PERIPHERALLY ADMINISTERED VISCOUS FORMULATIONS

• US 20080044476A1
• Filed: 07/26/2007
• Published: 02/21/2008
• Est. Priority Date: 11/12/2003
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Robinson, Michael, Lyons, Robert, Trogden, John, Whitcup, Scott
• Granted Patent: US 8,846,094 B2
• Time in Patent Office: Days
• US Class Current: 424/488
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/40 Cyclodextrins; Derivatives thereof
• 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 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Viscous formulations and methods of using such compositions, useful for intramuscular and intra-articular injection are provided to treat peripheral conditions. Such compositions can include triamcinolone particles present in a therapeutically effective amount, a viscosity inducing component, and an aqueous carrier component. The compositions have viscosities of at least about 10 cps or about 100 cps at a shear rate of 0.1/second. In a preferred embodiment, the viscosity is in the range of from about 80,000 cps to about 300,000 cps. In a most preferred embodiment, the viscosity is in the range of from about 140,000 cps to about 280,000 cps at a shear rate of 0.1/second at 25° C. The compositions advantageously suspend the triamcinolone particles for prolonged periods of time.

Claims

1. A method for treating a peripheral condition, the method comprising the step of administering to a peripheral location of a human body a viscous formulation comprising a viscous polymer, wherein the viscous formulation has a viscosity of between about 130,000 cps and about 300,000 cps at a shear rate of about 0.1/second at about 25°

C., thereby treating at least one symptom of the peripheral condition.

2. The method of claim 1 wherein the peripheral condition is an articular pathology.

3. The method of claim 1, wherein the peripheral location is an intra-articular location.

4. The method of claim 1, wherein the step of administering is carried out by injecting.

5. The method of claim 1, wherein the viscous formulation further comprises a plurality of corticosteroid particles mixed with the viscous polymer.

6. The method of claim 1, wherein the corticosteroid is a triamcinolone.

7. The method of claim 1, wherein the viscous polymer is a polymeric hyaluronate or a polymeric hyaluronic acid.

8. A method for treating a peripheral condition, the method comprising the step of injecting into a peripheral location of a patient with a peripheral condition a viscous formulation comprising a plurality of corticosteroid particles mixed into a viscous polymeric matrix, wherein the pharmaceutical composition has a viscosity of between about 130,000 cps and about 300,000 cps at a shear rate of about 0.1/second at about 25°

C., such that about one hour after the peripheral injection only about 10% or less of the corticosteroid particles are present at the peripheral location free of the polymeric matrix.

9. The method of claim 8, wherein about one hour after the peripheral injection only about 5% or less of the corticosteroid particles are present at the peripheral location free of the polymeric matrix.

10. The method of claim 8, wherein about one hour after the peripheral injection only about 3% or less of the corticosteroid particles are present at the peripheral location free of the polymeric matrix.

11. A method for treating arthritis, the method comprising the step of injecting into a joint of a patient with arthritis a viscous formulation comprising a plurality of corticosteroid particles mixed into a viscous polymeric matrix, wherein the viscous formulation has a viscosity of between about 130,000 cps and about 300,000 cps at a shear rate of about 0.1/second at about 25°

C.

12. A method for treating a peripheral condition, the method comprising the steps of

(a) administering to a peripheral location of a human body a viscous formulation comprising a viscous polymer, wherein the viscous formulation has a viscosity of between about 130,000 cps and about 300,000 cps at a shear rate of about 0.1/second at about 25°

C., thereby treating at least one symptom of the peripheral condition, and;

(b) administering to a peripheral location of a human body a plurality of corticosteroid particles, thereby treating at least one symptom of the peripheral condition.

13. The method of claim 12, wherein the plurality of corticosteroid particles are mixed with the viscous polymer.

14. A method for treating a peripheral condition of a patient selected from the group of peripheral conditions consisting of osteoarthritis, radiculopathy, spondylitis, and spondylosis, the method comprising the step of injecting into a peripheral location of the patient a viscous formulation comprising a plurality of corticosteroid particles mixed into a viscous polymeric matrix, wherein the pharmaceutical composition has a viscosity of between about 130,000 cps and about 300,000 cps at a shear rate of about 0.1/second at about 25°

C.