GB2425479A

GB2425479A - Aloe vera coated contraceptive

Info

Publication number: GB2425479A
Application number: GB0508308A
Authority: GB
Inventors: Mehmet Hussein
Original assignee: BRITANNIA MEDICARE Ltd
Current assignee: BRITANNIA MEDICARE Ltd
Priority date: 2005-04-25
Filing date: 2005-04-25
Publication date: 2006-11-01
Also published as: GB0508308D0

Abstract

A contraceptive device having a lubricant and aloe vera gel on a surface thereof is disclosed. The latex or polyurethane contraceptive may be a sealed package containing an aloe vera coated condom (male or female), diaphragm or cervical cap, coated with no greater than 0.04 weight percent lubricant plus aloe vera; alternatively, the gel may comprise no more than 0.03 % lubricant plus aloe vera. Low concentrations of aloe vera are apparently advantageous: higher aloe vera concentrations have been shown to reduce bursting pressure and volume, tensile elongation and force at break of condoms - see example graphs below.

Description

M&C Folio: GBP92365 2425479

LUBRICATED CONTRACEPTIVE DEVICE

The present invention is concerned with improved contraceptive devices, particularly condoms, more particularly male condoms.

It is well known in the art to apply lubricants to contraceptive devices, and a wide range of lubricants are commercially available which are suited to use with the various types of contraceptive devices and their component materials. As well as acting to help prevent pregnancy, contraceptive devices are also useful in helping limit the spread of sexually transmitted infections (STIs) by acting as a barrier device between two people, e.g. between the penis and vagina. In the case of condoms, they are also often coated on their inner surface or a part thereof with spermicidal and virucidal agents to further aid in preventing pregnancy and spreading STIs.

Contraceptive devices are frequently worn skin-tight, but this can result in discomfort, hence the incorporation of lubricants in e.g. condoms. Even with modem lubricated contraceptive devices, discomfort and irritation to the skin of a user can be problematic.

The present inventor has now devised improved lubricated contraceptive devices that seek to overcome the prior art disadvantages. In particular, they seek to be highly comfortable to apply and to wear and also seek to provide enhanced care to the skin of a user so as to help reduce skin breakages which can result in the leakage of blood and serum and which can result in the spread of diseases between people.

Thus according to the present invention there is provided a sealed package containing within it a contraceptive device having a lubricant and aloe vera gel on at least a portion of a surface thereof.

The sealed package may be a manufactured contraceptive article containing within it the contraceptive device. In particular, the contraceptive device may be hermetically sealed within the package.

As used herein, the term "aloe vera gel" (also "aloe gel") is used to indicate the leaf pulp or mucilage, a thin clear gelatinous substance obtained from the parenchymal tissue of the leaves of the Aloe plant, and is distinct from Aloe latex which is an exudates from the pericyclic tubules of the Aloe plant. The terms are further defined by e.g. Tyler, Varro E. ("The honest herbal: a sensible guide to the use of herbs and related remedies", 3rd ed., London: Pharmaceutical Products Press, 1993; ISBN: 1560242868). The aloe vera gel used in the present invention may be ACTIVE-ALOE (RTM) Gel-D (Aloecorp, Washington, USA - www.aloecorp.com) which is derived from Aloe barbadensis Miller, and which is also called ACTIVa1oe (RTM) Aloe vera gel-D.

The contraceptive device may be a male condom, a female condom, a diaphragm or cervical cap. It is particularly preferred that the contraceptive device is a male condom.

The contraceptive may comprise latex or polyurethane. For example, the contraceptive device may be a latex condom.

As is shown in the experiments below, it has been found that the proportion of aloe vera in the lubricant and aloe vera mixture applied to the contraceptive device can critically affect its mechanical properties. In particular, the experiments below show that higher concentrations of aloe vera reduce the bursting pressure, tensile elongation, and force at break of condoms. Although this has not previously been recognised or identified as being a problem with applying lubricants incorporating aloe vera to contraceptives such as condoms during use, this is critical when they are supplied in a packaged form which can often remain unused for long periods at elevated temperatures, for example in a user's pocket or wallet. Although it is desired to enhance the characteristics of the contraceptive devices, this should not adversely affect their mechanical properties.

Thus in the sealed packages of the present invention, it is preferred that the aloe vera gel comprises no more than about 0.04% w/w of the total weight of lubricant plus aloe vera gel, and more preferably it comprises no more than about 0.03% w/w of the total weight of lubricant plus aloe vera gel.

Contraceptive devices of the present invention preferably comprise no aloe vera, i.e. the contraceptive device (without the lubricant and aloe vera gel on at least a portion of its surface) may not comprise aloe vera.

