Patent Application: US-88462301-A

Abstract:
compositions comprising lycopene , serenoa repens , pygeum africanum , and urtica dioica are provided . the compositions are preferably formulated with an alcohol extract of the dried , cut plant parts . methods of using such compositions for treating various conditions and diseases , including benign prostatic hypertrophy and prostate cancer are also provided .

Description:
the composition of this invention includes a combination of the herbs , serenoa repens , pygeum africanum , and urtica dioica , or extracts thereof , and the pytochemical lycopene , which were specifically chosen and combined according to their biological activities , the term “ herb ” as used herein refers to the whole herb or tuber , or to the seeds , leaves , stems , flowers , roots , berries , bark , or any other plant parts that are used for healing . the lycopene component of the composition was obtained is available commercially from hoffman la roche , of nutley , n . j ., u . s . a ., as a synthetic chemical availabe at a 5 % strength that is chemically identical to the lycopene extracted from tomato fruit using standard methods . the natural standardized extract is available from many sources well known to those of ordinary skill in the art at a strength of 3 %, including brainway , inc ., senovazne 23 , praha 1 , 110 czech republic . the serenoa repens component of the composition is available commercially around the world , through distributors such as amira , box 1717 , alachua fla ., u . s . a . the component is obtained from the berry portion of the herb and the component is preferably powdered but may also be cut , and preferably contains about 40 % fatty acids . the pygeum africanum component of the composition is available commercially around the world , through distributors , such as advanced alternatives for better health , 1344 lansing avenue , lansing mich ., u . s . a . preferably , the powdered bark is used and contains about 2 . 0 - 2 . 5 % steroids . the urtica dioca component of the composition is available commercially around the world , through distributors such as advanced alternatives for better health , 1344 lansing avenue , lansing mich . 48915 and amira , box 1717 , alachua fla ., u . s . a . the preferred embodiment of the invention contains the component from the powdered root , with 0 . 8 % sterols , but alternatively the root may be cut or powdered or cut leaves may be utilized . the methods for combining the herbs , extracts , and vitamins are well known to those of ordinary skill in the art and may be accomplished at a number of commercial production laboratories around the world . each herbal component selected in this group has been well characterized and used individually before for the treatment of bph and for the prevention of prostate cancer . however , they have not , to date , been used together as is disclosed in this invention . it is the synergism between all of the herbs that renders the administration of a combination containing each of the herbs desirable . as a holistic approach to combating the treatment of bph and prevention of prostate cancer , herbs were selected which possess the following biological activities : ( 1 ) anti - tumor activity ; ( 2 ) immune stimulating activity ; ( 3 ) anti - androgen activity ; ( 4 ) anti - bph activity ; and ( 5 ) activities to restore micturitional disorders . most of the herbs have multi functional activities . in a specific embodiment of the invention , the composition comprises between 0 . 1 and 180 mg lycopene , an amount that will comprise from 0 . 1 to 10 % by weight of a tablet or capsule having a total weight of 100 to 1800 mg , between 30 and 1080 mg serenoa repens , an amount that will comprise from 30 to 60 % by weight of a tablet or capsule having a total weight of 100 to 1800 mg , between 4 and 450 mg pygeum africanum , and amount that will comprise from 4 to 25 % by weight of a tablet or capsule having a total weight of 100 to 1800 mg , and between 30 and 1080 mg urtica dioica , an amount that will comprise from 30 to 60 % by weight of a tablet or capsule having a total weight of 100 to 1800 mg . in yet another embodiment of the invention , the composition comprises between 0 . 1 and 60 mg lycopene , an amount that will comprise from 0 . 1 to 10 % by weight of a tablet or capsule having a total weight of 100 to 600 mg , between 30 and 360 mg serenoa repens , an amount that will comprise from 30 to 60 % by weight of a tablet or capsule having a total weight of 100 to 600 mg , between 4 and 150 mg pygeum africanum , and amount that will comprise from 4 to 25 % by weight of a tablet of capsule having a total weight of 100 to 600 mg , and between 30 and 360 mg urtica dioica , an amount that will comprise from 30 to 60 % by weight of a tablet or capsule having a total weight of 100 to 600 mg . in yet another embodiment of the invention , the composition comprises about 50 mg lycopene , about 150 mg serenoa repens , about 50 mg pygeum africanum , and about 150 mg urtica diocia . in a preferred embodiment , the composition further comprises between about 3 and 3 mg vitamin a ; between about 5 and 150 mg vitamin b6 ; between about 1 mg and 25 mg zinc ; between about 0 . 1 and 5 mg copper ; between about 10 mg and 600 mg bee pollen powder ; between about 10 mg and 1800 mg each of the amino acids alanine , glutamine , and glycine ; between about 5 mg and 500 mg panax ginseng extract ; and between about 1 and 100 mg hydrangea arborescens extract . in yet another embodiment , the composition further comprises between 1 and 2 mg vitamin a , between 5 and 50 mg vitamin b6 , between 1 and 15 mg zinc , between 0 . 