THERAPEUTIC AGENT DELIVERY SYSTEMS AND DEVICES

• US 20080177153A1
• Filed: 12/07/2007
• Published: 07/24/2008
• Est. Priority Date: 12/07/2006
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Bachman, Mark, Kupperman, Baruch, Divetia, Asheesh, Li, Guann Pyng
• Granted Patent: US 8,617,143 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• 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 9/025 characterised by shape or structure, e.g. hollow layered, coated

Abstract

Devices, systems and methods for delivering pre-determined quantities of an active ingredient to a biological system are provided.

Claims

1. A device for controlled release of an active ingredient, the device comprising:

a) a release aperture operably associated with a deflectable member;

b) a base comprising a porous substrate layer; and

c) at lease one chamber juxtaposed between the release aperture and the porous substrate layer, the chamber containing a matrix comprising one or more active ingredients and an agent that expands when contacted with an aqueous solution,

wherein the device is suitable for implantation in a biological system.

2. The device of claim 1, wherein the base further comprises a non-porous substrate layer associated with the porous substrate layer and comprising at least one channel suitable for contacting the porous substrate layer with an aqueous solution.

3. The device of claim 2, wherein the non-porous substrate layer comprises a plurality of channel configured in a pre-determined pattern.

4. The device of claim 1, wherein the deflectable member is a rupturable membrane.

5. The device of claim 1, wherein the deflectable member is a deflectable cap.

6. The device of claim 5, wherein the cap is comprised of polymer, wax or gel.

7. The device of claim 1, wherein the matrix comprises a plurality of active ingredients.

8. The device of claim 7, wherein each active ingredient is released according to a specific release profile.

9. The device of claim 1, wherein the active ingredient is a pharmaceutical compound.

10. The device of claim 1, wherein the agent is a polymer.

11. The device of claim 10, wherein the polymer is PLGA.

12. The device of claim 1, wherein the matrix further comprises hydrophilic binders, aqueous solution-soluble diluents, surfactants, lubricants, disintegrants, antioxidants, or non aqueous solution-soluble diluents, or any combination thereof.

13. The device of claim 1, wherein the biological system is an ocular system.

15. A system comprising a plurality of devices as set forth in claim 1 or claim 14 arrayed in a housing, wherein each device in the system comprises the same or different active ingredient and wherein each device in the system comprises the same or different release kinetics of the active ingredient.

22. A pulse therapy method for treating a subject, the method comprising:

a) identifying a subject having a condition and selecting one or more active ingredients suitable for treating the condition;

b) correlating the quantity and type of active ingredients with a pulse therapy dosing profile suitable for treating the condition;

c) configuring a device of claim 1, 14, 16 or 19, or a system of claim 15 to obtain a device suitable for delivering the dosing profile of b) to the subject; and

d) implanting the device in the subject.

14. A device for controlled release of an active ingredient, the device comprising:

a) a release aperture operably associated with a deflectable member;

b) a base comprising a porous substrate layer; and

c) at lease one chamber juxtaposed between the release aperture and the porous substrate layer, the chamber comprising;

i) a first compartment comprising an active ingredient; and

ii) a second compartment comprising an agent that expands when contacted with an aqueous solution,

wherein the device is suitable for implantation in a biological system.

16. A device for controlled release of an active ingredient, the device comprising:

a) a plurality of chambers, each chamber comprising a release aperture operably associated with a deflectable member and an active ingredient;

b) a compartment comprising an agent that expands when contacted with an aqueous solution, wherein the compartment is in expandable communication with each chamber of the device; and

c) a base comprising a porous substrate layer adjacent to and in fluidic communication with the compartment,

wherein the device is suitable for implantation in a biological system.

17. A computer-assisted method for designing a device or system for controlled release of an active ingredient in a biological system, the method comprising:

a) selecting at least one active ingredient for controlled release in a biological system;

b) identifying a dosing profile suitable for eliciting an active ingredient-induced response in the biological system;

c) determining the geometries of the device or system suitable to obtain the dosing profile of b) using finite element analysis;

d) optionally repeat b) and c); and

e) manufacturing the device or system according to the identified geometry.

18. The method of claim 17, wherein the manufacturing is by lithography, micromachining, laser machining, precision machining or computer numerically controlled (CNC) machining, or any combination thereof.

19. A device for controlled release of an active ingredient and suitable for implantation in a biological system, the device comprising:

a) a first non-porous plate;

b) a second non-porous plate; and

c) a matrix juxtaposed between the first and second plate, the matrix comprising;

i) a first porous material comprising one or more active ingredients positioned in a pre-determined pattern; and

ii) a second porous material encapsulating the first porous material and in fluid communication with the biological system in which the device is implanted.

20. The device of claim 19, wherein the second porous material does not contain an active ingredient.

21. A system comprising a plurality of devices of claim 19.