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US 2015/0028503 A1Published application
Method for making homogeneous spray-dried solid amorphous drug dispersions utilizing modified spray-drying apparatus
AssigneeBend Research, Inc.
InventorsRonald A. Beyerinck, Heather L. M. Deibele, Dan E. Dobry, Roderick J. Ray, Dana M. Settell, Ken R. Spence
Life of this patent
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Abstract
Conventional spray-drying methods are improved by incorporation of a pressure nozzle and a diffuser plate to improve the flow of drying gas and a drying chamber extension to increase drying time, such improvements leading to the formation of homogeneous solid dispersions of drugs in concentration-enhancing polymers.
Claims8
A process for producing a pharmaceutical composition comprising the steps:
- (a) forming a feed solution comprising a drug, hydroxypropyl methyl cellulose acetate succinate, and a solvent;
- (b) directing said feed solution to a spray-drying apparatus comprising
- (i) a drying chamber having a volume Vdryer and a height H,
- (ii) atomizing means for atomizing said feed solution into droplets, and
- (iii) a source of heated drying gas for drying said droplets, said source delivering said drying gas to said drying chamber at a flow rate of G,
- wherein Vdryer is measured in m3,
- H is at least 1.0 m,
- G is measured in m3/sec,
- and wherein the following mathematical relationship is satisfied
- V
- dryer
- G
- ≥
- 10
- seconds;
- (c) atomizing said feed solution into droplets in said drying chamber by said atomizing means;
- (d) contacting said droplets with said heated drying gas to form particulates of a solid amorphous dispersion of said drug homogeneously distributed throughout said polymer;
- and
- (e) collecting said particulates.
16 more elements
Dependencies are inferred from the claim text.