Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2002-06-28
2003-12-30
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S778000
Reexamination Certificate
active
06669967
ABSTRACT:
FIELD OF THE INVENTION
The invention relates in a first aspect to a method for the treatment of disorders related to normal hormonal variations in women during fertile as well as, peri- and post-menopausal age, by the administering of a composition comprising, as active ingredients, a water- and/or fat-soluble cytosolic extract of pollen and optionally pistils.
The invention, in another aspect, relates to a composition comprising, as active ingredients, a water- and/or fat-soluble cytosolic extract of pollen and optionally pistils for the treatment of disorders relating to normal hormonal variations in women during fertile, as well as peri- and post-menopausal age.
BACKGROUND OF THE INVENTION
Disorders relating to normal variation of the sex hormone cycle of women of fertile age are tension, irritability, dysphoria, abdominal distension or bloatedness, severe breast tension, headache or migraine, edema, weight changes, sleep disturbances etc. The overall well being as well as the social and professional life may be influenced.
Over the years different treatment options have been suggested to be effective for the treatment of the above-mentioned disorders. However few have shown a consistent efficacy on irritability, dysphoria, bloatedness and edema, tension, breast tension, weight gain, headache and sleep disturbances related to normal variations in the sex hormone cycle of women of fertile age. The pharmacological treatments that have been tried include serotonin re-uptake inhibitors, diuretics, hormonal treatment as well as dietary interventions with e.g. vitamin and mineral supplementation, and natural products. Many of the compounds used for the treatment are limited due to adverse effects.
Also menopause, which is caused by a lowering of the production of female sex hormones at the age around 50, can to many women generate disorders such as edema, hot flushes, attacks of sweating, muscle and possibly joint pain, sleep disturbances, dysphoria, nervousness, mood swings, headache, palpitations (enhanced frequency of heart rate), dry mucous membranes and pain during intercourse, urinary disturbances such as stress incontinence, frequent passing water and pain/irritability of the bladder and urethra during the process of passing water etc. All these disorders reflect age related hormonal changes which hitherto only have been alleviated effectively by the administration of female sex hormones like estrogen and the like. However, there are studies showing that hormone therapy may have a carcinogenic effect as a negative side effect.
Four out of five women have disturbing menopause disorders for at least one year and 25% of women have menopause disorders for more than 5 years. Half of all women have severe disorders and a population of 5 million inhabitants will constantly include about 200,000 women in the period of life where menopause trouble is disrupting their life.
In view of the above, it is apparent that there still is a great need for safe compositions with a consistent efficacy for the treatment of disorders relating to normal hormonal variations in women during fertile as well as, peri- and post-menopausal age.
A composition comprising an extract of combined pollen and pistils combined with a pollen grain extract, Royal Jelly and Vitamin E has been sold by Natumin Pharma AB, Kungsängsvägen 27, 561 56 Huskvarna, Sweden, for the treatment of Pre-Menstrual Syndrome (PMS). Said composition was thought to be active against PMS disorders in general.
SUMMARY OF THE INVENTION
The present inventors during research work found out that the composition as disclosed in the application showed an unexpected advantageous effect on some disorders relating to normal variations in the hormone cycle of women. Other physiological parameters, such as heart rate and blood pressure, remain unaffected by the remedy.
The present inventors thus found an unexpected beneficial effect on some disorders relating to normal hormone variations of women of fertile, as well as peri- and post-menopausal age, obtained by the administering of a composition comprising, as active ingredients, a water- and/or fat-soluble cytosolic extract of pollen and optionally pistils, optionally in combination with Royal Jelly and Vitamin E. The invention is based on this discovery.
Said disorders in the peri- and post-menopausal women comprise menopausal hot flashes, tendencies of sweating, palpitations, muscle pains, headache, difficulties in passing water, stress incontinence, dysphoria, dry vaginal and mucous membranes, arthralgia, water retention, irritability, and variations in mood.
For women in fertile age the most unexpected and surprising effects were obtained on the disorders selected from irritability, dysphoria, bloatedness, edema, breast tension (mastalgia), weight changes, tension, headache, sleep disturbances, deteriorated overall wellbeing and interference in social and professional life.
The scope and preferred embodiments of the invention are as defined in the appended claims.
DETAILED DESCRIPTION OF THE INVENTION
The water-and/or fat-soluble cytosolic extract of pollen and optionally pistils preferably comprises an extract of pollen and pistils (PI 82) combined with an extract of pollen grain (GC FEM), as specified herein below. Both types of extract may be purchased from Allergon AB, Välingevägen 309, S-262 92 Ängelholm, Sweded, a Pharmacia company.
The pollens and pistils used for manufacturing of PI82 and GC FEM extracts are selected and harvested primarily from plants belonging to the grass family (Poaceae). During processing, treatment is performed on the pollen to open and remove the outer cell wall thereof as well as to minimize the risk of allergic pollen re-actions.
PI 82 is a cytosolic pollen-pistil extract rich in superoxide dismutase (SOD) mimics. The source of PI 82 is freshly harvested pollen grains and pistils. The pollen and pistils are allowed to react under very specific conditions. In the reaction, the process of fertilization is initiated between pollen and pistils, and the extract comprises the product thereof. Substances obtained in this reaction are SOD mimics, flavonoids, tannins and polyphenols. In vitro studies have shown that the extract has high superoxide dismutase activity and prevents the formation of free radicals. Experiences from double blind patient investigation show that PI 82 protects the body from the negative influence of free radicals. Furthermore, PI 82 improves the red cell function, thus improving oxygen perfusion to different tissues.
GC FEM is a water-soluble cytosolic extract from pollen. The cytoplasm content of the pollen contains, in addition to the above-mentioned substances, a high amount of carbohydrates and protein. Furthermore, carotenoids and traces of estrogen substances are found. GC FEM contains natural bioflavonoids, vitamins, enzymes and trace elements.
Royal Jelly is a product of the processing of various plant materials within the salivary glands of the worker honeybees. It is rich in pantothenic acid (also called Vitamin B
5
), further vitamins and sterols. It is preferably included in the composition in lyophilized form, preferably concentrated by drying to a ratio of at least 1:3. Royal Jelly may be purchased from AB Montoil, Box 24150, S-104 51 Stockholm, Sweden.
As a source of Vitamin E, use is preferably made of Dry Vitamin E 50%, Type SD, from F. Hoffmann-La Roche Ltd., CH-4070 Basel, Switzerland. Preferably dl-alpha-tocopherol is used, but other forms might also be valuable.
Further, common drug processing compounds may be included, such as diluents, glidants, lubricants, disintegrants, flavoring and coloring agents well known to the man skilled in the art of pharmaceutical sciences.
The active ingredients may be included in formulations of any form, such as tablets, powders, granules, and tinctures. They also may be included in foodstuff of different origin, e.g. as functional food. Administration to the woman in need thereof may take place several times a day, such as 1-8 times daily, 1-6 times daily or 1-4 times daily.
A daily do
Hedman Christer
Kärnerud Lars
Winter Kaj
Browdy and Neimark PLLC
Natumin Pharma AB
Patten Patricia
Tate Christopher R.
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