Lubricated packaged condoms

Abstract

The present invention provides a packaged condom comprising a sealed packaging, in which the condom comprises natural rubber latex and / or synthetic polyisoprene, and the condom comprises an aqueous lubricant in contact with the natural rubber latex and / or synthetic polyisoprene on one or more surfaces thereof. The aqueous lubricant comprises a thickener and one or more organic compounds independently selected from the group consisting of polyhydric alcohols and sugars in a total amount of 5 to 25% by weight of the aqueous lubricant, each of the one or more organic compounds having at least four hydroxyl groups and a molecular weight of 120 to 10000. The present invention further provides a method of preparing a packaged condom, a packaged condom obtainable or obtained by this method, and use of the aqueous lubricant to lubricate one or more surfaces of a condom comprising natural rubber latex and / or synthetic polyisoprene while maintaining transparency of the condom within the sealed packaging during storage.

Description

Technical Field

[0001] The present invention relates to a lubricated packaged condom. Specifically, the present invention relates to a packaged condom lubricated with an aqueous lubricant, which preferably presents a transparent appearance to the end user.

Background Art

[0002] Personal lubricants are special lubricants that play a role in reducing friction with body tissues during sexual intercourse. In particular, personal lubricants can be used to provide lubrication or slipperiness during sexual intercourse by applying them directly to the vagina. For example, personal lubricants can be used to increase pleasure or reduce pain during sexual intercourse and can help reduce vaginal dryness. In medicine, personal lubricants can be used for gynecological examinations and the like.

[0003] Condoms can be pre-provided with a lubricant on the surface. The technical considerations for such lubricants are different from those of single personal lubricants in that the composition needs to be stable with the condom material (and the condom packaging material) over a long storage period. Furthermore, the lubricant should not be quickly rubbed off the condom during sexual intercourse, and the method of administering the lubricant to the condom during manufacturing affects requirements regarding, for example, viscosity and adhesiveness, but still provides the desired degree of lubrication.

[0004] Lubricated condoms have been sold for many years. The most common lubricants are silicone-based because silicone-based lubricants provide good lubricity and are very compatible with the long-term integrity of common condom materials (including natural rubber latex ("NRL") and synthetic polyisoprene ("PI")). However, silicone lubricants may be difficult to wash off if they adhere to the skin or clothing considering their hydrophobicity. Therefore, they may be recognized as troublesome by consumers.

[0005] To address this problem, various water-soluble lubricants have been tried. However, many of these lubricants cause the appearance of condoms to become opaque during storage, especially when applied to NRL or PI condoms. More specifically, these condoms typically have a transparent appearance before the application of lubricants and finishing powders. A transparent appearance is desirable to consumers, for one thing, as consumers associate a transparent appearance with thinness. Many existing water-soluble lubricants tend to whiten and opaqueize condoms, resulting in a compromised appearance that is undesirable to consumers. However, the exact mechanism by which this occurs is not well understood in the art.

[0006] U.S. Patent No. 6,196,227 acknowledges the problem of whitening caused by water-soluble lubricants when applied to condoms. This document suggests that whitening may be caused by water absorption and teaches that the water content of the lubricant should be limited to prevent whitening of the condom surface. It also discloses that humectants such as glycerin, propylene glycol, and polyethylene glycol may be added to aid in wetting and lubrication.

[0007] Aside from the tendency of condoms, such as NRL and PI condoms, to whiten, there are also issues related to the osmotic pressure of aqueous lubricants. Historically, single aqueous personal lubricants have tended to have osmotic pressures much higher than the typical vaginal osmotic pressure of 200 to 300 mOsm / kg. Currently, it is recognized that the osmotic pressure of lubricants is important because the epithelial cells lining the vaginal wall constantly strive to maintain homeostasis. High-osmotic lubricants cause vaginal cells to release fluid and dilute the lubricant. This can result in epithelial cell damage, which in turn leads to an increased risk of infection due to impaired epithelial barrier function. It can also increase vaginal dryness. This is a particular problem for menopausal women, as vaginal dryness is exacerbated by the use of high-osmotic lubricants. In 2012, the World Health Organization (WHO) recommended that healthcare facilities procure single personal lubricants with an osmotic pressure of less than 1200 mOsm / kg. However, formulating a single personal lubricant within this range is not easy, while balancing the need to achieve many other parameters, including required viscosity, lubricity, and hydrodynamic stability during storage. This is reflected in the fact that, despite WHO recommendations issued nearly a decade ago, the osmotic pressures of many water-based lubricants currently on the market are still between 2000 and 6000 mOsm / kg. Applying these WHO recommendations to condom lubricants is even more difficult, as a further set of technical constraints comes into play. Moreover, since the typical amount of lubricant pre-applied to condoms is far less than the amount of single lubricant applied by the consumer by hand, it has not been understood in this field as essential for lubricated condoms, potentially at the expense of other important properties.

[0008] The osmotic pressure of a solution in Osm / kg is defined as the number of osmoles of solute per 1 kg of solvent. The osmotic pressure of aqueous lubricants disclosed in U.S. Patent No. 6,196,227, published in 2001, is high when considering high concentrations of low molecular weight solute molecules. Therefore, U.S. Patent No. 6,196,227 does not disclose any aqueous lubricants that appear to correlate with the newer WHO recommendations regarding the osmotic pressure of individual personal lubricants. Increasing the water content of the lubricant in U.S. Patent No. 6,196,227 and decreasing the solute concentration would decrease its osmotic pressure, but this would likely cause whitening of the condom if the water absorption action assumed in this document is followed. Furthermore, since each of the solutes disclosed in this document is included to maintain specific properties of the lubricant, it is expected that the physical properties of the lubricant will be impaired. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] U.S. Patent No. 6,196,227 [Overview of the Initiative] [Problems that the invention aims to solve]

[0010] There remains a need for low-osmotic-pressure aqueous lubricants that possess physical properties suitable for use on condoms, particularly those containing NRL or PI, and that have reduced adverse effects on condom transparency during storage. [Means for solving the problem]

[0011] According to a first aspect, the present invention provides a packaged condom, the packaged condom is, Sealed packaging, Condoms containing natural rubber latex and / or synthetic polyisoprene in sealed packaging, Equipped with, The condom contains an aqueous lubricant in contact with natural rubber latex and / or synthetic polyisoprene on one or more of its surfaces. Water-based lubricants are Thickening agent, A total amount of 5 to 25% of the weight of the aqueous lubricant, consisting of one or more organic compounds independently selected from the group consisting of polyhydric alcohols and sugars, The compound comprises one or more organic compounds, each having at least four hydroxyl groups and a molecular weight of 120 to 10,000.

