RU2016111112A - COMPOSITIONS AND METHODS FOR TREATMENT OF PATHOLOGICAL CONDITIONS OF THE NOSE - Google Patents

COMPOSITIONS AND METHODS FOR TREATMENT OF PATHOLOGICAL CONDITIONS OF THE NOSE Download PDF

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RU2016111112A
RU2016111112A RU2016111112A RU2016111112A RU2016111112A RU 2016111112 A RU2016111112 A RU 2016111112A RU 2016111112 A RU2016111112 A RU 2016111112A RU 2016111112 A RU2016111112 A RU 2016111112A RU 2016111112 A RU2016111112 A RU 2016111112A
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amount
present
sodium phosphate
polyethylene glycol
brimonidine
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RU2016111112A
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RU2016111112A3 (en
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Джеральд ХОРН
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ПиЭс ТЕРЭПИС ЛТД.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (60)

1. Композиция, содержащая1. A composition comprising бримонидин или его фармацевтически приемлемую соль;brimonidine or a pharmaceutically acceptable salt thereof; консервант, состоящий из смеси динатриевой соли этилендиаминтетрауксусной кислоты в количестве от примерно 0,01% до примерно 0,1 мас./об.% и бензилового спирта в количестве от примерно 0,1% до примерно 1,0 мас./об.%;a preservative consisting of a mixture of disodium salt of ethylenediaminetetraacetic acid in an amount of from about 0.01% to about 0.1% w / v% and benzyl alcohol in an amount of from about 0.1% to about 1.0% w / v% ; носитель, состоящий из смеси копреципитата, содержащего карбоксиметилцеллюлозу и микрокристаллическую целлюлозу в количестве от примерно 1,0% до примерно 5,0 мас./об.%, при этом соотношение карбоксиметилцеллюлозы и микрокристаллической целлюлозы составляет от примерно 991 до примерно 1387, поливинилпирролидона в количестве от примерно 1,0% до примерно 5,0 мас./об.% и гидроксипропилцеллюлозы в количестве от примерно 0% до примерно 5 мас./об.%;a carrier consisting of a mixture of coprecipitate containing carboxymethyl cellulose and microcrystalline cellulose in an amount of from about 1.0% to about 5.0% w / v, wherein the ratio of carboxymethyl cellulose to microcrystalline cellulose is from about 991 to about 1387, polyvinylpyrrolidone in an amount from about 1.0% to about 5.0% w / v% and hydroxypropyl cellulose in an amount of from about 0% to about 5% w / v; регулятор тоничности, состоящий из глицерина, в количестве от примерно 0,1% до примерно 1,0 мас./об.%;a tonicity regulator consisting of glycerin in an amount of from about 0.1% to about 1.0% w / v; регулятор pH, состоящий из смеси двухосновного фосфата натрия в количестве от примерно 0,01% до примерно 0,1 мас./об.% и одноосновного фосфата натрия в количестве от примерно 0,1% до примерно 1,0 мас./об.%; иa pH regulator consisting of a mixture of dibasic sodium phosphate in an amount of from about 0.01% to about 0.1% w / v and a monobasic sodium phosphate in an amount of from about 0.1% to about 1.0 w / v. %; and усилитель проницаемости, состоящий из смеси полиэтиленгликоля в количестве от примерно 1,0% до примерно 10,0 мас./об.% и ментола в количестве от примерно 0,001% до примерно 0,1 мас./об.%;a permeation enhancer, consisting of a mixture of polyethylene glycol in an amount of from about 1.0% to about 10.0% w / v% and menthol in an amount of from about 0.001% to about 0.1% w / v; при этом бримонидин присутствует в количестве от примерно 0,03% до примерно 0,035 мас./об.%, значение pH композиции составляет от примерно 5,0 до примерно 8,0, и мас./об. означает объемную массу.while brimonidine is present in an amount of from about 0.03% to about 0.035 wt./about., the pH of the composition is from about 5.0 to about 8.0, and wt./about. means bulk density. 2. Способ лечения патологического состояния носа у субъекта, который нуждается в этом, включающий введение субъекту фармацевтически эффективного количества композиции по п. 1.2. A method of treating a pathological condition of the nose in a subject that needs it, comprising administering to the subject a pharmaceutically effective amount of a composition of claim 1. 