Compositions and methods useful in treatment of lower urinary tract symptoms, benign prostatic hyperplasia, erectile dysfunction

Abstract

The invention relates to therapeutic compositions, solid oral dosage forms, and methods for treating, preventing, or alleviating lower urinary tract symptoms (LUTS), benign prostatic hyperplasia (BPH), erectile dysfunction (ED), urinary incontinence, bladder obstruction, overactive bladder (OAB), underactive bladder, interstitial cystitis, prostatitis, bladder and prostate inflammation, prostate fibrosis or pelvic pain. The therapeutic compositions can comprise cranberry powder enriched in cranberry seeds or cranberry seed meal.

1 . A therapeutic composition comprising dried cranberry powder and dried cranberry seeds. 
     
     
         2 . A therapeutic composition comprising dried cranberry powder and cranberry seed meal. 
     
     
         3 . The composition of  claim 1  or  2 , wherein the cranberry is  Vaccinium macrocarpon.    
     
     
         4 . The composition of  claim 1  or  2 , wherein the cranberry is  Vaccinium microcarpon.    
     
     
         5 . The composition of  claim 1  or  2 , wherein the cranberry is  Vaccinium oxycoccus.    
     
     
         6 . The composition of  claim 1 , wherein the cranberry seeds are present in an amount of about 5% to about 50% by weight of the dried cranberry powder. 
     
     
         7 . The composition of  claim 6 , wherein the cranberry seeds are present in an amount of about 15% to about 25% by weight of the dried cranberry powder. 
     
     
         8 . The composition of  claim 7 , wherein the cranberry seeds are present in an amount of about 20% by weight of the dried cranberry powder. 
     
     
         9 . The composition of  claim 2 , wherein the cranberry seed meal is present in an amount of about 5% to about 50% by weight of the dried cranberry powder. 
     
     
         10 . The composition of  claim 9 , wherein the cranberry seed meal is present in an amount of about 15% to about 25% by weight of the dried cranberry powder. 
     
     
         11 . The composition of  claim 10 , wherein the cranberry seed meal is present in an amount of about 20% by weight of the dried cranberry powder. 
     
     
         12 . The composition of  claim 1  or  2 , wherein the composition comprises less than about 12% of organic acids by weight. 
     
     
         13 . The composition of  claim 1  or  2 , wherein the composition comprises less than 10% of organic acids by weight. 
     
     
         14 . The composition of  claim 1  or  2 , wherein the composition comprises about 5% to about 8% of organic acids by weight. 
     
     
         15 . The composition of  claim 1  or  2 , wherein the composition comprises less than about 15% of sugars by weight. 
     
     
         16 . The composition of  claim 15 , wherein the composition comprises less than about 12% of sugars by weight. 
     
     
         17 . The composition of  claim 1  or  2 , wherein the composition comprises from about 1% to about 5% of quinic acid by weight. 
     
     
         18 . The composition of  claim 17 , wherein the composition comprises from about 2.2% to about 3.2% of quinic acid by weight. 
     
     
         19 . The composition of  claim 1  or  2 , wherein the composition comprises from about 0.4% to about 4% of malic acid by weight. 
     
     
         20 . The composition of  claim 19 , wherein the composition comprises from about 0.8% to about 1.8% of malic acid by weight. 
     
     
         21 . The composition of  claim 1  or  2 , wherein the composition comprises from about 1% to about 5% of citric acid by weight. 
     
     
         22 . The composition of  claim 21 , wherein the composition comprises from about 1.8% to about 3.2% of citric acid by weight. 
     
     
         23 . The composition of  claim 1  or  2 , wherein the composition comprises: 0.5% to 5.0% proanthocyanidins, 0.05% to 1.5% quercetin, 0.001% to 0.1% quercetin-3-glucoside, 0.001% to 0.1% quercetin-3-rhamnoside, 0.001% to 0.1% quercetin-3-xyloside, 0.001% to 0.1% quercetin-3-arabinoside, 0.001% to 0.5% myricetin, 0.001% to 0.1% peonidin-3-galactoside, 0.001% to 0.1% peonidin-3-glucoside, 0.001% to 0.1% peonidin-3-arabinoside, 0.001% to 0.1% cyanidin-3-glucoside, 0.001% to 0.1% cyanidin-3-galactoside, 0.001% to 0.1% cyanidin-3-arabinoside, 0.001% to 0.1% protocatechuic acid 0.001% to 0.1% p-coumaric acid, 0.001% to 0.1% caffeoyl-glucoside, 0.001% to 0.1% coumaroyl-glucoside, 0.001% to 0.1% cafeic acid, 0.001% to 0.1% chlorogenic acid or 0.01 to 1.5% ursolic acid by weight. 
     
