Preparation method of inhalation dry powder composition

A technology of composition and dry powder, which is applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve problems such as hydrolysis instability, high industrial production costs, and reduced interparticle forces , to achieve the effects of excellent inhalation characteristics, strong stability of formulation characteristics, and high safety

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

AI Technical Summary

Problems solved by technology

[0007] However, in practical application, it is found that the existing technical solutions have certain defects, which will lead to higher industrial production costs of products or shorter validity periods of products.
For example, the fluidity of the composition will be greatly reduced after adding an excessive amount of fine carrier components, thereby affecting the uniformity of subsequent filling and mixing, and increasing the product fine particle delivery fraction (FPF) is not effective; use a large amount of lubricant, and Although the method of mixing the two active ingredients with the lubricant using high-energy mixing methods (such as co-micronization and mechanical fusion) reduces the force between the particles and increases the product fine particle delivery fraction (FPF), the amount of lubricant The use may affect the safety of the dr

Method used

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  • Preparation method of inhalation dry powder composition
  • Preparation method of inhalation dry powder composition
  • Preparation method of inhalation dry powder composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: the preparation of micronized tiotropium bromide

[0033] 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

[0034] Embodiment 2: Preparation of micronized formoterol fumarate

[0035] 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

[0036] Embodiment 3: take lactose monohydrate as pharmaceutical carrier, magnesium stearate as lubricant, tiotropium bromide formol for inhalation Tero dry powder preparation

[0037] Weigh lactose monohydrate and magnesium stearate (D 50= 3.01 μm) mixed in a three-dimensional mixer for 10min, transferred to a high-speed mixer, mixed for 10min with a cutter linear speed of 10m / s, and left to stand properly to prepare a carrier compound, and then added the micronized thiamine prepared in Example 1 Trotropium bromide monohydrate and the formoterol fumarate dihydrate prepared in Example 2 were mixed in a high-speed mixer for 10 minutes at a cutter speed of 10 m / s, and finally mixed in a three-dimensional mixer for 20 minutes.

[0038]

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PUM

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Abstract

The invention relates to a preparation method of an inhalation dry powder composition. The method comprises the following steps that 1, a lubricant and a medicinal carrier are subjected to first shearmixing to obtain a carrier compound; 2, the carrier compound in the step 1, a long-acting cholinergic receptor blocking agent and a long-acting beta receptor stimulant are subjected to second shear mixing, so that the inhalation dry powder composition is obtained.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a method for preparing a dry powder composition for inhalation. The dry powder composition contains a long-acting cholinergic receptor blocker and a long-acting β-receptor agonist, which can be injected into the drug through a dry powder inhalation device. Pulmonary administration. 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 cel...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K9/72A61K47/12A61K47/18A61K47/10A61K47/26A61P11/00
Inventor 金方薄浩洋闻聪
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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