[0012] The inventors have found that the inclusion of such polyhydric alcohols and / or sugars in specific amounts in aqueous lubricants helps maintain transparency during storage and prevent whitening of natural rubber latex condoms while maintaining low osmotic pressure. While not intended to be theoretically limiting, natural rubber latex condoms are considered particularly susceptible to the effects of whitening from aqueous lubricants due to the interaction of water with impurities or additives in the natural rubber latex. Synthetic polyisoprene, having fewer impurities (such as proteins), still exhibits the ability to whiten. The same principle should apply when NRL / PI is included in a condom with another material (preferably a initially transparent material), provided that the lubricant is not shielded from contact with the NRL / PI by the other material. It is believed that the inclusion of specific amounts of polyhydric alcohols or sugars having a large number (at least four) hydroxyl groups can reduce or eliminate the degree of interaction between the water in the lubricant and impurities or additives in the condom material. As a result of the molecular weight of the polyhydric alcohol or sugar, the polyhydric alcohol or sugar can be included in an amount sufficient to have the desired anti-whitening effect without causing an unacceptably high osmotic pressure of the lubricant. Conveniently, the aqueous lubricant of the present invention also provides good lubricity and is non-sticky. Furthermore, the aqueous lubricant of the present invention is perfectly compatible with condom materials and does not affect the physical properties of the condom, such as burst pressure, burst volume, and tensile strength.

[0013] According to a second aspect, the present invention provides a method for preparing a packaged condom, the method comprising: (i) A step of providing an aqueous lubricant, wherein the aqueous lubricant comprises a thickener and one or more organic compounds independently selected from the group consisting of polyhydric alcohols and sugars in a total amount of 5 to 25 wt% relative to the weight of the aqueous lubricant, and each of the one or more organic compounds has at least four hydroxyl groups and a molecular weight of 120 to 10000, (ii) the step of providing a condom as defined in the first aspect, (iii) Applying a single dose of aqueous lubricant to one or more surfaces of a condom in order to form a lubricated condom in which the aqueous lubricant comes into contact with natural rubber latex and / or synthetic polyisoprene, (iv) The step of sealing the lubricated condom inside the packaging, Includes.

[0014] According to a third aspect, the present invention provides a packaged condom that can be obtained or obtained by the method of the second aspect.

[0015] According to a fourth aspect, the present invention provides the use of an aqueous lubricant as defined in a second aspect to lubricate one or more surfaces of a condom as defined in a first aspect, the aqueous lubricant being in contact with natural rubber latex and / or synthetic polyisoprene while maintaining the transparency of the condom in sealed packaging during storage. [Modes for carrying out the invention]

[0016] The present invention will be described further below. Different aspects / embodiments of the present invention will be described in more detail in the following sections. Each of the aspects / embodiments described herein may be combined with any other aspect / embodiment unless otherwise explicitly stated. In particular, any feature indicated as preferred or advantageous may be combined with any other feature indicated as preferred or advantageous.

[0017] The present invention provides a packaged condom comprising a sealed package and a condom with a lubricant therein. The sealed package preferably isolates the condom from the external environment to such an extent that molecules within the package do not readily pass through the package boundary and oxygen does not readily pass into the package (the low levels at which these molecules and oxygen can pass are within levels accepted in the condom industry). Suitable sealed packages for condoms are known in the art and can include, for example, two laminated materials sealed along the edges around the condom. The laminated materials can include, for example, an aluminum layer. Another possible sealed package is a plastic pot sealed with a film lid, a so-called "butter dish". The condom is preferably provided within the package in a rolled state. The condom is preferably a male condom, preferably intended to substantially cover the entire penis.

[0018] The condom comprises natural rubber latex ("NRL") and / or synthetic polyisoprene ("PI"). Optionally, the NRL and / or PI can be present as a blend with one or more other polymeric condom materials that can be elastomers (e.g., polyurethane, "PU"). Alternatively or additionally, the NRL and / or PI can be provided on one or more outer layers of the condom (regardless of whether it is the side facing the penis or the opposite side), provided that it contacts the lubricant. However, preferably, the NRL and / or PI is the sole elastomer or the sole polymeric condom material in the condom. Preferably, the condom is a natural rubber latex condom. That is, the condom is formed from a natural rubber latex base with natural rubber latex or one or more additives incorporated. Natural rubber latex typically contains cis-1,4-polyisoprene along with small amounts of impurities such as proteins, fatty acids, inorganic salts, etc. Synthetic polyisoprene does not contain, for example, the allergenic proteins found in natural rubber latex. Suitable formulations of natural rubber latex and synthetic polyisoprene are known in the art.

[0019] The condom itself can be manufactured in any suitable manner. Typically, this is done by dipping a condom-shaped mold into latex or a latex blend to form a film that is then dried and cured. It should be understood that the manufacture of suitable rubber latex and the subsequent formation of condoms therefrom are procedures well understood by those skilled in the art. As described above, the inventors believe that NRL and PI condoms are particularly susceptible to the opacifying effects of aqueous lubricants.

[0020] NRL and PI condoms are normally transparent and essentially colorless when provided in the dry state and before being coated with a lubricant or finishing powder (although some condoms may, of course, be slightly yellowish). It should be understood that this is not always the case. In some instances, for example, if an opaque or colored condom is desired, an opacifying agent or coloring agent can be included. However, consumer demand for transparent condoms is increasing, in part to enhance the perception of thinness, which is also an increasingly desired characteristic of condoms in many markets.

[0021] Preferably, the condom of the present invention is formed from a transparent material. That is, the condom is transparent before application of an aqueous lubricant or optional finishing powder. The problem of reduced transparency is particularly acute for condoms that are transparent prior to lubrication because the effects caused by a typical aqueous lubricant are much more visible than when the condom is already substantially opaque. Thus, the advantageous effects of the aqueous lubricant used in the present invention are particularly pronounced for condoms that are transparent from the start.

[0022] Condoms can be transparent and colored, transparent and colorless, or essentially colorless. It should be understood that the considerations relating to "whitening" in this specification also apply to opacity of colored condoms. Preferably, the condom formulation does not contain colorants. Consumers may tolerate increased opacity if the condom is already designed to be colored.

