US2016129041A1PendingUtilityA1
Topical formulations for the prevention of sexually transmitted disease and methods of producing the same
Est. expirySep 28, 2026(~0.2 yrs left)· nominal 20-yr term from priority
A61P 31/04A61P 31/00A61P 31/12A61Q 17/00A61K 8/925A61K 31/765A61K 9/0034A61K 8/86A61K 8/416A61K 8/27A61K 8/342A61K 9/107A61Q 19/00A61K 31/80A61K 9/7015A61K 8/345A61K 9/0014A61K 8/44A61K 9/06A61K 31/045A61K 33/30A61K 8/891
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Claims
Abstract
The present invention is directed towards various topical protective formulations which may be used as an adjunct in preventing the spread of a broad range of sexually transmitted diseases. The product is intended to be used as a topical lotion, cream, emulsion, or the like. The film forming excipients and active ingredients in the following formulations have demonstrated unique skin protective barrier properties with enhanced persistence that inhibits transmission of sexually transmitted diseases.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . An oil-in-water formulation for the prevention of sexually transmitted diseases, characterized by enhanced skin protective properties comprising in combination:
(1) a skin protectant composition provided in a skin protecting effective concentration; (2) a silicone-based skin protectant composition provided in a skin protecting effective concentration; (3) a humectant-excipient, in the range of about 0.5 to 15.0% wt/wt; (4) a non-ionic emulsifier in the range from about0.5 to 15.0% w/w; (5) a chelating compound in the range from about 0.1 to 0.01% w/w; (6) a quaternary ammonium salt in the range from about 0.01 to 0.25% w/w; (7) a film-forming emollient in the range from about 1.0 to 10.0% w/w; and (8) water; wherein contact with the skin results in the in situ formation of a skin protective barrier layer effective in preventing transmission of sexually transmitted diseases.
2 . The formulation of claim 1 , wherein said emulsifier is cetearyl alcohol, ceteareth-20 or a mixture thereof.
3 . The formulation of claim 1 , wherein said emulsifier is ceteareth-12.
4 . The formulation of claim 1 , wherein said emulsifier is a mixture of cetearyl alcohol and ceteareth-20 and co-emulsifier ceteareth-12.
5 . The formulation of claim 1 wherein said skin protectant is zinc oxide.
6 . The formulation of claim 1 wherein said humectant-excipient is glycerin.
7 . The formulation of claim 1 wherein said humectant-excipient is anhydrous lanolin.
8 . The formulation of claim 1 wherein said humectant-excipient is a combination of glycerin and anhydrous lanolin.
9 . The formulation of claim 1 wherein said silicone-based skin protectant is dimethicone 20.
10 . The formulation of claim 1 wherein said silicone-based skin protectant is dimethicone 12500.
11 . The formulation of claim 1 wherein said silicone-based skin protectant is a combination of dimethicone 20 and dimethicone 12500.
12 . The formulation of claim 1 , wherein said film-forming emollient is cetostearyl alcohol.
13 . The formulation of claim 1 , wherein said film-forming emollient is cetyl alcohol.
14 . The formulation of claim 1 , wherein said film-forming emollient is a combination of cetostearyl alcohol and cetyl alcohol.
15 . The formulation of claim 1 , wherein said chelating compound is disodium edetate.
16 . The formulation of claim 1 , wherein said quaternary ammonium salt is benzalkonium chloride.
17 . The formulation of claim 1 , wherein said quaternary ammonium salt is cetrimide.
18 . The formulation of claim 1 , wherein said formulation is in the form of a cream.
19 . The formulation of claim 1 , wherein said formulation is in the form of a lotion.
20 . An oil-in-water cream for the prevention of sexually transmitted diseases, characterized by enhanced skin protective properties comprising in combination:
(1) Dimethicone 20, in the range of 10.0 to 20.0% wt/wt; (2) Dimethicone 12500, in the range of 3.0-10.0% wt/wt; (3) Zinc oxide, in the range of 1.0 to 8.0% wt/wt; (4) a mixture of Cetearyl alcohol and Ceteareth-20, in the range of 6.0 to 10.0% wt/wt; (5) Glycerin, in the range of 2.0 to 10.0% wt/wt; (6) Ceteareth-12, in the range of 0.5 to 3.0% wt/wt; (7) disodium edetate, in the range of 0.01 to 0.1% wt/wt; (8) Benzalkonium Chloride, in the range of 0.01 to 0.25% wt/wt; (9) Anhydrous lanolin, in the range of 0.5 to 3.0% wt/wt; (10) Cetostearyl alcohol, in the range of 1.0 to 5.0% wt/wt; (11) Cetyl alcohol, in the range of 1.0 to 5.0% wt/wt; and (12) a sufficient quantity of deionized water to form the cream; wherein contact with the skin results in the in situ formation of a skin protective barrier layer.
