Compositions and methods for treatment of inflammation
Inventors
McDonald, Thomas • Drescher, Kristen
Assignees
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Publication Number
US-9993452-B2
Publication Date
2018-06-12
Expiration Date
Abstract
The present invention is directed to novel anti-inflammatory immunomodulators including creatinine or a creatinine salt, for example, creatinine hydrochloride. The present invention is also directed to methods for treating inflammation and inducing an immunomodulatory response. In particular, the anti-inflammatory immunomodulators are useful for treating an inflammatory condition or an autoimmune disease.
Core Innovation
Creatinine salts, including creatinine hydrochloride, are described as anti-inflammatory immunomodulators that reduce pro-inflammatory signaling in an immunological context. The described effects include reduction of tumor necrosis factor alpha (TNF-b1) expression at the mRNA and protein levels, together with suppression of interleukin 6 (IL-6). Creatinine hydrochloride is specifically positioned as an effective anti-inflammatory immunomodulator for inflammatory and autoimmune conditions.
The disclosed solution provides a method that administers an anti-inflammatory agent comprising a creatinine salt or its precursors, where TNF-b1 levels in the patient are reduced by at least 40 percent compared to levels prior to administration. The patent problem being solved is the treatment of inflammatory and autoimmune diseases in a patient, including rheumatoid arthritis, osteoarthritis, psoriatic arthritis, multiple sclerosis, and inflammatory bowel disease.
In addition, the document describes treating inflammation by administering a topical formulation to an inflamed area of the patient, where the topical formulation comprises an effective amount of creatinine hydrochloride. Topical dosage forms are described including ointment, lotion, cream, gel, adhesive patch, and wrap, including controlled release and transdermal diffusion approaches.
Claims Coverage
The independent claims cover two inventive approaches: systemic treatment of specified inflammatory and autoimmune diseases with a creatinine-salt-based anti-inflammatory agent producing a quantified TNF-b1 reduction, and localized topical treatment of inflammation using an effective amount of creatinine hydrochloride in a topical formulation applied to an inflamed area. Across these independent claims, the inventive features comprise creatinine-salt anti-inflammatory immunomodulation with quantified TNF-b1 reduction, and topical administration of creatinine hydrochloride to an inflamed area.
Treating specified inflammatory and autoimmune diseases via creatinine salt anti-inflammatory agent with quantified TNF-b1 reduction
Administering an effective amount of an anti-inflammatory agent to a patient, wherein the anti-inflammatory agent comprises a creatinine salt or its precursors, and wherein levels of tumor necrosis factor alpha in the patient are reduced by at least 40 percent when compared to levels prior to administration of the anti-inflammatory agent for rheumatoid arthritis, osteoarthritis, psoriatic arthritis, multiple sclerosis, or inflammatory bowel disease.
Topical administration of creatinine hydrochloride to an inflamed area
Administering a topical formulation to an inflamed area of the patient, wherein the topical formulation comprises an effective amount of creatinine hydrochloride to treat inflammation associated with rheumatoid arthritis, osteoarthritis, psoriatic arthritis, or multiple sclerosis.
The claims emphasize creatinine-salt-based anti-inflammatory immunomodulation with a quantified reduction in TNF-b1 for systemic treatment of specified diseases, and a separate approach using topical formulations containing creatinine hydrochloride administered to an inflamed area for localized treatment of inflammation associated with selected diseases.
Stated Advantages
Reduces levels of tumor necrosis factor alpha in the patient by at least 40 percent compared to levels prior to administration.
Reduces TNF-b1 expression at the mRNA and protein levels, and suppresses IL-6.
Documented Applications
Treating rheumatoid arthritis, osteoarthritis, psoriatic arthritis, multiple sclerosis, or inflammatory bowel disease in a patient by administering an anti-inflammatory agent comprising a creatinine salt or its precursors.
Treating inflammation associated with rheumatoid arthritis, osteoarthritis, psoriatic arthritis, or multiple sclerosis by administering a topical formulation to an inflamed area of the patient containing an effective amount of creatinine hydrochloride.
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