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US 2006/0216351 A1Published application
Pharmaceutical Compositions of Dispersions of Drugs and Neutral Polymers
AssigneePfizer Inc.
InventorsDwayne Friesen, Michael Gumkowski, Rodney Ketner, Douglas Lorenz, James Nightingale, Ravi Shanker, James West
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Abstract
In one aspect, pharmaceutical compositions comprising dispersions of an acid-sensitive drug and a neutral dispersion polymer are disclosed. The acid-sensitive drug has improved chemical stability relative to dispersions of the drug and acidic polymers. In another aspect, pharmaceutical compositions of low-solubility drugs and amphiphilic, hydroxy-functional vinyl copolymers are disclosed.
Claims21
1-76. (canceled)
A pharmaceutical composition comprising a solid amorphous dispersion comprising
- (i) an acid-sensitive drug;
- (ii) a neutral concentration-enhancing dispersion polymer:
- and
- (iii) optionally, an excipient selected from the group consisting of a base and a buffer;
- wherein
- (a) said dispersion is substantially homogeneous and is formed by spray-drying;
- (b) said drug in the absence of said polymer has a minimum solubility in aqueous solution of less than 1 mg/ml at any pH of from about 1 to 8;
- and
- (c) said polymer is cellulosic and is selected from the group consisting of HPMC and HPMCA;
- wherein said composition provides improved chemical stability relative to a control composition comprised of either an equivalent quantity of a dispersion of said drug and an acidic polymer or of an equivalent quantity of a dispersion of said drug and said neutral polymer but free from said base and said buffer.
7 more elements
Dependencies are inferred from the claim text.