Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-08-02
2001-04-17
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S561000, C514S562000, C514S567000
Reexamination Certificate
active
06218420
ABSTRACT:
DESCRIPTION
The present invention refers to compositions based on aminoacids, for preventing and treating alimentary overloads in conditions of elevate body nitrogen requirements, without causing calcium losses.
It is well known that carbon, oxygen and hydrogen are the atoms that form carbohydrates and lipids being necessary to our metabolic energy requirements.
Nitrogen is instead the component of the structural elements of our body, i.e. the proteins, and must be introduced daily in quantities that should match the daily losses.
While carbohydrates can be transformed only in lipids, proteins can be transformed both in carbohydrates and in lipids, according to body needs, however neither carbohydrates nor lipids can be transformed in proteins (just a minimum quantity and only of some among the chemically simplest aminoacids can be obtained from carbohydrates, involving a very high consumption of body energy).
Thus we depend on an adequate nitrogen intake to maintain the integrity of our body. The average nitrogen introduction by aminoacids, both in free form and bound one another to form proteins, is easily calculated by dividing the weight of aminoacids or proteins to 6.5.
In 1942 Rose et al., having identified 10 aminoacids as indispensable for the growth of the rat, started applying this knowledge to human nutrition. Eight aminoacids were initially recognized as being indispensable to maintain the balance in studies which utilized the elimination of any single aminoacid from diet separately from the others, with the purpose of evaluating its impact on the overall body protein equilibrium.
These studies, if are fundamental to our knowledge of protein precursors (i.e. aminoacids) needs in a proper diet, were not lacking of important methodological mistakes, which have been then identified and understood.
This is why, for example, Rose concluded that histidine, an aminoacid which was found indispensable to the growth of rats, could be labeled as not indispensable for the maintenance of nitrogen balance in the adult man.
These works were so influential and the study protocol so complicated that only in 1975 the evidence was acquired that histidine is instead an indispensable aminoacid. For further information on the ten aminoacids nowadays recognized as indispensable to human needs of protein balance maintenance, see for example Stryer, Biochemistry, III Edition.
A wide literature is available, concerning the use of aminoacids.
For instance, from U.S. Pat. No. 4,670,261 a balanced parenteral alimentation solution is known, containing reducing sugars, essential aminoacids and electrolytes, and which does not discolour on sterilisation.
From EP-A-0 057 209 a composition is known, containing leucine, valine and isoleucine, for treating stress and injury, especially as parenteral feeding solution.
From DE-A-25 30 246 amino acid mixtures are also known, for treating kidney and liver disorders.
From DE-A-25 31 204 oral and parenteral amino acid solutions are known, containing essential and nonessential l-amino acids in specified proportions, having high nutritive values.
From JP-A-3 204 814 aminoacid preparations are known, for treatment of renal insufficiency, which comprises granule mixture coated with methacrylic copolymer, mixed with cellulose.
From EP-A-0 413 528 the treatment of skin conditions is known, by using compositions containing alpha hydroxy:acid, alpha keto:acid or polymeric hydroxyacid(s) and amphoteric agent.
The present invention is based on the acknowledgment of the fact that the need of nitrogen (i.e. of alimentary proteins, i.e. of aminoacids) is the product of a very complex whole of factors:
1) The quantities of proteins present in the body are subject to dimensional modifications according to adaptive needs. The most striking examples are the development of muscular hypertrophy in weight lifters, or hyper gammaglobulinemia in response to bacterial infections. Particular stress can, on the contrary, accelerate protein turnover, such as sun exposure, whose ultraviolet or infrared solar rays rapidly degrade skin collagens (see U.S. Pat. No. 5,198,465 in the name of Dioguardi, 1993) or a bad nutrition which leads to a weight and muscular loss.
2) A part of protein (i.e. aminoacids) input is utilized for energy purposes to balance inadequate glucose availability or to spare glucose, when this is required by specific metabolic needs, as in athletes during protracted efforts and/or in prolonged fasting and/or during a weight reduction, either because of dietary programs or of medical needs. It should be noticed that a ratio of 150 Kcal of carbohydrates is generally suggested to be assumed each 6.5 g. of aminoacids (that is to say each nitrogen gram), to achieve the maximal synthetic nitrogen utilization and to lower then aminoacidic losses for oxidative purposes (i.e. for energy). Some aminoacids are more suitable than others for these purposes (see for instance the above-mentioned Stryer, Biochemestry, III Edition).
3) The changes in alimentary habits due to cultural models, or to working rhythms or to ideal physical models, are very often, not in favor of a sufficiently complex and varied nutritional introduction. This, in turn, especially for aminoacids intake, could be obtained only if a very large amount of food (i.e. of calories) is introduced, (see for instance Tab. 4 in the following).
4) Current daily requirements of aliments are underestimated for different aminoacids, and calculated for a very sedentary theoretic individual, and consistent with mere survival and for a short time (some weeks), than for bearing an active life; thus they are very criticized by clinical nutritionists (see: European Journal of Clinical Nutrition Vol. 50, S2-S197 supplement-1 February 1996). Two situations are worthy of attention because even a careful nutrition may not be sufficient to body needs: for instance in pancreatectomized patients (e.g.: for pancreatic cancer) and in elderly people. In both cases, for different reasons, a reduction in digestive enzymes would be observed. Proteins, if not digested to aminoacids, could not be absorbed. Thus a malnutrition can occur even during a normal nutrition. Free aminoacids are instead absorbed without any contribution by the digestive system.
5) All aliments contain aminoacids in proportions not corresponding to specific human needs. Therefore, the bigger is the load of not utilized aminoacids, the bigger is the quantity of nitrogen disposal loads.
Disposal of nitrogen is based manly on an efficient kidney function, so for people depending on dialysis to maintain their life, the more usable is the aminoacidic content of diet, the less their body needs to eliminate nitrogen under the form of urea, thus contributing to a better compliance to alimentary introduction. This is a totally different approach from Giordano's one, who derived an aminoacidic formulation from the hypothesis that a mixture containing a reduced average of urea precursors aminoacids (mainly arginine and glutammine), when used as a nutritional device, would have led to a better nitrogen tolerance.
6) The only risk, traditionally mentioned by nutritionists, following the administration of large quantities of aminoacids, either as acute or chronic supplement to diet, is the well known effect of high nitrogen intakes on calcium balance (see, Kim Y, and Linkswiler H. M.: Effect of level of protein intake on calcium metabolism and on parathyroid and renal function in the adult human male Journal of Nutrition, 109, 1399-1404, 1979). There is no known aminoacid based formulation that can be expressly considered as safe in relationship to calcium metabolic losses, and at the same time being efficient so that it can refuel the body according to the said biological needs.
On the basis of the above considerations, the aim of the present invention is that of indicating compositions based on aminoacids that can enhance the maintenance of the equilibrium between synthesis and degradation of proteins, reducing the risks of under nutrition for some aminoacids and/or the r
Henley III Raymond
Levine & Mandelbaum
Professional Dietetics S.r.l.
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