U.S. patent application number 15/338406 was filed with the patent office on 2017-05-25 for method and compositions for treating chronic inflammatory disorders.
This patent application is currently assigned to ELORAC INC. The applicant listed for this patent is JOEL E. BERNSTEIN. Invention is credited to JOEL E. BERNSTEIN.
Application Number | 20170143752 15/338406 |
Document ID | / |
Family ID | 57749266 |
Filed Date | 2017-05-25 |
United States Patent
Application |
20170143752 |
Kind Code |
A1 |
BERNSTEIN; JOEL E. |
May 25, 2017 |
METHOD AND COMPOSITIONS FOR TREATING CHRONIC INFLAMMATORY
DISORDERS
Abstract
A method and composition for treating chronic inflammatory
disorders comprising a pharmaceutically acceptable carrier suitable
for oral administration or injection and containing a therapeutic
amount of a complex of dietary supplement ingredients comprising
nicotinamide, quercetin, curcumin, EPA, DHA, hesperetin and
glychrrhizin.
Inventors: |
BERNSTEIN; JOEL E.;
(HIGHLAND PARK, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BERNSTEIN; JOEL E. |
HIGHLAND PARK |
IL |
US |
|
|
Assignee: |
ELORAC INC
VERNON HILLS
IL
|
Family ID: |
57749266 |
Appl. No.: |
15/338406 |
Filed: |
October 30, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14950030 |
Nov 24, 2015 |
9545419 |
|
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15338406 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 31/12 20130101;
A61K 9/0053 20130101; A23V 2002/00 20130101; A61K 31/352 20130101;
A61K 31/202 20130101; A61K 9/4858 20130101; A61K 31/7084 20130101;
A61K 9/0019 20130101; A23L 5/00 20160801; A23L 33/12 20160801; A23L
33/10 20160801; A61K 9/48 20130101; A61K 31/704 20130101; A61K
31/455 20130101; A61K 31/353 20130101; A23L 33/105 20160801; A61K
31/455 20130101; A61K 2300/00 20130101; A61K 31/352 20130101; A61K
2300/00 20130101; A61K 31/12 20130101; A61K 2300/00 20130101; A61K
31/202 20130101; A61K 2300/00 20130101; A61K 31/704 20130101; A61K
2300/00 20130101 |
International
Class: |
A61K 31/7084 20060101
A61K031/7084; A61K 31/455 20060101 A61K031/455; A61K 31/352
20060101 A61K031/352; A23L 33/10 20060101 A23L033/10; A61K 31/202
20060101 A61K031/202; A61K 31/353 20060101 A61K031/353; A61K 9/48
20060101 A61K009/48; A61K 9/00 20060101 A61K009/00; A61K 31/12
20060101 A61K031/12 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. (canceled)
5. (canceled)
6. (canceled)
7. (canceled)
8. A composition for treating chronic inflammatory disorders
comprising a pharmaceutically acceptable carrier suitable for oral
administration or injection containing a therapeutic amount of a
complex of dietary supplement ingredients comprising nicotinamide,
quercetin, curcumin, EPA, DHA, hesperetin and glycyrrhizin, and
wherein the dietary supplement ingredients are present in the
carrier in the following concentration ranges set forth in the
table below: TABLE-US-00002 Ingredient % By Weight in Oral-Dosage
Form Nicotinamide 20-40 Quercetin 10-15 Curcumin 10-20 EPA 12-26
DHA 4-12 Hesperetin 0.4-1.sup. Glycyrrhizin 1-4
9. (canceled)
10. The composition of claim 8, wherein the ratio of EPA to DHA
(EPA/DHA) must be .gtoreq.2.5 and .ltoreq.3.2 and the ratio of
nicotinamide to the combination of quercetin and curcumin must be
.gtoreq.0.80 and .ltoreq.1.50.
11. The composition of claim 8, wherein the carrier is a tablet,
capsule, caplet, or solution and suspension, suitable for oral
administration.
12. The composition of claim 8, wherein the carrier is a sterile
solution or suspension suitable for injection.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/950030, filed on Nov. 24, 2015, and the
benefit of such date is claimed herein.
TECHNICAL FIELD
[0002] The present invention relates to an immune-modulating
dietary supplement for treating chronic disorders, such as
psoriasis, rheumatoid arthritis, inflammatory bowel disease and
uveitis.
BACKGROUND OF THE INVENTION
[0003] Inflammation is part of the body's attempt at
self-protection, and functions to remove harmful stimuli and begin
the healing process. Inflammatory disorders arise when inflammation
becomes uncontrolled and causes destruction of healthy tissue.
Inflammation can be acute or chronic. Acute inflammation has a
rapid onset, often becomes severe, and usually resolves in days or
weeks. Chronic inflammation generally progresses less rapidly, and
may last for months or even years.
