OA18227A

OA18227A - Lubricants formulations.

Info

Publication number: OA18227A
Application number: OA1201700058
Authority: OA
Inventors: Kurt Richards; Andrew Hoover
Original assignee: Reoxcyn Discoveries Group, Inc.
Priority date: 2016-05-18
Filing date: 2017-02-16
Publication date: 2018-09-04

Abstract

A composition for lubricant formulations is disclosed. The composition may include hypochlorite, dimethicone, and an emulsifier for improvement of lubricity. Methods of making and using the lubricant formulations are also disclosed.

Description

LUBRICANT FORMULATIONS

FIELD OF THE DISCLOSURE [0001] The présent disclosure relates generally to lubricant compositions including antimicrobial agents. More specifically, the présent disclosure is related to Personal lubricants having hypochlorite, or acids or salts thereof, a silicone polymer, and one or more emulsifîers. The disclosure also relates to methods of making and using the lubricant.

BACKGROUND [0002] Lubricants are useful generally for providing lubricity to various instruments and/or parts of the body, thereby reducing friction. For example, medical or surgical lubricants are useful for providing lubrication for decreasing the discomfort to a patient during certain medical and surgical procedures, including, for example, rectal or vaginal examinations. Personal lubricants function similarly, and can be used, for example, for intimate contact, by increasing lubricity and comfort during sexual intimacy.

[0003] Personal lubricants are of various types, with each type having different advantages. Water-based lubricants are water-soluble, and generally include water and a cellulose or glycerin solution. Oil-based lubricants are derived from either synthetic or natural oils, and can include, for example, a petroleum ingrédient, such as petroleum jelly. Silicone-based lubricants are manufactured from synthetic chemical compounds, and do not contain water. Silicone-based lubricants are commonly formulated with a silicone ingrédient, such as dimethicone or other polymeric organosilicon compound. Additional lubricants include hybrid lubricants, which may be formulated with water and silicone. Certain lubricants also further include sensory enhancing agents, that provide, for example, a warming or cooling sensation, or that provide a variety of odors or flavors.

[0004] Lubricants can be used as a stand-alone product for use during sexual intimacy, or hâve been used in combination with other products, such as with medical devices or with condoms, which facilitâtes pénétration or insertion of the product. For example, personal lubricants may be used alone or in combination with condoms or other devices to improve lubrication and comfort during sexual intimacy. Surgical or medical lubricants or gels may be used for medical purposes such as spéculum insertion or introduction of a cathéter, ultra sounds, or other medical devices.

[0005] Personal lubricants hâve been developed that prevent or stop the development of itching from the vagina or other body parts. For example, U.S. Patent No. 6,114,398 describes a Personal lubricant having CIO2, which is effective for the prévention of itching by eliminating Candida species.

[0006] Vaginal itching is a common complaint among women. Vaginal itching primarily originates from Candida albicans, a diploid fungus that grows as both a yeast and as a filamentous cell. C. albicans is the most common and possibly the most important causative agent of human fungal infections (Edmond, Μ. B., et al. 1999, Clin. Infect. Dis. 29:239-244). C. albicans is a major opportunistic pathogen of immunocompromised hosts, including AIDS patients and patients undergoing chemotherapy, patients who hâve had tissue transplants, and patients with central venous cathéters. Studies indicate that up to ninety percent of AIDS patients suffer from oropharyngeal and esophageal candidiasis, in which C. albicans is the major causative agent (Schmidt-Westhausen, A., et al., 1991, J. Oral Pathol. Med. 20:467-472). C. albicans is a commensal of human mucosal surfaces. C. albicans causes a wide variety of diseases including oral thrush and disseminated candidiasis. Systemic fungal infections hâve emerged as important causes of morbidity and mortality in immunocompromised patients (e.g., as a resuit of AIDS, cancer chemotherapy, organ or bone marrow transplantation). In addition, hospital-related infections in patients not previously considered at risk (e.g., patients in an intensive care unit) hâve become a cause of major health concern. C. albicans is also the major fungus that colonizes medical implants, causing device-associated infections with high mortality. (Kojic E.M., Darouiche R.O.: Candida Infections of Medical Devices. Clin Microbiol Rev 2004, 17:255-267; Nobile et al., Critical Rôle of Ber 1-dépendent Adhesins in C. albicans Biofilm Formation In Vitro and In Vivo. PLoS Pathog. 2006, 2: e63). Infections involving medical devices are notoriously difficult to eliminate and generally necessitate removal of the device. C. albicans colonizes the surfaces of cathéters, prostheses, and epithelia, forming biofilms that are extremely résistant to antifungal drugs. Mature C. albicans biofilms show a complex three-dimensional architecture with extensive spatial heterogeneity, and consist of a dense network of yeast, hyphae and pseudo hyphae encased within a matrix of exopolymeric material.

SUMMARY [0007] The présent disclosure describes lubricant formulations and compositions having hypochlorite, or acids and salts thereof, a silicone polymer, and an emulsifier. Also described are methods of making and using the lubricant formulations.

[0008] In some embodiments is provided a lubricant having hypochlorite, an emulsifier, and a silicone polymer. In some embodiments, the silicone polymer is dimethicone.

[0009] In some embodiments is provided a personal lubricant including hypochlorite or acids or salts thereof, and a silicone polymer. In some embodiments, the hypochlorite is hypochlorous acid (HCIO). In some embodiments, the hypochlorite is a hypochlorite sait, such as NaCIO, KCIO, or Ca(ClO)2. In some embodiments, the silicone polymer is a polymeric organosilicon compound. In some embodiments, as the polymeric organosilicon compound is dimethicone.

[0010] In some embodiments, the lubricant composition further includes, for example, sodium magnésium silicate, sodium phosphate monobasic, water, buffer, sodium chloride, or combinations thereof.

[0011] In some embodiments, the lubricant includes hypochlorite. In some embodiments, the hypochlorite is a sait or acid of hypochlorite, or a hypochlorite solution. In some embodiments, a final concentration of hypochlorite in the lubricant is about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 250, or 300 ppm or within a range defined by any two of the aforementioned amounts. In some embodiments, the final concentration of hypochlorite in the lubricant is about 50 to 100 ppm. In some embodiments, the final concentration of hypochlorite in the lubricant is about 75 ppm.

[0012] In some embodiments, the emulsifier is sodium phosphate. In some embodiments, the emulsifier is présent in the lubricant in an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, or 2.5% w/v or within a range defined by any two of the aforementioned amounts.. In some embodiments, the emulsifier is présent in the lubricant in an amount of about 0.2% w/v.

[0013] In some embodiments, the silicone polymer is dimethicone. In some embodiments, the silicone polymer is présent in the lubricant in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v or within a range defined by any two of the aforementioned amounts.. In some embodiments, the silicone polymer is présent in the lubricant in an amount of about 10% w/v.

[0014] In some embodiments, the lubricant further includes sodium magnésium silicate, water, or buffer or combinations thereof. In some embodiments, the sodium magnésium silicate is présent in the lubricant in an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v or within a range defined by any two of the aforementioned amounts. In some embodiments, the sodium magnésium silicate is présent in the lubricant in an amount of about 3.25% w/v. In some embodiments, the water and/or buffer makes up the balance of the lubricant, and includes about 20%, 30%, 40%, 45%, 50%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 61.55%, 62%, 62.5%, 63%, 65%, 70%, 75%, 80%, or 90% w/v or within a range defined by any two of the aforementioned amounts.

