Non-irritating lubricant compositions with active sensorial agents

Abstract

A non-irritating personal lubricant composition comprises a silicone fluid carrier and at least one sensorial agent, the composition having a viscosity of at least 175 centistokes.

Claims

1. An anhydrous silicone-based lubricant composition comprising 1) a silicone fluid carrier comprising a combination of at least 60 wt. % of dimethylpolysiloxane, and 5-15 wt. % of hydroxyl-terminated dimethylpolysiloxane, based on the total weight of said silicone fluid carrier; and 2) at least one sensorial agent, said composition having a viscosity of between 400 to 800 centistokes, and said silicone fluid carrier present in an amount of at least 98 wt. % of said composition, wherein said lubricant composition is a non-encapsulated lubricant composition.

2. The composition of claim 1, having a water content of less than 2.0 wt. %.

3. The composition of claim 1, wherein said at least one sensorial agent includes a warming agent.

4. The composition of claim 1, wherein said at least one sensorial agent includes a cooling agent.

5. The composition of claim 1, wherein said at least one sensorial agent includes a mixture of at least one warming agent and at least one cooling agent.

6. The composition of claim 5, wherein said warming agent is vanillyl butyl ether and said cooling agent is menthol.

7. The composition of claim 1, wherein said silicone, fluid carrier comprises at least 99 wt. % of said composition.

8. The composition of, claim 1, wherein said silicone fluid carrier comprises at least 99.5 wt. % of said composition.

9. A condom having an anhydrous silicone based lubricant composition placed on either an outside portion, an inside portion or both of said portions, wherein said lubricant composition comprises 1) a silicone fluid carrier comprising at least 60 wt.% of dimethylpolysiloxane, and 5-15 wt.% of hydroxyl-terminated dimethylpolysiloxane based on the total weight of said silicone fluid carrier; and 2) at least one sensorial agent, said composition having a viscosity of between 400 to 800 centistokes, and said silicone fluid carrier present in an amount of at least 98 wt. % of said composition, wherein said lubricant composition is a non-encapsulated, lubricant composition.

10. The condom of claim 9, wherein said at least one sensorial agent includes a warming agent and a cooling agent.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) The effect of sensorial agents is moderated when combined with a carrier fluid comprising silicone (e.g. dimethicone), instead of aqueous-based carriers. It has also been found that skin irritation or even adverse affects of the sensorial agent are moderated using silicone as the carrier for the sensorial agent. The sensorial agents of this invention can include warming, cooling or tingling agents, as well as vasodilating agents.

(2) Warming Agents

(3) As used herein warming agents refer to compounds that impart heating or warming sensation upon topical application to the skin, oral cavity, throat or mucous membrane. Warming agents may be selected from the group consisting of capsaicin, gingerol, vanillyl ethyl ether, vanillyl propyl ether, vanillyl butyl ether, vanillyl pentyl ether, vanillyl hexyl ether, vanillyl butyl ether acetate, 4-(1-menthoxymethyl)-2-phenyl-1,3-dioxolan, 4-(1-menthoxymethyl)-2-(3,4-dihydroxyphenyl)-1,3-dioxolan, 4-(1-menthoxymethyl)-2-(2-hydroxy-3-methoxyphenyl)-1,3-dioxolan, 4-(1-menthoxymethyl)-2-(4-methoxyphenyl)-1,3-dioxolan, 4-(1-menthoxymethyl)-2-(3,4-methylenedioxyphenyl)-1,3-dioxolan, 4-(1-menthoxymethyl)-2-(3-methoxy-4-hydroxyphenyl)-1,3-dioxolan, red, pepper oil, red pepper oleoresin, ginger oleoresin, nonylic acid vanillyl amide, Spilanthes acmella extract, Zanthoxylum alatum extract, Zanthoxylum piperitum extract, sanshool I, sanshool II, sanshoamide, black pepper extract, chavicine, piperine, spilanthol, or those warming agents disclosed in U.S. Pat. No. 6,780,443, which is hereby incorporated by reference in its entirety.