     
         24 . The composition of  claim 23 , wherein the composition comprises: 1.0% to 1.2% proanthocyanidins, 0.16% to 0.20% quercetin, 0.07% to 0.09% quercetin-3-glucoside, 0.03% to 0.04% quercetin-3-rhamnoside, 0.019% to 0.025% quercetin-3-xyloside, 0.025% to 0.035% quercetin-3-arabinoside, 0.010% to 0.014% myricetin, 0.022% to 0.030% peonidin-3-galactoside, 0.0025% to 0.0035% peonidin-3-glucoside, 0.010% to 0.020% peonidin-3-arabinoside, 0.0005% to 0.0015% cyanidin-3-glucoside, 0.015% to 0.030% cyanidin-3-galactoside, 0.010% to 0.025% cyanidin-3-arabinoside, 0.019% to 0.025% protocatechuic acid, 0.04% to 0.06% p-coumaric acid, 0.015% to 0.025% caffeoyl-glucoside, 0.005% to 0.015% coumaroyl-glucoside, 0.010% to 0.015% cafeic acid or 0.030% to 0.04% chlorogenic acid by weight. 
     
     
         25 . The composition of  claim 24 , wherein the composition comprises about: 1.1% proanthocyanidins, 0.18% quercetin, 0.083% quercetin-3-glucoside, 0.034% quercetin-3-rhamnoside, 0.022% quercetin-3-xyloside, 0.030% quercetin-3-arabinoside, 0.012% myricetin, 0.027% peonidin-3-galactoside, 0.003% peonidin-3-glucoside, 0.014% peonidin-3-arabinoside, 0.001% cyanidin-3-glucoside, 0.022% cyanidin-3-galactoside, 0.018% cyanidin-3-arabinoside, 0.022% protocatechuic acid, 0.052% p-coumaric acid, 0.021% caffeoyl-glucoside, 0.011% coumaroyl-glucoside, 0.014% cafeic acid, 0.034% chlorogenic acid or 0.92% ursolic acid by weight. 
     
     
         26 . The composition of  claim 1  or  2 , wherein the composition comprises 1 to 100 μg lariciresinol, 1 to 100 μg secoisolariciresinol or 1 to 100 μg/pinoresinol per 100 g of the composition by weight. 
     
     
         27 . The composition of  claim 26 , wherein the composition comprises about 51 μg lariciresinol, about 12 μg secoisolariciresinol or about 78 μg/pinoresinol per 100 g of the composition by weight. 
     
     
         28 . A solid oral dosage comprising the therapeutic composition of  claim 1  or  2 . 
     
     
         29 . The solid oral dosage of  claim 28  which is a tablet. 
     
     
         30 . The solid oral dosage of  claim 28  which is a capsule. 
     
     
         31 . The solid oral dosage of  claim 28  which is a softgel. 
     
     
         32 . The solid oral dosage of  claim 30  comprising 100 mg to 500 mg of the therapeutic composition. 
     
     
         33 . The solid oral dosage of  claim 32  comprising 250 mg of the therapeutic composition. 
     
     
         34 . The solid oral dosage of  claim 32  comprising 500 mg of the therapeutic composition. 
     
     
         35 . A method for alleviating lower urinary tract symptoms (LUTS) in a subject comprising administering to the subject in need thereof an effective amount of the composition of  claim 1  or  2 . 
     
     
         36 . A method for alleviating the symptoms of benign prostatic hyperplasia (BPH) in a subject comprising administering to the subject in need thereof an effective amount of the composition of  claim 1  or  2 . 
     
     
         37 . A method for treating erectile dysfunction (ED) in a subject comprising administering to the subject in need thereof an effective amount of the composition of  claim 1  or  2 . 
     
     
         38 . A method for treating urinary incontinence in a subject comprising administering to the subject in need thereof an effective amount of the composition of  claim 1  or  2 . 
     
     
         39 . A method for treating overactive bladder (OAB) in a subject comprising administering to the subject in need thereof an effective amount of the composition of  claim 1  or  2 . 
     
     
         40 . A method for treating bladder obstruction, interstitial cystitis, underactive bladder, prostatitis, bladder and prostate inflammation, prostate fibrosis or pelvic pain in a subject comprising administering to the subject in need thereof an effective amount of the composition of  claim 1  or  2 . 
     
     
         41 - 43 . (canceled)