JP2011518646A - Condoms with localized active agents - Google Patents

Abstract

  Condoms and methods of making and using the same are provided, the condoms having a low melting wax bead containing the active ingredient mixed with an elastomer layer, the beads being secured to the inner surface of the elastomer layer at the tip of the condom. Active ingredients can include spermicides such as nonoxynol-9 and vasodilators such as niacin, sildenafil citrate, and nitroglycerin, and male desensitizers such as benzocaine. The beads can comprise natural wax in combination with polyethylene glycol or can be a polyethylene glycol based wax. The outer surface of the elastomer layer is substantially free of active ingredients.

Description

  Embodiments of the invention relate to a condom having an active ingredient localized at the closed end of the condom. Specifically, a condom is provided having one or more active ingredients solubilized or mixed as a fine water soluble powder in low melting wax beads. Ingredients include, for example, liquid nonoxynol-9 and other spermicides, as well as niacin, nitroglycerin, and sildenafil citrate, and other vasodilators.

  Condoms and other prophylactic and protective devices provide a physical barrier to permeation of body fluids or other fluids. To prevent such permeation, chemical barriers can also be used alone or in conjunction with condoms. In some cases, the chemical barrier serves as an auxiliary form of protection when the physical barrier is breached. US Pat. No. 5,284,158 (Mallette) provides a sensitive condom that localizes the spermicide in the latex cap of the condom and in the space between the main sheath and the reinforcing membrane of the condom. Mallett's packaging further includes a spermicide to prevent drying of the membrane. U.S. Pat. No. 4,795,425 (Pugh) provides a double dosage of spermicide, the first dosage being given in a semi-solid state in the closed end of the condom. The second dosage is given to the outer surface of the condom. Semi-solid dosages include a spermicide, Carbowax 400 (which is not a solid wax at room temperature), and Carbowax 3350 (which is a solid and has a melting point in the range of 54 ° C to 57 ° C). Provided as a cream or ointment mixed in the form of polyethylene glycol. Such creams or ointments are described as having a melting point in the range of 113-127 ° F (45-53 ° C).

  However, spermicides such as nonoxynol-9 have been identified as possible irritants to the mucosa. US Pat. No. 5,387,611 (Rubinstein) provides non-irritating agents with antibacterial and antiviral activity using butylurea in combination with nonoxynol-9 and / or benzalkonium chloride.

  In addition to spermicides, other active ingredients can be delivered by condoms and other prophylactic and protective devices that treat sexual dysfunction, for example. Topical application of therapeutic agents such as vasodilators is one option. As provided in US Pat. Nos. 4,829,991 (Boeck) and 6,840,244 (Kemp), condoms are used to deliver therapeutic agents such as vasodilators and erection-promoting compounds. Can be used. In Kemp, the erection-promoting compound is immobilized on the closed end of the condom using a solvent carrier that will later evaporate to leave the erection-promoting compound in fine powder form or as a film layer, in the presence of any film-forming agent. Kemp's erection-promoting compound (or composition) is immiscible with the condom lubricant. The erection-promoting composition may comprise an erection-promoting compound dispersed or dissolved in a gel carrier that includes a liquid medium and a thickening agent. The desired thickness depends on the liquid medium. For water-based lubricants, vegetable oil liquid media are preferred, and thickeners therefor include hectorite, jojoba oil, and waxes. With respect to oil-based lubricants, polyhydroxy media are preferred, and thickeners therefor include cellulose derivatives. This erection-promoting compound dispersed or dissolved in the gel carrier does not include an erection-promoting compound in the softening or melting wax at the closed end of the condom. In US Pat. No. 7,086,403 (Harrison), a condom has a relatively high viscosity, a first lubricating composition comprising a male genital desensitizer located on the inner surface, and a lower on the outer surface. Having a second lubricating composition having a viscosity;

  Wax particles are provided, for example, in US Pat. Nos. 5,405,666 (Brindle), 6,075,081 (Nile), and 6,306,514 (Weikel). Can be used for coating on elastomeric articles to aid wearing or blocking. However, the use of such wax does not provide a localized supply of active agent.

  Accordingly, there is a need to provide active agents to condoms in a convenient manner to reduce mucosal irritation by dilution of the delivered drug. There is a need for a condom having one or more localized components located at the tip. There is also a need to localize spermicides and / or erection-promoting compounds and / or male desensitization compounds inside the condom to avoid such contact with female partners.

