EP4167956A1 - Personal lubricants comprising lambda-carrageenan - Google Patents
Personal lubricants comprising lambda-carrageenanInfo
- Publication number
- EP4167956A1 EP4167956A1 EP20942177.5A EP20942177A EP4167956A1 EP 4167956 A1 EP4167956 A1 EP 4167956A1 EP 20942177 A EP20942177 A EP 20942177A EP 4167956 A1 EP4167956 A1 EP 4167956A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- carrageenan
- antiviral
- composition
- lubricous
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/731—Carrageenans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
Definitions
- the present invention relates to processes for making personal lubricant compositions useful for reducing or inhibiting the transmission of human papillomavirus among partners during sexual activity.
- HPV human papillomavirus
- STI sexually transmitted infection
- HPV is the root cause of essentially all cervical cancers, the second most common cancer in women worldwide by age-standardized incidence rate, leading to approximately 500,000 deaths per year. More than 85% of cervical cancer deaths are in developing countries, where it accounts for 13% of all female cancers. WHO also estimates that HPV causes 90% of anal cancer. In a separate study on HPV and throat cancer, AECOM found that the presence of an HPV type in the mouth increases the odds of developing head and neck cancer by twenty-two times. HPV is also the underlying cause of all genital warts.
- HPV is spread from skin-to-skin contact, most commonly transmitted during sexual activity to the genitals, anus, and mouth. Consequently, condoms are only marginally effective in preventing transmission of HPV. While there are some treatment options for HPV, the reality is that there are more than 150 strains of HPV, approximately 30 of which have been shown to cause cancers and genital warts. Vaccines have been developed and can be useful — however, the best HPV vaccine available in the United States today only provides antiviral activity against 9 of the more than 150 HPV strains and they are only efficacious for a small subset of people.
- HPV vaccines only have an uptake rate 40% among adolescents, and that they are generally ineffective for people over 26 years old, as well as African-American women of any age. Further, the CDC has also reported that vaccines are also ineffective if the person has previously been exposed to HPV. Additionally, HPV vaccines are typically expensive, require multiple treatments or injections, and are largely unavailable to people in developing countries. As a result, a large proportion of people are unvaccinated and rely on condoms as their only protection against HPV.
- Carrageenans are large, highly flexible polysaccharides that are almost exclusively obtained as complex mixtures of at least two, and typically three, different forms: kappa-carrageenan, iota-carrageenan, and lambda-carrageenan, which differ in their degree of sulfation kappa- and iota-forms of carrageenan, which contain the fewest number of ester sulfate groups per molecule, predominate most carrageenan mixtures and are typically used in the food or cosmetic industries as gelling or thickening agents.
- lambda-carrageenan has the most ester sulfate groups per polysaccharide, and is unable to form a gel at all.
- carrageenan-based formulations are prone to drying quickly after being applied, resulting in sticky, non-lubricous residues that defeat the purpose of using a personal lubricant in the first place.
- the viscosity of a particular carrageenan-containing composition is highly sensitive to the exact proportions of the kappa-, iota-, and lambda-forms within the composition.
- a composition that contains 50% lambda-carrageenan and 50% kappa- carrageenan will have a different viscosity than a composition that contains 70% lambda-carrageenan and 30% kappa-carrageenan, even where the total concentration of carrageenan in both compositions is identical.
- compositions that comprise all three forms of carrageenan that comprise all three forms of carrageenan. Consequently, the viscosity of carrageenan-containing compositions is generally not predictable from one composition to the next when the proportions of the kappa-, iota-, and lambda-forms are different, even when the total carrageenan concentration is the same.
- the processing steps themselves that are used to make carrageenan-containing compositions can have an effect on the viscosity and performance as a sexual lubricant.
- the temperature at which components are mixed has a dramatic effect on the viscosity of a carrageenan-containing product, particularly as a function of the ratio of each form of carrageenan within the mixture.
- the proportions of each form of carrageenan that are contained within the composition can affect what happens upon cooling.
- the predominant form is kappa- or iota-carrageenan
- the cooled composition will form a gel
- the predominant form is lambda-carrageenan
- the cooled composition will not form a gel.
