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Novel dosage and formulation

A dosage and formulation technology, applied in the field of treatment of respiratory diseases, can solve the problem that the dosage has not been disclosed

Inactive Publication Date: 2015-03-04
ALMIRALL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although this compound is known as a long-acting anticholinergic drug and is helpful in the treatment of respiratory diseases, the optimal dosage has not yet been revealed

Method used

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  • Novel dosage and formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043]METHODS: In patients with moderate-to-severe long-term COPD, randomized double blind, once-daily adenia (25, 50, 100, 200 or 400 micrograms) over four weeks They were treated, given a placebo, or given 18 micrograms of open-label tiotropium. Spirometric measurements were performed as follows: 22 to 24 hours after the first dosing and weekly thereafter, and 0.5 to 6 hours after the first day of dosing and at the fourth week (Day 29).

[0044] RESULTS: The ITT population included 460 patients. On Day 29, trough FEV1 with dose-related increases in Aldenia is presented in the table below.

[0045] The average change in the baseline value of the FEV1 valley value on the 29th day

[0046]

[0047] *p<0.05 vs placebo

[0048] Unlike tiotropium, Adenia had a comparable bronchodilation effect (for all doses) to day 1 within the first 6 hours after dosing on day 29. For 100 to 400 micrograms of adenia, peak FEV1 was achieved 3 hours after administration. Adenia was well to...

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Abstract

This invention relates to a novel dosage for aclidinium and to novel methods and formulations for the treatment of respiratory diseases, especially asthma and chronic obstructive pulmonary disease (COPD), using aclidinium.

Description

[0001] This application is a divisional application of the No. 200980105118.8 invention patent application entitled "Novel Dosage and Formula". The parent case corresponds to the international application PCT / EP2009 / 001831, the filing date is March 13, 2009, and the priority date is March 13, 2008. technical field [0002] The present invention relates to a novel dose of aclidinium and methods and formulations for treating respiratory diseases (especially asthma and chronic obstructive pulmonary disease) using aclidinium. Background technique [0003] Aclidinium bromide (aclidinium bromide) is (3R)-(2-hydroxyl-2,2-dithiophen-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azabicyclo[ 2.2.2] Octane bromide (ie described eg in patent application WO0104118). Although this compound is known as a long-acting anticholinergic drug and is helpful in the treatment of respiratory diseases, its optimal dosage has not yet been revealed. Contents of the invention [0004] Surprisingly found in th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/46A61P11/00
CPCA61M15/0065A61K31/167A61K9/0075A61K31/46A61K31/58A61K31/439A61K9/0073A61K45/06A61P11/00A61P11/06A61P11/08A61P43/00A61K2300/00
Inventor 罗莎·拉玛克卡萨多冈萨洛·德米克尔塞拉
Owner ALMIRALL