Mometasone furoate dry powder inhalation and preparing process thereof

A technology of mometasone furoate and dry powder inhaler, which can be applied in the directions of anti-inflammatory agent, respiratory system disease, non-central analgesic agent, etc., can solve problems such as complicated preparation process, and achieve simplified preparation process, convenient administration and convenience carry effect

Inactive Publication Date: 2010-06-30
张凯
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing mometasone dry powder preparation in the United States (ASMANEX ) is marketed and sold, using the technology of crushing raw materials and auxiliary materials and then granulating, the preparation process is relatively complicated

Method used

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  • Mometasone furoate dry powder inhalation and preparing process thereof
  • Mometasone furoate dry powder inhalation and preparing process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Process: The active ingredient mometasone furoate is mixed with lactose 1 and lactose 2, and mixed with a high-speed shear mixer to prepare intermediate powder. In the high-speed shear mixer, two kinds of mixing blades are contained in the mixing cavity, which move in horizontal and vertical directions respectively. The dry powder mixture of the active ingredient and the pharmaceutical auxiliary material thereof is obtained. Quantitatively filling the prepared mixture into a multi-dose storage type dry powder administration device.

[0076] Element:

[0077] Mometasone Furoate 6g

[0078] Lactose 170g

[0079] Lactose II 24g

[0080] When mixing:

[0081] Stirring speed in horizontal direction 100rpm

[0082] Shear speed in vertical direction 50rpm

[0083] Mixing time 30min

Embodiment 2

[0085] Technology: with embodiment one.

[0086] Element:

[0087] Mometasone Furoate 4g

[0088] Lactose 170g

[0089] Lactose II 26g

[0090] When mixing:

[0091] Stirring speed in horizontal direction 100rpm

[0092] Vertical shear speed 300rpm

[0093] Mixing time 45min

Embodiment 3

[0095] Technology: with embodiment one.

[0096] Element:

[0097] Mometasone Furoate 6g

[0098] Lactose 1 140g

[0099] Lactose II 54g

[0100] When mixing:

[0101] Stirring speed in horizontal direction 200rpm

[0102] Vertical shear speed 300rpm

[0103] Mixing time 30min

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Abstract

The invention provides a mometasone furoate dry powder inhalation, which comprises the following components by mass percentage: an active ingredient: 0.7 percent to 5.7 percent of mometasone furoate; and a pharmaceutical adjuvant: 99.3 percent to 94.3 percent of lactose. The lactose comprises lactose one and lactose two; lactose one accounts for 10-90 percent of the dry powder inhalation, and so does lactose two. The dry powder inhalation has the advantages of high bioavailability, portability, convenient administration, no pollution and the like. Successive administration or single administration is available, and the mometasone furoate dry powder inhalation is used for treating inflammation or obstructive disease of a respiratory system and has good application prospect. The preparing process is simple and is suitable for industrial production.

Description

Technical field: [0001] The invention relates to pharmaceutical preparations, in particular to a dry powder inhaler using mometasone furoate and a preparation process thereof. Background technique: [0002] Mometasone furoate is a steroid hormone compound for the treatment of inflammation, the chemical name is 9,21-dichloro-11b,17-dihydroxy-16a-methylpregna-1,4-diene-3, 20-Diketone 17-(2-furoate). The chemical structure is C 27 h 30 Cl 2 o 6 , the molecular weight is 521.44, and the structural formula is as follows: [0003] [0004] Mometasone furoate can reduce the airway response to adenosine monophosphate (AMP), while improving lung function in asthmatic patients. The effect on reducing AMP-induced bronchoconstriction was significant, and it also improved several other indicators of asthma control, including lung function, maximum expiratory flow rate, dyspnea, nocturnal asthma attacks, and emergency use of bronchodilators. [0005] In the past ten years, dry p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/58A61P11/00A61P11/06A61P29/00
Inventor 曾昭氚田杰廖琼邓伟
Owner 张凯
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