| 主权项 |
1. A process for preparing inhalable powders containing a crystalline matrix forming agent, which is selected from among sugars, polyols, polymers, amino acids, proteins, di-, tri-, oligo- and polypeptides; as well as one or more pharmaceutical active substances,
characterised in that a spray solution that comprises the matrix forming agent and the pharmaceutical active substance is spray-dried, comprising the steps of: (a) dissolving one or more active substances and the matrix forming agent in water, an organic solvent or an organic-aqueous solvent mixture in order to prepare a solution with a dissolved solids content of between 1% by weight and 20% by weight, (b) spraying the solution thus obtained in the conventional manner, so as to obtain a spray mist with a droplet size having (i) the characteristic value Q(5.8) of between 50% and 100% and (ii) the average droplet size X50 in the range from 1 μm to 20 μm, (c) drying the resulting spray mist using a drying gas while applying the following parameters: (i) an entry temperature of the drying gas (1) of from 80° C. to 200° C., and (ii) subjecting the aerosol to secondary drying in the spray chamber using a second drying gas (2), the temperature of the drying gas (2) being between 200° C. and 400° C., (iii) the ratio of the volume flow of drying gas (1):drying gas (2) being between 20:1 and 3:1, (iv) the drying gas coefficient V1 being between 100 K and 2000 K and the drying coefficient V2 being between 250 K and 4000 K and (v) an exit temperature of the drying gas of from 40° C. to 90° C. and (d) separating the dried particles of solid from the current of drying gas in conventional manner. |
