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Fluorometholone eye drops

A technology for eye drops and fluorometholone, which is applied in the directions of liquid delivery, emulsion delivery, and medical preparations with inactive ingredients, etc. The effect of good dispersibility, high content uniformity and good redispersion characteristics

Inactive Publication Date: 2014-02-12
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It solves the problem that the concentration of the drug in the eye drops does not match the nominal value due to the poor redispersibility of the existing eye drops

Method used

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  • Fluorometholone eye drops
  • Fluorometholone eye drops
  • Fluorometholone eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0039] Component 2 in Example 2 is tobramycin, component 2 in Example 6 is levofloxacin hydrochloride, and component 2 in Example 10 is gatifloxacin hydrochloride.

[0040] The preparation method of the fluorometholone micropowder is as follows: dissolving the drug raw material in an organic solvent (heating if necessary), passing through a 0.45 μm microporous membrane, stirring with water for injection, and slowly adding and dissolving it into the water while maintaining stirring. Added the organic solvent of the medicine, stopped stirring after the addition was completed, left to stand for 1 hour, filtered and dried to obtain the medicine micropowder. The particle size distribution of the drug micropowder meets the following conditions simultaneously:

[0041] D50 is 3.0-4.0μm, the maximum particle size is less than 30μm

[0042] For fine powder with a particle size of 1-7.5 μm, the percentage of particles is 78%-84%, of which

[0043] For fine powder with a particle size of...

Embodiment 1

[0048] The auxiliary material formula is hydroxypropyl methylcellulose 10g

[0049] Tween-80 1g

[0050] Propylparaben 0.5g

[0051] Methylparaben 0.5g

[0052] Edetate Calcium Sodium 1g

[0053] Sodium chloride 7g

[0054] Water for injection up to 1000ml

[0055] Example 2

[0056] The auxiliary material formula is hydroxyethyl methylcellulose 10g

[0057] Tween-80 0.5g

[0058] Glycerin 10g

[0059] Sodium Hyaluronate 1g

[0060] Polyoxyethylene hydrogenated castor oil 60 0.5g

[0061] Benzalkonium chloride

[0062] Edetate Calcium Sodium 1g

[0063] Water for injection up to 1000ml

[0064] Add tobramycin to solution during preparation and adjust the pH to 5-6 with sulfuric acid.

Embodiment 3

[0066] The excipient formula is methyl cellulose 4g

[0067] Tween-80 3g

[0068] Propylparaben 0.5g

[0069] Methylparaben 0.5g

[0070] Edetate Disodium 1g

[0071] Sodium chloride 7g

[0072] Water for injection up to 1000ml

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Abstract

The invention discloses fluorometholone eye drops. The fluorometholone eye drops comprise fluorometholone as an active component, water and one or more accessory materials for eye drops. The fluorometholone eye drops are characterized in that particle size distribution of the used fluorometholone in the form of micro-powder meet conditions that D50 is in a range of 3.0-4.0 microns, the maximum grain size is less than 30 microns, a ratio of grains having sizes of 1-7.5 microns is in a range of 78-84%, and a ratio of grains having sizes of 1-5 microns is in a range of 61-67%.

Description

Technical field: [0001] The invention relates to a glucocorticoid eye drop. Background technique: [0002] Fluorometholone (CAS: 426-13-1, Fluorometholone), as a glucocorticoid, is mainly used to prepare ophthalmic preparations. Chinese patent application CN99802317.5 and Chinese patent application CN200880010531.1 respectively disclose a kind of fluorometholone Eye drops, the former uses a formula containing Tween-80 as an auxiliary material to avoid agglomeration of fluorometholone micropowder during storage, and the latter adds polyoxyethylene hydrogenated castor oil 60 or polyoxyethylene castor oil on the basis of the former 60 is used to avoid the fluorometholone micropowder from adhering to the eye drop container wall during storage, but the particle size range of the fluorometholone micropowder used is not disclosed in these two applications. The particle size range of the dexamethasone drug micropowder as the active ingredient and distributed. Nearly 99% of the dr...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/14A61K31/57A61K47/48A61P29/00
Inventor 韩昆颖李金禄李静
Owner TIANJIN JINYAO GRP
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