Appeal No. 2006-3379 Page 3
Application No. 10/393,549
78. A process for forming a pharmaceutical composition, comprising the steps of:
(a) forming a solution comprising a sparingly soluble drug, a
concentration-enhancing polymer, and a solvent;
(b) spray drying said solution under conditions whereby said solution is
atomized to form droplets ranging in size from 1 to 500 µm, said droplets
solidifying to form solid amorphous dispersion particles comprising said
drug and said concentration-enhancing polymer; and
(c) further drying said solid amorphous dispersion particles in a separate
drying apparatus, thereby removing residual solvent to less than 1 wt% of
said composition.
Anticipation
Claims 74-77 and 84-88 stand rejected under 35 U.S.C. § 102(b) as anticipated
by Kigoshi.1
Claim construction
Claim 74 is a process of forming a pharmaceutical composition which has four
steps. In the first step (a), a solid amorphous dispersion is formed of a sparingly soluble
drug and a concentration enhancing polymer. The amorphous dispersion is blended
with a matrix material in the second step (b). The blend in step (c) is fed “to a melt
congeal process to form a molten mixture.” Finally, in step (d), the molten mixture is
cooled, “forming solid particles each comprising said solid amorphous dispersion
particles trapped within said matrix material.”
The term “amorphous” is defined in the specification to mean “a non-crystalline
state.” Specification, page 4, lines 35-36; page 21, lines 9-15. The “concentration-
enhancing polymer” can be “cellulosic and non-cellulosic” polymers. Id., page 10,
lines 35-36. “The amorphous solid dispersion of drug may be prepared by any of the
known ways . . . including, for example, by melt fusion, by melt congealing, by
1 Kigoshi et al. (Kigoshi), EP 0 784 974 A1, published July 23, 1997
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