IP Library Granted Patent US 8,957,034
Granted Patent B2
US 8,957,034 · App. 10/587,512 · Granted Feb 17, 2015

Drugs and gene carrier particles that rapidly move through mucous barriers

Inventors: Justin Hanes (Baltimore, MD); Michelle Rose Dawson (Arlington, MA); Denis Wirtz (Washington, DC); Jie Fu (Baltimore, MD); Eric Mark Krauland (Somerville, MA)
Assignee: Johns Hopkins University
A61K9/5123A61K9/0073A61K9/167A61K9/5031A61K9/5153A61K47/48046A61K47/48907A61K47/48915B82Y5/00
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Quick Facts
Patent No.
US 8,957,034
App. No.
10/587,512
Granted
Feb 17, 2015
Kind
B2
Abstract

The invention generally relates to polymeric particles suitable for transporting bioactive agents across mucosal barriers. The invention also relates to methods of making and using those polymeric particles.

Claims (34)

1. A polymeric particle comprising a pharmaceutically acceptable polymer core, a bioactive agent, and a surface-altering agent disposed on the surface of the core, wherein the surface-altering agent enhances the average rate at which the particle moves in mucus by at least 5-fold compared to the same particle except without a surface-altering agent disposed on the surface,

wherein the surface-altering agent reduces the overall charge on the surface of the polymeric particle and enhances the hydrophilicity of the surface of the polymeric particle compared to the same particle except without a surface-altering agent disposed on the surface,

wherein the surface-altering agent comprises polyethylene glycol having a molecular weight of about 2-3kDa, and

wherein the polymeric particle is less than about 1 micron in diameter.

2. The polymeric particle of claim 1 , wherein the bioactive agent is encapsulated in the polymer core.

3. The polymeric particle of claim 1 , wherein the pharmaceutically acceptable polymer core comprises a polymer selected from the group consisting of: a poly (D,L-lactic-co-glycolic) acid, polyethylenimine, dioleyltrimethylammoniumpropane/dioleyl -sn-glycerolphosphoethanolamine, poly(anhydrides), and a polymer formed from clinically approved monomers.

4. The polymeric particle of claim 1 , wherein the bioactive agent is a therapeutic agent or an imaging agent.

5. The polymeric particle of claim 4 , wherein the therapeutic agent is a DNA, an RNA, a small molecule, a peptidomimetic, or a protein.

6. The polymeric particle of claim 1 , wherein the bioactive agent is a diagnostic agent.

7. The polymeric particle of claim 4 , wherein the imaging agent further comprises a detectable label.

8. The polymeric particle of claim 1 further comprising an adjuvant.

9. The polymeric particle of claim 1 , wherein the polymeric particle is less than 200nm in diameter.

10. The polymeric particle of claim 1 , wherein the polymeric particle passes through mucus at a greater rate than a polystyrene particle of the same size.

11. A pharmaceutical composition comprising the polymeric particle of claim 1 and a pharmaceutically acceptable carrier.

12. An inhaler comprising the polymeric particle of claim 1 .

13. The polymeric particle of claim 1 , wherein the average rate at which the particle moves in mucus is at least 10-fold greater than the rate of the same particle except without the surface-altering agent disposed on the surface.

14. The polymeric particle of claim 1 , wherein the polyethylene glycol has a molecular weight of about 2 kDa.

15. The polymeric particle of claim 1 , wherein the polyethylene glycol has a molecular weight of about 3 kDa.

16. The polymeric particle of claim 1 , wherein the polyethylene glycol is attached to polyethyleneimine (PEI).

17. The polymeric particle of claim 1 , wherein the polymeric particle is less than about 500 nm in diameter.

18. A particle comprising a pharmaceutically acceptable core, a bioactive agent, and a surface-altering agent disposed on the surface of the core, wherein the surface-altering agent enhances the average rate at which the particle moves in mucus by at least 5-fold compared to the same particle except without a surface-altering agent disposed on the surface,

wherein the surface-altering agent reduces the overall charge on the surface of the particle and enhances the hydrophilicity of the surface of the particle compared to the same particle except without a surface-altering agent disposed on the surface,

wherein the surface-altering agent comprises polyethylene glycol having a molecular weight of about 2-3 kDa, and

wherein the particle is less than about 1 micron in diameter.

