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(12) Patent Application Publication (10) Pub. No.: US 2016/0081959 A1 Bartos Et Al

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US 20160O81959A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0081959 A1 BartOS et al. (43) Pub. Date: Mar. 24, 2016 (54) METHOD OF USING ARGINNE SILICATE Publication Classification NOSITOL COMPLEX FOR WOUND HEALING OR REPAIR (51) Int. Cl. A63L/98 (2006.01) (71) Applicant: Glanbia plc, Carlsbad, CA (US) A63L/047 (2006.01) A6II 45/06 (2006.01) (72) Inventors: Jeremy David Bartos, San Marcos, CA A619/00 (2006.01) (US); Mayuresh Dilip Bedekar, (52) U.S. Cl. Carlsbad, CA (US) CPC ............. A6 IK3I/198 (2013.01); A61 K9/0053 (2013.01); A61 K9/0014 (2013.01); A61 K (73) Assignee: GLANBLA PLC, Carlsbad, CA (US) 9/0019 (2013.01); A61K3I/047 (2013.01); A61K 45/06 (2013.01) (21) Appl. No.: 14/850,685 (57) ABSTRACT A method for treating a wound or injury in an individual is (22) Filed: Sep. 10, 2015 provided, comprising the steps of administering to the indi vidual afflicted with the wound or injury a composition Related U.S. Application Data including an effective amount of arginine silicate inositol (60) Provisional application No. 62/054,789, filed on Sep. (ASI), optionally in combination with another component, 24, 2014. and a nutraceutically or pharmaceutically acceptable carrier. Patent Application Publication Mar. 24, 2016 Sheet 2 of 2 US 2016/0081959 A1 Mean Plasma Arginine Levels (Human Study) 409/o 359/6 309/o 259/o 200/o 150/6 109/ 59/o Time (hrs) FIG. 2 US 2016/008 1959 A1 Mar. 24, 2016 METHOD OF USING ARGINNE SILICATE SUMMARY NOSITOL COMPLEX FOR WOUND 0009. A nutritional composition is provided comprising HEALING OR REPAIR an effective amount of arginine silicate inositol (ASI), option 0001. This application claims the benefit of earlier filed ally in combination with another component, and a nutraceu U.S. Provisional application No. 62/054,789, filedon Sep. 24, tically acceptable carrier. 2014, which is hereby incorporated by reference herein. 0010. Other optional components can include compounds selected from vasodilators, NO-precursors, or eNOS activa TECHNICAL FIELD tors. Further optional components can include compounds selected from proline, hydroxyproline, IGF-1 activators, or 0002. A method of using arginine silicate inositol (ASI) polyamine precursors. complex is provided, optionally in combination with one or 0011. A method for treating a wound in an individual is more nutritional components, flavoring compounds, dietary provided, comprising the steps of administering to the indi Supplements, or other edible components. In an embodiment, vidual in need of Such treatment a composition including an a nutritional composition includes ASI. In another embodi effective amount of arginine silicate inositol (ASI), optionally ment, ASI is used in a method of treating wounds, i.e. wound in combination with another component, and a nutraceuti healing or repair. cally or pharmaceutically acceptable carrier. The present method can include oral/nutritional, intravenous, or topical BACKGROUND treatment. 0003 Treatment of wounds and other acute injuries is one of the primary responsibilities taken on by first responders BRIEF DESCRIPTION OF THE DRAWINGS (e.g., police, firemen, military, EMTs, and all manner of 0012 FIG. 1 depicts plasma concentration of arginine (ug/ emergency medical service (EMS) personnel) and medical ml) over time as single dose oral pharmacokinetic results staff (e.g., nurses, orderlies, military medics, triage or emer from testing in fasted male Sprague Dawley rates (equivalent gency room staff, physicians, and Surgeons). Methods of dose of 500 mg/kg. L-Arginine) for L-Arginine (free base), treatment for wounds are a critical need often requiring L-Arginine HCl, ResArgin, and Arginine silicate inositol immediate care. Many established methods of treatment are (ASI). known, included Standard first aid (field dressing and bandag 0013 FIG. 2 depicts percent change in concentration of ing), administration of drugs or medicines, and Surgical repair plasma L-arginine in human Subjects after a single dose of including Stitching, grafting and bone-setting. ASI, represented as mean value vs. time, relative to baseline. 