- the relative proportions of kappa- and iota- carrageenan within the composition nonetheless affect the viscosity in lambda-carrageenan containing compositions that do not gel.
- the present invention provides processes for making low-viscosity, antiviral lubricous compositions that include lambda-carrageenan and are useful for reducing, inhibiting, or ameliorating the transmission, persistence, or symptoms caused by viruses, including but not limited to sexually- transmitted viruses and other disease-causing viruses from a taxonomic family can include any one of, and alternatively can be selected from the group consisting of, Or thorny xo viridae , paramyxoviridae, pneumoviridae , coronaviridae , retroviridae , herpesviridae , papdlomaviridae , picornaviridae , reoviridae , and adenoviridae , and combinations thereof.
- antiviral lubricous compositions made according to the disclosed processes can be applied to any epithelial or skin tissue which a virus can reside or be spread, including the tissue within or on the cervix, vulva, vagina, clitoris, penis, anus, mouth, nose, nasal cavity, or throat.
- antiviral lubricous compositions made by processes of the present invention can be used in conjunction with sexual activity.
- sexual activity includes intimate or sexual contact with the skin or epithelial tissue within or on the cervix, vulva, vagina, clitoris, penis, anus, mouth, or throat of one, two, or more sexual partners.
- the application of antiviral lubricous compositions of the present invention are effective in reducing the transmission of sexually-transmitted viruses in humans, non-limiting examples of which include human papilloma virus (HPV), human immunodeficiency virus (HIV), and herpes simplex virus (HSV), relative to placebo compositions that do not contain lambda- carrageenan.
- HPV human papilloma virus
- HSV herpes simplex virus
- the antiviral lubricous compositions provide protection against the transmission of HPV, including but not limited to HPV strains known to cause cancer, that can occur during male-female sexual encounters, male-male sexual encounters, and female-female sexual encounters.
- the antiviral lubricous compositions can provide protection against the transmission of HPV among high-risk sexual partners, including those who are already infected with at least one strain of HPV.
- any of the antiviral lubricous compositions described herein can be contacted with the skin or epithelial tissue, particularly skin or epithelial tissue located on or within at least one of the vagina, anus, mouth, or penis, of one or more of the sexual partners prior to sexual activity, in order to prophylactically inhibit the transmission of HPV from one sexual partner to another.
- the antiviral lubricous composition can be contacted with the skin of one or more of the sexual partners less than 8 hours prior, for example, less than 4 hours, 2 hours, 1 hour, 30 minutes, 15 minutes, 5 minutes, 1 minute, or 30 seconds prior, to sexual activity, down to less than 1 second prior to sexual activity.
- the antiviral lubricous composition can be contacted with the skin or epithelial tissue, particularly skin or epithelial tissue located on or within at least one of the vagina, anus, mouth, or penis, of one or more of the sexual partners after sexual activity, in order to reduce the spread of HPV from cell to cell after HPV has been transmitted.
- the antiviral lubricous composition can be contacted with the skin or epithelial tissue of one or more of the sexual partners less than 8 hours after, for example, less than 4 hours, 2 hours, 1 hour, 30 minutes, 15 minutes, 5 minutes, 1 minute, or 30 seconds after, sexual activity, down to less than 1 second after sexual activity.
- antiviral lubricous compositions made by processes of the present invention can be applied to a person’s skin or epithelial tissue independently of engaging in sexual activity.
- the antiviral lubricous composition can be applied to reduce, inhibit, or ameliorate the transmission or effects of non-sexually transmitted viruses, including but not limited to coronaviruses, reoviruses, adenoviruses, orthomyxoviruses, paramyxoviruses, pneumoviruses, picornaviruses, and non-sexually transmitted retroviruses and herpes viruses.
- Non limiting examples of diseases caused by such viruses include, but are not limited to severe acute respiratory disease (SARS), COVID-19, influenza, measles, mumps, varicella, enterovirus, rhinovirus, polio, adenovirus, and rotavirus.
- the antiviral lubricous composition can be applied to animals having an infection from a disease caused by a virus caused by any of the viral families or types described above. Methods and substrates for applying an antiviral lubricous composition to help treat or reduce the effects of such conditions, in humans or animals, is described in further detail below.
