Replacement of Chlorofluorocarbons (cfc) in Metered Dose Inhalation Products
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Additional Notes This guideline is intended to facilitate companies in compiling the dossier for submission for the replacement of a CFC propellant in an already authorised medicinal product. It identifies the considerations of quality, safety and efficacy which should be taken into account. The need for this guideline has been accentuated by the imminent lack of availability of existing replacements for CFC propellants for these important medicinal products.
منابع مشابه
The CFC to HFA transition and its impact on pulmonary drug development.
The terms of the Montreal Protocol have eliminated chlorofluorocarbons (CFCs) and other ozone-depleting agents from commercial use, with the exemption of their use as propellants in metered-dose inhalers. Two new propellants have been approved for CFC substitutes: hydrofluoroalkane (HFA)-134a and HFA-227. An extensive safety program was conducted by the International Pharmaceutical Aerosol Cons...
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متن کاملReview of therapeutically equivalent alternatives to short acting beta(2) adrenoceptor agonists delivered via chlorofluorocarbon-containing inhalers.
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تاریخ انتشار 1998