Preparation for improving hair growth, the skin structure...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...

Reexamination Certificate

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C514S880000

Reexamination Certificate

active

06331569

ABSTRACT:

The present invention relates to a preparation for the improvement of the hair growth and/or nail regeneration in accordance with the generic part of claim
1
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This invention relates to a dietetic preparation for the support and/or regulation of the various energy metabolism pathways in the human body, for the specific purpose of improving the synthesis of structural proteins. An oral administration of the preparation in accordance with the present invention therefore has a positive effect, particularly on the hair growth and hair structure.
The term metabolism denotes the entirety of the chemical conversions in an organism that are necessary to maintain the life processes. These are related to the intake, deposit, conversion and catabolism, as well as the elimination of substances for the preservation and/or development of the body substance and, of course, also for the production of energy.
The terms energy metabolism or operating metabolism are used to refer to the conversion of endogenic materials for the production of energy: as heat energy to maintain the body heat, as mechanical energy for the work performed by the organs and muscles, as chemical energy for the synthesis of species-characteristic proteins, fats, glycogen, polynucleotides, high-energy phosphate compounds, to generate electrical potentials, for osmotic work, and so on. Closely connected to the energy metabolism is the building or preservation metabolism, which supports both, the production (biogenesis) of necessary cell components from simple elements, and the catabolism of polymolecular materials to low-molecular substances, which are either used for synthesis reactions elsewhere in the organism or eliminated.
In the energy metabolism—but not in the building metabolism—the energy suppliers, such as carbohydrates, protein and fats, can substitute for each other to a certain degree since they are ultimately converted into energy through similar catabolism pathways. Of particular importance in this context are the amino acids. By amino acids one understands the 20 (proteinogenic) L-aminocarbonic acids, which take part in the synthesis of proteins. Plants are able to synthesize all amino acids from simpler preliminary stages. Humans and animals, by contrast, can produce only the so-called non-essential amino acids alanine, asparagine, aspartic acid, glutamine, glutaminic acid, hydroxy-L-proline, proline, glycine and serine. The essential amino acids isoleucine, leucine, lysine, methionine, phenyl-alanine, ornithine, threonine, tryptophane and valine must be absorbed with the food. Arginine and histidine, which must be supplied externally only during growth phases and if deficiency symptoms are present, are considered semi-essential. Cysteine and tyrosine, which can be synthesized from the essential amino acids methionine and phenyl-alanine, form a special group. The most important function of the amino acids is that of components for the biosynthesis of proteins; if essential amino acids are absent in the food, the protein synthesis, among other things, starts to slow down, and life-threatening deficiency symptoms may result as a further consequence.
The physiological synthesis and catabolism of the amino acids occurs via the catabolic products of the glycolysis and alpha-ketonic acids, of which 2-oxoglutaric acid and oxalacetic acid are members of the citric acid cycle. Through them, the metabolism of amino acids is linked with that of fats and carbohydrates. Regarding their catabolic products, one differentiates between glucogenic amino acids, which supply intermediates of the citric acid cycle or pruvic acid, and ketogenic amino acids, which cannot be used for the glucose synthesis, since their catabolism produces ketones such as acetoacetic acid. Since the amino acids are also of great importance as nutrients, there are various specific cellular transport systems that adjust the intake of amino acids through the membrane.
The normally balanced ratio of absorption, conversion, catabolism and elimination of the various substances, above all also in the case of the amino acid metabolism, can be unbalanced by various disorders. Examples for these are diabetes, lipidoses, gout, hyperthyreosis, rachitis, phenylketonuria, infections and many other disorders, which may be acquired or inherited. Disorders which are caused by stress and environmental factors (e.g., all sorts of toxins), as well as by medication should, of course, also not be overlooked.
The results are oftentimes a loss of energy, tiredness, muscle atrophy, reduced brain performance, impaired potency, or changes in the blood fat and blood sugar values. A particularly striking external indication for such a disorder is the non-hormone based, i.e., non-testosterone based hair loss, which can manifest itself as the so-called “effluvium” or also as “alopecia”, in which hair loss occurs, which may be concentrated in one area, scattered, or complete baldness. Regarding the prognosis, one differentiates between reversible and irreversible alopecia, whereby the irreversible alopecia is characterized by a destruction and/or an absence of the potential to grow hair. The preparation claimed in the present application had the surprising effect of reversing the course of the alopecia in 2 of 10 cases, and in 6 cases stopped the alopecia after a 2-month treatment. In one case a reduction of the hair loss was registered and in 2 further cases no effect was seen. This means that a healing process was found in 7 of 10 patients within 2 months, which is an unequaled healing success for alopecia.
The human hair goes through a life cycle comprising three phases, i.e., the anagenic or growth phase, the katagenic or transitional phase, and the telogenic or resting phase. Under normal conditions 80 to 85% of the hair is in the anagenic phase and 15 to 20% in the transitional and/or resting phase. The anagenic phase is the period of active hair growth and lasts approx. 3 to 5 years. The katagenic phase is a transitional phase between active growth and resting phase and lasts about 1 to 2 weeks. The following telogenic phase lasts 3 to 4 months. At this time the growth stops and the hair may be cast off, after which new hair growth begins. If increased hair loss occurs in a patient, this may be due to the fact that a larger portion than the above-mentioned 15 to 20% of the hair is present in the telogenic phase. A further cause is to be seen in a reduction in the number of hair follicles, which amount to approximately 500 follicles per square centimeter in a person with normal hair growth and decrease in number if hair growth disorders are present.
A multiplicity of the most diverse preparations is available commercially, which are used both externally, in the form of cosmetics such as hair tonics, hair shampoo and the like, and as preparations for internal use, i.e., orally administered preparations of greatly differing compositions, which frequently have undesired side effects.
It is already known that the administration of a number of amino acids can contribute to strengthening the human organism, and that certain combinations of various amino acids lead to a strengthening of the muscles, build-up of the brain, stimulation of the hair growth etc. In particular, a mixture of the amino acids leucine, isoleucine and valine has been sold as a hair-restorer, either alone or in combination, e.g., with fructose and/or glucose. However, in the persons tested within the framework of the present invention, this preparation did not have an actual effect.
A multiplicity of preparations is recommended for external application, for purely cosmetic purposes. So far it has not been possible to prove any significant absorption of nutrition through the skin; an external use of amino acids, vitamins, trace elements, proteins, fats and fatty acids is thus likely without benefit. An external treatment can generally improve the quality of already existing hair, but will not improve its growth. Growth-related damage and disorders can be treated in a meaningful way only through oral adminis

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