WO2000030626A2 - Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate - Google Patents

Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate Download PDF

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Publication number
WO2000030626A2
WO2000030626A2 PCT/US1999/027091 US9927091W WO0030626A2 WO 2000030626 A2 WO2000030626 A2 WO 2000030626A2 US 9927091 W US9927091 W US 9927091W WO 0030626 A2 WO0030626 A2 WO 0030626A2
Authority
WO
WIPO (PCT)
Prior art keywords
miconazole nitrate
cream
vaginally
patients
pharmaceutically acceptable
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.)
Ceased
Application number
PCT/US1999/027091
Other languages
English (en)
French (fr)
Other versions
WO2000030626A3 (en
Inventor
David H. Upmalis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kenvue Brands LLC
Original Assignee
McNeil PPC Inc
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=22727682&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2000030626(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to KR1020007007770A priority Critical patent/KR100701490B1/ko
Priority to CA002318125A priority patent/CA2318125C/en
Priority to BR9907150-9A priority patent/BR9907150A/pt
Priority to EP99963905A priority patent/EP1051162B1/en
Priority to HK01106686.5A priority patent/HK1036930B/xx
Application filed by McNeil PPC Inc filed Critical McNeil PPC Inc
Priority to JP2000583509A priority patent/JP2002530327A/ja
Priority to DE69930725T priority patent/DE69930725T2/de
Priority to AU20248/00A priority patent/AU777508B2/en
Publication of WO2000030626A2 publication Critical patent/WO2000030626A2/en
Publication of WO2000030626A3 publication Critical patent/WO2000030626A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
    • 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
    • A61P31/10—Antimycotics
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules

Definitions

  • the present invention relates to methods for the treatment of vulvovaginal
  • candidiasis with miconazole nitrate and more particularly to methods for the
  • Vulvovaginal candidiasis is a relatively common form of yeast infection.
  • nitrate is well known.
  • candidiasis with miconazole nitrate comprises the intra-vaginal application of a
  • kits for the treatment of vulvovaginal for the treatment of vulvovaginal
  • candidiasis with miconazole nitrate comprise a supply of vaginal suppositories or
  • the present invention is directed to a method for treating vulvovaginal
  • candidiasis consisting essentially of the steps of: (a) administering a single dose
  • the present invention is also directed to a kit for the treatment of
  • vulvovaginal candidiasis comprising: (a) a single dose of an effective amount of
  • miconazole nitrate in a pharmaceutically acceptable carrier and in a form adapted to
  • treatment regimens comprising 3 to 7 daily intra-vaginal doses of miconazole
  • intra-vaginal treatment regimens to treatment regimens comprising a single intra-
  • nitrate in accordance with the present invention comprise the steps of: (a)
  • nitrate in a pharmaceutically acceptable carrier to the vulva as needed.
  • carrier administered intra-vaginally may be in the form of a gelatin capsule, a
  • miconazole nitrate preferably comprises from about 400-2000 mg of miconazole
  • nitrate more preferably from about 600-1200 mg of miconazole nitrate. Delivery
  • miconazole nitrate are known to those of ordinary skill in the art.
  • the dose of miconazole nitrate applied to topically to the vulva may
  • topical cream comprising 2% miconazole nitrate is marketed by Advanced Care
  • the topical doses provide for immediate temporary relief of vulvovaginal candidiasis symptoms. Accordingly, the dose of miconazole nitrate applied to the
  • vulva is preferably applied 1-2 times daily as needed for up to about 7 days for the
  • Example 1 A study was performed comparing results of treatment of vulvovaginal
  • the study population was as follows. 278 patients with vulvovaginal
  • Example 2 a second population.
  • the study population was as follows. 280
  • microbiological cure rates (-12.7, 13.4) and therapeutic cure rates (-13.3, 14.2)
  • Group 1 a single intra-vaginal dose of 2.5 grams of 16% miconazole
  • VULVAR CREAM (with instructions to apply as necessary
  • Group 2 a single intra-vaginal dose of 5 grams of 8% miconazole
  • VULVAR CREAM (with instructions to apply as necessary
  • Group 3 a single intra-vaginal dose of 5 grams of 12% miconazole
  • VULVAR CREAM (with instructions to apply as necessary
  • Group 4 a single intra-vaginal dose of 5 grams of 16% miconazole
  • VULVAR CREAM (with instructions to apply as necessary
  • Group 5 7 daily doses of MONISTAT ® 7 (2% miconazole nitrate)
  • Vaginal Cream each containing 100 mg per dose of
  • vaginal dose plus topical cream regimens than Group 5 (7-day/dose intra-vaginal
  • NULNAR CREAM (with instructions to apply as necessary, up to twice daily, for
  • the study population was as follows. 263 patients were enrolled. 257

