US2016129042A1PendingUtilityA1
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
A61K 8/86A61K 8/416A61P 15/00A61K 9/7015A61K 9/107A61K 31/80A61Q 19/00A61K 8/891A61Q 17/00A61K 9/0014A61K 33/30A61K 8/925A61K 8/345A61K 9/0034A61K 8/342A61K 31/765A61K 8/27A61K 8/44A61K 9/06
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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 cream for the inhibition of the transmission of sexually transmitted diseases, characterized by enhanced skin protective properties consisting of 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) Anhydrous lanolin, in the range of 0.5 to 3.0% wt/wt; (9) Cetostearyl alcohol, in the range of 1.0 to 5.0% wt/wt; (10) Cetyl alcohol, in the range of 1.0 to 5.0% wt/wt; and (11) 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.
2 . An oil-in-water cream for the inhibition of the transmission of sexually transmitted diseases, characterized by enhanced skin protective properties consisting of 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) Anhydrous lanolin, at about 1.0% wt/wt; (9) Cetostearyl alcohol, at about 3.0% wt/wt; (10) Cetyl alcohol, at about 2.0% wt/wt; and (11) 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.
3 . An oil-in-water cream for the inhibition of the transmission of sexually transmitted diseases, characterized by enhanced skin protective properties consisting of 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) Anhydrous lanolin, at about 1.0% wt/wt;
(9) Cetostearyl alcohol, at about 3.0% wt/wt; (10) Cetyl alcohol, at about 2.0% wt/wt; and (11) 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.
4 . An oil-in-water formulation for the inhibition of the transmission of sexually transmitted diseases, characterized by enhanced skin protective properties consisting of in combination the following ingredients in % w/w:
a water phase consisting of
(1) DEIONIZED WATER (USP) in quantities sufficient to
dissolve ingredients 2-4;
(2) DISODIUM EDETATE
0.01-0.1
(3) ZINC OXIDE
1.0-8.0
(4) GLYCERIN (USP)
2.0-10.0
and an oil phase consisting of
(5) DIMETHICONE 20
10.0-20.0
(6) DIMETHICONE 12500
3.0-10.0
(7) CETEARYL ALCOHOL and/or CETEARETH-20
6.0-10.0
(8) CETEARETH-12
0.5-3.0
(9) ANYHDROUS LANOLIN
0.5-3.0
(10) CETOSTEARYL ALCOHOL
1.0-5.0
(11) CETYL ALCOHOL
1.0-5.0
5 . A process for forming an oil-in-water cream consisting of:
a water phase consisting of (in % w/w)
(a) Deionized Water (USP) in quantities sufficient to
incorporate therein ingredients b-d;
(b) Disodium Edetate
0.01-0.1
(c) Zinc Oxide
1.0-8.0
(d) Glycerin (USP)
2.0-10.0
and an oil phase consisting of (in % w/w)
(e) Dimethicone 20
10.0-20.0
(f) Dimethicone 12500
3.0-10.0
(g) Cetearyl Alcohol And/or Ceteareth-20
6.0-10.0
(h) Ceteareth-12
0.5-3.0
(i) Anyhdrous Lanolin
0.5-3.0
(j) Cetostearyl Alcohol
1.0-5.0
(k) 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. Heating Step #2 to 75-78° C.;
4. Dispersing the Zinc Oxide in the Glycerin to form a homogeneous dispersion;
5. With high speed mixing, slowly adding the materials from Step #3 (Water phase) to the materials from Step #1 (Oil phase) and initiating cooling;
6. When at 60° C.; adding the dispersion from Step#4 to the materials from Step #5;
7. When at 50° C., reduce mixing speed;
8. When at 40° C., further reduce the mixing speed;
9. When at 25° C. stop mixing.
6 . An oil-in-water formulation for the inhibition of the transmission of sexually transmitted diseases, characterized by enhanced skin protective properties comprising in combination:
(1) a skin protectant composition selected from the group consisting of Allantoin, Aluminum hydroxide gel, Calamine, Cocoa Butter, Cod Liver Oil, Colloidal Oatmeal, Hard Fat, Kaolin, Mineral Oil, Petrolatum, Topical Starch, White Petrolatum, Zinc Acetate, Zinc Carbonate, Zinc Oxide, and mixtures thereof, provided in a skin protecting effective concentration; (2) a silicone-based skin protectant composition containing at least one silicone-containing excipient provided in a skin protecting effective concentration; (3) a humectant-excipient, selected from the group consisting of glycerin, anhydrous lanolin and combinations thereof, in the range of about 0.5 to 15.0% wt/wt; (4) a non-ionic emulsifier selected from the group consisting of cetearyl alcohol, ceteareth-12, ceteareth-20 and mixtures thereof, 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 film-forming emollient in the range from about 1.0 to 10.0% w/w; and (7) water; wherein contact with the skin results in the in situ formation of a skin protective barrier layer effective in inhibiting the transmission of sexually transmitted diseases.
7 . The formulation of claim 6 wherein said skin protectant is zinc oxide.
8 . The formulation of claim 6 wherein said silicone-based skin protectant is Dimethicone 20.
9 . The formulation of claim 6 wherein said silicone-based skin protectant is Dimethicone 12500.
10 . The formulation of claim 6 wherein said silicone-based skin protectant is a combination of Dimethicone 20 and Dimethicone 12500.
11 . The formulation of claim 6 , wherein said film-forming emollient is cetostearyl alcohol.
12 . The formulation of claim 6 , wherein said film-forming emollient is cetyl alcohol.
13 . The formulation of claim 6 , wherein said film-forming emollient is a combination of cetostearyl alcohol and cetyl alcohol.
14 . The formulation of claim 6 , wherein said chelating compound is disodium edetate.
15 . The formulation of claim 6 , wherein said formulation is in the form of a cream.
16 . The formulation of claim 6 , wherein said formulation is in the form of a lotion.Join the waitlist — get patent alerts
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