Process for preparing crystalline micronisate, crystalline tiotropium bromide micronisate and its use for preparing a pharmaceutical composition and such composition as inhalable powder

摘要

A novel crystalline, micronized form (I) of tiotropium bromide (TTB) has particle size X 5 0 of 1-3.5 Microm, a Q ( 5.8) value of more than 60%, a specific surface of 2-5 m 2/g, a specific heat of solution of more than 65 Ws/g and a water content of 1-4.5%. Independent claims are also included for: (1) the production of (I); (2) medicaments (specifically inhalable powders) containing (I); (3) preparation of inhalable powders; and (4) capsules (inhalettes') containing inhalable powders. ACTIVITY : Antiasthmatic; antiinflammatory. MECHANISM OF ACTION : Anticholinergic.