[0015] In some embodiments is provided a lubricant, wherein the lubricant includes a hypochlorite solution in an amount of about 25% w/v. In some embodiments, the hypochlorite solution includes about 300 ppm hypochlorite, dimethicone in an amount of about 10% w/v, sodium phosphate in an amount of about 0.2% w/v. In some embodiments, the lubricant further includes sodium magnésium silicate in an amount of about 3.25% w/v and water and/or buffer in an amount of about 61.55% w/v. In some embodiments, the water and/or buffer makes up ail or substantially ail of the balance of the lubricant.

[0016] In some embodiments is provided a lubricant including about 75 ppm hypochlorite, about 10% w/v dimethicone, and optionally 0.2% w/v sodium phosphate. In some embodiments, the lubricant further includes sodium magnésium silicate and water. In some embodiments, the personal lubricant may further include a buffer.

[0017] In some embodiments, the lubricant as disclosed herein is characterized in having an osmolality by vapor pressure of about 10, 20, 30, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46 ,47, 48, 49, 50, 55, 60, 70, 80, 90, or 100 mmol/kg, or within a range defined by any two of the aforementioned amounts. In some embodiments, the osmolality by vapor pressure is about 38 mmol/kg. In some embodiments, the osmolality by vapor pressure is about 49 mmol/kg. In some embodiments, the lubricant is characterized in having an osmolality by freezing point dépréssion of about 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100 mOsm/kg, or within a range defined by any two of the aforementioned amounts. In some embodiments, the osmolality by freezing point dépréssion is about 22 mOsm/kg. In some embodiments, the osmolality by freezing point dépréssion is about 54 mOsm/kg.

[0018] In some embodiments is provided a method of making the lubricant formulation. In some embodiments, the method includes providing hypochlorite. In some embodiments, the hypochlorite is provided as a hypochlorite acid or sait. In some embodiments, the hypochlorite is provided as a hypochlorite solution. In some embodiments, the method of making the lubricant includes providing hypochlorite in an amount of about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 250, or 300 ppm or within a range defined by any two of the aforementioned amounts. In some embodiments, hypochlorite is provided in an amount of about 50 to 100 ppm. In some embodiments, the hypochlorite is provided in an amount of about 75 ppm.

[0019] In some embodiments, the method of making the lubricant includes providing a hypochlorite solution. In some embodiments, the hypochlorite solution is prepared from hypochlorite acids or salts. In some embodiments, the hypochlorite sait is sodium hypochlorite. In some embodiments, the hypochlorite solution is prepared from sodium chloride. In some embodiments, the method includes running sodium chloride solution through electrolysis. In some embodiments, the sodium chloride solution is provided in an amount of about 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, or 0.4% w/v. In some embodiments, the sodium chloride is 0.28%, and the resulting hypochlorite solution is about 300 ppm. In some embodiments, the method of making the lubricant includes diluting the hypochlorite solution to provide hypochlorite in an amount of about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 250, or 300 ppm or within a range defined by any two of the aforementioned amounts. In some embodiments, hypochlorite is diluted to an amount of about 50 to 100 ppm. In some embodiments, the hypochlorite is diluted to an amount of about 75 ppm.

[0020] In some embodiments, the method of making the lubricant further includes providing a silicone polymer. In some embodiments, the silicone polymer is dimethicone. In some embodiments, the silicone polymer is provided in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v, or within a range defined by any two of the aforementioned amounts. In some embodiments, the silicone polymer is provided in an amount of about 10% w/v.

[0021] In some embodiments, the method further includes providing an emulsifier. In some embodiments, the emulsifier is sodium phosphate. In some embodiments, the emulsifier is provided in an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, or 2.5% w/v or within a range defined by any two of the aforementioned amounts.. In some embodiments, the emulsifier is provided in an amount of about 0.2% w/v.

[0022] In some embodiments, the method of making the lubricant further includes providing sodium magnésium silicate, water, or buffer or combinations thereof. In some embodiments, the sodium magnésium silicate is provided in an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v or within a range defined by any two of the aforementioned amounts. In some embodiments, the sodium magnésium silicate is provided in an amount of about 3.25% w/v. In some embodiments, the water and/or buffer is provided in an amount to make up ail or substantially ail of the balance of the lubricant, and is provided in an amount of about 20%, 30%, 40%, 45%, 50%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 61.55%, 62%, 62.5%, 63%, 65%, 70%, 75%, 80%, 90% or 95% w/v or within a range defined by any two of the aforementioned amounts.

[0023] In some embodiments is provided a method of using a lubricant. In some embodiments, the method includes providing the lubricant and applying the lubricant. In some embodiments, the lubricant is provided as a ready-to-use formulation that includes hypochlorite or acids or salts thereof, silicone polymer, and an emulsifier, and further may include sodium magnésium silicate, water, or buffer. In some embodiments, the lubricant is provided in portions, and further additions and/or mixing is required prior to use. In some embodiments, the lubricant is applied in the penile or vaginal régions. In some embodiments, the lubricant is applied on a condom or other device. In some embodiments, the lubricant is applied multiple times daily, once daily, multiple times weekly, once weekly, multiple times monthly, or once monthly, or within a time frame defined by any two of the aforementioned time frames. In some embodiments, the lubricant is applied liberally. In some embodiments, the lubricant is applied meagerly.

[0024] In some embodiments is provided a method of using a lubricant for increasing comfort and lubricity. In some embodiments, the increase in comfort and lubricity is experienced during sexual intimacy. In some embodiments, the lubricant is used alone or in combination with condoms or other devices.

[0025] In some embodiments is provided a method of using a lubricant for the cessation, amelioration, prévention, or inhibition of the development of itching from the vagina or other body parts by eliminating microbial causing infections.

[0026] In some embodiments is provided a method of using the lubricant composition to stop a fungal infection. In some embodiments, the fungal infection is caused by a yeast of the Candida genus. In one embodiment, the yeast is of the Candida albicans species. In other embodiments, the Candida yeast may be of the Candida dubliniensis, Candida parapsilosis, Candida tropicalis, Candida kerfyr, Candida guilliermondii, Candida inconspicua, Candida famata, Candida glabrata, Candida krusei, Candida lusitaniae, or other Candida species, or combinations thereof. In some embodiments, the lubricant composition is used to stop a viral infection.

DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS [0027] In the following detailed description, reference is made to the accompanying drawings, which form a paît hereof. In the drawings, similar symbols typically identify similar components, unless context dictâtes otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the présent disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, ail of which are explicitly contemplated herein.

[0028] Lubricants, including personal lubricants are described herein that are useful for increasing lubricity. In some embodiments, the personal lubricant is useful for penile and/or vaginal application for increasing lubricity and for enhancing the ease and comfort of sexual intimacy, and for supplementing the body’s natural lubrication. In some embodiment, the personal lubricant may be used alone or in combination with condoms or other devices to improve lubrication and comfort during sexual intimacy. In some embodiments, lubricants may be useful for treating, ameliorating, or reducing the itchiness associated with fungal, viral, or other skin conditions. In some embodiments, the personal lubricant is a hybrid-based lubricant that includes water and silicone. In some embodiments described herein are methods of rnaking and using the lubricant formulations.

