May 4--Ridgefield-based Boehringer Ingelheim Pharmaceuticals is working on creating an inhaler free of chlorofluorocarbons for its Combivent respiratory medicine to conform to pending Food and Drug Administration regulations.
"It's been a very challenging process," said Emily Baier, Boehringer Ingelheim Pharmaceuticals' manager of public relations, of the company's 10-year effort. "There was a tremendous amount of trial and error involved."
Respiratory treatments containing albuterol sulfate alone can be administered with inhalers using environmentally safe hydrofluoroalkane as a propellant. But the gas cannot be used for propelling its Combivent drug, which contains ipratropium bromide and albuterol sulfate, Baier said.
"Unfortunately, we realized early on that HFA would not release the product effectively," she said.
The FDA recently extended an "essential use" exemption for prescription oral pressurized metered-dose inhalers to the end of 2013, requiring pharmaceutical companies to come up with chlorofluorocarbon-free inhalers by that time. The regulation, created in response to the 1989 Montreal Protocol on Substances that Deplete the Ozone Layer, affects seven remaining metered dose-inhalers on the market to treat asthma and chronic obstructive pulmonary disease, including Combivent.
Boehringer Ingelheim expects to have the new product on the market within the required timeframe, Baier said.
"We're fully committed to complying with the Montreal Protocol," she said, adding that the exemption will allow the company to continue supplying the product to more than two million chronic obstructive pulmonary disease patients who rely on it as a bronchodilator.
Chronic obstructive pulmonary disease, also known as COPD, is a progressive but treatable lung disease that affects 24 million Americans, according to Boehringer Ingelheim.
Inhalers using hydrofluoroalkane have presented "subtle differences" in taste and "a puff that is a little softer" compared with those using chlorofluorocarbons to dispense the product, said Sharon Schumack, director of education for the New England chapter of the Asthma and Allergy Foundation of America. The hydrofluoroalkane inhalers also have required users to clean and prime the mechanism to prevent clogging, she said.
Whether Boehringer Ingelheim will face the same issues with its proposed chlorofluorocarbon-free inhaler for Combivent has yet to be seen, Schumack said.
"It's an ongoing dilemma," she said.
Privately held Boehringer Ingelheim Pharmaceuticals is the largest U.S. subsidiary of Boehringer Ingelheim Corp., which also is based in Ridgefield, and is a member of the Boehringer Ingelheim group of companies. Based in Ingelheim, Germany, Boehringer Ingelheim has 138 affiliates in 47 countries and employs about 41,300 workers.
-----
To see more of the Connecticut Post, or to subscribe to the newspaper, go to http://www.connpost.com/.
Copyright (c) 2010, Connecticut Post, Bridgeport
Distributed by McClatchy-Tribune Information Services.
For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.