US2003022818A1PendingUtilityA1

Formulations of tocopherols and methods of making and using them

55
Priority: Oct 8, 1999Filed: Jul 2, 2002Published: Jan 30, 2003
Est. expiryOct 8, 2019(expired)· nominal 20-yr term from priority
A61K 45/06A61K 31/355
55
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Claims

Abstract

Non-naturally-occuring compositions for use in amelioration of disruption of energy metabolism secondary to stress are described. The compositions comprise a tocopherol and/or a derivative thereof, and a synergist, and are particularly suited for use as nutritional supplements. Synergists include, but are not limited to, flavonoids and lactoferrin and/or derivatives thereof. Compositions comprising an optimized formulation comprising a tocopherol and an additional compound such as daidzein or biochanin A are also described. Methods of making these compositions and methods of ameliorating injury(ies) or disruption of energy metabolism secondary to stress, comprising administering such compositions, are also disclosed.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A non-naturally-occurring nutritional composition for amelioration of disruption of energy metabolism in cells secondary to stress comprising a tocopherol selected from the group consisting of alpha-, delta- and gamma-tocopherol and combinations and derivatives thereof, and a synergist selected from the group consisting of a flavonoid and lactoferrin, and combinations and derivatives thereof, wherein the tocopherol and the synergist are present in amounts effective to ameliorate said disruption of energy metabolism secondary to stress.  
     
     
         2 . The composition according to  claim 1 , wherein the tocopherol is alpha-tocopherol.  
     
     
         3 . The composition according to  claim 1 , wherein the tocopherol is delta-tocopherol.  
     
     
         4 . The composition according to  claim 1 , wherein the tocopherol is gamma-tocopherol.  
     
     
         5 . The composition according to  claim 1 , wherein the tocopherol is a combination of alpha- and gamma-tocopherol.  
     
     
         6 . The composition according to  claim 1 , wherein the synergist is hesperetin.  
     
     
         7 . The composition according to  claim 6 , wherein the synergist is quercetin.  
     
     
         8 . The composition according to  claim 6 , wherein the synergist is diosmin.  
     
     
         9 . The composition according to  claim 1 , wherein the synergist is lactoferrin.  
     
     
         10 . The composition according to  claim 1 , wherein the stress is induced by an environmental alteration, chemical insult or physiological condition.  
     
     
         11 . The composition of  claim 10 , where the environmental alteration is hypothermia, hyperthermia, hypoxia or ionizing radiation.  
     
     
         12 . The composition of  claim 10 , where the chemical insult is drug toxicity, chemotherapy, exposure to at least one toxin, or cell culture.  
     
     
         13 . The composition of  claim 10 , where the physiological condition is physical exertion, aging, pre-surgical preparation or post-surgical conditions.  
     
     
         14 . A nutritional supplement, comprising a formulation containing a tocopherol and a flavonoid in amounts effective to provide a synergist combination effective to ameliorate disruption of energy metabolism in cells secondary to stress.  
     
     
         15 . The nutritional supplement of  claim 14 , wherein said tocopherol is selected from the group consisting of alpha, gamma and delta tocopherols.  
     
     
         16 . The nutritional supplement of  claim 14 , wherein said tocopherol comprises a mixture of alpha-tocopherol and gamma-tocopherol.  
     
     
         17 . The nutritional supplement of  claim 16 , wherein said flavonoid is selected from the group consisting of hesperetin and diosmin.  
     
     
         18 . The nutritional supplement of  claim 16 , wherein said alpha-tocopherol is (+/−) alpha tocopherol.  
     
     
         19 . The nutritional supplement of  claim 16 , wherein said flavonoid comprises a combination of hesperetin and quercetin.  
     
     
         20 . A method of making a non-naturally-occurring composition to ameliorate disruption of energy metabolism secondary to stress comprising adding a tocopherol selected from the group consisting of alpha-, delta- and gamma-tocopherol and combinations and derivatives thereof, and synergist selected from the group consisting of flavonoid and lactoferrin and combinations or derivatives thereof, in sufficient amounts to ameliorate said stress.  
     
