Boehringer Ingelheim Pharmaceuticals, Inc.

Paul Donald Jager

Jurgen Hubert Nagel

Mark James Kontny

Daniel P McNamara

Jadwiga Jachowicz

George A DeStefano

A method and apparatus for homogenizing and micronizing aerosol formulations. The method includes the steps of homogenizing and micronizing an aerosol formulation at ambient temperature in a closed apparatus where the entire apparatus is maintained under elevated pressure. The apparatus includes a closed loop containing a reaction vessel, a homogenizer and a fluid conduit interconnecting the reaction vessel and the homogenizer. The homogenizer includes an interaction chamber and an intensifier pump. The interaction chamber includes a stream splitter for separating a stream of aerosol formulation components into two streams and an impaction chamber for recombining the stream.

Method and apparatus for homogenizing aerosol formulations

Stabilized medicinal aerosol solution formulations comprising medicaments that degrade or decompose by interaction with solvents or water, an HFC propellant, a cosolvent and an acid are described. Further, specific medicinal aerosol solution formulations comprising ipratropium bromide or fenoterol, ethyl alcohol, 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoropropane, and either an inorganic acid or an organic acid are described. The acids are present in amounts sufficient to reduce the degradation of the medicaments to acceptable levels.

Stabilized medicinal aerosol solution formulations

Stabilized medicinal aerosol solution formulations containing

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Waterbury, CT, United States of America

Paul Donald Jager