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A kind of preparation method of dry powder inhaler

A technology for dry powder inhaler and equipment, which is applied in the field of preparation of dry powder inhaler, can solve problems such as difficulty in controlling and reduce drug efficacy, and achieve the effects of good content uniformity, excellent inhalation characteristics, and suitable aerodynamic fine particle fraction.

Active Publication Date: 2022-02-22
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

However, the impact-type high-shear mixing mentioned above easily causes the active ingredient to be pulverized again during the preparation process, so that the actual particle size of the active ingredient in the finished preparation is too fine and difficult to control, and the too fine active ingredient will be exhaled with the airflow , cannot stay in the lungs, which greatly reduces the actual efficacy of the drug

Method used

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  • A kind of preparation method of dry powder inhaler
  • A kind of preparation method of dry powder inhaler
  • A kind of preparation method of dry powder inhaler

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 - Preparation of micronized active ingredient

[0043] Aclidinium bromide is micronized in a jet mill, the pulverization pressure is 0.6Mpa, and the particle size D50 of the obtained product reaches 2.8 μm, and D10>1 μm.

[0044] The umeclidinium bromide is respectively micronized in a jet mill, the pulverization pressure is 0.4Mpa, and the particle size D50 of the obtained product reaches 2-3 μm, and D10>1 μm.

[0045] The glycopyrronium bromide is respectively micronized in a jet mill, the pulverization pressure is 0.4Mpa, and the particle size D50 of the obtained product reaches 2-3 μm, and D10>1 μm.

[0046] Micronize formoterol fumarate dihydrate and formoterol fumarate in a jet mill respectively, the pulverization pressure is 0.6Mpa, the particle size D50 of the obtained product reaches 2-3μm, and D10>1μm .

[0047] Indacaterol fumarate is micronized in a jet mill respectively, the pulverization pressure is 0.8Mpa, and the particle size D50 of the ob...

Embodiment 2

[0051] The preparation of embodiment 2-aclidinium bromide dry powder inhalation

[0052] The aclidinium bromide of lactose monohydrate and the micronization in the following table is mixed in a three-dimensional mixer for 10min, transferred to a high-speed mixer, and an appropriate paddle is selected so that the gap between the paddle and the container wall is 0.5mm, reverse the stirring paddle, mix with the paddle linear speed of 5m / s for 10min, and let stand properly to prepare aclidinium bromide dry powder inhaler.

[0053]

Embodiment 3

[0054] The preparation of embodiment 3-aclidinium bromide dry powder inhalation

[0055] The aclidinium bromide of lactose monohydrate and the micronization in the following table is mixed in a three-dimensional mixer for 10min, transferred to a high-speed mixer, and an appropriate paddle is selected so that the gap between the paddle and the container wall is 1.0mm, reverse the stirring paddle, mix with the paddle linear speed of 8m / s for 10min, and let stand properly to prepare aclidinium bromide dry powder inhaler.

[0056]

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Abstract

The invention provides a method for preparing a dry powder inhaler, which comprises dispersing active ingredients in a carrier through a specific mixing method, wherein the specific mixing method is extrusion shear mixing. The dry powder inhaler is prepared by the method provided by the invention, the particles of the active ingredient are not easily crushed during the mixing process, and the prepared dry powder inhaler has suitable aerodynamic fine particles when it is administered to the lungs through a dry powder inhalation device Fraction (FPF) and good content uniformity, excellent inhalation characteristics and other characteristics.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of a dry powder inhaler. Background technique [0002] Dry powder inhaler is a new drug dosage form. The drug in this dosage form can be atomized by the applicator and deposited in the lungs for absorption. The drug targeting is further enhanced, the toxic and side effects are significantly reduced, and the onset speed is also significantly faster. It has been proven to be safe and well tolerated by clinical trials. [0003] The preparation of dry powder inhalation products often has high technical difficulties, because the aerodynamic diameter of the active ingredient is usually required to be between 1 and 5 μm in order to deposit the active ingredient in the lungs and exert a local effect. However, at this time The binding force between particles, including electrostatic force, van der Waals force, capillary force, etc., has complex ...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/14A61K47/26A61K31/439B01F35/222B01F35/50B01F101/22
CPCA61K9/0075A61K9/14A61K47/26A61K31/439B01F35/221421B01F35/51B01F2101/22
Inventor 金方薄浩洋闻聪
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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