Stable pharmaceutical composition useful for treating gastrointestinal disorders
AssigneePharmacia Corporation
InventorsLorraine E. Pena, Dennis L. Huczek
Life of this patent
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Abstract
The present invention provides a pharmaceutical composition comprising at least one pharmaceutically acceptable bismuth-containing compound, at least one pharmaceutically acceptable non-clay-derived suspending agent, and water. The suspension exhibits reduced upward pH drift by comparison with an otherwise similar suspension which comprises a clay-derived suspending agent. Such compositions are useful in the prevention and treatment of gastrointestinal diseases and/or disorders.
Claims68
An orally deliverable pharmaceutical suspension comprising:
- (a) at least one pharmaceutically acceptable bismuth-containing compound;
- (b) at least one pharmaceutically acceptable non-clay-derived suspending agent;
- and
- (c) water;
- wherein during storage in a closed container maintained under ambient conditions for a period of at least about 5 months, the suspension exhibits reduced upward pH drift by comparison with an otherwise similar comparative suspension that comprises at least 0.1% magnesium aluminum silicate.
An orally deliverable pharmaceutical suspension comprising:
- (a) at least one pharmaceutically acceptable bismuth-containing compound;
- (b) at least one pharmaceutically acceptable non-clay-derived suspending agent;
- and
- (c) water;
- wherein the suspension comprises zero to not more than 0.08%, by weight, of a clay-derived suspending agent and wherein the suspension has a pH, measured immediately after preparation, of about 2 to about 8.
An orally deliverable pharmaceutical suspension comprising:
- (a) at least one pharmaceutically acceptable bismuth-containing compound present in a total amount of about 0.5% to about 5%, by weight;
- (b) at least one pharmaceutically acceptable non-clay-derived suspending agent present in a total amount of about 0. 1% to about 5%, by weight;
- (c) at least one pharmaceutically acceptable anti-microbial preservative present in a total amount of about 0.01% to about 5%, by weight;
- and
- (d) water;
- wherein the suspension comprises not more than 0.08% of a clay-derived suspending agent and wherein the suspension has a pH, measured immediately after preparation, of about 2 to about 8.
An orally deliverable pharmaceutical suspension comprising:
- (a) at least one pharmaceutically acceptable bismuth-containing compound;
- (b) at least one pharmaceutically acceptable non-clay-derived suspending agent;
- and
- (c) water;
- wherein during storage in a closed container maintained under ambient conditions for a period of at least about 5 months, the suspension exhibits an average increase in pH of zero to not more than 0.06/month.
Dependencies are inferred from the claim text.