[0023] "Transparent" means the property of transmitting visible light without significant scattering, such that an object on the other side of the condom can be seen through it. It should be understood that, as used herein, the term "transparent" does not include materials that contain a limited amount of light scattering but are substantially opaque and do not transmit a perceptible amount of light. Many natural rubber latex condoms have a yellowish tint resulting from some limited scattering of light, but are still largely translucent. Such condoms are considered "transparent" for the purposes of this invention. It should be understood that transparency refers to the unrolled condom, as when condoms are packaged in a roll, the rolled portion of the condom may appear substantially opaque even if the condom material itself is transparent.

[0024] The condom of the present invention is preferably formed from a material having a haze value of up to 70%. That is, the condom preferably has a haze value of up to 70% before the application of an aqueous lubricant or optional finishing powder. More preferably, the haze value is up to 60%, even more preferably up to 50%, even more preferably up to 40%, and most preferably up to 30%. In some embodiments, the haze value is at least 10%, or at least 15%. In embodiments including a finishing powder, the condom preferably also has a haze value within these ranges after the application of the finishing powder but before the application of the lubricant. The haze value of a sample can be measured using a UV-Vis spectrophotometer, and this value quantifies the percentage of incident light scattered as it passes through the sample. The lower the haze value of the material, the more transparent it is. In connection with this disclosure, the haze value is defined according to ASTM standard D1003-00 and refers to the percentage of light that deviates from the incident light at an angle greater than 2.5 degrees from the normal (wide-angle scattering) as it passes through the material. Preferably, the haze value is the average of three measurements taken along the length of the unrolled condom at the open end, the closed end, and the midpoint. Preferably, the haze value is determined according to the method disclosed in the "Examples".

[0025] The present invention encompasses condoms having patterns or other surface features applied to one or more of its surfaces, such as ribs or dots intended to provide physical stimulation to the user or their partner. However, in embodiments, the condom has no visible surface indentations or protrusions. The advantageous effect on transparency is more likely to be pronounced in condoms without raised surface features that may themselves scatter light.

[0026] In embodiments of the present invention, the condom has a thickness of 60 microns or less, 55 microns or less, 50 microns or less, 45 microns or less, 40 microns or less, and / or at least 20 microns, at least 25 microns, or at least 30 microns. While thinner condoms meet consumer expectations for transparency, they also need to maintain sufficient structural integrity to perform their primary function as a barrier.

[0027] The condom of the present invention contains an aqueous lubricant on one or more of its surfaces. The one or more surfaces may be the inner surface and / or outer surface of the condom. In relation to male condoms, "inner" refers to the side facing the penis, while "outer" refers to the side facing the user's partner. Preferably, the aqueous lubricant is present on at least the outer surface of the condom. Preferably, the one or more surfaces are substantially coated with the lubricant. Preferably, at least 25% of the area of ​​the one or more surfaces is coated with the lubricant, more preferably at least 40%, even more preferably at least 60%, and most preferably at least 70%. It should be understood that the condom, in its unrolled state, has a length extending from the open end to the closed end of the condom. The one or more surfaces are preferably coated along at least 25% of the length, more preferably at least 50%, more preferably at least 60%, even more preferably at least 70%, and most preferably at least 80%. Preferably, the lubricant is contained on one or more surfaces of the condom in an amount of 100 mg to 1.5 g, more preferably 200 mg to 1 g, even more preferably 300 mg to 800 mg, and most preferably 400 mg to 700 mg.

[0028] The lubricant comprises one or more organic compounds independently selected from the group consisting of polyhydric alcohols and sugars, each of which must have at least four hydroxyl groups and a molecular weight of 120 to 10,000. The total amount of these organic compounds is 5 to 25 wt%. As described above, the inclusion of a specific amount of polyhydric alcohols and / or sugars having a large number (at least four) hydroxyl groups can reduce or eliminate the interaction between the water in the lubricant and impurities / additives on the surface of the natural rubber latex and / or PI, thereby maintaining the transparency of the condom and preventing the whitening associated with other aqueous lubricants on such condoms. As a result of the molecular weight of the polyhydric alcohols and / or sugars, this can be included in an amount sufficient to have the desired anti-whitening effect without producing an undesirably high osmotic pressure of the lubricant.

[0029] In embodiments of the present invention, the total amount of these specific organic compounds in the lubricant is 24 wt% or less, 23 wt% or less, 22 wt% or less, 21 wt% or less, 20 wt% or less, 19 wt% or less, 18 wt% or less, 17 wt% or less, 16 wt% or less, 15 wt% or less, 14 wt% or less, 13 wt% or less, 12 wt% or less, 11 wt% or less, or 10 wt% or less, and / or 6 wt% or more, 7 wt% or more, 8 wt% or more, 9 wt% or more, 10 wt% or more, 11 wt% or more, or 12 wt% or more.

[0030] For example, the lubricant may contain a total amount of these organic compounds (or any number of them) in the following proportions relative to the weight of the lubricant: 5 to 24 wt%, or 5 to 23 wt%, or 5 to 22 wt%, or 5 to 21 wt%, or 5 to 20 wt%, or 5 to 19 wt%, or 5 to 18 wt%, or 7 to 15 wt%.

[0031] The term polyhydric alcohol refers to an alcohol having at least two hydroxyl groups. However, as described above, the polyhydric alcohols used in this invention have at least four hydroxyl groups. The polyhydric alcohols used in this invention may include polyhydric alcohol derivatives such as ethers and esters, provided that they have at least four free hydroxyl groups. However, in some embodiments, the polyhydric alcohol does not contain any functional groups other than hydroxyl groups. In other embodiments, the polyhydric alcohol is composed of carbon, hydrogen, and oxygen atoms. Preferably, the polyhydric alcohol is water-soluble. Preferably, the polyhydric alcohol is present in the lubricant in a completely dissolved state throughout a temperature of 25°C, preferably in the range of at least 10 to 35°C. This ensures that the polyhydric alcohol does not scatter light itself and contribute to an increase in the opacity of the lubricated condom.

[0032] As used herein, the term sugar refers to water-soluble monosaccharides, disaccharides, oligosaccharides, or polysaccharides. Water solubility means that the sugar dissolves in water at a temperature of 25°C. Suitable examples of monosaccharides include glucose, galactose, ribose, deoxyribose, L-arabinose, fructose, sorbose, and xylose. Suitable examples of disaccharides include sucrose, trehalose, lactose, and maltose. Suitable examples of polysaccharides include glycogen. As used herein, the term sugar includes sugar derivatives such as ethers and esters of monosaccharides, disaccharides, oligosaccharides, or polysaccharides. However, preferably, sugars do not contain functional groups other than hydroxyl groups, intracyclic oxygen atoms, and acetal bonds on one or more cyclic carbon atoms of the sugar. It should be understood that this description refers to the cyclic form of sugar. The cyclic form of sugar can exist in equilibrium with the linear form in aqueous solution. The linear form contains a carbonyl group. When sugars exist in equilibrium with the chain form, references to the number of hydroxyl groups in a compound herein refer to the number of hydroxyl groups in the compound when it is in the cyclic form.