  Condoms and methods for making and using the same are provided, the condoms having a low melting wax bead containing an active ingredient mixed with an elastomeric layer, the beads being secured to the inner surface of the elastomeric layer at the tip of the condom . In a detailed embodiment, the condom has low melting wax beads comprising nonoxynol-9 mixed with an elastomeric layer. In another detailed embodiment, male desensitizers, such as benzocaine, dibucaine, lidocaine, tetracaine, and their salts and derivatives mixed in beads are included. The beads can comprise a polyethylene glycol based wax of selected molecular weight having a melting point in the range of 25 ° C to 40 ° C. Alternatively, the beads can be a solidified liquid solution of a natural wax such as beeswax, whose melting point can be lowered by the addition of an appropriate molecular weight polyethylene glycol in the liquid state. Wax beads are affixed to the inner surface of the elastomer layer at the tip of the condom, and the outer surface of the elastomer layer substantially contains active ingredients such as nonoxynol-9, niacin, nitroglycerin, sildenafil citrate, or benzocaine. Absent.

  In one aspect, a method for producing a condom, comprising: supplying a molten solution of a low melting wax containing an active ingredient; supplying a condom; and dropping the molten solution beads on the inner surface at the tip of the condom. There is provided a method comprising: allowing the beads to reach ambient temperature, solidifying the beads so that they are localized on the inner surface at a condom tip, and packaging the condom. Supplying the molten solution may include melting the low melting wax and mixing an active ingredient having a melting point below the low melting wax melting with the low melting wax to form a substantially uniform molten solution. Alternatively or additionally, such steps may include melting the wax and adding a fine powder of water soluble active agent.

  In a further aspect, a method of providing a spermicide within the closed end of a condom comprising the step of providing a condom having low melting wax beads comprising nonoxylol-9 mixed with an elastomeric layer, The beads comprise a natural wax modified to have a melting point in the range of 25 ° C. to 40 ° C. and a polyethylene glycol polymer having an appropriate molecular weight to have a melting point in the range of 25 ° C. to 40 ° C. A method is included in which the outer surface of the elastomer layer is substantially free of nonoxynol-9 and is secured to the inner surface of the elastomer layer at the tip of the condom.

  In a further aspect, a method for providing an erection-promoting compound within a closed end of a condom, the method comprising providing a condom having a low melting wax bead comprising the erection-promoting compound mixed with an elastomeric layer, the bead comprising A natural wax modified to have a melting point in the range of 25 ° C. to 40 ° C. and a polyethylene glycol polymer having an appropriate molecular weight to have a melting point in the range of 25 ° C. to 40 ° C. A method is included in which the outer surface of the elastomer layer is fixed to the inner surface of the elastomer layer at the tip, and the erection promoting compound is substantially free of the erection promoting compound.

  Delivery of the active ingredient through the condom may be accomplished by localizing the active ingredient with wax beads or other suitable carrier on its inner surface at the condom tip. In this way, the active ingredient can be delivered in a diluted but still effective form to reduce irritation. Furthermore, the placement of the active ingredient inside the condom reduces, for example, the exposure of the user's partner to the active ingredient. The use of a low melting wax allows for a substantially uniform distribution of the active ingredient incorporated into the beads and further aids in the effective delivery of this ingredient.

  In a first aspect, there is provided a condom having a low melting wax bead containing an active ingredient mixed with an elastomer layer, wherein the bead is secured to the inner surface of the elastomer layer at the tip of the condom. Is done. In one or more embodiments, it is provided that the outer surface of the elastomeric layer is substantially free of active ingredients. By "substantially free of active ingredient" is meant that no active ingredient is provided on the outer surface of the elastomeric layer or that there is no significant amount of active ingredient on the outer surface. It can be seen that as a result of handling condoms, only a small amount of active ingredient can be accidentally present on the outer surface. For the purposes of the present invention, active ingredients that are not intentionally placed on the outer surface are considered insignificant.

  Reference to “low melting point” refers to a substance such as a wax or other suitable carrier that softens, flattens and / or melts in the presence of body temperature which is about 37 ° C. In one embodiment, the beads soften in the presence of body temperature, thereby substantially exposing the active ingredient. In one or more embodiments, the wax or other suitable carrier melts in the range of 25 ° C to 40 ° C.

