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US 8,343,550 B2Granted
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
Estimating the term…
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.
Claims19
A process for producing a pharmaceutical composition comprising the steps:
- (a) forming a feed solution comprising a drug, a polymer 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 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 dispersion of said drug and said polymer;
- and
- (e) collecting said particulates.
20 more elements
A process for producing a pharmaceutical composition comprising the steps:
- (a) forming a feed solution comprising a drug, a polymer 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,
- (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, and
- (iv) a gas dispersing means for dispersing said gas into said drying chamber such that the primary axis of flow of said drying gas is parallel to the axis of said atomizing means;
- wherein
- Vdryer is measured in m3,
- H is at least 1 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 dispersion of said drug and said polymer;
- and
- (e) collecting said particulates.
21 more elements
A process for producing a pharmaceutical composition comprising the steps:
- (a) forming a feed solution comprising a drug, a polymer 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,
- (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, and
- (iv) a gas dispersing means for dispersing said gas into said drying chamber such that the primary axis of flow of said drying gas is parallel to the axis of said atomizing means;
- wherein
- Vdryer is measured in m3,
- H is at least 1 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, said droplets having an average diameter of at least 50 μm and a D10 of at least 10 μm;
- (d) contacting said droplets with said heated drying gas to form particulates of a solid dispersion of said drug and said polymer;
- and
- (e) collecting said particulates.
21 more elements
Dependencies are inferred from the claim text.