[0033] Preferably, each of the organic compounds(s) is a natural component, i.e., obtained directly or indirectly from natural products such as plant-derived products.

[0034] The organic compound(s) preferably independently has at least 5 hydroxyl groups, or at least 6 hydroxyl groups, or at least 10 hydroxyl groups, or at least 15 hydroxyl groups, or at least 20 hydroxyl groups. In some embodiments, the organic compound(s) may have up to 12 hydroxyl groups, or up to 10 hydroxyl groups. In some embodiments, one or more of the organic compound(s) may be high molecular weight polyols such as glycogen. In other embodiments, one or more of the organic compound(s) may be small molecules containing up to 20 carbon atoms, or up to 15 carbon atoms, or up to 10 carbon atoms. A mixture of any of the above compounds may exist.

[0035] Preferably, the molecular weight of at least one or each of the organic compounds is at least 150, or at least 180. In some embodiments, the molecular weight of at least one or each of the organic compounds is at least 300. The molecular weight of each of the organic compounds is at most 10000. Preferably, the molecular weight of at least one or each of the organic compounds is at most 5000, or at most 2000, or at most 1000, or at most 500. In some embodiments, the molecular weight of at least one or each of the organic compounds is from 150 to 500, or from 150 to 200, or from 300 to 500. Generally, low molecular weight compounds are more likely to produce higher osmotic pressure than high molecular weight compounds, while high molecular weight compounds may tend to adversely affect viscosity. Therefore, the amount of polyhydric alcohols and / or sugars can be adjusted according to their molecular weight to result in a low osmotic pressure composition. In embodiments where the maximum molecular weight of the organic compound(s) is 500, the lubricant is preferably contained in a total amount of 5 to 20 wt%, preferably 5 to 18 wt%, or 5 to 15 wt%, relative to the weight of the organic compound(s). Surprisingly, the lubricant has been found to have the desired effect on transparency even when the organic compound(s) are contained in this amount. In embodiments where the organic compound(s) can have a higher molecular weight, the organic compound(s) can be included in a higher total amount, such as 15 to 25 wt%.

[0036] Preferably, one or more organic compounds have at least 2.5 hydroxyl groups per 100 molecular weight, more preferably at least 3.

[0037] Preferably, if an organic compound contains or consists of one or more polyhydric alcohols, the polyhydric alcohols are or contain sugar alcohols. The term "alcohol" is known in the art and refers to a polyhydric alcohol corresponding to a sugar in which the carbonyl group of the chain of the sugar is reduced to a hydroxyl group. Sugar alcohols are typically, but not essentially, derived from sugars. Sugar alcohols can be produced, for example, by reducing the carbonyl group of the chain of the corresponding sugar. However, some sugar alcohols are naturally occurring. Sugar alcohols that can be used in the present invention are preferably naturally occurring and preferably not produced by reducing the carbonyl group of the chain of the corresponding sugar. Suitable sugar alcohols for use in the present invention include sorbitol, maltitol, mannitol, xylitol, lactitol, isomalt, and hydrolyzed starch (HSH). When a sugar alcohol contains a sugar component, and that sugar component exists in equilibrium with the chain form, references to the number of hydroxyl groups in the compound herein refer to the number of hydroxyl groups in the cyclic form.

[0038] In some embodiments, the organic compound(s) are independently selected from the group consisting of disaccharides and disaccharide-derived sugar alcohols. The disaccharide may be, for example, sucrose, trehalose, lactose, or maltose. The disaccharide-derived sugar alcohol may be, for example, maltitol. "Derived from" means that the sugar alcohol corresponds to a disaccharide, where the carbonyl group in the chain of the disaccharide is reduced to a hydroxyl group. However, the sugar alcohol does not necessarily have to be produced from a disaccharide (for example, it can exist naturally). When the organic compound(s) are independently selected from the group consisting of disaccharides and disaccharide-derived sugar alcohols, the lubricant preferably contains a total amount of these organic compounds(s) of 5 to 15 wt%, more preferably 6 to 14 wt%, even more preferably 8 to 14 wt%, and most preferably 11 to 13 wt%, relative to the weight of the lubricant.

[0039] In other embodiments, the organic compound(s) are independently selected from the group consisting of monosaccharides and monosaccharide-derived sugar alcohols. Monosaccharides may be, for example, glucose, galactose, ribose, deoxyribose, L-arabinose, fructose, sorbose, or xylose. Monosaccharide-derived sugar alcohols may be, for example, sorbitol. The term "derived from" has the meaning corresponding to the meaning given in relation to disaccharides above. When the organic compound(s) are independently selected from the group consisting of monosaccharides and monosaccharide-derived sugar alcohols, the lubricant preferably contains a total amount of these organic compounds(s) of 5 to 12 wt%, more preferably 6 to 10 wt%, and most preferably 6 to 8 wt%, relative to the weight of the lubricant.

[0040] The organic compound(s) consists of or contains a mixture of sugar alcohols derived from one or more monosaccharides and sugar alcohols derived from one or more disaccharides.

[0041] Most preferably, the organic compound(s) is or contains sorbitol and / or maltitol. If sorbitol is the only organic compound present, the lubricant preferably contains 5 to 12 wt%, more preferably 6 to 10 wt%, and most preferably 6 to 8 wt% of sorbitol based on the weight of the lubricant. If maltitol is the only organic compound present, the lubricant preferably contains 5 to 15 wt%, more preferably 6 to 14 wt%, even more preferably 8 to 14 wt%, and most preferably 11 to 13 wt% of maltitol based on the weight of the lubricant.

[0042] Preferably, the lubricant contains at least 70 wt%, more preferably at least 75 wt%, and most preferably at least 80 wt%, of water relative to the weight of the lubricant. In some embodiments, the lubricant contains up to 90 wt%, or up to 85 wt%, of water. High levels of water can be included in the lubricant without causing whitening of the condom as a result of the inclusion of polyhydric alcohols and / or sugars in the present invention.