- the antiviral lubricous compositions can be utilized in conjunction with feminine hygiene, for such purposes including but not limited to: as a vaginal moisturizer, as a vaginal deodorizer, and as a vaginal odor eliminator.
- the antiviral lubricous compositions are non-Newtonian, pseudoplastic fluids that undergo thixotropic shear thinning that reduces the composition’s viscosity even further in response to mechanical strain.
- mechanical strain can occur when one, two, or more people engage in sexual activity, including sexual activity between male and female sexual partners, two or more male sexual partners, two or more female sexual partners, and combinations thereof.
- the antiviral lubricous compositions possess a rheological profile in which the lubricity of a dried antiviral lubricous composition on the skin can be retained upon adding water or other bodily fluids to the dried antiviral lubricous composition.
- bodily fluids include saliva and vaginal secretions or discharge.
- the antiviral lubricous composition upon adding water or bodily fluids to a dried antiviral lubricous composition, the antiviral lubricous composition retains its antiviral activity, including against HPV.
- the antiviral lubricous compositions of the present invention can be prepared substantially free of components typically utilized in commercially-available personal lubricants, including but not limited to: oils, particularly silicone oils; cellulose; and polyquaterniums.
- the antiviral lubricous compositions can be prepared to be substantially free of spermicides, such as nonoxynol-9, that are also often present commercially- available personal lubricants.
- the antiviral lubricous compositions can be prepared to include oils, cellulose, polyquaterniums, and/or nonoxynol-9.
- processes to form antiviral lubricous compositions of the present invention can comprise the steps of: (a) providing a carrageenan powder comprising carrageenan, the carrageenan comprising at least 80% by weight lambda-carrageenan and up to 10% by weight of a secondary carrageenan selected from the group consisting of iota carrageenan and kappa-carrageenan, including combinations thereof, and preferably 10% by weight kappa- carrageenan; (b) combining, while mixing, the carrageenan powder with an aqueous solution comprising a quantity of a polyol, to form an aqueous carrageenan suspension; (c) heating the aqueous carrageenan suspension up to a temperature of at least 60 °C; (d) mixing for a time sufficient to transform the heated aqueous carrageenan suspension into an aqueous homogeneous solution; (e) cooling the aqueous homogeneous solution to a
- the carrageenan suspension is turbid. When substantially all of the polysaccharides within the carrageenan suspension are homogenized upon heating and mixing, the carrageenan suspension clarifies and the resulting homogeneous solution is translucent.
- the antiviral carrageenan suspension becomes and remains transparent upon formation of the homogeneous solution.
- the turbidity of any of the mixtures, suspensions, or antiviral lubricous compositions disclosed herein can be described quantitatively based on the method of determining the concentration of suspended particles in the sample, including but not limited to Formazin Nephelometric Units (FNU), Jackson Turbidity Units (JTU), and Nephelometric Turbidity Units (NTU).
- FNU Formazin Nephelometric Units
- JTU Jackson Turbidity Units
- NTU Nephelometric Turbidity Units
- the turbidity of any of the mixtures, suspensions, or antiviral lubricous compositions described herein are characterized as a function of NTU.
- the turbidity of the carrageenan suspension upon the addition of carrageenan to the aqueous solution is at least 100 NTU, including at least 200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, or 3000 NTU, up to at least 4000 NTU.
- the turbidity of the homogenized antiviral lubricous composition is less than 25 NTU, including less than 20, 15, 10, 8, 6, 5, 4, 3, or 2 NTU, down to less than 1 NTU, preferably less than or equal to 5 NTU, and more preferably approximately equal to the turbidity of drinking water.
- the step of combining while mixing the carrageenan powder with the aqueous solution comprises the sub-steps of (A): mixing the carrageenan powder with a polyol for a time sufficient to form a wet carrageenan mixture, and (B) combining, while mixing, the wet carrageenan mixture with an aqueous solution for a time sufficient to form the aqueous carrageenan suspension.
- the weight ratio of the polyol to the carrageenan within the wet carrageenan mixture is at least 1:10, including at least 1:5, 1:1, 2:1, 4:1, 6:1, 8:1, 10:1, 20: 1, 30:1, or 40: 1, up to at least 50: 1.
