Topical pharmaceutical composition comprising tenofovir, an antibacterial agent and,optonally ciclopirox

A topical drug, tenofovir technology, applied in the field of contraceptives and the preparation of the topical pharmaceutical composition, can solve the problems of no public use and the like

Inactive Publication Date: 2016-01-20
CIPLA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0025] However, it should be noted that no prior art discloses the combination of tenofovir, lactic acid an

Method used

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  • Topical pharmaceutical composition comprising tenofovir, an antibacterial agent and,optonally ciclopirox
  • Topical pharmaceutical composition comprising tenofovir, an antibacterial agent and,optonally ciclopirox
  • Topical pharmaceutical composition comprising tenofovir, an antibacterial agent and,optonally ciclopirox

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0146]

[0147] Preparation of the organic phase:

[0148] 1. Heat the glycerin.

[0149] 2. Add and dissolve the methylparaben and propylparaben in the heated glycerin.

[0150] 3. Cool the solution obtained in step 2.

[0151] 4. Add and disperse hydroxyethyl cellulose in the solution obtained from step 3 to obtain a thick dispersion.

[0152] Preparation of the drug phase:

[0153] 1. Dissolve disodium edetate in water.

[0154] 2. Lactic acid was added and dissolved in the solution obtained in step 1.

[0155] 3. Disperse tenofovir in the solution obtained in step 2.

[0156] 4. Adjust the pH to 3.8-4.5 using sodium hydroxide and hydrochloric acid until a solution of tenofovir is obtained.

[0157] Gel preparation:

[0158] 1. Add the drug phase to the organic phase under continuous stirring to obtain a gel.

Embodiment 2

[0160]

[0161]

[0162] Preparation of the organic phase:

[0163] 1. Heat the glycerin.

[0164] 2. Add and dissolve the methylparaben and propylparaben in the heated glycerin.

[0165] 3. Cool the solution obtained in step 2.

[0166] 4. Add and disperse polycarbophil in the solution obtained from step 3 to obtain a thick dispersion.

[0167] Preparation of the drug phase:

[0168] 1. Dissolve disodium edetate in water.

[0169] 2. Lactic acid was added and dissolved in the solution obtained in step 1.

[0170] 3. Disperse tenofovir in the solution obtained in step 2.

[0171] 4. Adjust the pH to 3.8-4.5 using sodium hydroxide and hydrochloric acid until a solution of tenofovir is obtained.

[0172] Gel preparation:

[0173] 1. Add the drug phase to the organic phase under continuous stirring to obtain a gel.

Embodiment 3

[0175]

[0176] Preparation of tenofovir drug phase

[0177] 1) dissolving disodium edetate in purified water;

[0178] 2) adding citric acid, lactic acid and tenofovir to the solution obtained in step (1);

[0179] 3) adding hydrochloric acid to the solution obtained in step (2) to dissolve tenofovir;

[0180] 4) adjusting the pH of the solution obtained in step (3) with sodium hydroxide solution;

[0181] 5) Add xanthan gum to the solution obtained in step (4) to form a lump-free gel.

[0182] Preparation of ciclopirox olamine solution

[0183] 1) Add glycerin and propylene glycol to purified water and heat;

[0184] 2) Add methylparaben, propylparaben, cocoyldiethanolamine and polysorbate 60 to the solution obtained in step (1).

[0185] Gel preparation:

[0186] 1) The drug phase is added to the organic phase under continuous stirring to obtain a gel and the required volume is made up with purified water and the pH is measured.

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Abstract

The present invention relates in general to a topical pharmaceutical composition comprising an antiretroviral agent in combination with a bactericidal agent and optionally an antifungal agent, particularly for use as a contraceptive.

Description

field of invention [0001] The present invention relates to a topical pharmaceutical composition comprising an antiretroviral agent together with an antiseptic and optionally an antifungal agent, in particular for use as a contraceptive. Also disclosed are methods of preparing the topical pharmaceutical compositions, as well as certain uses of the compositions. Background technique [0002] Oral contraceptives are the most common form of reversible contraception. Approximately 30% of women of reproductive age currently use oral contraceptives, and 80% of all women use oral contraceptives at some time during their reproductive years. Oral contraceptives offer both a high degree of contraceptive efficacy and a range of non-contraceptive health benefits such as reduction of menstrual cramps, protection against ovarian and endometrial cancer, ectopic pregnancy and pelvic inflammatory disease. An estimated 1614 out of every 100,000 oral contraceptive users currently avoid hospit...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/19A61K31/4418A61K31/675A61P15/18A61P31/00
Inventor G·马尔霍特拉S·M·普兰德尔
Owner CIPLA LTD
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