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Medicinal composition product containing salmeterol and roflumilast

A technology of roflumilast pharmaceuticals and combination products, which is applied in the field of diseases such as chronic obstructive disorder, and can solve the problems of no evidence base for efficacy

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

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 500 μg roflumilast and 30 μg salmeterol per single dose

[0036] A 500 g amount of micronized roflumilast was mixed with 1000 g of α-lactose monohydrate, the mixture was sieved through a 0.5 mm mesh sieve, and finally mixed again. 30 g of micronized salmeterol and 60 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 2000 g. Subsequently, it is mixed again and the powder mixture received is filled into a powder inhaler releasing 10 mg of powder per single dose. Each unit dose releases 500 μg of roflumilast and 30 μg of salmeterol from a powder inhaler and delivers to the patient's airways.

Embodiment 2

[0038] Powder inhalation of 100 μg roflumilast and 50 μg salmeterol per single dose

[0039] A 100 g amount of micronized roflumilast was mixed with 200 g of α-lactose monohydrate, the mixture was sieved through a 0.5 mm mesh sieve, and finally mixed again. 50 g of micronized salmeterol and 1000 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 2000 g. Subsequently, it is mixed again and the powder mixture received is filled into a powder inhaler releasing 10 mg of powder per single dose. Each unit dose releases 100 μg of roflumilast and 50 μg of salmeterol 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 consisting of inhalation / oral roflumilast or a pharmaceutically acceptable salt thereof and inhalation salmeterol 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 the combination of inhalation / oral salmeterol or its pharmaceutically acceptable salt combined with inhalation of roflumilast or its pharmaceutically acceptable salt for simultaneous, sequential or separate administration for respiratory tract Curative or preventive treatment of diseases or their symptoms, especially those associated with 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 years as a major public health problem worldwide. Although data suggest th...

Claims

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Application Information

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IPC IPC(8): A61K31/44A61P11/00A61P11/06A61K31/137
Inventor 代先慧张绪伟刘英勋冷玲
Owner QINGDAO CITY CHENGYANG DISTRICT PEOPLES HOSPITAL
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