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Kits for treating vulvovaginal candidiasis with micronazole nitrate

A technology for vaginal candidiasis and miconazole nitrate is applied in the field of miconazole nitrate for the treatment of vulvovaginal candidiasis and multi-dose miconazole nitrate, and can solve problems such as affecting patient compliance, discomfort, affecting treatment effects and the like

Inactive Publication Date: 2007-08-22
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] These methods of treating vulvovaginal candidiasis, while highly effective, present some discomfort and inconvenience to the patient by having to repeatedly administer intravaginal miconazole nitrate
Both of these disadvantages can affect patient compliance and thus treatment efficacy
Also, relief of symptoms may take 4-5 days or longer

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] A study was conducted to compare the results of the following two approaches for the treatment of vulvovaginal candidiasis: (1) a single dose of 1200 mg miconazole nitrate gelatin capsules in an intravaginal ointment base, in combination with MONISTAT  Vulva cream (apply according to the instructions when needed, no more than twice a day, to relieve symptoms); (2) MONISTAT  Vaginal creams.

[0017] The subject population is as follows: 278 patients with vulvovaginal candidiasis participated in the trial. 266 patients (96%) were safe and effective, and 213 patients (77%) were effective at the first follow-up. 196 patients (71%) were fully effective. About 60% of patients are white, and most of the remainder are Latino or black. The mean age of the patients was 33-34 years. More than 1 / 3 patients use oral contraceptives. More than 90% of patients have mild or moderate disease. 4-7% of patients are severely ill. Baseline levels were comparable between the two trea...

Embodiment 2

[0025] A study of the same design as reported in Example 1 was performed in a second population. In Example 2, the test population is as follows: 280 patients with vulvovaginal candidiasis participated in the test. 271 patients (97%) were safe and effective, and 205 patients (73%) were effective at the first follow-up. 194 (69%) patients were fully effective. Slightly fewer patients in the second group had both the first follow-up visit and the overall assessment because there were more screening failures in this group. About 70% of patients are white, and most of the remainder are black or Latino. The mean age of the patients was 36.3 years. About 20-25% of patients use oral contraceptives. More than 95% of the patients were mild or moderate. 2% of patients were severely ill. Baseline levels were comparable between the two treatment groups.

[0026] The treatment results of Example 2 are shown in Tables 3 and 4.

[0027] table 3

[0028] overall cure rate

...

Embodiment 3

[0033] A dose-ranging study was conducted to compare the results of the following two approaches for the treatment of vulvovaginal candidiasis: (1) single-dose miconazole nitrate cream formulations at various doses, combined with MONISTAT  Vulva cream (apply according to the instructions when needed, no more than twice a day, to relieve symptoms); (2) MONISTAT  7 vaginal creams.

[0034] Patients were randomly assigned to one of the following five treatment regimen groups:

[0035] Group 1: 16% miconazole nitrate vaginal cream 2.5 g single intravaginal dose containing 400 mg miconazole nitrate, in combination with MONISTAT  Vulva cream (apply according to the instructions when needed, no more than twice a day, to relieve symptoms);

[0036] Group 2: single intravaginal dose of 8% miconazole nitrate vaginal cream 5 g containing 400 mg miconazole nitrate, in combination with MONISTAT  Vulva cream (apply according to the instructions when needed, no more than twice a day, ...

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PUM

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Abstract

A method for treating vulvovaginal candidiasis including the steps of: (a) administering a single dose of an effective amount of miconazole nitrate in a pharmaceutically acceptable carrier intra-vaginally; and (b) applying miconazole nitrate in a pharmaceutically acceptable carrier to the vulva. Also a kit for the treatment of vulvovaginal candidiasis including: (a) a single dose of an effective amount of miconazole nitrate in a pharmaceutically acceptable carrier and in a form adapted to be administered intra-vaginally; and (b) an amount of miconazole nitrate in a pharmaceutically acceptable carrier adapted to be applied topically to the vulva.

Description

field of invention [0001] The present invention relates to a method of treating vulvovaginal candidiasis with miconazole nitrate, and more particularly to the treatment of vulvovaginal candidiasis using a single dose of miconazole nitrate administered intravaginally, plus multiple doses of miconazole nitrate topically applied to the vulva method of fungal disease. background of the invention [0002] Vulvovaginal candidiasis is a common form of yeast infection. The treatment of vulvovaginal candidiasis with antifungal miconazole nitrate compositions is well known. The most common treatment regimen for vulvovaginal candidiasis with miconazole nitrate consists of intravaginal administration of miconazole nitrate-containing cream or other pharmaceutically acceptable vehicle, depending on the concentration of miconazole nitrate in the cream, daily Once, for 1, 3 or 7 days. Commercially available kits for the treatment of vulvovaginal candidiasis with miconazole nitrate includ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4174A61P15/02A61K9/06A61K9/00A61K9/02A61K31/4164
CPCA61K31/4174A61K9/02Y10S514/931A61K9/0034A61P15/02A61P31/10A61K31/40
Inventor D·H·乌普马利斯
Owner MCNEIL PPC INC
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