Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1989-03-27
2001-09-25
Gitomer, Ralph (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S002600, C514S904000, C514S270000, C514S922000
Reexamination Certificate
active
06294520
ABSTRACT:
This invention relates to materials and methods for passing, and transporting other substances, through the blood-brain barrier.
BACKGROUND OF THE INVENTION
If one accepts the premise that most physiological functions are controlled by the brain and the medium of that control is electrical signalling as an incident to chemical activity in the brain, then it seems logical to conclude that an absence in the brain of the chemicals required for that activity can result in signal failure and consequent physiological disfunction. It is possible also to conclude that a genetic trait which interferes with such chemical activity can result in signal failure and disfunction. It is also possible to conclude that the presence of a given substance in the brain may interfere chemically with the proper generation of control signals.
Such considerations, the search for an understanding of the mechanism of drug dependence, drunkenness, Alzheimer's disease, schizophrenia and other disorders, some associated with the brain and others apparently not, have lead many researchers to look for a relation between such disorders and availability of chemicals in the brain. The medical literature includes descriptions that comparison of brain tissue of persons who succumbed to a given disease with that of persons who died of unrelated causes suggest a relation between a given chemical and the disease. Thus lack of lithium has been mentioned in connection with schizophrenia and lack of neuropeptides has been mentioned in connection with Alzheimer's disease.
Studies in that area, the chemical treatment of brain cancers, and other studies and procedures are hampered by the difficulty in introducing chemicals into the brain because of what is commonly called the blood-brain barrier. The blood vessels of the brain are formed by cells which are more closely packed than are the vessels elsewhere in the body. That fact and the action of the astrocyte cells account for the fact that many materials are difficult to introduce into the glia of the brain. In some cases the only way that researchers had of getting those materials was to form a hole in the subject's skull and inject the desired material into the brain.
This invention relates to the transportation of material through that blood-brain barrier.
SUMMARY OF THE INVENTION
It is an object of the invention to provide novel substances and methods which are useful in conducting research with animal and human subjects into the causes and cure of certain disorders and for the treatment of those disorders.
A related object is to provide substances of that kind which can be utilized by ingestion by a test subject or patient.
Another object is to provide a vehicle and a method for transporting substances across the blood-brain barrier.
Another object is to provide particular substances which are suitable for the study, and in some cases the treatment, of specific disorders. One of those disorders is loss of hair.
One related object is to provide a substance which, at least for some subjects, has the effect of restoring hair.
These and other objects and advantages of the invention which will hereinafter appear, are realized by the provision of materials which appear to pass through the blood-brain barrier and are capable restoring impeded neuro-transmitter function and apparently of transporting other materials through the barrier or at least facilitating their utilization in the chemical processes of the body. The material that provides those actions is a combination of one or more of a number of “pure” sugars and or pure amino sugars from the group consisting of one or more of a number of amino acids. The sugars are meso erythritol, xylitol, D(+) galactose, D(+) lactose, D(+) xylose, dulcitol, myo-inositol, L(−) fructose, D(−) mannitol, sorbitol, D(+) glucose, D(+) arabinose, D(−) arabinose, cellobiose, D(+) maltose, D(+) raffinose, L(+)rhamnose, D(+) melibiose, D(−) ribose, adonitol, D(+) arabitol, L(−) arabitol, D(+) fucose, L(−) fucose, D(−) lyxose, L(+) lyxose, L(−) lyxose, D(+) glucosamine, D mannosamine, and D galactosamine. The term “pure” as applied to sugar herein means crystalline purity, 98 or 99 percent pure. The requirement for high purity is based upon both a need for purity and the fact that the character of impurities is unknown and some can negate the effectiveness of the sugar or the amino acids.
The amino acids are glutamine, lysine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glycine, histidine, leucine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, and taurine. The amino acids may be those found in common foodstuffs such as orange juice, clam chowder, soy bean soup, sheep milk, and others, but for uniform and more predictable result it is preferred that the amino acid be incorporated in pure crystalline form.
Both the proportions in which those materials are combined, and of any added test substances materials, and the quantity of the combination varies with the nature and weight of the test subject. In the case of humans an excessive amount of any of the listed sugars can cause nausea, heat sensation, flushing, and ringing of the ears. More than 6 grams of sugar at one time may produce the adverse side effects listed above. Except that excess amounts of amino acid may have harmful effect on subjects afflicted with certain illness, there appears to be no upper limit to the amount of amino acid that is safely ingested at least by humans.
Haklitch and Naito, in attempting to apply the base material to the treatment of alcohol induced drunkenness in humans, have discovered that certain proportions and dosages appear to be both effective to restore motor functions in humans and to be safe for human consumption. The same proportions of sugar and amino acids, and the same dosage in combination with beta carotene have been found to be effective in arresting hair loss and in restoring hair growth. However, different proportions and dosages are preferred in other cases. Drunkenness and hair loss occur in primarily in adults. The invention is applicable to humans and animals of various sizes. The base material is a combination of sugar and amino acid which is effective to permit transportation of other materials into the glia of the brain past the blood brain barrier. The preferred dosage is, in general, the minimum amount of base material which permits such transportation, one eighth gram of sugar and 10 to 50 milligrams of amino acid is probably the minimum for adults and medium to large animals when the amount of material to be transported is minimal. In most cases it will be desireable to transport more than minimal quantities, the actual amount being related to the subject's weight. The examples set out below assume a weight range which extends from less than a pound for small animals and four pounds in the case of premature human infants to 350 pound, active athletes.
That the base material or some component of it, after having been ingested and entering the blood stream, or having been introduced directly into the blood stream, does actually cross the blood-brain barrier is most readily shown in a test of a person whose motor functions have been very obviously impaired by ingestion of alcohol. Ingestion by that subject of the base material has the effect of restoring the subject's motor functions in a matter of seconds notwithstanding that the alcohol level in the subject's blood remains high.
Evidence has been found that ingesting other substances with the basic combination of sugar and amino acid so that they coexist in the blood stream can result in facilitation of the use of the added material by the body. In one example, adding beta carotene, or xanthophyll, has the effect of increasing the growth of hair and of replacing greyness with original hair color without yellowing the skin. The chemistry of hair restoration by the addition of beta caroten
Eisenberg Howard M.
Gitomer Ralph
Khare Devesh
Roberts Edward E.
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