PT1280486E - Redução de episódios indesejáveis associados a uma terapia com a oxibutinina - Google Patents

Redução de episódios indesejáveis associados a uma terapia com a oxibutinina Download PDF

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PT1280486E
PT1280486E PT01927318T PT01927318T PT1280486E PT 1280486 E PT1280486 E PT 1280486E PT 01927318 T PT01927318 T PT 01927318T PT 01927318 T PT01927318 T PT 01927318T PT 1280486 E PT1280486 E PT 1280486E
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oxybutynin
use according
desethyloxybutynin
auc
ratio
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PT01927318T
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Charles D Ebert
Steven W Sanders
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Watson Pharmaceuticals Inc
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
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    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)

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  • Pharmacology & Pharmacy (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
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Description

DESCRIÇÃO
REDUÇÃO DE EPISÓDIOS INDESEJÁVEIS ASSOCIADOS A UMA TERAPIA
COM A OXIBUTININA
CAMPO DA INVENÇÃO A presente invenção diz respeito ao uso da oxibutinina para a preparação de um sistema transdérmico de matriz para a administração a um mamífero para proporcionar uma área de plasma sob a relação da curva (AUC) de oxibutinina a N-desetiloxibutinina de cerca de 0,5:1 a cerca de 5:1 para minimizar uma experiência adversa com fármacos associados com a terapia de oxibutinina, o dito sistema transdérmico de matriz tendo triacetina como um melhorador de penetração. Assim, a presente invenção cobre os campos das ciências farmacêuticas, medicina e ciências da saúde.
ANTECEDENTES DA INVENÇÃO A oxibutinina oral é actualmente usada para tratar várias formas de bexiga hiperactiva e a incontinência urinária. Particularmente, a oxibutinina trata efectivamente distúrbios da bexiga causados por afecções neurológicas. O alivio de tais distúrbios é atribuído à acção anticolinérgica e antiespasmódica que oxibutinina transmite para o sistema nervoso parassimpático e ao músculo detrusor da bexiga urinária.
Acredita-se geralmente que, embora esta actividade anticolinérgica contribua para a utilidade clínica da oxibutinina, ele também contribui para certos incómodos provocados por experiências adversas, tais como, boca seca, tonturas, visão turva e obstipação. Mais especificamente, estas experiências têm sido atribuídas à presença e 1 quantidade de metabólitos activos da oxibutinina, por exemplo, a N-desetiloxibutinina. As acima referidas experiências adversas são observadas na maioria dos pacientes usando formulações correntes de oxibutinina. Em alguns casos, estas reacções adversas são graves o suficiente para persuadir o paciente a interromper o tratamento.
Gupta et al (Journal of Clinicai Pharmacology vol 39.n° 3. 1999, páginas 289-296) refere-se à administração oral de oxibutinina com uma composição de libertação controlada. A WO 99/48493 (Schwartz Pharma) refere-se a um sistema de entrega transdérmica para evitar altas concentrações de oxibutinina.
Buyse et al. (Journal of Urology, vol. 160. 1998, páginas 892-896) refere-se à administração intravesical de oxibutinina. A US 5840754 (Alza Corporation) refere-se a composições orais contendo oxibutinina. A US 5500222 (Alza Corporation) refere-se à administração transdérmica de oxibutinina na forma de uma camada de reservatório.
Em vista do exposto, são extremamente desejáveis composições e métodos para administrar a oxibutinina para ajudar a minimizar a incidência e/ou gravidade das acima descritas experiências adversas com fármacos. 2

Claims (18)

