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Topical and oral delivery of arginine to cause beneficial effects
Abstract
The use of orally administered L-arginine in conjunction with a topical preparation for producing enhanced blood flow in tissue thus causing beneficial effects such as warming cold tissue of the hands and feet, promoting hair growth on bald scalp tissue, promoting healing of superficial Ilcers such as leg ulcers in persons with diabetes, and overcoming male erectile failure (impotence) is disclosed. Specifically, use of orally administered L-arginine in conjunction with this is topical preparation provides local delivery of the amino acid L-arginine, an important biological precursor to the main substance which is responsible for relaxation of blood vessels permitting enhancement of blood flow. In the preferred embodiments, the L-arginine is provided so that it can be topically applied to the cold tissue. The preparation also contains an agent which aids in the transfer of L-arginine into the tissue. In the preferred embodiments this agent overcomes the resistance to transfer caused by the high charge density of L-arginine. In the preferred embodiments this means is high ionic strength created by addition of sodium chloride. This preparation, when topically applied to cold tissue, warming begins within 10 to 45 minutes and is sustained for periods as long as 2 to 18 hours. Further this preparation when applied nightly to bald scalp tissue-for a period of time causes substantial growth of hair on the bald scalp, causes the healing of superficial ulcers such as leg ulcers and overcomes impotence.
Inventors: Fossel; Eric T. (South Hero, VT)
Assignee: New England Property Holdings, LLC (Burlington, VT)
Appl. No.: 734096
Filed: December 11, 2000
Current U.S. Class: 514/565; 424/401; 424/439; 424/450
Intern'l Class: A61K 031/195; A61K 006/00; A61K 047/00; A61K 009/127
Field of Search: 514/565 424/401,450,439
References Cited [Referenced By]
U.S. Patent Documents
5595753 Jan., 1997 Hechtman 424/436.
5629002 May., 1997 Weuffen et al. 424/401.
5925372 Jul., 1999 Berner et al. 424/448.
Other References
Cooper et al., "Transdermal Delivery of Drugs", vol. II, editors Kydonieus and Berner, CRC Press, Inc., Boca Raton, FL, 1987, pp. 57-52. (Library of Congress Card No. 86-2585).
Primary Examiner: Criares; Theodore J.
Attorney, Agent or Firm: Lorusso & Loud
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This is a Divisional application of U.S. Ser. No. 08/936,189, filed Sep. 17, 1997, now U.S. Pat. No. 6,207,713 the contents of which are incorporated herein by reference.
Claims
What is claimed is:
1. A method of promoting hair growth by delivering a nitric oxide releasing substance selected from a member of the group consisting of L-arginine, L-arginine salts and L-arginine derivatives comprising the step of orally administering to the body a delivery vehicle for the substance, said delivery vehicle containing an effective amount of the substance and a concentration of ionic salt sufficient to create a hostile biophysical environment which causes the substance to migrate from said delivery vehicle to the surrounding tissue where it is absorbed.
2. The method of claim 1 wherein the vehicle is selected from a member of the group consisting of capsules, tablets, and liquids containing the substance.
3. The method of claim 1 comprising the further step of topically applying a delivery vehicle containing an effective amount of the substance and a concentration of ionic salt sufficient to create a hostile biophysical environment which causes the substance to migrate from the vehicle to the selected area of skin where hair growth is desired.
4. The method of claim 3 wherein the delivery vehicle that is topically applied is selected from the group consisting of topical creams, topical liquids, topical lotions and topical ointments.
5. The method of claim 3 wherein the delivery vehicle that is topically applied is hydrophobic.
6. The method of claim 3 wherein a transdermal patch containing the delivery vehicle that is topically applied is applied to the selected area of the skin.