Définitions [0029] Unless defined otherwise, technical and scientific terms used herein hâve the same meaning as commonly understood by one of ordinary skill in the art to which the présent disclosure belongs. For purposes of the présent disclosure, the following terms are defined below.

[0030] By “about” is meant a quantity, level, value, number, frequency, percentage, dimension, size, amount, weight or length that varies by as much as 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% to a reference quantity, level, value, number, frequency, percentage, dimension, size, amount, weight or length.

[0031] Throughout this spécification, unless the context requires otherwise, the words “comprise,” “comprises,” and “comprising” will be understood to imply the inclusion of a stated step or element or group of steps or éléments but not the exclusion of any other step or element or group of steps or éléments.

[0032] By “consisting of ’ is meant including, and limited to, whatever follows the phrase “consisting of.” Thus, the phrase “consisting of’ indicates that the listed éléments are required or mandatory, and that no other éléments may be présent. By “consisting essentially of ’ is meant including any éléments listed after the phrase, and limited to other éléments that do not interfère with or contribute to the activity or action specified in the disclosure for the listed éléments. Thus, the phrase “consisting essentially of ’ indicates that the listed éléments are required or mandatory, but that other éléments are optional and may or may not be présent depending upon whether or not they materially affect the activity or action of the listed éléments.

[0033] In some embodiments, the “purity” of any given agent (for example, dimethicone or hypochlorous acid) in a composition may be specifically defined. For instance, certain compositions may include, for example, an agent that is at least 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100% pure, including ail décimais in between, as measured, for example and by no means limiting, by analytical chemistry techniques.

[0034] As used herein, the terms “function” and “functional” and the like refer to a biological, chemical, mechanical, or therapeutic function.

[0035] “Hypochlorous acid”, as used herein, refers to a weak acid having the chemical formula HC1O. Hypochlorous acid is also known as chloric (I) acid, chloranol, or hydroxidochlorine. Salts of hypochlorite are also referred to herein and can include sodium hypochlorite (NaCIO), calcium hypochlorite (Ca(ClO)2), or potassium hypochlorite (KCIO). As described herein, hypochlorous acid and hypochlorite are used as killing agents, skin cleansing agents, disinfectants, antibacterial agents, sanitizers, and/or preservatives. Hypochlorite, or acids and salts thereof, may be used in the lubricants and personal lubricants of the présent invention at an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, or greater w/v%, or within a range defined by any two of the aforementioned amounts. In some embodiments, the w/v% of hypochlorite or an acid or sait thereof is about 25% w/v. In some embodiments, the hypochlorite sait or hypochlorous acid is added directly to a personal lubricant, wherein the final amount of hypochlorite is less than, greater than, or equal to about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 300 ppm or within a range defined by any two of the aforementioned amounts. In some embodiments, the amount of hypochlorite in the lubricant is between about 50 to about 100 ppm. In some embodiments, the amount of hypochlorite in the lubricant is about 75 ppm.

[0036] In some embodiments, the hypochlorite is added to the lubricant as a hypochlorite solution. In some embodiments, the hypochlorite solution is prepared from hypochlorite sait or hypochlorous acid. In some embodiments, the solution of hypochlorite is prepared by passing a sodium chloride solution through electrolysis. In some embodiments, the sodium chloride solution is a 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4% or greater w/v% or within a range defined by any two of the aforementioned amounts. In some embodiments, the sodium chloride is 0.28%, and the resulting hypochlorite solution is 300 ppm. In some embodiments, the hypochlorite solution is added to the personal lubricant in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50% or greater w/v%, or within a range defined by any two of the aforementioned amounts. In some embodiments, the solution includes, for example, about 300 ppm hypochlorite is added to a personal lubricant in an amount of about 25% w/v.

[0037] As used herein, silicone polymers include dimethicone, which is also known as polydimethylsiloxane (PDMS), dimethylpolysiloxane, E900, or polymerized siloxane and has the chemical formula of CH3[Si(CH3)2O]„Si(CH3)3 where n is the number of repeating monomer [Si(CH3)2] units. Silicone polymers are used as an inert slip agent or lubricant. The silicone polymer may be used in the lubricant or personal lubricant in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, 50%, or greater w/v%, or in an amount within any two of the aforementioned values or between a range defined by these values. In some embodiments, the amount of silicone polymer is about 10% w/v.

[0038] As used herein, the term “sodium magnésium silicate” refers to a silicate of sodium and magnésium and is a synthetic silicate clay, having magnésium and sodium silicate. It is used as a binder and bulking agent in cosmetics and personal care products, in part because of its ability to absorb water. It is also used in the création of concrète. Sodium magnésium silicate is effective in slowing the décomposition of formulas, and can prevent prématuré darkening of the cosmetic composition and prevent prématuré development of a foui odor, thereby improving the shelf life of cosmetic compositions. In some embodiments, the sodium magnésium silicate is Laponite. As used herein, sodium magnésium silicate is useful as a gelling agent or rheology modifier. Sodium magnésium silicate may be used in the lubricant or personal lubricant in an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, 15%, or greater w/v%, or in an amount within any two of the aforementioned values or between a range defined by these values. In some embodiments, the amount of sodium magnésium silicate is about 3.25% w/v.

[0039] As used herein, the term “sodium phosphate monobasic” refers to the chemical formula of NaEyPO^ an inorganic compound of sodium with dihydrogen phosphate. Sodium phosphate monobasic is also referred to as sodium dihydrogen phosphate, sodium phosphate, monosodium phosphate, sodium biphosphate, acid sodium phosphate, monosodium orthophosphate, or primaiy sodium phosphate. As described herein, it may be used for adjustment of pH, as a thickening agent, or as an emulsifier. Sodium phosphate monobasic may be used in the lubricant or personal lubricant in an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, 15%, or greater w/v%, or in an amount within any two of the aforementioned values. In some embodiments, the amount of sodium phosphate is about 3.25% w/v.

[0040] The personal lubricants described herein may further include an additive known in the art can be included. Exemplary additives include émollients, moisturizers, humectants, pigments, dyes, pearlescent compounds, nacreous pigments, bismuth oxychloride coated mica, titanium dioxide coated mica, colorants, fragrances, biocides, preservatives, alpha hydroxy acids, antioxidants, anti-microbial agents, anti18227 fungal agents, antiperspirant agents, exfoliants, hormones, enzymes, médicinal compounds, vitamins, salts, electrolytes, alcohols, polyols, polypropylene glycol, polyisobutene, polyoxyethylene, behenic acid, behenyl, sugar-alcohols, absorbing agents for ultraviolet radiation, botanical extracts, surfactants, silicone oils, organic oils, waxes, alkaline or acidic or buffering agents, film formers, thickening agents, hyaluronic acid, fumed siiica, hydrated siiica, talc, kaolin, starch, modified starch, mica, nylon, clay, bentonite, organo-modified clays and combinations thereof.

