CN103763925A - 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途 - Google Patents

高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途 Download PDF

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Publication number
CN103763925A
CN103763925A CN201280040540.1A CN201280040540A CN103763925A CN 103763925 A CN103763925 A CN 103763925A CN 201280040540 A CN201280040540 A CN 201280040540A CN 103763925 A CN103763925 A CN 103763925A
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China
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weight
approximately
mtz
gel
mucosal adhesive
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Pending
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CN201280040540.1A
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English (en)
Chinese (zh)
Inventor
M·T·诺德斯基
K·S·巴拉吉
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Medicis Pharmaceutical Corp
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Medicis Pharmaceutical Corp
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47391265&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN103763925(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Medicis Pharmaceutical Corp filed Critical Medicis Pharmaceutical Corp
Priority to CN201710998632.5A priority Critical patent/CN107823123A/zh
Publication of CN103763925A publication Critical patent/CN103763925A/zh
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41681,3-Diazoles having a nitrogen attached in position 2, e.g. clonidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • A61P33/02Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201280040540.1A 2011-06-28 2012-06-28 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途 Pending CN103763925A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710998632.5A CN107823123A (zh) 2011-06-28 2012-06-28 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161502285P 2011-06-28 2011-06-28
US61/502,285 2011-06-28
US201161508058P 2011-07-14 2011-07-14
US61/508,058 2011-07-14
PCT/US2012/044738 WO2013003646A1 (en) 2011-06-28 2012-06-28 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201710998632.5A Division CN107823123A (zh) 2011-06-28 2012-06-28 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途

Publications (1)

Publication Number Publication Date
CN103763925A true CN103763925A (zh) 2014-04-30

Family

ID=47391265

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201280040540.1A Pending CN103763925A (zh) 2011-06-28 2012-06-28 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途
CN201710998632.5A Pending CN107823123A (zh) 2011-06-28 2012-06-28 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201710998632.5A Pending CN107823123A (zh) 2011-06-28 2012-06-28 高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途

Country Status (9)

Country Link
US (4) US8946276B2 (https=)
EP (1) EP2725904B1 (https=)
JP (2) JP5986632B2 (https=)
CN (2) CN103763925A (https=)
AU (2) AU2012275292B2 (https=)
BR (1) BR112013033759B1 (https=)
CA (2) CA3054236A1 (https=)
MX (1) MX381271B (https=)
WO (1) WO2013003646A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110693812A (zh) 2012-06-13 2020-01-17 伊沃菲姆股份有限公司 用于增强避孕杀微生物剂有效性的组合物和方法
EP3013368A1 (en) 2013-06-25 2016-05-04 Mission Pharmacal Company Novel formulations for the treatment of vaginal disorders
AU2014368971B2 (en) 2013-12-19 2020-02-06 Evofem, Inc. Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
KR20170052626A (ko) * 2014-09-05 2017-05-12 심바이오믹스 세러퓨틱스 엘엘씨 세균질증 치료에 사용하기 위한 세크니다졸
US11253501B2 (en) 2015-06-01 2022-02-22 Lupin Inc. Secnidazole formulations and use in treating bacterial vaginosis
US10759740B2 (en) 2016-03-24 2020-09-01 Rutgers, The State University Of New Jersey Antibacterial agents
CN110225750A (zh) * 2016-10-04 2019-09-10 伊沃菲姆股份有限公司 细菌性阴道病的治疗和预防方法
SE1750680A1 (en) * 2017-05-30 2018-12-01 Peptonic Medical Ab Composition for treating or preventing climacteric disorders
US20200126094A1 (en) * 2018-10-19 2020-04-23 BioIDC, Inc. Medical research fraud detection system and software
US12280037B2 (en) 2020-09-22 2025-04-22 Evofem Biosciences, Inc. Method and pharmaceutical composition for treating or preventing trichomoniasis and uses thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020012674A1 (en) * 1996-08-02 2002-01-31 Marco Fabrizio Saettone Bioadhesive complexes of polycarbophil and azole antifungal or antiprotozoal drugs
US20090030060A1 (en) * 2004-10-29 2009-01-29 Tolmar, Inc. Intravaginal treatment of vaginal infections with metronidazole compositions
US20100048645A1 (en) * 2005-06-17 2010-02-25 Claire Mallard Solubilizing of metronidazole

