Ambroxol hydrochloride is a medicine available in a number of countries worldwide. It is the active ingredient of mucosolvan, lasolvan or mucoangin. Ambroxol 15 mg5 ml syrup, 30 mg5 ml syrup, 60 mg effervescent tablets, 30 mg tablets and ambroxol 10 mgdose spray. Excessive nitric oxide no is associated with inflammatory and some other disturbances of airways function. Ambroxol passes into breast milk, therefore it is not recommended to use this medicine during breastfeeding. In vitro dissolution profile study of mucolytic drug. Oct 15, 2015 in this study, we investigated the pharmacokinetics of ambroxol and clenbuterol after oral administration of single dosage and multiple dosages of ambroxol and clenbuterol tablets in healthy chinese adults, based on which to provide the reference information for the clinical application of the medication. Sigmaaldrich offers a number of ambroxol hydrochloride products.
Cholestyramine can reduced intestinal absorption, and potentially, the effectiveness of other drugs taken at the same time. Sustained release microspheres of ambroxol hcl, it used as a recipiratory disease ambroxol hcl is water soluble drug, having low oral bioavailability 3355% due to complete metabolism of drug available in market were having daily administration. Here you will find listings of ambroxol hcl, ambroxol hydrochloride manufacturers, ambroxol hydrochloride suppliers, ambroxol hcl exporters and manufacturing companies from india. Ambroxol is used to treat respiratory diseases associated with thick mucus production including emphysema with bronchitis, tracheobronchitis, bronchiectasis, bronchitis with bronchospasm, asthma and other lung diseases such as pneumoconiosis and chronic inflammatory pulmonary conditions. The selected drugs were ambroxol hydrochloride, cetirizine hydrochloride, chlorpheniramine maleate, guaiphenesin, paracetamol, phenylephrine. R medical university chennai, in partial fulfilment of the requirements for the award of the degree of. Pdf formulation and characterization of ambroxol hydrochloride. Bioequivalence assessment of ambroxol tablet after a single. Syrup, 6mgml filmcoated tablets, 60mg powder for oral solution sachet 60mg. Formulation and evaluation of sustained release matrix tablets of ambroxol hydrochloride hemul v. Conditions for safe storage keep container tightly closed in a dry and wellventilated place. Download pdf journal of scientific and innovative research.
A chemically related drug, bromhexine, was introduced in 1965 to treat mild respiratory disorders. It promotes mucus clearance, facilitates expectoration and eases. Inquire about dmf, cgmp, price, availability, samples, sourcing, purity and more. Formulation development of stable ambroxol hydrochloride syrup and comparative evaluation with marketed samples a dissertation submitted to the tamil nadu dr. This medicine works by helping to break down the structure of mucus in the lungs and therefore facilitates expectoration. Read all of this leaflet carefully before you start. Ambroxol has been shown to inhibit the nodependent activation of soluble guanylate cyclase. Nikolic1 1faculty of medicine, university of nis, serbia 2institute of forensic medicine, toxicology laboratory, nis, serbia abstract.
The selected drugs were ambroxol hydrochloride, cetirizine hydrochloride, chlorpheniramine maleate, guaiphenesin, paracetamol, phenylephrine hydrochloride and salbutamol. Monolithic matrix tablets of ambroxol hydrochloride were formulated as sustained release tablets employing hydroxypr opyl methylcellulose polymer, and the sustained r elease behaviour of the fabr icated tablets was inv estigated. The drug is chemically trans42amino3,5dibromobenzyl amino cyclohexanol hydrochloride with molecular weight of 414. Simultaneous estimation of ambroxol hydrochloride and. An accurately weighed quantity of powder equivalent to 100 mg of ambroxol hydrochloride was transferred into a beaker and it was shaken with 20 ml of ethyl alcohol and filtered. Drug s profile the drugs for present study were selected on the basis of market survey. Ambroxol is a drug that breaks up phlegm, used in the treatment of respiratory diseases associated with viscid or excessive mucus. According to the survey conducted by the website, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. The matrix tablets for these formulations were prepared by direct compression and their invitro release tests were carried out for a period of 12. Pharmacokinetics of ambroxol and clenbuterol tablets in. Mar 14, 2008 a chemically related drug, bromhexine, was introduced in 1965 to treat mild respiratory disorders.
Oral sustained release matrix tablets of ambroxol hcl were formulated in order to improve efficacy, reduce. In vitro dissolution profile study of mucolytic drug ambroxol. Please follow your doctors advice on how you should use this medicine. Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. In vitro release kinetics study of ambroxol hydrochloride. A list of us medications equivalent to ambroxol hydrochloride is available on the website. Simple spectrophotometric methods for determination of. Simulating the pharmacokinetics of tabletized ambroxol using. Design of dual release drug delivery system of roxythromycin. This study was supported by the contract, bioequivalence assessment of roisol tablet to mucopect tablet of ambroxol hydrochloride after a single oral administration to healthy male volunteers, from sin poong pharm co. Investigation of the metabolism and pharmacokinetics of. Ambroxol, clenbuterol, lcmsms, pharmacokinetics introduction ambanr to, rxo24l s ami no35bod,rmi obe n zyl aminocyclohexanol, is an active ingredient of ambroxol hydrochloride which is usually used as bronchosecretolytic and expectorant drug 1. The pharmacokinetics of ambrogexal generic and ambroxol inn tablets were investigated in 18 healthy volunteers after peroral administration in a single dose of 60 mg.
