METHOD AND COMPOSITION FOR SURGERY PREPAREDNESS AND RECOVERY

Abstract

The present invention relates to compositions and methods to increase nitric oxide production to: accelerate wound healing, reduce complications from surgery as well as accelerating the recovery period after surgery. The compositions comprise of l-arginine and l-citrulline in ratios and dosages which enable enhanced bioavailability. The method for using the composition for promoting surgery recovery and preparedness includes the step of administering the composition to a patient pre-procedure as well as post-procedure in accordance with a prescribed protocol. The compositions may be customized to include one or more additional agents that are effective for promoting nutritional health and/or treating a particular medical problem.

Claims

1. A micronutrient composition to enhance nitric oxide production administered in a unit dose wherein said unit dose comprises: a. The amino-acids l-arginine and l-citrulline in mass ratios between about 0.3 and 3.0 (l-arginine/l-citrulline) with a combined total mass of between about 1 g and 20 g.

2. A composition of claim 1, wherein said unit dose further includes one or more antioxidant(s), amino acid(s) and/or proteolytic or hemolytic enzyme(s). This includes, but is not limited to: vitamin C, glutamine, and bromelain.

3. A method to reduce complications associated with a surgical procedure comprising the step of orally administering a unit dose of the composition of claims 1 and/or 2 to the patient beginning at least 2 days prior to a surgical procedure and at least 3 days after.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0017] The present invention relates to an orally administrable composition comprising a combination of l-arginine and l-citrulline in specific ratios to enhance bioavailability and increase nitric oxide production in order to enhance wound healing and reduce complications associated with surgical trauma. The invention also may contain one or more additional antioxidants and/or amino acids used in tissue production, and/or proteolytic and/or hemolytic enzymes.

[0018] The present invention is further directed to a method for the administration of said compositions for surgical preparedness and the modulation of the phases of wound healing in order to: reduce complications from surgery (including but not limited to complications due to inflammation, in particular ischemia-reperfusion injury, pain, swelling and bruising) accelerate wound healing, as well as accelerating the recovery period after surgery.

[0019] Nitric oxide is responsible for controlling blood vessel dilation and regulating blood flow. Nitric oxide also plays a critical role in the inflammatory and proliferation phases of wound healing. Specifically, nitric oxide is a mediator in the formation of new blood vessels (angiogenesis), wound healing (epithelization) and collagen formation. Depletion of nitric oxide in the inflammatory phase is partially responsible for ischemia-reperfusion injuries, which can delay healing and lead to the formation of chronic wounds.

[0020] L-arginine and l-citrulline are used by the body in the synthesis or nitric oxide, however oral administration of l-arginine or l-citrulline on their own results in negligible increases in endothelial nitric oxide production.

[0021] L-arginine get rapidly broken down in the digestive system by the enzyme arginase as part of the urea cycle. This converts l-arginine to ornithine and urea, resulting in no nitric oxide production.

[0022] L-citrulline can be converted by the body to l-arginine. However, this process is slow and inefficient resulting in low levels of l-arginine and nitric oxide production at a given time.

[0023] The present inventions composition of orally administered l-arginine and l-citrulline taken together, in specific ratio ranges and dosages, inhibits the urea pathway and favors the production of nitric oxide. L-citrulline can inhibit arginase activity allowing more efficient absorption of l-arginine. Excess l-citrulline can be converted to l-arginine for sustained and longer acting nitric oxide production. The favoring of the nitric oxide pathway by the inhibition of arginase enables the invention to increase nitric oxide production at relatively low doses, avoiding negative side effects associated with high doses of the amino-acids which include gout, abdominal pain, acid-reflux and diarrhea.

[0024] Embodiments of the composition should contain a unit dose of at least 1 g total of l-arginine and l-citrulline in mass ratios between 0.3 and 3.0 (l-arginine/l-citrulline). The unit dose should not contain in excess of about 20 g total of l-arginine and l-citrulline as undesirable side effects such as abdominal pain and diarrhea may occur. A unit dose may contain additional antioxidants, amino acids, proteolytic and/or hemolytic enzymes. These can be used to address additional dietary and/or health concerns and/or be used to provide additional anti-inflammatory effects and/or effects beneficial to wound healing.

[0025] Examples of additional antioxidants includes, but is not limited to: resveratrol, beta-carotene, lutein, quercetin, and vitamin C.

[0026] Examples of additional beneficial amino acids includes, but is not limited to: leucine, isoleucine, valine and glutamine.

[0027] Examples of additional proteolytic and hemolytic enzymes includes, but is not limited to: bromelain and papain.

[0028] Examples of additional nutrients for a most preferred embodiment includes: vitamin C, l-glutamine, and bromelain.

[0029] Antioxidants scavenge inflammation causing free radicals which can be formed by tissue damage and oxidative stress. Vitamin C has been shown to be a powerful and well tolerated antioxidant which theoretically could help reduce inflammation,

[0030] L-glutamine is an amino acid used in protein synthesis. Exogenous l-glutamine supplementation has been reported to improve immune response.

[0031] Proteolytic enzymes (proteases) help digest the proteins in food. Exogenous supplementation of proteolytic enzymes such as bromelain, can be absorbed internally and can help reduce ecchymosis and edemas.

[0032] A unit dose of a composition in accordance with a most preferred embodiment of the present invention includes: 1 g l-arginine, 1 g l-citrulline, 2 g l-glutamine, 500 mg vitamin C and 500 mg bromelain.

[0033] In accordance with the most preferred method for surgical preparedness and recovery, one-unit dose such as that described in [032] is taken twice daily, 3 days prior to the procedure, and one-unit dose of the composition is taken twice daily for 6 days after the procedure. Other embodiments of the method may include the administration of the composition 2 to 5 days before surgery and be taken 3 days to up to 20 days after surgery.

[0034] In a preferred embodiment the composition of [032] may be individually packaged as a flavored powder in sealed foil for dilution in water and ingested orally.

[0035] In other embodiments of the invention, the composition may be packaged as a bulk powder with an appropriately sized scoop to measure out the unit dose which can then be dissolved in water. Another possible packaging option is to have the composition in a bottle or carton as an aqueous solution in either a unit dose or a bulk liquid.

[0036] It will be apparent to those skilled in the art that various other changes and modifications can be made without departing from the scope and spirit of the invention. The embodiments described do not limit the claims made to this invention and any modifications containing any or all features of the invention are intended to be covered in the appended claims.