- the weight ratio of the polyol to the carrageenan is 1:1 to 10:1. In various embodiments, the weight ratio of the aqueous solution mixed with the wet carrageenan mixture to form the carrageenan suspension is 3:1 to 60:1. In still further embodiments, the weight ratio of the aqueous solution mixed with the wet carrageenan mixture to form the carrageenan suspension is 8:1 to 45:1.
- the step of mixing the wet carrageenan mixture with the aqueous solution comprises dispersing the carrageenan contained in the wet carrageenan mixture within the aqueous solution.
- the step of dispersing comprises sufficient shear mixing of the carrageenan powder with the polyol with a dispersing mixer for a time sufficient to homogenize the carrageenan into the aqueous solution, while also minimizing the breaking of intramolecular bonds between sugar residues within each carrageenan polysaccharide.
- heating one or more of the wet carrageenan mixture, the aqueous carrageenan suspension, and/or the antiviral lubricous composition enables the solubilization and homogenization of the carrageenans in water.
- one or more of the wet carrageenan mixture, the aqueous carrageenan suspension, and/or the antiviral lubricous composition is heated to a temperature of at least 60 °C, for example, at least 65 °C, 70 °C, 75 °C, 80°C, 85 °C, or 90 °C, and optionally up to at least 95 °C.
- the aqueous carrageenan suspension is heated to at least 70 °C, and up to 75 °C.
- a step of mixing of other powdered, solid, or liquid adjuvants into the aqueous solution comprises agitating the adjuvants within the aqueous solution under sufficient shear mixing and for a time sufficient to form a compositionally uniform solution.
- the carrageenan powder comprising lambda-carrageenan is a dried extract from sea algae, particularly from the red algae, Chondrus crispus.
- lambda-carrageenan comprises at least 80%, for example, at least 85%, 90%, or 95% by weight of the sea algae extract.
- lambda-carrageenan comprises up to 100%, for example, up to 95%, 90%, or 85%, by weight of the sea algae extract.
- lambda-carrageenan comprises 90% by weight of the sea algae extract.
- the carrageenan powder consists of carrageenan in powder form. In another embodiment, the carrageenan powder consists essentially of carrageenan in powder form.
- the carrageenan powder can comprise carrageenan in powder form and an additional powder component.
- an additional powder component includes a pH adjusting agent, a disinfectant, a preservative, a sweetener, and a salt, which are all described in further detail, below.
- the remaining carrageenan species can comprise kappa-carrageenan, iota-carrageenan, or a combination of kappa-carrageenan and iota-carrageenan.
- either or both of kappa-carrageenan and iota-carrageenan can comprise up to 20% by weight of the carrageenan powder, for example, up to 15%, 10%, 8%, 6%, 4%, 2%, or 1%, by weight of the carrageenan powder.
- kappa-carrageenan and iota-carrageenan together comprise at least 1%, for example, 2%, 4%, 6%, 8%, or 10%, by weight, and up to at least 15% by weight of the carrageenan powder.
- lambda-carrageenan can comprise 90% by weight of the carrageenan powder, and kappa-carrageenan and iota-carrageenan together comprise 10% by weight of the carrageenan powder.
- lambda-carrageenan can comprise 90% by weight of the carrageenan powder, and kappa-carrageenan comprises 10% of the carrageenan powder.
- lambda-carrageenan can comprise 90% by weight of the carrageenan powder, and lambda-carrageenan comprises 10% of the carrageenan powder.
- antiviral lubricious composition comprises, by weight, at least 0.001% carrageenan, for example, at least 0.01, 0.1, 0.5, 0.75, 1.0, 1.2, 1.4, 1.6, 1.8, 2.0, 2.2, 2.4, 2.5, or 3%, carrageenan, and optionally up to at least 5% carrageenan.
- the antiviral lubricious composition comprises less than 5% by weight carrageenan, for example, less than 3, 2.5, 2.4, 2.2, 2, 1.8, 1.6, 1.4, 1.2, 1.0, 0.75, 0.5, 0.1, 0.01, or 0.001%, by weight.
- the antiviral lubricious composition comprises 0.2% to 2.3% by weight carrageenan. In even further embodiments, the antiviral lubricous composition comprises 0.8% by weight to 2% by weight carrageenan. In still further embodiments, the antiviral lubricous composition comprises 1.5% to 1.7% by weight carrageenan.