[0043] Preferably, the lubricant has an osmotic pressure of less than 1200 mOsm / kg, less than 1100 mOsm / kg, less than 1000 mOsm / kg, or between 800 and 1000 mOsm / kg. The osmotic pressure is preferably measured by the freezing point depression method. As described above, the WHO has recommended that single personal lubricants (i.e., those not pre-provided in condoms) have an osmotic pressure of less than 1200 mOsm / kg. The inventors have found that the inclusion of polyhydric alcohols and / or sugars in the above amounts in the present invention has a favorable anti-whitening effect on condoms without raising the osmotic pressure of the lubricant to an undesirable level.

[0044] Preferably, the lubricant contains at least four hydroxyl groups and does not contain any polyhydric alcohols other than a polyhydric alcohol having a molecular weight of at least 120. In embodiments in which one or more polyhydric alcohols other than those described above are present, these one or more polyhydric alcohols are preferably present in an amount of up to 5 wt%, more preferably up to 3 wt%, even more preferably up to 2 wt%, even more preferably up to 1 wt%, and most preferably up to 0.5 wt%. Preferably, the lubricant does not contain or substantially contains any polyhydric alcohols other than those described above. Other polyhydric alcohols (for example, glycerol and propylene glycol) are generally undesirable in the lubricants of the present invention because they are generally ineffective in preventing the whitening of condoms during storage and / or increase the osmotic pressure of the lubricant to an undesirably high value.

[0045] In some embodiments, the lubricant contains or essentially does not contain glycerol, propylene glycol, or PEG having a molecular weight of 600 or less in amounts less than 5 wt%, less than 4 wt%, less than 3 wt%, less than 2 wt%, or less than 1 wt%. In one embodiment, the lubricant does not contain glycerol, propylene glycol, or PEG having a molecular weight of 600 or less.

[0046] Preferably, the lubricant has a pH of 3.5 to 5.0. This is intended to match the pH of the vagina. When referring to the pH of the lubricant, it should be understood that this refers to the pH of the lubricant on one or more surfaces of the condom in its sealed packaging. This can be determined by removing the condom from its packaging, extracting a certain amount of lubricant from the surface of the condom, and measuring the pH of that certain amount (or, if necessary, a certain amount pooled across multiple condoms from the same batch). The pH is preferably measured at a temperature of 25°C. Preferably, the pH is measured after the condom has been stored in its sealed packaging for at least 3 months, preferably at least 6 months.

[0047] The pH of the lubricant extracted from the condom in this way is not necessarily the same as the pH of the lubricant when it was first applied to the condom. This is because, in the absence of a strong buffer in the lubricant, the pH of the lubricant typically equilibrates with the pH of the condom over time. The pH of the condom is typically generally higher than the pH of the lubricant when it was applied to the condom, especially in embodiments where the condom is coated with an alkaline finishing powder. Therefore, the pH of the lubricant when applied to the condom typically rises over time until it reaches an equilibrium value.

[0048] In some embodiments, the lubricant contains a buffer or acid to adjust the pH. Suitable buffers include polybasic acids and salts of polybasic acids (e.g., sodium salts). In these embodiments, the buffer is present in an amount of 0.1 to 10 wt%, more preferably 1 to 10 wt%, even more preferably 2 to 8 wt%, and most preferably 3 to 7 wt%, relative to the weight of the lubricant. Preferably, the buffer contains polybasic acids and salts of polybasic acids in a weight ratio of polybasic acid to salt of 1:5 to 10:1, more preferably 1:2 to 5:1, and even more preferably 1:1 to 3:1. Preferably, the buffer contains citric acid and sodium citrate in the weight ratios described above. Suitable acids include weak acids, more preferably weak organic acids. The inventors have found that citric acid is an effective acidifying agent that does not adversely affect the structural integrity of the condom to which the lubricant is applied.

[0049] In some embodiments, the lubricant contains a preservative. In these embodiments, the preservative is preferably present in an amount of 0.01 to 5 wt%, more preferably 0.05 to 2 wt%, and even more preferably 0.1 to 1 wt%, relative to the weight of the lubricant. Preferably, the preservative is benzoic acid and / or benzoates, preferably sodium benzoate or chlorphenesin, or contains them. The inventors have found that benzoic acid / its salts are effective preservatives for use in the lubricant of the present invention, particularly at a desired acidic pH. Preferably, the lubricant is paraben-free.

[0050] The lubricant of the present invention further comprises a thickening agent. Suitable thickening agents include carbomer, hydroxyethylcellulose, xanthan gum, alginate, acrylate, methacrylate, silicone, ceramide and polyvinylpyrrolidone, agar, locust bean gum and gum arabic.

[0051] Preferably, the thickener is crosslinked polyacrylic acid, hydroxyethylcellulose, or xanthan gum, more preferably xanthan gum. When used, the thickener is preferably 0.01 to 2 wt%, more preferably 0.1 to 1 wt%. In one embodiment, the lubricant is dimethicone-free or silicone-free.

[0052] In some embodiments, the lubricant contains a humectant in an amount of preferably 0.01 to 2 wt%, more preferably 0.02 to 1 wt%, and most preferably 0.05 to 0.5 wt%, relative to the weight of the lubricant. Preferably, the humectant is hyaluronic acid, sodium hyaluronate, and / or collagen, or contains them.

[0053] In some embodiments, the lubricant includes a surfactant. The surfactant can help the lubricant migrate along the length of the condom during storage if the lubricant is applied to only a portion of the condom surface during manufacturing. In some embodiments, the surfactant is present in an amount of up to 2 wt%, or up to 1 wt%, or up to 0.5 wt%, relative to the weight of the lubricant. In some embodiments, the surfactant is present in an amount of at least 0.05 wt%, or at least 0.1 wt%, relative to the weight of the lubricant.

[0054] The lubricant is preferably free from or substantially free from artificial colorants and / or fragrances. Substantially free means that any artificial colorants and / or fragrances are present in a total amount of less than 1 wt%, preferably less than 0.5 wt%, and more preferably less than 0.1 wt%, relative to the weight of the lubricant. In some embodiments, the lubricant may contain an odor masker, such as a composition that masks the malodorous odor of the NRL.

[0055] Of course, the lubricant itself is preferably transparent. The anti-whitening effect of the lubricant on condoms can be most easily observed when the lubricant itself is transparent.

[0056] Preferably, the aqueous lubricant contains an aqueous solution of a specific organic compound(s) and any of the optional components of the present invention described above. Therefore, all components of the lubricant are preferably soluble in water, at least in the amount used. The lubricant is preferably oil-free. The lubricant is preferably not in the form of an emulsion.