     
         21 . The method according to  claim 20 , wherein the tocopherol is alpha-tocopherol.  
     
     
         22 . The method according to  claim 20 , wherein the tocopherol is delta-tocopherol.  
     
     
         23 . The method according to  claim 20 , wherein the tocopherol is gamma-tocopherol.  
     
     
         24 . The method according to  claim 20 , wherein the tocopherol is in the form of a pharmaceutically acceptable salt.  
     
     
         25 . The method according to  claim 20 , wherein the tocopherol is a combination of alpha- and gamma-tocopherol.  
     
     
         26 . The method according to  claim 20 , wherein the flavonoid is hesperetin.  
     
     
         27 . The method according to  claim 20 , wherein the flavonoid is diosmin.  
     
     
         28 . The method of  claim 20  wherein said flavonoid comprises a combination of hesperetin and quercetin.  
     
     
         29 . The method according to  claim 20 , wherein the synergist is lactoferrin.  
     
     
         30 . The method according to  claim 20 , wherein the stress is induced by an environmental alteration, chemical insult or physiological condition.  
     
     
         31 . The method of  claim 30 , where the environmental alteration is hypothermia, hyperthermia, hypoxia or ionizing radiation.  
     
     
         32 . The method of  claim 30 , where the chemical insult is drug toxicity, chemotherapy, exposure to at least one toxin, or cell culture.  
     
     
         33 . The method of  claim 30 , where the physiological condition is physical exertion, aging, pre-surgical preparation or post-surgical conditions.  
     
     
         34 . A method for the amelioration of disruption of energy metabolism secondary to stress, comprising administering to a subject a non-naturally-occurring composition comprising a tocopherol selected from the group consisting of alpha-, delta- and gamma-tocopherol and combinations and derivatives thereof, and a synergist selected from the group consisting of flavonoid and lactoferrin and combinations or derivatives thereof, wherein the tocopherol and the synergist are present in amounts effective to ameliorate said stress.  
     
     
         35 . The method according to  claim 34 , wherein the tocopherol is alpha-tocopherol.  
     
     
         36 . The method according to  claim 34 , wherein the tocopherol is delta-tocopherol.  
     
     
         37 . The method according to  claim 34 , wherein the tocopherol is gamma-tocopherol.  
     
     
         38 . The method according to  claim 34 , wherein the tocopherol is a combination of alpha- and gamma-tocopherol.  
     
     
         39 . The method according to  claim 34 , wherein the synergist is in the form of a pharmaceutically acceptable salt.  
     
     
         40 . The method according to  claim 34 , wherein the flavonoid is hesperetin.  
     
     
         41 . The method according to  claim 34 , wherein the flavonoid is diosmin.  
     
     
         42 . The method of  claim 34  wherein said flavonoid comprises a combination of hesperetin and quercetin.  
     
     
         43 . The method according to  claim 34 , wherein the flavonoid is lactoferrin.  
     
     
         44 . The method according to  claim 34 , wherein the stress is induced by an environmental alteration, chemical insult or physiological condition.  
     
     
         45 . The method of  claim 44 , where the environmental alteration is hypothermia, hyperthermia, hypoxia or ionizing radiation.  
     
     
         46 . The method of  claim 44 , where the chemical insult is drug toxicity, chemotherapy, exposure to at least one toxin or cell culture.  
     
     
         47 . The method of  claim 44 , where the physiological condition is physical exertion, aging, pre-surgical preparation or post-surgical conditions.  
     
     
         48 . The method of  claim 44 , wherein the subject is an individual.  
     
     
         49 . The method of  claim 48 , wherein the individual is a mammal.  
     
     
         50 . The method of  claim 49 , wherein the mammal is a human.

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