3. Композиция по п. 1, в которой3. The composition according to p. 1, in which бримонидин присутствует в количестве примерно 0,035 мас./об.%;brimonidine is present in an amount of about 0.035% w / v; копреципитат представляет собой Avicel 591® в количестве примерно 3,0 мас./об.%;coprecipitate is Avicel 591® in an amount of about 3.0% w / v; поливинилпирролидон присутствует в количестве примерно 3,0 мас./об.%;polyvinylpyrrolidone is present in an amount of about 3.0% w / v; полиэтиленгликоль представляет собой полиэтиленгликоль-32 в количестве примерно 5,0 мас./об.%;polyethylene glycol is polyethylene glycol-32 in an amount of about 5.0% w / v; двухосновный фосфат натрия присутствует в количестве примерно 0,0975 мас./об.%;dibasic sodium phosphate is present in an amount of about 0.0975% w / v; одноосновный фосфат натрия присутствует в количестве примерно 0,5525 мас./об.%;monobasic sodium phosphate is present in an amount of about 0.5525% w / v; динатриевая соль этилендиаминтетрауксусной кислоты присутствует в количестве примерно 0,03 мас./об.%;ethylenediaminetetraacetic acid disodium salt is present in an amount of about 0.03% w / v; бензиловый спирт присутствует в количестве примерно 0,25 мас./об.%;benzyl alcohol is present in an amount of about 0.25% w / v; глицерин присутствует в количестве примерно 0,5 мас./об.%;glycerin is present in an amount of about 0.5% w / v; ментол присутствует в количестве примерно 0,00375 мас./об.%;menthol is present in an amount of about 0.00375% w / v; гидроксипропилцеллюлоза присутствует в количестве примерно 0,0 мас./об.%.hydroxypropyl cellulose is present in an amount of about 0.0% w / v. 4. Композиция по п. 1, в которой4. The composition according to claim 1, in which бримонидин присутствует в количестве примерно 0,035 мас./об.%;brimonidine is present in an amount of about 0.035% w / v; копреципитат представляет собой Avicel 591® в количестве примерно 3,0 мас./об.%;coprecipitate is Avicel 591® in an amount of about 3.0% w / v; поливинилпирролидон присутствует в количестве примерно 3,0 мас./об.%;polyvinylpyrrolidone is present in an amount of about 3.0% w / v; полиэтиленгликоль представляет собой полиэтиленгликоль-32 в количестве примерно 5,0 мас./об.%;polyethylene glycol is polyethylene glycol-32 in an amount of about 5.0% w / v; двухосновный фосфат натрия присутствует в количестве примерно 0,0975 мас./об.%;dibasic sodium phosphate is present in an amount of about 0.0975% w / v; одноосновный фосфат натрия присутствует в количестве примерно 0,5525 мас./об.%;monobasic sodium phosphate is present in an amount of about 0.5525% w / v; динатриевая соль этилендиаминтетрауксусной кислоты присутствует в количестве примерно 0,03 мас./об.%;ethylenediaminetetraacetic acid disodium salt is present in an amount of about 0.03% w / v; бензиловый спирт присутствует в количестве примерно 0,25 мас./об.%;benzyl alcohol is present in an amount of about 0.25% w / v; глицерин присутствует в количестве примерно 0,5 мас./об.%;glycerin is present in an amount of about 0.5% w / v; ментол присутствует в количестве примерно 0,00375 мас./об.%;menthol is present in an amount of about 0.00375% w / v; гидроксипропилцеллюлоза присутствует в количестве примерно 1,0 мас./об.%.hydroxypropyl cellulose is present in an amount of about 1.0% w / v. 5. Композиция по п. 1, в которой5. The composition according to p. 1, in which бримонидин присутствует в количестве примерно 0,035 мас./об.%;brimonidine is present in an amount of about 0.035% w / v; копреципитат представляет собой Avicel 591® в количестве примерно 3,0 мас./об.%;coprecipitate is Avicel 591® in an amount of about 3.0% w / v; поливинилпирролидон присутствует в количестве примерно 3,0 мас./об.%;polyvinylpyrrolidone is present in an amount of about 3.0% w / v; полиэтиленгликоль представляет собой полиэтиленгликоль-32 в количестве примерно 5,0 мас./об.%;polyethylene glycol is polyethylene glycol-32 in an amount of about 5.0% w / v; двухосновный фосфат натрия присутствует в количестве примерно 0,0975 мас./об.%;dibasic sodium phosphate is present in an amount of about 0.0975% w / v; одноосновный фосфат натрия присутствует в количестве примерно 0,5525 мас./об.