US20110039928A1 - Cetylated fatty acid and alkali buffered creatine anti-inflammatory composition - Google Patents

Cetylated fatty acid and alkali buffered creatine anti-inflammatory composition Download PDF

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Publication number
US20110039928A1
US20110039928A1 US12/806,436 US80643610A US2011039928A1 US 20110039928 A1 US20110039928 A1 US 20110039928A1 US 80643610 A US80643610 A US 80643610A US 2011039928 A1 US2011039928 A1 US 2011039928A1
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Prior art keywords
fatty acid
creatine
cetyl
composition according
anti
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Abandoned
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US12/806,436
Inventor
Jeffrey M. Golini
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Golini Jeffrey M
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Priority to US12/806,436 priority patent/US20110039928A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • A61K31/231Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms having one or two double bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms

Abstract

An anti-inflammatory composition for treatment of inflamed joints. This composition includes an alkali buffered creatine and a cetylated fatty acid. The composition can be used for treating inflammation either by oral ingestion or by topical treatment.

Description

  • This application claims the benefit of provisional application Ser. No. 61/274,175 filed Aug. 13, 2009.
  • BACKGROUND OF INVENTION
  • The present invention refers to a composition composed of a cetylated fatty acid and alkali buffered creatine for reducing joint and muscle related inflammation.
  • Chronic inflammation and muscle pain affects the body's ability to execute fluid motion. Ensuing joint stiffness restricts range of motion (ROM), which in turn negatively impacts quality of life (QOL). Chronic inflammation is a primary reason for doctor visits and increased costs in our healthcare system. Thousands of “Baby Boomers” born between 1946 and 1950, are now transitioning through age 60 and beyond. Along with the prospect of living to the century mark, comes the reality that osteoarthritis, sports and non-sports related injuries also increase. This year, the Arthritis Foundation has estimated that immune-related joint degenerative conditions are expected to strike more than 27 million Americans during the next decade, with additional untold numbers afflicted with ligament weakness, fibromyalgia, idiopathic pains and muscle trauma. Pain reducing medications are utilized daily, essentially to combat the symptoms of immune-related aging issues. Unfortunately, prescription drugs are not without side effects and many consumers are turning or have already turned to over-the-counter (OTC) substances in the hopes of obtaining pain relief without those side effects.
  • It has been found that creatine is helpful in reducing inflammation as discussed in U.S. Publication No. 2009/0137669. Further, cetylated fatty acids have been reported to exhibit anti-inflammatory activity in joint and muscle regions.
  • It would be desirable to provide a composition which would deliver cetylated fatty acids and alkali buffered creatine to a joint for treating inflammation.
  • SUMMARY OF INVENTION
  • The present invention relates to an anti-inflammatory composition for treatment of inflamed joints. This composition includes an alkali buffered creatine and a cetylated fatty acid. The composition can be used for treating inflammation either by oral ingestion or by topical treatment.
  • DESCRIPTION OF A PREFERRED EMBODIMENT
  • The present invention relates to an oral, alkali buffered creatine and cetylated fatty acid composition for reducing joint and muscle inflammation. When taken orally, the fatty acids bonded with the creatine get into the bloodstream and are delivered to the inflamed joint. The cell lipid structure surrounding the joint are lubricated by the fatty acids allowing the creatine to work more effectively in reducing inflammation.
  • A preferred embodiment of the present invention utilizes an alkalyn buffered creatine sold under the trade name Kre-Alkalyn® by All American Pharmaceutical and Natural Foods Corporation. This creatine is then mixed, bonded, reacted or compounded with a cetylated fatty acid as follows:
  • Typical Formulation:
  • Formulation 1: Kre-Alkalyn ® creatine 500 mg Soy Bean Oil 250 mg Cetyl Myristoleate 250 mg
  • The Kre-Alkalyn® creatine is an alkalyn buffered creatine. The soybean oil is a fatty acid and is used as a base. The cetyl myristoleate is a member of the cetylated fatty acid family.
  • Clinical tests were performed to determine the efficacy of this formulation.
  • Clinical Tests: Objectives:
  • Determine if a unique oral, alkali buffered-creatine—cetylated fatty acid composition (Kre-1), (a) is capable of reduce chronic joint and muscle related inflammation/pain, (b) can address site-specific pain with equal effectiveness, and, (c) will increase range of motion (ROM) in the afflicted area.
  • Design:
  • A total of 35 subjects (21 males, 14 females), each experiencing isolated areas of joint/muscle inflammation/pain, were divided into 2 groups: Group A was assigned four capsules of Kre-1 daily, Group B, an equal number of placebo capsules. The duration of the study was 30 days.