[0057] Preferably, the lubricant has a viscosity of 100 to 10,000 mPa·s, more preferably 500 to 2,000 mPa·s, and even more preferably 800 to 1,000 mPa·s. The viscosity can be measured using a Brookfield viscometer with a spindle RV04 at a temperature of 20°C and a shear rate of 50 rpm.

[0058] In some embodiments, a condom contains a finishing powder on one or more of its surfaces. The one or more surfaces may be the inner surface and / or outer surface of the condom. Preferably, the condom contains the finishing powder on both the inner surface and / or outer surface. Finishing powders are known in the art. Finishing powders are typically alkaline and typically based on compounds such as silica, talc, carbonate, and cornstarch. Finishing powders are used to prevent the surfaces of condoms from sticking together and to aid in fitting. In particular, containing the finishing powder on the inner surface helps prevent the condom from sticking to itself, while containing the finishing powder on the outer surface also helps prevent the condom from sticking to other condoms during manufacturing.

[0059] In embodiments in which the condom contains a finishing powder on one or more of its surfaces, the finishing powder is preferably supplied in an amount of up to 100 mg, preferably up to 50 mg, and most preferably 20 to 40 mg. The use of excessively large amounts of finishing powder tends to increase the opacity of the coated condom, which is undesirable in relation to the present invention. If the amount of finishing powder described herein is small, the whitening effect of many existing aqueous lubricants becomes more pronounced, because a small amount of finishing powder itself has little effect on the opacity of the condom. Therefore, the advantageous anti-whitening properties of the lubricant of the present invention are particularly pronounced when a small amount of finishing powder is used. In some embodiments, the condom does not contain the finishing powder. In other embodiments, the condom contains a finishing powder comprising carbonates (such as magnesium carbonate and / or calcium carbonate) and / or corn starch.

[0060] Preferably, the condom of the present invention, which contains an aqueous lubricant and optional finishing powder on one or more of its surfaces, is transparent. It should be understood that the transparency associated with this refers to the unrolled condom after it has been removed from its packaging, as the rolled portion of a rolled condom may appear substantially opaque even if the condom material itself is transparent. In practice, the packaging itself can be opaque. Preferably, the condom, which contains an aqueous lubricant and optional finishing powder on one or more of its surfaces, remains transparent for at least 6 months, or at least 12 months, or at least 18 months, or at least 24 months after storage in sealed packaging at a temperature of 10 to 40°C. Preferably, the transparency of the condom, which contains an aqueous lubricant and optional finishing powder on one or more of its surfaces, is substantially the same as the transparency of the condom before the application of the aqueous lubricant or optional finishing powder after storage in sealed packaging.

[0061] Preferably, a condom containing an aqueous lubricant and optional finishing powder on one or more of its surfaces has a haze value of up to 70% after the storage period specified in the preceding paragraph. Preferably, the haze value is up to 60%, more preferably up to 50%, still more preferably up to 40%, and most preferably up to 30%. In some embodiments, the haze value is at least 10% or at least 15%. The haze value is defined elsewhere in this specification.

[0062] Preferably, a condom containing an aqueous lubricant and optional finishing powder on one or more of its surfaces preferably has a haze value up to 10% higher relative to the haze value of the condom before the application of the lubricant and optional finishing powder after the storage period specified above. In embodiments in which the condom contains finishing powder, a condom containing an aqueous lubricant and finishing powder on one or more of its surfaces preferably has a haze value that is at least 50% lower, at least 60% lower, or at least 70% lower relative to the haze value of the condom after the application of the finishing powder but before the application of the lubricant. This is preferably after the storage period specified above. That is, the application of the lubricant increases the transparency of the condom coated with the finishing powder, and this increase in transparency can be maintained during storage.

[0063] In a particular preferred embodiment, the present invention provides a packaged condom comprising a sealed package and a condom of natural rubber latex inside the package. A condom contains an aqueous lubricant on one or more of its surfaces. The aqueous lubricant comprises a thickener and 5 to 19 wt% (preferably 8 to 13 wt%) of a polyhydric alcohol relative to the weight of the aqueous lubricant, wherein the polyhydric alcohol has at least 8 hydroxyl groups (preferably at least 9 hydroxyl groups) and a molecular weight of 300 to 500. The aqueous lubricant contains at least 8 (or preferably 9) hydroxyl groups and 0 to 2 wt% of polyhydric alcohols other than polyhydric alcohols having a molecular weight of 300 to 500.

[0064] In these embodiments, the lubricant preferably contains maltitol, and the lubricant preferably has an osmotic pressure of less than 1200 mOsm / kg and / or a pH of 3.5 to 5.0.

[0065] In a particular preferred embodiment, the present invention provides a packaged condom comprising a sealed package and a condom of natural rubber latex inside the package. A condom contains an aqueous lubricant on one or more of its surfaces. The aqueous lubricant comprises a thickener and 5 to 19 wt% (preferably 6 to 10 wt%) of a polyhydric alcohol relative to the weight of the lubricant, wherein the polyhydric alcohol has at least 5 hydroxyl groups (preferably at least 6 hydroxyl groups) and a molecular weight of 150 to 200. The aqueous lubricant contains 0 to 2 wt% of polyhydric alcohols other than polyhydric alcohols having at least 5 (or at least 6) hydroxyl groups and a molecular weight of 150 to 200.

[0066] In these embodiments, the lubricant preferably comprises sorbitol, and the lubricant preferably has an osmotic pressure of less than 1200 mOsm / kg and / or a pH of 3.5 to 5.0.

[0067] According to a second aspect, the present invention provides a method for preparing packaged condoms. This method is (i) A step of providing an aqueous lubricant, wherein the aqueous lubricant comprises a thickener and one or more organic compounds independently selected from the group consisting of polyhydric alcohols and sugars in a total amount of 5 to 25 wt% relative to the weight of the aqueous lubricant, and each of the one or more organic compounds has at least four hydroxyl groups and a molecular weight of at least 120, (ii) the step of providing a condom as defined in the first embodiment, (iii) Applying a single dose of aqueous lubricant to one or more surfaces of a condom so as to form an aqueous lubricant-coated condom in which the aqueous lubricant comes into contact with natural rubber latex and / or synthetic polyisoprene, (iv) The step of sealing the water-based lubricated condom inside the packaging, Includes. These steps are intended to be performed sequentially, however, there may be some overlap between steps when this method is performed sequentially, and there may be further steps, such as electrical testing of the condom hole.

