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Tiotropium bromide capsule-type inhalation aerosol powder

A technology for inhaling powder aerosol and tiotropium bromide is applied in respiratory diseases, drug delivery, active ingredients of heterocyclic compounds, etc. The effect of low hygroscopicity and high deposition amount

Active Publication Date: 2015-02-18
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The present invention overcomes defects such as complex process, high cost, and organic solvent pollution in the prior art. Use ground lactose 40M (the average particle size of the particles is 40μm) and crystalline lactose for inhalation to mix evenly in a certain weight ratio

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Preparation of tiotropium bromide inhalation powder

[0053] Tiotropium Bromide Superfine Powder 360mg

[0054] Ground Lactose 108g

[0055] Crystallized lactose 396g

[0056] A total of 20,000 capsules were made

[0057] Crush the tiotropium bromide raw material, weigh the prescribed amount of tiotropium bromide superfine powder, mix it with the prescribed amount of ground lactose, and then mix it evenly with the prescribed amount of crystallized lactose, measure the content, calculate the filling amount, and use a microcapsule The filling machine fills the No. 3 capsule.

[0058] Embodiment 1 sample detection result

[0059] 1. Particle size of dry powder: The particle size of tiotropium bromide is 3.07μm±0.89μm.

[0060] 2. Angle of repose: 50°.

[0061] 3. Hygroscopicity: relative weight gain of 2.1%.

[0062] 4. Content uniformity: ±3.0%.

[0063] 5. Empty rate: 99.8%.

[0064] 6. Drug deposition on the effective site: 29%.

[0065] 7. Irritation to respi...

Embodiment 2

[0067] Preparation of tiotropium bromide inhalation powder

[0068] Tiotropium Bromide Superfine Powder 360mg

[0069] Ground Lactose 36g

[0070] Crystallized lactose 468g

[0071] A total of 20,000 capsules were made

[0072] Crush the tiotropium bromide raw material, weigh the prescribed amount of tiotropium bromide superfine powder, mix it with the prescribed amount of ground lactose, and then mix it evenly with the prescribed amount of crystallized lactose, measure the content, calculate the filling amount, and use a microcapsule The filling machine fills the No. 3 capsule.

[0073] Example 2 sample detection result

[0074] 1. Particle size of dry powder: The particle size of tiotropium bromide is 3.96 μm±0.71 μm.

[0075] 2. Angle of repose: 50°.

[0076] 3. Hygroscopicity: relative weight gain of 2.9%.

[0077] 4. Content uniformity: ±3.5%.

[0078] 5. Empty rate: 99.6%.

[0079] 6. The amount of drug deposition on the effective site: 25%.

[0080] 7. Irritat...

Embodiment 3

[0082] Preparation of tiotropium bromide inhalation powder

[0083] Tiotropium Bromide Superfine Powder 360mg

[0084] Ground Lactose 216g

[0085] Crystallized lactose 288g

[0086] A total of 20,000 capsules were made

[0087] Crush the tiotropium bromide raw material, weigh the prescribed amount of tiotropium bromide superfine powder, mix it with the prescribed amount of ground lactose, and then mix it evenly with the prescribed amount of crystallized lactose, measure the content, calculate the filling amount, and use a microcapsule The filling machine fills the No. 3 capsule.

[0088] Embodiment 3 sample detection result

[0089] 1. Particle size of dry powder: The particle size of tiotropium bromide is 4.18 μm±0.54 μm.

[0090] 2. Angle of repose: 53°.

[0091] 3. Hygroscopicity: relative weight gain of 4.8%.

[0092] 4. Content uniformity: ±4.1%.

[0093] 5. Empty rate: 99.2%.

[0094] 6. The amount of drug deposition in the effective part: 30%.

[0095] 7. Irr...

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Abstract

The invention relates to tiotropium bromide capsule-type inhalation aerosol powder and a preparation process thereof. The bromide capsule-type inhalation aerosol powder comprises a capsule shell and a capsule content, wherein the capsule content is prepared from tiotropium or tiotropium monohydrate, inhalation crystal lactose and inhalation grinding lactose in a certain proportion. The preparation process of the triotropium bromide capsule-type inhalation aerosol powder is simple, the particles have excellent liquidity, active components are uniformly distributed, and the effective part has high sediment yield.

Description

technical field [0001] The invention relates to a medicine for treating chronic obstructive pulmonary disease, more specifically, the invention relates to a tiotropium bromide capsule type inhalation powder and a preparation process thereof. Background technique [0002] Chronic obstructive pulmonary disease is a prevalent and increasingly progressive disease in industrialized countries and is an umbrella term for a spectrum of symptoms including chronic cough, sputum production, exertional dyspnea, and markedly reversible and irreversible progressive reduction in airflow. At present, chronic obstructive pulmonary disease ranks fourth among the diseases that cause death in the world. The World Bank and WHO predict that by 2020, the economic burden caused by chronic obstructive pulmonary disease will rank fifth globally. [0003] Tiotropium bromide inhalation was launched by Boehringer Ingelheim and Pfizer in the Netherlands and the Philippines in 2002. In August 2004, the U....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K31/46A61K47/26A61P11/00
CPCA61K31/439
Inventor 赵志全胡守艳张丽萍韩忠丽
Owner SHANDONG NEWTIME PHARMA
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