Indacaterol and roflumilast-containing pharmaceutical combined product

A technology of roflumilast pharmacy and combination products, applied in diseases such as chronic resistance, can solve the problem of no evidence base for efficacy

Inactive Publication Date: 2014-05-28
QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although inhaled corticosteroids do have benefits in asthma control, until recently their utility in non-asthmatic smoking-related COPD was not evidence-based (Bonay et al., Drug Saf 2002:25:57-71)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Powder inhalation of 100μg roflumilast and 50μg indacaterol per single dose

[0036] 100 g of micronized Roflumilast and 200 g of alpha lactose monohydrate were mixed, the mixture was sieved through a sieve with 0.5 mm mesh, and finally mixed again. 50 g of micronized indacaterol and 100 g of alpha 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 2000g. Subsequently, they are mixed again and the received powder mixture is filled into a powder inhaler that releases 10 mg of powder per single dose. Each unit dose releases 100 μg of roflumilast and 50 μg of indacaterol from the powder inhaler and provides them to the airway of the patient.

Embodiment 2

[0038] Powder inhalation of 500μg roflumilast and 10μg indacaterol per single dose

[0039] 500 g of micronized Roflumilast and 1000 g of alpha lactose monohydrate were mixed, the mixture was sieved through a sieve with 0.5 mm mesh, and finally mixed again. 10 g of micronized indacaterol and 200 g of alpha 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 2000g. Subsequently, they are mixed again and the received powder mixture is filled into a powder inhaler that releases 10 mg of powder per single dose. Each unit dose releases 500 μg roflumilast and 10 μg indacaterol from the powder inhaler and delivers them to the airway of the patient.

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Abstract

The invention relates to a combination of inhaled / oral roflumilast or its pharmaceutically acceptable salt combined with inhaled indacaterol or its pharmaceutically acceptable salt, and the pharmaceutical combined product is used for simultaneous, successive or respective drug administration, is used for treatment or prevention of respiratory tract disease or its symptoms, and is especially used for treatment of obstruction or inflammation-accompanying diseases such as chronic obstructive pulmonary disease (COPD) or asthma.

Description

Invention field [0001] The present invention relates to a combination of inhaled / oral indacaterol or its pharmaceutically acceptable salt in combination with inhaled roflumilast or its pharmaceutically acceptable salt. The drug combination is used for simultaneous, sequential or separate administration for Treatment or preventive treatment 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, which affects up to 10% of individuals in industrialized countries, is characterized by bronchoconstriction, chronic bronchitis, airway hyperreaction, and mucosal edema. The non-cholinergic and non-adrenergic neurotransmission of airway remodeling and changes can cause irreversible airway obstruction and pulmonary hypofunction. In the past 20 years, bronchitis and asthma have emerged as a major public health problem worldwide...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4704A61K9/72A61P11/00A61P11/06A61K31/44
Inventor 代先慧张绪伟刘英勋冷玲
Owner QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL
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