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(12) Patent Application Publication (10) Pub. No.: US 2014/0234227 A1 Yelin Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2014/0234227 A1 Yelin Et Al US 20140234227A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0234227 A1 Yelin et al. (43) Pub. Date: Aug. 21, 2014 (54) FOAM FORMULATIONS Publication Classification (71) Applicant: OTIC PHARMA LTD, Rehovot (IL) (51) Int. C. A 6LX3/573 (2006.01) (72) Inventors: Rodrigo Yelin, Kfar Yona (IL); Jorge 469/12 (2006.01) Danziger, Rishon LeZion (IL); Eran A613 L/496 (2006.01) Eilat, Herzliya (IL) (52) U.S. C. CPC ............. A6 IK3I/573 (2013.01); A61 K3I/496 (73) Assignee: OTIC PHARMA LTD., Rehovot (IL) (2013.01); A61 K9/122 (2013.01) USPC ............................................................ 424/43 (21) Appl. No.: 14/350,948 (22) PCT Fled: Oct. 10, 2012 (57) ABSTRACT (86) PCT NO.: PCT/L2012/OSO4O1 The present invention provides foamable pharmaceutical compositions comprising water-soluble antibiotics and anti S371 (c)(1), inflammatory steroids and methods of preparing same. Par (2), (4) Date: Apr. 10, 2014 ticularly, the present invention relates to oil-free pharmaceu tical compositions comprising a quinolone, an anti Related U.S. Application Data inflammatory Steroid, a polar co-solvent, and propellant gas, (60) Provisional application No. 61/545.209, filed on Oct. administered to the ear in the form of foam for treating ear 10, 2011. disorders. US 2014/0234227 A1 Aug. 21, 2014 FOAM FORMULATIONS propyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3- quinolinecarboxylic acid with the following chemical struc FIELD OF THE INVENTION ture: 0001. The present invention relates to foamable pharma ceutical compositions comprising water-soluble antibiotics together with anti-inflammatory steroids and methods of pre F COOH paring same. Particularly, the present invention relates to oil-free pharmaceutical compositions comprising quinolo nes, anti-inflammatory Steroids, polar co-solvents, water, and propellant gas, Suitable for administration to the ear in the form of foam for treating ear disorders. BACKGROUND OF THE INVENTION 0002 Otitis externa which involves the ear canal of the 0007 Due to its proven safety and lack of ototoxicity, external ear is a common otologic problem occurring mainly ciprofloxacin ear drops are prescribed to treat patients with during hot and humid weather. Otitis externa is five times Acute Otitis Externa with intact or non-intact tympanic mem more frequent in Swimmers than in non-Swimmers. It is an brane. For example, topical otic compositions containing a acute or chronic inflammation of the epithelium of the exter combination of either ciprofloxacin and hydrocortisone or nal ear canal. It may develop anywhere from the tympanic ciprofloxacin and dexamethasone are sold in the forms of membrane to the pinna. It is variably characterized by aqueous Solutions or Suspensions. erythema, edema, increased sebum or exudates, and descqua 0008 U.S. Pat. No. 5,061,729 to Kincses et al. discloses mation of the epithelium. In later stages, Suppuration occurs ear drop compositions for the treatment of chronic otitis in the ear canal and hearing may be decreased. Over 90% of media which consists essentially of: (a) 3 to 19% of a sulfhy cases of acute Otitis Externa (AOE) are due to bacterial infec dryl compound selected from the group consisting of tions and more rarely to fungal infections. N-acetyl-L-cysteine, disulfiram, and pantetheline; (b) an anti 0003 Otitis media involves infections of the middle ear bacterial agent selected from the group consisting of tobra and it is a very common otologic problem in adults and mycin, neomycin, polymixin B. gentamycin, a combination particularly in children. It has been estimated that nearly 95% of tobramycin and neomycin in a 1:1 weight ratio, and a of all children experience one or more episodes of otitis by combination of polymixin B and neomycin, tobramycin, or age 9, and that about 15% of all visits by children to pedia gentamycin in a ratio of 100,000 IU to about 100 mg; (c) an tricians are in regard to otitis media. In children, the disease is anti-inflammatory agent selected from the group consisting often associated with upper respiratory tract infections which of hydrocortisone, maZipredone, beclomethasone dipropi trigger a transudate secretion response in the Eustachian tube onate, triamcinolone acetonide, prednisolone, dexametha and middle ear. Bacteria and viruses migrate from the naso Sone, and betamethasone; and (d) the balance of an aqueous pharynx to the middle ear via the Eustachian tube, and can Solution of propylene glycol; in admixture with Zinc oxide in cause the Eustachian tube to become blocked, preventing an amount effective to stabilize the sulfhydryl compound. ventilation and drainage of the middle ear. 0009 U.S. Pat. No. 5,843,930 to Purwar et al. discloses a 0004 Otitis externa is the most common disease of the ear non-ototoxic, topical, otic pharmaceutical composition for canal in dogs and cats, and is occasionally seen in rabbits (in the treatment of otitis which comprises ciprofloxacin in aque which it is usually due to the mite Psoroptescuniculi). ous Solution, a non-ionic viscosity augmenter being at least 0005. The common treatment of AOE consists of topical 85% hydrolyzed polyvinyl alcohol, a non-ototoxic preserva antibiotics, with or without steroids, analgesia and water tive, water Sufficient to produce an aqueous composition, avoidance. Otic preparations are generally supplied in the hydrocortisone in aqueous Suspension, lecithin in an amount form of ear drops. In advanced cases, when Suppuration effective for enhancing Suspension of other constituents, and blocks the external ear canal, a wick is inserted and soaked in polysorbate 20 to 80 in an amount effective for spreading the the topical preparation. However, its insertion may be trau composition on a hydrophobic skin surface. U.S. Pat. No. matic, inconvenient and painful. Antibiotic agents commonly 5,843.930 further discloses methods for treating otitis which used in ear drops include aminoglycosides (mainly neomy comprise administering the otic pharmaceutical composition cin) in combination with polymyxin B and hydrocortisone or topically into the ear. fluoroquinolones such as ciprofloxacin and ofloxacin. The (0010 U.S. Pat. No. 6,284.804 to Singh et al. discloses incidence of hypersensitivity reactions to neomycin-contain Suspension formulations comprising dexamethasone, ciprof ing ear drops has been reported to be as high as 13%, while loxacin, sodium chloride as an ionic tonicity agent, anonionic Such reactions to fluoroquinolones have been reported to be polymer, and a nonionic Surfactant. According to U.S. Pat. rare. In addition, aminoglycosides have the potential to dam No. 6,284.804, dexamethasone can be present in any oph age the inner ear when the tympanic membrane is perforated, thalmically or otically acceptable form having poor water while ototoxicity is not a concern with fluoroquinolones. solubility Such that the resulting formulation is a Suspension 0006 Ciprofloxacin is a safe and efficacious antibacterial formulation. fluoroquinolone active against a broad spectrum of gram (0011 U.S. Pat. No. 6,462,033 to Singh discloses a method positive and gram-negative bacteria. Ciprofloxacin is present of preparing a topical composition comprising ciprofloxacin as Ciprofloxacin base and Ciprofloxacin HC1. Ciprofloxacin and hydrocortisone. The method according to U.S. Pat. No. HCl is the monohydrochloride monohydrate salt of 1-cyclo 6,462,033 involves dispersing hydrocortisone with lecithin US 2014/0234227 A1 Aug. 21, 2014 for greater than 45 minutes prior to combining hydrocorti ing a dispersing agent that is a foam forming agent; wherein Sone with the remainder of the composition. the pharmaceutical composition being dispensed from a dis 0012 U.S. Pat. No. 6,919,069 to Akehurst et al. discloses pensing device to the external auditory meatus. aerosol formulations comprising particulate steroid drugs, a (0018 International Application Publication No. WO polar co-solvent, and a propellant. U.S. Pat. No. 6,919,069 2010/143186 to the inventors of the present invention dis further discloses methods for treating respiratory disorders closes pharmaceutical compositions comprising oil-in-water comprising administering said formulations by inhalation. emulsions comprising fluoroquinolones and gas propellants, 0013 U.S. Pat. No. 7,704,518 to Tamarkinet al. discloses administered to the ear in the form of foam for treating ear a hygroscopic pharmaceutical composition which includes at disorders. least one hygroscopic Substance at a concentration Sufficient 0019. There is an unmet need for foamable, clinically effi to provide an Aw value of at least 0.9 and an anti-infective cacious, and stable compositions comprising a quinolone and agent. U.S. Pat. No. 7.704,518 further discloses a foamable an anti-inflammatory steroid which can be readily and com pharmaceutical carrier which includes about 50% to about pliantly used by a patient for the treatment of ear disorders. 98% of a polar solvent selected from the group consisting of a polyol and a polyethylene glycol; 0% to about 48% of a SUMMARY OF THE INVENTION secondary polar solvent; about 0.2% to about 5% by weight of a surface-active agent; about 0.01% to about 5% by weight of 0020. The present invention provides foamable antibiotic at least one polymeric agent; and a liquefied or compressed compositions which comprise a quinolone and a steroidal gas propellantata concentration of about 3% to about 25% by anti-inflammatory agent. Advantageously, the present inven weight of the total composition. According to U.S. Pat. No. tion provides oil-free foamable compositions comprising as 7.704,518, the compositions further comprise up to 10% active agents a quinolone and a steroidal anti-inflammatory Water. agent, a polar co-solvent, water and a compressed gas for 0014 U.S. Pat. No. 7,973,022 to Murthy discloses phar treating otitis. The present invention further provides meth maceutical compositions that are a solution of a salt formed ods for preparing the oil-free foamable compositions. between a fluoroquinolone and a carboxylic acid, a cyclodex 0021.
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