Bioerodible system for delivering drug manufactured from poly(carboxylic acid)

• US 4,249,531 A
• Filed: 07/05/1979
• Issued: 02/10/1981
• Est. Priority Date: 07/05/1979
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Baker, Richard W., Heller, Jorge
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): ROSENBAUM, C FRED
• Application Number:
  US06/054,788
• Time in Patent Office: 586 Days
• Field of Search: 128/260, 128/271, 424/19-22, 424/33, 71/1, 71/65, 71/3, 71/64 F
• US Class Current: 424/426
• CPC Class Codes: A61F 6/142 Wirelike structures, e.g. loops, rings, spirals
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0039 Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A device for the controlled continuous administration of an active agent to an environment of use is disclosed. The device comprises a body of erodible agent release rate controlling material containing an agent dispersed therethrough; the rate controlling material is a hydrophobic poly(carboxylic acid) having one ionizable carboxylic hydrogen for each 8 to 12 carbon atoms, which material erodes at a controlled and continuous rate over a prolonged period of time in response to the environment by a process of carboxylic hydrogen ionization, thereby releasing the dispersed agent at a controlled rate over a prolonged period of time.

Claims

1. A surgical implant for the controlled and continuous administration of an active drug to an implant receiving animal having an essentially constant pH throughout the period of administration, the implant consisting essentially of a body sized, shaped and adapted for placement and retention in the animal, said body formed of a bioerodible drug release rate controlling material containing the active drug, the material comprising a hydrophobic poly(carboxylic acid) having one ionizable carboxylic hydrogen atom for each 8 to 22 carbon atoms, which material bioerodes at a controlled and continuous rate over a prolonged period of time in response to the essentially constant pH in the range of from pH 6 to pH 9, by a process of carboxylic hydrogen ionization, thereby releasing the active drug at a controlled and continuous rate to the animal over a prolonged period of time.

2. The surgical implant for the controlled and continuous administration of the active drug to the animal according to claim 1 wherein the body is a matrix and the drug is dispersed therethrough.

3. The surgical implant for the controlled and continuous administration of the active drug to the animal according to claim 1 wherein the body is a hollow reservoir and the drug is in the reservoir.

4. The surgical implant for the controlled and continuous administration of the active drug to the animal according to claim 1 wherein the implant is implanted subcutaneously in the animal.

5. A suppository for the controlled and continuous administration of an active drug to the rectal environment having essentially constant pH throughout the period of rectal administration, said suppository consisting essentially of a body, sized and shaped for placement in the rectal environment, said body formed of a bioerodible drug release rate controlling material containing the active drug, the material comprising a hydrophobic poly(carboxylic acid) having one ionizable carboxylic hydrogen atom for each 8 to 22 carbon atoms, which material bioerodes at a controlled and continuous rate over a prolonged period of time in response to the essentially constant pH environment in the range from pH 6 to pH 9, by a process of carboxylic hydrogen ionization, thereby releasing the active drug at a controlled and continuous rate to the rectal environment over a prolonged period of time.

6. The suppository for the controlled and the continuous administration of the active drug to the rectal environment according to claim 5 wherein the body is a matrix and the drug is dispersed therethrough.

7. The suppository for the controlled and the continuous administration of the active drug to the rectal environment according to claim 5 wherein the body is a hollow reservoir and the drug is in the reservoir.

8. A bioerodible device for the controlled and continuous topical administration of an active drug to an animal having an essentially constant pH throughout the period of drug administration, said device consisting essentially of a body shaped and adapted for topical placement and retention on the animal and formed of a bioerodible drug release rate controlling material containing the active drug, the material comprising a hydrophobic poly(carboxylic acid) having one ionizable hydrogen for each 8 to 22 carbon atoms, which material bioerodes at a controlled and continuous rate over a prolonged period of time in response to the essentially constant pH environment in the range of from pH 6 to 9, by a process of carboxylic hydrogen ionization, thereby releasing the active drug at a controlled and continuous rate to the animal over a prolonged period of time.

9. The bioerodible device for the controlled and continuous topical administration of drug to the animal according to claim 8 wherein the topical placement consists in nasal administration of the drug.

10. The bioerodible device for the controlled and continuous topical administration of drug to the animal according to claim 8 wherein the topical placement consists in buccal administration of the drug.

11. The bioerodible device for the controlled and continuous topical administration of drug to the animal according to claim 8 wherein the body is a matrix and the drug is dispersed therethrough.

12. The bioerodible device for the controlled and continuous administration of drug to the animal according to claim 8 wherein the body is a hollow reservoir and the drug is in the reservoir.

13. A bioerodible device for the controlled and continuous administration of an active drug to an animal drug receptor site having an essentially constant pH throughout the period of drug administration, the device comprising a body sized, shaped and structured for administrating drug to the animal receptor and formed of a bioerodible material containing the active drug, said material a terpolymer comprising a monomeric unit consisting of at least one α

,β

-unsaturated aliphatic acid of 3 to 8 carbon atoms, a monomeric unit consisting of an alkyl ester of an α

,β

-unsaturated aliphatic acid in which said alkyl group is of 2 to 8 carbon atoms, and a monomeric unit selected from acrylic acid and lower substituted acrylic acids of 4 to 8 carbon atoms, which terpolymer bioerodes at a controlled and continuous rate over a prolonged period of time in response to the essentially constant pH in the range of from pH 6 to pH 9, by a process of carboxylic hydrogen ionization, thereby releasing the active drug from the bioeroding terpolymer at a controlled and continuous rate to the animal receptor over a prolonged period of time.

14. the bioerodible device for the controlled and continuous administration of the active drug to the animal drug receptor site according to claim 13 wherein the body is a matrix and the drug is in the matrix.

15. The bioerodible device for the controlled and continuous administration of the active drug to the animal drug receptor site according to claim 13 wherein the body is a hollow reservoir and the drug is in the reservoir.