21 . An oil-in-water cream for the prevention of sexually transmitted diseases, characterized by enhanced skin protective properties comprising in combination:
(1) Dimethicone 20, at about 15.0% wt/wt; (2) Dimethicone 12500, at about 5.0% wt/wt; (3) Zinc oxide, at about 2.0% wt/wt; (4) a mixture of Cetearyl alcohol and Ceteareth-20, at about 8.0% wt/wt; (5) Glycerin, at about 5.0% wt/wt; (6) Ceteareth-12, at about 1.0% wt/wt; (7) disodium edetate, at about 0.05% wt/wt; (8) Benzalkonium Chloride, at about 0.2% wt/wt; (9) Anhydrous lanolin, at about 1.0% wt/wt; (10) Cetostearyl alcohol, at about 3.0% wt/wt; (11) Cetyl alcohol, at about 2.0% wt/wt; and (12) a sufficient quantity of deionized water to form the cream; wherein contact with the skin results in the in situ formation of a skin protective barrier layer.
22 . An oil-in-water cream for the prevention of sexually transmitted diseases, characterized by enhanced skin protective properties comprising in combination:
(1) Dimethicone 20, at about 15.0% wt/wt; (2) Dimethicone 12500, at about 5.0% wt/wt; (3) Zinc oxide, at about 5.0% wt/wt; (4) a mixture of Cetearyl alcohol and Ceteareth-20, at about 7.0% wt/wt; (5) Glycerin, at about 8.0% wt/wt; (6) Ceteareth-12, at about 1.0% wt/wt; (7) disodium edetate, at about 0.05% wt/wt; (8) Benzalkonium Chloride, at about 0.2% wt/wt; (9) Anhydrous lanolin, at about 1.0% wt/wt; (10) Cetostearyl alcohol, at about 3.0% wt/wt; (11) Cetyl alcohol, at about 2.0% wt/wt; and (12) a sufficient quantity of deionized water to form the cream; wherein contact with the skin results in the in situ formation of a skin protective barrier layer.
23 . An oil-in-water formulation for the prevention of sexually transmitted diseases, characterized by enhanced skin protective properties comprising in combination the following ingredients in % w/w:
a water phase including
(1)
DEIONIZED WATER (USP) in quantities sufficient to
dissolve ingredients 2-5;
(2)
DISODIUM EDETATE
0.01-0.1
(3)
BENZALKONIUM CHLORIDE
0.01-0.25
(4)
ZINC OXIDE
1.0-8.0
(5)
GLYCERIN (USP)
2.0-10.0
and an oil phase including
(6)
DIMETHICONE 20
10.0-20.0
(7)
DIMETHICONE 12500
3.0-10.0
(8)
CETEARYL ALCOHOL and/or CETEARETH-20
6.0-10.0
(9)
CETEARETH-12
0.5-3.0
(10)
ANYHDROUS LANOLIN
0.5-3.0
(11)
CETOSTEARYL ALCHOHOL
1.0-5.0
(12)
CETYL ALCOHOL
1.0-5.0
24 . A process for forming an oil-in-water cream comprising:
a water phase including (in % w/w)
(1)
Deionized Water (USP) in quantities sufficient to
incorporate therein ingredients 2-5;
(2)
Disodium Edetate
0.01-0.1
(3)
Benzalkonium Chloride
0.01-0.25
(4)
Zinc Oxide
1.0-8.0
(5)
Glycerin (USP)
2.0-10.0
and an oil phase including (in % w/w)
(6)
Dimethicone 20
10.0-20.0
(7)
Dimethicone 12500
3.0-10.0
(8)
Cetearyl Alcohol And/Or Ceteareth-20
6.0-10.0
(9)
Ceteareth-12
0.5-3.0
(10)
Anyhdrous Lanolin
0.5-3.0
(11)
Cetostearyl Alcohol
1.0-5.0
(12)
Cetyl Alcohol
1.0-5.0
wherein said oil-in-water cream is produced in accordance with the following steps:
1. heating to 75° C. Dimethicone 20, Dimethicone 12500, Cetearyl Alcohol, Ceteareth-20, Ceteareth-12, Anhydrous Lanolin, Cetostearyl Alcohol and Cetyl Alcohol to allow the materials to melt;
2. dissolving Disodium Edetate in the deionized water;
3. Adding Benzalkonium Chloride to Step #2;
4. Heating Step #3 to 75-78° C.;
5. Dispersing the Zinc Oxide in the Glycerin to form a homogeneous dispersion;
6. With high speed mixing, slowly adding the materials from Step #4 (Water phase) to the materials from Step #1 (Oil phase) and initiating cooling;
7. When at 60° C.; adding the dispersion from Step#5 to the materials from Step #6;
8. When at 50° C., reduce mixing speed;
9. When at 40° C., further reduce the mixing speed;
10. When at 25° C. stop mixing.Join the waitlist — get patent alerts
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