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Title:  Topical and oral delivery of arginine to cause beneficial effects

United States Patent:  6,207,713

Inventors:   Fossel; Eric T. (17 Sunset View Rd., S. Hero, VT 05486)

Appl. No.:  936189

Filed:  September 17, 1997

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 scalp tissue lacking sufficient hair, promoting healing of superficial ulcers 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 scalp tissue lacking sufficient hair for a period of time causes substantial growth of hair on the scalp lacking sufficient hair, causes the healing of superficial ulcers such as leg ulcers and overcomes impotence.

SUMMARY OF THE INVENTION

Accordingly, several objects and advantages of the instant invention are to warm cold tissue in hands, feet or other tissue by increasing blood flow in the tissue means of enhancement of the body's natural mechanisms. It is further an object and advantage of the instant invention to prophylactically prevent tissue from becoming cold by use prior to entering into situations which induce cold hands and feet such as skiing or other winter outdoors activities. It is further an object and advantage of the instant invention to induce the growth of hair on portions of human scalp deficiency in hair by means of enhancement of the body's natural mechanisms. It is yet another object of the instant invention to induce healing of superficial ulcers of the limbs by means of enhancement of the body's natural mechanisms. It is still further another object of the instant invention to provide a means for overcoming impotence in many men.

In preferred embodiments, the oral delivery vehicles are capsules or tablets containing L-arginine used alone or in conjunction with a topical delivery vehicle such as a penetrating cream. In the cream the L-arginine is present as L-arginine hydrochloride in a concentration sufficient to produce the desired effect and the agent which creates the hostile biophysical environment is sodium chloride at a concentration sufficient to aid in tissue absorption.

PREFERRED EMBODIMENTS

The preferred embodiment uses tablets or capsules containing 200-500 mg of L-arginine to be used alone or in conjunction with a base cream with the properties of excellent absorption into the skin which also contains L-arginine hydrochloride (12.5% w/v), choline chloride (10%l w/v), magnesium chloride (5% w/v) and sodium chloride (5% w/v). The components of the base cream may be those commonly found in hand creams. The purpose of L-arginine hydrochloride is to provide a precursor to the molecule, nitric oxide, NO. The purpose of the sodium chloride is to provide a high ionic strength environment for the highly charged molecule, L-arginine. The base cream containing L-arginine and sodium chloride is the agent which is applied to the hands and/or feet to produce to produce a warming effect in the tissue, to produce hair growth or to effect healing of ulcers such as leg ulcers, or directly to the penis in order to aid in overcoming impotence.

The treatment consisting of oral administration of capsules or tablets containing L-arginine used alone or in conjunction with the cream acts effectively to warm cold tissue such as hands, fingers, feet, toes or other tissue when applied to the tissue and rubbed into the tissue to assure maximal absorption. The warming effect, caused by increased blood flow in the tissue is not instant but begins within 5 to 20 minutes. The effect is long lasting. Often the tissue remains warm for more than 2 to 18 hours. The treatment consisting of oral administration of capsules or tablets containing L-arginine used alone or in conjunction with the cream acts effectively to induce hair growth on bald human scalp when applied nightly to the bald area each night for several months. Hair growth is naturally a slow process. However, substantial hair growth is achieved over large areas of scalp with results becoming evident in a few weeks and substantial within several months. The cream further acts to promote healing of superficial ulcers such as those sometimes found on the legs of persons with severe diabetes. Application twice dally for a period of two weeks causes substantial healing and in many cases complete healing is achieved within this time period or slightly longer (3-4 weeks). Further the treatment consisting of oral administration of L-arginine used alone or in conjunction with the cream when carried out daily for a period of 7-10 days and then maintained with daily administration causes substantial relief from impotence in many men.

Claim 1 of 11 Claims

What is claimed is:

1. A method of increasing local blood flow 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 the delivery vehicle to the skin where the substance is absorbed by the surrounding tissue.

 

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