US2005239714A1PendingUtilityA1

Compositions and methods for treating female sexual arousal disorder using hydrophobic-calcitonin gene related peptide

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Individually held — no corporate assignee on recordPriority: Jan 8, 2002Filed: Oct 21, 2004Published: Oct 27, 2005
Est. expiryJan 8, 2022(expired)· nominal 20-yr term from priority
Inventors:Jeffrey L. SouthardGerald L. YeweyGary J. Rosenthal
A61K 38/23A61K 9/0034
61
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Claims

Abstract

The present invention provides a method and composition for the treatment of Female Sexual Arousal Disorder. Calcitonin gene-related peptide, a naturally occurring substance in the human body, is chemically conjugated to a hydrophobic agent thereby increasing its permeability across the skin membrane. When locally applied to female genitalia localized blood flow is promoted thus resulting in increased sexual arousal.

Claims

exact text as granted — not AI-modified
1 - 16 . (canceled)  
   
   
       17 . A method of decreasing the refractory time, following ejaculation, in males by delivering a CGRP releasing substance selected from a member of the group consisting of hydrophobic-CGRP comprising the step of topically administering to the ventral surface of the penis a delivery vehicle for the substance, said delivery vehicle containing an effective amount of the substance, sufficient to migrate from the delivery vehicle to the skin where the substance is absorbed by the surrounding tissue.  
   
   
       18 . The method of  claim 17 , wherein said hydrophobic-CGRP is CGRP-linolenic acid.  
   
   
       19 . The method of  claim 17 , wherein said hydrophobic-CGRP is Boc-[[(alaninyloxy)methyl]-carbonyl]-N-tryptophan benzyl ester.  
   
   
       20 . The method of  claim 17 , wherein said delivery vehicle is selected from the group consisting of creams, gels, ointments, oils or sprays containing the hydrophobic-CGRP is topically administered to the body.  
   
   
       21 . The method of  claim 20 , wherein the delivery vehicle comprising CGRP-linolenic acid in the range of 1-50 μg/dose is administered.  
   
   
       22 . The method of  claim 19 , wherein the delivery vehicle comprising Boc-[[(alaninyloxy)methyl]-carbonyl]-N-tryptophan benzyl ester in the range of 1-50 μg/dose is administered.  
   
   
       23 . The method of  claim 17 , wherein a delivery vehicle that is topically administered comprises CGRP-linolenic acid (0.0004-0.005%), L-Arginine (0-5%), L-Valine (0-5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       24 . The method of  claim 23 , wherein the delivery vehicle is any combination of water, glycerine, cocoa butter, polyglycerylmethacrylate, methylparaben, carboxymethylcellulose, hydroxymethylcellulose, silicone, waxes, petroleum jelly, polyethylene glycol, propylene glycol, liposomes, transfersomes, vitamin E, or sugars.  
   
   
       25 . The method of claim  8 , wherein the delivery vehicle further comprises permeation enhancers.  
   
   
       26 . The method of claim  10 , wherein said permeation enhancers are selected from the following, dimethylsulfoxide (DMSO), dimethyl formamide (DMF), N,N-dimethyl-acetamide (DMA), decylmethylsulfoxide (C10MSO), polyethylene glycol monolaurate (PEGML), glyceral monolaurate, lecithin, 1-substituted azacycloheptan-2-ones, L-Arginine, L-Valine, vitamin E, particularly 1-N-dodecylcyclazacylcoheptan-2-ones.  
   
   
       27 . The method of claim  1 , wherein a delivery vehicle that is topically administered comprises Boc-[[(alaninyloxy)methyl]-carbonyl]-N-tryptophan benzyl ester (0.0004-0.005%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and Crataegus pinnatifidia (0-≦10%).  
   
   
       28 . The method of claim  12 , wherein the delivery vehicle is any combination of water, glycerine, cocoa butter, polyglycerylmethacrylate, methylparaben, carboxymethylcellulose, hydroxymethylcellulose, silicone, waxes, petroleum jelly, polyethylene glycol, propylene glycol, liposomes, transfersomes, vitamin E, or sugars.  
   
   
       29 . The method of claim  12 , wherein the delivery vehicle further comprises permeation enhancers.  
   
   
       30 . The method of claim  14 , wherein said permeation enhancers are selected from the following, dimethylsulfoxide (DMSO), dimethyl formamide (DMF), N,N-dimethyl-acetamide (DMA), decylmethylsulfoxide (C10MSO), polyethylene glycol monolaurate (PEGML), glyceral monolaurate, lecithin, 1-substituted azacycloheptan-2-ones, L-arginine, L-Valine, vitamin E, particularly 1-N-dodecylcyclazacylcoheptan-2-ones.  
   
   
       31 . The method of claim  1 , wherein said hydrophobic-CGRP is CGRP, CGRP analogues and polypeptides containing the active site of CGRP.  
   
   
       32 . A composition comprising a delivery vehicle, Boc-[[(alaninyloxy)methyl]-carbonyl]-N-tryptophan benzyl ester (0.0004-0.005%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       33 . A composition comprising a delivery vehicle, CGRP-linolenic acid (0.0004-0.005%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       34 . A composition comprising a delivery vehicle, Boc-[[(alaninyloxy)methyl]-carbonyl]-N-tryptophan benzyl ester (0.0004-0.005%), PGE1 (0.001-0.05%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       35 . A composition comprising a delivery vehicle, CGRP-linolenic acid (0.0004-0.005%), PGE1 (0.001-0.05%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦1 0%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       36 . A composition comprising a delivery vehicle, Boc-[[(alaninyloxy)methyl]-carbonyl]-N-tryptophan benzyl ester (0.0004-0.005%), Yohimbine (1-5%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       37 . A composition comprising a delivery vehicle, CGRP-linolenic acid (0.0004-0.005%), Yohimbine (1-5%), L-Arginine (0-≦5%), L-Valine (0-≦5%), vitamin E (9-99.99%), cinnamon oil (0-≦5%), ginger oil (0-≦5%), peppermint oil (0-≦5%),  Gynostemma pentaphyllum  (0-≦10%) and  Crataegus pinnatifidia  (0-≦10%).  
   
   
       38 . A pharmaceutical kit comprising, a predetermined quantity of hydrophobic-CGRP and an applicator.  
   
   
       39 . A pharmaceutical kit comprising an applicator having at least two distinct chambers wherein said first chamber comprises a predetermined quantity of hydrophobic-CGRP, and said second chamber comprises a predetermined quantity of a delivery vehicle such that when said hydrophobic-CGRP and said delivery vehicle are dispensed said hydrophobic-CGRP and said delivery vehicle are also mixed.  
   
   
       40 . The method of  claim 29 , wherein permeation enhancers comprise block copolymers.  
   
   
       41 . The method of  claim 40 , wherein said block copolymer is ethylene oxide and propylene.  
   
   
       42 . The method of  claim 40 , wherein said block copolymer is pluronics L61 or P85 having different hydrophobicity.

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