[0004] Although limited, mild to moderate psoriatic skin disease
can often be controlled by topical agents; more severe disease
usually requires systemic therapy. While psoriasis was once thought
to be a local hyper-proliferative disorder of keratinocytes, it is
now recognized that psoriasis is a chronic systemic inflammatory
disease with a prominent role for the immune system. Psoriasis
affects 2-3% of the U.S. population and is a source of substantial
morbidity. Psoriasis often has a significant effect on patients'
quality of life due both to the physical appearance of the skin
lesions and the psychosocial consequence of their appearance.
[0005] Rheumatoid arthritis is the most common form of
immune-mediated arthritis, affecting more than 1.3 million
Americans, and is the most disabling type of arthritis. It most
commonly affects the wrist and small joints of the hand.
Inflammatory bowel disease (IBD) involves chronic inflammation of
all or part of the lower digestive tract. The two most common types
of IBD are ulcerative colitis and Crohn's disease. In Crohn's
disease, inflammation can affect the entire digestive tract, while
in ulcerative colitis, only the large intestine is affected by
inflammation. Uveitis is a destructive inflammatory disease of the
middle layer of the eye, and is the third leading cause of
blindness worldwide. Uveitis can occur as an autoimmune disorder or
as a result of injury, infection or exposure to toxins.
[0006] The recognition of the immune mediation of these disorders
has led to a number of new therapeutic targets for these disorders.
Among the principal targets are actions of proinflammatory
cytokines and their associated transduction pathways, which include
tumor necrosis factor alpha (TNF-.alpha.), various interleukins
(especially IL-6 and IL-12), the Janus kinases (JAKS) and
phosodiesterase-4 (PDE4). A number of recent studies suggest that
the release of these cytokines and their transduction pathways
contribute to the initiation or persistence of the inflammatory
process in psoriasis, rheumatoid arthritis, IBD and uveitis.
[0007] The past 20 years have witnessed the development of a
succession of biologic therapies for psoriasis, rheumatoid
arthritis, inflammatory bowel disease and uveitis. Biologic
therapies or biologicals are medicinal substances that are
extracted from or synthesized from a living organism or its
products for prevention or treatment of a disease. They interfere
with specific components of the body's immune system and are
consequently more targeted than older systemic treatments for many
inflammatory disorders. Biologicals have proven to be effective
therapies for these complex inflammatory diseases. However, while
useful treatment options, biologicals have a number of limitations,
including uncommon but extremely serious side effects (such as
reduced ability to fight infections and a measurable increase in
the incidence of lymphoma), high patient costs, and a lack of or
loss of efficacy in a material number of patients.
[0008] These issues have prompted a continuing search for
additional or alternative therapies which are directed at the
inflammatory pathways. To improve patient response rates and reduce
the substantial annual cost a patient and the U.S. health system is
burdened with, I have investigated the therapeutic use of
combinations of natural dietary constituents, a number of which
have purported anti-inflammatory properties. I have discovered that
a handful of natural dietary constituents combined in natural
complexes, in very specific proportions, have clinically useful
anti-inflammatory properties. Such complexes can be administered by
themselves in pharmaceutical preparations designed for oral
administration, e.g. tablets, capsules, oral solutions and
suspensions for amelioration of psoriasis, rheumatoid arthritis,
IBD and uveitis; or they can be administered in oral pharmaceutical
preparations with other dietary supplement ingredients.
Additionally, and perhaps most importantly, such complexes can be
adjunctively administered with biologicals to improve patient
responsiveness as well as potentially dramatically reduce costs of
therapy.
SUMMARY OF THE INVENTION
[0009] The present invention relates to a method and composition
for treating chronic inflammatory disorders, such as psoriasis,
rheumatoid arthritis, inflammatory bowel disease and uveitis,
administered orally or by intravenous or subcutaneous
injection.
[0010] A principal object of the present invention is to provide a
method and composition for treating chronic inflammatory conditions
such as psoriasis, rheumatoid arthritis, inflammatory bowel disease
and uveitis, comprising administering to patients with such
inflammatory disorders a complex of natural dietary supplement
ingredients in specific proportions, either providing the complex
by itself or in combination with one or more biological agents.
[0011] Another object of the present invention is to provide a
method of the type set forth wherein the complex of natural dietary
supplement ingredients contains nicotinamide (aka niacinamide),
curcumin, quercetin, hesperetin, eicosapentaenoic acid (EPA),
docosahexaenoic acid (DHA) and glycyrrhizin.
[0012] A further object of the present invention is to provide a
method of administering the natural dietary supplement ingredient
complex as an adjunctive treatment for patients already receiving a
biological agent for their condition in order to effect a greater
improvement in their condition than with the biological alone.
[0013] Still another object of the present invention is to provide
a composition for reducing inflammation in chronic inflammatory
disorders comprising an amount of a small number of natural dietary
supplement ingredients in proprietary proportions so that when such
a composition is added to the biological drug in a patient's
treatment regimen, the dosage of the biological can be reduced
without adversely affecting the disease-state of the patient.