(4) As would be understood by one of ordinary skill in the art, the same compound may act differently depending on its, use level in the composition. For example, a compound may act as a warming agent at a certain use level, yet the same compound will act as a tingling sensorial agent at a higher use level.

(5) Cooling Agents

(6) When cooling agents (also known as cooling sensates) are added to compositions containing warming agents, the cooling agent increases the warming effect of the warming agent. See, e.g. U.S. Pat. No. 6,780,443 which is hereby incorporated by reference. Accordingly, topical warming compositions of the present invention may contain a cooling agent. In embodiments in which a warming effect is desired, the compositions should contain higher amounts of warming agents than cooling agents.

(7) It has also been found that topical cooling compositions containing a cooling agent (and smaller amounts or no warming agent) increase the cooling effect of the cooling agent. Therefore, the present invention also provides compositions that include a cooling agent contained in a silicone-containing fluid carrier. These compositions contain a majority of a cooling agent, based on the total amount of sensorial agents added to the composition.

(8) Cooling agents which may be included in compositions of the present invention include, but are not limited to, menthol, menthone, camphor, pulegol, isopulegol, cineol, mint oil, peppermint oil, spearmint oil, eucalyptus oil, 3-1-menthoxypropane-1,2-diol, N-alkyl-p-menthane-3-carboxamide, 3-1-menthoxy-2-methylpropane-1,2-diol, p-menthane-3,8-diol, 2-1-menthoxyethane-1-ol, 3-1-menthoxpropane-1-ol, 4-1-menthoxybutane-1-ol, 1-(2-hydroxy-4-ethylcyclohexyl)-ethanone, menthyl 3-hydroxybutanoate, menthyl lactate, menthone glycerin ketal, 2-(2-1-menthyloxyethyl)ethanol, menthyl glyoxylate, N-methyl-2,2-isopropylmethyl-3-methylbutanamide, menthyl 2-pyrrolidone-5-carboxylate, monomenthyl succinate, alkali metal salts of monomenthyl succinate, and alkali earth metal salts of monomenthyl succinate, monomenthyl glutarate, alkali metal salts of monomenthyl glutarate, alkali earth metal salts of monomenthyl glutarate, N-[[5-methyl-2-(1-methylethyl) cyclohexyl]carbonyl]glycine, p-menthane-3-carboxylic acid glycerol ester, Menthol propylene glycol carbonate; Menthol ethylene glycol carbonate, and 6-isopropyl-3,9-dimethyl-1,4-dioxaspiro[4.5]decan-2-one.

(9) Other cooling agents are disclosed in U.S. Pat. Nos. 7,030,273 and 6,780,443, which are hereby incorporated by reference in their entirety.

(10) For example, a compound may act as a cooling agent at a certain use level, yet the same compound will act as a tingling sensorial agent at a higher use level. In particular, this is true for menthol and menthol derivatives.

(11) In other embodiments of the present invention, sensorial agents besides warming agents and cooling agents are added to a silicone-containing component in order to enhance the sensorial material. For example, in one embodiment of the present invention a tingling agent is added to a silicone-containing component to enhance the tingling effect of the sensorial material.

(12) Silicone-Containing Component

(13) Compositions of the present invention comprise a silicone-containing fluid carrier, which is essentially water free. Although the silicone-containing fluid carrier, per se, does not generally yield a warming or cooling effect when topically applied, it appears to moderate the warming or cooling effect of known sensorial agents compared to aqueous-based carriers. Similarly, the silicone-containing fluid carrier reduces any irritation known to be caused by warming or cooling agents, which are directed to the skin or mucosa by aqueous carriers.

(14) Examples of silicone-containing fluids that may be used in compositions of the present invention include, but are not limited to, polymers based on methyl silicones, such as cyclomethicone and dimethicone; siloxanes, such as cyclopentasiloxane. Cyclomethicone and Dimethicone Copolyol (DC 5225 C and DC 3225 available from Dow Corning) and Cyclopentasiloxane & Dimethicone Copolyol (GE SF 1528) may also be used as a silicone-containing component of the present invention.

