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Claims for Patent: 4,662,880

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Claims for Patent: 4,662,880

Title: Pseudoephedrine, brompheniramine therapy
Abstract:A dosage form is disclosed for delivering the beneficial drugs pseudoephedrine and brompheniramine to a biological environment of use.
Inventor(s): Hamel; L. G. (Sunnyvale, CA), Landrau; Felix A. (Miliptas, CA), Wong; Patrick S. L. (Hayward, CA), Guittard; George V. (Cupertino, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:06/839,384
Patent Claims: 1. A dosage form for delivering the beneficial drugs pseudoephedrine and brompheniramine to an environment of use, the dosage form comprising:

(a) a wall comprising cellulose triacetate and hydroxypropylcellulose, which wall is permeable to the passage of fluid present in the environment, substantially impermeable to the passage of drug, and surrounds and defines;

(b) a compartment;

(c) a dosage amount of pseudoephedrine and brompheniramine in the compartment;

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

(e) a lamina comprising pseudoephedrine, brompheniramine and hydroxypropylmethylcellulose in laminar arrangement with the exterior of the wall; and,

(f) wherein when the dosage form is in operation, the dosage form codelivers pseudoephedrine and brompheniramine at a ratio greater than their mutual equilibrium solubility in fluid that enters the dosage form.

2. A dosage form for delivering the beneficial drugs pseudoephedrine and brompheniramine to an environment of use, the dosage form comprising:

(a) a wall comprising cellulose triacetate and hydroxypropylcellulose, which wall is permeable to the passage of fluid present in the environment of use, substantially impermeable to the passage of drug, and surrounds and defines:

(b) a compartment;

(c) a dosage amount of pseudoephedrine and brompheniramine in the compartment, said drugs present in a mass ratio of from 8:1 to 20:1;

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

(e) a lamina comprising pseudoephedrine, brompheniramine and hydroxyproplmethylcellulose in laminar arrangement with the exterior of the wall; and,

(f) wherein when the dosage form is in operation, the dosage form codelivers pseudoephedrine and brompheniramine in a mass ratio of from 8:1 to 20:1 to the environment of use.

3. The dosage form for delivering the beneficial drugs to the environment of use according to claim 2, wherein pseudoephedrine is present as its pharmaceutically acceptable salt.

4. The dosage form for delivering the beneficial drugs to the environment of use according to claim 2, wherein brompheniramine is present as its pharmaceutically acceptable salt.

5. A dosage form for delivering the beneficial drugs pseudoephedrine and brompheniramine to a warm-blooded animal, wherein the dosage form comprises:

(a) a wall comprising cellulose triacetate and hydroxypropylcellulose, which wall surrounds and forms;

(b) a compartment;

(c) a dosage amount of 170 to 200 mg of pseudoephedrine and 10 to 20 mg of brompheniramine in the compartment;

(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 pseudoephedrine, 5 to 8 mg of brompheniramine and hydroxypropylmethylcellulose in lamina arrangement with the exterior of the wall; and,

(f) wherein when the dosage form is in operation the dosage form codelivers from the compartment pseudoephedrine and brompheniramine in a mass ratio of 10:1 to 15:1 which ratio corresponds to their initial ratio in the compartment.

6. The dosage form for delivering the beneficial drugs according to claim 5, wherein the compartment comprises 180 mg of pseudoephedrine hydrochloride.

7. The dosage form for delivering the beneficial drugs according to claim 5 wherein the compartment comprises 10 mg of brompheniramine maleate.

8. The dosage form for delivering the beneficial drugs according to claim 5, wherein the lamina comprises 60 mg of pseudoephedrine hydrochloride.

9. The dosage form for delivering the beneficial drugs according to claim 5, wherein the lamina comprises 6 mg of brompheniramine maleate.

10. A dosage form for delivering the beneficial drugs pseudoephedrine and brompheniramine to a warm-blooded animal, wherein the dosage form comprises:

(a) a wall comprising cellulose triacetate and hydroxypropylcellulose, which wall surrounds and defines;

(b) a compartment;

(c) a dosage amount of 80 to 110 mg of pseudoephedrine and 3 to 8 mg of brompheniramine in the compartment;

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

(e) a lamina comprising 25 to 35 mg of pseudoephedrine, 2 to 5 mg of brompheniramine and hydroxypropylmethylcellulose coated onto the exterior surface of the wall; and,

(f) wherein when the dosage form is in the animal, the dosage form codelivers from the compartment pseudoephedrine and brompheniramine in a mass ratio of 10:1 to 15:1 which corresponds to their initial ratio in the compartment.

11. The dosage form for delivering the beneficial drugs according to claim 10, wherein the compartment comprises 90 mg of pseudoephedrine hydrochloride.

12. The dosage form for delivering the beneficial drugs according to claim 10, wherein the compartment comprises 3 mg of brompheniramine maleate.

13. The dosage form for delivering the beneficial drugs according to claim 10, wherein the lamina comprises 30 mg of pseudoephedrine hydrochloride.

14. The dosage form for delivering the beneficial drugs according to claim 10, wherein the lamina comprises 3 mg of brompheniramine maleate.
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