  1. REIVINDICAÇÕES 1. Uso de oxibutinina para a preparação de um adesivo transdérmico de matriz para a administração a um mamífero para proporcionar uma área de plasma sob a relação de curva (AUC) de oxibutinina para N- desetiloxibutinina de 0,5:1 a 5:1 para minimizar uma experiência adversa associadas com terapia de oxibutinina, o dito adesivo transdérmico de matriz tendo triacetina como um intensificador de penetração.
  2. 2. Uso de acordo com a reivindicação 1, em que a experiência adversa associadas com a terapia de oxibutinina é a boca seca.
  3. 3. Uso de acordo com a reivindicação 1 ou 2, em que a razão AUC de oxibutinina para N-desetiloxibutinina é de 0,5:1 a 2:1.
  4. 4. Uso de acordo com a reivindicação 1 ou 2, em que a razão AUC de oxibutinina para N-desetiloxibutanina é de 1:1 a 5:1.
  5. 5. Uso de acordo com a reivindicação 1 ou 2, em que a razão AUC de oxibutinina para N-desetiloxibutinina é de 0,8:1 a 5:1.
  6. 6. UsO de acordo com a reivindicação 1, em que a oxibutinina no plasma é (R)-oxibutina, (S)-oxibutinina, ou uma combinação dos dois.
  7. 7. Uso de acordo com a reivindicação 1, em que N- desetiloxibutinina é (R)-N-desetiloxibutinina, (S)-N-desetiloxibutinina, ou uma combinação dos dois.
  8. 8. Uso de acordo com a reivindicação 6, em que a razão AUC de (R)-oxibutinina para (S)-oxibutinina é 0.7:1.
  9. 9. Uso de acordo com a reivindicação 7, em que a proporção de AUC de (R)-N-desetiloxibutinina para (R)-oxibutinina é de 0,4:1 para 1,6:1.
  10. 10. Uso acordo com a reivindicação 9, em que a razão da AUC de (R)-N-desetiloxibutinina para (R)-oxibutinina é de 1:1. 1
  11. 11. Uso de acordo com a reivindicação 7, em que a proporção de AUC de (R)-N-desetiloxibutinina para (S)—N— desetiloxibutinina é 0,5:1 para 1,3:1.
  12. 12. Uso de acordo com a reivindicação 7, em que a proporção de AUC de (R)-N-desetiloxibutinina para (S)-N- desetiloxibutinina é 0,9:1.
  13. 13. Uso de acordo com a reivindicação 1, em, que a concentração plasmática de N-desetiloxibutinina atinge um valor máximo de menos de 8 ng/ml.
  14. 14. Uso de acordo com a reivindicação 1, em que a concentração plasmática de N-desetiloxibutinina atinge um valor máximo de menos de 5 ng/ml.
  15. 15. Uso de acordo com a reivindicação 1, em que o adesivo transdérmico de matriz é uma composição de libertação sustentada.
  16. 16. Uso de acordo com a reivindicação 1, em que o adesivo transdérmico de matriz compreende ainda um componente seleccionado a partir de um anti-irritante, um ajustador de adesão, ou uma combinação dos dois.
  17. 17. Uso de acordo com a reivindicação 1, em que as experiências adversas associadas com a terapia de oxibutinina é uma experiências seleccionados do sistema gastrointestinal/geniturinário, sistema nervoso, cardiovascular, dermatológica, oftalmológico, ou uma combinação destes.
  18. 18. Uso de acordo com a reivindicação 17, em que a experiência é uma experiência adversa anticolinérgica, ou uma experiência adversa antimuscarínica. 2 RESUMO REDUÇÃO DE EPISÓDIOS INDESEJÁVEIS ASSOCIADOS A UMA TERAPIA COM A OXIBUTININA A presente invenção fornece composições e métodos para administrar oxibutinina enquanto minimiza a incidência e ou severidade de experiências adversas associadas com a terapia com oxibutinina. Num aspecto, essas composições e métodos proporcionam uma menor concentração plasmática de metabólitos de oxibutinina, tais como N-desetiloxibutinina, que se presume estar a contribuir, pelo menos em parte, para algumas das experiências adversas, mantendo a concentração plasmática de oxibutinina suficiente para beneficiar um sujeito com a terapia de oxibutinina. A invenção também fornece isómeros de oxibutinina e seus metabólitos que atendem essas caracteristicas de minimização da incidência e/ou gravidade de experiências adversas e manutenção de terapia benéfica e eficaz para a bexiga hiperactiva. —^ —^
    « HG. ί
    HG. 2 ca jngímí}
    FIO, 3
    Período de Estudo Figura 4
    Nenhum Moderado Tolerável Intolerável Avaliação dos Pacientes sobre a Severidade dos Sintomas Figura 5
    Figura 6
    Figura 7
    Europãisches Patentamt European Patent Office Office européen des brevets European Patent Office 80298 MUNICH GERMANY Tel. +49(0)89 2399-0 Fax +49 (0)89 2399 - 4465 Schlich, George William Schlich & Co 34 New Road Littlehampton West Sussex BN17 5AT GRANDE BRETAGNE For any questions about this communication: Tel.:+31 (0)70 340 45 00 Date 21.10.10 Reference Application No./Patent No. P39661EP 01927318.4-2112/1280486 Applicant/Proprietor Watson Pharmaceuticals, Inc. Decision to grant a European patent pursuant to Article 97(1) EPC Following examination of European patent application No. 01927318.4 a European patent with the title and the supporting documents indicated in the communication pursuant to Rule 71(3) EPC dated 24.07.09 is hereby granted in respect of the designated Contracting States. The request for amendments received at the EPO on 23.11.09 and any subsequent modifications agreed with the applicant have been taken into account. Patent No. Date of filing Priority claimed 1280486 24.04.01 26.04.00/USA 559711 Designated Contracting States and Proprietor(s) : AT BE CH CY DE DK ES Fl FR GB GR ΙΕ IT LI LU MC NL PT SE TR Watson Pharmaceuticals, Inc. 311 Bonnie Circle Corona, CA 92880/US This decision will take effect on the date on which the European Patent Bulletin mentions the grant (Art. 97(3) EPC). The mention of the grant will be published in European Patent Bulletin 10/46of 17.11.10. Examining Division HerreraS Kling I Thalmair-De Meyere M
    Registered letter to EPO postal Service: 15.10.10 EPO Form 2006A 12.07 (15/10/10)
PT01927318T 2000-04-26 2001-04-24 Redução de episódios indesejáveis associados a uma terapia com a oxibutinina PT1280486E (pt)

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JP (3) JP2003531157A (pt)
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AU (2) AU5378201A (pt)
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EP1280486A4 (en) 2006-03-29
JP2013082720A (ja) 2013-05-09
JP6077294B2 (ja) 2017-02-08
HK1052287A1 (en) 2003-09-11
EP2322170A1 (en) 2011-05-18
EP1280486A1 (en) 2003-02-05
MXPA02010542A (es) 2003-10-14
US20040259954A1 (en) 2004-12-23
CN1438861A (zh) 2003-08-27
CN102327253A (zh) 2012-01-25
CN101305994A (zh) 2008-11-19
US20040120996A1 (en) 2004-06-24
US20020147236A1 (en) 2002-10-10
BR0110381A (pt) 2003-12-30
DE60143477D1 (de) 2010-12-30
US6743441B2 (en) 2004-06-01
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US20050048106A1 (en) 2005-03-03
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US7081252B2 (en) 2006-07-25
JP6253734B2 (ja) 2017-12-27
US20060078613A1 (en) 2006-04-13
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