- the addition of one or more polyols to the carrageenan powder causes the carrageenan polysaccharides within the powder to partially unwind, making additional polarizable contacts available to interact upon addition of the aqueous solution.
- the presence of polyols within the antiviral lubricous composition enhances the sensation, tactility, and/or lubricity experienced by the wearer or his or her partners during sexual activity.
- the at least one polyol can be selected from the group consisting of: glycerol; propylene glycol (1,2-propanediol); 1,3-propanediol; 1,3-butanediol; 1,4-butanediol; 2,3-butanediol; xylitol; sorbitol; erythritol; isomalt; lactitol; maltitol; mannitol; polyethylene glycol; and polypropylene glycol; including combinations thereof.
- the antiviral lubricous composition comprises less than 50% by weight polyol, for example, less than 25, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, or 0.1 % by weight of the antiviral lubricous composition. In other embodiments, the antiviral lubricous composition comprises at least 0.1% by weight of polyol, for example, at least 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 25, or 35% by weight of the polyol. In still further embodiments, the antiviral lubricous composition comprises less than 10% by weight polyol. In even still further embodiments, the antiviral lubricous composition comprises 0.5% to 5% by weight of the polyol.
- the antiviral lubricous composition comprises 4% to 4.5% by weight of the polyol.
- the polyol is propylene glycol.
- the polyol is 1,3-propanediol.
- the antiviral lubricous composition is a pourable composition that has a viscosity of less than 10,000 cP, for example, less than 8,000, 6,000, 5,000, 4,000, 3,000, 2,000 or 1,000 cP.
- the antiviral lubricous composition has a viscosity of at least 500 cP, for example, at least 1,000, 2,000, 3,000, 4,000, 5,000, 6,0000 cP, or 8,000 cP. In further embodiments, the antiviral lubricous composition has a viscosity between 500 cP and 8,000 cP, more particularly between 1,000 cP and 4,000 cP, even more particularly between 2,000 cP and 3,000 cP. In some embodiments, the antiviral lubricous composition has a viscosity between 1,500 cP and 2,500 cP. In some embodiments, the antiviral lubricous composition has a viscosity of 2,000 cP.
- the antiviral lubricous composition has a viscosity that enables it to be poured from an open container, yet remains on a sloped, slanted, curved, or inverted surface upon application.
- surfaces include skin or epithelial tissue such as the cervix, vulva, vagina, clitoris, penis, anus, nose, nasal cavity, mouth, and throat.
- surfaces to which an antiviral lubricous composition can be applied can include sexual accessories or devices such as sex toys, vibrators, rings, or beads, or internal applicators such as swabs, elongate stick or rods, wearable inserts, injectors, syringes, cannulas, or pipettes.
- sexual accessories or devices such as sex toys, vibrators, rings, or beads
- internal applicators such as swabs, elongate stick or rods, wearable inserts, injectors, syringes, cannulas, or pipettes.
- the viscosity of the antiviral lubricous composition decreases in a non-Newtonian manner.
- the viscosity reduces to less than 5,000 cP, for example, less than 4,000, 3,000, 2,500, 2,000, 1,500, 1,000, 800, 600, 500, 400, or 300 cP, and optionally less than 200 cP.
- the lubricity of the antiviral lubricous composition is retained upon exerting the shearing forces continuously for at least 15 seconds, for example, at least 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, or 45 minutes, and optionally up to at least one hour.
- increasing the total concentration of carrageenan within the antiviral lubricous composition has an exponential increase on the composition’s viscosity.
- the relative concentration of the kappa-, iota-, and lambda-forms of carrageenan differentially affect the rate of exponential growth of the viscosity of the antiviral lubricous composition.
- the antiviral lubricous composition comprises 90% lambda-carrageenan and 10% of one or both of kappa-carrageenan or iota-carrageenan.
- the antiviral lubricous composition comprises 90% of lambda-carrageenan and 10% of kappa-carrageenan. In even still further embodiments, the antiviral lubricous composition comprises 90% of lambda-carrageenan and 10% of iota-carrageenan.
- the mixing rotor type and mixing speed can be optimized to control the viscosity of the resulting antiviral lubricous composition.
