Dosage form comprising fast agent delivery followed by slow agent delivery

• US 4,814,181 A
• Filed: 09/03/1987
• Issued: 03/21/1989
• Est. Priority Date: 09/03/1987
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Edgren, David E., Ayer, Atul D., Magruder, Paul R., Jordan, Maureen L.
• Primary Examiner(s): Dixon, Jr., William R.
• Assistant Examiner(s): Brunsman, David M.
• Application Number:
  US07/092,857
• Time in Patent Office: 565 Days
• Field of Search: 424/473, 424/467
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A dosage form is disclosed comprising a wall that surrounds a compartment with an exit means in the wall. The compartment comprises a first or fast releasing lamina and a second or short releasing lamina that are delivered through the exit means over two different periods of time.

Claims

1. A method for administering a beneficial agent to an animal, said method comprising:

(a) admitting into the animal dosage form comprising;

(1) a wall comprising at least in part a semipermeable composition permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent the wall surrounding;

(2) a lumen;

(3) a first lamina composition in the lumen, said first lamina composition means for forming a dispensable composition that is delivered from the dosage form in a short period of time;

(4) a second lamina composition in the lumen, said second lamina composition comprising means for forming a dispensable composition that is delivered from the dosage form over a long period of time;

(5) a beneficial agent in each lamina composition;

(6) at least one exit means through the wall connecting the exterior of the dosage form with the lumen, said exit means sized for delivering the first dispensable composition in a short period of time;

(b) imbibing fluid through the wall into each lamina composition at a rate determined by the permeability of the wall to provide fluid means for forming the dispensable composition; and

(c) delivering the dispensable composition through the passageway from the dosage form to the animal for administering the beneficial agent to produce a beneficial result.

2. The method for administering the beneficial agent to an animal according to claim 1, wherein the dosage form comprises an exit means through the wall connecting the lamina that is delivered over a long period of time with the exterior of the dosage form.

3. The method for administering the beneficial agent to an animal according to claim 1, wherein the short period of time is from 1 minute to 2 hours.

4. The method for administering the beneficial agent to an animal according to claim 1, wherein the long period of time is from 1 to 11/2 hours up to 24 hours.

5. The method for administering the beneficial agent to an animal according to claim 1, wherein the beneficial agent is a drug.

6. The method for administering the beneficial agent to an animal according to claim 1, wherein the animal is a human.

7. The method for administering the beneficial agent to an animal according to claim 1, wherein the dosage form is orally admitted into the animal.

8. The method for administering the beneficial agent to an animal according to claim 1, wherein the dispensable composition that is delivered in a short period of time is delivered first and the dispensable composition that is delivered over a long period of time is delivered thereafter.

9. A dosage form for delivering a beneficial agent to an environment of use, wherein the dosage form comprises:

(a) a wall comprising at least in part a semipermeable composition permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent, which wall surrounds and forms;

(b) a compartment;

(c) a first lamina composition in the compartment comprising means for delivering a beneficial agent from the dosage form in a short period of time;

(d) a second lamina composition in the compartment comprising means for delivering a beneficial agent from the dosage form over a long period of time;

(e) a beneficial agent selected from like and unlike beneficial agents in each lamina; and

,

(f) at least one exit means in the wall communicating the exterior of the dosage form with the compartment, said exit means shaped and sized for delivering said first dispensable composition in a short period of time, through the exit means to the environment of use.

10. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the environment of use is a warm-blooded animal.

11. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the environment of use is a human.

12. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the environment of use is a gastrointestinal tract and the dosage form is orally admitted into the gastrointestinal tract.

13. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the beneficial agent is a drug and the dosage form is a drug administration device.

14. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the first lamina composition that is delivered in a short period of time comprises a gel composition, and the second lamina composition that is delivered in a long period time comprises a different gel composition.

15. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, where the first lamina composition that is delivered in a short period of time comprises a cellulosic composition, and the second lamina composition that is delivered in a long period of time comprises a different cellulosic composition.

16. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the exit means is longer than wide.

17. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the first lamina composition that is delivered in a short period of time is initially in contact with the second lamina composition that is delivered in a long period of time.

18. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the first lamina composition lamina that is delivered in a short period of time is parallel with the second lamina composition that is delivered in a long period of time.

19. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the second lamina composition that is delivered in a long period of time is thicker than the first lamina composition that is delivered in a short period of time.

20. The dosage form for delivering the beneficial agent to the environment of use according to claim 9, wherein the second lamina composition that is delivered in a long period of time comprises at least one polymeric member exhibiting a larger molecular weight than a polymeric member in the first lamina composition that is delivered in a short period of time.