  In one embodiment, it is provided that the active ingredient comprises a spermicide. In one specific embodiment, the spermicide comprises nonoxynol-9. Other spermicides include oxytoxinol-9, memphegol, vaginal contraceptive compounds with the surfactant p-menthanylphenyl polyoxyethylene ether, lactic acid, neem oil, membrane breakers, derivatives thereof, and their Combinations are included.

  In another embodiment, it is provided that the active ingredient comprises a vasodilator. In a specific embodiment, the vasodilator is provided comprising a niacin component. The niacin component includes niacin (also known as nicotinic acid), nicotinamide, methyl nicotinate (niacin methyl ester), derivatives thereof, or combinations thereof.

  As used herein, the terms “erection-promoting compound” and “vasodilator” cause vasodilation, enhance blood circulation to body parts, increase nitrous oxide concentration, generate heat. Or it refers to a substance that produces a hot sensation and / or increases sexual stimulation, sexual response or otherwise cures sexual dysfunction. Such materials must be readily absorbed by the skin and must not adversely react with any other ingredients, capsules and / or films used in some embodiments of the invention. In embodiments of the invention, selective inhibitors of phosphodiesterases, such as cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (“PDE-5”) may be used. PDE-5 inhibitors include, but are not limited to, sildenafil, tadalafil, vardenafil, derivatives, and pharmaceutically acceptable salts thereof. Other suitable vasodilators include prostaglandin compounds such as prostaglandin E-1, known by the drug name alprostadil. Another suitable ingredient is testosterone.

  Other embodiments may include compounds with vasodilatory effects, including niacin, L-arginine, ginger, menthol, menthyl lactate, and other menthol derivatives and precursors, peppermint, spearmint and other Includes compounds such as mint oil, nitric oxide, precursors of nitric oxide, ie, glyceryl trinitrate (nitroglycerin), organic nitrites, ie, amyl nitrite, isoamyl nitrite, etc., and variations thereof In other embodiments, other vasodilators known in the art are used.

  In some embodiments, the elastomeric layer is comprised of natural rubber latex, synthetic polyisoprene, guayule rubber, polyurethane, copolymers or combinations thereof. The term “natural rubber latex” as used in this disclosure includes Hevea brasiliensis (former rubber tree), guayule argentatum (guayule gum), sunflower, linden, etc., as well as these and other Includes cured elastomeric materials supplied from genetically modified variants of biological sources.

  In other embodiments, other materials forming an elastomeric layer known in the art are used.

  The beads can include waxes that are synthetic or natural. Commonly used natural waxes include montan, carnauba, beeswax, bayberry, canderia, carlandy, castor bean, asparto-grass, Japan, aurikuri, retamo-ceri, minbi (Mibi), shrack, whale wax, sugar cane, and wool lanolin. Synthetic waxes generally include polyethylene and modified polyethylene, polypropylene and modified polypropylene, and hydrogen-based materials. If the melting point exceeds the range of 25 ° C. to 40 ° C., the wax can be melted, and a low melting wax such as polyethylene glycol wax having an appropriate low molecular weight and corresponding low melting point is added to the wax to obtain a molten solution And can be frozen to produce a wax having a melting point in the range of 25 ° C to 40 ° C.

  The beads can include polyethylene glycol (PEG). One exemplary PEG is PEG 600 having a melting point of 20-25 ° C. (68-77 ° F.). Another possible PEG is PEG 1500 that melts at 44-48 ° C. (111-118 ° F.), which may be appropriate for beads when mixed with lower melting materials. Thus, in one or more embodiments, the beads have a total molecular weight in the range of 400-1500 (or 600-1300, or even 800-1100) and a range of 25-40 ° C (or even 36-39 ° C). One or more polyethylene glycol polymers having a melting point of An additional PEG is PEG 1000, which has a melting point of 38 ° C. and is suitable for localized uptake of the active ingredients of the present invention. Polyethylene glycol-based waxes including PEG-6 and PEG-32 having a molecular weight in the range of 470-530 g / mol may also be suitable. For PEG-containing beads, warming occurs due to a melting exotherm with an increase in temperature of about 5-7 ° C. after contact with skin-generated moisture. The warming effect can help to widen skin pores and enhance penetration of the active ingredient.

