PACKAGED LUBRICATED CONDOM

Abstract

The present invention provides a packaged condom comprising a sealed package and, within the package, a condom comprising natural rubber latex and/or synthetic polyisoprene, wherein the condom comprises, on one or more surfaces thereof and in contact with the natural rubber latex and/or synthetic polyisoprene, an aqueous lubricant. The aqueous lubricant comprises a thickener and, in a total amount of from 5 to 25% by weight of the lubricant, one or more organic compounds independently selected from the group consisting of a polyhydric alcohol and a sugar, each of said one or more organic compounds having at least 4 hydroxyl groups and a molecular weight of from 120 to 10000. The invention further provides a method for preparing a packaged condom, a packaged condom obtainable by or obtained by this method, and the use of the aqueous lubricant to lubricate one or more surfaces of a condom comprising natural rubber latex and/or synthetic polyisoprene while maintaining the transparency of the condom during storage within a sealed package.

Claims

1. A packaged condom comprising: a sealed package; and within the sealed package, a condom comprising natural rubber latex and/or synthetic polyisoprene; wherein the condom further comprises an aqueous lubricant on one or more surfaces thereof, the aqueous lubricant in contact with the natural rubber latex and/or synthetic polyisoprene, wherein the aqueous lubricant comprises: a thickener; and one or more organic compounds in a total amount of from 5 to 25% by weight of the aqueous lubricant, the one or more organic compounds independently selected from the group consisting of a polyhydric alcohol and a sugar, each of said one or more organic compounds having at least 4 hydroxyl groups and a molecular weight of from 120 to 10000.

2. The packaged condom according to claim 1, wherein each of said one or more organic compounds has a molecular weight of from 150 to 1000, preferably from 150 to 500.

3. The packaged condom according to claim 1, wherein the aqueous lubricant comprises a total amount of from 5 to 20 wt % of the one or more organic compounds, preferably from 7 to 15 wt %.

4. The packaged condom according to claim 1, wherein the polyhydric alcohol is a sugar alcohol and/or the one or more organic compounds are independently a polyhydric alcohol.

5. The packaged condom according to claim 1, wherein the one or more organic compounds are independently selected from the group consisting of a monosaccharide, a disaccharide, a sugar alcohol derived from a monosaccharide, and a sugar alcohol derived from a disaccharide.

6. The packaged condom according to claim 5, wherein the one or more organic compounds are independently selected from the group consisting of a disaccharide and a sugar alcohol derived from a disaccharide, and the lubricant comprises a total amount of from 5 to 15 wt % of the organic compound(s), more preferably from 6 to 14 wt %, still more preferably from 8 to 13 wt % and most preferably from 11 to 13 wt %.

7. The packaged condom according to claim 5, wherein the one or more organic compounds are independently selected from the group consisting of a monosaccharide and a sugar alcohol derived from a monosaccharide, and the lubricant comprises a total amount of from 5 to 12 wt % of the organic compound(s), more preferably from 6 to 10 wt % and most preferably from 6 to 8 wt %.

8. The packaged condom according to claim 5, wherein at least one of the one or more organic compounds is sorbitol and/or at least one of the one or more organic compounds is maltitol.

9. The packaged condom according to claim 1, wherein the aqueous lubricant comprises at least 70 wt % water, preferably at least 75 wt % water, preferably at least 80 wt % water.

10. The packaged condom according to claim 1, wherein the aqueous lubricant has an osmolality of less than 1200 mOsm/kg.

11. The packaged condom according to claim 1, wherein the aqueous lubricant has a pH of from 3.5 to 5.0 before being applied to the condom.

12. The packaged condom according to claim 1, wherein the condom further comprises, on one or more surfaces thereof, a finishing powder, wherein the finishing powder is provided in an amount of at most 100 mg, preferably at most 50 mg, and most preferably from 20 to 40 mg.

13. The packaged condom according to claim 1, wherein the condom is transparent.

14. The packaged condom according to claim 1, wherein the condom is a natural rubber latex condom.

15. A method for preparing a packaged condom, the method comprising: (i) providing an aqueous lubricant, wherein the aqueous lubricant comprises a thickener and one or more organic compounds in a total amount of from 5 to 25% by weight of the aqueous lubricant, the one or more organic compounds independently selected from the group consisting of a polyhydric alcohol and a sugar, each of said one or more organic compounds having at least 4 hydroxyl groups and a molecular weight of from 120 to 10000; (ii) providing a condom comprising natural rubber latex and/or synthetic polyisoprene; (iii) applying a dose of the aqueous lubricant to one or more surfaces of the condom such that the aqueous lubricant is in contact with the natural rubber latex and/or synthetic polyisoprene; and (iv) sealing the condom within a package.

