US2019224213A1PendingUtilityA1

Vaginal composition comprising a combination of estrogen and vitamin d

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Assignee: CHEMO RES S LPriority: Jul 22, 2016Filed: Jul 20, 2017Published: Jul 25, 2019
Est. expiryJul 22, 2036(~10 yrs left)· nominal 20-yr term from priority
Inventors:Enrico ColliDavid Archer
A61K 31/065A61K 9/02A61K 31/593A61P 15/02A61K 31/59A61K 31/565A61K 47/14A61K 9/0036A61K 9/0034
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Claims

Abstract

The invention relates to vaginal composition comprising a combination of estrogen and vitamin D or a vitamin D analog at a daily dosage delivery of (i) estrogen ranging from 1 μg to 100 μg estrogen of estradiol equivalent and (ii) vitamin D or analog ranging from 7.5 μg to 100 μg of vitamin D equivalent.

Claims

exact text as granted — not AI-modified
1 . A vaginal composition comprising a combination of estrogen and vitamin D or a vitamin D analog at a daily dosage delivery of (i) estrogen ranging from 1 μg to 100 μg estrogen or estradiol equivalent and (ii) vitamin D or analog ranging from 7.5 μg to 100 μg of vitamin D equivalent. 
     
     
         2 . The vaginal composition according to  claim 1 , wherein the daily dosage delivery of estrogen ranges from 1 μg to 10 μg. 
     
     
         3 . The vaginal composition according to  claim 1  wherein the said composition has a liquid, solid or semi-solid presentation. 
     
     
         4 . The vaginal composition according to  claim 1  wherein said vaginal composition is a cream or a gel composition. 
     
     
         5 . The vaginal composition according to  claim 1  presented as daily unit dosage form of a suppository. 
     
     
         6 . The vaginal composition according to  claim 5 , wherein the suppository is selected from a group consisting of a capsule, an ovule and a tablet. 
     
     
         7 . The vaginal composition according to  claim 1  which is comprised in a delivery device selected from the group consisting of a transmucosal device and a vaginal ring. 
     
     
         8 . The vaginal composition according to  claim 1  wherein the said estrogen is selected from the group consisting of, estradiol valerate, estradiol benzoate, estradiol 17β-cypionate, estradiol dipropionate, estradiol enanthate, estropipate, equilenin, equilin, estriol, estriol succinate, estrone, ethinyl estradiol, estetrol, quinestrol, quinestranol, conjugated estrogens, esterified estrogens, and mixtures thereof. 
     
     
         9 . The vaginal composition according to  claim 1  wherein the said estrogen is estradiol or a derivative thereof. 
     
     
         10 . The vaginal composition according to  claim 1  wherein the vitamin D analog is selected from the group consisting of cholecalciferol, ergocalciferol, paricalcitol, doxercalciferol, dihydrotachysterol and derivatives thereof. 
     
     
         11 . The vaginal composition according to  claim 1  wherein the vitamin D analog is selected from the group consisting of calcitriol and calcipotriol. 
     
     
         12 . The vaginal composition according to  claim 1  comprising a combination of estradiol and calcitriol at a daily dosage delivery of (i) estradiol ranging from 1 μg to 10 μg and (ii) calcitriol ranging from 0.075 μg to 1 μg. 
     
     
         13 . A method, comprising providing to the vagina of a subject a combination of estrogen and vitamin D or vitamin D analog at a daily dosage delivery of (i) estrogen ranging from 1 μg to 100 μg estrogen or estradiol equivalent and (ii) vitamin D or analog ranging from 7.5 μg to 100 μg of vitamin D equivalent. 
     
     
         14 . The method of  claim 13 , wherein the daily dosage delivery of estrogen ranges from 1 μg to 10 μg. 
     
     
         15 . The method of  claim 13  wherein the providing is sufficient for treating vaginal atrophy. 
     
     
         16 . The method of  claim 15 , wherein the daily dosage delivery of estrogen ranges from 1 μg to 10 μg. 
     
     
         17 . A method, comprising providing to the vagina of a subject a combination of estradiol and calcitriol at a daily dosage delivery of (i) estradiol ranging from 1 μg to 100 μg and (ii) calcitriol ranging from 0.075 μg to 1 μg. 
     
     
         18 . The method of  claim 17 , wherein the daily dosage delivery of estrogen ranges from 1 μg to 10 μg. 
     
     
         19 . The method of  claim 17  wherein the providing is sufficient for treating vaginal atrophy. 
     
     
         20 . The method of  claim 19 , wherein the daily dosage delivery of estrogen ranges from 1 μg to 10 μg.

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