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4837378A (en) 1986-01-15 1989-06-06 Curatek Pharmaceuticals, Inc. Topical metronidazole formulations and therapeutic uses thereof
EP0305380B1 (en) 1987-03-20 1991-09-25 Galderma S.A. Novel topical metronidazole formulations
US5536743A (en) 1988-01-15 1996-07-16 Curatek Pharmaceuticals Limited Partnership Intravaginal treatment of vaginal infections with buffered metronidazole compositions
CA1337279C (en) 1989-06-06 1995-10-10 Robert J. Borgman Intravaginal treatment of vaginal infections with buffered metronidazole compositions
EP0537784B1 (en) 1991-10-18 1995-03-01 Dow Corning Corporation Silicone pressure sensitive adhesives having enhanced adhesion to low energy substrates
GB9626513D0 (en) 1996-12-20 1997-02-05 Bioglan Ireland R & D Ltd A pharmaceutical composition
DE69819748T2 (de) 1997-09-12 2004-09-30 Columbia Laboratories (Bermuda) Ltd. Arzneimittel zur behandlung von dysmenorrhöe und verfrühten wehen
WO1998014768A2 (en) 1997-10-06 1998-04-09 Schwartz Sorell L Transdermal chemical monitoring device
US6468989B1 (en) 2000-07-13 2002-10-22 Dow Pharmaceutical Sciences Gel compositions containing metronidazole
US6881726B2 (en) 2001-12-24 2005-04-19 Dow Pharmaceutical Sciences Aqueous compositions containing metronidazole
US7368122B1 (en) 2002-03-08 2008-05-06 Dow Pharmaceutical Sciences Skin cream
US7704518B2 (en) 2003-08-04 2010-04-27 Foamix, Ltd. Foamable vehicle and pharmaceutical compositions thereof
US20050186142A1 (en) 2002-10-25 2005-08-25 Foamix Ltd. Kit and composition of imidazole with enhanced bioavailability
US9211259B2 (en) 2002-11-29 2015-12-15 Foamix Pharmaceuticals Ltd. Antibiotic kit and composition and uses thereof
US7456207B2 (en) * 2003-09-25 2008-11-25 Teva Pharmaceuticals Usa, Inc. Vaginal pharmaceutical compositions and methods for preparing them
FR2882552B1 (fr) 2005-02-25 2008-12-26 Galderma Sa Gel aqueux de haute stabilite a base de metronidazole et procedes pour leur preparation
WO2007039825A2 (en) 2005-05-09 2007-04-12 Foamix Ltd. Saccharide foamable compositions
WO2007099396A2 (en) 2005-06-07 2007-09-07 Foamix Ltd. Antibiotic kit and composition and uses thereof
FR2890560B1 (fr) 2005-09-13 2011-06-24 Galderma Sa Mousses dermatologiques a base de metronidazole et emulsions pour leur preparation
FR2890559B1 (fr) 2005-09-13 2011-06-24 Galderma Sa Mousses dermatologiques a base de metronidazole et emulsions pour la preparation
EP1945227A4 (en) 2005-11-09 2009-09-30 Dow Pharmaceutical Sciences AZITHROMYCIN FOR THE TREATMENT OF GRANULOMATOUS ROSACEA
EA200870153A1 (ru) 2006-01-05 2008-12-30 Драгтек Корпорейшн Композиция и способ ее использования
FR2899475A1 (fr) 2006-04-10 2007-10-12 Galderma Res & Dev Composition pharmaceutique pour le traitement de la rosacee
EP2029106A2 (en) 2006-06-07 2009-03-04 Foamix Ltd. Foamable vehicle comprising polypropylene glycol alkyl ether and pharmaceutical compositions thereof
US20080287513A1 (en) 2007-05-14 2008-11-20 Jerry Zhang Topical compositions containing metronidazole
US20080287514A1 (en) 2007-05-14 2008-11-20 Jerry Zhang Topical compositions containing metronidazole
US20080287515A1 (en) * 2007-05-14 2008-11-20 Jerry Zhang Topical compositions containing metronidazole
US20080312304A1 (en) 2007-06-13 2008-12-18 Jerry Zhang Topical compositions containing metronidazole
US7893097B2 (en) * 2008-02-02 2011-02-22 Dow Pharmaceutical Sciences, Inc. Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water
US20100105750A1 (en) 2008-10-23 2010-04-29 Nycomed Us Inc. Stable metronidazole gel formulations
CA2790682C (en) 2010-03-03 2020-11-24 Neocutis Sa Compositions and methods for the treatment of skin diseases and disorders using antimicrobial peptide sequestering compounds

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020012674A1 (en) * 1996-08-02 2002-01-31 Marco Fabrizio Saettone Bioadhesive complexes of polycarbophil and azole antifungal or antiprotozoal drugs
US20090030060A1 (en) * 2004-10-29 2009-01-29 Tolmar, Inc. Intravaginal treatment of vaginal infections with metronidazole compositions
US20100048645A1 (en) * 2005-06-17 2010-02-25 Claire Mallard Solubilizing of metronidazole

Also Published As

Publication number Publication date
US8946276B2 (en) 2015-02-03
CA2840571A1 (en) 2013-01-03
JP2014518272A (ja) 2014-07-28
US10596155B2 (en) 2020-03-24
US9198858B2 (en) 2015-12-01
US20160106714A1 (en) 2016-04-21
AU2016200825B2 (en) 2017-10-26
US20130005787A1 (en) 2013-01-03
JP5986632B2 (ja) 2016-09-06
MX2014000066A (es) 2014-05-01
AU2012275292A1 (en) 2014-01-23
WO2013003646A1 (en) 2013-01-03
BR112013033759A8 (pt) 2018-07-31
JP6235087B2 (ja) 2017-11-22
AU2016200825A1 (en) 2016-03-03
BR112013033759B1 (pt) 2021-05-25
AU2012275292B2 (en) 2015-11-12
CA3054236A1 (en) 2013-01-03
US20130005785A1 (en) 2013-01-03
US10238634B2 (en) 2019-03-26
US20190183859A1 (en) 2019-06-20
JP2017014248A (ja) 2017-01-19
MX381271B (es) 2025-03-11
EP2725904B1 (en) 2024-12-11
EP2725904A1 (en) 2014-05-07
CA2840571C (en) 2020-03-24
BR112013033759A2 (pt) 2016-08-16
EP2725904A4 (en) 2014-12-10
CN107823123A (zh) 2018-03-23

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Application publication date: 20140430

RJ01 Rejection of invention patent application after publication