16. A packaged condom obtainable by or obtained by the method according to claim 15.

17. A method of using an aqueous lubricant to lubricate one or more surfaces of a condom comprising natural rubber latex and/or synthetic polyisoprene while maintaining the transparency of the condom during storage within a sealed package, the method comprising applying the aqueous lubricant to one or more surfaces of the condom such that the aqueous lubricant is in contact with the natural rubber latex and/or synthetic polyisoprene, wherein the aqueous lubricant comprises a thickener and, in a total amount of from 5 to 25% by weight of the aqueous lubricant, one or more organic compounds independently selected from the group consisting of a polyhydric alcohol and a sugar, wherein each of the one or more organic compounds has at least 4 hydroxyl groups and a molecular weight of from 120 to 10000.

Description

[0102] The present invention will now be described in relation to the following non-limiting Examples.

EXAMPLE 1

[0103] Following an observation by the inventors that a commercially available natural rubber latex condom, lubricated with an aqueous lubricant, appeared white after 7 days' storage in a sealed package, whereas the same condom lubricated with silicone oil appeared transparent, the inventors sought to investigate whether water was causing or at least contributing to the whitening. To do this, a natural rubber latex condom was immersed in deionized water. Initially, the condom was observed to be transparent. After 5 hours, the condom appeared white. The longer the condom was immersed, the whiter it appeared. It was therefore concluded that the water in the existing aqueous lubricant was causing or at least contributing to the whitening of the condom.

EXAMPLE 2

[0104] Solutions of different concentrations of polyhydric alcohols (glycerol, 1,3-propanediol, PEG400 and sorbitol) were tested for their effect on the whitening of a transparent natural rubber latex condom during storage. For each composition in Table 1, 600 mg of the solution was dosed onto the tip of a rolled transparent natural rubber latex condom. In each case, the solution was transparent prior to application to the condom, and the condom was found to be transparent immediately after application of the solution. The treated condom was then sealed in a foil package. After storage under the conditions shown in Table 1, the condom was removed from the packaging and inspected. The visual appearance of the condom is recorded in Table 1 (T=transparent, L=translucent, O=opaque).

TABLE-US-00001 TABLE 1 Testing of different polyhydric alcohols for effect on whitening of a transparent natural rubber latex condom C, D, E, J, K, L, P, Q, R, Composition A B F, G, H I M, N, O S, T U V W X Water 100 90 balance 90 balance balance 20 0 95 90 Glycerol 10 20, 40, 50, 60, 80, 100 1,3- 10 20, 40, Propanediol 50, 60, 80, 100 PEG400 10, 20, 80 100 40, 50, 60 Sorbitol 5 10 Transparency O O L O L L T T T T of lubricated condom (after 7 days' storage at 70 C.).sup.# .sup.#No further change was observed for any of the samples after 28 days' storage at 70 C.

[0105] As can be seen from Table 1, the transparency is not only affected by the water content of the applied solution, but also by the selection of the solute. As well as pure water, glycerol and 1,3-propanediol themselves caused whitening when used at 100% concentration; when in solution with water, they were found to have a very limited anti-whitening effect of the water. In particular, the condom was still found to be opaque after storage if 10 wt % glycerol or 10 wt % 1,3-propanediol was included. Including higher levels of glycerol or 1,3-propanediol (lower levels of water) prevented the condom from going fully opaque, but the condom appeared translucent and not transparent. PEG400 was able to maintain the transparent appearance of the condom but only when included at very high concentrations (at least 80 wt %).

[0106] Sorbitol was the only polyhydric alcohol tested that was able to keep the condom transparent at low concentrations (5 wt % or 10 wt %), or put another way, sorbitol in these solutions does not itself cause whitening and additionally enables a high concentration of water to be used.

EXAMPLE 3

[0107] An aqueous lubricant formulation in accordance with the invention was prepared and dosed onto the tips of two rolled transparent natural rubber latex condoms (600 mg of lubricant per condom). The lubricated condoms were sealed in individual foil packages. After 1 week of storage at either room temperature or 70 C., the condoms were removed from the packaging and observed to be transparent. The lubricant composition is shown in Table 2.

TABLE-US-00002 TABLE 2 Lubricant in accordance with the invention Composition 1 (wt %) Water 82.8 1,2-Hexanediol 1 Phenethyl Alcohol 1 Glycerol 4 Xanthan gum 0.7 Sodium hyaluronate 0.1 Lactic acid/Potassium Lactate 0.4 Sorbitol 10

EXAMPLE 4

[0108] The haze value (%) was measured for a series of natural rubber latex condoms based on ASTM Standard D 1003. The procedure involved the following steps: [0109] the condom was removed from its packaging (when present), unrolled, and cut along the length of the condom from the open end to the closed end; [0110] the cut condom was laid on a surface as a flat film; [0111] three spots were marked on the film (a first spot at the end of the film that previously formed the closed end of the condom or as close thereto as possible, a second spot at the end of the film that previously formed the open end of the condom or as close thereto as possible, and a third sport at a midpoint between the first and second spots); [0112] the marked film was placed into a thin film sample holder; [0113] the sample holder was placed into a UV-Visible spectrophotometer (BYK Haze-gard i); [0114] the haze value was measured at each of three spots (specifically for a circle having a diameter of 18 mm encompassing each of the three spots); and [0115] the haze value for the condom was calculated as the mean average of the three measurements (open end, closed end and midpoint).

