Methods and apparatus for pulsatile release of medicaments from a punctal plug

• US 20110054418A1
• Filed: 08/17/2010
• Published: 03/03/2011
• Est. Priority Date: 08/31/2009
• Status: Active Grant

• Current Assignee: Johnson & Johnson Vision Care Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Vision Care Incorporated (Johnson & Johnson)
• Inventors: Tokarski, Jason M., Pugh, Randall B., Coldren, Bret A.
• Granted Patent: US 8,808,257 B2
• Time in Patent Office: Days
• US Class Current: 604/285
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• 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: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

This invention discloses methods and apparatus for providing pulsatile release of active agents via a punctal plug inserted into a punctum. A tube is provided which may be inserted into a cavity of a punctal plug. One or more pulsatile delivery units are arranged in a generally linear fashion within the tube. The pulsatile delivery units include a core comprising the active agent and an encapsulation layer around the core.

Claims

1. A pulsatile delivery device of an active agent, the device comprising:

a tube inserted into a cavity of a punctal plug; and

one or more pulsatile delivery units arranged in a generally linear fashion within the tube, wherein two or more pulsatile delivery units comprise a core comprising the active agent and an encapsulation layer around the core.

2. The pulsatile delivery device of claim 1 wherein the one or more pulsatile delivery units comprise water soluble encapsulated beads.

3. The pulsatile delivery device of claim 2 wherein the generally linear arrangement of the pulsatile delivery units limits exposure of pulsatile delivery units to tear fluid to one pulsatile delivery unit at a time.

4. The pulsatile delivery device of claim 2 further comprising a boundary layer between a first pulsatile delivery unit and a second pulsatile delivery unit.

5. The pulsatile delivery device of claim 1 further comprising a boundary layer between a pulsatile delivery unit and an opening in the cavity of the punctal plug.

6. The pulsatile delivery device of claim 5 wherein the boundary layer comprises a biodegradable membrane.

7. The pulsatile delivery device of claim 5 wherein the boundary layer comprises a semi-porous membrane.

8. The pulsatile delivery device of claim 5 wherein the boundary layer comprises a mesh.

9. The pulsatile delivery device of claim 2, wherein the active agent-containing material comprises poly(epsilon-caprolactone) and ethylene vinyl acetate.

10. The pulsatile delivery device of claim 9, wherein the poly(epsilon-caprolactone) and ethylene vinyl acetate are each present in an amount of about 50 weight percent.

11. The pulsatile delivery device of claim 2, wherein the tube comprises a first pulsatile delivery unit comprising a first active-agent containing material comprising a relatively low concentration of the active agent and a second pulsatile delivery unit comprising a second active-agent containing material comprising a relatively high concentration.

12. The pulsatile delivery device of claim 1 wherein the core comprises an active agent-containing material and a phase separated inclusion.

13. The pulsatile delivery device of claim 1 wherein the core comprises an active agent-containing material and a destabilizing inclusion.

14. The pulsatile delivery device of claim 1 wherein the core comprises an active agent-containing material and a stabilizing inclusion.

15. The pulsatile delivery device of claim 1 wherein the punctal plug additionally comprises a punctal plug body and a cavity within the punctal plug body.

16. The pulsatile delivery device of claim 15 wherein the punctal plug additionally comprises an access opening to the cavity from a position external to the body when the plug is inserted into a punctum.

17. The pulsatile delivery device of claim 15 wherein the punctal plug additionally comprises a seal across the opening to the cavity, blocking access to the cavity from a position external to the body when the plug is stored outside a punctum.