Osmotic drug delivery system

• US 4,439,196 A
• Filed: 03/18/1982
• Issued: 03/27/1984
• Est. Priority Date: 03/18/1982
• Status: Expired due to Term

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Higuchi, Takeru
• Primary Examiner(s): Padgett, Benjamin R.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/359,447
• Time in Patent Office: 740 Days
• Field of Search: 604/890-900, 424/19-25
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic drug (or other beneficial substance) delivery system comprises a multi-chamber compartment formed by an external shell and one or more chamber-dividing walls each with a small orifice, of a microporous material and overlayers of semipermeable membranes completely covering the outer shell of all but one chamber and substantially covering the outer shell of the remaining chamber. Osmotic agents, adjuvants, enzymes, drugs, pro-drugs, pesticides and the like are incorporated in the chambers covered by the semipermeable membrane, and external fluids that diffuse into those chambers form solutions and by osmotic pressure are forced through the orifice to the drug chamber to form a solution thereof and then through the exposed microporous shell to the exterior of the device at a rate controlled by the permeability of the semipermeable overlay and the osmotic pressure gradient across the shell.

Claims

1. An osmotic delivery system shaped and sized for oral ingestion, implantation, rectal, vaginal or ocular insertion, for delivery of a drug or other beneficial substance comprising a compartment consisting of 2 or more chambers in series, the chambers being adapted to house osmotically active agents, adsorption adjuvants, drugs, and pro-drugs, the chambers being formed by an external shell and 1 or more chamber-dividing walls, each chamber-dividing wall having a micro-orifice connecting adjacent chambers, the external shell and chamber-dividing walls being of a rigid microporous material;

one or more succesive overlayers of a semipermeable membrane, the first overlayer completely covering the external shell of all but one chamber and substantially covering the external shell of the one chamber leaving exposed a microporous drug-emitting surface; and

each successive overlayer completely covering all but one more chamber and substantially covering the one more chamber; and

optionally including a quick release loading dose of drug external to and covering the microporous drug-emitting surface.

2. The osmotic delivery system of claim 1 shaped and sized for oral ingestion, implantation, rectal, vaginal or ocular insertion, for delivery of a drug or other beneficial substance comprising a compartment with 2 or 3 chambers in series, the chambers being adapted to house osmotically active agents, adsorption adjuvants, drugs, and pro-drugs, the chambers being formed by an external shell and 1 or 2 chamber-dividing walls, each chamber-dividing wall having a micro-orifice connecting adjacent chambers, the external shell and chamber-dividing walls being of a rigid microporous material;

an overlayer of a semipermeable membrane completely covering the external shell of all but one chamber and substantially covering the external shell of the remaining chamber; and

in the embodiment with 3 chambers, an additional overlayer completely covering the external shell and first overlayer of one chamber and substantially covering the external shell and first overlayer of the second chamber; and

optionally including a quick release loading dose of drug external to and covering the microporous drug-emitting surface.

3. The osmotic delivery system of claim 1 shaped and sized for oral ingestion, implantation, rectal, vaginal or ocular insertion, for delivery of a drug or other beneficial substance comprising a compartment with 2 chambers formed by an external shell and a chamber-dividing wall, the chamber-dividing wall having a micro-orifice connecting the adjacent chambers, the external shell and chamber-dividing wall being of a rigid microporous material;

and an overlayer of a semipermeable membrane completely covering the external shell of one chamber and substantially covering the external shell of the remaining chamber and optionally including a quick release loading dose of drug external to and covering the microporous drug-emitting surface.

4. The delivery system of claim 1 wherein the microporous material of the external shell and the semipermeable membranes of the overlayers are fabricated from a cellulose acetate.

5. The delivery system of claim 2, wherein the microporous material of the external shell and the semipermeable membrane of the overlayer are fabricated from a cellulose acetate.

6. The delivery system of claim 3, wherein the microporous material of the external shell and the semipermeable membrane of the overlayer are fabricated from a cellulose acetate.

7. The delivery system of claim 1, wherein the micro-orifice connecting the chamber with the drug-emitting surface and the adjacent chamber is a pressure actuated controlling valve.

8. The delivery system of claim 2 wherein the micro-orifice connecting the chamber with the drug-emitting surface and the adjacent chamber is a pressure actuated controlling valve.

9. The delivery system of claim 3 wherein the micro-orifice is a pressure actuated controlling valve.

10. The delivery system of claim 4, wherein the micro-orifice connecting the chamber with the drug-emitting surface and the adjacent chamber is a pressure actuated controlling valve.

11. The delivery system of claim 5, wherein the micro-orifice connecting the chamber with the drug-emitting surface and the adjacent chamber is a pressure actuated controlling valve.

12. The delivery system of claim 6, wherein the micro-orifice is a pressure actuated controlling valve.

13. The delivery system of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 comprising 2 chambers wherein the first chamber is adapted to house an osmotically active agent and the second chamber is adapted to house a drug or other beneficial substance.

14. The delivery system of claims 1, 2, 4, 5, 7, 8, 10, or 11 comprising 3 chambers wherein the first chamber is adapted to house a composition comprising an absorption adjuvant, the middle chamber is adapted to house a composition comprising an osmotically active agent and the third chamber is adapted to house a composition comprising a drug or other beneficial substance.