Method and mixture for treating and preventing inflammatory bowel disease
Inventors
Assignees
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Publication Number
US-9029347-B2
Publication Date
2015-05-12
Expiration Date
Abstract
A method and a mixture for treating and preventing the inflammatory bowel disease (IBD) by applying a predetermined therapeutically effective amount of a mixture of hyaluronic acid to individuals is disclosed. The mixture includes at least two different average molecular weight hyaluronic acids (Mw) with different rheology to gain a hyaluronic acid with the proper adhesion property, functions of tissue scaffold and insulation and treatment time, in order to treat and to prevent IBD (inflammatory bowel disease) includes ulcerative colitis, Crohn's disease or wound healing in stomach and intestine, thus to achieve the prompt treatment and to prolong the effect.
Core Innovation
The invention provides a method for treating and ameliorating inflammatory bowel disease (IBD) by administering to a subject a therapeutically effective amount of a hyaluronic acid mixture. The mixture consists essentially of low average molecular weight hyaluronic acid (LMWHA) and high average molecular weight hyaluronic acid (HMWHA), with defined average molecular weight ranges for each fraction.
The hyaluronic acid mixture is defined by a mixing ratio of LMWHA and HMWHA in a range from 20:80 to 80:20 and by a mixture concentration of 0.5 mg/ml to 50 mg/ml. The mixture has different rheology and is used to improve adhesion and provide rapid coverage together with prolonged degradation and a sustained effect.
The described approach is applied to treatment and prevention of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, and is also associated with enteritis and wound healing contexts. Delivery and formulation options described include oral enteric-coated tablets and rectal suppositories, foam, perfusion, or enema formulations using pharmaceutically acceptable excipients.
Claims Coverage
The independent claim covers administering a therapeutically effective hyaluronic acid mixture with defined molecular-weight ranges, a specified LMWHA/HMWHA mixing ratio, and a specified mixture concentration for treating and ameliorating inflammatory bowel disease. Dependent claims further refine the ratio and concentration and add excipient-based dosage form options and combination therapy with other therapeutic agents.
Defined LMWHA and HMWHA molecular weight fractions for IBD treatment
A therapeutically effective amount of a hyaluronic acid mixture consisting essentially of a low average molecular weight hyaluronic acid (LMWHA) and a high average molecular weight hyaluronic acid (HMWHA), wherein the average MW of said LMWHA is 100 kilo Da to 700 kilo Da, and the average MW of said HMWHA is 1.5 million Da to 2.5 million Da.
Specified LMWHA:HMWHA mixing ratio and mixture concentration
A mixing ratio of said LMWHA and said HMWHA in a range from 20:80 to 80:20, wherein the concentration of the mixture of said LMWHA and said HMWHA is 0.5 mg/ml to 50 mg/ml, for treating and ameliorating a subject suffering from inflammatory bowel disease (IBD).
Single LMWHA:HMWHA ratio embodiment
The mixing ratio of LMWHA to HMWHA is 1:1.
Narrowed mixture concentration range
The concentration of a solution mixture of LMWHA and HMWHA is within the range of 0.5 mg/ml to 5 mg/ml.
Excipient-enabled oral solid dosage form
The hyaluronic acid mixture includes an excipient to formulate an oral solid dosage form.
Excipient-enabled rectal/local formulations
The hyaluronic acid mixture contains an excipient for formulating suppositories, foam, or a rectal perfusate or enema.
Combination with steroid or immunosuppressive/anti-inflammatory drug
The method further combines the hyaluronic acid mixture with a steroid, an immunosuppressive agent, or an anti-inflammatory drug.
Overall, the claim set centers on treating and ameliorating IBD by administering a hyaluronic acid mixture that consists essentially of LMWHA and HMWHA with specified molecular-weight ranges, a defined mixing ratio, and a defined concentration. The dependent claims narrow ratio or concentration ranges, specify excipient-based oral solid and rectal/local formulation options, and allow combination with a steroid or immunosuppressive/anti-inflammatory drug.
Stated Advantages
Improves adhesion of the administered hyaluronic acid mixture.
Provides rapid coverage.
Provides prolonged degradation and a sustained effect.
Reduces inflammatory cytokines in disclosed examples (e.g., TNF-α and IL-1β in some cases).
Improves colon lesion recovery in disclosed examples.
Alters hyaluronic acid degradation kinetics under HAase and acidic conditions.
Injured colon tissue shows greater hyaluronic acid absorption, with lower-Mw hyaluronic acid showing better adhesion/uptake.
Body-weight outcomes suggest colitis relief for hyaluronic acid mixtures.
Documented Applications
Treatment and amelioration of inflammatory bowel disease (IBD) in a subject, including ulcerative colitis and Crohn’s disease.
Treatment/prevention contexts described for enteritis and wound healing.
Use of oral solid dosage forms (including enteric-coated tablets) and rectal/local formulations (suppositories, foam, perfusate, and enema) for administration in the disclosed method.
Combination use with a steroid, an immunosuppressive agent, or an anti-inflammatory drug as described for the treatment method.
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