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Dry powder composition for inhalation and preparation method thereof

A composition and dry powder technology, which is applied in the directions of pharmaceutical combinations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. Avoid stability degradation, extend shelf life, and have good chemical stability

Active Publication Date: 2019-05-14
SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, considering the safety of inhalation administration, common stabilizers, antioxidants, etc. cannot be added to dry powder inhalation preparations, and due to low moisture, it is easy to generate static electricity or cause problems with the properties of packaging systems (such as capsules or plastic materials). changes, the use of desiccants is often subject to certain restrictions

Method used

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  • Dry powder composition for inhalation and preparation method thereof
  • Dry powder composition for inhalation and preparation method thereof
  • Dry powder composition for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1: the preparation of micronized tiotropium bromide

[0035] Tiotropium bromide monohydrate and tiotropium bromide anhydrate are micronized respectively in a jet mill, and the pulverization pressure is 0.6Mpa, and the resulting product particle diameter is D 50 Reach below 5μm.

Embodiment 2

[0036] Embodiment 2: Preparation of micronized formoterol fumarate

[0037] Formoterol fumarate dihydrate and formoterol fumarate were micronized in a jet mill respectively, the crushing pressure was 0.6Mpa, and the particle size of the obtained product was D 50 Reach below 5μm.

Embodiment 3

[0038] Embodiment 3: take lactose monohydrate as carrier, magnesium stearate as stabilizer, tiotropium bromide formoterol for inhalation Dry powder preparation

[0039] Take by weighing the magnesium stearate of recipe quantity 1 / 10 and the micronized formoterol dihydrate that makes in the embodiment 2 and stir and mix 2min according to the table, transfer in the planetary ball mill, set the sun gear rotating speed 500r / min mixed for 10min, allowed to stand properly, and prepared powder compound (D 50 =2.23 μm), then add the micronized tiotropium bromide monohydrate (D 50 = 2.65 μm), lactose monohydrate and the remaining magnesium stearate of the prescription amount were mixed in a high-speed mixer for 2 min, and the linear speed of the stirring paddle was 10 m / s.

[0040]

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Abstract

The invention relates to a dry powder composition for inhalation and a preparation method thereof. The composition comprises a long-acting cholinergic receptor blocker, a long-acting beta receptor agonist, a stabilizer and a pharmaceutically acceptable carrier, a portion of the stabilizer forms a coating with the long-acting beta receptor agonist, and the amount of the portion of the stabilizer isthe amount used for the purpose that the long-acting beta receptor agonist is completely coated. The dry powder composition has good chemical stability and can be targeted for pulmonary administration by a dry powder inhalation device.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a dry powder composition for inhalation and a preparation method thereof. Background technique [0002] Long-acting cholinergic receptor blockers and long-acting beta-agonists are common drugs used to treat COPD. Long-acting cholinergic receptor blockers can bind to acetylcholine receptors and β receptors, thereby inhibiting bronchial tone mediated by choline transmitters, and can also block the bronchoconstriction reflex mediated by the vagus nerve. Long-acting β-receptor agonists can bind to β-receptors, increase the level of cyclic adenosine monophosphate (cAMP), relax the tracheal smooth muscle, and may also reduce the release of mast cell mediators, and inhibit neutrophils and eosinophils. and lymphocyte responses, increasing mucociliary transport. The combination of the two can relieve the symptoms of dyspnea in patients with chronic obstru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K9/72A61K47/12A61K47/18A61K47/10A61K47/26A61P11/00
Inventor 金方薄浩洋闻聪巩馥玮
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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