategy for management. Objective To compare fast effectiveness between the nebulized salbutamol with normal Saline and salbutamol with magnesium sulphate by nebulizer in treatment of acute asthma. Patients and Methods: This two armed prospective randomized study included 60 patients admitted to Intensive Care Unit, Ain Shams University Hospital from July 2019 to July 2020. Patients were randomized into two equal groups: group A which included 30 patients on salbutamol nebulization and group B that included 30 patients on combination of salbutamol and magnesium sulphate. Results systolic blood pressure, diastolic Bl. P and FEVI were higher among salbutamol group (A) than combination group (B), meanwhile HR and 02% were significantly lower among group A than group B with statistically insignificant differences (p &amp;gt; 0.05). Group A had significantly higher mean of RR (20±1.33) than group B (17.2 ±1.14) (p &amp;lt; 0.001). Also, Group A had significantly higher mean of PEFR (217.5 ±74.72) than group B (125±78.05) (p = 0.014). There were significant differences between in group A in HR and 02% before and after TTT (p &amp;lt; 0.05). With treatment, the pulse rate rose significantly (p = 0.010) but there was no significant change in the systolic or diastolic blood pressure. The 02% rose significantly (p&amp;lt;O.001). There were significant differences between in group B in RR, HR, 02%, PEFR and FEVI before and after TTT (p &amp;lt; 0.05). With treatment, the respiratory rate declined significantly (p &amp;lt; 0.001), the pulse rate declined significantly (p = 0.013) in but there was no significant change in the systolic or diastolic blood pressure. The PEFR rose significantly (p = 0.001) and also the 02% rose significantly (p &amp;lt; 0.001). Conclusion Nebulized MgS04, either alone or combined with salbutamol, has a clinically significant bronchodilator effect in acute asthma. This suggests that a combination of MgS04 and salbutamol may be the best choice for the management of acute exacerbations of asthma.

The therapeutic effect of budesonide on childhood asthma and its influence on growth and development 1 to 2 years after the treatment

Objective To explore the effect of budesonide suspension for inhalation in the treatment of childhood asthma and its influence on growth and development in 1-2 years. Methods The 68 children with asthma admitted to our hospital from October 2016 to January 2017 were selected. Every patient had acute attacks and received continued medication. 34 patients treated with salbutamol sulfate inhaled aerosol were used as the control group. 34 patients treated with budesonide suspension combined with salbutamol sulfate aerosol were classified as the observation group. The interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α), high-sensitivity-C-reactive protein (hs-CRP), maximum respiratory flow, IS maximum expiratory volume, regulatory B cell ratio, wheezing disappearance time, shortness of breath relief time, wet rales disappearing time, cough disappearing time, and the two year follow-up indicators of growth and development were compared. Results After medication, IL-6, TNF-α, hs-CRP, regulatory B cell ratio, wheezing disappearance time, shortness of breath relief time, moist rales disappearance time, and cough disappearance time were lower in the observation group(P Conclusion Budesonide suspension combined with salbutamol sulfate aerosol inhalation therapy can alleviate the inflammatory reaction, improve the lung function and immune function of children, and accelerate the disappearance of clinical symptoms, but it will affect the growth and development of children to a certain extent.

Determination of Salbutamol Sulfate in pharmaceutical formulation with differential pulse voltammetry using poly(Benzofuran-2-Boronic acid) modified platinum electrode

In this study, determination of salbutamol sulfate (SBS) was carried out using poly(benzofuran-2-boronic acid)/platinum electrode (BF2BA/PtE). Polymerization of BF2BA was conducted in acetonitrile (AcN) containing 0.1 M sodium perchlorate (NaClO4) on bare PtE by cyclic voltammetry (CV) method. The electrochemical properties of the prepared polymer electrode were investigated by CV and electrochemical impedance spectroscopy (EIS) techniques in ferricyanide/KNO3 solution. Then, prepared poly(BF2BA/PtE) was used for detection of the SBS. Monomer type, concentration, the number of cycles and scan rate were worked using differential pulse voltammetry (DPV) in citrate-phosphate buffer containing 1.15 mM SBS. The effects of parameters such as electrolyte type, pH effect on SBS DPV responses were studied. The SBS responses of the modified electrodes were also investigated by square wave voltammetry (SWV). The oxidative current peak stem from SBS concentration showed at 0.65V potential and a linear calibration curve was obtained in the range from 50 to 2000 μM SBS concentration. Limit of dedection (LOD), and limit of quantitation (LOQ), was calculated as 49.14 µM and 163.80 µM, respectively. The recovery efficiency for synthetic urine samples was obtained from 91.47 to 110.43% by using BF2BA/PtE.