- mixing can be conducted under shear conditions sufficient to homogenize the carrageenan-containing composition while preserving the length of each carrageenan polysaccharide and maintaining their lubricity prior to applying the composition to the skin or epithelial tissue, particularly before or in conjunction with sexual activity.
- a device for performing a mixing step of the present invention can comprise any conventional mixing apparatus for the intended use.
- a mixing apparatus is a paddle mixer.
- a paddle mixer is a mixer that comprises at least one folding impeller blade.
- One specific example of a paddle mixer is a Mixer Direct R-AD665 industrial gallon paddle mixer with two folding impeller blades.
- a paddle mixer is used for each of the mixing steps for forming the antiviral lubricous composition.
- each of the mixing steps is conducted with low-speed mixer operating at a rotational speed of equal or less than 500 revolutions per minute (RPM).
- RPM revolutions per minute
- mixing of the antiviral lubricous composition after homogenizing the carrageenan within the aqueous solution can occur at speeds less than or equal to 250 RPM.
- an antiviral lubricous composition formed by a process of the present invention has an osmolality that enables skin or epithelial tissue, particularly epithelial tissue within the vagina or rectum, to maintain a healthy plasma water-electrolyte balance.
- the osmolality of the antiviral lubricous compositions is less than 1200 mOsmol/kg, for example, less than 1000, 900, 800, 700, 600, 500, 400, 300, or 200 mOsmol/kg, and optionally, less than 100 mOsmol/kg.
- the osmolality of the antiviral lubricous composition is 650 mOsmol/kg to 800 mOsmol/kg. In other even further embodiments, the osmolality of the antiviral lubricous composition is isosmolal with the normal osmolality of human semen, between 250 mOsmol/kg and 380 mOsmol/kg. In still further embodiments, the osmolality of the antiviral lubricous composition is isosmolal with the normal osmolality of vaginal secretions, between 260 mOsmol and 290 mOsmol/kg.
- antiviral lubricous compositions of the present invention can further comprise one or more pH-adjusting agents comprising an acid, particularly an organic acid, and more particularly citric acid.
- the one or more pH-adjusting agents can include a weak acid and its conjugate base to create a buffer.
- the addition of citrate to the antiviral lubricous composition can be accomplished by adding both citric acid and a citrate salt, such as sodium or magnesium citrate.
- the pH of the antiviral lubricous composition is less than 9.0, for example, less than 8.0, 7.0, 6.5, 6.0, 5.5, 5.0, 4.5, or 4.0, and optionally less than 3.5. In other further embodiments, the pH of the antiviral lubricous composition is at least 3.5, for example, at least 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 or 8.0, and optionally, at least 9.0. In even further embodiments, the pH of the antiviral lubricous composition is between 5.5 and 7.0.
- the pH of the antiviral lubricous composition can be optimized to be either applied to the vagina directly, or to contact the vagina during sexual activity.
- the pH of the antiviral lubricous composition is between 3.5 and 5.5, particularly 4.5.
- the pH of the antiviral lubricous composition is adjusted after the carrageenan has been homogenized and the resulting antiviral lubricous composition has been cooled.
- the antiviral lubricous composition can be cooled to less than 50 °C, for example, less than 45 °C, 40 °C, 35 °C, 30 °C, or 25 °C, and optionally, less than 20 °C.
- the antiviral lubricous composition is cooled to less than 30 °C before the pH of the composition is adjusted.
- the concentration of the one or more pH-adjusting agents within the pH-adjusted antiviral lubricous composition is less than 1% by weight of the antiviral lubricous composition, for example, less than 0.5%, 0.25%, 0.1%, or 0.05%, and optionally, less than 0.01% by weight of the antiviral lubricous composition.
- the concentration of the one or more pH-adjusting agents within the pH-adjusted antiviral lubricous composition is equal or less than 0.1% by weight.
- the weight of the one or more pH- adjusting agents within the pH-adjusted antiviral lubricous composition is equal or less than 0.05% by weight.
- the pH-adjusting agents can be added into the composition as a component of the carrageenan powder to which the polyol is added, into the carrageenan suspension, or into the antiviral lubricous composition after the carrageenan is homogenized.
