IP Library Granted Patent US 11,510,916
Granted Patent B2
US 11,510,916 · App. 17/083,232 · Granted Nov 29, 2022

Pharmaceutical compositions for intraocular administration and methods for fabricating thereof

Inventors: Jeffrey T. Liegner (Boise, ID); John Scott Karolchyk (Lake Hopatcong, NJ); Bernard Covalesky (Randolph, NJ); Richard Dilzer (Long Valley, NJ); Kallan Kuper (Flemington, NJ)
Assignees: NOVEL DRUG SOLUTIONS LLC; EYE CARE NORTHWEST, PA
A61K31/4709A61K9/0048A61K31/407A61K31/496A61K31/573A61K31/58A61K38/14A61K45/06
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Quick Facts
Patent No.
US 11,510,916
App. No.
17/083,232
Granted
Nov 29, 2022
Kind
B2
Abstract

Pharmaceutical compositions for intraocular injection are described, the compositions consisting essentially of a therapeutically effective quantity of an anti-bacterial agent (such as moxifloxacin), a therapeutically effective quantity of an anti-inflammatory agent (such as triamcinolone), at least one pharmaceutically acceptable excipient and a pharmaceutically acceptable carrier. Methods for fabricating the compositions and using them for intraocular injections are also described.

Claims (19)

1. A pharmaceutical composition, comprising:

(a) a therapeutically effective quantity of triamcinolone or a derivative thereof;

(b) a therapeutically effective quantity of moxifloxacin;

(c) a non-ionic poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) block copolymer having a molecular weight of the polyoxypropylene portion of about 4,000 Daltons and about a 70% polyoxyethylene content, with an overall molecular weight of between about 9,840 Daltons and about 14,600 Daltons, wherein the concentration of the non-ionic polyoxyethlene-polyoxypropylene block copolymer is between about 1 mass % and about 2 mass % of the pharmaceutical composition;

(d) a non-steroid anti-inflammatory drug (NSAID);

(e) about 1% of polysorbate 80; and

(f) a pharmaceutically acceptable carrier.

2. The composition of claim 1 , wherein said composition further comprises a therapeutically effective quantity of a glycopeptide antibiotic selected from the group consisting of vancomycin, teicoplanin, telavancin, decaplanin, ramoplanin, gentamicin, tobramycin, amikacin, cefuroxime, polymyxin B sulfate, trimethoprim, and a combination thereof.

3. The composition of claim 2 , wherein said antibiotic is vancomycin.

4. The composition of claim 1 , wherein said NSAID is selected from the group consisting of ketorolac, etodolac, sulindac, diclofenac, aceclofenac, nepafenac, tolmetin, indomethacin, nabumetone, ketoprofen, dexketoprofen, ibuprofen, flurbiprofen, dexibuprofen, fenoprofen, loxoprofen, oxaprozin, naproxen, aspirin, salicylic acid, diflunisal, salsalate, mefenamic acid, meclofenamic acid, flufenamic acid, tolfenamic acid, meloxicam, piroxicam, ternoxicam, droxicam, lornoxicam, isoxicam, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib, firocoxib, nimesulide, clonixin, licofelone, pharmaceutically acceptable salts, hydrates, solvates, ethers, esters, acetals and ketals thereof and a combination thereof.

5. The composition of claim 1 , wherein said pharmaceutically acceptable carrier is selected from the group consisting of sterile water, a sterile water solution of edetate calcium disodium, a sterile water solution of hydrochloric acid, and combinations thereof.

6. A method for treating an ophthalmological disease, condition or pathology in a mammalian subject in need of such treatment comprising delivering to the subject by intraocular injection, an effective amount of a composition in accordance with claim 1 .

7. The method of claim 6 , wherein said composition further comprises a therapeutically effective quantity of a glycopeptide antibiotic selected from the group consisting of vancomycin, teicoplanin, telavancin, decaplanin, ramoplanin, gentamicin, tobramycin, amikacin, cefuroxime, polymyxin B sulfate, trimethoprim, and a combination thereof.

8. The method of claim 7 , wherein said antibiotic is vancomycin.

9. The method of claim 6 , wherein said NSAID is selected from the group consisting of ketorolac, etodolac, sulindac, diclofenac, aceclofenac, nepafenac, tolmetin, indomethacin, nabumetone, ketoprofen, dexketoprofen, ibuprofen, flurbiprofen, dexibuprofen, fenoprofen, loxoprofen, oxaprozin, naproxen, aspirin, salicylic acid, diflunisal, salsalate, mefenamic acid, meclofenamic acid, flufenamic acid, tolfenamic acid, meloxicam, piroxicam, ternoxicam, droxicam, lornoxicam, isoxicam, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib, firocoxib, nimesulide, clonixin, licofelone, pharmaceutically acceptable salts, hydrates, solvates, ethers, esters, acetals and ketals thereof and a combination thereof.

10. The method of claim 6 , wherein said pharmaceutically acceptable carrier is selected from the group consisting of sterile water, a sterile water solution of edetate calcium disodium, a sterile water solution of hydrochloric acid, and combinations thereof.

11. The method of claim 6 , wherein said intraocular injection comprises intravitreal injection.

12. The method of claim 6 , wherein said intraocular injection comprises intracameral injection.

13. The method of claim 11 , wherein the intravitreal injection is intraoperative.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2021
From: LIEGNER, JEFFREY T.; KAROLCHYK, JOHN SCOTT; COVALESKY, BERNARD; KUPER, KALLAN
To: NOVEL DRUG SOLUTIONS LLC; EYE CARE NORTHWEST, PA
Reel/Frame 056795/0119 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2020
From: DILZER, RICHARD
To: IMPRIMIS PHARMACEUTICALS, INC.
Reel/Frame 054238/0198 →
CHANGE OF NAME Recorded Nov 2, 2020
From: IMPRIMIS PHARMACEUTICALS, INC
To: HARROW HEALTH, INC.
Reel/Frame 054275/0157 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 30, 2020
From: HARROW HEALTH, INC.
To: NOVEL DRUG SOLUTIONS LLC; EYE CARE NORTHWEST, PA
Reel/Frame 054219/0131 →
Continuity (4)
Division 14629173 · Feb 23, 2015
Continuation In Part 14227819 · Mar 27, 2014
Provisional Application 61958170 · Jul 22, 2013
Related Publication 20210038592A1 · Feb 11, 2021