%;monobasic sodium phosphate is present in an amount of about 0.5525% w / v; динатриевая соль этилендиаминтетрауксусной кислоты присутствует в количестве примерно 0,03 мас./об.%;ethylenediaminetetraacetic acid disodium salt is present in an amount of about 0.03% w / v; бензиловый спирт присутствует в количестве примерно 0,25 мас./об.%;benzyl alcohol is present in an amount of about 0.25% w / v; глицерин присутствует в количестве примерно 0,5 мас./об.%;glycerin is present in an amount of about 0.5% w / v; ментол присутствует в количестве примерно 0,015 мас./об.%;menthol is present in an amount of about 0.015% w / v; гидроксипропилцеллюлоза присутствует в количестве примерно 2,0 мас./об.%.hydroxypropyl cellulose is present in an amount of about 2.0% w / v. 6. Композиция, содержащая6. The composition comprising бримонидин или его фармацевтически приемлемую соль в количестве примерно 0,035 мас./об.%;brimonidine or a pharmaceutically acceptable salt thereof in an amount of about 0.035% w / v; Avicel 591® в количестве примерно 3,0 мас./об.%;Avicel 591® in an amount of about 3.0% w / v; поливинилпирролидон в количестве примерно 3,0 мас./об.%;polyvinylpyrrolidone in an amount of about 3.0% w / v; полиэтиленгликоль-32 в количестве примерно 5,0 мас./об.%;polyethylene glycol-32 in an amount of about 5.0% w / v; двухосновный фосфат натрия в количестве примерно 0,0975 мас./об.%;dibasic sodium phosphate in an amount of about 0.0975% w / v; одноосновный фосфат натрия в количестве примерно 0,5525 мас./об.%;monobasic sodium phosphate in an amount of about 0.5525% w / v; динатрий ЭДТА в количестве примерно 0,03 мас./об.%;disodium EDTA in an amount of about 0.03% w / v; бензиловый спирт в количестве примерно 0,25 мас./об.%;benzyl alcohol in an amount of about 0.25% w / v; глицерин в количестве примерно 0,5 мас./об.%;glycerin in an amount of about 0.5% w / v; ментол в количестве примерно 0,00375 мас./об.%; иmenthol in an amount of about 0.00375% w / v; and гидроксипропилцеллюлозу в количестве примерно 2,0 мас./об.%,hydroxypropyl cellulose in an amount of about 2.0% w / v%, при этом мас./об. означает объемную массу.while wt./about. means bulk density. 7. Способ лечения патологического состояния носа у субъекта, который нуждается в этом, включающий введение указанному субъекту фармацевтически эффективного количества композиции по п. 6.7. A method of treating a pathological condition of the nose in a subject that needs it, comprising administering to said subject a pharmaceutically effective amount of a composition according to claim 6. 8. Способ по п. 7, отличающийся тем, что патологическое состояние носа выбирают из группы, состоящей из недостаточной проходимости ноздрей для достижения максимальных спортивных результатов, медикаментозного ринита, вызванного применением назального спрея оксиметазолина, аллергического ринита, вазомоторного ринита, апноэ сна, вызванного назальной секрецией гастроэзофагеального рефлюкса, апноэ во время сна из-за закупоренных или частично закупоренных носовых раковин, а также частичной или полной закупорки носа из-за полипов носовой полости, или их сочетания. 8. The method according to p. 7, characterized in that the pathological condition of the nose is selected from the group consisting of insufficient patency of the nostrils to achieve maximum sports results, drug rhinitis caused by the use of nasal spray of oxymetazoline, allergic rhinitis, vasomotor rhinitis, sleep apnea caused by nasal secretion of gastroesophageal reflux, sleep apnea due to blocked or partially blocked nasal concha, as well as partial or complete blockage of the nose due to nasal polyps awn, or their combination.
RU2016111112A 2013-08-26 2014-08-22 COMPOSITIONS AND METHODS FOR TREATMENT OF PATHOLOGICAL CONDITIONS OF THE NOSE RU2016111112A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14/010,340 US8952011B2 (en) 2008-08-01 2013-08-26 Compositions and methods for the treatment of nasal conditions
US14/010,340 2013-08-26
PCT/US2014/052242 WO2015031183A1 (en) 2013-08-26 2014-08-22 Compositions and methods for the treatment of nasal conditions

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RU2016111112A true RU2016111112A (en) 2017-09-29
RU2016111112A3 RU2016111112A3 (en) 2018-06-04

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