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(12) Patent Application Publication (10) Pub. No.: US 2007/0224267 A1 Pschorn Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2007/0224267 A1 Pschorn Et Al US 20070224267A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0224267 A1 PSchorn et al. (43) Pub. Date: Sep. 27, 2007 (54) AMBROXOL FOR THE TREATMENT OF (30) Foreign Application Priority Data PAINFUL CONDITIONS IN THE MOUTH AND PHARYNGEAL CAVITY Feb. 27, 2002 (DE)................................. DE 102 08 313 (76) Inventors: Uwe Pschorn, Mainz (DE): Publication Classification Jean-Michel Vix, Wiesbaden (DE); Anke Esperester, Mainz (DE) (51) Int. Cl. A6II 3/85 (2006.01) Correspondence Address: A6II 3 L/13 (2006.01) MICHAEL P. MORRIS A6II 3/19 (2006.01) BOEHRINGERINGELHEM CORPORATION A6II 3L/435 (2006.01) 900 RIDGEBURY ROAD A6IR 9/20 (2006.01) P. O. BOX 368 A6II 3/34 (2006.01) RIDGEFIELD, CT 06877-0368 (US) A6II 3 L/35 (2006.01) 21) Appl. No.: 11A51245 (21) Appl. No 9 (52) U.S. Cl. ......................... 424/464; 514/277: 514/470; (22) Filed: May 21, 2007 514/557; 514/576; 514/638; 5147646 Related U.S. Application Data (63) Continuation of application No. 11/185.558, filed on (57) ABSTRACT Jul. 20, 2005, which is a continuation of application No. 10/376,349, filed on Feb. 27, 2003, now aban doned. The invention relates to the use of ambroxol and the phar macologically acceptable salts thereof for preparing a phar (60) Provisional application No. 60/386,164, filed on Jun. maceutical composition for the treatment of painful condi 5, 2002. tions in the oral and pharyngeal cavity. -o- ambroXOl 20 mg -O- placebo O 20 40 60 8O 100 120 140 160 18O time after first suckable tablet in min) Patent Application Publication Sep. 27, 2007 Sheet 1 of 2 US 2007/0224267 A1 -o- ambrOXOl 20 mg -O- placebo C CS CD S a n 1OO 120 140 160 180 time after first suckable tablet in min) Figure 1 Patent Application Publication Sep. 27, 2007 Sheet 2 of 2 US 2007/0224267 A1 -A- ambroXol 20 mg A -O- ambroXol 30 mg V -O- placebo E R A G E P D O 20 40 60 80 100 120 140 160 180 time after first suckable tablet in min) Figure 2 US 2007/0224267 A1 Sep. 27, 2007 AMBROXOL FOR THE TREATMENT OF PAINFUL the tablet (base line) up to 3 hours after taking the first CONDITIONS IN THE MOUTH AND suckable tablet containing 20 mg or 30 mg of ambroxol PHARYNGEAL CAVITY hydrochloride and placebo. RELATED APPLICATION DESCRIPTION OF THE INVENTION 0001. This application claims priority benefit of U.S. 0009 Surprisingly, it has been found that, when admin provisional application Ser. No. 60/386,164, filed Jun. 5, istered locally in Suitable doses or concentrations, ambroXol 2002. has a very good pain-relieving effect in the oral and pha ryngeal cavity in addition to being very well tolerated. BACKGROUND TO THE INVENTION 0010) The invention therefore relates to the use of 0002 The invention relates to the use of ambroxol and ambroXol or one of the pharmacologically acceptable salts the pharmacologically acceptable salts thereof for preparing thereof for preparing a pharmaceutical composition for the a pharmaceutical composition for the treatment of painful treatment of pain in the oral and/or pharyngeal cavity, conditions in the oral and pharyngeal cavity. selected from among acute Sore throat, aphthae, gingivitis, parodontopathies, pressure points caused by prostheses, pain 0003 Painkillers for relieving pain in the oral and pha after oro-pharyngeal interventions, lesions on the mucous ryngeal cavity often have the drawback of side effects, e.g. membrane in the oral and pharyngeal cavity and herpes in the form of local irritations. simplex in the oral and pharyngeal cavity, particularly 0004 The active substance ambroxol (trans-4-(2-amino aphthae, gingivitis, parodontopathies, pressure points 3,5-dibromobenzylamino)-cyclohexanol) is a known expec caused by prostheses, pain after oro-pharyngeal interven torant and mucolytic. It is used in oral preparations such as tions, lesions on the mucous membrane in the oral and syrups, capsules, tablets, inhalable solutions, drops or Suck pharyngeal cavity and herpes simplex in the oral and pha able pastilles. ryngeal cavity, most particularly for the treatment of acute Sore throats. By acute Sore throats are meant severe Sore 0005 The aim of the present invention is to prepare a throats, for example inflamed throats with difficulty swal well-tolerated active substance for the treatment of pain in the oral and pharyngeal cavities. lowing or with burning in the throat. 