Method for making homogeneous spray-dried soild amorphous drug dispersions utilizing modified spray-drying apparatus
AssigneePfizer 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.
Claims25
A process for producing a pharmaceutical composition comprising the steps:
- (a) forming a feed solution comprising a drug, a concentration-enhancing 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) gas-dispersing means for dispersing said drying gas into said drying chamber, said gas-dispersing means causing organized plug flow of said drying gas,
- 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
- 10 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 amorphous dispersion of said drug and said concentration-enhancing polymer;
- and
- (e) collecting said particulates,
- wherein said concentration-enhancing polymer is present in said solution in an amount sufficient that said solid amorphous dispersion provides concentration enhancement of said drug in a use environment relative to a control composition consisting essentially of an equivalent amount of said drug alone.
A composition comprising a plurality of solid amorphous dispersion particles comprising a drug and a polymer wherein said particles have an average diameter of at least 40 μm and a bulk specific volume of less than 5 mL/g, and wherein at least 80 vol % of said particles have diameters of greater than 10 μm.
Dependencies are inferred from the claim text.