[0041] In some embodiments, the personal lubricant described herein is characterized in having an osmolality by vapor pressure of about 10, 20, 30, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46 ,47, 48, 49, 50, 55, 60, 70, 80, 90, or 100 mmol/kg, or within a range defined by any two of the aforementioned amounts. In some embodiments, the osmolality by vapor pressure is about 38 mmol/kg. In some embodiments, the osmolality by vapor pressure is about 49 mmol/kg. In some embodiments, the lubricant is characterized in having an osmolality by freezing point dépréssion of about 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100 mOsm/kg, or within a range defined by any two of the aforementioned amounts. In some embodiments, the osmolality by freezing point dépréssion is about 22 mOsm/kg. In some embodiments, the osmolality by freezing point dépréssion is about 54 mOsm/kg.

[0042] In some embodiments is provided a method of making the lubricant formulation. In some embodiments, the method includes providing hypochlorite. In some embodiments, the hypochlorite is provided as a hypochlorite acid or sait. In some embodiments, the hypochlorite is provided as a hypochlorite solution. In some embodiments, the method of making the lubricant includes providing hypochlorite in an amount of about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150. 175, 200, 250, or 300 ppm or within a range defined by any two of the aforementioned amounts. In some embodiments, hypochlorite is provided in an amount of about 50 to 100 ppm. In some embodiments, the hypochlorite is provided in an amount of about 75 ppm.

[0043] In some embodiments, the method of making the lubricant includes providing a hypochlorite solution. In some embodiments, the hypochlorite solution is prepared from hypochlorite acids or salts. In some embodiments, the hypochlorite sait is sodium hypochlorite. In some embodiments, the hypochlorite solution is prepared from sodium chloride. In some embodiments, the method includes running sodium chloride solution through electrolysis. In some embodiments, the sodium chloride solution is provided in an amount of about 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%o, or 0.4% w/v. In some embodiments, the sodium chloride is 0.28%, and the resulting hypochlorite solution is about 300 ppm. In some embodiments, the method of making the lubricant includes diluting the hypochlorite solution to provide hypochlorite in an amount of about 10, 15, 20, 25, 30, 35, 40,45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200,250, or 300 ppm or within a range defined by any two of the aforementioned amounts. In some embodiments, hypochlorite is provided in an amount of about 50 to 100 ppm. In some embodiments, the hypochlorite is provided in an amount of about 75 ppm.

[0044] In some embodiments, the method of making the lubricant further includes providing a silicone polymer. In some embodiments, the silicone polymer is dimethicone. In some embodiments, the silicone polymer is provided in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v, or within a range defined by any two of the aforementioned amounts. In some embodiments, the silicone polymer is provided in an amount of about 10% w/v.

[0045] In some embodiments, the method further includes providing an emulsifier. In some embodiments, the emulsifier is sodium phosphate. In some embodiments, the emulsifier is provided in an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, or 2.5% w/v or within a range defined by any two of the aforementioned amounts.. In some embodiments, the emulsifier is provided in an amount of about 0.2% w/v.

[0046] In some embodiments, the method of making the lubricant further includes providing sodium magnésium silicate, water, or buffer or combinations thereof. In some embodiments, the sodium magnésium silicate is provided in an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v or within a range defined by any two of the aforementioned amounts. In some embodiments, the sodium magnésium silicate is provided in an amount of about 3.25% w/v. In some embodiments, the water and/or buffer is provided in an amount to make up the balance of the lubricant, and is provided in an amount of about 20%, 30%, 40%, 45%, 50%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 61.55%, 62%, 62.5%, 63%, 65%, 70%, 75%, 80%, or 90% w/v or within a range defined by any two of the aforementioned amounts.

[0047] As used herein, the term “buffer” refers to a buffering agent and is used for balancing the pH and/or osmolality of the lubricant. Examples of a buffer for use herein include, for example, salts of phosphates, borates, citrates, ascorbates, carbonates, bicarbonates, TRIS, HEPES, sodium ions, potassium ions, chloride ions, bicarbonate ions, glucose, sucrose, peptides, proteins, a combination or mixture thereof or other agents that are chemically, functionally, or physiologically équivalent or similar. The lubricant compositions provided herein hâve an optimum pH and viscosity, with an osmolality that is hypo-osmotic, having an osmolality by vapor pressure of about 10, 20, 30, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 70, 80, 90, or 100 mmol/kg, or within a range defined by any two of the aforementioned amounts. In some embodiments, the osmolality by vapor pressure is about 38 mmol/kg. In some embodiments, the osmolality by vapor pressure is about 49 mmol/kg. In some embodiments, the lubricant is characterized in having an osmolality by freezing point dépréssion of about 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100 mOsm/kg, or within a range defined by any two of the aforementioned amounts. In some embodiments, the osmolality by freezing point dépréssion is about 22 mOsm/kg. In some embodiments, the osmolality by freezing point dépréssion is about 54 mOsm/kg. The osmolality of the lubricant can be determined by vapor pressure osmometry or freezing point osmometry.

[0048] In some embodiments is provided a method of using a lubricant. In some embodiments, the method includes providing the lubricant and applying the lubricant. In some embodiments, the lubricant is provided as a ready-to-use formulation that includes hypochlorite or acids or salts thereof, silicone polymer, and an emulsifier, and further may include sodium magnésium silicate, water, or buffer. In some embodiments, the lubricant is provided in portions, and further additions and/or mixing is required prior to use. In some embodiments, the lubricant is applied in the penile or vaginal régions. In some embodiments, the lubricant is applied on a condom or other device. In some embodiments, the lubricant is applied multiple times daily, once daily, multiple times weekly, once weekly, multiple times monthly, or once monthly, or within a time frame defined by any two of the aforementioned time fiâmes. In some embodiments, the lubricant is applied liberally. In some embodiments, the lubricant is applied meagerly.

[0049] In some embodiments, the personal lubricant as disclosed herein is useful for improving lubrication and comfort during sexual intimacy. In some embodiments, the personal lubricant described herein is a hybrid lubricant that includes both water and silicone. In some embodiments, the personal lubricant includes hypochlorite, or a sait or acid thereof, dimethicone, and an emulsifier. In some embodiments, the personal lubricant includes water and/or buffer, hypochlorous acid solution, dimethicone, sodium magnésium silicate, and sodium phosphate.

[0050] In some embodiments is provided a method of using a lubricant for the cessation, amelioration, prévention, or inhibition of the development of itching from the vagina or other body parts by eliminating microbial causing infections.

[0051] In some embodiments, the personal lubricant is useful for alleviating discomfort in a subject having inflammation or discomfort in the vaginal or vulvovaginal area. Symptoms can include but are not limited to irritation and/or itching of the génital area, inflammation of the vaginal or périnéal area or pain. Causes can include but are not limited to disruption of the healthy microbiota, infections, yeast, bacteria or viruses. Pathogens that can cause irritation can include but are not limited to Candida, Gardnerella, gonorrhea, chlamydia, Mycoplasma, herpes, Campylobacter, or Trichomonas vaginalis. Irritation can also occur due to effects of diabètes, birth control, bad diet, tight clothing, use of antibiotics, hormonal vaginitis due to post-menopause or postpartum, or loss of estrogen. Irritants also originate from condoms, spermicides, soaps, perfumes, and lubricants. Loss of estrogen or hormonal vaginitis can also lead to dryness of tissues.