(15) Preferably, although not invariably, the silicone component of the present compositions often comprises a dimethicone (trimethyl siloxane-terminated polydimethylsiloxane) or phenyltrimethicone component. Additional or alternative silicones may be present; these additional or alternative silicone components may include one or more of the following: a dimethiconol (hydroxy-terminated polydimethylsiloxane) component, a cyclopentasiloxane component, a dimethicone/vinyl dimethicone cross-polymer component. For example, a silicone component may be a D5 cyclic or small linear dimethicone, disiloxane vinyl cross polymer.

(16) In one embodiment, the amount of silicone-containing carrier fluid is at least 98% by weight, preferably at least 99% by weight, more preferably at least 99.5% by weight of the total composition. The fluid carrier is essentially water free, and is preferably anhydrous. As shown in the examples, compositions of the present invention may include a combination of one or more sensorial agents of the same type. For example, the compositions may contain a mixture of warming agents. On the other hand, a mixture of sensorial agents having differing affects may be used, e.g. warming and cooling agents. The selection of the sensorial agent combinations may be adjusted to fine-tune the intensity and duration of the sensation desired. In addition, time-release effects may be achieved by certain sensorial agent combinations, or by treatment of sensorial agents such as by encapsulation methods and the like, to provide extended solubility in the base composition.

(17) An important feature of the personal lubricants of this invention is the ease with which the lubricant can be applied, and the ability of the lubricant to be maintained on the area of skin and/or mucosa once it has been applied. The lubricant of this invention can also be readily applied and maintained on the inside and/or outside surfaces of condoms and personal sensorial devices. Thus, the viscosity of the personal lubricant is controlled by manipulating the molecular weights and ratios of any different silicone fluids used as the fluid carrier. Thus, the molecular weights of the silicone fluids utilized and the ratios of any different types of silicone fluids utilized need to yield a viscosity of at least 175 centistokes. Viscosities of at least 200 centistokes are also useful. A typical maximum viscosity would be between about 500 to 700 centistokes. In addition, if the composition of this invention is used as a condom lubricant, the viscosity of the silicone carrier should preferably be between about 180 to 220 centistokes, with 190 to 210 centistokes preferred.

EXAMPLES

(18) The prior art has focused on the incorporation of various functional agents into personal lubricant compositions that are water-based or water-soluble, in order to enhance pleasurable feelings during sexual activity, and/or to heighten sexual arousal. However, the prior art does not teach how to formulate a lubricant composition that is deemed non-irritating by virtue of the addition of the functional agents, in the absence of insulating agents, encapsulation, or controlled dosage.

(19) In this example, various lubricant prototypes were assessed to understand strengths and weaknesses of each as a stand-alone lubricant for use with a partner and for self-masturbation.

(20) Methodology:

(21) In the study, participating couples were randomly assigned to one of four cells. In each cell, couples were given water-based lubricant with no functional agents (K-Y Natural Feeling Liquid) to use as, a control product. Both the male and female partner used the control product during multiple sexual experiences. The couples then filled out questionnaires about the control product (couples were instructed not to discuss their answers to the questions with each other).

(22) No adverse reactions were observed in this study.

(23) After submitting their responses for the control product, couples were given one of four test products and repeated the procedure. The test products are set forth in Table 1 below. Couples in row 1 were provided Prototype A; couples in row 2 were provided Prototype B; couples in row 3 were provided Prototype C; couples in row 4 were provided Prototype D. A total of 84 couples completed the study, with 21 couples in row 1, 22 couples in row 2, 23 couples in row 3, and 18 couples in row 4.

(24) TABLE-US-00001 TABLE 1 Product ID Base Composition Functional agents Prototype Silicone-Based 0.06% Menthol and 0.01% VBE #623 Prototype Silicone/Water Based 0.06% Menthol and 0.01% VBE #732 Hybrid Prototype Water-Based 0.01% VBE, 0.05% Hexyl Nicotinate, #125 (~90% water content) 0.01% Ginger, 0.01% Maca, 0.01% L- Arginine Prototype Water-Based 0.01% VBE, 0.05% Hexyl Nicotinate, #352 (~60% water content) 0.01% Ginger, 0.01% Maca, 0.01% L- Arginine

