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Medicinal composition product containing roflumilast and tiotropium bromide

A technology of tiotropium bromide and roflumilast, which is applied in the direction of drug combinations, active ingredients of heterocyclic compounds, respiratory diseases, etc. Ammonium bromide drug combination forms and other issues

Inactive Publication Date: 2014-05-14
QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The application number is CN02805346, which discloses a pharmaceutical composition based on anticholinergic drugs and PDE4 inhibitors, but does not disclose the drug combination form of roflumilast and tiotropium bromide, let alone the drug dosage of the combination

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Powder inhalation of 50 μg tiotropium bromide and 1000 μg roflumilast per single dose

[0037] A 50 g amount of micronized tiotropium bromide was mixed with 100 g of alpha lactose monohydrate, the mixture was sieved through a 0.5 mm mesh sieve, and finally mixed again. 1000 g of micronized roflumilast and 2000 g of α-lactose monohydrate were mixed, the mixture was sieved through a 0.8 mm mesh sieve, and finally mixed again. The two mixtures received were mixed and supplemented with alpha lactose monohydrate to 13500 g. Subsequently, it is mixed again and the powder mixture received is filled into a powder inhaler releasing 24 mg of powder per single dose. Each unit dose releases 50 μg of tiotropium bromide and 1000 μg of roflumilast from a powder inhaler and delivers to the patient's airways.

Embodiment 2

[0039] Powder inhalation of 100 μg tiotropium bromide and 500 μg roflumilast per single dose

[0040] A 100 g amount of micronized tiotropium bromide and 200 g of α-lactose monohydrate were mixed, the mixture was sieved through a 0.5 mm mesh sieve, and finally mixed again. 500 g of micronized roflumilast and 1000 g of α-lactose monohydrate were mixed, the mixture was sieved through a 0.8 mm mesh sieve, and finally mixed again. The two mixtures received were mixed and supplemented with alpha lactose monohydrate to 12150 g. Subsequently, it is mixed again and the powder mixture received is filled into a powder inhaler releasing 15 mg of powder per single dose. Each unit dose releases 100 μg of tiotropium bromide and 500 μg of roflumilast from a powder inhaler and delivers to the patient's airways.

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PUM

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Abstract

The invention relates to a combination product consisting of inhalation / oral roflumilast or a pharmaceutically acceptable salt thereof and inhalation tiotropium bromide or a pharmaceutically acceptable salt thereof. The medicinal composition product is administrated synchronously, sequentially or separately, and is applied to treatment or preventive treatment of respiratory diseases or symptoms thereof, particularly treatment of diseases accompanied with obstruction or inflammation such as chronic obstructive pulmonary disease (COPD) or asthma.

Description

field of invention [0001] The present invention relates to a pharmaceutical combination product of inhalation / oral roflumilast or its pharmaceutically acceptable salt combined with inhalation of tiotropium bromide or its pharmaceutically acceptable salt, and the pharmaceutical combination product is used for simultaneous, sequential or separate administration , for the treatment or prophylaxis of respiratory diseases or their symptoms, especially those accompanied by obstruction or inflammation such as chronic obstructive pulmonary disease (COPD) or asthma. Background of the invention [0002] Bronchial asthma, affecting up to 10% of individuals in industrialized countries, is characterized by bronchoconstriction, chronic bronchitis, airway hyperresponsiveness, and mucosal edema. Airway remodeling and altered noncholinergic, nonadrenergic neurotransmission can cause irreversible airway obstruction and reduced lung function. Bronchitis Asthma has emerged over the past 20 yea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61P11/00A61P11/06A61K31/44
Inventor 代先慧张绪伟刘英勋冷玲
Owner QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL