Fluticasone Propionate/Salmeterol/Albuterol (Generic Drug Development)

In recent years, there has been increased interest in the development of generic OIPs as the patents on the original formulations expire.

This generic drug development has led to the reintroduction into the Pharmacopoeia of some of the test methods employed in the development of the original drugs.

This section describes three such methods, and the test equipment required to perform them, now embedded in USP and relating to fluticasone propionate (aerosol and powder), salmeterol (powder) and fluticasone propionate/salmeterol combinations (aerosol and powder) respectively.

The test equipment concerned comprises two Glass Sample Collection Apparatuses for the DDU testing of aerosols (MDIs) and powders (DPIs) and a modified Andersen Cascade Impactor (ACI) for APSD studies.

Further test equipment is described to meet the new proposed monograph requiring a special Glass Sample Collection Apparatus for DDU testing and a modified ACI for APSD studies that is currently undergoing in-process revision for Albuterol Inhalation Aerosol products.

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