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
PCT/US1999/027091 1998-11-20 1999-11-15 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate Ceased WO2000030626A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
AU20248/00A AU777508B2 (en) 1998-11-20 1999-11-15 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate
CA002318125A CA2318125C (en) 1998-11-20 1999-11-15 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate
BR9907150-9A BR9907150A (pt) 1998-11-20 1999-11-15 Métodos e kits para tratar candidìase vulvovaginal com nitrato de miconazol
EP99963905A EP1051162B1 (en) 1998-11-20 1999-11-15 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate
HK01106686.5A HK1036930B (en) 1998-11-20 1999-11-15 Kits for treating vulvovaginal candidiasis with miconazole nitrate
KR1020007007770A KR100701490B1 (ko) 1998-11-20 1999-11-15 마이코나졸 질산염으로 외음부질 칸디다증을 치료하는방법 및 키트
JP2000583509A JP2002530327A (ja) 1998-11-20 1999-11-15 硝酸ミコナゾールによる陰門膣カンジダ症を治療するための方法および装置
DE69930725T DE69930725T2 (de) 1998-11-20 1999-11-15 Verfahren und kits zur behandlung von vulvovaginalen candidosen mit mikonazolnitrat

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/197,019 US6153635A (en) 1998-11-20 1998-11-20 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate
US09/197,019 1998-11-20

Publications (2)

Publication Number Publication Date
WO2000030626A2 true WO2000030626A2 (en) 2000-06-02
WO2000030626A3 WO2000030626A3 (en) 2000-11-23

Family

ID=22727682

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/027091 Ceased WO2000030626A2 (en) 1998-11-20 1999-11-15 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate

Country Status (13)

Country Link
US (1) US6153635A (https=)
EP (1) EP1051162B1 (https=)
JP (1) JP2002530327A (https=)
KR (1) KR100701490B1 (https=)
CN (1) CN1332663C (https=)
AR (1) AR021863A1 (https=)
AU (1) AU777508B2 (https=)
BR (1) BR9907150A (https=)
CA (1) CA2318125C (https=)
DE (1) DE69930725T2 (https=)
ES (1) ES2262353T3 (https=)
TW (1) TWI229599B (https=)
WO (1) WO2000030626A2 (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004054576A1 (en) * 2002-12-18 2004-07-01 Ferrer Internacional, S.A. Pharmaceutical compositions of sertaconazole for vaginal use
EP1667632A4 (en) * 2003-09-18 2009-07-01 Childrens Medical Center TREATMENT OF HEAVY DISTAL COLITIS
US8057433B2 (en) 2004-07-08 2011-11-15 Drugtech Corporation Delivery system

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1500394A1 (en) * 2003-07-22 2005-01-26 Polichem S.A. Pharmaceutical compositions comprising ascorbic acid or the treatment of fungal superinfections and fungal recurrences
US20070065504A1 (en) * 2004-03-23 2007-03-22 Lin Shun Y Products and methods for treating vaginal infections
US20050214364A1 (en) * 2004-03-23 2005-09-29 Hutman Herbert W Products and methods for treating vaginal infections
US20090156987A1 (en) * 2007-12-14 2009-06-18 Mclean Barbara Wanamaker Apparatus and method of delivery of substances into target tissue
WO2018013625A1 (en) * 2016-07-13 2018-01-18 Concert Pharmaceuticals, Inc. Deuterated miconazole
JP2025507426A (ja) * 2022-02-17 2025-03-18 ゼンビジョン ファルマ エルエルピー ミコナゾール及びルリコナゾール又はそれらの塩を含む膣用医薬組成物

