Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1997-02-28
2001-01-16
MacMillan, Keith D. (Department: 1618)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S276000, C514S904000, C514S905000
Reexamination Certificate
active
06174890
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an orally-administered drug having anti-stress, anti-impairment and anti-aging etio-pathogenic actions, and manifold therapeutic efficiency, as a result of its synergistic biological, neurometabolic and cell-trophic composition. The invention also relates to a process for its manufacturing. This drug supports and enhances the adaptation capability and the neuropsychic and biological resistance, simultaneously achieves the anti-stress protection of the brain, liver and heart, and corrects the main ultrastructural and metabolic imbalances brought about by acute and chronic stress, prolonged biological wear and tear, oxidative stress, ischemia-hypoxia, chronic alcoholism and premature aging, thus being meant for stress-dependent pathology. The non-conventional pharmaceutical process for its manufacturing further provides the controlled guidance in the release and absorption of the active substances, and the prolonged cerebral vasodilative action, which together promote maximum bioavailability and therapeutic efficacy.
BACKGROUND ART
Acute and chronic stress, a negative and permanent characteristic of present-day life, comprises the unfolding of three processes: first—the aggression of the body by stressors, in a continuous growth, diversification and perpetuation; second—the body response, which may be adaptively, maladaptively or pathologically stress-dependent; and third—the intense, accelerated and chronically accumulated wear and tear of the brain and of the organism, premature aging.
The adaptive response of the body (the general adaptation syndrome) consists of three successive stages: immediate adaptation, long-term adaptation and the stage of exhaustion—neuropsychic and biological impairment (SELYE, H., The evolution of the stress concept, American Scientist, 61, 692-699, 1973). Chronic wear and tear means the neuropsychic and biological progressive incapacitation; it results in the decrease of the adaptation capability and in the diminution of body vitality and resistance, and it is the consequence of accumulation in the course of time and stressful life events and stress-induced lesions. When the adaptation capabilities of the organism are exceeded, due to the intensification, frequency and chronicization of stress and impairment, diseases of adaptation appear, meaning the stress-dependent pathology: neuropsychiatric and psychosomatic illnesses (WILDER, J. F., PLUTCHIK, R., Stress and psychiatry (Cap. 25.11), pp. 1198-1203, In: KAPLAN, H. I., SADOCK, B. J. (Eds.), Comprehensive Textbook of Psychiatry/IV, vol. 1, Williams and Wilkins, Baltimore, 1985).
The human brain, through its triple functionality—neurobiological, psychic and social—and due to the loss, after birth, of the neuron regeneration capacity through cell division, represents the global “receiver” of stresses (ischemic, hypoxic, oxidative etc.) and the “storage” of chromic, progressive, neuropsychic and biological impairment. Thus, in the central nervous system, specific ultrastructural and biochimical imbalances and lesions are accumulated, reaching all levels of metabolism (energy, anabolism, catabolism), then they extend with age and determine the incapacitation of the brain and body functions. The cerebral blood flow diminution as a consequence of stress and aging (progressive chromic hypoxia) and the neuronal hypoanabolism (the disturbance and decrease of nucleic acid and protein synthesis, the reduction and impairment of Nissl bodies—crowds of rough endoplasmic reticulum and free ribosomes—and of Golgi apparatus) induce the diminution of plasticity and anabolic regeneration, both functional (enzymes and neurotransmitters) and ultrastructural (neurosomes and extensions), (TERRY, R. D., GERSHON, S. (Eds.), Aging, vol. 3 (Neurobiology of Aging), Raven Press, New York, 1976). Oxidative stress, neuronal hypercatabolism, lipid peroxidation, especially of membranes, and the premature chronic impairment of subcellular organelles, mainly mitochondria, in all cases finally result in a progressive accumulation of lipofuscin pigments (wear and tear pigments, age pigments, tertiary lysosomes, insoluble subcellular wastes coming from peroxidation, polymerization and cross-linkages by free radicals) in neurons and glial cells (RIGA, D., RIGA, S., POPESCU, A., CONSTANTINESCU, E., PERIETEANU, M., Subcellular genesis of the nerve lipofuscin pigments, 4th European Anatomical Congress, Basle, Switzerland, 1977; Acta Anatomica, 99, 307-308, 1977; ZS.-NAGY, I. (Ed.), Lipofuscin—1987: State of the Art, Academiai Kiado, Budapest, 1988).