  • Settings/Location:
  • Participants entrance and exit interviews were conducted in the conference center at the All American Pharmaceutical. Study information (informed consent, test and placebo materials) was provided by an administrative assistant at All American Pharmaceutical. Pre and post blood tests (creatinine, AST, C-reactive protein) were accomplished at a local Laboratory Corporation of America blood lab. Physical examinations (entrance and exit), blood pressures, ROM, target area tenderness assessments, scoring and review of personal ‘Pain Journals’ by the test subjects and physicians were conducted at the Yellowstone Naturopathic Clinic, in Billings, Mont.
  • Subjects:
  • Group A (n=24; age 55 +/−32 yrs) received Kre-1, and ‘Group B’ (n=11; age 45 +/−15 yrs) received the placebo.
  • RESULTS
  • Data indicated approximately: 100% of ankle and foot pain, 80-85% of neck, shoulder, elbow, wrist, and hand pain, 71% of knee pain, respondents rated Kre-1 better than/as good as a prescription product in its ability to reduce/eliminate pain. Hip and back pain scores were no better than placebo scores for the same areas. ‘Group A’ experienced a modest increase in mobility (35%), but no measurable increase in ROM over that experienced in the placebo group (Group B).
  • CONCLUSIONS
  • Kre-1 exerts it greatest impact on areas of inflammation/pain in the extremities, as well as in the neck and shoulder region.
  • TABLE 1 Oral Kre-1 for Joint and Muscle Inflammation - Study Data Participants: Group A (Kre-1) Group B (Placebo) Initial 24 11 Completing 20 (21)* 11 Gender 17 males/3 females 4 males/7 females Age 23-88 years Drop outs (M/F) 3 F  0 Entrance blood tests: Overall average creatinine 0.9 mg/dl 0.8 mg/dl 23 IU/L AST (SGOT) 4.1 mg/dl 6.2 mg/dl 22 IU/L C-reactive Protein Exit blood tests: Overall average creatinine 0.9 mg/dl 0.8 mg/dl AST (SGOT) 25 IU/L 21 IU/L C-reactive Protein 4.2 mg/L 5.1 mg/L Pain Relief: Per Area: Percentage of participants rating Ankle/Foot - 100% (2/2) 0% their treatment, “as good as” or Knee (and leg) - 71+% (5/7) 0% “better than” their usual OTC or Hip - 33% (1/3) 33% (1/3) prescription pain reliever Back - 50% (5/10) 0% Neck/Shoulders - 85+% (6/7) 33% (1/3) Elbow/Wrist/Hand 80% (4/5) 33% (1/3) No Pain Relief: Per Area: Percentage of participants rating Ankle/Foot - 0% 100% (3/3) their treatment, “not as good as” or Knee (and leg) - 29% (2/7) 100% (5/11) “didn't work” compared to their Hip - 67% (2/3) 66% (2/3) usual OTC or prescription pain Back - 50% (5/10) 100% (1/1) reliever Neck/Shoulders - 15% (1/7) 66% (2/3) Elbow/Wrist/Hand 20% (1/5) 66% (2/3) Overall Average Yes No Yes No Personally said they experienced 60% 40% 27% 73% reduced pain/increased mobility (12/20) (8/20) (3/11) (8/11) Blood Pressure: Overall Average Entrance Systolic/Diastolic 127/83 129/82 Exit Systolic/Diastolic 125/75 119/77 *This participant withdrew before the end of the study.
  • TABLE 2 Kre-1 for Joint and Muscle Inflammation - Physicians Reports Pain: Group A (Kre-1) Group B (Placebo) Decrease 90% (18/20) 36% (4/11) No Change 10% (2/20) 55% (6/11)
  • The results of this study show that a combination of a cetylated fatty acid and an alkali buffered creatine provides an effective non-prescription material for reduction of pain and stiffness of the extremities, neck and shoulder regions in humans. It is intended that members of the cetylated fatty acid family including cetyl myristoleate, cetyl mylistate, cetyl palmitoleate, cetyl laureate, cetyl plamitate and cetyl oleate could be used equally as well. The cetylated fatty acids have anti-inflammatory properties with the ability to suppress pro-inflammatory cytokines. The alkali buffered creatine positively affects endothelial permeability, thereby inhibiting potentially inflammatory stimulating molecules from adhering and expressing their action as endothelial cells.
  • Delivery of the creatine/fatty acid composition may preferably occur through ingestion. It is contemplated that the creatine/fatty acid composition may be formulated such as a liquid drink and allow for oral ingestion. Further, the creatine/fatty acid composition may be formulated including solid formulations such as granules, a tablet, a capsule and the like for oral ingestion. Further, a food supplement such as a sports bar, and the like, may be employed for delivery of the creatine/fatty acid composition.
  • In addition, other formulations such as an emulsion, suspension and the like may be employed and allow delivery of the creatine/fatty acid composition to an inflamed joint. These formulations allow application through a variety of methods such as topical applications including ointments, lotions, creams and gels.
  • While the fundamental novel features of the invention have been shown and described, it should be understood that various substitutions, modifications, and variations may be made by those skilled in the arts, without departing from the spirit or scope of the invention. Accordingly, all such modifications or variations are included in the scope of the invention as defined by the following claims:

Claims (8)

I claim:
1. An anti-inflammatory creatine composition comprising an alkali buffered creatine and a cetylated fatty acid.
2. The composition according to claim 1 wherein the cetylated fatty acid includes at least one of cetyl myristoleate, cetyl mylistate, cetyl palmitoleate, cetyl laureate, cetyl plamitate and cetyl oleate.
3. The composition according to claim 1 formed in a solid form capable of ingestion.
4. The composition according to claim 3 wherein the solid form is configured as at least one of a food supplement, a tablet, a granule and a capsule.
5. The composition according to claim 1 formed in a liquid form capable of ingestion.
6. The composition according to claim 1 suitable for being received by topical application.
7. The composition according to claim 6 suitable for being received by at least one of a suspension, an emulsion and a solution.
8. The composition according to claim 7 which is configured as at least one of an ointment, lotion, cream and gel.
US12/806,436 2009-08-13 2010-08-12 Cetylated fatty acid and alkali buffered creatine anti-inflammatory composition Abandoned US20110039928A1 (en)

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US27417509P true 2009-08-13 2009-08-13
US12/806,436 US20110039928A1 (en) 2009-08-13 2010-08-12 Cetylated fatty acid and alkali buffered creatine anti-inflammatory composition

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US14/120,457 US9968581B2 (en) 2009-08-13 2014-05-20 Cetylated fatty acid and alkali buffered creatine anti-inflammatory composition

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016134150A1 (en) * 2015-02-18 2016-08-25 Tersus Life Sciences, LLC Methods for improving joint function