  In one or more embodiments, it is provided that the outer surface of the condom includes a lubricant. The lubricant may include silicone or any other lubricant that is compatible with the wax beads and not miscible. With respect to compatible, it is meant that when the lubricant is in contact with the wax beads, it does not destabilize the wax beads or release the active ingredient. Suitable lubricants may include silicone oils such as dimethicone, dimethylsiloxane, cyclomethicone and other silicone derivatives, and other non-PEG wax soluble materials. The lubricant may further include substances that improve sexual experience for women and / or reduce symptoms associated with female sexual dysfunction. Such materials include L-arginine; menthol, menthyl lactate, and other menthol derivatives and precursors; prostaglandin compounds such as prostaglandin E-1, known by the drug name of alprostadil. Including, but not limited to. Another possible addition to the lubricant is astringen such as witch hazel.

  In one or more embodiments, it is provided that the inner surface of the condom further includes a lubricant that does not include an active agent. The lubricant may include silicone or any other lubricant that is compatible with the wax beads and not miscible. Given the lubricant on the outer surface, the lubricant on the inner surface is typically more viscous than that on the outer surface.

  In a detailed embodiment, a condom comprising an elastomeric layer and a low melting wax bead comprising mixed nonoxynol-9, wherein the bead comprises a modified natural wax and a polyethylene glycol polymer wax having an appropriate molecular weight and melting point. The bead is secured to the inner surface of the elastomeric layer at the tip of the condom, and the outer surface of the elastomeric layer provides a condom substantially free of nonoxynol-9.

  In one or more embodiments, the mixed, bead nonoxynol-9 is present in an amount ranging from 10 to about 100 mg. Wax beads may be up to 1 gram or more. The active ingredient is 1- (1 + 1/2) times the required dose, which is the amount of nonoxynol-9 generally required in water-based or silicone-based lubricants (more than more than 3 times the required dose) Rather, it may be desirable to give it in an amount in the range.

  In a further aspect, a method for producing a condom comprising the steps of melting a low melting wax, and mixing the active ingredient in the form of a molten liquid or as a fine dispersion of a water soluble powder with the low melting wax. Forming an essentially uniform mixture, supplying the condom, dripping beads of the mixture onto the inner surface at the tip of the condom, and solidifying the bead to provide the active ingredient to the condom A method is provided that includes allowing the beads to reach ambient temperature so as to localize to the inner surface thereof at the tip of the substrate and packaging the condom.

  In a further aspect, a method for providing a spermicide at the closed end of a condom comprising the step of providing a condom comprising an elastomer layer and a low melting wax bead (including mixed nonoxynol-9), The beads include a modified natural wax and a polyethylene glycol polymer wax having an appropriate molecular weight and melting point, the beads being fixed to the inner surface of the elastomer layer at the tip of the condom, and the outer surface of the elastomer layer substantially containing nonoxynol-9. Methods that are not included.

  Further embodiments of the invention include packaging comprising condoms, as described elsewhere herein. Examples of packaging include, without limitation, wrapping paper, boxes, tabs with hermetic seals, and combinations thereof.

  At least one embodiment of the present invention includes the step of packaging the finished condom. Specifically, in some embodiments, the molded elastomer layer having localized beads thereon is packaged in wrapping paper, boxes, tabs with hermetic containment, or any combination thereof. At least one embodiment of the method of manufacturing a condom of the present invention includes the step of packaging the finished condom. Specifically, in some embodiments, the molded elastomer layer having at least one component placed on the molded elastomer layer is a wrapping paper, a box, a tab with a sealed containment, or any combination thereof. Packaged with. In some embodiments, the material used to form the package is selected from materials that can form a package that is substantially impermeable to air and moisture. This packaging material includes, but is not limited to, cellulosic materials such as paper or paperboard, polymer films and mattresses, metal foils, and composite materials formed from two or more of these materials. The package may be sealed by a bonding process including, but not limited to, adhesive, heat, ultrasonic welding, pressure, and combinations of these bonding processes.

  Processes that may be useful in the manufacture of condoms according to various aspects of the present invention are well known to those skilled in the art.

