Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2002-10-08
2003-10-28
Azpuru, Carlos A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
Reexamination Certificate
active
06638525
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to mixtures comprising at least one of the fatty acids eicosapentaenoic acid (20:5n3) and docosahexaenoic acid (22:6n3) and the plant Zingiber officinale Roscoe or parts thereof or an extract or a component thereof
More specifically, the invention relates to novel pharmaceuticals, dietary supplements or cosmetic compositions containing such mixtures, and to the use of such mixtures for preparing a medicament or a dietary supplement for the suppression of hypersensitivity and/or inflammatory reaction
BACKGROUND OF THE INVENTION
Hypersensitivity is defined as a state of altered reactivity in which the body reacts with an exaggerated immune response to a substance (antigen) Hypersensitivity may be caused by exogenous or endogenous antigens.
Hypersensitivity reactions underlie a large number of diseases. Among these, allergic and autoimmune conditions are of great importance. A classification of hypersensitivity diseases is given in the textbook Clinical Medicine (Kumar, P and Clark, M., “Clinical Medicine”, 3rd edition, p 147-150, 1994, Bailliere Tindall, London)
Type I hypersensitivity reactions (IgE mediated allergic reactions) are caused by allergens (specific exogenous antigens), e g. pollen, house dust, animal dandruff, moulds, etc. Allergic diseases in which type I reactions play a significant role include asthma, eczema (atopic dermatitis), urticana, allergic rhinitis and anaphylaxis.
Type II hypersensitivity reactions are caused by cell surface or tissue bound antibodies (IgG and IgM) and play a significant role in the pathogenesis of myasthenia gravis, Good-pasture's syndrome and Addisonian pernicious anaemia.
Type III hypersensitivity reactions (immune complex) are caused by autoantigens or exogenous antigens, such as certain bacteria, fungi and parasites. Diseases in which type III hypersensitivity reactions play a significant role include lupus erythematosus, rheumatoid arthritis and glomerulonephritis.
Type IV hypersensitivity reactions (delayed) are caused by cell or tissue bound antigens. This type of hypersensitivity plays a significant role in a number of conditions, e g graft-versus-host disease, leprosy, contact dermatitis and reactions due to insect bites
A number of drug classes are available for the treatment of hypersensitivity reactions. Some of these are applied systemically and some are applied topically
The corticosteroids are among the most widely used drugs for the treatment of hypersensitivity diseases. Corticosteroids primarily exert their pharmacological action by non-selectively inhibiting the function and proliferation of different classes of immune cells resulting in suppression of hypersensitivity reactions. Unfortunately the corticosteroids are associated with a number of serious side effects, e.g. immuno-suppression, osteoporosis and skin atrophy (when applied topically)
Zingiber officinale Roscoe (family Zingiberacea), commonly known as ginger, is an erect perennial herb with thick tuberous rhizomes (underground stems) from which the aerial stem grows about 1 m high Zingiber officinale Roscoe is native to Southern Asia and is extensively cultivated in the tropics, e.g. India, China, Jamaica, Haiti and Nigeria.
Ginger or ginger volatile oil is widely used as a flavour ingredient in the food industry.
Due to the extensive use of Zingiber officinale Roscoe in the food industry, it has been subject to some chemical investigations.
The ginger rhizome contains a volatile oil which can be obtained by steam distillation. The chemical composition of ginger oil depends on its geographic origin. Ginger volatile oil generally contains the sesquiterpenes zingiberene and bisabolene as its major components. Other sesquiterpenes and sesquiterpene alcohols present include ar-curcumene, &bgr;-sesquiphelandrene, sesquithujene, &bgr;-bisabolone, (E)-&agr;-farnesene, zingiberol, zingiberenol, cis-sesquisabinene hydrate, and cis- and trans-sesquiphellandrol. It also contains monoterpenes such as camphor, &bgr;-phellandrene, geranial, neral, linalool, camphene and d-borneol.