(25) TABLE-US-00002 TABLE 2 % w/w Improved Silicone with Prototype # 623 Ingredients VBE + Menthol RT Product Number 623 Cosmetic Fluid 2006-OH.sup.1 99.93 Vanillyl Butyl Ether, Food Grade 0.01 DL-Menthol 0.06 Total 100.00 .sup.1ChemSil Silicones, Inc. >60% Dimethylpolysiloxane 5-15% Dimethylpolysiloxane, Hydroxyl-terminated

(26) TABLE-US-00003 TABLE 3 % w/w Hybrid with Prototype # 732 Ingredients VBE + Menthol RT Product Number 732 Deionized Water 30.93 Propylene Glycol, USP 52.00 DL-Menthol, USP 0.06 Vanillyl Butyl Ether 0.01 Emulsil WSL-CF.sup.1 17.00 Propylene Glycol, USP Q.S.* Total 100.00 .sup.1ChemSil Silicones, Inc. 80-90% Dimethylpolysiloxane 5-15% Reaction product of dimethyl siloxane, vinyl-terminated and dimethyl, methyl-hydrogen siloxane 2-8% 2-Propenoic acid, 2-hydroxyethyl ester polymer with 2-methyl-2-[(1-oxo-2-propenyl) amino]-1-propanesulfonic acid monosodium salt

(27) TABLE-US-00004 TABLE 4 % w/w Water Prototype #125 Ingredients Based 90% RT Product Number 125 Deionized Water 93.58 Methylparaben, NF 0.10 Propylparaben, NF 0.05 Sodium Hyaluronate 0.50 Hydroxyethylcellulose 0.50 Lactic Acid, 88% 0.26 Urea 1.00 Glycerin, USP 2.00 Citric Acid 0.10 Sodium Citrate, USP 0.47 Sodium Chloride 0.35 Ginger LE 0.01 MACA LE 0.01 L-Arginine 0.01 Vanillyl Butyl Ether 0.01 Hexyl Nicotinate 0.05 Polysorbate 60 1.00 Total 100.00

(28) TABLE-US-00005 TABLE 5 % w/w Water Based Prototype # 352 Ingredients 60% RT Product Number 352 Deionized Water 58.28 Polyquaternium-7 (Mirapol 550) 5.00 Propylene Glycol, USP 5.00 Methylparaben, NF 0.10 Propylparaben, NF 0.05 Citric Acid, Anhydrous, Granular, 0.08 USP Sodium Citrate Dihydrate, USP 0.05 Glycerin, USP 30.00 Hydroxyethyl Cellulose (Natrosol 0.35 250HX PHARM) Vanillyl Butyl Ether, Food Grade 0.01 Polysorbate-60 1.00 Hexyl Nicotinate 0.05 Ginger 0.01 aca 0.01 L-Arginine 0.01 Total 100.00

Summary of Key Findings

(29) Prototype A:

(30) Overall

(31) The warming (sometimes tingling/cooling) sensations contributed to favorable reactions to this lubricant, and heightened the overall experience for a number of men and women.

(32) Sensations

(33) A warming sensation was experienced by many as a comfortable warming, and was not too hot. There was no burning at any point. The sensation gradually increased in warmth after application. This increased pleasure when used for both self-masturbation as well as with partner. Some also felt a pleasurable and not too extreme tingling or cooling sensation, either right after application and/or during intercourse.

(34) Only a very few (2 women for solo and partnered sex, 1 woman for solo sex) did not feel any sensations, but were very positive about this lubricant due to its superior lubrication qualities.

(35) Prototype B:

(36) Overall

(37) Reactions were highly polarized: respondents were either very negative to the intense sensations or liked it very much.

(38) Sensations

(39) Over half of the women and men in this study found this lubricant too hot and burning, especially when used with a partner, and strongly disliked this lubricant. It was so intense that it curtailed the sexual experience for some. A few men found this tolerable (although not ideal), yet most would not continue to use it since it was overwhelmingly hot for their partners. Some also felt a tingling or cooling sensation.

(40) The remaining women (less than half) were favorable towards this lubricant, because it had an intense, pleasurable tingling, warming, or cooling sensation. All of these women indicated that they preferred sensation producing lubricants, prior to the test. It had no or very little sensation, but was a very good lubricant.