- processes for forming the antiviral lubricous composition can further comprise the step of mixing one or more sweeteners and/or one or more preservatives into either the carrageenan powder, the aqueous carrageenan suspension, or the cooled aqueous homogenous solution.
- one or more sweeteners are added to the aqueous carrageenan suspension.
- one or more preservatives are added along with the one or more pH-adjusting agents to the aqueous homogeneous solution.
- each of the additional components can be included within the antiviral lubricant composition to supplement its antiviral activity, aid in application to skin or epithelial tissue, and/or enhance its performance during sexual activity.
- an antiviral lubricous composition of the present invention can further comprise one or more sweeteners, particularly saccharin, comprising 0.01% by weight to 1% by weight of the antiviral lubricous composition, particularly 0.1% to 0.5% by weight of the antiviral lubricous composition.
- the concentration of saccharin in the antiviral lubricous composition is up to 0.5% by weight. In another embodiment, the concentration of saccharin in the antiviral lubricous composition is 0.125% by weight.
- saccharin can be added to the carrageenan mixture or the carrageenan suspension as an aliquot from a concentrated stock solution.
- the total weight of the saccharin stock solution added to the carrageenan mixture or the antiviral lubricous composition comprises 1% to 10% by weight of the completed antiviral lubricous composition.
- the saccharin stock solution is a 2.5% by weight of saccharin in water.
- the amount of 2.5% by weight saccharin stock solution added to the carrageenan mixture is equal to 5% by weight of the antiviral lubricous composition, wherein the final concentration of saccharin in the antiviral lubricous composition is 0.125% by weight.
- an antiviral lubricous composition of the present invention can further comprise 0.01% to 1.0% by weight of one or more preservatives, particularly one or more preservatives selected from the group consisting of 2-phenoxylethanol, chlorphenesin, and sodium dehydroacetate, including combinations thereof.
- the antiviral lubricous compositions of the present invention can optionally further comprise one or more aromatic agents designed to provide a pleasing fragrant effect on the composition.
- Aromatic agents can include essential oils or component compounds within essential oils capable of imparting an odor.
- Non-limiting examples of fragrances that can be provided by such aromatic agents include citrus, lemon, berry, or peppermint fragrances.
- aromatic agents can comprise between 0.01% and 5% by weight of the antiviral lubricous composition, particularly between 0.1% and 2.5% by weight of the antiviral lubricous composition.
- the antiviral lubricous compositions of the present invention can further comprise a salt, particularly a sodium salt or a zinc salt, more particularly a zinc salt, that can be utilized to increase the ionic strength of the composition while also supporting or complementing either or both of the rheological properties or antiviral activity of the composition.
- the salt can be added into the composition as a component of the carrageenan powder to which the polyol is added, into the carrageenan suspension, or into the antiviral lubricous composition after the carrageenan is homogenized.
- processes to form homogenized antiviral lubricous compositions of the present invention can be completed in less than 12 hours, for example, less than 10, 8, 6, 4, or 3 hours, and optionally, less than 2.5 hours. In further embodiments, processes to form homogenized antiviral lubricous compositions of the present invention are completed in 2 to 3 hours.
- a method for forming an antiviral lubricous composition can comprise the steps of: (a) providing a carrageenan powder comprising carrageenan, the carrageenan comprising 90% by weight lambda-carrageenan and 10% by weight kappa-carrageenan; (b) combining, while mixing, the carrageenan powder with an aqueous solution comprising propylene glycol, to form an aqueous carrageenan suspension; (c) adding one or more sweeteners to the aqueous carrageenan suspension; (d) heating the aqueous carrageenan suspension up to a temperature of at least 70 °C and up to 75 °C; (e) mixing the heated aqueous carrageenan suspension for a time sufficient to form an aqueous homogenous solution; (f) cooling the aqueous homogeneous solution to a temperature of less than 30 °C; and (g) mixing one or more pH-adjusting agents and one or more preservative
- an antiviral lubricous composition formed by the above process can consist essentially of: 1.5% to 1.7% by weight of carrageenan, 4.0% to 4.5% by weight of propylene glycol, up to 0.5% by weight of the one or more sweeteners, up to 1% by weight of the one or more preservatives, and 0.01% to 1% by weight of one or more pH-adjusting agents, the balance water.
