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(R,R)-formoterol inhalation dust cloud agent and preparation method thereof

A technology for inhaling powder aerosol and formoterol, which is applied in the field of formoterol inhalation powder aerosol, can solve the problems of large disparity in the dosage of the main drug and auxiliary materials, low hygroscopicity, etc., and achieves low cost, low hygroscopicity, and method. simple effect

Inactive Publication Date: 2012-01-04
天津天士力大健康产业投资集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The (R, R)-formoterol inhalation powder and aerosol provided by the invention has good fluidity and low hygroscopicity; and the preparation method is simple to operate, easy to mix, and the cost is reduced, which solves the problem of disparity in the dosage of the main drug and auxiliary materials

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The preparation of embodiment 1 carrier micropowder

[0041] Weigh 0.5g of lactose and dissolve it in 500ml of deionized water. The solution was sprayed with a spray dryer, and the droplets were sprayed into isopropanol, stirring occasionally. After spraying, filter, then dry and pulverize the filter cake to obtain the product. When spraying, control the atomization airflow speed to 30ml / h, and the peristaltic pump speed to 8ml / min.

[0042] Powder inspection results: the particle size of the carrier fine powder is 80%, the particle size is in the range of 40μm-100μm, and the angle of repose is 35.6 degrees

Embodiment 2

[0043] The preparation of embodiment 2 carrier micropowder

[0044] Weigh 50g of lactose and add water to prepare a saturated solution. The solution was sprayed with a spray dryer, and the droplets were sprayed into isopropanol, stirring occasionally. After spraying, filter, then dry and pulverize the filter cake to obtain the product. When spraying, control the atomizing air flow rate to 30ml / h, and the peristaltic pump speed to 1ml / min.

[0045] Powder inspection results: the particle size of the carrier fine powder is 80% in the range of 40μm-100μm, and the angle of repose is 36.7 degrees

Embodiment 3

[0046] The preparation of embodiment 3 carrier micropowder

[0047] Weigh 45g lactose and dissolve it in 150ml deionized water. The solution was sprayed with a spray drier, and the droplets were sprayed into ethanol, stirring occasionally. After spraying, filter, then dry and pulverize the filter cake to obtain the product. When spraying, control the atomizing air flow rate to 30ml / h, and the peristaltic pump speed to 5ml / min.

[0048] Powder inspection results: the particle size of the carrier fine powder is 80%, the particle size is in the range of 40μm-100μm, and the angle of repose is 38.2 degrees

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Abstract

The invention discloses (R,R)-formoterol powder inhalation which is composed of carrier powders and (R,R)-formoterol medicine carrier powders; wherein, the content of the medicine carrier powders is 5 percent to 80 percent (w / w), and the particulate diameter of at least 90 percent (w / w) of powder particulate is smaller than 10Mum; the content of the carrier powders is 20 percent to 95 percent (w / w), and the particulate diameter of at least 80 percent (w / w) of powder particulate is smaller than 40Mum to 100Mum. The powder inhalation of the invention is prepared by the follower steps: 1) preparing the carrier powders with a solvent crystallization method; 2) preparing the medicine carrier powders with a spray drying method; 3) mixing the medicine carrier powders and the carrier powders to obtain the preparation. The power inhalation of the invention has favorable fluidity and lower moisture-absorptivity; the preparation method is easy to operate, the cost is low, and the invention solves the problem of great disparity between main drug and auxiliary material.

Description

technical field [0001] The invention relates to an inhalation powder, in particular to a formoterol inhalation powder and a preparation method thereof. Background technique [0002] Asthma is one of the common chronic diseases in the world. At present, the types of drugs used to treat asthma include: 1. Adrenal receptor agonists; 2. Antiallergic drugs; 3. Theophylline drugs; 4. Glucocorticoids. Formoterol is a β2-adrenoreceptor agonist successfully developed in the late 1980s. It has a strong and long-lasting effect. It has been widely used in asthma and other airway obstruction diseases. At present, its fumaric acid is mainly used Salt. There are two asymmetric carbon atoms in the racemate formoterol structure, so there are four different stereo configurations, namely (R, R)-type, (S, S)-type (enantiomers) , (R, S) type, (S, R) type (diastereoisomers). Currently widely used clinically is the (R, R) and (S, S) type equal mixture of formoterol, and the (S, S)-isomer is com...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K31/167A61P11/14
Inventor 王国成陈莹
Owner 天津天士力大健康产业投资集团有限公司
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