[0068] In the step of providing an aqueous lubricant, the aqueous lubricant is substantially the same as the lubricant defined in relation to the first embodiment. However, it should be noted that the aqueous lubricant in the first embodiment is a lubricant contained on one or more surfaces of the condom, whereas the aqueous lubricant in step (i) above refers to the lubricant before it is applied to one or more surfaces of the condom. In step (i) above, the lubricant before it is applied to the condom preferably has a pH of 3.0 to 5.0, more preferably 3.0 to 4.5, 3.0 to 4.0, or 3.5 to 4.5. As described above, the pH of the lubricant (including optional finishing powders) may increase when it equilibrates with the surface of the condom, but this can be mitigated at least to some extent by using a suitable buffering system or acid.

[0069] In step (ii), the condom may be supplied in a roll. In this embodiment, one dose of lubricant in step (iii) may be applied to or near the tip of the rolled condom. The lubricant may then move along the roll of condom over time (including after the condom has been sealed in the packaging). In this embodiment, the condom is already in the packaging or on a material (such as a single foil piece) that will form part of the packaging at the time the lubricant is applied. Only the sealing step must necessarily be performed after the lubricant has been applied.

[0070] In an alternative embodiment, in step (ii), the condom is provided in a non-rolled state. In this embodiment, one application of lubricant in step (iii) is applied to one or more surfaces of the condom before it is rolled. The lubricant can be applied by various known methods, for example, by spraying or by rolling a sponge soaked in lubricant, or one application of lubricant can be applied to one or more points along the length of the condom before rolling. It should be understood that a higher viscosity of the lubricant is acceptable if the lubricant is pre-applied to all or substantially all of the required areas of the condom so that the lubricant does not need to move to the desired area.

[0071] In some embodiments, the method further includes the step of coating one or more surfaces of the condom with a finishing powder. The one or more surfaces may be the inner surface and / or the outer surface, preferably the inner surface and the outer surface. This is done before rolling and before lubrication is applied. The step of coating one or more surfaces of the condom with a finishing powder may include the step of applying the finishing powder to one or more surfaces as a powder or as a liquid slurry (preferably an aqueous slurry). In the latter embodiment, water may be evaporated to form a coating of finishing powder on one or more surfaces of the condom.

[0072] Preferably, the packaged condom prepared by the method of the second embodiment is the packaged condom of the first embodiment.

[0073] According to a third aspect, the present invention provides a packaged condom that can be obtained or obtained by the method according to the second aspect.

[0074] According to a fourth aspect, the present invention provides the use of an aqueous lubricant as defined in a second aspect for lubricating one or more surfaces of a condom as defined in a first aspect, such that the lubricant comes into contact with the natural rubber latex and / or synthetic polyisoprene, while maintaining the transparency of the condom within the sealed packaging during storage.

[0075] Preferably, transparency is maintained during storage at a temperature of 10°C to 40°C for at least 6 months, or at least 12 months, or at least 18 months, or at least 24 months. The condom may contain finishing powder on one or more surfaces thereon, preferably in an amount of up to 100 mg, more preferably up to 50 mg, and most preferably 20 to 40 mg.

[0076] After storage as described above, a condom containing an aqueous lubricant and optional finishing powder on one or more surfaces preferably has a haze value less than 10% higher relative to the haze value of the condom before the application of the lubricant and optional finishing powder. In embodiments containing finishing powder, a condom containing an aqueous lubricant and finishing powder on one or more surfaces has a haze value that is at least 50% lower, at least 60% lower, or at least 70% lower relative to the haze value of the condom after the application of the finishing powder but before the application of the lubricant.

[0077] The embodiments described above can be freely combined with any of the embodiments disclosed herein.

[0078] Herein, the present invention will be described in relation to the following non-limiting embodiments. [Examples]

[0079] The following observations by the inventors revealed that commercially available natural rubber latex condoms lubricated with aqueous lubricants turned white after 7 days of storage in sealed packaging, while the same condoms lubricated with silicone oil remained transparent. The inventors sought to investigate whether water causes or at least contributes to this whitening. To do this, natural rubber latex condoms were immersed in deionized water. Initially, the condoms were observed to be transparent. After 5 hours, the condoms turned white. The longer the immersion, the whiter the condoms became. Therefore, it was concluded that water in existing aqueous lubricants causes or at least contributes to the whitening of condoms. [Examples]

[0080] The effects of solutions of polyhydric alcohols (glycerol, 1,3-propanediol, PEG400, and sorbitol) at different concentrations on the whitening of clear natural rubber latex condoms during storage were tested. For each composition shown in Table 1, 600 mg of the solution was applied to the tip of a roll of clear natural rubber latex condom. In all cases, the solution was clear before application to the condom, and the condom remained clear immediately after application. The treated condoms were then sealed in foil packaging. After storage under the conditions shown in Table 1, the condoms were removed from their packaging and examined. The appearance of the condoms was recorded in Table 1 (T=clear, L=translucent, O=opaque). (Table 1) Tests of various polyhydric alcohols on the effect of whitening of transparent natural rubber latex condoms TIFF0007902188000001.tif93141 # After storage at 70°C for 28 days, no further changes were observed in any of the samples.

[0081] As can be seen from Table 1, transparency is affected not only by the water content of the applied solution but also by the choice of solute. Similar to pure water, glycerol and 1,3-propanediol themselves caused whitening when used at 100% concentration, and when in solution with water, glycerol and 1,3-propanediol themselves had a very limited effect in preventing water whitening. In detail, condoms were found to remain opaque after storage when containing 10 wt% glycerol or 10 wt% 1,3-propanediol. By including higher levels of glycerol or 1,3-propanediol (lower levels of water), the condoms were prevented from becoming completely opaque, but they had a translucent appearance and were not transparent. PEG400 was able to maintain the transparent appearance of the condoms, but only when included at very high concentrations (at least 80%).

[0082] Sorbitol is the only tested polyhydric alcohol that has been able to keep condoms clear at low concentrations (5 wt% or 10 wt%), in other words, sorbitol in these solutions does not cause whitening itself and, in addition, allows the use of high concentrations of water. [Examples]

[0083] An aqueous lubricant formulation according to the present invention was prepared and administered to the tips of two rolled-up transparent natural rubber latex condoms (600 mg of lubricant per condom). (Table 2) Lubricant according to the present invention TIFF0007902188000002.tif47129 [Examples]

[0084] The haze values ​​(%) of a series of natural rubber latex condoms were measured according to ASTM standard D 1003. The procedure included the following steps: Remove the condom from its packaging (if any), unfold it, and cut it along the length from the open end to the closed end of the condom. • Place the cut condom on the surface as a flat, thin film. • Three points are marked on the thin film (the first point at or as close as possible to the end of the membrane that previously formed the closed end of the condom, the second point at or as close as possible to the end of the membrane that previously formed the open end of the condom, and the third point midway between the first and second points), Place the marked thin film into the thin film sample holder. • Set the thin film sample holder in the UV-Vis spectrophotometer (BYK Haze-gard i), • Measure the haze value at each of the three points (specifically, with respect to a circle with a diameter of 18 mm surrounding each of the three points), • The condom's haze value was calculated as the average of three measurements (open end, closed end, and midpoint).

