Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1999-08-03
2002-01-22
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S463000, C424S468000, C424S474000, C514S783000
Reexamination Certificate
active
06340474
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a composition for effecting the release of hormones in a mammal and specifically to a composition in capsule form, for ingestion into the human system and absorption in the intestine of the human system, that results in stimulating the release of human growth hormone by the pituitary gland. The composition of the present invention also reduces the incidence of erectile dysfunction in males and enhanced prosexual behavior.
BACKGROUND OF THE INVENTION
Human growth hormone (somatotropin) is a physiological substance produced in the anterior lobe of the pituitary gland of the human system. It is the most abundant hormone produced by the anterior pituitary lobe, accounting for as much as eight to ten percent of the dry weight of the gland. The physiological effects of human growth hormone are macroscopic, extending beyond cellular, chemically mediated events. One example of this is the effect of human growth hormone on whole body growth. Growth hormone effects an increase in tissue and organ weight, which results from an increase in mitosis, cellular hypertrophy, hyperplasia and cellular water. Growth hormone also stimulates the increased uptake of amino acids into cells, resulting in protein synthesis. Growth hormone is responsible for proper growth and development until adulthood and then regulates nearly every organ in the body.
Growth hormone also has prosexual effects, such as enhanced sexual performance and a decrease in the incidence of impotence in males. Studies have suggested that an estimated 70%-80% of cases of erectile dysfunction may be caused by increased levels of prolactin, another hormone released by the pituitary gland. Growth hormone release from the pituitary gland can be associated with a decrease in the release of prolactin.
Growth hormone is synthesized in the acidophilic somatotropes, which are specialized cells located in the anterior of the pituitary gland. Secretion of the growth hormone by the pituitary gland is episodic. The anterior pituitary operates in conjunction with the hypothalamus and adrenal glands as an integrated unit. The large array of physiological factors that effect growth hormone secretion act on the pituitary gland through the hypothalamus. The hypothalamus controls this secretion by causing the release of either growth hormone release stimulating or inhibiting factors. These factors result in the release or retention of human growth hormone by the pituitary gland.
Human growth hormone was first discovered by researchers in the 1920s, and due to its effects on whole body growth, was considered to be a promising therapeutic agent. In 1958, growth hormone extracted from the pituitary glands of cadavers was injected into a growth stunted child at the New England Medical Center in Boston, Mass. As a result the child grew taller and popularity for the use of growth hormone in medical applications grew.
However, one major drawback of the natural growth hormone, is that heat destroys the pituitary extract. Thus, it cannot be pasteurized to eliminate the possibility of disease transmission. Therefore, before the use of growth hormone as a therapeutic agent could become widespread, it either had to be sterilized or a synthetic hormone had to be produced to reduce the potential for transmission of disease.
In 1986, the Eli Lilly Company developed “Humatrope”, a manmade growth hormone identical in structure to the actual human growth hormone. Soon after, in 1990, the New England Journal of Medicine released the results of a six month clinical study on human growth hormone administered to a group of men aged 61 to 81. Without exercise, these men lost body fat and wrinkles and gained lean muscle, along with a thickening of the skin and a regeneration of failing liver tissue.
Following the above-noted study, the potential use of human growth hormone for therapeutic and possibly cosmetic benefits caused an increased demand for growth hormone treatments. However, a number of problems are associated with such use. First, cost is a factor. For example, increased levels of growth hormone have been provided through the injection of human growth hormone (natural or synthetic) from a foreign source directly into the human subject. However, such injections are prohibitively expensive, costing anywhere from $1,200 to $3,500 per month.
Additionally, the injections have to be performed in a medical environment under a physician's supervision. This requirement not only adds to the cost of the treatment, but is also inconvenient to the patient's schedule.
Secondly, increasing levels of a foreign growth hormone within a subject also results in negative side effects. For example, in response to the injection of a foreign growth hormone the hypothalamus triggers elevated levels of somatostatin, a growth hormone release inhibitor, which then prompts the pituitary gland of the subject individual to curb the release of its naturally produced growth hormone. Of course, it is undesirable to inhibit the natural release of the growth hormone from the pituitary gland in favor of the synthetic hormone. More particularly, the release of natural growth hormone from the pituitary gland is controlled by negative feedback involving growth hormone releasing and release inhibiting factors. If growth hormone levels are low, the pituitary gland is stimulated by releasing factors in the hypothalamus to increase the release of natural growth hormone. If growth hormone levels are high, the pituitary gland is inhibited from releasing natural growth hormone by the release inhibiting factor, somatostatin, from the hypothalamus. Thus any addition of growth hormone to the human system, whether natural or synthetic, will impact this negative feedback loop, thereby disrupting the balance of growth hormone levels achieved by the tandem operation of hypothalamus and pituitary gland. As a result, the pituitary gland may slow down or even cease production and release of the natural growth hormone, and the normal function of the pituitary gland of the subject is disrupted.
Due to the aforementioned drawbacks with current procedures for increasing growth hormone level within the body, it is desirable to increase growth hormone levels in the human system without negatively affecting the natural production and release of growth hormone by the pituitary gland. It is also desirable to increase growth hormone levels in a manner which does not require physician supervision. It is further desirable that any such composition or method to achieve such objectives be available at a low cost. Finally, it is desirable for any composition to involve a delivery system that protects the components from degradation in order to achieve a heightened efficiency in increasing growth hormone levels in the human system.
SUMMARY OF THE INVENTION
The present invention solves the problems in the prior art and addresses the above objectives by increasing levels of human growth hormone within the human body. The present invention also results in enhancement of prosexual characteristics in the human system. The present invention comprises a synergistic blend of at least two herbal extracts combined with a unique delivery system to produce a very potent and effective growth hormone-potentiating composition. This combination of herbal extracts is provided in pill form to eliminate the need for physician supervision and to reduce costs. Finally, this combination of herbal extracts works in concert with a unique protective coating to enhance uptake levels of the growth hormone potentiator by the human system.
There are several factors which stimulate growth hormone release by the pituitary. One group of releasing factors includes catecholamines, which are amine derivatives of dihydroxybenzene (or catechol), including norepinephrine, epinephrine and dopamine. Upon introduction to the body, the composition of the present invention acts to affect the production of dopamine within the human system.
The presence of dopamine in the human system stimulates the r
Page Thurman K.
Ware Todd D
Wood Herron & Evans LLP
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