Method of making solanaceae fruit extracts

Abstract

Provided are methods of making an extract of fruit of the Solanaceae family wherein fruit is processed to optimise the platelet aggregation inhibiting activity of the extract. The methods involve preparing a start mix of homogenised fruit; separating a water soluble fraction from fruit solids; filtration of the water soluble fraction; and concentration of active agents in the filtration permeate. The invention also provides fruit extracts manufactured by such methods, and also fruit extracts containing glycosylated phenolic acid or a phenolic ester, or derivatives thereof; a glycosylated flavonoid; and a nucleoside. The extracts of the invention are useful as medicaments for the treatment or prevention of a medical condition characterised by inappropriate platelet aggregation. In particular, the medicaments may be of use in maintaining heart health by reducing platelet aggregation; benefiting the circulation; and/or normalizing or otherwise benefiting blood flow.

1 - 23 . (canceled) 
     
     
         24 . A substantially lycopene-free extract of fruit of the Solanaceae family comprising:
 (a) glycosylated phenolic acid or a phenolic ester, or derivatives thereof;   (b) a glycosylated flavonoid; and   (c) a nucleoside;   wherein the extract contains <1% sugars and contains >95% of the bioactive components (a), (b) and (c) that are contained in a start mix from which the extract is prepared.   
     
     
         25 . The substantially lycopene-free extract of  claim 24 , further comprising an excipient. 
     
     
         26 . The substantially lycopene-free extract of  claim 24  wherein the glycosylated phenolic acid or a phenolic ester is a glycosylated cinnamic acid or derivative thereof and may be selected from the group comprising Caffeoyl-4-O-quinic acid, Caffeoyl-4-O-glucoside, Coumaroyl-4-O-glycoside (gluc/gal) and Coumaroyl-4-O-glycoside (disaccharide). 
     
     
         27 . The substantially lycopene-free extract of  claim 24  wherein the glycosylated phenolic acid or a phenolic ester is selected from: Caffeic acid glucoside; p-Coumaric acid hexose/dihydrokaempferol hexose; Ferulic acid glycoside; and a p-Coumaric acid derivative. 
     
     
         28 . The substantially lycopene-free extract of  claim 24  wherein the glycosylated flavonoid is Quercetin-3-O-glucoside or Rutin. 
     
     
         29 . The substantially lycopene-free extract of  claim 24  wherein the nucleoside is selected from the group comprising AMP, Uridine, Adenosine, Guanosine or GMP. 
     
     
         30 . The substantially lycopene-free extract of  claim 24  formulated as a solution, suspension, syrup, tablet, capsule or lozenge. 
     
     
         31 . A dosage form of the substantially lycopene-free extract of  claim 24  comprising 10 -500 mg dry weight of the extract. 
     
     
         32 . The dosage form of  claim 31 , further comprising an excipient. 
     
     
         33 . The dosage form of  claim 31 , comprising between about 85 mgs and about 150 mg dry weight of the extract. 
     
     
         34 . A method for treating or inhibiting a medical condition characterised by inappropriate platelet aggregation comprising administering a substantially lycopene-free extract of tomato fruit to a subject in need thereof,
 wherein the substantially lycopene-free extract comprises:
 (a) glycosylated phenolic acid or a phenolic ester, or derivatives thereof; 
 (b) a glycosylated flavonoid; and 
 (c) a nucleoside; and 
   wherein the substantially lycopene-free extract contains <1% sugars and contains >95% of the bioactive components (a), (b) and (c) that are contained in a tomato fruit start mix from which the extract is prepared.   
     
     
         35 . The method of  claim 34 , wherein the treatment or inhibition of the medical condition characterised by inappropriate platelet aggregation is for a purpose selected from the group consisting of: maintaining heart health by reducing platelet aggregation; benefiting the circulation; and normalizing or otherwise benefiting blood flow. 
     
     
         36 . The method of  claim 35 , wherein the substantially lycopene-free extract:
 (a) reduces occurrence of a hypercoagulable or prothrombotic state;   (b) reduce development of atherosclerosis;   (c) reduces development of coronary disease;   (d) reduces development of restenosis following angioplasty and bypass procedures;   (e) treats coronary disease resulting from thrombo-embolic disorders;   reduces the risk of deep vein thrombosis;   (g) benefits the circulation to maintain good circulatory health; or   (h) maintains healthy blood flow in the cardiovascular system.   
     
     
         37 . An substantially lycopene free extract of fruit of the Solanaceae family having optimized platelet aggregation inhibiting activity made by a process, comprising:
 (a) preparing a start mix of homogenized fruit, wherein the start mix has a pH that does not exceed 5.5 and the start mix is held at a temperature that does not exceed 35° C.;   (b) separating a water soluble fraction from the start mix from insoluble solids of the start mix, wherein the water soluble fraction is obtained without raising the temperature of the fraction above 60° C.;   (c) filtering the water soluble fraction;   (d) removing free sugars from the filtered water soluble fraction with a food grade resin, wherein the resin adsorbs components from the fraction but does not adsorb free sugars, organic acids and salts, wherein the adsorbed components are recovered from the resin by elution with an ethanol/water mixture to provide a solution, and wherein ethanol is removed from the solution by evaporation under reduced pressure or by reverse osmosis; and   (e) concentrating the solution to provide the extract of fruit of the Solanaceae family, wherein the extract is a concentrated aqueous solution containing <1% sugar and >95% of bioactive components contained in the start mix.   
     
     
         38 . The substantially lycopene free extract of  claim 37 , wherein the browning index of the start mix does not exceed 0.4 AU at 4% solids. 
     
     
         39 . The substantially lycopene free extract of  claim 37 , wherein the sugars are removed by resin-mediated separation. 
     
     
         40 . The substantially lycopene free extract of  claim 37 , wherein the extract is further processed into a powder. 
     
     
         41 . The substantially lycopene free extract of  claim 37 , wherein the start mix is diluted and comprises less than 33% solids. 
     
     
         42 . The substantially lycopene free extract of  claim 37 , further comprising an excipient.