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Ciclesonide suspension composition for inhalation

A technology of ciclesonide and suspension, which is applied in the direction of drug combination, steroids, liquid delivery, etc., and can solve the problem of not obtaining crystal form III of ciclesonide

Inactive Publication Date: 2017-05-24
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

By repeating Example 8 of WO2008062450, it was found that ciclesonide crystal form I was obtained, but ciclesonide crystal form III was not obtained

Method used

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  • Ciclesonide suspension composition for inhalation
  • Ciclesonide suspension composition for inhalation
  • Ciclesonide suspension composition for inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Invention Example 1 Preparation of Ciclesonide Monohydrate by Supercritical Method

[0050] (1) Preparation of ciclesonide solution 1: 5 g of ciclesonide was completely dissolved in a mixed solution of 200 ml of acetone and 20 ml of water at 50° C.;

[0051] (2) The ciclesonide solution 1 configured in step (1) is connected to the solution pump 2, and the working pressure is controlled to be 10MPa;

[0052] (3) Carbon dioxide feeding: the CO in the steel cylinder is input into the supercritical fluid anti-solvent equipment system through the booster pump 8, and enters the crystallization kettle 4, the flow rate is controlled at 10ml / min, the starting temperature is controlled at 50°C, and the pressure is 10MPa;

[0053] (4) The ciclesonide solution 1 configured in the above step (1) is rapidly sprayed into the crystallization kettle 4 through the nozzle 3 in the supercritical fluid antisolvent equipment system by the solution pump 2, and the flow control is 1.5ml / min, a...

Embodiment 2

[0058] Invention Example 2 Preparation of Ciclesonide Monohydrate

[0059] Take 5g of ciclesonide and add 100ml of ethanol, 10ml of water, and 10ml of acetonitrile into the mixed solution and heat to 50°C, heat filter to remove insoluble matter, cool to 30°C (if crystals are precipitated, take the supernatant), Then add the seed crystals prepared in Example 1 of the invention, heat and stir for 30 minutes, a large amount of crystals are precipitated, cooled to 0-5°C, filtered, and dried. The dried crystals are analyzed by TG-DTA, and the weight loss is about 3.1%, which is confirmed to be ring crystals. Sonide monohydrate. The obtained crystals were subjected to X-ray powder diffraction measurement, and the measured characteristic peak positions were 2θ=5.1°, 9.0°, 11.2°, 12.8°, 15.0°, 16.2°, 16.9°, 20.7°, 21.8°, 24.3°, 29.1° °, 32.7°.

Embodiment 3

[0060] Invention Example 3 Preparation of Ciclesonide Monohydrate

[0061] Take 5g of ciclesonide and add 100ml of ethanol, 10ml of water, and 15ml of acetonitrile into the mixed solution and heat to 50°C, heat filter to remove insoluble matter, cool to 30°C (if crystals are precipitated, take the supernatant), Then add the seed crystals prepared in Example 1 of the invention, heat and stir for 30 minutes, a large amount of crystals are precipitated, cooled to 0-5°C, filtered, and dried. The dried crystals are analyzed by TG-DTA, and the weight loss is about 3.1%. Sonide monohydrate. The obtained crystals were subjected to X-ray powder diffraction measurement, and the measured characteristic peak positions were 2θ=5.1°, 9.0°, 11.2°, 12.8°, 15.0°, 16.2°, 16.9°, 20.7°, 21.8°, 24.3°, 29.1° °, 32.7°.

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Abstract

The invention discloses a ciclesonide suspension composition for inhalation. The composition contains a ciclesonide hydrate and a pharmaceutically acceptable carrier, wherein the ciclesonide hydrate exists in a form of crystal.

Description

[0001] Technical field: [0002] The invention relates to a ciclesonide monohydrate suspension solution composition for inhalation. It belongs to the field of pharmaceutical technology. [0003] Background technique: [0004] Drug atomization inhalation therapy, as a new treatment method, uses high-speed airflow to spray the drug into mist and directly rushes to the small bronchus, terminal bronchi and alveoli, so that the drug can directly contact the lesion, thereby increasing the local drug concentration and playing a role. It can expand the bronchus and reduce inflammation, and can keep the airway moist and dilute sputum to facilitate expectoration. Therefore, it also has important clinical significance for upper respiratory tract infection, trachea and bronchial inflammation, pneumonia, bronchial asthma, and bronchiectasis; Not only that, the study found that the treatment of other diseases also has obvious therapeutic effects through drug aerosol inhalation therapy. The...

Claims

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Application Information

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IPC IPC(8): A61K31/58C07J71/00A61K9/72A61P11/02
CPCA61K31/58A61K9/0078A61K9/10A61K47/02A61K47/12A61K47/26A61K47/44C07B2200/13C07J71/00
Inventor 李静王淑丽韩昆颖金玉鑫
Owner TIANJIN JINYAO GRP
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