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Claims for Patent: 5,616,346

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Claims for Patent: 5,616,346

Title: Non-aqueous colonic purgative formulations
Abstract:Orally administered colonic purgative formulations and methods of its use for effecting partial or complete purgation of the colon in mammals, the formulations consisting of non-aqueous admixtures of monobasic, dibasic and tribasic sodium phosphates administered in tablet or capsule form in concentrations of from 0.01 to 0.85 grams per kilogram body weight. Preferred embodiments include the addition of binders, dispersants and buffers which do not adversely affect osmolality or effectiveness of the purgative formulations.
Inventor(s): Aronchick; Craig A. (Penn Valley, PA)
Assignee:
Application Number:08/669,834
Patent Claims: 1. An orally administrable composition capable of dispersal in the stomach for inducing purgation of the colon in humans consisting essentially of an effective colonic purgative amount of at least one sodium phosphate salt wherein said composition is in a non-aqueous form selected from the group consisting of tablets and gelatin capsules and wherein one or more additives selected from the group consisting of buffering agents, dispersal agents and binding agents are optionally present.

2. The composition in claim 1 wherein said sodium phosphate salt is monobasic sodium phosphate and further wherein the concentration of said salt is from approximately 70 to 73 percent by weight.

3. The composition of claim 1 wherein said sodium phosphate salt is dibasic sodium phosphate and further wherein the concentration of said salt is from approximately 26 to 30 percent by weight.

4. The composition of claim 1 wherein said sodium phosphate salt is a mixture of monobasic sodium phosphate in a concentration range from approximately 70 to 73 percent by weight and-dibasic sodium phosphate in a concentration range from approximately 26 to 30 percent by weight.

5. The composition of claim 1 wherein said sodium phosphate salt is a mixture of monobasic sodium phosphate, dibasic sodium phosphate and tribasic sodium phosphate.

6. The composition of claim 5 wherein a buffering agent is present and is selected from the group consisting of magnesium hydroxide, aluminum hydroxide, calcium carbonate and magnesium carbonate.

7. The composition of claim 5 wherein a buffering agent is present and is selected from the group consisting of anhydrous lactose, microcrystalline cellulose and AC-DI-SOL.

8. The composition of claim 5 wherein a buffering agent is present and is selected from the group consisting of non-ionic detergents, mechanical adhesives and microcrystalline cellulose.

9. A method of inducing purgation in the colon of humans comprising the steps of:

(a) preparing a non-aqueous mixture consisting essentially of at least one sodium phosphate salt to form a purgative formulation;

(b) forming an orally administrable, dry dosage form of said purgative formulation;

(c) orally administering a pharmaceutically effective amount of said formulation to a human without dispersing said dry dosage form into water prior to administration; and

(d) allowing said administered dry dosage form to induce purgation.

10. The method of claim 9 wherein step (a) further includes the step of adding to said purgative formulation at least one member selected from the group consisting of buffering agents, dispersal agents and binders.

11. The method of claim 9 wherein said orally administrable dosage form is selected from the group consisting of gelatin capsules and tablets.

12. The method of claim 9 wherein the admixture formed in step (a) includes monobasic sodium phosphate and dibasic phosphate.

13. The method of claim 12 wherein said monobasic sodium phosphate is administered at rate of from about 0.4 grams per kilogram body weight to 0.85 grams per kilogram body weight.

14. The method of claim 12 Wherein said dibasic sodium phosphate is administered at a rate of from about 0.1 grams per kilogram body weight to 0.5 grams per kilogram body weight.

15. The method of claim 9 wherein said sodium phosphate salt is tribasic sodium phosphate.

16. The method of claim 9 wherein said sodium phosphate salt is dibasic sodium phosphate and at least one member selected from the group consisting of monobasic sodium phosphate and tribasic sodium phosphate.

17. A method of inducing purgation of the colon in mammals comprising the steps of:

(a) preparing a non-aqueous admixture of approximately 72% by weight monobasic and approximately 26% by weight dibasic sodium phosphate salts to form a purgative formulation;

(b) forming orally administrable tablets of said purgative formulation;

(c) orally administering said tablets to said mammal at a rate of from 0.1 to 0.5 grams per kilogram body weight of dibasic sodium phosphate; and

(d) allowing said administered dosage to induce purgation.

18. The method of claim 17 wherein step (c) is repeated at least once.

19. An orally administrable, nonaqueous composition capable of dispersal within the stomach for inducing purgation in the colon of humans comprising an effective colonic purgative amount of approximately 70 to 73% monobasic sodium phosphate, approximately 26 to 30% dibasic sodium phosphate and approximately 1 to 4% inert additives selected from the group consisting of tablet binders, dispersants and buffering agents, wherein said composition is in a form selected from the group consisting of tablets and gelatin capsules.
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