Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-04-20
2002-05-21
Pryor, Alton (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
Reexamination Certificate
active
06391332
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the use of the amino acid glutamine in combination with additional micronutrients in a composition for treating stress responses associated with severe trauma, bums, injury, infection and for promoting wound healing.
2. Discussion of the Background of the Invention
Major injury, burns, trauma, infection, or any critical illness, characteristically lead to profound metabolic abnormalities, lean mass catabolism, ongoing oxidant induced tissue damage, immune deficiency states and impaired wound healing. The metabolic abnormalities lead to increased cell energy demands and inefficient nutrient utilization. Tissue damage is observed as progressive lipid peroxidation. An immune deficiency state can lead to increased infections. The addition of micronutrients to a patient's therapeutic regime enhances recovery from severe stree induced responses caused by injury, burns, or sepsis. Micronutrients are essential for cellular function and the addition of such to a patient with metabolic derangement and ongoing catabolism will enhance recovery.
SUMMARY OF THE INVENTION
The present invention comprises a micronutrient composition in unit dosage form comprising L-glutamine, L-arginine, N-acetyl-cysteine, vitamin A, vitamin C, vitamin E, Thiamin, riboflavin, niacin, vitamin B
6
, folate, vitamin B
12
, pantothenic acid, magnesium, zinc, selenium and copper.
In a preferred embodiment, the unit dosage form comprises about 140 mg of L-arginine per 10 g glutamine, about 600 mg of N-acetyl-cysteine per 10 g glutamine, about 5,000 IU of vitamin A per 10 g glutamine, about 500 mg of vitamin C per 10 g glutamine, about 200 IU of vitamin E per 10 g glutamine, about 6 mg of thiamin per 10 g glutamine, about 6.8 mg of riboflavin per 10 g glutamine, about 80 mg of niacin per 10 g glutamine, about 8 mg of vitamin B
6
per 10 g glutamine, about 400 &mgr;g of folate per 10 g glutamine, about 50 &mgr;g of vitamin B
12
per 10 g glutamine, about 40 mg of pantothenic acid per 10 g glutamine, about 200 mg of magnesium per 10 g glutarnine, about 20 mg of zinc per 10 g glutamine, about 100 &mgr;g of selenium per 10 g glutamine, and about 0.75 mg of copper per 10 g glutamine.
The present invention also relates to a method of treating a stress response associated with severe trauma, bums, injury or infection which comprises administering to a patient in need thereof at least one unit dosage of a micronutrient composition according to the present invention in a 24 hours period.
In another embodiment, the present invention relates to a method of treating stress induced catabolic disorders associated with severe trauma, bums, injury or infection which comprises administering to a patient in need thereof at least one unit dosage of a micronutrient composition according to the present invention in a 24 hours period.
Yet another embodiment of the present invention relates to a method of treating an immune deficiency associated with severe trauma, bums, injury or infection which comprises administering to a patient in need thereof at least one unit dosage of a micronutrient composition according to the present invention in a 24 hours period.
A further embodiment of the present invention relates to a method of treating a stress induced oxidant injury associated with severe trauma, bums, injury or infection which comprises administering to a patient in need thereof at least one unit dosage of a micronutrient composition according to the present invention in a 24 hours period.
Yet another embodiment includes a method of promoting wound healing which comprises administering to a patient in need thereof at least one unit dosage of a micronutrient composition according to the present invention in a 24 hours period.
In a preferred embodiment, at least two unit dosage forms of the inventive composition are administered to a patient in need thereof in a 24 hours period.
In a particularly preferred embodiment, at least three unit dosage forms of the inventive composition are administered to a patient in need thereof in a 24 hours period.
Additional objects, features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
REFERENCES:
patent: 6051236 (2000-04-01), Portman
patent: 6159476 (2000-12-01), Djananov et al.
Mary Parry-Billings et al. “Does glutamine contribute to immunosuppression after major burns?” The Lancet vol. 336, pp. 523-525 (1990) Published by Williams & Wilkins.
Deborah R. Hunt, M.S., R.D. et al. “Selenium Depletion in Burn Patients” Journal of Parenteral and Enteral Nutrition vol. 8, No. 6, pp. 695-699 (1984) Published by American Society For Parenteral And Enteral Nutrition.
T.C. Welbourne et al. “Enteral glutamine supports hepatic glutathione efflux during inflammation” J. Nutr. Biochem., vol. 4, pp. 236-242 (Apr. 1993) Published by Butterworth-Heinemann.
Metaform / MetaPlexx, Weider Nutrition International, Inc., 98.
Sherratt J. Dale
Somerville Joann A.
Baxter International Inc.
Buonaiuto Mark J.
Kowalik Francis C.
Nichols Jeffrey C.
Pryor Alton
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