[0085] The results are shown in Table 3. (Table 3) Haze value measurement results for various lubricated condoms TIFF0007902188000003.tif57147 ( # -After soaking, ## (Removed from packaging)

[0086] It should be noted that there is a direct correlation between the haze value measurement results and the observation results of condom transparency. The condom with the highest transparency had the lowest haze value, and vice versa. This confirms the effectiveness of the haze value as a parameter for quantifying the transparency of lubricated (and unlubricated) condoms. [Examples]

[0087] Several lubricants according to the present invention were prepared. Their osmotic pressures were measured using the freezing point depression method. Specifically, 100 μL of each test sample was pipetteed into a sample tube and placed in the freezing chamber of a LOSER OM819 freezing point osmometer. The amount of freezing point depression was then measured using the osmometer and converted to an osmotic pressure value.

[0088] The pH value of the lubricant was measured at room temperature using a pH probe.

[0089] The viscosity of the lubricant was measured at 20°C and a shear cutting speed of 50 rpm using a Brookfield viscometer spindle RV04. (Table 4) The embodied lubricant according to the present invention TIFF0007902188000004.tif93146

[0090] It was found that all lubricants have a low osmotic pressure, meeting the WHO recommended value of less than 1200 mOsm / kg.

[0091] Subsequently, 600 mg of each lubricant was applied to the tip of a roll of clear natural rubber latex condom. The lubricated condoms were sealed in foil packaging. After storage at room temperature or 70°C for one week, the condoms were removed from the packaging and examined. All lubricated condoms were observed to be transparent after storage and removal from the foil packaging. [Examples]

[0092] In this invention, several lubricants were prepared, with maltitol being the polyhydric alcohol. The pH of the lubricant was adjusted using citric acid, and chlorphenesin and 1,2-hexanediol were used as preservatives. To test its effect on condom whitening, this lubricant was applied to a clear natural rubber latex condom. (Table 5) The embodied lubricant according to the present invention TIFF0007902188000005.tif57132

[0093] Subsequently, each lubricant (600 mg) was applied to the tip of a roll of clear natural rubber latex condom. The lubricated condoms were sealed in foil packaging. After storage at 70°C for one week, the condoms were removed from the packaging and examined. All lubricated condoms remained transparent upon observation after storage and foil packaging. Furthermore, strength tests of the condoms showed compliance with ISO standards, with zero instances of nipple breakage (teat breakage). The wt% values ​​expressed herein are based on the total weight of the lubricant unless otherwise specified.

[0094] The above detailed description is provided for illustrative and explanatory purposes only and is not intended to limit the scope of the appended claims. Many modifications of the currently preferred embodiments described herein will be obvious to those skilled in the art and will remain within the scope of the appended claims and their equivalents.

Claims

1. It is a packaged condom, Sealed packaging, A condom containing natural rubber latex and / or synthetic polyisoprene, contained within the aforementioned sealed packaging, Equipped with, The condom contains an aqueous lubricant in contact with the natural rubber latex and / or the synthetic polyisoprene on one or more surfaces. The aqueous lubricant is Thickening agent, A total amount of sorbitol and / or maltitol, in an amount of 5 to 15% relative to the weight of the aqueous lubricant, Includes, The aqueous lubricant is a packaged condom having an osmotic pressure of less than 1200 mOsm / kg.

2. The packaged condom according to claim 1, wherein the aqueous lubricant comprises a total amount of 7 to 15 wt% of sorbitol and / or maltitol.

3. The packaged condom according to claim 1 or 2, wherein the aqueous lubricant comprises a total amount of 5 to 15 wt% of maltitol.

4. The packaged condom according to claim 3, wherein the aqueous lubricant comprises a total amount of maltitol from 6 to 14 wt%.

5. The packaged condom according to claim 3 or 4, wherein the aqueous lubricant comprises a total amount of 8 to 13 wt% maltitol.

6. The packaged condom according to any one of claims 3 to 5, wherein the aqueous lubricant comprises 11 to 13 wt% of maltitol in total.

7. The packaged condom according to claim 1 or 2, wherein the aqueous lubricant comprises a total amount of 5 to 12 wt% of sorbitol.

8. The packaged condom according to claim 7, wherein the aqueous lubricant comprises a total amount of 6 to 10 wt% of sorbitol.

9. The packaged condom according to claim 7 or 8, wherein the aqueous lubricant comprises a total amount of 6 to 8 wt% sorbitol.

10. The packaged condom according to any one of claims 1 to 9, wherein the aqueous lubricant has a pH of 3.5 to 5.0 before being applied to the condom.

11. The packaged condom according to any one of claims 1 to 10, wherein the condom further comprises a finishing powder on one or more surfaces, the finishing powder being provided in an amount of up to 100 mg.

12. The condom is transparent, as described in any one of claims 1 to 11.

13. The packaged condom according to any one of claims 1 to 12, wherein the condom is a condom made of natural rubber latex.

14. A method for preparing packaged condoms, (i) A step of providing an aqueous lubricant, wherein the aqueous lubricant comprises a thickener and sorbitol and / or maltitol in a total amount of 5 to 15% relative to the weight of the aqueous lubricant, and the lubricant has an osmotic pressure of less than 1200 mOsm / kg, (ii) A step of providing a condom comprising natural rubber latex and / or synthetic polyisoprene, (iii) The step of applying one dose of the aqueous lubricant to one or more surfaces of the condom such that the aqueous lubricant comes into contact with the natural rubber latex and / or the synthetic polyisoprene, (iv) The step of sealing the condom inside the packaging, A method that includes this.

15. A packaged condom obtainable or obtained by the method described in Claim 14.

16. The use of an aqueous lubricant for lubricating one or more surfaces of a condom containing natural rubber latex and / or synthetic polyisoprene, while maintaining the transparency of the condom within the sealed packaging during storage, The aqueous lubricant comprises a thickener and sorbitol and / or maltitol in a total amount of 5 to 15% relative to the weight of the aqueous lubricant, and the lubricant has an osmotic pressure of less than 1200 mOsm / kg.

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