Stable hydroalcoholic compositions

• US 6,534,069 B1
• Filed: 06/08/1999
• Issued: 03/18/2003
• Est. Priority Date: 06/22/1995
• Status: Expired due to Term

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Charpentier, Jill R., Scholz, Matthew T., Asmus, Robert A.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Sheikh, Humera N.
• Application Number:
  US09/327,978
• Time in Patent Office: 1,379 Days
• Field of Search: 424/70.12, 424/401, 424/78.02, 424/78.03, 424/78.07, 424/78.18, 424/422.1, 424/405, 514/772.3
• US Class Current: 424/401
• CPC Class Codes: A61K 8/34 Alcohols
• CPC Class Codes: A61K 8/342 Alcohols having more than seven atoms in an unbroken chain
• CPC Class Codes: A61K 8/375 the alcohol moiety containing more than one hydroxy group
• CPC Class Codes: A61K 8/39 Derivatives containing from 2 to 10 oxyalkylene groups
• CPC Class Codes: A61K 8/86 Polyethers
• CPC Class Codes: A61Q 17/005 Antimicrobial preparations
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin

Abstract

A hydroalcoholic lotion is disclosed which comprises (a) a lower alcohol and water in a weight ratio of about 35:65 to 100:0, and (b) between at least 0.5% and 8% by weight thickener system comprised of at least one emulsifier present in at least 0.05% by weight wherein the composition in a polymer free state has a viscosity of at least 4,000 centipoise at 23 degrees C. and wherein the emulsifier is comprised of at least one hydrophobic group and at least one hydrophilic group. The hydroalcoholic composition is useful as a hand preparation such as a lotion or as a presurgical scrub replacement.

Claims

1. A hydroalcoholic composition comprising:

a) a major amount of a hydroalcoholic solvent comprising a lower alcohol and water in a weight ratio of about 60;

40 to about 75;

25; and

b) a thickener system present in an amount of about 0.5% by weight to about 8% by weight, based on the total weight of the composition;

wherein the thickener system comprises at least one emulsifier in an amount of at least about 0.05% by weight, based on the total weight of the composition;

wherein the emulsifier comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an alcohol group;

(C) a polyhydric alcohol group;

(D) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof;

(E) an ester or ether group of sorbitan or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(F) combinations thereof,

wherein;

the composition has a melt temperature of greater than about 35°

C. when in the absence of an auxiliary thickener and a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter.

2. The composition of claim 1 further comprising at least one emollient distinct from the thickener system.

3. The composition of claim 2 wherein the at least one emollient is in the form of a wax or a liquid.

4. The composition of claim 1 further comprising an antimicrobial agent distinct from the lower alcohol.

5. The composition of claim 4 wherein the antimicrobial agent is selected from the group of a chlorhexidine salt, iodine, a complexed form of iodine, parachlorometaxylenol, triclosan, hexachlorophene, Lauricidin, a phenol, a surfactant having a long chain hydrophobic group and a quaternary group, a quaternary silane, hydrogen peroxide, silver, a silver salt, silver oxide, silver sulfadiazine, and mixtures thereof.

6. The composition of claim 1 wherein the emulsifier is selected from the group of a poly(ethoxylated and/or propoxylated)alcohol, a poly(ethoxylated and/or propoxylated)ester, a derivative of a poly(ethoxylated and/or propoxylated)alcohol, a derivative of a poly(ethoxylated and/or propoxylated)ester, an alkyl alcohol, an alkenyl alcohol, an ester of a polyhydric alcohol, an ether of a polyhydric alcohol, an ester of a polyalkoxylated derivative of a polyhydric alcohol, an ether of a polyalkoxylated derivative of a polyhydric alcohol, a sorbitan fatty acid ester, a polyalkoxylated derivative of a sorbitan fatty acid ester, and mixtures thereof.

7. The composition of claim 1 wherein the thickener system comprises one or more emulsifiers capable of forming an alcoholic composition having a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener, wherein the very low shear viscometer is a Brookfield LVDV-I⁺ equipped with a model D Brookfield heliopath and T spindles B-F.

8. The composition of claim 1 further comprising a polymeric thickening agent.

9. The composition of claim 1 wherein the emulsifier includes at least two hydrophobic groups.

10. The composition of claim 1 wherein at least one of the emulsifiers is a solid at room temperature and the thickener system hydrophobe number average chain length is at least about 20.

11.The composition of claim 1 which has a melt temperature of greater than about 40° C. when in the absence of an auxiliary thickener.

11. A lotion comprising:

a) a major amount of a solvent comprising a lower alcohol and water in a weight ratio of about 60;

40 to 100;

0;

b) a thickener system present in an amount of about 0.5% by weight to about 8% by weight, based on the total weight of the lotion;

wherein the thickener system comprises at least two emulsifiers, each in an amount of at least about 0.05% by weight, based on the total weight of the lotion;

wherein at least one of the emulsifiers comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an ester or ether group of a polyalkoxylated polyhydric alcohol;

(C) an ester or ether group of a polyalkoxylated sorbitan having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(D) combinations thereof;

wherein at least one of the other emulsifiers comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one alcoholic or polyhydroalcoholic hydrophilic group; and

c) an antimicrobial agent distinct from the lower alcohol;

wherein;

the lotion has a melt temperature of greater than about 35°

C. when in the absence of an auxiliary thickener and the at least two emulsifiers provide the lotion with a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter.

