Controlled release implantable dispensing device and method

• US 20090270308A1
• Filed: 04/23/2009
• Published: 10/29/2009
• Est. Priority Date: 05/14/2007
• Status: Active Grant

• Current Assignee: Sustained Nano Systems, LLC
• Original Assignee: Sustained Nano Systems, LLC
• Inventors: Chen, Weiliam, Liebmann, Jeffrey M., Libin, Barry M.
• Granted Patent: US 8,071,119 B2
• Time in Patent Office: Days
• US Class Current: 514/1.100
• CPC Class Codes: A61K 31/7088 Compounds having three or more nucleosides or nucleotides
• 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 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/204 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00

Abstract

A dispensing device having a polymer which is combined with a therapeutic agent in the form of a microparticle or nanoparticle which is “hyper-compressed” to form a controlled release dispensing device and methods of locally administering a therapeutic agent using said microparticles.

Claims

1. A dispensing device which comprises a polymer which is combined with a therapeutic agent in the form of micro or nano particles which are hyper-compressed to form a controlled release dispensing unit.

2. A dispensing device as defined in claim 1 where the therapeutic agent is selected from the group consisting of steroids, non-steroidal anti-inflammatory drugs, antihistamines, antibiotics, mydriatics, beta-adrenergic antagonists anesthetics, alpha-2-beta adrenergic agonists, mast cell stabilizers, prostaglandin analogues, sympathomimetics, parasympathomimetics, antiproliferative agents, agents to reduce ocular angiogenesis and neovascularization, vasoconstrictors, anti-neoplastic agents, a polynucleotide, or a recombinant protein analog an angiogenic inhibitors and combinations thereof.

3. A dispensing device as defined in claim 1 where the polymer is selected from the group consisting of poly(alpha hydroxy butyric acid), poly(p-dioxanone) poly(l-lactide), poly(dl-lactide), polyglycolide, poly(glycolide-co-lactide), poly(glycolide-co-dl-lactide), a block polymer of polyglycolide, trimethylene carbonate and polyethylene oxide, or a mixture of any of the foregoing.

4. A dispensing device as defined in claim 2 where the polymer is biodegradable.

5. A dispensing device as defined in claim 4 where the microcapsule which has been compressed by the application of 150 K psi to 600 K psi.

6. A dispensing device as defined in claim 4 where the microcapsule which has been compressed by the application of 200 Kpsi to 400 Kpsi.

7. A dispensing device as defined in claim 4 where the microcapsule which has been compressed by the application of 220 psi.

8. A dispensing device as defined in claim 7 where the therapeutic agent is a steroid.

19. A transdermal patch which comprises hypercompressed microparticules or nano particles of a drug and a polymer as defined in claim 1.

20. An oral dosage form which comprises hypercompressed microparticles or nanoparticles as defined in claim 1.

9. A method of locally administering a drug which comprises forming a dispensing device comprising a polymer in combination with a therapeutic agent in the form of a microparticle or nanoparticle which is compressed to form a controlled release dispensing unit and thereafter placing said dispensing unit in a patient in a location that will provide for the localized or systemic release of the drug.

10. A method as defined in claim 9 where the therapeutic agent is selected from the group consisting of. steroids, non-steroidal anti-inflammatory drugs, antihistamines, antibiotics, mydriatics, beta-adrenergic antagonists, anesthetics, alpha-2-beta adrenergic agonists, mast cell stabilizers, prostaglandin analogues, sympathomimetics, parasympathomimetics, antiproliferative agents, agents to reduce ocular angiogenesis and neovascularization, vasoconstrictors and combinations thereof.

11. A method as defined in claim 10 where the polymer is selected from the group consisting of poly(alpha hydroxy butyric acid), poly(p-dioxanone) poly(l-lactide), poly(dl-lactide), polyglycolide, poly(glycolide-co-lactide), poly(glycolide-co-dl-lactide), a block polymer of polyglycolide, trimethylene carbonate and polyethylene oxide, or a mixture of any of the foregoing.

12. A method as defined in claim 10 where the polymer and the therapeutic agent are in the form of a rod or other shape ranging in variation of degrees of elongation, circularity, and convexity or surface roughness.

13. A method as defined in claim 12 where the microparticles have been compressed by the application of 150 K to 600 K psi.

14. A method as defined in claim 12 where the microparticles have been compressed by the application of 200 K psi to 400 K psi)

15. A method as defined in claim 12 where the therapeutic agent is a steroid.

16. A method as defined in claim 14 where the microparticles have been compressed by the application of 220 K psi.

17. A method of locally administering a drug which comprises forming a dispensing device comprising a polymer in combination with a therapeutic agent in the form of a microparticle which is compressed to form a controlled release dispensing unit and thereafter placing said dispensing unit in contact with an injectable liquid to disperse the microparticles and form a suspension of microparticles prior to placing said suspension in a patient in a location that will provide for release of the drug.

18. A method as defined in claim 17 where the suspension of microparticles is dried and administered by inhalation as a dry dispersion.