7. The method of claim 3 wherein the delivery vehicle that is orally administered further comprises L-arginine from 0.5-30 g/day and the delivery vehicle that is topically administered further comprises water from 20-80%, mineral oil from 3-18%, glyceryl stearate from 0.5-12%, squalene from 0.2-12%, cetyl alcohol from 0.1-11%, propylene glycol stearate from 0.1-11%, wheat germ oil from 0.1-6%, glyceryl stereate from 0.1-6%, isopropyl myristate from 0.1-6%, stearyl stearate from 0.1-6%, polysorbate from 60 0.1-5%, propylene glycol from 0.05-5%, tocopherol acetate from 0.05-5%, collagen from 0.05-5%, sorbitan stearate from 0.05-5%, vitamin A&D from 0.02-4%, triethanolamine from 0.01-4%, methylparaben from 0.01-4%, aloe vera extract from 0.01-4%, imidazolidinyl urea from 0.01-4%, propylparaben from 0.01-4%, bha from 0.01-4%, L-arginine hydrocholide from 0.25-25%, sodium chloride from 0.25-25%, and magnesium chloride from 0.25-25%.
8. The method of claim 7 wherein the delivery vehicle that is topically applied further includes choline chloride from 0.25-25%.
9. The method of claim 7 wherein the delivery vehicle that is topically applied further comprises L-arginine glutamate (0.25-25%).
10. A method of promoting hair growth by delivering a nitric oxide releasing substance selected from a member of the group consisting of L-arginine, L-arginine salts and L-arginine derivatives comprising the step of orally administering to the body a delivery vehicle for the substance, said delivery vehicle containing an effective amount of the substance and a concentration of ionic salt sufficient to create a hostile biophysical environment which causes the substance to migrate from said delivery vehicle to the surrounding tissue where it is absorbed, in conjunction with the step of topically applying to a selected area of skin a topical delivery vehicle containing an effective amount of the substance within a liposome, so that the liposome containing the substance migrates from the delivery vehicle into the skin where the substance is absorbed by tissue.
Description
BACKGROUND
1. Field of the Invention
This invention relates to the use of L-arginine orally alone or in conjunction with topical application of a cream, gel, or other vehicle which contains substances such as L-arginine which delivers these substances into tissue for the purpose of producing beneficial effects such as warming of cold or cool tissues, growth of hair on the scalp, healing of leg ulcers secondary to diabetes or confinement to bed, relief of impotence, as well as beneficial effects through restoration of natural mechanisms based on improvement of local blood supply.
2. Prior Art
Approaches to improving local blood flow have been many and consist of both systemic and topical approaches. Many beneficial effects could be obtained should improvement in local blood flow be achieved since impairment of local blood flow causes a variety of negative consequences. Among these are cold hands and feet, baldness, leg ulcers, certain forms of impotence, as well as a variety of other things. Approaches to warming cold tissue including cold hands, fingers, feet and toes constitute one section of the prior art. Many persons suffer from cold hands, feet or other body parts. This is often caused by insufficient blood flow in the cold tissue. Previously cold hands or feet have been treated by wearing warm socks or gloves, sometimes even socks or gloves which are mechanically heated. The use of hot packs and glove or shoe inserts which generate heat through chemical reactions has also been a potential solution. Certain liniments which are essentially irritants, such as those containing the red pepper derived substance, capsicum fall into this category. More recently, topical creams containing nitroglycerine have been used. See H. Natsuda et al., Ryumachi 34, 849 (1994). All of these approaches work at one level or another though are often extremely transient in nature. Nitroglycerine creams also have the disadvantage that nitroglycerine is a cardioactive drug, raising concerns of effects on the heart.
It has been recognized that deficiencies in blood flow in the scalp occur in male pattern baldness. See G. Duplechain et al., J. Lousiana State Med Soc. 146, 7 (1994); P Klemp et al., J Invests Dermatol 95, 725 (1989); S Toshitani et al., J Dermatol 17, 240 (1990). Topical minoxidil has been used as an agent for hair growth in male pattern baldness with varying results. Though the suggestion has been made that minoxidil operates through increase in the blood supply to the scalp, many investigators have failed to show such an effect. See E de Boer et al., Acta Dermato- Venereoligica 68, 271 (1988); C Bunker et al., British J Derm 117, 668 (1987).
__________________
CONTROLLED LABS - Winning the WAR against GENETICS
Email: pt [at] controlledlabs.com
IT'S a LIFESTYLE:
http://forum.bodybuilding.com/showthread.php?t=6492951
Disclaimer: The above post is my own PERSONAL OPINION and DOES NOT REPRESENT the official position of any company or entity. It DOES NOT constitute medical advice. CONTROLLED LABS products are produced in a GMP for Sport certified facility (no hormones produced in the facility / no cross contamination).
