Our Role in the Pharmaceutical Industry's Transition from Ozone-Depleting Chemicals
The DuPont Company has been a leader in the development of non-ozone-depleting alternatives as chlorofluorocarbon (CFC) replacements. DuPont has been a leader not only in the research to develop nonflammable alternatives to the CFCs used in medical aerosols, but also in our commitment to the environment by discontinuing production and sale of chlorofluorocarbons.
In 1987, the Montreal Protocol provided for an Essential Use Allowance, effectively exempting many medical aerosols, such as the metered dose inhalers used in the treatment of asthma, from the CFC use ban in industrialized nations. DuPont has preferred to exit the sale of ozone-depleting propellants completely, and instead, develop more environmentally friendly alternatives, hydrofluorocarbons (HFCs) 134a and 227ea. These two propellants are nonflammable and have been the subject of extensive toxicological testing via the IPACT-I (HFC-134a) and IPACT-II (HFC-227ea) consortiums. As such, HFC-134a and HFC-227ea, purified to pharmaceutical grade, have been approved in inhalation drug products. DuPont produces and purifies both of these pharmaceutical-grade propellants as Dymel® 134a/P and Dymel® 227ea/P.
By January 2006, CFC-propelled medical aerosols will no longer be sold in Europe. The transition away from these propellants in the United States is imminently expected. Other countries, such as Canada and Japan, have already transitioned out of ozone-depleting propellants. To support the important precepts set forth by the Montreal Protocol, DuPont provides the following important support to the pharmaceutical industry in transition:
- DuPont has made investments in dedicated cGMP production facilities for both Dymel® 134a/P and Dymel® 227ea/P ahead of the industry's need.
- DuPont has submitted Drug Master Files for both propellants with regulatory agencies around the world for customers to use in their drug applications.
- DuPont provides continuing support to customers with their reformulation efforts to the new propellants.
- DuPont participates in and supports efforts of key industry associations, like the International Pharmaceutical Aerosol Consortium (IPAC).
- DuPont has submitted extensive data and analytical methods to the United States Pharmacopoeia in conjunction with the preparations of a monograph for HFC-134a.
- DuPont participates in the Expert Committee named to achieve a monograph for HFC-134a (Norflurane) by European Pharmacopoeia.
- DuPont is providing extensive data and support to the IPACT-II subconsortium to gain additional regulatory guidance for HFC-227ea.
DuPont maintains an active role in the dynamic and changing pharmaceutical aerosol industry that we have served for over 60 years. We want work as a partner with our client companies and hope to put our extensive experience, raw materials and state-of-the-art technologies at your disposal.