12. The lotion of claim 12 wherein the thickener system comprises one or more emulsifiers capable of forming an alcoholic lotion having a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener, wherein the very low shear viscometer is a Brookfield LVDV-I⁺ equipped with a model D Brookfield heliopath and T spindles B-F.

13. A lotion comprising:

a) a major amount of a solvent comprising a lower alcohol and water in a weight ratio of about 60;

40 to about 100;

0; and

b) a thickener system present in an amount of about 0.5% by weight to about 8% by weight, based on the total weight of the lotion;

wherein the thickener system comprises at least one emulsifier in an amount of at least about 0.05% by weight, based on the total weight of the lotion;

wherein the emulsifier comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 20 carbon atoms;

(B) an alkenyl group of at least 20 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group which is bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an alcohol group;

(C) a polyhydric alcohol group;

(D) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof;

(E) an ester or ether group of sorbitan or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(F) combinations thereof; and

c) a chlorhexidine salt;

wherein;

the at least one emulsifier provides the lotion with a melt temperature of greater than about 25°

C. when in the absence of an auxiliary thickener and a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter.

14. The lotion of claim 14 wherein the thickener system comprises one or more emulsifiers capable of forming an alcoholic lotion having a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener, wherein the very low shear viscometer is a Brookfield LVDV-I⁺ equipped with a model D Brookfield heliopath and T spindles B-F.

15. A method of preparing a stable hydroalcoholic composition, the method comprising:

a) heating a thickener system to a temperature sufficient to melt it;

the thickener system comprising at least one emulsifier in an amount of at least about 0.05% by weight, based on the total weight of the composition;

wherein the emulsifier comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an alcohol group;

(C) a polyhydric alcohol group;

(D) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof;

(E) an ester or ether group of sorbitan or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(F) combinations thereof;

b) heating water to a temperature above the melt temperature of the thickener system;

c) combining the thickener system and the water; and

d) adding a lower alcohol to the thickener system and water to form a composition comprising a major amount of a hydroalcoholic solvent system comprising a lower alcohol and water;

wherein the composition has a melt temperature of greater than about 35°

C. when in the absence of an auxiliary thickener and a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter;

wherein the lower alcohol and water are present in a weight ratio of about 60;

40 to about 75;

25.

16. A method of preparing a lotion comprising:

a) heating a thickener system comprising at least two emulsifiers each in an amount of at least about 0.05% by weight, based on the total weight of the lotion;

wherein at least one of the emulsifiers comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an ester or ether group of a polyalkoxylated polyhydric alcohol;

(C) an ester or ether group of polyalkoxylated sorbitan having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(D) combinations thereof; and

wherein at least one of the other emulsifiers comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one alcoholic or polyhydroalcoholic hydrophilic group;

b) combining the thickener system and a major amount of an alcoholic solvent system comprising a lower alcohol and an antimicrobial agent distinct from the lower alcohol to form a lotion having a melt temperature of greater than about 35°

C. when in the absence of an auxiliary thickener and a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter;

wherein the alcoholic solvent system comprises a lower alcohol and water in a weight ratio of about 60;

40 to about 100;

0.

17. A hydroalcoholic lotion comprising:

a) a major amount of a hydroalcoholic solvent comprising a lower alcohol and water in a weight ratio of about 60;

40 to about 75;

25; and

b) a thickener system present in an amount of about 0.5% by weight to about 8% by weight, based on the total weight of the lotion;

wherein the thickener system comprises at least one emulsifier in an amount of at least about 0.05% by weight, based on the total weight of the lotion;

wherein the emulsifier comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an alcohol group;

(C) a polyhydric alcohol group;

(D) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof;

(E) an ester or ether group of sorbitan or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(F) combinations thereof

wherein;

the lotion has a melt temperature of greater than about 35°

C. when in the absence of an auxiliary thickener; and

the at least one emulsifier provides the lotion with a viscosity of at least about 4,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter.

18. A hydroalcoholic composition comprising:

a) a major amount of a hydroalcoholic solvent comprising a lower alcohol and water in a weight ratio of about 40;

60 to about 95;

5; and

b) a thickener system present in an amount of about 0.5% by weight to about 8% by weight, based on the total weight of the composition;

wherein the thickener system comprises at least one emulsifier in an amount of at least about 0.05% by weight, based on the total weight of the composition;

wherein the emulsifier comprises;

(i) at least one hydrophobic group selected from the group of;

(A) an alkyl group of at least 16 carbon atoms;

(B) an alkenyl group of at least 16 carbon atoms; and

(C) an aralkyl or an aralkenyl group of at least 20 carbon atoms; and

(ii) at least one hydrophilic group selected from the group of;

(A) an ethylene oxide- and/or propylene oxide-containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;

(B) an alcohol group;

(C) a polyhydric alcohol group;

(D) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof;

(E) an ester or ether group of sorbitan or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and

(F) combinations thereof;

wherein;

the composition has a melt temperature of greater than about 35°

C. when in the absence of an auxiliary thickener and a viscosity of at least about 20,000 centipoise at 23°

C. when in the absence of an auxiliary thickener;

wherein the viscosity is measured using a very low shear viscometer and T spindles with a heliopath adapter.