The necessity to develop a specific drug having an etio-pathogenic action against stress, impairment and premature aging was determined by the profound negative consequences of stress:
a) at the individual level—professional failure, disease, premature aging and death, and
b) at the level of the whole society—important economic and social losses, direct and indirect (COOPER, C., ARBOSE, J., Executive stress goes global, International Management, 39, 42-48, 1984).
From the prior art it can be seen that efforts made for the production of drugs efficient in the control and treatment of stress and impairment have so far failed to produce a specific drug with an etio-pathogenic action; only symptomatological purposes or energizing effects have been fulfilled.
Thus, for improving the symptomatology induced by stress, dysadaptation, maladaptation responses to stress and the stress-related disorders (anxiety, depression, asthenia, sleeplessness, neurotic, neurovegetative and psychosomatic disorders) the use of psychotropic medication is known (POLDINGER, W., SCHMIDLIN, P. E., WIDER, F., Index Psychopharmacorum, H. Huber, Bern, 1983). Depending on the prevailing symptomatology, the following are known as having been used:
a) anxiolytics (minor tranquilizers): diazepam, meprobamate, methylpentynol, etifoxine;
b) neuroleptics (major tranquilizers): chloropromazine, promethazine, azaperone;
c) beta-adrenergic blockers: bunitrolol;
d) antidepressants: tricyclic, tetracyclic compounds, alone or associated with neuroleptics;
e) psychostimulants: caffeine, amphetamine or derivatives;
f) sedatives and hypnotics: combining in the formula phenobarbital and codeine (Romanian Patents nos. 60376 and 64161).
These psychotropic drugs have the disadvantage of representing only a predominant symptomatic medication, without an etio-pathogenic action against stress; they do not reduce chronic impairment caused by stress, they do not act against stress through anabolic regeneration, they modify the normal (anti-stress) reactions of body adaptation and bring about numerous adverse reactions. Furthermore, the anxiolytic and psychostimulant drugs (of the amphetamine and caffeine type) often call for increasing posology, due to phenomena of acquired tolerance and determine, as important adverse reactions, the dependence on psychoactive substances (LADER, M., Benzodiazepines—the opium of the masses?, pp. 609-615, In: SMITH, A. D., LLINAS, R., KOSTYUK, P. G. (Eds.), Commentaries in the Neurosciences, Pergamon Press, Oxford, 1980; W.H.O. Europe, Prevention of Mental Psychosocial and Neurological Disorders in the European Region, 38th Session, Copenhagen, 12-17 September, 1988).
One also knows many anti-stress drug compositions used for energizing, activatory, stimulating, trophic, tonic, fortifying—neuropsychic and/or biological—purposes. They are employed in treating disorders caused by acute and chronic stress, by stress-dependent pathology and especially against their most frequent consequences: nervous, psychic and biological exhaustion, accelerated chronic impairment, premature senescence.
a) Some of these compositions contain polyvitamins: hydrosoluble (American Medical Association, AMA Drug Evaluations, Publishing Sciences Group, Acton, Mass., 1973), hydrosoluble together with liposoluble (U.S. Pat. No. 3,493,659), or polyvitamins with bioelements (French Patent no. 7404 M);
b) Other mixtures associate amino acids with or without vitamins (acetylaspartic acid, argini
Riga Dan
Riga Sorin
Cohen & Pontani, Lieberman & Pavane
MacMillan Keith D.
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