1 and 2 mg copper , between 10 mg and 240 mg bee pollen powder , between 10 and 600 mg each of alanine , glutamine , and glycine , between 5 and 100 mg panax ginseng extract and between 1 and 25 mg hydrangea arborescens extract . in yet another embodiment , the composition further comprises about 1 . 5 mg vitamin a , about 15 mg vitamin b6 , about 5 mg zinc , about 0 . 5 mg copper , about 60 mg bee pollen powder , about 60 mg each of alanine , glutamine , and glycine , about 10 mg panax ginseng extract , and about 5 mg hydrangea arborescens extract . in a more preferred embodiment the composition is present in a 500 mg tablet or capsule containing about 50 mg lycopene , an amount that will comprise about 10 % by weight of the tablet or capsule , about 150 mg serenoa repens , and amount that will comprise about 30 % by weight of the tablet or capsule , about 50 mg pygeum africanum , an amount that will comprise about 10 % by weight of the tablet or capsule , and about 150 mg urtica dioica , and amount that will comprise about 30 % by weight of the tablet or capsule , and about 1 . 5 mg vitamin a , about 15 mg vitamin b6 , about 5 mg zinc , about 0 . 5 mg copper , about 60 mg bee pollen powder , about 60 mg each of alanine , glutamine , and glycine , about 10 mg panax ginseng extract , and about 5 mg hydrangea arborescens extract . in a further embodiment , the composition is administered in four tablets , each comprising about 500 mg red yeast rice , about 15 mg coenzyme q 10 , about 50 mcg chromium , about 13 mg inositol , about 50 mcg selenium , and about 20 iu mixed tocopherols to provide a total daily dose of about 2 gm red yeast rice , about 60 mg coenzyme q 10 , about 200 mcg chromium , about 52 mg inositol , about 200 mcg selenium and about 80 iu mixed tocopherols . preferably , the compositions of the present invention are prepared in a tablet dosage form , however it will be understood by those skilled in the art that other dosage forms may also be suitably prepared by known methods , for example , capsules , caplets , powders , pastes , liquids and similar dosage forms . also , it will be understood that the compositions may also contain one or more conventional pharmaceutically acceptable excipients , adjuvants , solvents or carriers and may also include flavors , colorings , coatings , etc . one dose of the pharmaceutical composition for the treatment of bph , for example one tablet or one capsule , may contain , for example 100 - 600 mg of the composition of the present invention . one dose of the pharmaceutical composition for the prevention of prostatic cancers may contain , for example , 600 - 1800 mg of the composition of the present invention . the compositions are preferably administered in spaced dosages throughout the day , for example , administered every three to six hours , so as to maintain the level of active ingredients in the system of the mammal . the dose may be administered in single or divided doses throughout the day and is preferably taken with food . a person skilled in the art will understand that the therapeutic effects of the compositions result from a plurality of active agents in each herb which when combined , act synergistically to enhance efficacy . it will also be understood that the compositions comprising all agents , are also contemplated herein , as are liquid or slow release formulations of the composition . thus , it will be understood that the compositions of the invention can be administered orally , rectally ( as suppositories ), intravenously , topically or by other known means . as a capsule , the formulation should be stored at a temperature of 80 ° or less . the administration of the composition would be in accordance with a predetermined regimen , which would be at least once daily and over an extended period of time as a chronic treatment , and could last for one year or more , including the life of the host . the dosage administered will depend upon the frequency of the administration , the blood level desired , other concurrent therapeutic treatments , the severity of the condition , whether the treatment is for prophylaxis or therapy , the age of the patient , the levels of ldl - cholesterol and hdl - cholesterol in the patient , and the like . the following examples will serve to further typify the nature of the invention , but is not limited on the scope thereof , which is defined solely by the appended claims . lycopene 0 . 4 g . serenoa repens 150 g . pygeum africanum 50 g . urtica dioica 50 g . lycopene 0 . 4 g . serenoa repens 150 g . pygeum africanum 50 g . urtica dioica 150 g . vitamin a 5 , 000 iu vitamin b6 15 mg zinc ( as arginate ) 5 mg copper ( as gluconate ) 0 . 5 mg urtica dioica extract ( root , 0 . 8 % sterols ) 150 mg serenoa repens extract ( berry , 40 % fatty acids ) 150 mg bee pollen powder 60 mg l - alanine 60 mg l - glutamic acid 60 mg l - glycine 60 mg pygeum africanum extract ( bark , 2 . 0 - 2 . 5 % sterols ) 50 mg panax ginseng extract ( root , 25 % ginsenosides ) 10 mg lycopene ( 5 %) 50 mg hydrangea arborescens extract ( root , 4 : 1 ) 5 mg the following references are incorporated herein by reference : u . s . provisional application no . 60 / 153 , 322 ; kupelian p a , et al ., ( 1997 ) j . of urol 158 ( 6 ): 2197 - 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