Combination of Chinese and Western Medicine Optimizes the Intestinal Microbiota of Exacerbated Chronic Obstructive Pulmonary Disease in Rats.

Chronic obstructive pulmonary disease (COPD) changes the structure of the intestinal microbiota and activates the acute exacerbation of COPD (AECOPD). Previous studies showed that the way to treat COPD and AECOPD via combination of Chinese and Western medicine was successful. However, the effect of the intervention on the structure of the intestinal microbiota has not been studied. In this study, we collected feces from model rats following intervention, integrated with Chinese and Western medicine, and used 16S rRNA gene sequencing to clarify the effect on intestinal microbiota. Methods. Twenty-five rats were randomized into the control, COPD, AECOPD, Western medicine (moxifloxacin hydrochloride tablets + salbutamol sulfate tablets, MXF/STL), and integrated Chinese and Western medicine (Tong Sai granules + moxifloxacin hydrochloride tablets + salbutamol sulfate tablets + Bu Fei Yi Shen granules + salbutamol sulfate tablets, TMS/FS) groups. Lipopolysaccharide-combined cigarette smoke exposure method was used to simulate the acute exacerbation-stabilization of COPD. Then, the model rats were intervened. Results. The intervention of combination Chinese and Western medicine improved the lung function, decreased the C-Reactive Protein (CRP) and Serum Amyloid A (SAA), and relieved pathological damage to the pulmonary alveoli and intestinal mucous of AECOPD rats. The proportion of Firmicutes, TM7, Oscillospira, Clostridium, Ruminococcus, Blautia, Treponema, and Turicibacter decreased, whereas that of Bacteroidetes, Proteobacteria, Lactobacillus, and Allobaculum increased via the intervention with the combination of Chinese and Western medicine. Conclusions. The intervention with Chinese and Western medicine optimizes the intestinal microbiota structure in AECOPD rat model, which provides a basis for the COPD study in the Chinese medicine.

Study of pressurised metered dose inhalers for the purpose of standardization of quality attributes characterizing uniformity of dosing

Aim. The purpose was to provide the rationale of test in regard to uniformity of fine particles dose for pressurised metered dose inhalers (pMDIs). Materials and methods. The pMDIs containing suspensions of salbutamol sulfate (SS) or solutions of beclometasone dipropionate (BD) were studied by laser diffraction and high performance liquid chromatography (HPLC). The particle size distribution of SS, the average dose mass and uniformity of dose mass, the average delivered dose and the uniformity of delivered dose, the average fine particles dose and uniformity of fine particles dose were determined. Apparatus A was used for assessment of fine particles dose. Results. The two analytical procedures for the quantitative determination of SS and BD by HPLC were validated in the ranges with low concentrations of these substances. The 5 medicinal products in pMDI dosage form were studied: 3 preparations were with SS and 2 ones contained BD. It was shown that three products with SS were very similar in regard to particle size distribution in containers and the average values of delivered dose were almost the same, but these products were different in the average dose mass and fine particle dose. According to the research results, the expediency of determining the average dose mass and the tests concerning uniformity of dosing of preparations by dose mass and by fine particle dose was substantiated. It was shown that in the case of pMDI the dosing of solutions of BD was more uniform compared to suspensions of SS. The approaches of leading and other pharmacopoeias concerning uniformity of dosing for pMDIs were critically discussed. The expediency of determination of uniformity of fine particle dose at the stage of pharmaceutical development was substantiated, as the therapeutic effect depends on fine particle dose. Issues concerning standardization pMDIs in regard to uniformity of fine particle dose were discussed. Conclusions. The expediency of standardization and quality control of pMDIs in regard to such attributes as the average dose mass, which characterizes the volume of the metering chamber of the valve as well as the uniformity of the dose mass and the uniformity of fine particle dose, which assure the therapeutic effect of each dose of the product was substantiated

Spectrophotometric Determination of Salbutamol and Terbutaline using 9-Chloroacridine Reagent

A simple and sensitive spectrophotometric method has been described for the assay of Salbutamol sulphate (SBS) and Terbutaline sulphate (TERS) in their pure and dosage forms. The method was based on the reaction of the nucleophilic compensation by interacting of drugs with the reagent 9-chloroacridine (9-CA) in basic medium. The products have absorption bands with maximum absorbance at 600 nm and 588 nm for SBS and TERS respectively. Beer’s law was obeyed in the range 0.5-12.0 μg.ml-1 and 0.1-6.0 μg.ml-1 with molar absorptivity values 1.913×104 and 1.0755×105 l.mol-1.cm-1, recoveries are 101.3% and 99.6% for above drugs respectively. The relative standard deviation (RSD) is less than 1.7% for both drugs. The probable reactions have been suggested.