0011. The invention further relates to a pharmaceutical SUMMARY OF THE INVENTION composition containing ambroxol or one of the pharmaco logically acceptable salts thereof and one or more active 0006 The invention relates to pharmaceutical composi Substances selected from among the antiseptics, vitamins, tions comprising ambroXol, bromhexine or one of the phar corticoids, antiinflammatories, Virostatics, antibiotics, anti macologically acceptable salts thereof. The invention also mycotics and proteolytic enzymes. relates to pharmaceutical compositions comprising ambroXol or one of the pharmacologically acceptable salts 0012 Suitable antiseptics are for example cetylpyri thereof and one or more active Substances (e.g., antiseptics, dinium-Cl, dequalinium-Cl, chlorhexidine-digluconate, Vitamins, corticoids, antiphlogistics, antibiotics, antimy benzalkonium-Cl or ethacridine-lactate. cotics, and proteolytic enzymes, lysozyme hydrochloride, 0013 Suitable vitamins are for example dexpanthenol dipotassium glycyrrhizinate, ammonium glycyrrhizinate, (pantothenic acid) or ascorbic acid. cetylpyridinium chloride, chlorpheniramine maleate, nos capine, dequalinium chloride, dextromethorphane, phenol 0014 Suitable corticoids are for example triamcinolone phthalinate, potassium guaiacolsulphonate, d1-methylephe or prednisolone-acetate. drine hydrochloride, chlorhexidine hydrochloride, and 0015 Suitable antiinflammatories are for example ben potassium cresolsulphonate). The invention also relates to Zydamine-Cl or choline Salicylate. methods comprising administering a pharmaceutical com position of the invention for the treatment of painful con 0016 Suitable virostatics are for example acyclovir or ditions in the oral and pharyngeal cavity (e.g., acute Sore idoxuridine. throat, aphthae, gingivitis, parodontopathies, pressure points 0017 Suitable antibiotics are for example thyrotricin or caused by prostheses, pain after oro-pharyngeal interven bacitracin. tions, lesions on the mucous membrane in the oral and pharyngeal cavity and herpes simplex in the oral and pha 0018 Suitable antimycotics are for example amphoteri ryngeal cavity). Various formulations are provided in the cin B or nystatin. invention (e.g., Solid. Suckable or slowly dissolving formu 0019. An example of a suitable proteolytic enzyme is lation, semisolid formulation). lysozyme. BRIEF DESCRIPTION OF THE FIGURES 0020 Suitable ethereal oils are for example peppermint oil, thyme or Sage oils. 0007 FIG. 1 shows the course, over time, of the average 0021. The invention further relates to a pharmaceutical change in pain intensity (PID) for the period before taking composition containing ambroXol or one of the pharmaco the tablet (base line) up to 3 hours after taking the first logically acceptable salts thereof and one or more active suckable tablet containing 20 mg of ambroxol hydrochloride Substances, selected from the group consisting of lysozyme and placebo. hydrochloride, dipotassium glycyrrhizinate, ammonium gly 0008 FIG. 2 shows the course, over time, of the average cyrrhizinate, cetylpyridinium chloride, chlorpheniramine change in pain intensity (PID) for the period before taking maleate, noscapine, dequalinium chloride, dextromethor US 2007/0224267 A1 Sep. 27, 2007 phan, phenolphthalinate, potassium guaiacolsulphonate, dil 0033. The invention further relates to the use of a suck methylephedrine hydrochloride, chlorhexidine hydrochlo able tablet containing ambroXol based on Sugar alcohols as ride, and potassium cresolsulphonate. the matrix material, characterised in that it contains a pharmaceutically acceptable layered silicate and a polyeth 0022 Ambroxol is a metabolite of the secretolytic bro yleneglycol, optionally together with other pharmaceutical mhexine. The two active substances represent a very well excipients, taste or flavouring agents to prepare a pharma tolerated combination of active substances which positively ceutical composition for treating pain in the oral and/or influences the dual effect of ambroXol. pharyngeal cavity, selected from among acute Sore throat, 0023 The invention therefore also relates to a pharma aphthae, gingivitis, parodontopathies, pressure points ceutical composition consisting of ambroXol, bromhexine or caused by prostheses, pain after oro-pharyngeal interven the pharmacologically acceptable salts thereof and pharma tions, lesions on the mucous membrane in the oral and ceutical excipients, preferably with a ratio of ambroxol to pharyngeal cavity and herpes simplex in the oral and pha bromhexine in the range from 4:1 to 6:1, more preferably ryngeal cavity, most particularly for the treatment of acute 5:1. Sore throats. 0034. The invention further relates to the use of ambroxol 0024. A particularly preferred pharmaceutical composi for preparing a pharmaceutical composition with a pain tion is one wherein the single dose contains 15 to 50 mg of relieving effect lasting for a period of at least 3 hours, ambroxol, preferably 20 mg of ambroxol. preferably more than 3 hours, after administration. 0.025 The invention further relates to a solid, suckable or 0035. The invention also relates to the use of a pharma slowly dissolving form of a pharmaceutical
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