AU2012275292B2 - High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis - Google Patents

High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis Download PDF

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Publication number
AU2012275292B2
AU2012275292B2 AU2012275292A AU2012275292A AU2012275292B2 AU 2012275292 B2 AU2012275292 B2 AU 2012275292B2 AU 2012275292 A AU2012275292 A AU 2012275292A AU 2012275292 A AU2012275292 A AU 2012275292A AU 2012275292 B2 AU2012275292 B2 AU 2012275292B2
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Australia
Prior art keywords
mtz
mucoadhesive
aqueous
gel
based gel
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AU2012275292A
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AU2012275292A1 (en
Inventor
Kodumudi S. Balaji
Michael T. Nordsiek
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Chemo Research SL
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Chemo Research SL
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Publication of AU2012275292A1 publication Critical patent/AU2012275292A1/en
Assigned to WATSON LABORATORIES, INC. reassignment WATSON LABORATORIES, INC. Request for Assignment Assignors: MEDICIS PHARMACEUTICAL CORPORATION
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Priority to AU2016200825A priority Critical patent/AU2016200825B2/en
Assigned to ALLERGAN SALES, LLC reassignment ALLERGAN SALES, LLC Request for Assignment Assignors: WATSON LABORATORIES, INC.
Assigned to CHEMO RESEARCH, S.L. reassignment CHEMO RESEARCH, S.L. Request for Assignment Assignors: ALLERGAN SALES, LLC
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Classifications

    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4168—1,3-Diazoles having a nitrogen attached in position 2, e.g. clonidine
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/4164—1,3-Diazoles
    • 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
    • A61K47/08—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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, 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)
AU2012275292A 2011-06-28 2012-06-28 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis Active AU2012275292B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2016200825A AU2016200825B2 (en) 2011-06-28 2016-02-09 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis

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
AU2016200825A Division AU2016200825B2 (en) 2011-06-28 2016-02-09 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis

Publications (2)

Publication Number Publication Date
AU2012275292A1 AU2012275292A1 (en) 2014-01-23
AU2012275292B2 true AU2012275292B2 (en) 2015-11-12

Family

ID=47391265

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2012275292A Active AU2012275292B2 (en) 2011-06-28 2012-06-28 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis
AU2016200825A Active AU2016200825B2 (en) 2011-06-28 2016-02-09 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2016200825A Active AU2016200825B2 (en) 2011-06-28 2016-02-09 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis

Country Status (9)

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

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013187984A1 (en) 2012-06-13 2013-12-19 Evofem, Inc. Compositions and methods for enhancing the efficacy of contraceptive microbicides
CA2916002A1 (en) 2013-06-25 2014-12-31 Mission Pharmacal Company Novel formulations for the treatment of vaginal disorders
NZ722215A (en) 2013-12-19 2019-02-22 Evofem Inc Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
AU2015311674B2 (en) 2014-09-05 2018-03-08 Evofem Biosciences, Inc. Secnidazole for use in the treatment of bacterial vaginosis
CA2988082C (en) 2015-06-01 2020-09-29 Symbiomix Therapeutics, Llc Novel nitroimidazole formulations and uses thereof
WO2017165836A1 (en) * 2016-03-24 2017-09-28 Rutgers, The State University Of New Jersey Antibacterial agents
AU2017338748A1 (en) * 2016-10-04 2019-05-02 Evofem Inc. Method of treatment and prevention of bacterial vaginosis
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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002006349A1 (en) * 2000-07-13 2002-01-24 Dow Pharmaceutical Sciences Gel compositions containing metronidazole
US20050080038A1 (en) * 2003-09-25 2005-04-14 Bentley Christine Lynn Vaginal pharmaceutical compositions and methods for preparing them
US20080287515A1 (en) * 2007-05-14 2008-11-20 Jerry Zhang Topical compositions containing metronidazole
US20090030060A1 (en) * 2004-10-29 2009-01-29 Tolmar, Inc. Intravaginal treatment of vaginal infections with metronidazole compositions
WO2009097143A1 (en) * 2008-02-02 2009-08-06 Dow Pharmaceutical Sciences, Inc. Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water

