Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-03-09
2003-03-18
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S774000, C424S776000
Reexamination Certificate
active
06534098
ABSTRACT:
The present invention relates to nutritional or pharmaceutical compositions comprising extracts or concentrates of plants of the genus anethum and their use as inhibitors of bone resorption.
The most common metabolic bone disorder is osteoporosis. Osteoporosis can be generally defined as the reduction in the quantity of bone, either from the reduction in bone formation or the acceleration of bone resorption, in either event the result is a decrease in the amount of skeletal tissue. Osteoclasts (bone resorbing cells) are responsible for the excavation of a portion of bone during the resorption process. After resorption, osteoblasts (bone forming cells) appear, which then refill the resorbed portion with new bone.
In young healthy adults, the rate at which the osteoclasts and osteoblasts are formed and operate maintains a balance between bone resorption and bone formation. However, as normal consequence of aging, an imbalance in this remodeling process develops, resulting in loss of bone. As imbalance continues over time, the reduction in bone mass and thus bone strength leads to fractures.
Many compositions and methods are described in the medical literature for the treatment of osteoporosis. For example, estrogens, calcitonin and bisphosphonates are known to be effective inhibitors of bone resorption.
It has now surprisingly been found that products derived from plants of the genus anethum have a potent inhibitory effect on bone resorption.
The present invention therefore foresees the use of an extract or concentrate from a plant of the genus anethum in the preparation of a pharmaceutical or nutritional composition for the treatment or prophylaxis of a disease or condition which is characterized by increased bone resorption, such as Paget's disease, tumor-induced bone disease or particularly osteoporosis.
Also provided is a method for the treatment or prophylaxis of a disease or condition which is characterized by increased bone resorption, such as Paget's disease, tumor-induced bone disease or particularly osteoporosis, comprising the administration of a pharmaceutical or nutritional composition to a human or other mammal, said pharmaceutical or nutritional composition comprising an extract or concentrate from a plant of the genus anethum, in an amount which is effective for inhibiting bone resorption.
The invention further provides the use of an extract or concentrate from a plant of the genus anethum in the preparation of a pharmaceutical or nutritional composition for one or more indications from the following group:
a) inhibiting bone resorption,
b) reducing the risk of developing a disease or condition which is characterized by increased bone resorption, such as Paget's disease, tumor-induced bone disease or particularly osteoporosis,
c) for supporting the treatment of a disease or condition which is characterized by increased bone resorption, such as Paget's disease, tumor-induced bone disease or particularly osteoporosis,
d) for supporting the treatment of osteoporosis, and
e) for reducing the risk of developing osteoporosis.
Further provided is a method for
a) inhibiting bone resorption,
b) reducing the risk of developing a disease or condition which is characterized by increased bone resorption, such as Paget's disease, tumor-induced bone disease or particularly osteoporosis,
c) for supporting the treatment of a disease or condition which is characterized by increased bone resorption, such as Paget's disease, tumor-induced bone disease or particularly osteoporosis,
d) for supporting the treatment of osteoporosis, and/or
e) for reducing the risk of developing osteoporosis
comprising the administration of a pharmaceutical or nutritional composition to a human or other mammal, said pharmaceutical or nutritional composition comprising an extract or concentrate from a plant of the genus anethum, in an amount which is effective for inhibiting bone resorption.
Osteoporosis as used herein includes osteoporosis induced by hormone deficiency (e.g. postmenopausal) and old age, as well as secondary osteoporosis such as osteoporosis secondary to steroid treatment or secondary to malnutrition caused by anorexia nervosa.
Preferably the concentrate or extract is derived from a plant of the botanical species
Anethum graveolens, Anethum hortorum
and/or
Anethum sowa
Roxb., preferably
Anethum hortorum.
The plant extracts and concentrates of the invention are preferably obtained from an edible portion of the plant. By edible portion is meant the portion which is consumed by humans in either raw or cooked form.
The extracts and concentrates of the above-mentioned plants may be in liquid form or in solid form such as in granulate or powder form.
Suitable plant concentrates are obtainable e.g. by drying or freeze-drying the fresh-cut plants or the respective roots, fruits or seeds thereof and then optionally grinding or granulating the dried material; or by squeezing the fresh-cut plants or the respective roots, fruits or seeds thereof and gathering the liquid fraction and optionally drying it. The use of a concentrate of the above-mentioned plants in solid form and particularly in powder form is preferred.
Suitable methods of obtaining extracts of the above-mentioned plants are known in the art. The plant extracts are obtainable e.g. by extracting the fresh-cut or dried plants or the respective roots, fruits or seeds thereof for example with water or with one or more food grade solvents or with a mixture of water and one or more food grade solvents. Suitable food grade solvents include propane, butane, butyl acetate, ethyl acetate, ethanol, carbon dioxide, acetone, nitrous oxide, methanol and propan-2-ol, whereby ethanol and carbon dioxide are preferred; ethanol is a particularly preferred food grade solvent. After the extraction step the liquid phase is optionally concentrated or dried by evaporation or freeze drying. The fresh-cut or dried plant material may be introduced in cold or preferably hot water and/or solvent, preferably water or a mixture of water with one or more solvents, for a specified period of time, which may vary within wide ranges depending on the kind of plant material or solvent used but commonly amounts for example to 1 to 30 minutes, preferably 2 to 15 minutes and most preferred 5 to 10 minutes for a water extraction and for example 30 to 90 minutes, preferably 60 minutes for an ethanol/water extraction. For a water extraction the temperature preferably lies in the range of 85 to 95° C. and for an alcohol/water extraction the temperature preferably lies in the range of 55 to 65° C. For a carbon dioxide extraction, the extraction preferably takes place at 0 to 40° C. and at super-critical pressure (e.g. 80-200 bar). After the extraction the liquid phase is separated and advantageously concentrated or evaporated to dryness according to known methods. To obtain a concentrated extract two or more extraction steps as described above may be combined. Moreover, the plant extracts may be obtained by introducing the fresh-cut or dried plant in water and subjecting the mixture to a steam distillation. The distillate is collected and is then advantageously concentrated or evaporated to dryness.
The extract may be used in liquid form, particularly in aqueous form, or in solid form, particularly in granulate or powder form. If the extract is in liquid form, it has a solid contents of for example from 1 to 25% by weight, preferably from 2 to 20% by weight and most preferred from 2 to 15% by weight.
The amount of inventive plant extract or concentrate to be supplied may vary within wide ranges, depending on i.a. the desired treatment, subject to be treated and his needs. Thus, where the subject to be treated is an adult person (typically of ca. 60 to 75 kg body weight), a satisfactory inhibitory effect on bone resorption is, in general obtained with compositions formulated to allow a daily administration of 0.1 to 20 grams, preferably 0.2 to 15 grams and most preferred 0.4 to 10 grams of plant concentrate or extract (on a solvent-free basis).
S
Kung John W.
Tate Christopher R.
Universitat Bern
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