[0052] In some embodiments is provided a method of using the lubricant composition to stop a fungal infection. In some embodiments, the fungal infection is caused by a yeast of the Candida genus. In one embodiment, the yeast is of the Candida albicans species. In other embodiments, the Candida yeast may be of the Candida dubliniensis, Candida parapsilosis, Candida tropicalis, Candida kerfyr, Candida guilliermondii, Candida inconspicua, Candida famata, Candida glabrata, Candida krusei, Candida lusitaniae, or other Candida species, or combinations thereof. In some embodiments, the lubricant composition is used to stop a viral infection.

[0053] In some embodiments, the lubricant as disclosed herein is useful as a medical or surgical lubricant for use with medical instruments for insertion, pénétration, or introduction of a cathéter, ultra sound, or other medical device into a subject.

[0054] The invention is generally disclosed herein using affirmative language to describe the numerous embodiments. The invention also includes embodiments in which subject matter is excluded, in full or in part, such as substances or materials, method steps and conditions, protocols, or procedures.

EXAMPLES [0055] Some aspects of the embodiments discussed above are disclosed in further detail in the following examples, which are not in any way intended to limit the scope of the présent disclosure. Those in the art will appreciate that many other embodiments also fall within the scope of the invention, as it is described herein above and in the claims.

Example 1

Préparation of Personal Lubricant Formulations [0056] The following example demonstrates the method of preparing the Personal lubricant and various compositions or formulations thereof.

[0057] A personal lubricant was prepared with the ingrédients as provided in Table 1. Hypochlorite or a sait or acid thereof was added to water, dimethicone, sodium magnésium silicate, and sodium phosphate in the préparation of a personal lubricant formulation PL-10.

Table 1. Personal Lubricant 10 (PL-10) Formulation

Ingrédient	Ouantity
Water and/or buffer	balance
Hypochlorite	75 ppm
Dimethicone	10% w/v
Sodium Magnésium Silicate	3.25% w/v
Sodium Phosphate	0.2% w/v

[0058] The personal lubricant formulation described in Table 1 was tested on various organisms associated with sexually transmitted diseases to détermine the efficacy of inhibiting, éradication, or reducing the organismal population. Various microbial pathogens were tested, including human immunodeficiency virus (HIV), Herpes simplex virus (HSV), Hepatitis B virus (HBV), Chlamydia trachomatis, and Neisseria gonorrhoeae. These studies are described in detail in the following examples.

Alternative Préparation Example 1 [0059] A personal lubricant having 25% of a 220 ppm hypochlorite solution was added to 10% w/v dimethicone, with 3.25% w/v sodium magnésium silicate and 0.2% sodium phosphate, with the balance of 61.55% water. The hypochlorite solution was prepared by passing 0.28% sodium chloride through electrolysis to provide a 220 ppm hypochlorite solution.

Example 2

Efficacy of Personal Lubricant Against HIV-1 in Suspension [0060] The following example shows the results of the efficacy of the personal lubricant against HIV-1 in suspension.

[0061] HIV-1 was evaluated in a virucidal suspension assay. The test medium was Roswell Parle Memorial Institute-1640 (RPMI-1640) medium supplemented with 15% (v/v) heat-inactivated fêtai bovine sérum (FBS). The medium was also supplemented with 2.0 mM L-glutamine and 50 pg/mL gentamicin. The suspension containing HIV-1 was exposed to the personal lubricant formulation. At a pre-determined exposure time, an aliquot was removed, neutralized by serial dilution, and assayed for the presence of virus. The virus controls, cytotoxicity control, and neutralization control were assays in parallel. Antiviral properties of the personal lubricant were evaluated and compared at the specified concentrations and time intervals.

[0062] HIV-1 strain HTLV III_B was exposed to a personal lubricant formulation, PL-10, for an exposure time of either 5 minutes or 10 minutes at a température of 20.0°C in the presence of a 5% FBS organic soil load. PL-10 demonstrated a greater than 99.99% réduction in viral titer following 5 and 10 minute exposure times to HIV-1, as compared to the titer of the corresponding virus control. The 50% tissue culture infective dose (TCIDso)/2OO pL, a measure of infectious virus titer, was less than 1O²'⁵⁰ at both 5 and 10 minutes. Table 2 summarizes the effects of exposure of the personal lubricant to a suspension of HIV-1. The cytotoxicity and neutralization control results are presented in Table 3. MT-2 (human T cell leukemia cells) were used as indicator cell cultures.

Table 2. Effects of PL-10 Against HIV-1 in Suspension

Dilution	Virus Control	HIV-1 + PL-10
5 minute exposure	10 minute exposure	5 minute exposure	10 minute exposure
Cell Control	00 00	0 000	00 00	0 0 00
10~²	+ + + +	+ + + +	TTTT	TTTT
10'³	+ + + +	+ + + +	0 00 0	00 0 0
10~⁴	+ + + +	+ + + +	0 0 0 0	0 0 0 0
10'⁵	+ + + +	+ + + +	00 0 0	0 0 0 0
1Q'⁶	+ + + +	j \|	0 0 0 0	0 0 00
10'⁷	00 00	0 000	00 00	0 0 00
TCIDsoÆOO uL	₁₀6.50	₁₀6.50	<1O²·⁵⁰	<10²·⁵⁰
Percent Réduction			>99.99%	>99.99%
Log Réduction			>4.00 logio	>4.00 logio

(+) = positive test for the presence of test virus (0) = no test virus recovered and/or no cytotoxicity présent (T) = cytotoxicity présent

Table 3. PL-10 Cytotoxicity and Neutralization Results for HIV-1

Dilution	Cytotoxicity Control	Neutralization Control
PL-10	HIV-1 + PL-10
Cell Control	0 000	0 0 0 0
10~²	TTTT	TTTT
10~³	0 000	+ + + +
lOj	0 00 0	+ + + +
10~⁵	0 000	+ + + +
10~⁶	0 000	+ + + +
10'⁷	0 0 00	+ + + +
TCIDsn/200 uL	1O²·⁵⁰	^Neutralized at <2.50 Lopin

(+) = positive test for the presence of test virus (Ό) = no test virus recovered and/or no cytotoxicity présent (T) = cytotoxicity présent (*) = Neutralization control reported as TCIDsn/250 uL

Example 3

Efficacy of Personal Lubricant Against HSV-2 in Suspension [0063] The following example shows the results of the efficacy of the personal lubricant against HSV-2 in suspension.

[0064] HSV-2 was evaluated in a virucidal suspension assay. The test medium was minimum essential medium (MEM) supplemented with 5% (v/v) heat-inactivated FBS. The medium was also supplemented with 100 units/mL penicillin, 10 pg/mL gentamicin, and 2.5 pg/mL amphotericin B. HSV-2 was exposed to the personal lubricant formulation. At a pre-detennined exposure time, an aliquot was removed, neutralized by serial dilution, and assayed for the presence of virus. The virus controls, cytotoxicity control, and neutralization control were assays in parallel. Antiviral properties of the personal lubricant were evaluated and compared at the specified concentrations and time intervals.

[0065] HSV-2, ATCC VR-734, Strain G was exposed to a personal lubricant formulation, PL-10. The exposure time was of either 5 minutes or 10 minutes at a température of 21.0°C in the presence of a 5% FBS organic soil load. PL-10 demonstrated a greater than 99.9997% réduction in viral titer following 5 minute exposure time and a greater than 99.998% réduction in viral titer following a 10 minute exposure time to HSV-2, as compared to the titer of the corresponding virus control. The log réductions in viral titer were greater than 5.50 logio and greater than 4.75 logio, respectively. Table 4 summarizes the effects of exposure of the personal lubricant to a suspension of HSV-2.