19. The particle of claim 18 , wherein the bioactive agent is encapsulated in the core.

20. The particle of claim 18 , wherein the average rate at which the particle moves in mucus is at least 10-fold greater than the rate of the same particle except without the surface-altering agent disposed on the surface.

21. The particle of claim 18 , wherein the bioactive agent is a DNA, a RNA, a small molecule, a peptidometic, or a protein.

22. The particle of claim 18 , wherein the bioactive agent comprises a siRNA.

23. The particle of claim 18 , wherein the polyethylene glycol has a molecular weight of about 2 kDa.

24. The particle of claim 18 , wherein the polyethylene glycol has a molecular weight of about 3 kDa.

25. The particle of claim 18 , wherein the polyethylene glycol is attached to polyethyleneimine (PEI).

26. The particle of claim 18 , wherein the particle is less than about 500nm in diameter.

27. The particle of claim 18 , wherein the particle is less than about 200nm in diameter.

28. A pharmaceutical composition comprising the particle of claim 18 and a pharmaceutically acceptable carrier.

Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE NAME OF THE ASSIGNOR PREVIOUSLY RECORDED ON REEL 027850 FRAME 0340. ASSIGNOR(S) HEREBY CONFIRMS THE CORRECT NAME OF THE ASSIGNOR IS LIGHTHOUSE CAPITAL PARTNERS VI, L.P. Recorded Mar 15, 2012
From: LIGHTHOUSE CAPITAL PARTNERS VI, L.P.
To: KALA PHARMACEUTICALS, INC.
Reel/Frame 027870/0777 →
RELEASE OF SECURITY INTEREST Recorded Mar 13, 2012
From: LUX VENTURES II, L.P.; LUX VENTURES II SIDECAR, L.P.; THIRD ROCK VENTURES, L.P.; POLARIS VENTURE PARTNERS V, L.P.; POLARIS VENTURE PARTNERS ENTREPRENEURS' FUND V, L.P.; POLARIS VENTURE PARTNERS FOUNDERS' FUND V, L.P.; POLARIS VENTURE PARTNERS SPECIAL FOUNDERS' FUND V, L.P.; WACHTEL, WILLIAM; KALISH, ADAM
To: KALA PHARMACEUTICALS, INC.
Reel/Frame 027850/0171 →
RELEASE OF SECURITY INTEREST Recorded Mar 13, 2012
From: LIGHTHOUSE CAPTIAL PARTNERS VI, L.P.
To: KALA PHARMACEUTICALS, INC.
Reel/Frame 027850/0340 →
SECURITY AGREEMENT Recorded Nov 30, 2010
From: KALA PHARMACEUTICALS, INC.
To: LUX VENTURES II, L.P.; LUX VENTURES II SIDECAR, L.P.; POLARIS VENTURE PARTNERS V, L.P.; POLARIS VENTURE PARTNERS ENTREPRENEURS' FUND V, L.P.; POLARIS VENTURE PARTNERS FOUNDERS' FUND V, L.P.; POLARIS VENTURE PARTNERS SPECIAL FOUNDERS' FUND V, L.P.; THIRD ROCK VENTURES, L.P.; WACHTEL, WILLIAM; KALISH, ADAM
Reel/Frame 025414/0032 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2008
From: HANES, JUSTIN; DAWSON, MICHELLE ROSE; WIRTZ, DENIS; FU, JIE; KRAULAND, ERIC MARK
To: JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE
Reel/Frame 020944/0729 →
Continuity (3)
Provisional Application 60539773 · Jan 28, 2004
Provisional Application 60579533 · Jun 14, 2004
Related Publication 20080166414A1 · Jul 10, 2008