Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-11-13
2002-08-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S725000
Reexamination Certificate
active
06440451
ABSTRACT:
The present invention relates to the use of formulations from Crataegus for the preparation of pharmaceutical preparations or food supplements for the prophylaxis and/or treatment of tumour diseases, the formulations substantially comprising constituents of Crataegus which are soluble in polar solvents. The invention furthermore relates to the use of Crataegus plant parts for the preparation of infusions. Compositions for the prophylaxis and/or treatment of tumour diseases are furthermore included.
In spite of advances in modern medicine, tumour diseases, i.e. malignant neoformations, still count among the most frequent diseases with in most cases very poor courses of the disease and predominantly fatal consequences. Undesirable side effects narrow the use of currently available medicaments in prophylaxis and treatment. A large number of active chemotherapeutics (cytostatics and cytotoxics), such as e.g. 5-fluorouracil or methotrexate, have so far been developed. However, the disadvantage of chemotherapeutics lies in the potent side effects. The side effects are to be attributed to the fact, inter alia, that the active compounds employed in chemotherapy also have a cytostatic and/or cytotoxic action on “healthy” cells, i.e. cells which proliferate normally. This leads in particular to damage to cells which normally divide frequently, such as e.g. keratinocytes, fibroblasts, endothelial and epithelial cells, stem cells of blood formation (haematopoietic system) and gametes, with the consequence of undesirable actions, such as e.g. hair loss (alopecia), damage to mucous membranes (mucosititis, intestinal ulcerations), suppression of blood formation (myelosuppression with the consequence of anaemia, infections and bleeding complications) and infertility. This limits the applicability of the currently available chemotherapeutics in treatment and prohibits their use in prophylaxis of neoplastic diseases.
The object of the present invention is therefore to provide a composition, in particular a pharmaceutical preparation or food supplement, for the prophylaxis and/or treatment of tumour diseases which does not have the side effects mentioned for the chemotherapeutics known in the prior art. In particular, an object of the present invention is to provide a composition which, in contrast to the chemotherapeutics currently used, has no effect or only a mild cytostatic or cytotoxic effect on normally proliferating cells.
The object is achieved according to the invention in that a formulation from Crataegus which substantially comprises constituents of Crataegus which are soluble in polar solvents (including polar protic solvents) is used for the preparation of a composition for the prophylaxis and/or treatment of tumour diseases (neoplastic diseases).
Formulations which substantially comprise constituents which are soluble in polar solvents are therefore to be understood as meaning those formulations which are obtainable employing processes with which polar constituents of Crataegus are obtained. The possible processes for the preparation of these formulations here are mentioned below by way of example. The term “polar solvents” in the context of the invention is generally understood as meaning aqueous and non-aqueous solvents, the latter group including, in particular, organic nitrogen and oxygen compounds, but not carbon disulphide, carbon tetrachloride and saturated hydrocarbons.
In the context of the present invention, the composition can be pharmaceutical preparations, medicaments, remedies, food supplements, dietary supplements, botanics, herbal remedies, additives to food supplements or to foodstuffs and the like, such as nutritive additives, teas or the like, in particular depending on the specification according to medical preparations law.
According to the invention, it has been found, surprisingly, that formulations which substantially comprise constituents of Crataegus which are soluble in polar solvents are particularly suitable for the prophylaxis and/or treatment of tumour diseases without showing the undesirable side effects of the chemotherapeutics known from the prior art.
Crataegus extracts have already been employed in folk medicine for a long time for the treatment of cardiovascular diseases, and have since also been recognized by science as effective for these diseases.