The cytotoxicity and neutralization control results are presented in Table 5. Vero cells were used as indicator cell cultures.

Table 4, Effects of PL-10 Against HSV-2 in Suspension

Dilution	Virus Control	HSV-2 + PL-10
5 minute exposure	10 minute exposure	5 minute exposure	10 minute exposure
Cell Control	0 0 00	0 0 00	00 0 0	00 0 0
10'²	+ + + +	+ 4- + +	0 00 0	0 0 00
10'³	+ + + +	+ + + +	0 0 0 0	0 0 00
10~⁴	+ + + +	+ + + +	00 00	0 0 00
10'⁵	+ + + +	+ + + +	00 00	0 0 00
10~⁶	+ + + +	+ 0 + +	00 0 0	0 0 0 0
10'⁷	+ 0 + 0	0 000	0 0 0 0	0 0 0 0
ÎO'⁸	00 00	0 00 0	0 00 0	0 00 0
TCIDsn/100 uL	107.00	10⁶·²⁵	<10‘·⁵⁰	<io^L50
Percent Réduction			>99.9997%	>99.998%
Log Réduction			5.50 logio	4.75 logio

(+) = positive test for the presence of test virus (Ό) = no test virus recovered and/or no cytotoxicity présent

Table 5. PL-10 Cytotoxicity and Neutralization Results for HSV-2

Dilution	Cytotoxicity Control	Neutralization Control
PL-10	HSV-2 + PL-10
Cell Control	0 0 0 0	0 0 00
10~²	0000	+ + + +
10~³	00 0 0	+ + + +
IA	0 0 00	+ + + +
TCIDsn/100 pL	<10^L5ü	*Neutralized at <1.50 Logio

(+) = positive test for the presence of test virus (θ') = no test virus recovered and/or no cytotoxicity présent (*) = Neutralization control reported as TCIDso/100 uL

Example 4

Efficacy of Personal Lubricant Against HBV in Suspension [0066] The following example shows the results of the efficacy of the personal lubricant against HBV in suspension.

[0067] HBV was evaluated in a virucidal suspension assay. The test medium was Leibovitz L-15 medium supplemented with 0.1% glucose, 10 μΜ dexamethasone, 10 μg/mL insulin, 20 mM HEPES, 100 units/mL penicillin, and 10 pg/mL gentamicin. HBV was exposed to the personal lubricant formulation. At a pre-determined exposure time, an aliquot was removed, neutralized by serial dilution, and assayed for the presence of virus. The virus controls, cytotoxicity control, and neutralization control were assays in parallel. Antiviral properties of the personal lubricant were evaluated and compared at the specified concentrations and time intervals.

[0068] Duck HBV was exposed to a personal lubricant formulation, PL-10. The exposure time was of either 5 minutes or 10 minutes at a température of 20.0°C in the presence of 100% duck sérum, with no additional soil load added. PL-10 demonstrated a greater than 99.999% réduction in viral titer following 5 minute exposure time and a greater than 99.998% réduction in viral titer following a 10 minute exposure time to duck HBV, as compared to the titer of the corresponding virus control. The log réductions in viral titer were greater than 5.00 logio and greater than 4.75 logio, respectively. Table 6 summarizes the effects of exposure of the personal lubricant to a suspension of HSV-2.

The cytotoxicity and neutralization control results are presented in Table 7. Primary duck hépatocytes were used as indicator cell cultures.

Table 6, Effects of PL-10 Against HBV in Suspension

Dilution	Virus Control	HBV + PL-10
5 minute exposure	10 minute exposure	5 minute exposure	10 minute exposure
Cell Control	00 00	0 000	0 0 0 0	0 0 0 0
10'²	+ 4 + +	+ + + +	0 00 0	0 0 00
10~³	+ + + +	+ + + +	00 00	00 0 0
10'⁴	+ + + +	+ + + +	0 0 0 0	0 00 0
ιοί	+ + + +	+ + + +	0 0 0 0	00 0 0
ioi	+ + + +	+ + + 0	0 0 0 0	0 00 0
ioi	0 0 0 0	0 0 0 0	0 00 0	0 0 0 0
TCKW250 uL	₁₀6.50	10⁶·²⁵	<io‘·⁵⁰	<10^L5ü
Percent Réduction			>99.999%	>99.998%
Log Réduction			>5.00 logjQ	>4.75 log]n

(+) = positive test for the presence of test virus (0) = no test virus recovered and/or no cytotoxicity présent

Table 7. PL-10 Cytotoxicity and Neutralization Results for HBV

Dilution	Cytotoxicity Control	Neutralization Control
PL-10	HBV + PL-10
Cell Control	000 0	00 0 0
ioi	000 0	+ + + +
ioi	0 0 00	+ + + +
îoj	00 0 0	+ + + +
TCIDso/250 uL	<io'·⁵⁰	*Neutralized at <1.50 Logm

(+) = positive test for the presence of test virus (Ό) = no test virus recovered and/or no cytotoxicity présent (*) = Neutralization control reported as TCIDsq/250 uL

Example 5

Efficacy of Personal Lubricant Against Chlamydia in Suspension [0069] The following example shows the results of the efficacy of the personal lubricant against Chlamydia trachomatis in suspension.

[0070] Chlamydia trachomatis was evaluated in a chlamydial suspension assay. The test medium was MEM supplemented with 10% (v/v) heat-inactivated FBS, 2 pg/mL cycloheximide, 4.5 g/L glucose, 10 mM HEPES, 10 pg/mL gentamicin, and 2.5 pg/mL amphotericin B. A suspension of chlamydia was exposed to the personal lubricant formulation. At a pre-determined exposure time, an aliquot was removed, neutralized by serial dilution, and assayed for the presence of chlamydia. The chlamydia controls, cytotoxicity control, and neutralization control were assays in parallel. Antichlamydia properties of the personal lubricant were evaluated and compared at the specified concentrations and time intervals.

[0071] Chlamydia trachomatis (Serotype K), ATCC VR-887, strain UW31/Cx was exposed to a personal lubricant formulation, PL-10. The exposure time was of either 5 minutes or 10 minutes at a température of 20.0°C in the presence of 5% FBS organic soil load. PL-10 demonstrated a greater than 99.999% réduction in chlamydia titer following 5 minute exposure time and a greater than 99.998% réduction in chlamydia titer following a 10 minute exposure time to Chlamydia trachomatis (Serotype K), as compared to the titer of the corresponding chlamydia control. The log réductions in chlamydia titer were greater than 5.00 logio and greater than 4.75 logio, respectively. Table 8 summarizes the effects of exposure of the personal lubricant to a suspension of chlamydia. The cytotoxicity and neutralization control results are presented in Table 9. McCoy indicator cell cultures were used.

