Concentrated aqueous formulation of azalides

A water-based preparation and preparation technology, applied in the direction of non-central analgesics, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc.

Active Publication Date: 2019-05-28
太阳药业国际公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for various reasons, such as difficulty in delivering effective amounts of antibiotics to treat infections, many antibiotics cannot or are not suitable for topical application to the eye or tissues surrounding the eye, such as the eyelids

Method used

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  • Concentrated aqueous formulation of azalides
  • Concentrated aqueous formulation of azalides
  • Concentrated aqueous formulation of azalides

Examples

Experimental program
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Effect test

Embodiment 1

[0070] Preparation of Ophthalmic Preparations in 12L Scale

[0071] In the first step, EDTA, sodium chloride, and polycarbophil (solution #1) were mixed for 30 minutes using an overhead mixer. The solution was then transferred to a stainless steel pressure tank. Use pressure to transfer the solution through a 100 mesh screen into a 12 L container. The solution was sterilized in the container at 121.1°C for 30 minutes. In the second step, sodium hydroxide was aseptically added to the container containing solution #1 through a 0.2 μm filter. The volume of sodium hydroxide required was based on making the final batch pH 6.3. The stainless steel pressure tank and transfer lines were then rinsed with house DI water. In the third step, mannitol, hydrochloric acid, azithromycin, benzalkonium chloride (BAC), and poloxamer 407 were mixed together (solution #2). Hydrochloric acid was added to facilitate the dissolution of azithromycin. After all solid ingredients in solution #2 we...

Embodiment 2

[0073] Embodiment 2 prepares the ophthalmic preparation of 12L scale with chitosan

[0074] In the first step, EDTA, sodium chloride, and polycarbophil (solution #1) were mixed for 30 minutes using an overhead mixer. The solution was then transferred to a stainless steel pressure tank. Use pressure to transfer the solution through a 100 mesh screen into a 12 L container. The solution was sterilized in the container at 121.1°C for 30 minutes. In the second step, sodium hydroxide was aseptically added to the container containing solution #1 through a 0.2 μm filter. The volume of sodium hydroxide required was based on making the final batch pH 6.3. The stainless steel pressure tank and transfer lines were then rinsed with residential deionized water and added to the vessel aseptically through a 0.2 μm filter. In the third step, mannitol and benzalkonium chloride are dissolved in water and added aseptically to the container. Disperse chitosan in water and add hydrochloric aci...

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Abstract

The present invention provides concentrated aqueous formulations of azithromycin containing about 2% to 20% azithromycin, and a method of preparing a concentrated aqueous formulation of azithromycin comprising the steps of: preparing a first solution containing a strong base and sterilizing To form a sterilizing solution, azithromycin is dissolved in an aqueous solution containing an acid consisting essentially of a strong acid, and the aqueous solution containing the strong acid is added to the sterilizing solution containing a strong base. Strong acids have a pKa of less than about -1.74, and the method is performed without the addition or use of weak acids.

Description

technical field [0001] The present invention relates to concentrated azalide antibiotic formulations, and methods of making and using such formulations. Background technique [0002] Compared with systemic administration, topical administration of drugs such as antibiotics to the eye is straightforward and has several advantages, including avoiding side effects, circumventing the hepatic first-pass effect, and reducing the likelihood of bacteria developing drug-resistant strains. However, many antibiotics cannot or are not suitable for topical application to the eye or tissues surrounding the eye, such as the eyelids, for various reasons, such as difficulty in delivering effective amounts of antibiotics to treat infections. [0003] US Patent No. 6,277,829 discloses a method for preparing an ophthalmic aqueous preparation containing azithromycin, which comprises ophthalmically usable polyphosphate, citric acid monohydrate and azithromycin. However, these solutions utilizing...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7052A61K31/7042A61K31/70A61P27/02
CPCA61K9/0048A61K31/573A61K31/7052A61K47/02A61K47/10A61K47/32A61K47/36A61P27/02A61P27/14A61P29/00A61P31/04A61P43/00A61K2300/00
Inventor 莱尔·M·鲍曼S·Y·E·侯T·源
Owner 太阳药业国际公司
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