JP5986632B2 - 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用 - Google Patents

高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用 Download PDF

Info

Publication number
JP5986632B2
JP5986632B2 JP2014519052A JP2014519052A JP5986632B2 JP 5986632 B2 JP5986632 B2 JP 5986632B2 JP 2014519052 A JP2014519052 A JP 2014519052A JP 2014519052 A JP2014519052 A JP 2014519052A JP 5986632 B2 JP5986632 B2 JP 5986632B2
Authority
JP
Japan
Prior art keywords
mtz
mucoadhesive
gel
aqueous gel
composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2014519052A
Other languages
English (en)
Japanese (ja)
Other versions
JP2014518272A (ja
JP2014518272A5 (cg-RX-API-DMAC7.html
Inventor
マイケル ティー. ノードシーク,
マイケル ティー. ノードシーク,
コドゥムディ エス. バラジ,
コドゥムディ エス. バラジ,
Original Assignee
メディシス ファーマシューティカル コーポレイション
メディシス ファーマシューティカル コーポレイション
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
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=JP5986632(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by メディシス ファーマシューティカル コーポレイション, メディシス ファーマシューティカル コーポレイション filed Critical メディシス ファーマシューティカル コーポレイション
Publication of JP2014518272A publication Critical patent/JP2014518272A/ja
Publication of JP2014518272A5 publication Critical patent/JP2014518272A5/ja
Application granted granted Critical
Publication of JP5986632B2 publication Critical patent/JP5986632B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
  • Tropical Medicine & Parasitology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2014519052A 2011-06-28 2012-06-28 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用 Active JP5986632B2 (ja)

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
JP2016154447A Division JP6235087B2 (ja) 2011-06-28 2016-08-05 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用

Publications (3)

Publication Number Publication Date
JP2014518272A JP2014518272A (ja) 2014-07-28
JP2014518272A5 JP2014518272A5 (cg-RX-API-DMAC7.html) 2015-08-13
JP5986632B2 true JP5986632B2 (ja) 2016-09-06

Family

ID=47391265

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2014519052A Active JP5986632B2 (ja) 2011-06-28 2012-06-28 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用
JP2016154447A Active JP6235087B2 (ja) 2011-06-28 2016-08-05 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2016154447A Active JP6235087B2 (ja) 2011-06-28 2016-08-05 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用

Country Status (9)

Country Link
US (4) US8946276B2 (cg-RX-API-DMAC7.html)
EP (1) EP2725904B1 (cg-RX-API-DMAC7.html)
JP (2) JP5986632B2 (cg-RX-API-DMAC7.html)
CN (2) CN103763925A (cg-RX-API-DMAC7.html)
AU (2) AU2012275292B2 (cg-RX-API-DMAC7.html)
BR (1) BR112013033759B1 (cg-RX-API-DMAC7.html)
CA (2) CA2840571C (cg-RX-API-DMAC7.html)
MX (1) MX381271B (cg-RX-API-DMAC7.html)
WO (1) WO2013003646A1 (cg-RX-API-DMAC7.html)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ703203A (en) 2012-06-13 2016-07-29 Evofem Inc Compositions and methods for enhancing the efficacy of contraceptive microbicides
WO2014210156A1 (en) 2013-06-25 2014-12-31 Mission Pharmacal Company Novel formulations for the treatment of vaginal disorders
KR102407408B1 (ko) 2013-12-19 2022-06-10 에보펨 인코포레이티드 알긴산계 항균성 화합물을 사용하는 염증 및 질병을 억제하기 위한 조성물 및 방법
KR20190026962A (ko) * 2014-09-05 2019-03-13 심바이오믹스 세러퓨틱스 엘엘씨 세균질증 치료에 사용하기 위한 세크니다졸
CA2988082C (en) 2015-06-01 2020-09-29 Symbiomix Therapeutics, Llc Novel nitroimidazole formulations and uses thereof
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

Family Cites Families (34)