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8830405D0 (en) * 1988-12-30 1989-03-01 Embil Koral Pharmaceutical formulation

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
"Selected medicaments for the treatment vulvovaginal candidiasis" INTERNET, [Online] 1997, page 1 XP002140027 Retrieved from the Internet: <URL:http://lib-sh.lsumc.edu/fammed/intern /vagysttx.html> [retrieved on 2000-06-09] *
ADVANCED CARE PRODUCTS, PERSONAL PRODUCTS COMPANY, MCNEILL-PPC: "Monistat 3 combination pack package insert" INTERNET, [Online] XP002140030 Retrieved from the Internet: <URL:http://www.monistat.com/pi_com3.html> [retrieved on 2000-06-09] *
ADVANCED CARE PRODUCTS, PERSONAL PRODUCTS COMPANY, MCNEIL-PPC : "Monistat 7 combination pack package insert" INTERNET, [Online] XP002140028 Retrieved from the Internet: <URL:http://www.monistat.com/pi_com7.html> [retrieved on 2000-06-09] *
CENTER WATCH, INC: "Newly approved drug therapies. Monistat 3" INTERNET, [Online] 1995 - 2000, page 1 XP002140029 Retrieved from the Internet: <URL:http://www.centerwatch.com/drugs/dru9 1.htm> [retrieved on 2000-06-09] *
GUMMERUS M. ET AL: "Miconazole in the treatment of vaginal candidosis. A multicenter study." MYCOSES, (1988) 31/3 (159-162). , XP000913466 *
REYNOLDS J.E.F.: "Martindale - The Extra Pharmacopeia" 1993 , PHARMACEUTICAL PRESS , LONDON, GB XP002140031 212040 page 329, column 2, paragraph 2 page 329, column 3, paragraph 4 page 1704, column 1, paragraph 8 *
UPMALIS DAVID H; LAMIA CATHLEEN A; HARLEY JOSEPHINE A; CONE FREDRICK L: "A new formulation of miconazole nitrate in the treatment of vulvovaginal candidiasis." ADVANCES IN THERAPY, vol. 15, no. 1, January 1998 (1998-01) - February 1998 (1998-02), pages 14-22, XP000913406 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004054576A1 (en) * 2002-12-18 2004-07-01 Ferrer Internacional, S.A. Pharmaceutical compositions of sertaconazole for vaginal use
EA010155B1 (ru) * 2002-12-18 2008-06-30 Феррер Интернасионал, С.А. Вагинальная мукоадгезивная композиция на основе нитрата сертаконазола, фармацевтический набор на основе композиции, фармацевтическая дозированная форма для лечения вульвовагинального кандидоза и способ его лечения
EP1667632A4 (en) * 2003-09-18 2009-07-01 Childrens Medical Center TREATMENT OF HEAVY DISTAL COLITIS
US9072728B2 (en) 2003-09-18 2015-07-07 Children's Medical Center Corporation Treatment of severe distal colitis
US8057433B2 (en) 2004-07-08 2011-11-15 Drugtech Corporation Delivery system

Also Published As

Publication number Publication date
KR20010034150A (ko) 2001-04-25
ES2262353T3 (es) 2006-11-16
EP1051162A1 (en) 2000-11-15
AU2024800A (en) 2000-06-13
TWI229599B (en) 2005-03-21
CA2318125A1 (en) 2000-06-02
WO2000030626A3 (en) 2000-11-23
CN1332663C (zh) 2007-08-22
KR100701490B1 (ko) 2007-04-02
EP1051162B1 (en) 2006-04-05
CN1288379A (zh) 2001-03-21
CA2318125C (en) 2005-03-08
AU777508B2 (en) 2004-10-21
US6153635A (en) 2000-11-28
DE69930725D1 (de) 2006-05-18
DE69930725T2 (de) 2007-04-12
BR9907150A (pt) 2000-10-24
AR021863A1 (es) 2002-08-07
HK1036930A1 (zh) 2002-01-25
JP2002530327A (ja) 2002-09-17

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