Single dose vaccination system

• US 5,593,697 A
• Filed: 11/17/1993
• Issued: 01/14/1997
• Est. Priority Date: 03/26/1991
• Status: Expired due to Fees

• Current Assignee: CSL Limited
• Original Assignee: CSL Limited
• Inventors: Barr, Ian G., Thiel, William J.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/119,174
• Time in Patent Office: 1,154 Days
• Field of Search: 424/423, 424/424, 424/425, 424/426, 424/487, 424/488, 424/490, 424/501, 514/772.3
• US Class Current: 424/490
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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 9/5031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5073 having two or more different coatings optionally including drug-containing subcoatings

Abstract

The invention provides a pharmaceutical or veterinary implant, which when parenterally administered releases a pulse of at least one biologically active material at a controllable time interval after implantation. The implant comprises the biologically active material; an excipient comprising at least one water soluble material and at least one water insoluble material; and a polymer film coating adapted to rupture at a predetermined period of time after implantation, and wherein the excipients and polymers are biocompatible. The biologically active material is selected from the group consisting of antigens, antibodies, hormones, growth promotants, antibiotics, nutrients, minerals and vitamins. Preferably the excipient comprises a combination of two or more water-soluble and water-insoluble materials.

Claims

1. A pharmaceutical or veterinary implant, which when parenterally administered releases a pulse of at least one biologically active material at a controllable time interval after implantation, said implant comprising:

a) a core comprising the biologically active material and a tabletting excipient comprising at least one water soluble material and at least one water insoluble swellable material; and

,

b) at least one polymer film coating adapted to rupture at a predetermined time after implantation, said coating being permeable or semi-permeable to physiological fluid and essentially surrounding said core and preventing release of the core prior to rupture,

wherein said excipient and said at least one polymer film coating are biocompatible.

2. An implant according to claim 1, in which the biologically active material is selected from the group consisting of antigens, antibodies, hormones, growth promotants, antibiotics, nutrients, minerals and vitamins.

3. An implant according to claim 1, in which the excipient comprises a combination of two or more water-soluble and water-insoluble materials.

4. An implant according to claim 3, in which the water-insoluble material is swellable.

5. An implant according to claim 1 wherein two different polymer film coatings are applied to a compressed core, and said polymer film coatings are:

i) a bilayer coating comprising an insoluble biocompatible film and an enteric (pH sensitive) polymer, or

ii) a single film comprising a mixture of insoluble and biodegradable polymer.

6. An implant according to claim 1, in which the polymer film coating comprises a mixture of water insoluble and biodegradable polymers.

8. A combined pharmaceutical or veterinary implant comprising an implant according to claim 1, further comprising the same or a different biologically active material formulated for release with substantially no delay when said implant is parenterally administered.

9. An implant according to claim 1, wherein the biologically active material is an antigen.

10. An implant according to claim 9, which additionally comprises an immunologically active adjuvant.

11. An implant according to claim 9 or claim 10 wherein the antigen is selected from the group consisting of caseous lymphadenitis toxoid, Clostridium botulinum toxoid, tetanus toxoid, and luteinizing hormone releasing hormone.

12. An implant according to claim 1, wherein the biologically active material is a hormone, a vitamin and a growth promotant.

14. An implant according to claim 1 wherein the polymer film coating is adapted to rupture at 9-60 days after implantation.

15. An implant according to claim 1 or claim 7, wherein the pulse of biologically active material is a first pulse, and the first pulse is followed by a second pulse of the same or a different biologically active material at a controllable time interval after the first pulse.

7. A pharmaceutical or veterinary implant which when parenterally administered releases a biologically active material in a delayed pulsed release manner, wherein the implant comprises the biologically active material and excipients as a compressed or moulded core encased within a polymeric coating which degrades sufficiently after a period of time to release the biologically active material, wherein all of the implant components are biocompatible.

13. A method of administration of a biologically active material to a mammal, comprising the step of parenterally implanting into said mammal an implant wherein the implant comprises:

a) a core comprising the biologically active material and a tabletting excipient comprising at least one water soluble material and at least one water insoluble swellable material; and

,

b) at least one polymer film coating adapted to rupture at a predetermined time after implantation, said coating being permeable or semi-permeable to physiological fluid and essentially surrounding said core and preventing release of the core prior to rupture,

wherein said excipient and said at least one polymer film coating are biocompatible.