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Loteprednol Etabonate suspension eye drops composition

A technology of loteprednol etabon and eye drops, applied in the directions of drug combination, steroid, liquid delivery, etc., can solve the problems of high requirements for drug storage conditions and the like

Inactive Publication Date: 2017-01-04
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] After testing, we found that the commercially available Eccarteprednol Suspension Eye Drops And the suspension eye drops prepared by using the existing etabacloteprednol crystal form II, stored at 40°C ± 2°C and 25% relative humidity for 3 months, the content of etabaclotepdnol decreased rapidly , higher requirements for the storage conditions of drugs

Method used

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  • Loteprednol Etabonate suspension eye drops composition
  • Loteprednol Etabonate suspension eye drops composition
  • Loteprednol Etabonate suspension eye drops composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Invention Example 1 Preparation of etabac loteprednol crystal form I

Embodiment 1-1

[0052] Get 12g of carteprednol and add 300ml of acetone, 60ml of n-hexane, and 60ml of acetonitrile in the mixed solution and heat until fully dissolved, put it in a 1000ml beaker, seal it with parafZlm sealing film, and pierce several small holes on the film, Place at room temperature at 20°C and evaporate slowly. After a few days, crystals precipitated out. Pour off the solution, let the crystal dry naturally, take it off carefully, pick a better crystal and send it as a sample for single crystal diffraction. Other crystals were crushed with a mortar and used as seeds. The following unit cell parameters were determined by single crystal diffraction structure analysis: α=90deg.; β=94.140(6)deg; γ=90deg; unit cell volume is The crystal belongs to monoclinic crystal system, space group, P2(1), and Z value is 2. The prepared single crystal I is subjected to X-ray powder diffraction measurement on the crystalline powder after crushing with a mortar, and the measured chara...

Embodiment 1-2

[0054] Take 5g of carteprednol and add 100ml of acetone, 20ml of n-hexane, and 20ml of acetonitrile in a mixed solution heated to 50°C, hot filter to remove insoluble matter, cool to 30°C (if any crystals are precipitated, take the supernatant solution), and then add the seed crystal prepared in Example 1-1 of the invention, keep stirring for 30 minutes, a large amount of crystals are precipitated, cooled to 0-5°C, filtered, dried, and the obtained crystals are subjected to X-ray powder diffraction measurement, and the obtained The characteristic peak positions are 2θ=7.1°, 9.2°, 11.5°, 13.7°, 14.1°, 15.5°, 16.3°, 18.6°, 19.7°, and it is confirmed as etabacloteprednol crystal form I.

[0055] Molecular formula: C24H31ClO7

[0056] Elemental analysis theoretical value: C, 61.73; H, 6.69; Cl, ​​7.59

[0057] Elemental analysis found values: C, 61.78; H, 6.75; Cl, ​​7.58

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PUM

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Abstract

Loteprednol Etabonate suspension eye drops are characterized by comprising Loteprednol Etabonate serving as the active component, water, suspending agent and other auxiliary materials. The auxiliary materials are one or more of pH regulator, osmotic pressure regulator, surfactant and antibacterial agent. The Loteprednol Etabonate exists in a crystal form, and the X-ray powder, diffracted at diffraction angles 2<theta>=9.2 degrees, 13.7 degrees, 14.1 degrees, 15.5 degrees, 16.3 degrees and 18.6 degrees, of the Loteprednol Etabonate has characteristic peaks.

Description

[0001] Technical field: [0002] The invention relates to a glucocorticoid ophthalmic suspension eye drop, in particular to an etabacloteprednol suspension eye drop and a preparation method thereof. [0003] Background technique: [0004] Loteprednol etabonate (CAS: 82034-46-6, Loteprednol etabonate), is a new type of glucocorticoid, developed and produced by American PharmaS, and designed according to the principle of "soft medicine". In 1998, Loteprednol etabonate Prednol Suspension Eye Drops was approved for marketing in the United States, and then ophthalmic ointment and ophthalmic gel were successively launched for the treatment of ocular inflammation, especially for steroids on the eyelids and bulbar conjunctiva, cornea and anterior part of the eyeball Medications for sensitive inflammatory and post-operative eye symptoms. The drug is currently on the market in many countries including the United States, China and Argentina. [0005] At present, the research on the crys...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07J3/00A61K31/56A61K9/10A61P27/02A61P29/00
Inventor 王淑丽韩昆颖
Owner TIANJIN JINYAO GRP
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