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US4113881A (en) * 1976-05-03 1978-09-12 Harry Weldon Diehl Method of treating rheumatoid arthritis
US6159485A (en) * 1999-01-08 2000-12-12 Yugenic Limited Partnership N-acetyl aldosamines, n-acetylamino acids and related n-acetyl compounds and their topical use
US6168802B1 (en) * 1996-05-31 2001-01-02 The Howard Foundation Compositions containing creatine and aloe vera extract
US6274161B1 (en) * 1996-05-31 2001-08-14 The Howard Foundation Compositions containing creatine in suspension
US6399661B1 (en) * 2000-06-26 2002-06-04 Jeffrey M. Golini Oral creatine supplement and method for making same
US6432929B1 (en) * 1999-06-22 2002-08-13 Joint Juice, Inc. Cartilage enhancing food supplements and methods of preparing the same
WO2003049687A2 (en) * 2001-12-06 2003-06-19 Weller Health, Inc. Medicinal compositions & therapeutic methods
US20030212130A1 (en) * 2000-09-14 2003-11-13 Miller Donald W. Creatine ester anti-inflammatory compounds and formulations
US20060062849A1 (en) * 2004-09-21 2006-03-23 Medical Research Institute Oral formulation of creatine derivatives and method of manufacturing same
US20060216251A1 (en) * 2005-03-24 2006-09-28 Tracie Martyn International, Llc Topical formulations and methods of use
US20090005450A1 (en) * 2007-04-09 2009-01-01 Belinda Tsao Nivaggioli Use of creatine compounds for the treatment of eye disorders
US20090105196A1 (en) * 2007-06-22 2009-04-23 Belinda Tsao Nivaggioli Use of creatine compounds to treat dermatitis

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US6417227B1 (en) * 1999-04-28 2002-07-09 Cg And Associates Methods of delivery of cetyl myristoleate
AU1953701A (en) * 1999-12-09 2001-06-18 Bruce Levin Methods and compositions for treatment of inflammatory disease
US6677321B1 (en) * 1999-12-09 2004-01-13 Bruce Levin Methods and compositions for treatment of inflammatory disease
DE10032964B4 (en) * 2000-07-06 2017-10-12 Beiersdorf Ag Use of creatine in cosmetic or dermatological preparations
US7772279B2 (en) * 2002-03-21 2010-08-10 Botanoceuticals, Inc. Use of vegetable butter-based cetyl myristoleate for treating osteoarthritis and other musculoskeletal disease conditions and injuries

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4113881A (en) * 1976-05-03 1978-09-12 Harry Weldon Diehl Method of treating rheumatoid arthritis
US6168802B1 (en) * 1996-05-31 2001-01-02 The Howard Foundation Compositions containing creatine and aloe vera extract
US6274161B1 (en) * 1996-05-31 2001-08-14 The Howard Foundation Compositions containing creatine in suspension
US6159485A (en) * 1999-01-08 2000-12-12 Yugenic Limited Partnership N-acetyl aldosamines, n-acetylamino acids and related n-acetyl compounds and their topical use
US6432929B1 (en) * 1999-06-22 2002-08-13 Joint Juice, Inc. Cartilage enhancing food supplements and methods of preparing the same
US6399661B1 (en) * 2000-06-26 2002-06-04 Jeffrey M. Golini Oral creatine supplement and method for making same
US20030212130A1 (en) * 2000-09-14 2003-11-13 Miller Donald W. Creatine ester anti-inflammatory compounds and formulations
US20090137669A1 (en) * 2000-09-14 2009-05-28 Miller Donald W Creatine ester anti-inflammatory compounds and formulations
WO2003049687A2 (en) * 2001-12-06 2003-06-19 Weller Health, Inc. Medicinal compositions & therapeutic methods
US20060062849A1 (en) * 2004-09-21 2006-03-23 Medical Research Institute Oral formulation of creatine derivatives and method of manufacturing same
US20060216251A1 (en) * 2005-03-24 2006-09-28 Tracie Martyn International, Llc Topical formulations and methods of use
US20090005450A1 (en) * 2007-04-09 2009-01-01 Belinda Tsao Nivaggioli Use of creatine compounds for the treatment of eye disorders
US20090105196A1 (en) * 2007-06-22 2009-04-23 Belinda Tsao Nivaggioli Use of creatine compounds to treat dermatitis

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016134150A1 (en) * 2015-02-18 2016-08-25 Tersus Life Sciences, LLC Methods for improving joint function
US10058524B2 (en) 2015-02-18 2018-08-28 Tersus Life Sciences, LLC Methods for improving joint function
EP3258928A4 (en) * 2015-02-18 2018-10-10 Tersus Life Sciences, LLC Methods for improving joint function

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EP2283836A1 (en) 2011-02-16
US20150011631A1 (en) 2015-01-08
US9968581B2 (en) 2018-05-15

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