Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
1999-11-04
2003-10-28
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S775000, C424S754000
Reexamination Certificate
active
06638540
ABSTRACT:
This application is a United States national stage filing of International Application No. PCT/EP98/02627, filed on May 4, 1998, which claims priority under 35 USC 119 from GB patent application 9709082.3, filed on May 6, 1997.
The present invention relates to nutritional or pharmaceutical compositions comprising extracts or concentrates of certain plants 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 certain plants or vegetables which belong for example to the botanical families of liliaceae, umbelliferae and cruciferae have a potent inhibitory effect on bone resorption.
Accordingly, the present invention relates to the use of a vegetable extract or concentrate, excluding extracts or concentrates derived from leguminosae and hop, having an inhibitory effect on bone resorption in the preparation of a medicament or nutritional formulation 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.
By the term leguminosae is meant the botanical family leguminosae (pea family) which includes for example soybean, beans, chick pea or lentil. By hop is meant the botanical species Humulus lupulus.
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.
The invention further provides 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 medicament or nutritional formulation to a human or other mammal, said medicament or nutritional formulation comprising a vegetable extract or concentrate, excluding extracts or concentrates derived from leguminosae and hop, in an amount which is effective for inhibiting bone resorption.
The present invention also foresees the use of an extract or concentrate from a plant selected from the group consisting of allium, petroselinum, brassica and eruca extracts and concentrates in the preparation of a medicament or nutritional formulation 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 medicament or nutritional formulation to a human or other mammal, said medicament or nutritional formulation comprising an extract or concentrate from a plant selected from the group consisting of allium, petroselinum, brassica and eruca extracts and concentrates, in an amount which is effective for inhibiting bone resorption.
Preferably the extracts and concentrates from allium, petroselinum, brassica and/or eruca are vegetable extracts or concentrates.
As used herein, the term vegetable refers to a herbaceous plant which has an edible portion which is consumed by humans in either raw or cooked form. The edible portion may be a root, such as rutabaga, beet, carrot, and sweet potato; a tuber or storage stem, such as potato and taro; the stem, as in asparagus and kohlrabi; a bud, such as brussels sprouts; a bulb, such as onion and garlic; a petiole or leafstalk, such as celery and rhubarb; a leaf, such as cabbage, lettuce, parsley and spinach; an immature flower, such as cauliflower, broccoli and artichoke; a seed; the immature fruit, such as eggplant, cucumber, and sweet corn (maize); or the mature fruit, such as tomato and pepper.
As used herein, the term allium refers to the genus allium (latin for garlic, a member of the onion family) and includes for example any member of the botanical species
Allium cepa
(onion),
Allium ascalonicum
(shallot),
Allium ampeloprasum
(leek/great-headed-garlic),
Allium porrum
(leek),
Allium schoenoprasum
(chive),
Allium ursinum
(bear's garlic),
Allium sativum
(garlic) or
Allium fistulosum
(bunching onion). Preferred species are
Allium ascalonicum
(shallot),
Allium porrum
(leek),
Allium cepa
(onion) and
Allium ursinum
(bear's garlic, also known as bear paw garlic), particularly the latter two, whereby
Allium cepa
is particularly preferred. Examples of members of the species
Allium cepa
are common onions (with red or white or yellow skins) or shallots, whereby red or white common onions are preferred.
The onion extracts and concentrates are prepared e.g. from the whole eatable part of the vegetable. Suitable chive extracts and concentrates are obtained e.g. from chive herbs. Suitable bear's garlic extracts and concentrates are obtained e.g. from bear's garlic bulbs, fresh herbs or from the whole blooming plant, preferably they are obtained form fresh herbs.
The term petroselinum as used herein refers to the genus petroselinum (common name parsley) and includes for example any member of the botanical species
Petroselinum crispum
. Examples are
Petroselinum crispum crispum
, that is common parsley with curly leaves,
Petroselinum crispum radiosum
or
Petroselinum crispum
var. neapolitanum also known as Italian Parsley with flat leaves.
Suitable petroselinum extracts or concentrates may be produced e.g. from roots, fruits or seeds, or particularly from herbs.
As used herein the term brassica refers to the genus brassica (latin for cabbage) and includes for example any member of the botanical species
Brassica oleracea, Brassica napus, Brassica rapa, Brassica alboglabra, Brassica juncea, Brassica perviridis, Brassica alba
and
Brassica nigra.
Brassica oleracea
is a preferred species, particularly preferred members of this species are
Brassica oleracea
var. italica, i.e. broccoli, or
Brassica oleracea
var. gemmifera, i.e. Brussels sprouts. Broccoli extracts and concentrates are particularly preferred as brassica extract or concentrate. Suitable extracts and concentrates of brassica oleraceae species are produced advantageously from the whole eatable part of the vegetable or from the freshly germinated sprouts or shoots.
As used herein the term eruca refers to the genus eruca and includes in particular any member of the botanical species
Eruca sativa
(wild form) or
Eruca vesicaria
subsp. sativa (cultivated form) for which the common name is arrugula or roquette.
The plant/vegetable extracts and concentrates of the invention are preferably obtained from an edible portion of the plant or vegetable. By edible portion is meant the portion which is consumed by humans in either raw or cooked form.
Kung John W.
Patten Patricia
Universitat Bern
Weber Jon P.
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