Ban of CFC in Inhalers Spurs Product Innovation

The respiratory disposables and reusable respiratory accessories market is undergoing a dramatic change caused in part by a recent U.S. government regulation that bans the use of chlorofluorocarbon (CFC) in inhalers.

A new report by Kalorama Information (New York, NY, USA) has found that more than 95% of inhalers used today contain ozone-depleting CFC as a propellant. To abide by international environmental guidelines, the United States released a new policy in 2005 that decreed that CFCs must be removed from inhalers by December 31, 2008, and be replaced with hydrofluoroalkane (HFA). As a result, inhaler equipment suppliers and pharmaceutical companies have been collaborating to face the phase-out, and are undertaking compound stability and product compatibility tests as a requirement for approval by the U.S. Food and Drug Administration (FDA). These new non-CFC inhalers will not see generic competition until they come off patent starting in 2010, and are therefore predicted to cost about twice as much as CFC inhalers. As a result, inhalers, which make up the lion's share of the U.S. US$36 billion market for respiratory devices, are expected to enjoy a strong 9.8% annual growth rate through 2012, spurred in part by new product innovations following the CFC ban.

"Compliance could be a blessing in disguise for inhaler companies,” said research analyst Joe Constance of Kalorama Information. "Until December 2007, companies with CFC-based products were allowed to market their product, so they have had sufficient time to take the necessary steps to shift towards HFA based products. And the companies did not need to make any significant changes in their manufacturing processes in order to abide by this new government regulation.”

HFA inhalers are designed to give the same dose of albuterol as current CFC inhalers. However, since HFAs are a different type of propellant, the albuterol HFA inhalers may taste and feel different. The force of the spray may feel softer from albuterol HFA than from albuterol CFC inhalers, and often hits the back of the mouth as a fine mist. Importantly, albuterol HFA inhalers have to be cleaned, dried, and primed to supply the right dose of medicine.

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