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Pharmaceutical composition

A technology of composition and medicine, applied in the field of preparing the pharmaceutical composition, treating asthma, COPD and other breathing disorders, can solve problems such as low amount, convenience change and the like

Inactive Publication Date: 2015-09-16
CIPLA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Although the prior art described above covers various techniques for the preparation of stable tiotropium bromide formulations, the use of lower amounts of excipients, specific types of containers and valves limits the ease of preparation and alters the cost

Method used

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  • Pharmaceutical composition
  • Pharmaceutical composition
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] method

[0083] 1) Homogenize tiotropium bromide with a portion of HFA-227.

[0084] 2) Transfer the suspension obtained in step (1) to a mixing vessel, and add enough HFA-227 to it to make up to the required tank volume.

[0085] 3) The resulting suspension is then mixed, recycled, and filled into pre-bent aluminum cans.

Embodiment 2

[0088] method

[0089] 1) Homogenize tiotropium bromide with lactose and a portion of HFA-227.

[0090] 2) Transfer the suspension obtained in step (1) to a mixing vessel, and add enough HFA-227 to it to make up to the required tank volume.

[0091] 3) The resulting suspension is then mixed, recycled, and filled into pre-bent aluminum cans.

Embodiment 3

[0094] method:

[0095] 1) Dissolve PEG and PVP in HFA-227.

[0096] 2) Homogenize tiotropium bromide with lactose and a portion of HFA-227.

[0097] 3) Transfer the suspension obtained in step (2) to a mixing vessel, and add enough HFA-227 to it to make up to the required tank volume.

[0098] 4) The resulting suspension is then mixed, recycled, and filled into pre-bent aluminum cans.

[0099] "q.s" as used in the above table refers to the quantity of propellant to fill the required inhaler volume, excluding the volumes of other components mentioned.

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Abstract

The present invention relates to a pharmaceutical composition comprising tiotropium, a hydrofluoroalkane (HFA) propellant, and optionally one or more pharmaceutically acceptable excipients; to a process for preparing such a pharmaceutical composition, and the use thereof in medicine, in particular for the prophylaxis and treatment of respiratory disorders.

Description

field of invention [0001] The present invention relates to stable pharmaceutical compositions comprising tiotropium bromide and at least one hydrofluoroalkane (HFA) propellant. The invention also relates to a process for the preparation of said pharmaceutical composition and its use for the treatment of asthma, COPD and other respiratory disorders. Background technique [0002] Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease with increasing prevalence worldwide. In India, the estimated prevalence is about 12.36 million people. It is currently the fourth leading cause of death in the UK and US and is expected to rank third in the 'global impact of the disease' by 2020. [0003] Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. Airflow obstruction is usually progressive and is associated with an abnormal inflammatory response of the lungs t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/46A61P11/06A61P11/08
CPCA61K9/008A61K31/439A61K31/46A61K47/06A61P11/00A61P11/06A61P11/08A61P11/14A61P43/00A61K2300/00
Inventor 吉娜·马尔霍特拉史瑞尼瓦·普瑞达尔
Owner CIPLA LTD
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