  Examples of condoms according to embodiments of the present invention are shown below. These and other exemplary components can be present in greater or lesser amounts in one or more faces of the condom for a particular application, as follows:

Example 1A
A modified natural wax and a formulation of a polyethylene glycol polymer wax having an appropriate molecular weight and melting point are melted and the wax is allowed to be several degrees above its melting point (about 1-10 ° C.), to which 100 mg of nonoxynol-9 liquid is added. Add to form a mixture. The beads of this mixture are dropped on the inner surface of the condom tip, allowing it to reach ambient temperature and solidifying the wax beads. The condom is then packaged. Nonoxynol-9 can be added up to 15-20% of the weight of the wax. The use of higher concentrations of nonoxynol-9 can result in separation of nonoxynol-9 within the wax beads, which can lead to possible skin irritation or even weakening of the condom. 0.5 grams of wax beads could contain 75 mg nonoxynol-9.

Example 1B
A raw material having a mixture of polyethylene glycol waxes (PEG-6 and PEG-32 are sold under the product name Lanogen 1500 by Clariant) is melted and the wax is melted several degrees from its melting point (approximately 1-10 ° C), to which was added a 20% nonoxynol-9 liquid to form a homogenized wax mixture without separation. Beads of this mixture were dropped onto the inner surface of the condom tip and allowed to reach ambient temperature to solidify the wax beads.

Example 2
A modified natural wax and a formulation of a polyethylene glycol polymer wax having an appropriate molecular weight and melting point are melted, the wax is allowed to be several degrees above its melting point (about 1-10 ° C.), and 100 mg of nitroglycerin solution is added thereto. To form a mixture. The beads of this mixture are dropped on the inner surface of the condom tip, allowing it to reach ambient temperature and solidifying the wax beads. The condom is then packaged.

Example 3A
A polyethylene glycol polymer wax (PEG 1000) having an appropriate molecular weight and melting point is melted and the wax is allowed to be several degrees above its melting point (about 1-10 ° C.), to which 100 mg of finely powdered water-soluble niacin is added, A mixture is formed. The beads of this mixture are dropped on the inner surface of the condom tip, allowing it to reach ambient temperature and solidifying the wax beads. The condom is then packaged. One gram of wax beads contains 5% niacin and can yield 50 mg niacin.

Example 3B
A polyethylene glycol polymer wax mixed with glycerin and containing 0.25% menthol is heated, to which 20 mg of finely powdered water-soluble niacin is added to form a mixture. The beads of this mixture are dropped on the inner surface of the condom tip, allowing it to reach ambient temperature and solidifying the wax beads. Tests were conducted with 2% or 20 mg of niacin incorporated in wax beads to obtain effective performance.

Example 4
A modified natural wax and a formulation of a polyethylene glycol polymer wax having the appropriate molecular weight and melting point are melted and the wax is allowed to be several degrees above its melting point (about 1-10 ° C.), to which 100 mg of finely powdered water-soluble citric acid Sildenafil is added to form a mixture. The beads of this mixture are dropped onto the inner surface of the condom tip and allowed to reach ambient temperature. The condom is then packaged. A 1% concentration of sildenafil citrate in 1 gram of wax beads delivers 10 mg of sildenafil citrate.

Example 5
A mixture of polyethylene glycol polymer waxes with the appropriate molecular weight and melting point is melted and the wax is allowed to be several degrees above its melting point (about 1-10 ° C.), to which 10-100 mg of powdered benzocaine is added and the mixture is Form. The beads of this mixture are dropped onto the inner surface of the condom tip and allowed to reach ambient temperature. The condom is then packaged.

Example 6
A raw material having a mixture of polyethylene glycol waxes (PEG-6 and PEG-32 are sold under the product name Lanogen 1500 by Clariant) is melted and several degrees from its melting point of this wax (approximately 1 to 10 ° C.) and 1 to 3% by weight of methyl nicotinate and 0.001 to 0.005% by weight of menthol crystals (menthol L) were added thereto to form a mixture. 0.5-2 grams of this mixture of beads was dropped onto the inner surface of the condom tip and allowed to reach ambient temperature. Silicone oil was applied to the outer surface of the condom in an amount ranging from 0.2 to 1 gram.

