Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-09-23
2003-02-18
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S219000, C514S458000, C424S730000, C424S752000
Reexamination Certificate
active
06521266
ABSTRACT:
TECHNICAL FIELD
The present invention is generally directed to methods and compositions that enhance growth hormone production and release, and which have been found to suppresses appetite, in human subjects.
BACKGROUND OF THE INVENTION
Growth hormone plays an important role in the physiology of warm-blooded animals, including humans. To date, there have been several methods developed to increase growth hormone levels within the body to influence a disease state such as, for example, pituitary dwarfism, or to facilitate healing after trauma associated with burns, surgery, etc. Relatedly, it has been noted that growth hormone levels within the body markedly decrease after puberty, and gradually decline thereafter throughout life. It has also been noted that growth hormone supplementation in elderly individuals cause physiological changes consistent with rejuvenation. Accordingly, growth hormone supplementation is considered by many to be highly advantageous.
Additionally, there are several known compounds which are considered to be growth hormone secretogogues, but these compounds do not necessarily promote growth hormone synthesis. There are also several known compounds which promote growth hormone synthesis, but these compounds do not necessarily induce the release or secretion of the growth hormone. Moreover, due to the large size and fragility associated with growth hormone molecules (191 peptide residues), growth hormone (and similar agents) is generally administered into the body via an injection. There are, however, several shortcomings associated with systemic delivery by injection, shortcomings such as increased risk of infection at the site of delivery.
Accordingly, there is a need in the art for a composition that enhances growth hormone production and release within a subject, as well as to methods relating thereto. The present invention fulfills these needs and provides for further related advantages.
SUMMARY OF THE INVENTION
In brief, the present invention is generally directed to compositions and methods for enhancing growth hormone production and release, in a subject so as to effectuate rejuvenation. In the practice of this invention, it has also been found that such compositions simultaneously serve to suppress appetite.
In one embodiment, a method for enhancing growth hormone production and release in a subject so as to effectuate rejuvenation and appetite suppression is disclosed. The method comprises the steps of administering to a subject in need thereof an effective amount of a first composition, wherein the first composition increases cholinergic tone above a baseline level; and administering to the subject an effective amount of a second composition, wherein the second composition decreases somatostatin below a baseline level. The first composition may be a combination of an acetylcholinesterase inhibitor and Vitamin E &agr;-D-succinate, whereas the second composition may be a combination of a salt of cysteamine (e.g., cysteamine hydrochloride salt) and an alkali buffer. Alternatively, the second composition may be a combination of pantothenic acid and an alkali metal salt, as well as a reducing agent as an optional component. It is to be understood that other forms of cysteamine, including the base, may also be used.
In another embodiment, a kit useful for enhancing growth hormone production and release so as to effectuate rejuvenation and appetite suppression is disclosed. The kit comprises a first composition and a second composition, wherein first composition comprises an acetylcholinesterase inhibitor and Vitamin E &agr;-D-succinate, whereas the second composition is a salt of cysteamine (e.g., cysteamine hydrochloride salt) and an alkali buffer, or pantothenic acid and an alkali metal salt. In a more specific embodiment, the first composition comprises choline bitartrate in an amount ranging from 0.01 to 95% by weight; dimethylaminoethanol in an amount ranging from 0.01 to 85% by weight; Vitamin E &agr;-D-succinate in an amount ranging from 0.01 o 85% by weight; gingko biloba 24% gingosides in an amount ranging from 0.001 to 30% by weight; Huperzine A in an amount ranging from 0.000000001 to 5% by weight; and 5-Hydroxytryptophan in an amount ranging from 0.001 to 30% by weight; and wherein the second composition comprises cysteamine HCL in an amount ranging from 0.001 to 90% by weight. In an alternative embodiment, the second composition comprises calcium pantothenate in an amount ranging from 0.01 to 99% by weight; magnesium phosphate tribasic in an amount ranging from 0.01 to 99% by weight; magnesium phosphate tribasic in an amount ranging from 0.1 to 85% by weight; magnesium sulfite in an amount ranging from 0.1 to 85% by weight; and citric acid in an amount ranging from 0.01 to 95% by weight of the second composition.
The present invention is also directed to a method for suppressing appetite within a subject, comprising the steps of orally administering an effective amount of the kit of this invention.
These and other aspects of this invention will be evident upon reference to the following detailed description.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is generally directed to compositions and methods for enhancing growth hormone production and release in a subject so as to effectuate rejuvenation and appetite suppression. Although many specific details associated with certain aspects of the present invention are set forth below, those skilled in the art of pharmacology, and especially neuropharmacology, will recognize that the present invention may have additional embodiments, or that the invention may be practiced without several of the details disclosed herein.
As noted above, it is known that growth hormone plays a vital role in human physiology, and numerous methods have been developed to increase growth hormone levels within a human body so as to influence a variety of disease states. It is also known that growth hormone levels decrease after puberty, and continue to gradually decline throughout life, and that growth hormone supplementation in elderly individuals causes changes consistent with rejuvenation. However, because of the size and fragility of the growth hormone molecule, it must be administered by injection. Accordingly, an orally available composition capable of enhancing growth hormone production and release is needed.
The present invention provides an orally administered composition for enhancing growth hormone production and release, and methods related thereto. In addition, it has been surprisingly found that the composition of this invention also serves to suppress appetite in human subjects, which is a desirable attribute in and of itself.
The composition of this invention is a kit formulation, wherein the first part of the composition enhances (1) cholinergic tone and (2) growth hormone synthesis, and wherein the second part of the composition inhibits (3) somatostatin production. Because of the importance associated with the above, each is more fully discussed below.
Increasing Cholinergic Tone
Substances that will increase acetylcholine production and release tend to result in an increase in cholinergic tone above baseline. These substances include, but are not limited to various choline-containing compounds, such as choline bitartrate or phosphatidyl choline; acetylcholine precursors, such as dimethylaminoethanol and congeners related thereto. Substances that increase blood flow in the cerebral cortex are known to increase acetylcholine levels. These substances include, but are not limited to: ginkgo biloba with gincosides assayed at 24% of total weight, niacin, papaverine, hydergine and other ergot alkaloids, etc. Other substances known to increase acetylcholine release include a variety of cholinergic agents, such as pyridostigmine, etc. However, for the purpose of the present invention, an acetylcholinesterase inhibitor is preferred. The Chinese moss derivative huperzine A, which is known to enhance cognition, also affects cholinergic tone. This substance, in conjunction with substances that i
Patten Patricia
Tate Christopher R.
The Halvorson Law Firm
LandOfFree
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