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Claims for Patent: 4,801,461

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Claims for Patent: 4,801,461

Title: Pseudoephedrine dosage form
Abstract:A dosage form is disclosed for delivering the beneficial drug pseudoephedrine to a biological environment of use.
Inventor(s): Hamel; Larry G. (Sunnyvale, CA), Landrau; Felix A. (Milpitas, CA), Guittard; George V. (Cupertino, CA), Wong; Patrick S. L. (Hayward, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:07/007,879
Patent Claims: 1. A dosage form for delivering the beneficial drug pseudoephedrine to an environment of use, the dosage form comprising:

(a) a compartment

(b) a dosage amount of about 160 to 200 mg of a member selected from the group consisting of pseudoephedrine and its therapeutically acceptable salts in the compartment;

(c) a wall comprising at least in part from 70 to 85 weight percent of a cellulose acetate comprising an acetyl content of 35% to 43.5% and from 15 to 30 weight percent hydroxypropylcellulose, which wall is permeable to the passage of an external fluid, surrounds and defines the compartment and aids in protecting pseudoephedrine present in the compartment from a premature exposure to the environment of use;

(d) at least one passageway in the wall for connecting the compartment with the exterior of the dosage form;

(e) a lamina comprising 55 to 65 mg of a member selected from the group consisting of pseudoephedrine and its therapeutically acceptable salts in laminar arrangement with the exterior of the wall; and,

(f) wherein, when the dosage form is in operation, the dosage form administers the pseudoephedrine immediately from the lamina and at a metered release rate per unit time from the compartment.

2. The dosage form for delivering the beneficial pseudoephedrine according to claim 1, wherein the pseudoephedrine is pseudoephedrine hydrochlorde.

3. The dosage form for delivering the beneficial pseudoephedrine according to claim 1, wherein the compartment comprises 10 to 30 mg of a pharmaceutically acceptable osmagent.

4. The dosage form for delivering the beneficial pseudoephedrine according to claim 1, wherein the compartment comprises 180 mg of pseudoephedrine.

5. The dosage form for delivering the beneficial pseudoephedrine according to claim 1, wherein the compartment comprises 2 to 9 mg of hydroxypropylmethycellulose.

6. The dosage for delivering the beneficial pseudoephedrine according to claim 1, wherein the compartment comprises 10 to 30 mg of microcrystalline cellulose.

7. A dosage form for delivering the beneficial drug pseudoephedrine to an environment of use, the dosage form comprising:

(a) a compartment;

(b) a dosage amount of about 80 to 115 mg of a member selected from the group consisting of pseudoephedrine and its therapeutically acceptable salts in the compartment;

(c) a wall comprising at least in part from 70 to 85 weight percent of a cellulose acetate comprising an acetyl content of 35% to 43.5% and from 15 to 30 weight percent hydroxypropylcellulose, which wall permeable to the passage of an external fluid, surrounds and defines the compartment and aids in sheltering pseudoephedrine in the compartment from a premature exposure to the environment of use;

(d) at least one passageway in the wall for connecting the compartment with the exterior of the dosage form;

(e) a lamina comprising from 25 to 35 mg of a member selected from the group consisting of pseudoephedrine and its therapeutically acceptable addition salts in laminar arrangement with the exterior of the wall; and,

(f) wherein, when the dosage form is in operation, the dosage form administers the pseudoephedrine immediately from the lamina and at a metered release rate per unit time from the compartment.

8. The dosage form for delivering the beneficial pseudoephedrine according to claim 7, wherein the pseudoephedrine is pseudoephedrine hydrochloride.

9. The dosage form for delivering the beneficial pseudoephedrine according to claim 7, wherein the compartment comprises 10 to 30 mg of a pharmaceutically acceptable osmagent.

10. The dosage form for delivering the beneficial pseudoephedrine according to claim 7, wherein the compartment comprises 2 to 9 mg of hydroxypropylmethylcellulose.

11. The dosage form for delivering the beneficial pseudoephedrine according to claim 7, wherein the compartment comprises 10 to 30 mg of microcrystalline cellulose.

12. A dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal, wherein the dosage form comprises: a wall comprising a member selected from the group consisting of cellulose acetate and cellulose triacetate for imparting physical and chemical integrity to the wall, and hydroxypropylcellulose, which wall surrounds a compartment; at least one passageway in the wall communicating with the compartment and the exterior of the dosage form; and, a therapeutic composition in the compartment comprising about 180 mg of pseudoephedrine hydrochloride, about 23 mg of sodium chloride and about 7.5 mg of hydroxypropylmethylcellulose.

13. The dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal according to claim 12, wherein the composition comprises poly(vinylpyrrolidone) and magnesium stearate.

14. The dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal according to claim 12, wherein the dosage form comprises a lamina comprising 60 mg of pseudoephedrine hydrochloride on the exterior surface of the wall.

15. A dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal, wherein the dosage form comprises: a wall comprising a member selected from the group consisting of cellulose acetate and cellulose triacetate for maintaining the physical and chemical integrity of the wall and hydroxypropylcellulose that surrounds a compartment; at least one passageway in the wall that communicates the compartment with the exterior of the dosage form; and, a therapeutic composition in the compartment comprising about 90 mg of pseudoephedrine hydrochloride, about 11.7 mg of sodium chloride and about 3.7 mg of hydroxypropylmethylcellulose.

16. The dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal according to claim 15, wherein the composition comprises poly(vinylpyrrolidone) and magnesium stearate.

17. The dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal according to claim 15, wherein the dosage form comprises a lamina comprising about 30 mg of pseudoephedrine hydrochloride on the exterior surface of the wall.

18. The dosage form for delivering the beneficial drug pseudoephedrine to a warm-blooded animal according to claim 15, wherein the passageway is a pore.

19. The dosage form for delivering the beneficial pseudoephedrine according to claim 1, wherein the cellulose acetate is cellulose triacetate.

20. The dosage form for delivering the beneficial pseudoephedrine according to claim 7, wherein the cellulose acetate is cellulose triacetate.
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