Investigation of the metabolism and pharmacokinetics of ambroxol in healthy male volunteers the safety and scientific validity of this study is. A list of us medications equivalent to ambroxol is available on the website. Description1, 2, 3 cetirizine hydrochloride, an antihistamine is a major metabolite of hydroxyzine. The noael in the peri and postnatal development study was 50 mgkgday. Nacetylcysteine is a derivative of the amino acid lcysteine, and is used as a mucolytic agent and an antidote in paracetamol acetaminophen poisoning. No enhances the activation of soluble guanylate cyclase and cgmp accumulation. No data about clinically significant adverse interactions with other medicines. Chapter 3 drugs profile school of pharmaceutical sciences, shobhit university 70 3. As ambroxol is a metabolite of bromhexine and hypersensitivity reactions are not dependent on the dose of the allergenic substance absorbed, the. Other pharmaceutical strengths may be more appropriate for administration to this. The 3 2 full factorial design was adopted for optimization of polymer concentration to achieve identical drug release with theoretical dissolution profile. Characterization of differential patient profiles and.
Sustained release matrix tablets containing 75 mg ambroxol hydrochloride were developed using different drug. Ambroxol and doxofylline extend it for their determination in formulation. Stability study of ambroxol hydrochloride sustained release pellets coated with acrylic polymer 38 pak. Ambroxol hydrochloride and cetirizine hydrochloride are used for the treatment of bronchitis, cough, and allergy. In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by uhplcmsms. Pdf in vitro dissolution profile study of mucolytic drug ambroxol. A sustained release matrix formulation for ambroxol hydrochloride was designed and developed to achieve a 12 h release profile. Product presentation ambroxol hydrochloride olon spa. Sparingly soluble ambroxol hydrochloride was used in the experiment as a model drug. Ambroxol is a metabolite of bromhexine, and has been used in the prevention of neonatal respiratory distress syndrome with no reported maternal or fetalneonatal side effects. It is used to treat acute and chronic respiratory diseases accompanied by an increased mucus production.
Ambroxol belongs to the mucolytic group of medicines. Ambroxol hydrochloride is a potent mucolytic agent capable of inducing bronchial secretions used in the treatment of respiratory disorders. Differential scanning calorimetric analysis confirmed the absence of any drug polymer interaction. Chapter 3 drugs profile school of pharmaceutical sciences, shobhit university 67 3.
Recently, a hypothesis suggested that it may have a potential role in treatment of pagets disease of bone, parkinsonism, and other common diseases of agingassociated diseases involving dysfunction of autophagy. Formulation and evaluation of ambroxol hydrochloride. It is advisable to avoid use during the first trimester of pregnancy. Ambroxol is a medicine available in a number of countries worldwide. Pdf upload prior to 2018 update your company profile here. In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by uhplcmsms maja m.
The present study was formulate and evaluate ambroxol hcl. Formulation and evaluation of sustained release matrix. While other drug from combination that is ambroxol hydrochloride is a mucoactive drug and produces secretolytic actions that restore the physiological clearance mechanisms of the respiratory tract, which play an important role in the bodys natural defense mechanisms. In this study, we investigated the pharmacokinetics of ambroxol and clenbuterol after oral administration of single dosage and multiple dosages of ambroxol and clenbuterol tablets in healthy chinese adults, based on which to provide the reference information for. Formulation design and optimization of sustained release. The ambroxol hydrochloride drug was allowed to react with the added 5. Revised assessment report european medicines agency. Handling and storage precautions for safe handling provide appropriate exhaust ventilation at places where dust is formed. Ambroxol hydrochloride has relatively short plasma half life. Ambroxol indications and usages, prices, online pharmacy health products information. The absence of an interaction does not necessarily mean no interactions exist. Occasional gastrointestinal side effects may occur but these are normally mild. The optimal habit for the crystals of direct compressible active agents and additives includes spherical morphology, proper mean particle size and appropriate surface.
Using hpmc k15m and eudragit rspo as an inert matrix forming agent to control the release of ambroxol hydrochloride. The need for the administration of the drug for two to three times a day can decrease patient compliance. One visitor reported useful how is the drug ambroxol hydrochloride useful in reducing or relieving the symptoms. May 12, 2009 the pharmacokinetics of ambrogexal generic and ambroxol inn tablets were investigated in 18 healthy volunteers after peroral administration in a single dose of 60 mg. Sustained release formulations that would maintain plasma level for 812 h might be sufficient for daily dosing of ambroxol hydrochloride. Ambroxol relieves cough symptoms based on its secretagogue, antiinflammatory, antioxidant, antibacterial, antiviral, immunomodulatory and local anesthetic effects. Ambroxol, the active metabolite of bromexine, has been found to be responsible for the therapeutic effect. In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by uhplcmsms in this paper, a simplified dissolution test was performed for the release of ambroxol from tablets according to the european pharmacopoeia. Formulation and release behaviour of sustained release. The results of in vitro drug release studies shows that the desired release rate is achieved by optimized formulation are releasing the drug up to 11 hrs. The present study was designed to explore differential patient profiles and efficacy against acute respiratory symptoms of four formulations registered as overthecounter medicines. The levels of ambroxol hydrochloride in saliva were significantly higher statistically reliable than those in the blood plasma for the first 1. Ambroxol hydrochloride for olon spa product presentation pdf document on. Ambroxol hydrochloride manufacturers, ambroxol hcl suppliers.
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