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Joint fat pad formulations, and methods of use thereof

By administering sustained-release formulations containing analgesics, anti-inflammatory agents, or immunosuppressants to the joint fat pad, the problems of significant side effects and insignificant efficacy in existing treatments have been solved, achieving effective treatment of arthritis and autoimmune diseases, reducing systemic exposure and side effects, and improving the duration and precision of treatment effects.

Inactive Publication Date: 2017-12-01
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Administration of viscosupplements (such as hyaluronic acid), although well tolerated, is not always effective

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0338] In one formulation, the steroid (powder) is combined with the biodegradable polymer (powder) by dry blending the powder. The powder mixture is then heated to a temperature to soften it (but not so high as to degrade the steroid) and form an implant by hot melt extrusion, injection molding or other thermoforming means. The steroid implant is then cut to size, finally sterilized, and implanted in the targeted fat pad. Steroids are continuously released into the surrounding area for days, weeks or months. The implant may contain from 0.1% to 70% by weight of steroid.

Embodiment B

[0339] Example B . In another formulation, the steroid is mixed with sterile buffered water to form a slurry. A sterile slurry is combined with a suspending agent such as a buffer, and the preparation mixed until the slurry is uniformly dispersed. The suspension is aseptically filled into unit dose syringes or sterile vials. The formulation is injected into the targeted fat pad and slowly releases the steroid over days, weeks or months. The suspension may contain from 0.1% to 50% by weight of steroid.

Embodiment C

[0340] Example C . In another formulation, the steroid, biodegradable polymer and other excipients are dissolved or suspended in a biocompatible solvent. The formulations are sterile filtered, autoclaved, or irradiated. Fill the solution into sterile vials or unit dose syringes. After injection into the fat pad, the biocompatible solvent exits the reservoir, leaving a firm, steroid-containing implant. As the polymer bioerodes, the depot releases the steroid for days, weeks or months. The drug loading in solution can range from 0.1% to 50%. The polymer loading in solution may range from 15% to 50%. Excipients may include poly(ethylene glycol), short chain fatty acids, waxes, co-solvents, or other compounds that modulate the hydrophobicity of the depot.

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PUM

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Abstract

The present invention relates to formulations for administration to a joint fat pad of a subject, and to methods of treating joint pain, inflammation or disease. The disclosed formulations are intended for local administration to the joint fat pad to provide sustained release of a therapeutic agent to the joint cavity and surrounding tissues. The joint may be an arthritic joint, an injured joint or a surgically replaced joint. The therapeutic agent may be an analgesic agent, an anti-inflammatory agent or an immunosuppressive agent. A single administration of the formulation to the joint fat pad delivers a therapeutically effective amount of the therapeutic agent with reduced systemic exposure relative to a single systemic or a single intra-articular administration of a therapeutic dose of an identical therapeutic agent.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 108,696, filed January 28, 2015, and U.S. Provisional Application Serial No. 62 / 108,709, filed January 28, 2015, the entire contents of which are incorporated in this Specific citations are incorporated herein. technical field [0003] The present invention generally relates to formulations for treating pain, inflammation or disease in a subject. More specifically, the present invention relates to formulations for topical administration to the articular fat pad of a subject that provide sustained release of a therapeutic agent into the joint cavity and surrounding tissue. The present invention also relates to methods for treating pain or inflammation in a subject suffering from arthritis, autoimmune disease, postoperative pain, or a subject with a surgically replaced joint by administering a sustained release formulation to the joint fat ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K9/00A61P29/00A61P19/02A61P37/02
CPCA61K9/0002A61K9/0024A61K45/06A61L31/145A61L31/16A61L2300/402A61L2300/41A61L2300/426A61L2300/43A61L2300/622A61L2300/624A61L2400/06A61L2430/24A61L31/042A61P19/02A61P23/00A61P25/04A61P29/00A61P37/02A61P37/06A61K31/573C08L5/08A61L29/06
Owner ALLERGAN INC