Table 8. Effects of PL-10 Against Chlamydia in Suspension

Dilution	Chlamydia Control	Chlamydia trachomatis + PL-10
5 minute exposure	10 minute exposure	5 minute exposure	10 minute exposure
Cell Control	00 00	00 00	00 00	0 0 00
10'²	+ + + +	+ + + +	0 00 0	00 0 0
10~³	+ + + +	+ + + +	00 00	0 0 00
lOj	+ + + +	+ + + +	0 00 0	00 0 0
10'⁵	+ + + +	+ + + +	0 0 0 0	0 00 0
10'⁶	+ + + +	+ + 0 +	0 0 0 0	00 0 0
iœ⁷	0 0 0 0	00 00	00 0 0	0 0 00
TCKW200 uL	1O⁶·⁵⁰	10⁶·²⁵	<10^L5°	<10^L5°
Percent Réduction			>99.999%	>99.998%
Log Réduction			>5.00 logio	>4.75 log_IQ

(+) = positive test for the presence of test chlamydia (0) = no test chlamydia recovered and/or no cytotoxicity présent

Table 9. PL-10 Cytotoxicity and Neutralization Results for Chlamydia

Dilution	Cytotoxicity Control	Neutralization Control
PL-10	Chlamydia trachomatis + PL-10
Cell Control	000 0	0000
10~²	0 000	+ + + +
iœ³	0 0 0 0	+ H^- 4~ +
10~⁴	0000	+ + + +
TCID₅o/1OO uL	<10^L5ü	*Neutralized at <1.50 Logio

(+) = positive test for the presence of test chlamydia (0) = no test chlamydia recovered and/or no cytotoxicity présent (*) = Neutralization control reported as TCIDW200 uL

Example 6

Efficacy of Personal Lubricant Against Neisseria Gonorrhoeae in Suspension [0072] The following example shows the results of the efficacy of the personal lubricant against Neisseria gonorrhoeae in suspension.

[0073] Neisseria gonorrhoeae was evaluated in a time kill assay. The test was conducted in an agar plate medium of chocolaté agar. Neisseria gonorrhoeae, ATCC 5 43069, was exposed to a personal lubricant formulation, PL-10 at exposure times of l, 2,

5, and 10 minutes in suspension at a température of 21.0°C. After exposure, an aliquot of the suspension was transferred to a neutralizer and was assayed for survivors. Appropriate culture purity, neutralizer sterility, test population, and neutralization confirmation controls were performed. The neutralizer was Letheen broth with 0.07% lecithin and 0.5% 10 Tween 80.

[0074] The neutralizer sterility control shows no growth of Neisseria gonorrhoeae. The control population of Neisseria gonorrhoeae shows 3.2 x 10⁴ colony forming units, and log réduction of 4.51 logio· The exposure of Neisserria gonorrhoeae to PL-10 for any of 1, 2, 5, and 10 minutes showed no survivors at any of the dilution. Table 15 10 summarizes the effects of exposure for PL-10 against Neisseria gonorrhoeae.

Table 10. PL-10 Ng&inst Neisseria gonorrhoeae

Exposure Time (minutes)	CFU/mL in Test population control (Logio)	CFU/mL of Survivors	Logjo Survivors	Percent Réduction	Logm Réduction
1		<5	<0.70	>99.9%	>3.81
2	3.2 x 10⁴ (4.51)	<5	<0.70	>99.9%	>3.81
5	<5	<0.70	>99.9%	>3.81
10		<5	<0.70	>99.9%	>3.81

CFU - colony forming units [0075] Table 11 summarizes the results of Examples 2-6 for the efficacy of PL-10 in reducing a variety of organismal populations.

Table 11. PL-10 Destroys Major Sexually Transmitted Infections

Test Organism	Max Control Population	Population at 5 minute exposure	Percent Réduction	Population atlO minute exposure	Percent Réduction
HIV-1	4.00 LoglO	0	>99.99%	0	>99.99%
Herpes simplex virus type 2	5.50 LoglO	0	>99.9997%	0	>99.998%
Hepatitis B virus	5.00 LoglO	0	>99.999%	0	>99.998%
Chlamydia trachomatis	5.00 LoglO	0	>99.999%	0	>99.998%
Neisseria gonorrhoeae	3.8 LoglO	0	>99.9%	0	>99.9%

Example 7

Cytotoxicity of Personal Lubricant on Cell Culture [0076] The following example shows the results of the cytotoxicity of the personal lubricant on cell cultures.

[0077] The personal lubricant PL-10 was added to mouse fibroblast cells and incubated for 24 hours. The cells were observed under 100X magnification and the amount of morphology was scored using a 0-4 scale, where 0 = no reactivity and 4 = severe reactivity. A score of 3 or greater indicates a cytotoxic effect. The personal lubricant received a score of 2, indicating that the personal lubricant is not cytotoxic on mouse fibroblast cultures.

Example 8

Sensitivity Test of Personal Lubricant [0078] The following example shows the results of the sensitivity of the personal lubricant on animal models.

[0079] The personal lubricant was tested on guinea pigs to détermine if exposure to the product produced a delayed-type hypersensitivity skin reaction. In this example, guinea pigs were exposed to the personal lubricant and to a control substance both underneath the skin and topically. After 14 days, the animais were again exposed to the lubricant or control. The test sites on the skin were evaluated at both 24 and 48 hours post treatment. No sensitization reactions were observed, and the test group did not exhibit différences from the control group.

Example 9

Vaginal Mucosal Irritation Test of Personal Lubricant [0080] The following example shows the results of the personal lubricant on vaginal mucosal irritation. The personal lubricant of Example 1, PL-10, was used on rabbits to détermine the effects of the personal lubricant on vaginal tissue. The study complied with ail applicable sections of the Final Rules of the Animal Welfare Act régulations (9 CFR 1-3), the Public Health Service Policy on Humane Care and Use of Laboratory Animais, and the Guide for the Care and Use of Laboratory Animais. Test procedures were reviewed and approved by PBL’s Institutional Animal Care and Use Committee (IACUC) in compliance with Animal Welfare Act.

[0081] Environment. New Zealand white rabbits were housed individually in stainless steel cages. Animais were maintained in a controlled environment at a nominal température range of 16 to 22°C, a humidity range of 50 □ 20%, and a light/dark cycle of 12 hours. Animais were maintained in rooms with at least ten room air changes per hour.

[0082] Diet and Feed. Animais received a Certified Laboratory Rabbit Diet approximately 165 g per day. The feed is analyzed by the supplier for nutritional components and environmental contaminants. There are no known contaminants in the feed that interfered with the conduct of this example.

[0083] Water. Fresh, potable drinking water was provided ad libitum to ail animais via a sipper tube. Water testing is conducted two times a year for total dissolved solids and specified microbiological content and selected éléments, heavy metals, organophosphates, and chlorinated hydrocarbons. There are no known contaminants in the water that interfered with the conduct of this example.

[0084] Acclimation. Animais placed on study were acclimated to the testing facility for at least 6 days prior to initiation of the study. Health observations were performed prior to the study to ensure that the animais were acceptable for study use.

[0085] Assignment to Study and Disposition. Animais were examined prior to study initiation, and determined (based on clinical observations) suitable as test subjects.

[0086] Test and Control Article Préparation: The personal lubricant PL-10 is applied. Physiological saline (SCI) is used as a négative control.