Crataegus is widespread throughout the world in the temperate climate zones on the northern and southern hemispheres and in the high mountains of the tropics (R. Kaul, “Der Wei&bgr;dorn: Botanik, Inhaltsstoffe, Qualitätskontrolle, Pharmakologie, Toxikologie und Klinik [The Hawthorn: Botany, constituents, quality control, pharmacology, toxicology and clinical aspects]”, 1st edition, Wissenschaftliche Verlagsgesellschaft, Stuttgart 1998). It is the largest genus of the Maloideae (Pomoideae) a sub-family of the Rosaceae. The genus Crataegus includes approx. 100 to 200 true species (I. Bauer and U. Hoelscher, “Crataegus” in R. Hänsel, K. Keller, H. Rimpler, G. Schneider (editors), Hagers Handbuch der Pharmazeutischen Praxis [Hagers handbook of pharmaceutical practice], volume 4, 5th edition, Springer verlag, Berlin 1992, 1040-1062). In Central Europe,
Crataegus laevigata
(synonym:
Crataegus oxyacantha
) and
Crataegus monogyna
and hybrids thereof are chiefly encountered; these are also the predominant Crataegus species in the western Mediterranean region and North Africa, while in the eastern Mediterranean region and Eurasia
Crataegus pentagyna
and
Crataegus nigra
are the preferred species, and in the eastern part of Eurasia, in addition to
C. laevigata
and
C. monogyna, C. curvisepala
and
C. azarolus
also grow.
C. cuneata
and
C. pinnatifida
are employed medicinally in Japan, China and adjacent regions, while in North America
C. berberifolia, C. aestivalis, C. chrysocarpa, C. crus
-
galli
and
C. pruinosa
are also taken for cardiovascular symptoms, at least in folk medicine. Most studies of the constituents carried out on
C. laevigata
have shown that all the plant parts of Crataegus contain a large number of constituents from the most diverse groups of substances (cf. F. Hoffmann, Pharmaceutica Acta Helvetiae 36 (1961) 30-39; B. Lay “Zur Chromatographie von Pimpinella major, Panax Ginseng,
Crataegus oxyacantha, Tussilago farfara
und
Mentha piperita
[The chromatography of Pipinella major,
Panax ginseng, Crataegus oxyacantha, Tussilago farfara
and
Mentha piperita
]”, dissertation 1965, Ludwig-Maximilians University Munich; N. Nikolov et al., “Recent investigations of Crataegus flavonoids” in L. Farkas, M. Gábor, F. Kállay, H. Wagner (editors), Elsevier Scientific Publishing Company, Amsterdam 1982, 325-344; M. Schüssler, “In-vitro-Untersuchungen zur Pharmakologie von Flavonoiden aus den offizinellen Crataegus Spezies und ihre analytische Charakterisierung [In vitro studies of the pharmacology of flavonoids from the officinal Crataegus species and their characterization by analysis]”, dissertation 1995, Philipps-University Marburg; R. Kaul, “Der Wei&bgr;dorn [The Hawthorn]”, loc. cit.).
Crataegus has a distinct cardiovascular action. The numerous studies are summarized in detail by Ammon et al. (H. P. T. Ammon et al., “Crataegus, Toxikologie und Pharmakologie, Teil I: Toxizität [Crataegus, toxicology and pharmacology, part I: Toxicity]”, Planta medica 43 (1981) 105-120; H. P. T. Ammon et al., “Crataegus, Toxikologie und Pharmakologie, Teil II: Pharmakodynamik [Crataegus, toxicology and pharmacology, part II: Pharmacodynamics]”, Planta medica 43 (1981) 209-239; H. P. T. Ammon et al., “Crataegus, Toxikologie und Pharmakologie, Teil III: Pharmakodynamik und Pharmakokinetik [Crataegus, toxicology and pharmacology, part III: Pharmacodynamics and pharmacokinetics]”, Planta medica 43 (1981) 313-322; the works of Ammon et al. have also served as a basis for the monograph in Bundesanzeiger [German Federal Gazette] no. 1 of Mar. 1, 1984, amended in Bundesanzeiger [German Federal Gazette]
Fubara Blessing
Nativia Health Products GmbH
Nixon & Vanderhye P.C.
Page Thurman K.
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