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Abstract
The use of orally administered L-arginine in conjunction with a topical preparation for producing enhanced blood flow in tissue thus causing beneficial effects such as warming cold tissue of the hands and feet, promoting hair growth on bald scalp tissue, promoting healing of superficial Ilcers such as leg ulcers in persons with diabetes, and overcoming male erectile failure (impotence) is disclosed. Specifically, use of orally administered L-arginine in conjunction with this is topical preparation provides local delivery of the amino acid L-arginine, an important biological precursor to the main substance which is responsible for relaxation of blood vessels permitting enhancement of blood flow. In the preferred embodiments, the L-arginine is provided so that it can be topically applied to the cold tissue. The preparation also contains an agent which aids in the transfer of L-arginine into the tissue. In the preferred embodiments this agent overcomes the resistance to transfer caused by the high charge density of L-arginine. In the preferred embodiments this means is high ionic strength created by addition of sodium chloride. This preparation, when topically applied to cold tissue, warming begins within 10 to 45 minutes and is sustained for periods as long as 2 to 18 hours. Further this preparation when applied nightly to bald scalp tissue-for a period of time causes substantial growth of hair on the bald scalp, causes the healing of superficial ulcers such as leg ulcers and overcomes impotence.
Inventors: Fossel; Eric T. (South Hero, VT)
Assignee: New England Property Holdings, LLC (Burlington, VT)
Appl. No.: 734096
Filed: December 11, 2000
Current U.S. Class: 514/565; 424/401; 424/439; 424/450
Intern'l Class: A61K 031/195; A61K 006/00; A61K 047/00; A61K 009/127
Field of Search: 514/565 424/401,450,439
References Cited [Referenced By]
U.S. Patent Documents
5595753 Jan., 1997 Hechtman 424/436.
5629002 May., 1997 Weuffen et al. 424/401.
5925372 Jul., 1999 Berner et al. 424/448.
Other References
Cooper et al., "Transdermal Delivery of Drugs", vol. II, editors Kydonieus and Berner, CRC Press, Inc., Boca Raton, FL, 1987, pp. 57-52. (Library of Congress Card No. 86-2585).
Primary Examiner: Criares; Theodore J.
Attorney, Agent or Firm: Lorusso & Loud
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This is a Divisional application of U.S. Ser. No. 08/936,189, filed Sep. 17, 1997, now U.S. Pat. No. 6,207,713 the contents of which are incorporated herein by reference.
Claims
What is claimed is:
1. A method of promoting hair growth by delivering a nitric oxide releasing substance selected from a member of the group consisting of L-arginine, L-arginine salts and L-arginine derivatives comprising the step of orally administering to the body a delivery vehicle for the substance, said delivery vehicle containing an effective amount of the substance and a concentration of ionic salt sufficient to create a hostile biophysical environment which causes the substance to migrate from said delivery vehicle to the surrounding tissue where it is absorbed.
2. The method of claim 1 wherein the vehicle is selected from a member of the group consisting of capsules, tablets, and liquids containing the substance.
3. The method of claim 1 comprising the further step of topically applying a delivery vehicle containing an effective amount of the substance and a concentration of ionic salt sufficient to create a hostile biophysical environment which causes the substance to migrate from the vehicle to the selected area of skin where hair growth is desired.
4. The method of claim 3 wherein the delivery vehicle that is topically applied is selected from the group consisting of topical creams, topical liquids, topical lotions and topical ointments.
5. The method of claim 3 wherein the delivery vehicle that is topically applied is hydrophobic.
6. The method of claim 3 wherein a transdermal patch containing the delivery vehicle that is topically applied is applied to the selected area of the skin.
