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(12) Patent Application Publication (10) Pub. No.: US 2004/0259955A1 Umehara Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2004/0259955A1 Umehara Et Al US 2004O259955A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0259955A1 Umehara et al. (43) Pub. Date: Dec. 23, 2004 (54) NEW PHARMACEUTICAL COMPOSITIONS (30) Foreign Application Priority Data CONTAINING AMBROXOLAND ISOPROPAMIDE ODIDE Nov. 8, 2002 (EP).......................................... O2O24 981 (75) Inventors: Norimitsu Umehara, Tokorozawa-shi Publication Classification (JP); Nobuo Miyadai, Narita (JP); Minoru Okada, Inzai (JP) (51) Int. Cl." ............................................ A61K 31/137 (52) U.S. Cl. .............................................................. 514/649 Correspondence Address: BOEHRINGER INGELHEM CORPORATION (57) ABSTRACT 900 RIDGEBURY ROAD The present invention relates to novel pharmaceutical com P. O. BOX 368 positions comprising as pharmacologically active com RIDGEFIELD, CT 06877 (US) pounds a combination of an expectorant-effective amount of brom hexine or ambroXol or a pharmacologically acceptable (73) Assignee: Boehringer Ingelheim International Salt thereof and a parasympatholytic (anticholinergic)-effec GmbH, Ingelheim (DE) tive amount of isopropamide iodide. Qualitative and quan Appl. No.: 10/691,101 titative formulae of this invention include pharmaceutically (21) acceptable carriers or excipients. The formulation further (22) Filed: Oct. 22, 2003 comprises Suitable pharmaceutically acceptable carriers or excipients. In addition, this invention is related to the usage Related U.S. Application Data of these compounds for treating the various Symptoms caused by the common cold. The composition of the present (60) Provisional application No. 60/498,406, filed on Aug. invention is especially effective in the treatment of Sputum 28, 2003. and/or runny nose caused by the common cold. US 2004/0259955 A1 Dec. 23, 2004 NEW PHARMACEUTICAL COMPOSITIONS 0010. Therefore, it is an objective of the present inven CONTAINING AMBROXOLAND SOPROPAMIDE tion to offer eXtremely effective pharmaceutical composi ODIDE tions that improve Sputum and/or runny nose. 0011) Another objective of the present invention is to RELATED APPLICATIONS offer a medicine for a cold using extremely effective phar 0001) The priority benefit of EP 02 024981.0 filed Nov. maceutical compositions that improve effectively sputum 8, 2002 and U.S. Provisional Application No. 60/498,406, and/or runny nose among the Symptoms of the common filed Aug. 28, 2003 are hereby claimed, both of which are cold. incorporated by reference herein. SUMMARY OF THE INVENTION BACKGROUND OF THE INVENTION 0012. The present invention relates to pharmaceutical 0002 The present invention relates to novel pharmaceu compositions comprising a combination of an expectorant tical compositions comprising as pharmacologically active effective amount of brom hexine or ambroXol or a pharma compounds a combination of an expectorant-effective ceutically acceptable Salt thereof and a parasympatholytic amount of brom hexine or ambroXol or a pharmacologically (anticholinergic) effective amount of isopropamide iodide. acceptable Salt thereof and a parasympatholytic (anticholin The pharmaceutical compositions further comprise pharma ergic)-effective amount of isopropamide iodide. ceutically acceptable carriers or excipients. 0003. The formulation further comprises suitable phar 0013 The invention further relates to methods of treating maceutically acceptable carriers or excipients. Additionally, various Symptoms caused by the common cold, in particular the present composition may contain other pharmaceutically Sputum and/or runny nose, comprising administering the active compounds. pharmaceutical compositions of the invention. 0004 Another aspect of the present invention relates to DESCRIPTION OF THE INVENTION methods of using these compositions in the treatment of Symptoms of the common cold. 0014 Thus, it has surprisingly been found that a phar maceutical composition according to the present invention 0005. In particular, the inventive composition is useful in comprising as pharmacologically active compounds a com the treatment of expectoration and/or runny nose in the bination of an expectorant-effective amount of bromhexine many Symptoms of the common cold. or ambroXol or a pharmacologically acceptable Salt thereof 0006 Common cold is a condition in which various and a parasympatholytic (anticholinergic)-effective amount reactions occur when Stimulated by microbes or chilliness to of isopropamide iodide, is Suitable for treating the Symptoms the respiratory organ (also known herein as respiratory of common cold. tract), and it is an acute inflammation in the respiratory 0015 The present invention relates to pharmaceutical organ, the airway from the mouth