The lubricant may be a water-based lubricant. It may comprise glycols. It may comprise silicone andlor silicone fluid. It may comprise a silicone polyester. Examples of brands of lubricant include Rhodia-Silbione (RTM) (www.rhodia.com, Rhodia Europe, France).

In the various aspects of the present invention a total of e.g. 0.2g to 0. 6g of lubricant and aloe vera gel may be applied to the surface of the contraceptive device. More particularly, about 0.45g of the lubricant and aloe vera gel may be applied to the surface of the contraceptive device.

Lubricant quantity can be readily determined by weighing the contraceptive firstly when it has the lubricant and aloe vera mix on its surface, and secondly after washing and drying to remove the lubricant and aloe vera mix. The difference between the two values is the quantity of lubricant and aloe vera mix on the contraceptive.

Also provided according to the present invention is a contraceptive device having a lubricant and aloe vera gel on at least a portion of a surface thereof, said aloe vera gel comprising no greater than about 0. 04% of the total weight of lubricant plus aloe vera gel.

Also provided according to the present invention are methods of manufacture of the contraceptive devices and sealed packages containing contraceptive devices. In particular, The various aspects and features detailed above for the sealed packages are equally applicable in the context of these aspect of the present invention. Thus, for example, the aloe vera gel may comprise no more than about 0.03% of the total weight of lubricant plus aloe vera gel.

The invention will be further apparent from the following description with reference to the drawings of the accompanying figures which shows by way of example only forms of contraceptive devices according to the present invention. Of the Figures: Figure 1 shows bursting volume results for 0.03% aloe vera; Figure 2 shows bursting pressure results for 0.03% aloe vera; Figure 3 shows bursting volume results for 0.04% aloe vera; Figure 4 shows bursting pressure results for 0.04% aloe vera; Figure 5 shows bursting volume results for 0.05% aloe vera; Figure 6 shows bursting pressure results for 0.05 % aloe vera; Figure 7 shows tensile elongation results for 0.03% aloe vera; Figure 8 shows tensile force at break results for 0.03% aloe vera; Figure 9 shows tensile elongation results for 0.04% aloe vera; Figure 10 shows tensile force at break results for 0.04% aloe vera; Figure 11 shows tensile elongation results for 0.05% aloe vera; and Figure 12 shows tensile force at break results for 0.05% aloe vera; The experiments detailed below were performed with a single batch of latex male condoms and were performed to determine the effect of varying concentrations of aloe vera gel (ACTIVa1oe (RTM) Aloe vera gel-D, Aloecorp, Washington, USA) mixed with silicone lubricant (Rhodia-Silbione (RTM), Rhodia Europe, France) upon the mechanical characteristics of the condoms.

The results detailed below show that using higher concentrations of aloe vera gel (concentrations are calculated as a percentage of the total weight of aloe vera gel plus lubricant) results in mechanical weakening of the condoms. Thus the conclusions drawn from the experiments are that the best concentration of aloe vera tested was 0.03% and that 0.04% also showed improved results as compared to higher concentrations of aloe vera gel.

Tests were performed to the standards detailed in BS EN 600:1996 and the relevant European CE standard.

The condoms were packed with lubricant plus aloe vera gel. The percentages of aloe vera gel used in the various experiments are 0.03%, 0. 04% and 0.05%, as shown in the "Test Results" section. For each group, the products were divided into 4 sets. One set is for Un-aged' and the other three sets are Aged' at 70 2 C for 7 days, 14 days and 21 days respectively. Each set were tested for water leakage, bursting volume, bursting pressure, tensile elongation, and force at break.

Test Results: 1. Water Leakage Test Water Leakage Poor Results Remarks Days in Oven _____________ _____________ at 70 2 C 0.03% 0.04% 0.05% 0 0/315 0/315 0/315 PASS 7 0/315 1/315 0/315 PASS Note: Water Leak Test performed on 14 and 21 days aged condoms.

2) Bursting Test Results - 0.03% Aloe Vera Days in Oven Poor Bursting Test (Mean Value) Remarks at 70 2 C Results Volume (dm3) Pressure (kPa) ______________ 0 0/125 33.40 1.88 PASS 7 0/125 31.40 1.61 PASS 14 0/125 31.20 1.56 PASS 21 9/125 28.80 1.46 FAIL 3) Bursting Test Results - 0.04% Aloe Vera Days in Oven Poor Bursting Test (Mean Value) Remarks at 70 2 C Results Volume (dm3) Pressure (kPa) ______________ 0 2/125 33.70 1.87 PASS 7 1/125 30.90 1.57 PASS 14 0/125 31.00 1.55 PASS 21 1/80 29.60 1.47 PASS 4) Bursting Test Results - 0.05% Aloe Vera ______________ Days in Oven Poor Bursting Test (Mean Value) Remarks at 70 2 C Results Volume (dm3) Pressure (kPa) ______________ 0 0/125 33.70 1.88 PASS 7 0/125 31.20 1.60 PASS 14 3/125 30.30 1.50 PASS 21 7/125 28.60 1.38 FAIL Note: The results show a decreasing trend towards 21 days. For 0.03% and 0.05%, high failure was found after 21 days of aging. Although 0.04% passed the tests, failure was found throughout the test period. Noted: 0.03% and 0.04% showed a better percentage difference between the un-aged and the 21 days aging results for both Bursting volume and pressure.

