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Ophthalmic composition containing gatifloxacin and lotepredenol etabonate and method of preparing the same

A technology of loteprednol etabonate and ophthalmic composition, which is applied in the field of ophthalmic composition containing gatifloxacin and loteprednol etabonate and its production field, and can solve problems such as not yet available

Active Publication Date: 2008-02-27
SHANDONG BAUSCH & LOMB FREDA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The combination of loteprednol etabonate and the aminoglycoside antibiotic tobramycin has been used commercially as eye drops, but so far, no eye drops containing the combination of gatifloxacin and loteprednol have been used. Satisfactory and Stable Formulation Reports of Suspension Solution Ophthalmic Compositions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Table 6 Prescription 1-6 Ophthalmic Composition Formulation

[0068] prescription

[0069] Preparation method: Take micronized loteprednol etabonate, add a little water, add polysorbate 80 to disperse it. Take gatifloxacin, add 1mol / L hydrochloric acid to dissolve it, add part of purified water, slowly add the prescribed amount of povidone K-90 while stirring, to completely dissolve without agglomeration, then add the prescribed amount in turn Disodium dibasic acid, glycerin and benzalkonium chloride, after mixing, add the slurry of loteprednol etabonate, measure the pH value of the solution, and adjust the pH value to about 6.0 with hydrochloric acid solution or sodium hydroxide solution, replenish water to Specified amount, stir evenly, and fill.

Embodiment 2

[0071] Table 7 Prescription 7-10 Ophthalmic Composition Formulation

[0072] prescription

[0073] Preparation method: Take micronized loteprednol etabonate, add a little water, and add surfactant to disperse it. Take gatifloxacin, add 1mol / L hydrochloric acid to dissolve it, add part of purified water, slowly add the prescribed amount of povidone K-90 while stirring, to completely dissolve without agglomeration, then add the prescribed amount in turn Disodium dibasic acid, glycerin and benzalkonium chloride, after mixing, add the slurry of loteprednol etabonate, measure the pH value of the solution, and adjust the pH value to about 6.0 with hydrochloric acid solution or sodium hydroxide solution, replenish water to Specified amount, stir evenly, and fill.

Embodiment 3

[0075] Table 8 Prescription 11 Ophthalmic Composition Formulation

[0076] name

[0077] Polysorbate 80

[0078] Preparation method: Take micronized loteprednol etabonate, add a little water, and add surfactant to disperse it. Take gatifloxacin, add 1mol / L hydrochloric acid to dissolve it, add part of purified water, slowly add the prescribed amount of povidone K-90 while stirring, to completely dissolve without agglomeration, then add the prescribed amount in turn Dibasic acid disodium, sodium chloride and benzalkonium chloride, after mixing, add the slurry of loteprednol etabonate, measure the pH value of the solution, and adjust the pH value to about 6.0 with hydrochloric acid solution or sodium hydroxide solution, Add water to the specified amount, stir evenly, and fill.

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Abstract

The invention discloses a turbid liquor eye composition with chlotiponuo and jiatishaxing and making method, which comprises the following parts: (a) 0. 2-2% chlotiponuo and salt with grain size below 50um, (b) 0. 2-1% jiatishaxing and salt, (c) 0. 5-2. 5% one or more non-ion polymer as suspension-assisting agent, (d) eye excipient agent. The making method comprises the following steps: grinding the chlotiponuo carbonate below 50um; sterilizing; adding jiatishaxing, non-ion polymer and other eye adjuvants to form an eye agent to treat and prevent opthalmitis and bacterial infection.

Description

technical field [0001] The invention belongs to the technical field of medicine and health, and relates to an ophthalmic composition and a preparation method thereof, in particular to an ophthalmic composition containing gatifloxacin and loteprednol etabonate for the treatment and prevention of eye inflammation and eye infection Compositions and methods of making them. Background technique [0002] Loteprednol etabonate is a new type of glucocorticoid drug, which has an obvious effect on reducing eye redness and swelling, and has a significant effect on various eye inflammations and seasonal allergic conjunctivitis, and has no intraocular Adverse reactions to increased blood pressure. Its anti-inflammatory effect is strong, which is 1.5 times that of dexamethasone; compared with prednisolone, loteprednol is rapidly metabolized into inactive products after being used in the eyes, so this type of drug is also anti-inflammatory. Systemic toxicity is reduced. Compared with pr...

Claims

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Application Information

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IPC IPC(8): A61K31/569A61K9/10A61K47/34A61K47/36A61P27/02A61K31/496A61K47/10A61K47/26A61K47/32
Inventor 凌沛学贺艳丽钱雪白若琬张青李永春潘继飞
Owner SHANDONG BAUSCH & LOMB FREDA PHARM CO LTD
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