Dermaceutical gel made using sodium fusidate & process to make it

A technology of sodium fusidate and fusidic acid, which is applied to skin diseases, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as not using fusidic acid

Inactive Publication Date: 2012-01-18
苏鲁・苏布拉马尼・瓦南加穆迪
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Also, there is currently no gel-stabilized form of fusidic acid in use

Method used

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  • Dermaceutical gel made using sodium fusidate & process to make it
  • Dermaceutical gel made using sodium fusidate & process to make it
  • Dermaceutical gel made using sodium fusidate & process to make it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0057] A preferred embodiment of the present invention discloses a method of preparing a fusidic acid-containing gel for the skin, which method comprises using sodium fusidate as the original API and converting it in situ in an oxygen-free environment in the gel matrix Steps for fusidic acid.

[0058] Embodiment 1

[0059] In an embodiment of the invention there is disclosed a method of preparing a composition wherein the gel base of preferred embodiment 1 comprises a preservative, an acid, a base, a co-solvent, a natural, semi-synthetic or synthetic polymer, and water , preferably pure water, and wherein the step of converting sodium fusidate into fusidic acid in situ comprises the following steps:

[0060] a. water, preferably purified water, preferably 10 to 75% w / w, more preferably 57% w / w, is heated in a mixing vessel to 50°C to 60°C,

[0061] b. Dissolving 0.05 to 0.5% w / w of preservative, preferably 0.2% w / w of benzoic acid in said mixing vessel,

[0062] c. adding a...

Embodiment approach 2

[0072] In an embodiment of the invention, the co-solvent also acts as a wetting agent. However, in another embodiment of the present invention, a wetting agent can be added to the mixing container in step a in embodiment 1, and the wetting agent is selected from the group including any one of glycerin, sorbitol, propylene glycol, etc. or any combination thereof , to form a proportion of propylene glycol of about 1% (w / w) to 30% (w / w), preferably 20% (w / w), more preferably 10% (w / w).

Embodiment approach 3

[0074] In another embodiment of the present invention, the method described in embodiment 2 further includes adding and dissolving a chelating agent in the mixing container of step a in embodiment 1, and the chelating agent is selected from any one including EDTA disodium salt, etc. or any combination thereof to form about 0.001% (w / w) to 1% (w / w), preferably 0.05% (w / w), more preferably 0.01% (w / w) of EDTA disodium salt Proportion.

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Abstract

The invention discloses a process to make dermaceutical gel containing Fusidic acid which is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment comprising an inert gas, preferably nitrogen. The gel produced by the process of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid. The gel also contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, in a gel base; said gel base comprising a natural, semi-synthetic or synthetic polymers, a preservative, an acid, an alkali, a co-solvent, along with water, preferably purified water. The gel produced by the process of the present invention further optionally contains an ingredient selected from a group comprising, an anti oxidant, a chelating agent, and a humectant, or any combination thereof.

Description

technical field [0001] The present invention relates to primary and secondary bacterial skin infections and, in particular, to a process for the preparation of a gel for the treatment of these infections, said gel comprising fusidic acid having used sodium fusidate as a starting point The active pharmaceutical ingredient (API) is generated in situ. Background technique [0002] A variety of treatments, both topical and systemic, are indicated for primary and secondary bacterial skin infections caused by sensitive Gram-positive organisms such as Staphylococcus aureus, Streptococcus spp, and others. Topical and systemic bacterial infection treatment compositions generally employ at least one active pharmaceutical ingredient (API) and a matrix component. In cream form, the API usually includes antibiotics / antibacterials such as fusidic acid etc. [0003] Fusidic acid is available in creams and ointments. In currently available fusidic acid creams, fusidic acid in fine powder...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/575A61K9/00A61K9/06A61K47/32
CPCA61K47/10A61K47/02A61K9/0014A61K47/18A61K47/32A61K47/38A61K9/06A61K31/56A61K47/183A61P17/00A61P31/04A61K31/575A61K9/14
Inventor 苏鲁·苏布拉马尼·瓦南加穆迪马达范·斯里尼瓦桑尼拉坎丹·纳拉亚南·许利耶尔森蒂·库马尔·库普萨米
Owner 苏鲁・苏布拉马尼・瓦南加穆迪
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