* 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
ATE67667T1 (de) 1987-03-20 1991-10-15 Curatek Pharmaceuticals Neue topische metronidazol-formulierungen.
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
DE69201547T2 (de) 1991-10-18 1995-08-03 Dow Corning Silikon druckempfindliche Klebstoffe mit verbesserter Haftung an Substraten mit niedriger Oberflächenspannung.
IT1284874B1 (it) * 1996-08-02 1998-05-22 Farmigea Spa Complessi bioadesivi di polycarbophil e farmaci antifungini o antiprotozoari azolici
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
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
US7704518B2 (en) 2003-08-04 2010-04-27 Foamix, Ltd. Foamable vehicle and pharmaceutical compositions thereof
US7456207B2 (en) * 2003-09-25 2008-11-25 Teva Pharmaceuticals Usa, Inc. Vaginal pharmaceutical compositions and methods for preparing them
FR2887149B1 (fr) 2005-06-17 2007-08-03 Galderma Sa Procede de solubilisation du metronidazole
US20060093675A1 (en) 2004-10-29 2006-05-04 Mathew Ebmeier Intravaginal treatment of vaginal infections with metronidazole compositions
FR2882552B1 (fr) 2005-02-25 2008-12-26 Galderma Sa Gel aqueux de haute stabilite a base de metronidazole et procedes pour leur preparation
MX2007014101A (es) 2005-05-09 2009-02-13 Foamix Ltd Vehiculo espumable y composiciones farmaceuticas del mismo.
AU2006339311A1 (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
WO2007086978A2 (en) 2005-11-09 2007-08-02 Dow Pharmaceutical Sciences Azithromycin for treatment of granulomatous rosacea
EP1968543A2 (en) 2006-01-05 2008-09-17 Drugtech Corporation Composition and method of use thereof
FR2899475A1 (fr) 2006-04-10 2007-10-12 Galderma Res & Dev Composition pharmaceutique pour le traitement de la rosacee
WO2008038140A2 (en) 2006-06-07 2008-04-03 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
US20080287515A1 (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
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
EP2542246A1 (en) 2010-03-03 2013-01-09 Neocutis SA Compositions and methods for treatment of skin diseases and disorders using antimicrobial peptide sequestering compounds

Also Published As

Publication number Publication date
MX2014000066A (es) 2014-05-01
AU2012275292B2 (en) 2015-11-12
CN107823123A (zh) 2018-03-23
US8946276B2 (en) 2015-02-03
US9198858B2 (en) 2015-12-01
AU2016200825A1 (en) 2016-03-03
JP2014518272A (ja) 2014-07-28
BR112013033759A2 (pt) 2016-08-16
US20130005787A1 (en) 2013-01-03
CA2840571C (en) 2020-03-24
JP2017014248A (ja) 2017-01-19
MX381271B (es) 2025-03-11
US20190183859A1 (en) 2019-06-20
CA2840571A1 (en) 2013-01-03
WO2013003646A1 (en) 2013-01-03
AU2016200825B2 (en) 2017-10-26
AU2012275292A1 (en) 2014-01-23
EP2725904A1 (en) 2014-05-07
EP2725904A4 (en) 2014-12-10
JP6235087B2 (ja) 2017-11-22
US20130005785A1 (en) 2013-01-03
BR112013033759B1 (pt) 2021-05-25
EP2725904B1 (en) 2024-12-11
CN103763925A (zh) 2014-04-30
CA3054236A1 (en) 2013-01-03
BR112013033759A8 (pt) 2018-07-31
US20160106714A1 (en) 2016-04-21
US10596155B2 (en) 2020-03-24
US10238634B2 (en) 2019-03-26

Similar Documents

Publication Publication Date Title
JP6235087B2 (ja) 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用
RU2632110C2 (ru) Способ лечения или профилактики бактериального вагиноза
AU2013292179B2 (en) Pharmaceutical compositions containing oligomeric lactic acid
US7456207B2 (en) Vaginal pharmaceutical compositions and methods for preparing them
US6479045B2 (en) Vaginal pH buffering for preventing miscarriage and premature labor, by treating or preventing bacterial vaginosis
JP2007077152A (ja) 膣のpHを低下させるための組成物および方法
JP2007077150A (ja) 酸−酸緩衝系を含有する無水組成物
WO2014100569A1 (en) High dosage topical metronidazole gel formulations

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150626

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20150626

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160318

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20160318

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160617

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20160712

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20160805

R150 Certificate of patent or registration of utility model

Ref document number: 5986632

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

S111 Request for change of ownership or part of ownership

Free format text: JAPANESE INTERMEDIATE CODE: R313113

R360 Written notification for declining of transfer of rights

Free format text: JAPANESE INTERMEDIATE CODE: R360

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R360 Written notification for declining of transfer of rights

Free format text: JAPANESE INTERMEDIATE CODE: R360

R371 Transfer withdrawn

Free format text: JAPANESE INTERMEDIATE CODE: R371

S111 Request for change of ownership or part of ownership

Free format text: JAPANESE INTERMEDIATE CODE: R313113

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250