7. The method of claim 3 wherein the delivery vehicle that is orally administered further comprises L-arginine from 0.5-30 g/day and the delivery vehicle that is topically administered further comprises water from 20-80%, mineral oil from 3-18%, glyceryl stearate from 0.5-12%, squalene from 0.2-12%, cetyl alcohol from 0.1-11%, propylene glycol stearate from 0.1-11%, wheat germ oil from 0.1-6%, glyceryl stereate from 0.1-6%, isopropyl myristate from 0.1-6%, stearyl stearate from 0.1-6%, polysorbate from 60 0.1-5%, propylene glycol from 0.05-5%, tocopherol acetate from 0.05-5%, collagen from 0.05-5%, sorbitan stearate from 0.05-5%, vitamin A&D from 0.02-4%, triethanolamine from 0.01-4%, methylparaben from 0.01-4%, aloe vera extract from 0.01-4%, imidazolidinyl urea from 0.01-4%, propylparaben from 0.01-4%, bha from 0.01-4%, L-arginine hydrocholide from 0.25-25%, sodium chloride from 0.25-25%, and magnesium chloride from 0.25-25%.
8. The method of claim 7 wherein the delivery vehicle that is topically applied further includes choline chloride from 0.25-25%.
9. The method of claim 7 wherein the delivery vehicle that is topically applied further comprises L-arginine glutamate (0.25-25%).
10. A method of promoting hair growth by delivering a nitric oxide releasing substance selected from a member of the group consisting of L-arginine, L-arginine salts and L-arginine derivatives comprising the step of orally administering to the body a delivery vehicle for the substance, said delivery vehicle containing an effective amount of the substance and a concentration of ionic salt sufficient to create a hostile biophysical environment which causes the substance to migrate from said delivery vehicle to the surrounding tissue where it is absorbed, in conjunction with the step of topically applying to a selected area of skin a topical delivery vehicle containing an effective amount of the substance within a liposome, so that the liposome containing the substance migrates from the delivery vehicle into the skin where the substance is absorbed by tissue.
Description
BACKGROUND
1. Field of the Invention
This invention relates to the use of L-arginine orally alone or in conjunction with topical application of a cream, gel, or other vehicle which contains substances such as L-arginine which delivers these substances into tissue for the purpose of producing beneficial effects such as warming of cold or cool tissues, growth of hair on the scalp, healing of leg ulcers secondary to diabetes or confinement to bed, relief of impotence, as well as beneficial effects through restoration of natural mechanisms based on improvement of local blood supply.
2. Prior Art
Approaches to improving local blood flow have been many and consist of both systemic and topical approaches. Many beneficial effects could be obtained should improvement in local blood flow be achieved since impairment of local blood flow causes a variety of negative consequences. Among these are cold hands and feet, baldness, leg ulcers, certain forms of impotence, as well as a variety of other things. Approaches to warming cold tissue including cold hands, fingers, feet and toes constitute one section of the prior art. Many persons suffer from cold hands, feet or other body parts. This is often caused by insufficient blood flow in the cold tissue. Previously cold hands or feet have been treated by wearing warm socks or gloves, sometimes even socks or gloves which are mechanically heated. The use of hot packs and glove or shoe inserts which generate heat through chemical reactions has also been a potential solution. Certain liniments which are essentially irritants, such as those containing the red pepper derived substance, capsicum fall into this category. More recently, topical creams containing nitroglycerine have been used. See H. Natsuda et al., Ryumachi 34, 849 (1994). All of these approaches work at one level or another though are often extremely transient in nature. Nitroglycerine creams also have the disadvantage that nitroglycerine is a cardioactive drug, raising concerns of effects on the heart.
It has been recognized that deficiencies in blood flow in the scalp occur in male pattern baldness. See G. Duplechain et al., J. Lousiana State Med Soc. 146, 7 (1994); P Klemp et al., J Invests Dermatol 95, 725 (1989); S Toshitani et al., J Dermatol 17, 240 (1990). Topical minoxidil has been used as an agent for hair growth in male pattern baldness with varying results. Though the suggestion has been made that minoxidil operates through increase in the blood supply to the scalp, many investigators have failed to show such an effect. See E de Boer et al., Acta Dermato- Venereoligica 68, 271 (1988); C Bunker et al., British J Derm 117, 668 (1987).
__________________
CONTROLLED LABS - Winning the WAR against GENETICS
Email: pt [at] controlledlabs.com
IT'S a LIFESTYLE:
http://forum.bodybuilding.com/showthread.php?t=6492951
Disclaimer: The above post is my own PERSONAL OPINION and DOES NOT REPRESENT the official position of any company or entity. It DOES NOT constitute medical advice. CONTROLLED LABS products are produced in a GMP for Sport certified facility (no hormones produced in the facility / no cross contamination).
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