[0087] Procedure: Six female rabbits were used in this example (three test and three control animais). Prior to the test and prior to each treatment, the animais were checked for vaginal discharge, swelling and/or other evidence of vaginal infection, irritation or injury. The animais were weighed prior to the initial dosing and at the termination of the test. Rabbits were dosed at 24 ± 2 hour intervals every day for a minimum of five consecutive days (Days 0, 1, 2, 3 and 4). A short, soft cathéter (approximately 6 cm) or blunt-tipped cannula (for example, 12 French Nelaton cathéter) attached to a syringe was used for administration of the personal lubricant. The dose volume was approximately 1 mL. The tip of the cathéter used for the test group animais was moistened with the personal lubricant and inserted into vagina. The tip of the cathéter used for the control group animais was moistened with a control lubricant (for example, Lubrivet) and inserted into the vagina. The personal lubricant or control (at least 1 mL) was introduced no more than 6 cm into the anterior vagina. Any expelled material was gently removed with a soft tissue and rabbit retumed to its cage.

[0088] Clinical Observation: At 24 ± 2 hours after the initial application and immediately prior to each treatment, the appearance of the vaginal opening and perineum was noted for signs of discharge, erythema and edema. At 24 ± 2 hours after the last dose, ail animais were euthanized. The entire urogénital tract (including the vagina and the cervix) was removed. The entire vagina was opened longitudinally, and examined for gross evidence of irritation, injury to épithélial layer of tissue and necrosis. The entire urogénital tract was placed in 10% formalin and samples further processed by approved histopathology laboratory (for example, HSRL, VA). Histopathological évaluation of tissues was performed by a Board Certified Pathologist. The vaginal tissues were evaluated for the irritant effects.

[0089] Results: No evidence of mucosal irritation was found in the test animais following vaginal exposure to the personal lubricant, based on both macroscopie (evidence of irritation, épithélial cell injury, and necrosis) and microscopie (histopathological) analysis.

Example 10

Acute Systemic Toxicity of Personal Lubricant [0090] The following example shows that the personal lubricant described herein does not show systemic toxicity in mice.

[0091] Mice were injected intraperitoneally with the personal lubricant and observed for 3 days. None of the animais tested exhibited any biological reactivity during the test period, including no différence in body weight, no signs of déhydration, no abnormal posture or appearance of skin, eyes, for and mucous membranes, no change in urine and fecal output, and no change in locomotor behavior.

Example 11

Condom Compatibility of Personal Lubricant [0092] The following example demonstrates that the personal lubricant as described herein is compatible with a variety of condoms in terms of being compatible with standard condom testing measures, such as burst pressure, burst volume, break force, and élongation.

[0093] The personal lubricant was tested with latex, polyisoprene, and polyuréthane condoms. As a baseline, each condom was tested as received, with no heat or lubricant applied. A control was performed with each condom exposed to 40°C for 1 hour, without lubricant. A positive control was performed with each condom exposed to 40°C for 1 hour with minerai oil applied. The test was performed at 40°C for 1 hour with the personal lubricant, PL-10. Test results indicate that the personal lubricant passed ail natural latex and polyisoprene condom compatibility testing.

[0094] In at least some of the previously described embodiments, one or more éléments used in an embodiment can interchangeably be used in another embodiment unless such a replacement is not technically feasible. It will be appreciated by those skilled in the art that various other omissions, additions and modifications may be made to the methods and structures described above without departing from the scope of the claimed subject matter. Ail such modifications and changes are intended to fall within the scope of the subject matter, as defined by the appended claims.

[0095] With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.

[0096] It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as “open” terms (for example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a spécifie number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is présent. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (for example, “a” and/or “an” should be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a spécifie number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such récitation should be interpreted to mean at least the recited number (for example, the bare recitation of “two recitations,” without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “ a system having at least one of A, B, and C” would include but not be limited to Systems that hâve A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “ a system having at least one of A, B, or C” would include but not be limited to Systems that hâve A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.” [0097] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0098] As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible sub-ranges and combinations of sub-ranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifiths, tenths, etc. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etc. As will also be understood by one skilled in the art all language such as “up to,” “at least,” “greater than,” “less than,” and the like include the number recited and refer to ranges which can be subsequently broken down into sub-ranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 articles refers to groups having 1, 2, or 3 articles. Similarly, a group having 1-5 articles refers to groups having 1,2, 3, 4, or 5 articles, and so forth.

[0099] While various aspects and embodiments hâve been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims

WHAT IS CLAIMED IS:

1. A lubricant, comprising:

hypochlorite;

an emulsifier; and a silicone polymer.
2. The lubricant of claim 1, further comprising a buffer.
3. The lubricant of claim 2, wherein the buffer is sodium phosphate.
4. The lubricant of any one of claims 2-3, wherein the buffer is présent in an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v.
5. The lubricant of any one of claims 2-4, wherein the buffer is présent in an amount of about 0.2% w/v.
6. The lubricant of any one of claims 1-5, wherein the hypochlorite is présent in an amount of about 50 to about 100 ppm.
7. The lubricant of any one of claims 1-6, wherein the hypochlorite is présent in an amount of about 75 ppm.
8. The lubricant of any one of claims 1-7, wherein the emulsifier is sodium magnésium silicate.
9. The lubricant of any one of claims 1-8, wherein the emulsifier is présent in an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v.
10. The lubricant of any one of claims 1-9, wherein the emulsifier is présent in an amount of about 3.25% w/v.
11. The lubricant of any one of claims 1-10, wherein the silicone polymer is dimethicone.

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12. The lubricant of any one of claims 1-11, wherein the silicone polymer is présent in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v.
13. The lubricant of any one of claims 1-12, wherein the silicone polymer is présent in an amount of about 10% w/v.
14. The lubricant of any one of claims 1-13, further comprising water.
15. The lubricant of any one of claims 1-14, wherein the lubricant has an osmolality of about 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100 mOsm/kg, as measured by freezing point osmometry.
16. The lubricant of any one of claims 1-15, wherein the lubricant has an osmolality of about 22 mOsm/kg, as measured by freezing point osmometry.
17. The lubricant of any one of claims 1-16, wherein the lubricant has an osmolality of about 54 mOsm/kg, as measured by freezing point osmometry.
18. The lubricant of claim 2, wherein the hypochlorite is in an amount of about 75 ppm, wherein the emulsifier comprises sodium magnésium silicate in an amount of about 3.25% w/v, wherein the silicone polymer comprises dimethicone in an amount of about 10% w/v, wherein the buffer comprises sodium phosphate in an amount of about 0.2% w/v, and wherein the lubricant further comprises water in an amount of about 61.55% w/v.
19. A lubricant, comprising:

hypochlorite;

sodium magnésium silicate;

dimethicone; and sodium phosphate.
20. The lubricant of claim 19, wherein hypochlorite is présent in an amount of about 75 ppm, sodium magnésium silicate is présent in an amount of about 3.25% w/v, dimethicone is présent in an amount of about 10% w/v, sodium phosphate is présent in an amount of about 0.2% w/v, and wherein the lubricant further comprises water in an amount of about 61.55% w/v.

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21. Use of the lubricant of any one of claims 1-20 for increasing comfort or lubricity.
22. A method of using a lubricant, comprising providing the lubricant of any one of claims 1-20 and applying the lubricant.
23. A method of making the lubricant of any one of claims 1-20, comprising providing a hypochlorite solution and a silicone polymer and mixing the ingrédients to form a lubricant.