Immediate release compositions and methods for delivering drug formulations using weak acid ion exchange resins in abnormally high pH environments

1. A solid oral dosage pharmaceutical composition comprising:

(i) at least one pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate; and

(ii) a release-enhancing agent consisting of FeCl 3 ;

wherein said pharmaceutical composition is capable of immediate release of said pharmaceutically active agent from said 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 31 NF 26 section 711.

2. The solid oral dosage pharmaceutical composition of claim 1 , wherein said weak add ion exchange resin is terminated in a carbonic acid moiety.

3. The solid oral dosage pharmaceutical composition of claim 1 useful for oral administration.

4. The solid oral dosage pharmaceutical composition of claim 1 , useful for patients having a condition selected from the group consisting of (original) Helicobacter pylori infection and atrophic gastritis.

5. The solid oral dosage pharmaceutical composition of claim 1 useful for administration to a patient within 24 hours of administration to said patient of a compound selected from the group consisting of a proton pump inhibitor, an H2 receptor antagonist, and an antacid.

6. The solid oral dosage pharmaceutical composition of claim 1 useful for administration to a patient having a condition selected from the group consisting of hypochlorhydria and achlorhydria in the stomach.

7. A solid oral dosage pharmaceutical composition comprising:

(i) at least one pharmaceutically active went bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate; and

(ii) a release-enhancing agent, wherein said release-enhancing agent is an organic base selected from the group consisting of thymine, guanine, and cytosine; and

wherein said pharmaceutical composition is capable of immediate release of said pharmaceutically active agent from said resinate at a pH of at least 1.5, immediate release being as at least 80% release of said pharmaceutically active agent within 45 minutes in a standard dissolution apparatus according to USP 31 NF 26 section 711.

8. The solid oral dosage pharmaceutical composition of claim 1 , wherein said composition is formulated as a member of the group consisting of a capsule, a powder, a thin film, a caplet and a tablet.

9. The solid oral dosage pharmaceutical composition of claim 8 , wherein said composition is formulated as a capsule.

10. The solid oral dosage pharmaceutical composition of claim 8 , wherein said composition is formulated as a tablet.

11. The solid oral dosage pharmaceutical composition of claim 1 , further comprising a second ion exchange resin; wherein said second ion exchange resin is bound to a pharmaceutically active agent and is coated with an extended release coating.

12. The solid oral dosage pharmaceutical composition of claim 11 , wherein said second ion exchange resin is bound to the same pharmaceutically active agent as the first weak acid ion exchange resin.

13. A method of treating a patient with a stomach pH of at least about 1.5 comprising administration of a solid oral dosage composition, said solid oral dosage composition comprising:

(i) at least one pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate; and

(ii) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;

wherein said administration results in immediate release of said pharmaceutically active agent from said weak acid ion exchange resinate, 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 31 NF 26 section 711.

14. 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) at least one first pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate; and

(ii) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;

wherein said administration results in immediate release of said pharmaceutically agent from said weak acid ion exchange resinate, 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 31 NF 26 section 711; 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.

15. 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) at least one pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate; and

(ii) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base;

wherein said administration results in immediate release of said pharmaceutically active agent from said weak acid ion exchange resinate, immediate release being defined as at least 80% release of said pharmaceutically active within 45 minutes in a standard dissolution apparatus according to USP 31 NF 26 section 711.

16. A method of delivering a pharmaceutically active agent to a patient, said method comprising orally administering a compound selected from the group consisting of a proton pump inhibitor, an H2 receptor antagonist, and an antacid; and

a solid oral dosage pharmaceutical composition, said solid oral dosage pharmaceutical composition comprising:

(i) at least one pharmaceutically active agent bound to a weak acid ion exchange resin to form a weak acid ion-exchange resinate; and

(ii) a release-enhancing agent selected from the group consisting of an inorganic salt and an organic base; and

wherein said administration results in immediate release of said pharmaceutically active agent from said weak acid ion exchange resinate, 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 31 NF 26 section 711;

and wherein said solid oral dosage composition is administered within 24 hours of said proton pump inhibitor, H2 receptor antagonist, or antacid.