Food supplements for use in the prophylaxis and treatment of migraine

Abstract

Association of dry extract of feverfew, dry extract of willow and magnesium for use as an adjuvant in the prophylaxis and treatment of migraine and related oral compositions, in particular as a food supplement.

Claims

1. A method for treating and preventing feverfew primary headaches comprising orally administering, as adjuvant to a subject in need thereof, a therapeutically effective amount of: feverfew dry extract, white willow dry extract and magnesium.

2. The method of claim 1, wherein said primary headaches are migraine with and without aura, tension headache, chronic headache and cluster headache.

3. The method of claim 1, wherein said feverfew dry extract comes from the blossomed part of said plant and has a parthenolide content not lower than 0.5% and not higher than 10% by weight of the overall weight of said extract.

4. The method of claim according to claim 1, wherein said dry white willow extract comes from the cortex of said plant and has a salicin content not lower than 15% and not higher than 30% by weight of the overall weight of said extract.

5. The method of claim 1, wherein said magnesium source is Magnesium oxide containing magnesium in amounts of 60% by weight on the weight of said oxide.

6. The method of claim 1, wherein said feverfew dry extract, white willow dry extract, and magnesium are administered in the form of and oral composition containing them, as active ingredients in combination with suitable excipients and/or diluents.

7. The method of claim 6, wherein said oral composition said feverfew extract comes from the blossomed aerial part of said plant and has a parthenolide content not lower than 0.5% and not higher than 10% by weight of the overall weight of said extract, said white willow dry extract comes from the cortex of said plant and has a salicin content not lower than 15% and not higher than al 30% by weight of the overall weight of said extract, said magnesium source is magnesium oxide which contains 60% by weight of magnesium of the weight of said oxide, provided that i) the amount of salicin does not exceed the maximum recommended daily dose of 96 mg; ii) the amount of magnesium does not exceed the maximum recommended daily dose of 450 mg.

8. The method of claim 6, wherein said oral composition is in the form of a tablet administrable twice a day including: feverfew in amounts between 100 and 170 mg, white willow extract in amounts between 300 and 350 mg magnesium in amount between 200 and 250 mg.

9. The method of claim 8, containing 140 mg of feverfew dry extract, 320 mg of white willow dry extract and 225 mg of magnesium.

10. The method of claim 6, wherein said oral composition is a dietary supplement.

Description

DETAILED DESCRIPTION OF THE PRESENT INVENTION

(1) For the purposes of the present invention, the expression “comprising/containing one or more components” does not exclude the presence of further components besides the one or more explicitly listed. For the purposes of the present invention, the expression in which an object “is made up or formed or composed of one or more components” means that the presence of further components in the object besides the one or more listed components is excluded.

(2) Preferably, the above-mentioned association for use according to the present invention is orally administered.

(3) The dry extract of feverfew in the association for use according to the present invention is preferably from the blossomed aerial parts of this plant and preferably has a parthenolide titration of at least 0.5%, and not more than 10%.

(4) The dry extract of white willow comes preferably from the cortex of this plant and has a content in salicylic derivatives, and in particular in salicin, characterized by the following formula:

(5) ##STR00002##
preferably not lower than 15% by weight based on the weight of the dry extract and preferably not higher than 30%. In any case, the amount of the dose of white willow extract to be administered for use according to the present invention must not exceed the maximum daily dose of salicin of 96 mg, as per Ministerial Regulations for Food Supplements.

(6) Preferably, oxide or a pharmaceutically acceptable salt is used as the source of magnesium. Magnesium oxide is even more preferably used. Magnesium oxide, in fact, makes up 60% of the total weight of this compound, unlike pharmaceutically acceptable magnesium salts such as magnesium carbonate or citrate, containing only 24% and 14% of this element.

(7) The oral compositions object of the present invention can be in the form of tablets, hard or soft capsules, powders or granules in the form of single-serving sachets, dispersible in water.

(8) They are preferably in the form of tablets and contain:

(9) feverfew with the aforesaid titration in amounts preferably ranging from 100 to 170 mg, more preferably 140 mg,

(10) white willow extract with the aforesaid salicin titration in amounts ranging from 300 to 350 mg, more preferably 320 mg, and

(11) magnesium in amounts ranging from 200 to 250 mg, more preferably 225 mg.

(12) Preferably, the food supplement consists of said tablets, which are administered twice a day. In any case, the daily salicin amount must not exceed the aforementioned maximum permitted amount of 96 mg, and must not exceed the maximum permitted daily amount of magnesium of 450 mg, as per Ministerial Regulations for Food Supplements.

(13) For the purposes of the present invention, food or dietary supplements correspond to the definition given in Article 2 of the Legislative Decree No. 169 of 21 May 2004, i.e. food products intended to supplement the common diet and constituting a concentrated source of nutrients, such as vitamins and minerals, or of other substances having a nutritional or physiological effect, in particular, but not exclusively, amino acids, essential fatty acids, fibres and extracts of plant origin, alone or in combination, in pre-dosed forms.

(14) The following is a particularly preferred form of composition for food supplement in the form of tablets, in which the excipients and their contents are not reported.

(15) The excipients involved in the preparation of this particularly preferred embodiment of food supplement according to the present invention are conventional excipients for the preparation of compressible powders, for example those mentioned in Remington the Science and Practice of Pharmacy 21st Edition.

Example 1—Food Supplement Formula for 1.2 g Tablets Administrable Twice a Day

(16) TABLE-US-00001 Components Doses for a 1.2 g tablet Feverfew - blossomed aerial 140 mg parts dry extract Parthenolides - minimum content: Min. 0.7 mg 0.5% White willow- cortex dry extract 320 mg Salicylic derivatives as salicin -  48 mg minimum content 15% Magnesium oxide 373 mg Magnesium content (60%) 225 mg (60% of VNR*) (50% of the maximum permitted daily amount) *VNR: nutritional value of reference

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