Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from ginkgo
Reexamination Certificate
2001-03-02
2002-08-20
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from ginkgo
C424S725000, C424S773000, C424S774000, C424S775000, C424S777000, C424S094100, C514S474000
Reexamination Certificate
active
06436449
ABSTRACT:
TECHNICAL FIELD
The present invention relates to the manufacture of a medicament for the treatment of a mammal suffering from tinnitus.
More specifically the present invention relates to the use of a composition comprising an extract from
Morinda citrifolia
L. (Rubiaceae) for the manufacture of such a medicament.
BACKGROUND ART
Morinda citrifolia
L. (Rubiaceae), the Indian mulberry, also called noni, is an evergreen shrub tree which is native to Asia, Australia and some Pacific Islands. Its botanical description is given e.g. in Levand O. (Part I Some chemical constituents of
Morinda citrifolia
L (noni), thesis, University of Hawaii, 1963). The roots, bark, stem, leaves and fruits thereof have traditionally been used in medicine, in food and as a dye in different cultures, e.g. on Hawaii and in the French Polynesia. As an example, a plurality of indications of use is reported in the indigenous Samoan medicine, (Dittmar A.“
Morinda citrifolia
L.—Use in Indigenous Samoan Medicine”, J. of Herbs, Spices & Medicinal Plants, Vol. 1(3) pp 77-91 (1993)), covering a wide range of ailments, such as tooth ache (roots), septicemia (leaf), diarrhea of infants (bark) and eye complaints (fruit) . . . just to mention a few.
In view of the multiple traditional uses and alleged beneficial properties on human health of the plant, scientific studies have been undertaken to try to identify the active principles in the different parts of the plant and to verify the medicinal effects obtained.
Thus, in view of a work by Bushnell et al. (Pacific Sci. 4, 167-83 (1950)) showing the antibacterial activity of the fruit of
Morinda citrifolia
(noni fruit), Levand (supra) tried to identify the chemical constituent of the fruit which would be responsible for this activity. A hypothesis was emitted that asperuloside, an aucubin-type glucoside found in an extract from the fruit, might have some antibacterial properties. Younos C. et al. (“Analgesic and Behavioural Effects of
Morinda citrifolia
”, Planta Med. 56 pp.430-434 (1990)) investigated lyophilised aqueous extracts of roots of
Morinda citrifolia
for analgesic and behavioural effects in mice, finding a dose-related central analgesic activity as well as sedative properties at doses of 500-800 mg of dried plant material/kg of body weight.
Hirazumi A. et al. (Proc. West. Pharmacol. Soc. 37: 145-146 (1994)) studied the antitumour activity of juice extracted from noni fruits on intraperitoneally implanted Lewis lung carcinoma in syngenic mice, and found that the noni juice at a dose of 15 mg per mouse significantly increased the life span of the animals. The active substance was isolated by ethanol precipitation, but was not chemically identified.
In her thesis, Hirazumi further identified the antitumour active substance as a polysaccharide-rich substance. Appendix A of the thesis gives a list of the medicinal uses of the noni plant in traditional medicine in different regions of the world, and Appendix B gives a list of chemical constituents of the different parts of the noni tree. From Appendix B it can be seen that each part of the plant contains a varying number of different chemical constituents; in the fruits 66 different compounds are reported to have been found.
In an article intitulated “The pharmacologically active ingredient of noni” Heinicke, R. M. states that the active ingredient of the noni fruit in fact is not present in any substantial amount in the fruit itself, but is generated, on ingestion of the fruit or of an extract thereof, within the human body from a precursor present in the fruit. The active substance is said to be an alkaloid, which the author names xeronine, its precursor being named proxeronine. The author further emits some hypotheses on the biochemistry involved in the generation of the alkaloid from its precursor as well as on the mode of action of the alkaloid within the body, and finally recommends a daily intake of 100 ml of noni juice half an hour before breakfast. The physical conditions that might be favourably influenced are said to be e.g. high blood pressure, menstrual cramps, arthritis, gastric ulcers, sprains, injuries, mental depression, senility, poor digestion, atherosclerosis, blood vessel problems, drug addiction, pain etc.
U.S. Pat. No. 4,543,212 (1985) to Heinicke relates to xeronine as a new alkaloid, and describes its characterization, assay, mode of action and utility within the medical, food and industrial fields. A process for obtaining xeronine from plant, bacteria and animal alkaloid producing lipophilic extracts is given. The activity of xeronine is stated to be due to its capacity to adhere to specific proteins as a modifier of rigidity of the same. The author notes that samples of xeronine acted as excellent anti-inflammatory agents when injected into mice, inhibited the in vitro aggregation of blood platelets by adenosine diphosphate, caused the debridement of burn eschars on mice, stimulated the partial breakdown of wheat grits and caused the aggregation of casein. Moreover, prediction is made that xeronine would be an effective antidote against alkaloid poisoning and addiction, and could be applied for the alleviation of symptoms of one type of senility and as a general stimulant or tonic. Finally, xeronine is also said to act as a coregulator for many hormone actions, a lack thereof thus being a possible cause contributing to e.g. diabetes.
U.S. Pat. No. 5,288,491 (1994) to Moniz relates to the noni plant as a medicinal product and teaches a method of processing the fruit into powder, mainly by picking, washing, cleaning and mashing the fruit, and then drying the pulp by thermal treatment in several steps and finally crushing and grinding the dried wafers. The author refers to the paper by Heinicke and proposes that either pure xeronine or a system that releases xeronine be produced.
From the above, it appears that
Morinda citrifolia
L. has been used and recommended for use against an important number of diseases and ailments, and that a theory exists that an important active ingredient of at least the fruits of the plant is xeronine, which possibly may be present therein only in the form of its precursor.
Tinnitus is the perception of sound when no external sound is present; it is often referred to as “ringing in the ears.” It can also take the form of hissing, roaring, whistling, chirping or clicking. The sensation may be objective (heard by the examiner) or subjective.
Objective tinnitus is uncommon and is caused by transmitted vascular vibrations in the blood vessels of the head and neck or by rythmic rapid contractions of the muscles of the soft palate or middle ear (Current medical diagnosis and treatment, 16th Annual revision, by Krupp M. A. and Chatton M. J. p.95 (1977)).
Subjective tinnitus is much less well understood. Although its etiology is at present not known, it is presumed to be due to irritation of nerve endings in the cochlea by degenerative vascular or vasomotor disease. It usually accompanies hearing loss or other disorders. The most frequent cause of tinnitus seems to be exposure to loud noise, either over an extended period of time or as one extreme incident.
The subjective form of tinnitus is very prevalent among adults. E.g. in a survey from Great Britain, about 10% of adults reported having prolonged, spontaneous tinnitus, with 1-3% reporting tinnitus severe enough to be disabling. Severe tinnitus is disabling due to the psychological effect of “hearing” sounds or noise continuously. Tinnitus prevents concentration, disrupts or prevents sleep, and in severe cases often leads to depression.
As stated in U.S. Pat. No. 5,840,723 (Sands), different modes of treatment are proposed to alleviate tinnitus, such as masking the noise by use of background music or “white noise” , relaxation training or medication. Medication has included intravenous administration of local anesthetics (lidocaine), trans-tympanic injections of local anesthetics, administration of zinc, steroids, anticonvulsants (carbamazepine), tranquilizers (alprazolam), barbiturates, antidepressants
Browdy and Neimark , P.L.L.C.
Coe Susan D.
Prats Francisco
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