Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1998-11-30
2001-04-03
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
Reexamination Certificate
active
06211143
ABSTRACT:
BACKGROUND OF THE INVENTION
The subject matter of the present invention includes an orally administered preparation containing highly purified hydrolyzed gelatin enriched with magnesium and B-group vitamins in individuals susceptible to joint injuries caused by excess effort (e.g. athletes), in order to increase the mass of the joint cartilage. This effect was proven by the ultrasonographic measurement of biometric values of the cartilage (thickness).
The injuries derived from the practice of sports represent a health problem due to the considerable requirements that these athletes place on their bodies. Over the last few decades an important increase has been observed in injuries derived from the practice of sports due to the increased number of participants, at a competitive as well as a recreational level, the increase in the number of hours of physical activity, as well as the development of diagnostic methods.
The majority of sports injuries, between 30 and 50%, are due to excessive use, that is to say, they are produced when the demands placed on anatomical structures surpass the tolerance level of the structure involved and repetition of the damaging activity; causing problems in the cartilage by overloading the joints. These types of injuries are more frequent when the athletes do not adhere to an adequate training program, vary their exercise routine, apply sudden changes in the intensity of the force, or do not correctly observe warm-up and/or rest periods. These circumstances often occur in amateur as well as professional competitors.
These problems could be solved by increasing the synthesis of cartilage mass so that the demands placed on the joint are compensated and the tolerance level of the structure is not exceeded. This is the only way to prevent all these joint problems caused by overload and excessive use.
It is well known that the daily ingestion of 5 to 15 g of enzymatically hydrolyzed gelatin has been used as a treatment for the symptoms of arthrosis and other degenerative joint diseases. This improves the general condition of patients affected by these pathologies and the symptoms produced by arthrosis as evaluated by different parameters such as clinical symptomatology (pain), articular mobility, reduction or suppression of the use of analgesics and improvement in limb movement.
These clinical studies and high-priority applications correspond to the following references: Koepff et al. U.S. Pat. No. 4,804,745, Feb. 14, 1989. Therapie der Osteoarthrose. Welche wirkung haben Gelatinepräparate. Adam Milan. Therapiewoche. 38, 2458-2461 (1992).
Although there is considerable speculation about the precise mechanism by which a hydrolyzed collagen can improve the symptomatology of arthritic lesions (e.g. regarding the potential action of glycine-histidine-lysine tripeptide, or modification in the synthesis of type II collagen); it seems that the mechanism could be related to a process of tolerance to proteins ingested by oral route, its effect on the synthesis of cartilaginous matter in these patients being discarded by radiographic studies.
On the other hand, there is a deep belief in the scientific community of the impossibility of generating greater cartilaginous mass by the ingestion of precursors of collagen synthesis, such as hydrolyzed gelatin.
Hydrolyzed gelatin was used to improve the symptomatology in cases of arthrosis or degenerative joint diseases. Even though the pathogenesis of the disease is unknown, in the majority of cases it is related with complex biochemical processes that are based on the synthesis of types of collagen other than the biologically useful type (an increase in the synthesis of type II collagen has been shown to take place in these diseases). At the same time, this can bring about self-immunity processes and the consequent degeneration of the affected joint or joints.
SUMMARY OF THE INVENTION
Surprisingly, the authors of this invention have been able to observe that the continued ingestion of a hydrolyzed gelatin enriched with magnesium and B-group vitamins increases the amount of cartilaginous mass, and this is extremely useful in the prevention of joint injuries caused by over-exertion.
The use of ultrasonography has been established as a reliable method for assessing the integrity and thickness of articular cartilage (ref.: Dondelinger R. F., Marcelis S., Daenen B., Ferrara M. A.: Peripheral musculoskeletal ultrasound atlas. 1996. Thieme Medical Publishers.) and an evaluation has been made of the effect of hydrolyzed gelatin dietary supplements on the ultrasonographic biometric values for the cartilage.
One important point is that gelatin is a protein extracted from the collagen present in the skin and cartilage of animals (mainly pigs, sheep and cattle, as well as fish) and so it contains all the amino acids, and in the same proportions, as required for the synthesis of collagen. Nevertheless, the administration of gelatin as a protein at the required daily dose, established as 0.2 g/Kg a day, would not be feasible since this administration would be quite difficult. This is why the gelatin obtained by extraction from the collagen is submitted to controlled hydrolysis by enzymatic or chemical processes in order to obtain short chain peptides (2000-50000), that can be administered comfortably either dissolved in water or mixed with food, and enable them to be fully absorbed by the organism. In order to improve the body's synthesis of proteins in general and collagen in particular, this substance should be administered in conjunction with magnesium in any of its salt forms (carbonate, citrate, chloride, . . . ) since it acts as a cofactor in numerous enzymatic systems and its presence activates protein synthesis.
Finally, it is also convenient that the administration be combined with various B-group vitamins (B1, B2, B3, B5, B6 . . . ) as adequate doses of these vitamins control the synthesis of proteins in the organism by acting as coenzymes.
As an example, the following is a description of a study proving the efficacy of the present invention. The main active ingredient is a hydrolyzed compound of gelatin, the basis for this patent application.
REFERENCES:
patent: 4804745 (1989-02-01), Koepff et al.
patent: 94 01 887 (1994-08-01), None
patent: 95 00 449 (1995-03-01), None
patent: 95 00 723 (1995-04-01), None
Peripheral Musculoskeletal Untrasound Atlas by S. Marcelis Et Al, 1996, Georg Thieme Verlag Stuttgart, New York, Theme Medical Publishers, Inc.
“Suppression of Type II Collagen-Induces Arthritis . . . ”, Nagler-Anderson Et Al, Proc. Natl. Acad. Sci. USA, vol. 83, pp. 7443-7446, Oct. 1986.
Therapie Woche, “Welche Wirkung Haben Gelatinepraeparate”, by Adam, pp. 1-6. (1991).
J. LI. Ribas Fernandez & O. Perez, “Effecto De Los Hidrolizados De Gelatina En La Prevencion De Las Lesiones En . . . ”, vol. XV, #66 (1998), pp. 277-282.
“Welche Wirkung Haben Gelatinepraeparate”, by Prof. Adam Milan, In Therapie Der Osteoarthrose. (1991).
Bernd Eggergluss: Gelatine Hydrolysate and its Health Aspects, European Food and Drink Review, Fall 1999, pp. 4-8.
Baños Jaime Melendo
Busquets Josep Junca
Garcia Pilar Quijano
Gil Gabriel Espelleta
Quilez Purificaciò Benavent
Henley III Raymond
Masterfarm S.L.
Striker Michael J.
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