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US 8,617,602 B2Granted
Immediate release compositions and methods for delivering drug formulations using weak acid ion exchange resins in abnormally high pH environments
OwnerWilliam Wayne Howard, Russell Francis Somma +4inventors
InventorsWilliam Wayne Howard, Russell Francis Somma, Sajeev Chandran, Pravin Megharji Bhutada, Ashish Ashokkao Deshmukh, Hemant Hanumant Bhalerao
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Abstract
Multi-layer solid oral dosage immediate release and extended release compositions and methods for delivering drug formulations using weak acid ion exchange resins in abnormally high pH environments.
Claims9
A multi-layer solid oral pharmaceutical composition comprising;
- (i) a first distinct layer comprising:
- (a) a first pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate;
- and
- (b) a release-enhancing agent consisting of FeCl3;
- (ii.) at least a second distinct layer comprising:
- (a) a drug selected from the group consisting of said first pharmaceutically active agent and a second pharmaceutically active agent, said drug being bound to a strong acid ion exchange resin to form a strong acid ion-exchange resinate;
- and
- (b) optionally, a coating to slow and extend release of the drug contained therein;
- wherein said pharmaceutical composition is capable of immediate release of said first pharmaceutically active agent from said weak acid resinate at a pH of at least 1.5, immediate release being defined as at least 80% release of said pharmaceutically active agent within 45 minutes in a standard dissolution apparatus according to USP 34 NF 26 section 711;
- and,
- wherein release of the drug from said strong acid resinate continues over a period of at least 8 hours after ingestion.
8 more elements
A method of treating a patient with a stomach pH of at least about 1.5 comprising administration of a multilayer solid oral dosage form said dosage form comprising:
- (i) a first distinct layer comprising:
- (a) a first pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate;
- and
- (b) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;
- (ii.) at least a second distinct layer comprising:
- (a) a drug selected from the group consisting of said first pharmaceutically active agent and a second pharmaceutically active agent, said drug being bound to a strong acid ion exchange resin to form a strong acid ion-exchange resinate;
- and,
- (b) optionally, a coating to slow and extend release of the drug contained therein;
- wherein said pharmaceutical composition is capable of immediate release of said first pharmaceutically active agent from said weak acid resinate at a pH of at least 1.5, immediate release being defined as at least 80% release of said pharmaceutically active agent within 45 minutes in a standard dissolution apparatus according to USP 34 NF 26 section 711;
- and,
- wherein release of the drug from said strong acid resinate continues over a period of at least 8 hours after ingestion.
8 more elements
A method of treating a patient having a first condition and a second condition with a pharmaceutically active agent effective for treating said second condition, said method comprising the step of administering a solid oral dosage pharmaceutical composition, said solid oral dosage pharmaceutical composition comprising:
- (i) a first distinct layer comprising:
- (a) a first pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate;
- and,
- (b) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;
- (ii.) at least a second distinct layer comprising:
- (a) pharmaceutically active agent selected from the group consisting of said first pharmaceutically active agent and a second pharmaceutically active agent, said pharmaceutically active agent bound to a strong acid ion exchange resin to form a strong acid ion-exchange resinate;
- and,
- (b) optionally, a coating to slow and extend release of the drug contained therein;
- wherein said pharmaceutical composition is capable of immediate release of said first pharmaceutically active agent from said weak acid resinate at a pH of at least 1.5, immediate release being defined as at least 80% release of said pharmaceutically active agent within 45 minutes in a standard dissolution apparatus according to USP 34 NF 26 section 711;
- and,
- wherein release of the drug from said strong acid resinate continues over a period of at least 8 hours after ingestion;
- and
- wherein said first condition is selected from the group consisting of Helicobacter pylori infection, atrophic gastritis, hypochlorhydria and achlorhydria in the stomach;
- and wherein said second condition is a condition other than said first condition.
11 more elements
A method of treating a patient wherein the patient has within the past 24 hours been administered a compound selected from the group consisting of a proton pump inhibitor, an H2 receptor antagonist, and an antacid, said method comprising the step of administering a solid oral dosage pharmaceutical composition, said solid oral dosage pharmaceutical composition comprising:
- (i) a first distinct layer comprising:
- (a) a first pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate;
- and;
- (b) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;
- (ii.) at least a second distinct layer comprising:
- (a) pharmaceutically active agent selected from the group consisting of said first pharmaceutically active agent and a second pharmaceutically active agent, said pharmaceutically active agent bound to a strong acid ion exchange resin to form a strong acid ion-exchange resinate, and
- (b) optionally, a coating to slow and extend release of the drug contained therein;
- wherein said pharmaceutical composition is capable of immediate release of said first pharmaceutically active agent from said weak acid resinate at a pH of at least 1.5, immediate release being defined as at least 80% release of said pharmaceutically active agent within 45 minutes in a standard dissolution apparatus according to USP 34 NF 26 section 711;
- and,
- wherein release of the drug from said strong acid resinate continues over a period of at least 8 hours after ingestion.
7 more elements
A method of delivering a pharmaceutically active agent to a patient, said method comprising orally administering a solid oral dosage composition comprising:
- (i) a first distinct layer comprising:
- (a) a first pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate;
- and
- (b) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;
- (ii.) at least a second distinct layer comprising:
- (a) pharmaceutically active agent selected from the group consisting of said first pharmaceutically active agent and a second pharmaceutically active agent, said pharmaceutically active agent bound to a strong acid ion exchange resin to form a strong acid ion-exchange resinate;
- and,
- (b) optionally, a coating to slow and extend release of the drug contained therein;
- wherein said pharmaceutical composition is capable of immediate release of said first pharmaceutically active agent from said weak acid resinate at a pH of at least 1.5, immediate release being defined as at least 80% release of said pharmaceutically active agent within 45 minutes in a standard dissolution apparatus according to USP 34 NF 26 section 711;
- and,
- wherein release of the drug from said strong acid resinate continues over a period of at least 8 hours after ingestion.
8 more elements
Dependencies are inferred from the claim text.