0004 Apart from a human emergency scenario, wound treatment and/or wound healing are an important component DETAILED DESCRIPTION of medical treatment for recovery after injury. Additionally, 0014 Wounds are injuries that break the skin or other body certain chronic or degenerative conditions may require con tissues. They include cuts, scrapes, scratches, burns, electri stant vigilance with respect to treatment of wounds or lesions. cal wounds, bites, stings, incisions, amputations, and punc Indeed, a key component of wound healing and/or repair tured skin. They often happen because of an accident, but involves regenerative processes including reestablishing Surgery, Sutures, and Stitches also cause wounds. homeostasis in the affected tissues (Wong, et al., “Wound 0015. As used herein, “wound healing refers to a biologi Healing: A Paradigm for Regeneration.” Mayo Clin. Proc. cally-mediated process of repair or remodeling that may (2013) 88(9): 1022-1031). involve treatment of skin or other body tissues with a medici 0005. Currently, researchers are taking a more holistic nal or nutritional composition. Such treatments as applied to view of human health and nutrition. Thus, integration of good the human body may include, but are not limited to, treatment nutrition into the daily routine is one way of maintaining good of damage or insult to skin, tissue, and organs, wherein the immune balance, cardiac and muscular tone, and metabolic affected area may be, for example, cutaneous, Subcutaneous, efficiency. For example, a human clinical study on the effects visceral, circulatory, lymphatic, gastrointestinal, mucosal, of 17 g/day of arginine on wound healing was performed on skeletal, muscular, etc. 30 elderly patients who sustained an experimental Surgical 0016. In one example, human skin is a remarkably plastic injury. After two weeks Supplemented patients demonstrated organ that Sustains insult and injury throughout life. Its ability significantly greater hydroxyproline and protein accumula to expeditiously repair wounds is paramount to Survival and is tion at the wound site when compared to non-supplemented thought to be regulated by wound components such as differ controls. Lymphocyte response was also elevated in the entiated cells, stem cells, cytokine networks, extracellular Supplemented group, as was IGF-1 (Kirk, et al., Surgery matrix, and mechanical forces. These intrinsic regenerative (1993) 114(2): 155-160). pathways are integrated across different skin compartments 0006. In another example of the potential for wound heal and are being elucidated on the cellular and molecular levels. ing, arginine has been used to treat anal fissures (Gosselinket Recent advances in bioengineering and nanotechnology have al., Dis. Colon Rectum (2005) 48(4):832-7). allowed researchers to manipulate these microenvironments 0007. However, arginine suffers from drawbacks includ in increasingly precise spatial and temporal scales, recapitu ing low bioavailability and an undesirable taste. Better treat lating key homeostatic cues that may drive regeneration. ments and/or products are needed for therapeutic and/or 0017. As used herein, “arginine' is intended to mean nutritional use that can replace arginine alone. One useful L-arginine (Arg), a naturally occurring amino acid, with or material is arginine silicate inositol (ASI) complex. without a salt counterion, available in purified form from 0008. Therefore, if certain nutritional products containing Glanbia Nutritionals, Inc. (Carlsbad, Calif.). ASI were able to promote wound healing, this would repre 0018. It has now unexpectedly been found that arginine sent a contribution to the medical and nutritional arts. silicate inositol (ASI) complex may be used to make an edible US 2016/008 1959 A1 Mar. 24, 2016 nutritional composition that is effective for treating wounds, increased bioavailability of the arginine coming from the ASI. i.e., useful for wound healing or repair. It is believed that In addition, arginine is known to have a very unpleasant taste ASI-containing compositions are useful for treating wounds which makes it relatively unpalatable, especially for patients including, but not limited to, cuts, scrapes, scratches, burns, coming off of Surgery who may be suffering from nausea or electrical wounds, bites, stings, incisions, amputations, anal who have other wound healing needs. The smaller dose of fissures, punctured