[0014] These and other objects of the present invention will be
more readily understood when considered in conjunction with the
following detailed description and examples.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0015] In the practice of the invention, pharmaceutical
preparations suitable for oral administration, including tablets,
capsules, caplets and liquid solutions or suspensions are prepared
containing a mixture nicotinamide, curcumin, quercetin, hesperetin,
glycyrrhizin, EPA and DHA, and administered to patients with
chronic inflammatory disorders experiencing exacerbations of their
diseases. The complex/mixture contains these ingredients in the
following concentrations by weight:
TABLE-US-00001 TABLE 1 Ingredient % By Weight in Oral Dosage Form
Nicotinamide 20-40 Quercetin 10-15 Curcumin 10-20 EPA 12-26 DHA
4-12 Hesperetin 0.4-1.sup. Glycyrrhizin 1-4
[0016] In addition to the percentage concentrations by weight
listed in Table 1 for the seven ingredients constituting the
natural dietary supplement immune-modulating complex, in order for
unequivocal efficacy of the complex certain specific ratios of the
ingredients must be present: 1) the ratio of EPA to DHA (EPA/DHA)
must be .gtoreq.2.5 .ltoreq.3.2) the ratio of nicotinamide to
quercetin+curcumin (N/Q&C) must be .gtoreq.0.80
.ltoreq.1.50.
[0017] In the practice of the invention, patients are administered
by mouth or by intravenous or subcutaneous injection of the natural
dietary supplement complex (the "Supplement Complex") in daily
dosages of 400 mg to 4000 mg once daily or in divided doses
administered 2 to 4 times per day. Oral dosages are incorporated
into pharmaceutically acceptable dosage forms including tablets,
capsules, caplets, and oral solutions or suspensions. Dosages
provided for injection are incorporated into pharmaceutically
acceptable solutions or stable suspensions.
[0018] The Supplement Complex may be administered by itself or in
combination with other dietary supplement ingredients including,
but not limited to, folic acid, vitamin A, vitamin D, vitamin C,
vitamin E, thiamine, pyridoxine, riboflavin, pantothenic acid and
biotin.
[0019] The Supplement Complex may be given as monotherapy or more
commonly as adjunctive therapy with biologicals to patients with
chronic inflammatory disorders. The following examples illustrate
the present invention.
EXAMPLE 1
[0020] A capsule containing 500 mg of a Supplement Complex
containing 200 mg nicotinamide, 75 mg quercetin, 75 mg curcumin,
100 mg EPA, 40 mg DHA, 5 mg hesperetin and 5 mg glycyrrhizin was
administered for 8 weeks to a 70 year old female with rheumatoid
arthritis and moderate pain. After 4 weeks of receiving the dietary
supplement, the patient reported mild joint pain and after 8 weeks
of receiving the dietary supplement, she reported no joint
pain.
EXAMPLE 2
[0021] A 69 year old woman with a 40 plus year history of Crohn's
disease ("CD") and multiple surgical procedures for CD, currently
receiving 80 mg of Humira every other week and still experiencing
frequent bloody stools and moderate pain, ingested for 4 weeks two
capsules BID of a dietary supplement containing 811.6 mg complex
comprised of 250 mg nicotinamide, 300 mg of a mixture of about 72%
EPA and about 28% DHA, 100 mg quercetin, 133.3 mg curcumin, 23 mg
glycyrrhizin, and 5.3 mg hesperetin. At the end of the 4-week
period, she had less frequent stools and a reduction in pain.
EXAMPLE 3
[0022] Nineteen (19) patients with moderate to severe plaque
psoriasis, who were being treated with a biological agent (8 on
Ustekinumab, 1 on Ustekinumab and Apremilast, 7 on Adalimumab, 3 on
Etanercept), had a dietary supplement having the composition of
Example 2 added to their treatment regimen. Each patient received 2
capsules of the dietary supplement once or twice daily for 8 weeks.
Determination of clinical benefits were assessed by a
Self-Administered Psoriasis Area Severity Index (SAPASI), a patient
global rating of overall improvement and a rating of body surface
area involvement. Of 11 patients with SAPASI >10 at baseline,
91% had an 8-week PASI 50 (.gtoreq.50% improvement at 8 weeks).
Sixty-three percent (63%) were rated by patients as Much Better or
Better, and mean psoriasis surface area decreased by a mean of 35%
by the end of the study.
EXAMPLE 4
[0023] Nineteen (19) patients with untreated plaque psoriasis
involving >5% body surface area were treated with the dietary
supplement capsules as in Example 2 and 3 for 28 days. None of the
patients had received any biological drug within 12 months or any
other oral treatment for psoriasis within 3 months of entering the
study. Serum biomarkers of inflammatory cytokines strongly
associated with the pathogenesis of psoriasis (tumor Necrosis
Factor-a, interleukin-2, interleukin-6 and interleukin-12) were
measured at baseline and after the 28-day treatment period. Serum
levels of IL-2 were below the level of quantification for all
patients. By day 28, patients had an 18.6% decrease in serum
TNF-.alpha. levels, and 53% had a mean decrease in IL6/IL12 serum
levels of 47.3%.
[0024] It will be apparent to those skilled in the art that only
the preferred embodiments have been described by way of
exemplification, and that there are various modifications which
fall within the scope of this invention.
* * * * *