Zingiber officinale Roscoe contains a number of phenolic compounds, most of which have a characteristic hydroxy-methoxy-phenyl moiety. These compounds are responsible for the pungency of ginger. The quantitatively dominating group of these phenolic compounds are the gingerols. The gingerols form a homologous series, 2-gingerol, 4-gingerol, 6-gingerol, 8-gingerol, 10-gingerol, 12-gingerol and 14-gingerol. The quantitatively dominating of these is 6-gingerol. Another group are the shogaols which are dehydration products of gingerols. The shogaols form a similar homologous series. Other similar compounds present are zingerone, 6-gingerdiol, gingerdione, gingerenones A-C, isogingerenone B, etc
Zingiber officinale Roscoe has been used in the traditional medicine in China and in the Indian subcontinent for more than 2500 years. The Chinese prescribe fresh or dried ginger for the relief of a number of conditions, e g gastrointestinal disturbances, colds, inflammations, headaches and as an antiemetic for the prevention of seasickness
The traditional use of Zingiber officinale Roscoe is limited to consumption of the ginger rhizome in a fresh or dried state. Obtaining an effect based on the traditional use requires high doses of the rhizome (Srivastava K C et al, Med Hypotheses May 1989, 29(1) 25-8 and Shrivastava K C et al, Med Hypothesis December 1992, 39(4) 342-8)
An inhibiting effect on the formation of pro-inflammatory eicosanoids has been established in vitro for some components of Zingiber officinale Roscoe (Kiuchi F, et al, Chem Pharm Bull Tokyo. February 1992; 40(2) 387-91) Furthermore an inhibiting effect of ginger oil on adjuvant arthritis in the rat has been established in vivo (Sharma J N et al, Pharmacology 1994; 49: 314-18). Despite these findings, the pharmacological effects of Zingiber officinale Roscoe upon administration to humans are mild and only of limited clinical relevance.
The arachidonic acid (AA) metabolism plays an essential role in hypersensitivity reactions because AA is converted by the enzyme cyclooxygenase into pro-inflammatory prostaglandins and by the enzyme 5-lipoxygenase into proinflammatory leukotrienes. The prostaglandins and leukotrienes are commonly termed eicosanoids. The modulation of the AA metabolism is a well established pharmacological strategy in relation to the treatment of hypersensitivity reactions.
Marine oils, especially fish oils, contain relatively high concentrations of the fatty acids eicosapentaenoic acid (20.5n3) and docosahexaenoic acid (22.6n3). These fatty acids have been shown to reduce inflammatory reactions because they can replace AA in the AA metabolism. The eicosanoids formed by the metabolism of eicosapentaenoic acid (20:5n3) and docosahexaenoic acid (22.6n3) have insignificant pro-inflammatory effects or even antiinflammatory effects
The drawback in relation to the therapeutic use of eicosapentaenoic acid (20:5n3) and docosahexaenoic acid (22:6n3) is that they are only mildly antiinflammatory and need to be administered for longer periods before a clinical effect can be observed
SUMMARY OF THE INVENTION
It has been found by the present inventor that a combination of
a) eicosapentaenoic acid (20:5n3) and/or docosahexaenoic acid (22.6n3), and
b) Zingiber officinale Roscoe or parts thereof or an extract or component thereof;
significantly suppresses hypersensitivity reactions, and that such a combination is far superior to any of its components when they are used alone
To the inventor's best knowledge, it is disclosed nowhere in the literature to use a combination of
a) eicosapentaenoic acid (20.5n3) and/or docosahexaenoic acid (22:6n3), and
b) Zingiber officinale Roscoe or parts thereof or an extract or component thereof, as active ingredients in pharmaceuticals, dietary supplements or cosmetics.
As mentioned above the therapeutic effect of Zingiber officinale Roscoe is derived from the ability of certain components to inhibit the generation of eicosanoids through a direct
Azpuru Carlos A.
Darby & Darby
Eurovita A/S
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