Example 7
A product having a mixture of polyethylene glycol waxes (PEG-6 and PEG-32 are sold by Clariant under the product name Lanogen 1500) is melted and the wax is melted several degrees from its melting point (approximately 1 to 10 ° C.) and 1 to 3% by weight methyl nicotinate and 2 to 5% by weight liquid lactate menthol were added to form a mixture. 0.5-2 grams of this mixture of beads was dropped onto the inner surface of the condom tip and allowed to reach ambient temperature. Silicone oil was applied to the outer surface of the condom in an amount ranging from 0.2 to 1 gram.

  Throughout this specification, references to “one embodiment,” “a certain embodiment,” “one or more embodiments,” or “an embodiment” are those specified in connection with that embodiment. Means that a feature, structure, material, or characteristic of the present invention is included in at least one embodiment of the present invention. Thus, the appearance of expressions such as “in one or more embodiments”, “in certain embodiments”, “in one embodiment”, or “in certain embodiments” in various places throughout this specification. And not necessarily referring to the same embodiment of the invention. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

  Although the invention herein has been described with reference to particular embodiments, these embodiments are merely illustrative of the principles and uses of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims (20)

  A condom having an elastomer layer and a low melting wax bead containing a mixed active ingredient, wherein the bead is secured to the inner surface of the elastomer layer at the tip of the condom.   The condom of claim 1, wherein the beads soften in the presence of body temperature, thereby substantially exposing the active ingredient.   The condom of claim 1, wherein the outer surface of the elastomeric layer is substantially free of active ingredients.   The condom of claim 1, wherein the outer surface of the elastomeric layer further comprises a lubricant that is compatible and immiscible with the low melting wax beads.   The condom of claim 1, wherein the inner surface of the elastomeric layer further comprises a lubricant that is compatible and immiscible with the low melting wax beads.   The condom of claim 1, wherein the active ingredient comprises a vasodilator.   The condom of claim 6, wherein the vasodilator comprises a niacin compound.   The condom of claim 6, wherein the vasodilator comprises a sildenafil citrate compound.   The condom of claim 1, wherein the beads have a melting point in the range of 25-40 ° C.   The melting point of the beads is reduced to 25 ° C. to 40 ° C. by melting with a low melting point wax. The condom of claim 1 comprising a natural wax selected from the group consisting of minbi, shrack, whale wax, sugar cane, and wool lanolin.   The condom of claim 1, wherein the beads comprise one or more polyethylene glycol polymers having a total molecular weight in the range of 600-1500 and a melting point in the range of 25 ° C.-40 ° C.   The condom of claim 1, wherein the elastomeric layer comprises natural rubber latex, synthetic polyisoprene, guayule rubber, polyurethane, copolymers thereof, or combinations thereof.   The condom of claim 4, wherein the lubricant on the outer surface of the elastomeric layer further comprises at least one component selected from the group consisting of L-arginine, menthol compound, prostaglandin compound, and astrogen.   An elastomer layer and a low melting wax bead comprising a mixed erection promoting component, spermicide, desensitizing compound, or combinations thereof, wherein the bead has a melting point in the range of 25 ° C to 40 ° C. A condom comprising a modified natural wax or a polyethylene glycol polymer wax, wherein the beads are fixed to the inner surface of the elastomer layer at the tip of the condom, and the outer surface of the elastomer layer is the erection promoting component, the spermicide And a condom substantially free of said desensitizing compound.   15. A condom according to claim 14, wherein the erection promoting component in the wax beads is a niacin compound present in an amount ranging from 1 to 3% by weight.   15. The condom of claim 14, wherein the erection promoting component in the wax beads is sildenafil citrate and is present in an amount ranging from 10 to about 100 mg.   15. The condom of claim 14, further comprising a lubricant that is compatible with the beads and immiscible on an outer surface, an inner surface, or both.   The condom of claim 14, wherein the wax beads further comprise menthol, menthyl lactate, derivatives thereof, or precursors thereof.   The condom of claim 14, wherein the beads have a melting point in the range of 25C to 40C. Melting a low melting wax;
Mixing an active ingredient in the form of a fine dispersion of a liquid or water-soluble powder with the low melting wax to form a substantially uniform mixture;
Supplying a condom;
Dropping the mixture beads on the inner surface of the condom at the tip;
Allowing the beads to reach ambient temperature and solidifying the wax beads so that the beads are localized on the inner surface at the tip of the condom;
Wrapping the condom;
Of condoms including