WO2000030626A2 - Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate - Google Patents
Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate Download PDFInfo
- 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
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)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Urology & Nephrology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Communicable Diseases (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020007007770A KR100701490B1 (en) | 1998-11-20 | 1999-11-15 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
BR9907150-9A BR9907150A (en) | 1998-11-20 | 1999-11-15 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
DE69930725T DE69930725T2 (en) | 1998-11-20 | 1999-11-15 | METHOD AND KITS FOR THE TREATMENT OF VULVOVAGINAL CANDIDOSES WITH MICONAZOLNITRATE |
AU20248/00A AU777508B2 (en) | 1998-11-20 | 1999-11-15 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
EP99963905A EP1051162B1 (en) | 1998-11-20 | 1999-11-15 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
JP2000583509A JP2002530327A (en) | 1998-11-20 | 1999-11-15 | Method and apparatus for treating vulva vaginal candidiasis with miconazole nitrate |
CA002318125A CA2318125C (en) | 1998-11-20 | 1999-11-15 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
HK01106686A HK1036930A1 (en) | 1998-11-20 | 2001-09-21 | Kits for treating vulvovaginal candidiasis with miconazole nitrate |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/197,019 | 1998-11-20 | ||
US09/197,019 US6153635A (en) | 1998-11-20 | 1998-11-20 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
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 WO2000030626A2 (en) | 1998-11-20 | 1999-11-15 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
Country Status (14)
Country | Link |
---|---|
US (1) | US6153635A (en) |
EP (1) | EP1051162B1 (en) |
JP (1) | JP2002530327A (en) |
KR (1) | KR100701490B1 (en) |
CN (1) | CN1332663C (en) |
AR (1) | AR021863A1 (en) |
AU (1) | AU777508B2 (en) |
BR (1) | BR9907150A (en) |
CA (1) | CA2318125C (en) |
DE (1) | DE69930725T2 (en) |
ES (1) | ES2262353T3 (en) |
HK (1) | HK1036930A1 (en) |
TW (1) | TWI229599B (en) |
WO (1) | WO2000030626A2 (en) |
Cited By (3)
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 |
EP1667632A2 (en) * | 2003-09-18 | 2006-06-14 | Children's Medical Center Corporation | Treatment of severe distal colitis |
US8057433B2 (en) | 2004-07-08 | 2011-11-15 | Drugtech Corporation | Delivery system |
Families Citing this family (5)
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 |
US20050214364A1 (en) * | 2004-03-23 | 2005-09-29 | Hutman Herbert W | Products and methods for treating vaginal infections |
US20070065504A1 (en) * | 2004-03-23 | 2007-03-22 | Lin Shun Y | 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 |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB8830405D0 (en) * | 1988-12-30 | 1989-03-01 | Embil Koral | Pharmaceutical formulation |
-
1998
- 1998-11-20 US US09/197,019 patent/US6153635A/en not_active Expired - Fee Related
-
1999
- 1999-11-15 WO PCT/US1999/027091 patent/WO2000030626A2/en not_active Application Discontinuation
- 1999-11-15 AU AU20248/00A patent/AU777508B2/en not_active Ceased
- 1999-11-15 JP JP2000583509A patent/JP2002530327A/en active Pending
- 1999-11-15 BR BR9907150-9A patent/BR9907150A/en not_active Application Discontinuation
- 1999-11-15 CN CNB998021989A patent/CN1332663C/en not_active Expired - Fee Related
- 1999-11-15 ES ES99963905T patent/ES2262353T3/en not_active Expired - Lifetime
- 1999-11-15 EP EP99963905A patent/EP1051162B1/en not_active Expired - Lifetime
- 1999-11-15 CA CA002318125A patent/CA2318125C/en not_active Expired - Fee Related
- 1999-11-15 KR KR1020007007770A patent/KR100701490B1/en not_active IP Right Cessation
- 1999-11-15 DE DE69930725T patent/DE69930725T2/en not_active Expired - Fee Related
- 1999-11-19 AR ARP990105925A patent/AR021863A1/en unknown
- 1999-12-09 TW TW088120198A patent/TWI229599B/en not_active IP Right Cessation
-
2001
- 2001-09-21 HK HK01106686A patent/HK1036930A1/en not_active IP Right Cessation
Non-Patent Citations (7)
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 (6)
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 (en) * | 2002-12-18 | 2008-06-30 | Феррер Интернасионал, С.А. | Vaginal mucoadhesive composition based on sertaconazole nitrate pharmaceutical kit based thereon, pharmaceutically dasage form for the treatment of vulvovaginal candidiasis and for the treatment thereof |
EP1667632A2 (en) * | 2003-09-18 | 2006-06-14 | Children's Medical Center Corporation | Treatment of severe distal colitis |
EP1667632A4 (en) * | 2003-09-18 | 2009-07-01 | Childrens Medical Center | Treatment of severe 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 |
---|---|
CN1288379A (en) | 2001-03-21 |
EP1051162B1 (en) | 2006-04-05 |
AR021863A1 (en) | 2002-08-07 |
JP2002530327A (en) | 2002-09-17 |
KR100701490B1 (en) | 2007-04-02 |
ES2262353T3 (en) | 2006-11-16 |
TWI229599B (en) | 2005-03-21 |
KR20010034150A (en) | 2001-04-25 |
CN1332663C (en) | 2007-08-22 |
WO2000030626A3 (en) | 2000-11-23 |
DE69930725T2 (en) | 2007-04-12 |
CA2318125C (en) | 2005-03-08 |
HK1036930A1 (en) | 2002-01-25 |
AU777508B2 (en) | 2004-10-21 |
CA2318125A1 (en) | 2000-06-02 |
DE69930725D1 (en) | 2006-05-18 |
BR9907150A (en) | 2000-10-24 |
AU2024800A (en) | 2000-06-13 |
EP1051162A1 (en) | 2000-11-15 |
US6153635A (en) | 2000-11-28 |
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