Family Cites Families (29)

* 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
EP0537784B1 (en) 1991-10-18 1995-03-01 Dow Corning Corporation Silicone pressure sensitive adhesives having enhanced adhesion to low energy substrates
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
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
US9211259B2 (en) 2002-11-29 2015-12-15 Foamix Pharmaceuticals Ltd. Antibiotic kit and composition and uses thereof
US20050186142A1 (en) 2002-10-25 2005-08-25 Foamix Ltd. Kit and composition of imidazole with enhanced bioavailability
US7704518B2 (en) 2003-08-04 2010-04-27 Foamix, Ltd. Foamable vehicle and pharmaceutical compositions thereof
FR2887149B1 (fr) 2005-06-17 2007-08-03 Galderma Sa Procede de solubilisation du metronidazole
FR2882552B1 (fr) 2005-02-25 2008-12-26 Galderma Sa Gel aqueux de haute stabilite a base de metronidazole et procedes pour leur preparation
CA2609953A1 (en) 2005-05-09 2007-04-12 Foamix Ltd. Saccharide foamable compositions
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
US20070105788A1 (en) 2005-11-09 2007-05-10 Serena Mraz-Gernhard Azithromycin for treatment of granulomatous rosacea
BRPI0620908A2 (pt) 2006-01-05 2011-11-29 Drugtech Corp composição farmacêutica, sistema de distribuição antibacteriana e antifúngica vaginal e uso da composição farmacêutica
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
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
WO2010047831A1 (en) 2008-10-23 2010-04-29 Nycomed Us Inc. Stable metronidazole gel formulations
KR20130018739A (ko) 2010-03-03 2013-02-25 네오큐티스 에스아 항균 펩티드 격리 화합물을 사용한 피부 질환 및 장애의 치료를 위한 조성물 및 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002006349A1 (en) * 2000-07-13 2002-01-24 Dow Pharmaceutical Sciences Gel compositions containing metronidazole
US20050080038A1 (en) * 2003-09-25 2005-04-14 Bentley Christine Lynn Vaginal pharmaceutical compositions and methods for preparing them
US20090030060A1 (en) * 2004-10-29 2009-01-29 Tolmar, Inc. Intravaginal treatment of vaginal infections with metronidazole compositions
US20080287515A1 (en) * 2007-05-14 2008-11-20 Jerry Zhang Topical compositions containing metronidazole
WO2009097143A1 (en) * 2008-02-02 2009-08-06 Dow Pharmaceutical Sciences, Inc. Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water

Also Published As

Publication number Publication date
US9198858B2 (en) 2015-12-01
BR112013033759A8 (pt) 2018-07-31
BR112013033759B1 (pt) 2021-05-25
US20160106714A1 (en) 2016-04-21
AU2012275292A1 (en) 2014-01-23
CA2840571A1 (en) 2013-01-03
BR112013033759A2 (pt) 2016-08-16
JP6235087B2 (ja) 2017-11-22
AU2016200825A1 (en) 2016-03-03
WO2013003646A1 (en) 2013-01-03
US20130005785A1 (en) 2013-01-03
US8946276B2 (en) 2015-02-03
JP5986632B2 (ja) 2016-09-06
CN107823123A (zh) 2018-03-23
CA3054236A1 (en) 2013-01-03
US20190183859A1 (en) 2019-06-20
JP2014518272A (ja) 2014-07-28
CN103763925A (zh) 2014-04-30
EP2725904A1 (en) 2014-05-07
EP2725904A4 (en) 2014-12-10
EP2725904B1 (en) 2024-12-11
JP2017014248A (ja) 2017-01-19
MX381271B (es) 2025-03-11
US10238634B2 (en) 2019-03-26
MX2014000066A (es) 2014-05-01
US10596155B2 (en) 2020-03-24
CA2840571C (en) 2020-03-24
AU2016200825B2 (en) 2017-10-26
US20130005787A1 (en) 2013-01-03

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Owner name: WATSON LABORATORIES, INC.

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PC Assignment registered

Owner name: ALLERGAN SALES, LLC

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PC Assignment registered

Owner name: CHEMO RESEARCH, S.L.

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