skin, and the like. ASI compared to other forms of arginine may help make a 0019. In addition, the arginine and silica from ASI are product more palatable or may be easier to mask flavor-wise. highly bioavailable meaning that less is needed to provide a 0025 Silicate is also a component of ASI and may also similar effect seen from other arginine sources. Stated in contribute to wound healing on its own. As used herein, another way, ASI contains about 40% by weight arginine. The 'silicate” means any of a number of materials including, but combination of the components as conjugates (silicon at 8% not limited to silica, Silica-containing compounds, silicate and inositol at 25%) make it more easily absorbed. Adminis salts, esters, and the like. Useful cationic counterions for tration of less arginine is needed to provide overall improve silicate include, but are not limited to, sodium, potassium, ment in taste, independent of the use of sweeteners or other lithium, calcium, magnesium, and the like. Silica
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    (19) TZZ ZZ__T (11) EP 2 808 015 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 03.12.2014 Bulletin 2014/49 A61K 31/34 (2006.01) A61K 31/502 (2006.01) A61K 31/353 (2006.01) A61P 9/00 (2006.01) (21) Application number: 14002458.9 (22) Date of filing: 16.11.2005 (84) Designated Contracting States: • O’Donnell, John AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Morgantown, WV 26505 (US) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI • Bottini, Peter Bruce SK TR Morgantown, WV 26505 (US) • Mason, Preston (30) Priority: 31.05.2005 US 141235 Morgantown, WV 26504 (US) 10.11.2005 US 272562 • Shaw, Andrew Preston 15.11.2005 US 273992 Morgantown, WV 26504 (US) (62) Document number(s) of the earlier application(s) in (74) Representative: Samson & Partner accordance with Art. 76 EPC: Widenmayerstraße 5 09015249.7 / 2 174 658 80538 München (DE) 05848185.4 / 1 890 691 Remarks: (71) Applicant: MYLAN LABORATORIES, INC This application was filed on 16-07-2014 as a Morgantown, NV 26504 (US) divisional application to the application mentioned under INID code 62. (72) Inventors: • Davis, Eric Morgantown, WV 26508 (US) (54) Compositions comprising nebivolol (57) The active ingredients of the pharmaceutical composition described consist of nebivolol, one or more ACE inhibitors and one or more ARB. EP 2 808 015 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 808 015 A1 Description [0001] This application is a continuation-in-part of application Ser.
  • Brain Peptides As Neurotransmitters (2)

    Brain Peptides As Neurotransmitters (2)

    as normal faults in Fig. 3 are actually complex 26. R. B. Herrnann and J. A. Canas, Bull. Seismol. 30. See, for example, L. R. Sykes, Rev. Geophys. zones with multiple offsets. Some of the faults Soc. Am. 68, 1095 (1978); R. B. Herrmann, J. Space Phys. 16, 621 (1979). can be interpreted as high-angle reverse faults Geophys. Res. 84, 3543 (1979). 31. W. Stauder et al., Cent. Miss. Val. Earthquake (line S-6). 27. R. R. Heinrich, Bull. Seismol. Soc. Am. 31, 187 Bull. 19 (1979). 23. R. G. Stearns, U.S. Nucl. Regul. Comm. Rep. (1941). 32. We thank R. E. Anderson, W. H. Diment, and NUREGICR-0874 (1979). 28. T. G. Hildenbrand, personal communication. 0. W. Nuttli, who reviewed the manuscript and- 24. W. M. Caplan, Arkansas Div. Geol. Bull. 20 29. The research well near line S-10 encountered suggested improvements. Appreciation is ex- (1954). highly fractured and altered Paleozoic rocks. tended to the U.S. Nuclear Regulatory Commis- 25. T. C. Buschbach, U.S. Nucl. Regul. Comm. The mineralogy and geochemistry of the rocks sion for providing the funds for the research Rep. NUREGICR-0450 (1978). suggests a nearby igneous body. well. addition, analgesia that follows electrical stimulation of the brainstem of rats could be partially reversed by the opiate antag- onist naloxone, an indication that a mor- phine-like substance was being released Brain Peptides as Neurotransmitters (2). To identify the postulated morphine- like factor two approaches were taken. Solomon H. Snyder Hughes (3) showed that brain extracts can mimic morphine's effects on electri- cally induced contractions of smooth muscle in a fashion that is blocked by It is generally agreed that information represent only 10 percent or less of the naloxone.