Pulsatile release of medicaments from a punctal plug

• US 9,125,715 B2
• Filed: 05/08/2013
• Issued: 09/08/2015
• 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: Pugh, Randall B., Tokarski, Jason M., Coldren, Bret A.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US13/890,066
• Publication Number:
  US 20130338611A1
• Time in Patent Office: 853 Days
• US Class Current: 1/1
• 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 punctal plug for delivering an active agent, the punctal plug comprising:

a body comprising a first end, and a second end, wherein the first end is capable of being inserted in a human punctum;

a tube inserted into a cavity in the body;

an area comprising the second end of the body which is conducive to elution of the active agent than a remainder of the body; and

two or more pulsatile delivery units arranged in a generally linear fashion within the tube, each unit comprising an active agent bead encapsulated by a water soluble layer, wherein each active agent bead comprises generally equal volumes and concentrations of an active agent, and wherein the arrangement of the pulsatile delivery units allow for a release of the active agent from the tube in multiple pulses of the active agent when the plug is exposed to tear fluid.

2. The punctal plug of claim 1 wherein the generally linear arrangement of the pulsatile delivery units is capable of limiting exposure of pulsatile delivery units to tear fluid to one pulsatile delivery unit at a time.

3. The punctal plug of claim 2 further comprising a boundary layer between each of the pulsatile delivery units.

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

5. The punctal plug of claim 4 wherein the boundary layer comprises a biodegradable membrane.

6. The punctal plug of claim 4 wherein the boundary layer comprises a semi-porous membrane.

7. The punctal plug of claim 4 wherein the boundary layer comprises a mesh.

8. The punctal plug of claim 1, wherein the water soluble layer comprises poly(epsilon-caprolactone) and ethylene vinyl acetate.

9. The punctal plug of claim 8, wherein the poly(epsilon-caprolactone) and ethylene vinyl acetate are each present in an amount of about 50 weight percent.

10. The punctal plug of claim 1, wherein the the two or more pulsatile delivery units comprise a first pulsatile delivery unit comprising a first active agent bead and a second pulsatile delivery unit comprising a second active agent bead, wherein the first active agent bead comprises a lower concentration of the active agent than the second active agent bead.

11. The punctal plug of claim 10 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 the human punctum.

12. The punctal plug of claim 10, wherein the first pulsatile delivery unit is capable of releasing the first active agent bead upon insertion of the punctal plug into the human punctum.

13. The punctal plug of claim 1 wherein an encapsulation of the active agent beads occurs through a phase-separated inclusion.

14. The punctal plug of claim 1 wherein an encapsulation of the active agent beads occurs through a destabilizing inclusion.

15. The punctal plug of claim 10 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 the human punctum.