Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
1998-01-30
2004-02-24
Kishore, Gollamudi S. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S456000, C424S457000, C424S463000, C424S464000, C424S468000, C424S474000, C424S630000, C424S641000, C424S646000, C424S702000, C514S052000, C514S251000, C514S356000, C514S474000, C514S725000
Reexamination Certificate
active
06696083
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to methods for treating disease states, and particularly to a method for the prevention and treatment of certain disease states in humans by the continuous administration of vitamins and minerals.
2. Description of Related Art
Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Recent studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies of these nutrients and the etiologies of certain disease states in humans.
In this regard, Diplock, “Antioxidant Nutrients and Disease Prevention: An Overview,”
Am. J. Clin. Nutr
., 53:189-193 (1991) describes the possible use of antioxidant nutrients to treat disease states which may be associated with free radical events in human physiology.
An article by Becker et al. in
Neurochirurgia
, Vol. 33 (1990), pages 113-121 discloses a study of the degenerative and regenerative changes in the saphenous nerve of rabbits following systematic treatment with a combination of the Vitamins B
1
, B
6
, and B
12
, in comparison with a control group. The data presented show that the degeneration of axons are lower in the group treated with these vitamins.
Varma, “Scientific Basis for Medical Therapy of Cataracts by Antioxidants,”
Am. J. Clin. Nutr
., Vol. 53 (1991), pages 335S-345S, suggests that exposure of animals and humans to oxyradicals may constitute a significant risk factor. The article teaches that nutritional and metabolic antioxidants such as ascorbate, vitamin E, and pyruvate may be useful for prophylaxis or therapy against cataracts.
DiMascio et al., “Antioxidant Defense Systems: the Role of Carotenoids, tocopherols, and Thiols,”
Am. J. Clin. Nutr
., Vol. 53 (1991), pages 194S-200S, suggests that aerobic metabolism involves the generation of oxygen species capable of damaging DNA, proteins, carbohydrates, and lipids. These reactive oxygen species are said to include the superoxide anion radical, hydrogen peroxide, the hydroxyl radical, and singlet molecular oxygen. The paper teaches that tocopherols function as efficient scavengers of hydroperoxyl radicals in biological membranes. The antioxidant functions of glutathione, the carotenoids, and the thiols, are also discussed.
Burton et al., “Vitamin E: Antioxidant Activity, Biokinetics, and Bioavailability,”
Annu. Rev. Nutr
., Vol. 10 (1990), pages 357-382, describes methods for studying the biokinetics and bioavailability of vitamin E.
While the foregoing references, which are incorporated herein by reference, illustrate the potential benefits that may be attained by the administration of vitamins and other nutrients, it would still be desirable to provide a means for improving the efficacy of known vitamin dosage forms and treatment regimens. For example, because vitamins are rapidly absorbed by the body, administration of conventional vitamin dosage forms results in low bioavailability and corresponding poor treatment efficacies. Effective treatment with water soluble vitamins, particularly vitamin C and the B vitamins, poses a particular problem because these vitamins are not stored in the body.
SUMMARY OF THE INVENTION
The invention is based on the discovery that the efficacy of vitamins and other nutritional agents in treating and preventing various disease states may be improved by administering therapeutically effective levels of these agents on a substantially continuous, i.e., over 24-hour period.
Thus, the invention contemplates a method of reducing the concentration of lipid peroxides formed by the autoxidation of lipids in a human, which comprises administering to the human, on a substantially continuous 24-hour basis, a therapeutically effective amount of a pharmaceutically-acceptable antioxidant agent.
Similarly, a second aspect of the invention relates to a method of reducing the concentration of oxygen free radicals in a human, which comprises administering to the human, on a substantially continuous 24-hour basis, a therapeutically effective amount of a pharmaceutically-acceptable antioxidant agent. Examples of oxygen free radicals include: superoxide anion radicals, hydroxyl radicals, peroxo radicals, and singlet molecular oxygen.
Antioxidant agents which may be employed in accordance with the above-described methods include antioxidant minerals, carotenoids, Vitamin E, Vitamin A, Vitamin C, thiols, and mixtures thereof. Vitamins E and C are preferred.
According to a third aspect of the invention, a method of improving the regeneration of nerve tissue in a human is provided, which comprises administering to the human, on a substantially continuous 24-hour basis, a therapeutically effective amount of at least one pharmaceutically-acceptable B complex Vitamin.
The substantially continuous 24-hour administration of the pharmaceutical agent may be achieved by administering the agent in multiple dosages during the daytime and at night. Continuous intravenous or similar method of administration is also possible. Preferably, however, substantially continuous 24-hour administration of the pharmaceutical agents is achieved by administering to the human a controlled release dosage form containing the pharmaceutical agent. In this regard, the controlled release dosage form may be administered about once every 24 hours so as to provide controlled release of the pharmaceutical agent over 24-hour period. Alternatively, the controlled release dosage form may be administered about twice every 24 hours so as to provide controlled release of the pharmaceutical agent over a 24-hour period. Dosage forms providing other than 12- or 24-hour controlled release of the nutritional agent may be employed, provided that therapeutically effective levels of the agents are maintained over a 24 hour period.
Thus, the invention permits the efficacious treatment and prevention of various disease states by maintaining therapeutically effective blood levels of vitamins and other nutritional agents over a substantially continuous, 24-hour dosing period. The inventive method overcomes the problems of rapid absorption and low bioavailability characteristic of conventional vitamin therapies.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Water soluble vitamins in conventional dosage forms and regimentation are absorbed by the upper small intestine and depleted from the system within about 3 to 4 hours after administration. Current vitamin dosage regimentation typically involves the administration of vitamins once in the morning.
The efficiency of vitamins and other nutritional agents in treating and preventing various disease states has been found to be improved by administering therapeutically effective levels of these agents on a substantially continuous, 24-hour basis.
According to a first aspect of the invention, a method of reducing the concentration of lipid peroxides formed by the autoxidation of lipids in a human is provided, which comprises administering to the human, on a substantially continuous 24-hour basis, a therapeutically effective amount of a pharmaceutically-acceptable antioxidant agent.
This therapy is believed to be useful in preventing the oxidative and enzymatic degradation of cholesterol in the body which results in the formation of very low density lipids (VLDL). These VLDL compounds are not desirable in that they tend to plaque within the vascular system, eventually leading to arteriosclerotic disease. The continuous administration of antioxidant agents prevents the formation of VLDL, thereby preventing the formation of arteriosclerotic plaque.
Useful antioxidant agents for purposes of the invention may be selected from the group consisting of antioxidant minerals, carotenoids, Vitamin E, Vitamin A, Vitamin C, thiols, and mixtures thereof. Vitamins E and C are preferred.
Antioxidant minerals include those selected from the group consisting of manganese, magnesium, copper, zinc, selenium, and mixtures thereof, with selenium being preferred.
Hermelin Marc S.
Kirschner Mitchell I.
Levinson R. Saul
Paradissis George N.
Blackwell Sanders Peper Martin LLP
DrugTech Corporation
LandOfFree
Vitamin/nutrient dosage regimentation does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Vitamin/nutrient dosage regimentation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Vitamin/nutrient dosage regimentation will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3343429