and nose through the compositions comprising as pharmacologically active com lungs. More precisely, it is called “common cold Syndrome' pounds a combination of an expectorant-effective amount of 0007 Nose inflammation caused by the common cold is brom hexine or ambroXol, preferably ambroXol, or a phar called acute rhinitis and brings about Symptoms Such as macologically acceptable Salt thereof and a parasym Sneezing and runny or Stuffy nose. In acute adenoiditis, patholytic (anticholinergic)-effective amount of isopropam which is an inflammation of the throat, congestion of the ide iodide. mucous membrane of the throat, Swelling, pain and other 0016 Ambroxol, to be used for pharmaceutical compo symptoms occur. When the infection affects the bottom of Sitions of the present invention, chemical name: trans-4-2- the respiratory organ, hoarse voice and Sometimes dyspnea amino-3,5-dibromobenzyl)aminocyclohexanol, is an occur. Once the infection reaches the bronchi, bronchioles, expectorant classified as a mucosal lubricant drug, which, by and lungs, onset of cough and Sputum begins. In addition to the increase in production of pulmonary Surfactant, has the the above-mentioned Symptoms in the respiratory organ, effect of lubricating the membrane of the airway. Ambroxol headache, fever, low back pain, wearineSS and anorexia of is a metabolite of brom hexine. the whole body appears. Furthermore, gastrointestinal Symptoms including abdominal pain and diarrhea Some 0017. In the present invention, preferably ambroxol times occur. hydrochloride is used. However, other acid addition salts including hydrobromate, oxalate, nitrate, Sulphonate, fuma 0008 Although coldness and allergic reaction are partly rate, maleate, Sulfate phosphate, and the like or freebase can attributed to the onset of the common cold, it is often caused also be used. by viral infection. The types of viruses that cause the common cold are thought to number more than 200. How 0018. In the present invention, bromhexine may be used ever, very few drugs are effective against the cold viruses at instead of part or all of the ambroxol. present. For this reason, Symptomatic treatment to control 0019 Bromhexine, to be used for pharmaceutical com Symptoms of common cold Such as runny nose, Stuffy nose, positions of the present invention, chemical name: 2-amino Sneezing, Sputum, throat pain, fever and muscle pain is the 3,5-dibromo-N-cyclohexyl-N-methylbenzylamine, is an main pharmaceutical therapy. expectorant classified as an airway Secretagogue, which has 0009. However, a drug effective for all symptoms has not the effect of increasing airway Secretion. been developed yet. Therefore, a combination drug manu 0020. In the present invention, preferably bromhexine factured for each Symptom is often used for treatment. hydrochloride is used. However, other acid addition salts US 2004/0259955 A1 Dec. 23, 2004 including hydrobromate, oxalate, nitrate, Sulphonate, fuma alimemazine tartrate, diphenhydramine tannate, diphe rate, maleate, Sulfate phosphate, and the like or freebase can nylpyraline teoclate, mebhydrolin napadisylate, promethaz also be used. ine methylene two Salicylates, carbinoxamine maleate, chlo rpheniramine maleate, difeterol phosphate, meduitazine, 0021. In the context of the present invention, brom hexine promethazine, cyproheptazine hydrochloride, iproheptine or its pharmacologically acceptable Salt may be blended hydrochloride, clemastine fumarate and epinastine hydro with the isopropamide iodide in an amount of 1.2 to 32 mg chloride, and the like. They can be used either Singly or in as daily dosage for adults, 8 to 16 mg is more preferable, and two or more combinations. The amount of antihistamic 12 mg is most preferable. agent is commonly 1 to 300 mg as daily dosage for adults 0022. In the context of the present invention, ambroxol or and preferably, it is 1.5 to 150 mg. its pharmacologically acceptable Salt may be blended with 0031 Examples of an antitussive are alloclamide hydro the isopropamide iodide in an amount of 5 to 90 mg as daily chloride, hydrochloric acid chloperastine, tipepidine citrate, dosage for adults, 10 to 60 mg is more preferable, and 22.5 Sodium dibunate, dextromethorphan hydrobromide, dex to 45 mg is most preferable. tromethorphan-phenol cover microcosmic Salt, tipepidine 0023) Isopropamide iodide, chemical name: 3-Carbam hibenzate, cloperastine fendizoate, codeine phosphate, dihy oyl-3,3-diphenylpropyl diisopropylmethylammonium drocodeine phosphate, pentoxyverine citrate, noScapine iodide, to be used in the pharmaceutical compositions of the hydrochloride, noScapine, dl-methylephedrine hydrochlo present invention is an anticholinergic drug which blocks the ride, d1-methylephedrine Saccharin Salt, carbetapentane cit parasympathetic nerve and Suppresses the excessive Secre rate, dimenorfan
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