US2015110856A1PendingUtilityA1
Testosterone formulations
Est. expiryJan 26, 2031(~4.5 yrs left)· nominal 20-yr term from priority
A61P 5/26A61P 5/00A61P 5/30A61P 25/24A61P 3/02A61P 19/10A61P 15/00A61P 15/08A61P 21/00A61P 15/10A61K 31/58A61K 9/0014A61K 31/568A61K 47/10A61K 47/18A61K 9/70A61K 47/32A61K 9/06A61K 47/183A61K 9/107A61K 9/10
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Claims
Abstract
The subject invention provides improved testosterone gel formulations.
Claims
exact text as granted — not AI-modified1 . A transdermal or transmucosal formulation comprising:
1-2% wt of testosterone, at least one C 2 to C 4 alkanol, 15-30% wt polyalcohol, and monoalkyl ether of diethylene glycol,
wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
2 . The transdermal or transmucosal formulation according to claim 1 , further comprising at least one of:
gelling agent, neutralizing agent, chelating agent and solvent
or any combinations thereof.
3 . The formulation of claim 2 , wherein the alkanol is present in an amount between about 5-50% wt, the gelling agent is present in an amount between about 0.05-4% wt, the neutralizing agent is present in an amount between about 0.05-1% wt, and the chelating agent is present in an amount between about 0.001-5.0% wt. and further comprising a permeation enhancer resent in an amount of between about 0.2-25% wt.
4 . The formulation of claim 1 , wherein the at least one alkanol is chosen from ethanol, isopropanol, n-propanol, and combinations thereof.
5 . The formulation of claim 1 , wherein the at least one alkanol is ethanol.
6 . The formulation of claim 1 , wherein the at least one alkanol is ethanol, present in an amount of about 44.0% wt.
7 . The formulation of claim 1 , wherein the polyalcohol is propylene glycol.
8 . The formulation of claim 7 , wherein the propylene glycol is present in an amount of about 20.0% wt.
9 . The formulation of claim 1 , wherein the monoalkyl ether of diethylene glycol is chosen from diethylene glycol monoethyl ether, diethylene glycol monomethyl ether, and combinations thereof.
10 . The formulation of claim 9 , wherein diethylene glycol monoethyl ether is present in an amount of 5.0% wt.
11 . The formulation of claim 2 , wherein the gelling agent is carbomer.
12 . The formulation of claim 11 , wherein the carbomer is present in an amount of 1.20% wt.
13 . The formulation of claim 2 , wherein the gelling agent is poly(acrylic acid), present in an amount of 1.20% wt.
14 . The formulation of claim 2 , wherein the neutralizing agent is triethanolamine.
15 . The formulation of claim 14 , wherein the triethanolamine is present in an amount of 0.35% wt.
16 . The formulation of claim 2 , wherein the chelating agent is edetate disodium.
17 . The formulation of claim 16 , wherein the edetate disodium is present in an amount of 0.06% wt.
18 . The formulation of claim 2 , wherein the solvent is water.
19 . (canceled)
20 . (canceled)
21 . (canceled)
22 . The formulation of claim 1 , wherein the formulation is in a form chosen from a gel, lotion, cream, spray, aerosol, ointment, emulsion, suspension, liposomal system, lacquer, patch, bandage, buccal tablet, sublingual tablet, suppository, vaginal dosage form and occlusive dressing.
23 . The formulation of claim 22 , wherein the form is a gel.
24 . The formulation of claim 1 , wherein the formulation is adapted for transdermal or transmucosal administration according to a schedule having a periodicity chosen from once to five times daily dosing, once-weekly dosing and bi-weekly dosing.
25 . The formulation of claim 1 , wherein the formulation is adapted for a once daily transdermal or transmucosal administration.
26 . The formulation of claim 1 , wherein the formulation is adapted for a once daily transdermal or transmucosal administration to the abdomen of a mammal in need thereof.
27 . The formulation of claim 1 , wherein the formulation is adapted for a once daily transdermal or transmucosal administration to the upper arm of a mammal in need thereof.
28 . A method for administering testosterone to a mammal in need thereof comprising:
transdermally administering to a skin or mucosal membrane of a mammal a formulation comprising:
1-2% wt of testosterone,
at least one C 2 to C 4 alkanol,
15-30% wt polyalcohol, and
monoalkyl ether of diethylene glycol,
wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
29 . A method of treating a disease or disorder associated with reduced endogenous testosterone production comprising:
transdermally administering to a skin or mucosal membrane of a mammal a formulation comprising:
1-2% wt of testosterone,
at least one C 2 to C 4 alkanol,
15-30% wt polyalcohol, and
monoalkyl ether of diethylene glycol,
wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.
30 . The method according to claim 28 or 29 , wherein the mammal is a male.
31 . (canceled)
32 . (canceled)
33 . (canceled)
34 . (canceled)
35 . The method according to claim 29 , wherein the disease or disorder associated with reduced endogenous testosterone production is hypogonadism.
36 . The method according to claim 29 , further comprising administering another treatment.
37 . A kit comprising at least one container comprising a formulation comprising: 1-2% wt of testosterone, at least one C 2 to C 4 alkanol, 15-30% wt polyalcohol, and monoalkyl ether of diethylene glycol, wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters, and instructions for use thereof.
38 . The kit according to claim 37 , wherein said container is adapted for dispensing a predetermined measured amount of the formulation.Join the waitlist — get patent alerts
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