5) Tensile Test Results - 0.03% Aloe Vera ________________ Days in Oven Poor Tensile Test (Mean Value) Poor Results at 70 2 C Results Elongation (%) Force (N) due to 0 0/13 836.19 101.97 - 7 0/13 843.90 95.65 - 14 0/13 825.51 86.17 - 21 0/13 819.02 84.30 - 6) Tensile Test Results 0.04% Aloe Vera ______________ Days in Oven Poor Tensile Test (Mean Value) Poor Results at 70 2 C Results Elongation (%) Force (N) due to 0 1/13 835.97 96.91 Force 7 0/13 833.00 88.89 - 14 2/13 814.22 79.95 Tensile 21 0/13 832.84 87.32 - 7) Tensile Test Results - 0.05% Aloe Vera Days in Oven Poor Tensile Test (Mean Value) Poor Results at 70 2 C Results Elongation (%) Force (N) due to 0 0/13 835.45 101.10 - 7 0/13 834.46 91.12 - 14 0/13 838.48 89.87 - 21 1/13 811.73 79.43 Tensile Note: The results show a decreasing trend towards 21 days of aging. However, for 0.04% the results were inconsistent and failures occurred due to Force at break and Tensile throughout the test period.

Noted: 0.03% and 0.05% showed a better percentage difference between the un-aged and the 21 days aged samples.

Noted: 0.03% and 0.05% showed a better percentage difference between the un-aged and the 21 days aging results for both Elongation and Force at break. But, for 0.05%, failure on Tensile was found after 21 days of aging.

Conclusions

On the basis of the above test results, and bearing in mind the need for condoms and other contraceptive devices to have a long shelf life, it is concluded that out of the percentages of aloe vera tested, the most preferable one is 0.03% based upon the consistent results achieved with it and lower percentage difference between the un-aged and the 21 days aged results. The results obtained for 0.04% aloe vera show that it also displays favourable results, albeit not as favourable as those obtained with 0.03% aloe vera. Finally, the results obtained with 0.05% aloe vera show the greatest decrease in mechanical performance of the condoms and as such its use cannot be recommended.

Claims

CLAIMS: 1. A sealed package containing within it a contraceptive device

having a lubricant and aloe vera gel on at least a portion of a surface thereof.
2. A sealed package according to claim 1, said contraceptive being selected from the group consisting of: male condom, female condom, diaphragm and cervical cap.
3. A sealed package according to either of claims 1 or 2, wherein the contraceptive comprises latex or polyurethane.
4. A sealed package according to any of claims 1-3, said aloe vera gel comprising no greater than about 0.04% of the total weight of lubricant plus aloe vera gel.
5. A sealed package according to claim 4, said aloe vera gel comprising no greater than about 0.0 3% of the total weight of lubricant plus aloe vera gel.
6. A contraceptive device having a lubricant and aloe vera gel on at least a portion of a surface thereof.
7. A contraceptive device according to claim 6, being selected from the group consisting of: male condom, female condom, diaphragm and cervical cap.
8. A contraceptive device according to either of claims 6 or 7, wherein it comprises latex or polyurethane.
9. A contraceptive device according to any of claims 6-8, said aloe vera gel comprising no greater than about 0.04% of the total weight of lubricant plus aloe vera gel.
10. A contraceptive device according to claim 9, said aloe vera gel comprising no greater than about 0.03% of the total weight of lubricant plus aloe vera gel.
11. A method of manufacture of a contraceptive device, comprising placing a lubricant and aloe vera gel on at least a portion of a surface said contraceptive device, and sealing said contraceptive device within packaging.
12. A method according to claim 11, said sealing step comprising hermetically sealing said contraceptive device within said packaging.
13. A method according to either of claims 11 or 12, said contraceptive being selected from the group consisting of: male condom, female condom, diaphragm and cervical cap.
14. A method according to any of claims 11-13, wherein the contraceptive comprises latex or polyurethane.
15. A method according to any of claims 11-14, said aloe vera gel comprising no greater than about 0.04% of the total weight of lubricant plus aloe vera gel.
16. A sealed package according to claim 15, said aloe vera gel comprising no greater than about 0.03% of the total weight of lubricant plus aloe vera gel.
17. A sealed package containing a contraceptive device, a contraceptive device, or a method of manufacture substantially as hereinbefore described.