Method of obtaining a dry amorphous product, dry amorphous product obtained thereby and method of stbilising a bilogically active material

摘要

A solution or suspension containing a biologically active material and a stabilizer comprising a zwitterion and optionally a carbohydrate is dried by convection drying under controlled conditions to give an amorphous product with improved stability. Production of a dry, amorphous product comprises: (i) preparing a solution or suspension of a biologically active material, especially a therapeutically active material, and a stabilizer comprising; (a) a mixture of a carbohydrate and at least 1 zwitterion having polar or apolar groups or one of its derivatives; and/or (b) at least 2 zwitterions having polar or apolar groups or one of their derivatives; and/or (c) (a salt of) 1 or more zwitterions having polar or apolar groups or (of) their derivatives; and (ii) drying the solution or suspension by convection drying at a relative humidity below 70% in the stationary phase at an inlet temperature of below 300 degrees C. An Independent claim is also included for amorphous or partly amorphous products containing a biologically active material and a stabilizer with a glass transition temperature of at least 20 degrees C and a residual moisture content of below 8% (g/g) obtained by the process.