[0116] The results are shown in Table 3.

TABLE-US-00003 TABLE 3 Measured haze values for a selection of lubricated condoms Haze Haze Haze (open (mid (closed Haze end) body) end) (condom) Condom Finishing powder Lubricant (%) (%) (%) (%) CE1.sup.# Carbonate-based None 84.28 87.50 83.31 85.03 CE2.sup.# Corn starch-based None 57.19 58.37 58.72 58.09 CE3.sup.## Carbonate-based Silicone oil 72.00 55.42 45.78 57.73 CE4.sup.## Corn starch-based Silicone oil 17.00 19.85 14.08 16.98 (.sup.#after dipping; .sup.##removed from packaging)

[0117] It was noted that there was a direct association between the measured haze value and the observed transparency of the condoms: the most transparent condoms had the lowest haze values and vice versa. This validated the haze value as a parameter for quantifying the transparency of lubricated (and unlubricated) condoms.

EXAMPLE 5

[0118] Several lubricants in accordance with the present invention were prepared. Their osmolalities were measured by a freezing point depression method. In particular, 100 L of each test sample was pipetted into sample tubes, which were placed in the freezing chamber of a LOSER 0M819 Freezing Point Osmometer. The freezing point depressions were then determined by the osmometer and converted to osmolality values.

[0119] The pH values of the lubricants were measured using a pH probe at room temperature.

[0120] The viscosities of the lubricants were also measured at 20 C. and a shear rate of 50 rpm using a Brookfield viscometer, spindle RV04.

[0121] The compositions together with the measured properties are shown in Table 4.

TABLE-US-00004 TABLE 4 Exemplary lubricants in accordance with the invention Composition 2 3 4 5 6 Water 85.3 86.3 80.3 81.3 83.3 Xanthan Gum FNCS 0.5 0.5 0.5 0.5 0.5 Sodium hyaluronate 0.1 0.1 0.1 0.1 0.1 Citric acid 3.5 3.5 3.5 3.5 3.5 Sodium citrate 2.4 2.4 2.4 2.4 2.4 Benzoic acid 0.2 0.2 0.2 0.2 0.2 Sorbitol 8 7 N/A N/A N/A Maltitol N/A N/A 13 12 10 pH 3.56 3.56 3.56 3.57 3.59 Viscosity/mPa .Math. s 840 840 840 900 860 Osmolality/mOsm/kg 1088 1005 1133 1099 941

[0122] All of the lubricants were found to have a low osmolality meeting the WHO recommendation of less than 1200 mOsm/kg.

[0123] The lubricants were each then dosed (600 mg) onto the tip of a rolled transparent natural rubber latex condom. The lubricated condoms were sealed in foil packages. After 1 week of storage at either room temperature or 70 C., the condoms were removed from the packaging and inspected. All of the lubricated condoms were observed to be transparent after storage and removal from the foil package.

EXAMPLE 6

[0124] Several lubricants in accordance with the present invention were prepared where the polyhydric alcohol is maltitol. Citric acid was used to adjust the pH of the lubricant and chlorphenesin and 1,2-hexanediol were used as the preservative. The lubricants were applied to transparent natural rubber latex condoms to test for their effect on whitening of the condoms.

TABLE-US-00005 TABLE 5 Exemplary lubricant in accordance with the invention Composition 7 8 Water 84.69 85.67 Citric acid 0 0.07 Chlorphenesin 0.2 0.2 1,2-hexanediol 1 1 Xanthan gum 0.6 0.6 Hyaluronic acid 0.1 0.1 Maltitol 13 13 Flavouring 0.01 0.01 Lactic acid/potassium 0.4 0 lactate

[0125] The lubricants were each then dosed (600 mg) onto the tip of a rolled transparent natural rubber latex condom. The lubricated condoms were sealed in foil packages. After 1 week of storage at 70 C., the condoms were removed from the packaging and inspected. All of the lubricated condoms were observed to be transparent after storage and removal from the foil package. Further, the condoms were strength tested and found to comply with the ISO standards with zero teat breakages.

[0126] The wt % values given herein are based on the total weight of the lubricant unless otherwise stated.

[0127] The foregoing detailed description has been provided by way of explanation and illustration, and is not intended to limit the scope of the appended claims. Many variations in the presently preferred embodiments illustrated herein will be apparent to one of ordinary skill in the art, and remain within the scope of the appended claims and their equivalents.