Topical formulations for the prevention of sexually transmitted disease and methods of producing the same
OwnerCraig LICHTBLAU, Jose IPARRAGUIRREinventors
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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.
Claims24
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 about 0.5 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.
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.
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.
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.
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
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.
Dependencies are inferred from the claim text.