(41) Prototype C:

(42) Overall

(43) There was a very wide range of reactions to the sensations generated by this lubricant.

(44) Sensations

(45) Some found it warm. The warmth seemed to gradually build for most, which added enjoyment to the sexual experience for some. Some would have liked the warming sensation to last longer. They reported it lasted from 2 to 5 minutes. Some reapplied the lubricant to re-ignite the warming feeling. A few mentioned feeling a warming, tingling, cooling sensation. Some found it too hot or burning (more so women), usually for a short period of timefrom a brief spike (for men, burning at penis tip or in urethra) to a few minutes (for women, internally). This got in the way of achieving an orgasm and/or enjoying sex. Some women noted that the intense warming or burning sensation eased after about 2-5 minutes, but did not go away completely for up to 15-25 minutes. A few felt no sensation or only a very slight warming.

(46) Prototype D:

(47) Overall

(48) Most men and women had very negative reactions to this prototype. Many said it was too hot/burning, particularly when used with a partner.

(49) Sensations

(50) There was very uncomfortable heat and burning for many during partnered sex, especially for women. Burning/heat was said to get even more intense for some women during penetration/intercourse due to friction, which was very distracting. For a few, the extreme sensation interrupted the sexual experience and/or made it so that the man/woman couldn't reach orgasm. A few men felt that the level of warmth was acceptable for themselves, but that their partner felt it to be too warm/hot and uncomfortable. A few women also said that the lubricant was warm, not hot, and increased/lengthened arousal when used solo. The burning/warmth lasted too long for many: up to 30 minutes for women, 5 minutes for men.

(51) Results:

(52) The quantitative data from the study revealed a consistent trend of prototype A outperforming the other test products, with prototype B receiving the next best scores, followed by prototype C, and then prototype D.

(53) For some questions, such as questions identifying levels of irritation (non-adverse reaction), responses for the control product were consistent across all cells. These questions showed a trend that prototype A outperformed prototype B, which outperformed prototype C, which outperformed prototype D.

(54) For questions identifying the perception of a sensation, responses for the control product were consistent across all cells. For responses for the question did you feel a sensation from the lubricant?, the control product received consistently low scores (lack of sensation), while the scores for the four test products demonstrated a perceived sensation.

(55) Those respondents indicating a sensation was felt with the test lubricant were asked to select the type of sensation felt from a list of options: burning, warming, cooling, irritation, numbing, tingling and other. A burning sensation was associated predominately with products C and D, followed by product B, whereas fewer respondents, both in absolute numbers and as a proportion of those who felt a sensation, associated product A with a burning sensation, compared to products C, D and B.

(56) Upon closer inspection of negative sensations, such as burning and irritation, product D displayed the highest percentage of respondents reporting burning and irritation. Product A displayed the lowest percentage of respondents reporting burning and irritation, compared to products D, C, and B.

(57) For respondents indicating that a sensation was felt with the test lubricant, respondents were asked to identify the onset of a sensation from a list of options: immediately (less than one minute), within 1-5 minutes, within 6-10 minutes, or after more than 10 minutes. The mean onset of sensation was perceived more quickly with products C and D, relative to products A, B and the control.

(58) Compiling the results of all of the tested products, the onset of the sensations of irritation, numbing, and burning occur later, compared to the other sensations.

(59) Finally, respondents were asked to identify the duration of the sensation from a list of options: a lot less time than desired, a little less time than desired, about the right time as desired, a little longer than desired and a lot longer time than desired. Product D received a higher average score than product A and the control, indicating, a longer-than-desired effect. Compiling the results of all of the tested products, negative sensations of burning, irritating, and numbing all had high average scores, indicating a longer-than-desired effect. The sensations cooling, tingling, and warming all had scores close to the desired length of time. Specifically, product B had an overall polarizing response with some negative responses to intense sensations. Similarly, product D had an overall negative qualitative response to intense sensations, primarily during intercourse.

CONCLUSION

(60) Product A received consistently outperforming scores over the other test products, whereas products C and D received, consistently lower-performing scores than the other test products.