- an antiviral lubricous composition formed by the above process can be translucent, have a viscosity of at least 2,000 cP, up to 3,000 cP, and a turbidity that is less than or equal to 25 NTU, preferably 5 NTU.
- the antiviral lubricous composition formed by the above process can have an osmolality in a range from at least 650 mOsmol/kg, up to 850 mOsmol/kg.
- the pH of the antiviral lubricous composition formed by the above process is 3.5 to 5.5.
- the pH of the antiviral lubricous composition formed by the above process is 5.5 to 7.0.
- the antiviral lubricous composition formed by the above process is effective in reducing, inhibiting, or ameliorating the transmission of HPV.
- the antiviral lubricous composition formed by the above process is effective in reducing, inhibiting, or ameliorating the transmission of COVID-19.
- the processes to form antiviral lubricous compositions of the present invention can comprise the steps of: (a) providing a carrageenan powder comprising carrageenan, the carrageenan comprising at least 90% by weight lambda-carrageenan and up to 10% by weight kappa-carrageenan; (b) mixing the carrageenan powder with a polyol, comprising agitating or stirring the carrageenan powder with the polyol for a time sufficient to form a wet carrageenan mixture, wherein the weight ratio of the glycol to the carrageenan is 1:1 to 10:1; (c) dispersing the wet carrageenan mixture into an aqueous solution under shear mixing for a time sufficient to form a turbid carrageenan suspension, wherein the weight ratio of the aqueous solution to the carrageenan is 45: 1 to 8: 1; (d) adding one or more sweeteners into the turbid carrageenan suspension, while agitating the
- the antiviral lubricous composition comprises: 1.5% to 1.7% by weight of the carrageenan; 4% to 4.5% by weight of 1,2-propanediol; a viscosity of 2,000 cP to 3,000 cP; an osmolality of 650 mOsmol/kg to 850 mOsmol/kg; and a pH of 6.25 to 6.75.
- the carrageenan comprises 90% by weight lambda-carrageenan and about 10% by weight kappa-carrageenan.
- the antiviral lubricous composition formed by the above process is effective in reducing, inhibiting, or ameliorating the transmission of HPV.
- the antiviral lubricous composition formed by the above process is effective in reducing, inhibiting, or ameliorating the transmission of COVID-19.
- the present invention also describes methods for reducing, inhibiting, or ameliorating the transmission, symptoms, or effects of a viral infection, comprising the steps of: (a) providing any of the above-described antiviral lubricous compositions; and (b) contacting the antiviral lubricous composition with the skin or epithelial tissue of one or more of the partners.
- Non limiting examples of skin or epithelial tissue to which the antiviral lubricous composition can be applied include the skin, cervix, vulva, vagina, clitoris, penis, anus, nose, nasal cavity, mouth, and throat.
- the antiviral lubricous composition can be applied to any skin or epithelial tissue, either internal or external, in which a viral infection is known to be present.
- methods for reducing, inhibiting, or ameliorating the transmission, symptoms, or effects of a viral infection can comprise the steps of: (a) providing a substrate comprising one or more skin-contacting surfaces, wherein the substrate is configured for contacting skin or epithelial tissue and/or insertion into one or more body cavities; (b) lubricating one or more of the skin-contacting surfaces of the substrate with the antiviral lubricous composition, thereby producing a lubricated substrate; (c) contacting the lubricated substrate with the skin or epithelial tissue; and (d) transferring the antiviral lubricous composition from the lubricated substrate to the skin or epithelial tissue.
- methods for reducing, inhibiting, or ameliorating the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between two or more partners engaging in sexual activity can comprise the steps of: (a) providing any of the above-described antiviral lubricous compositions, and (b) contacting the antiviral lubricous composition with the skin or epithelial tissue of one or more of the partners, wherein the skin or epithelial tissue located on or within at least one of the vagina, anus, mouth, or penis.
- at least one partner is male and at least one partner is female.
- at least two partners are male.
- at least two partners are female.
- methods for reducing, inhibiting, ameliorating, or preventing the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between partners engaging in sexual activity can comprise the steps of: (a) providing a substrate comprising one or more skin-contacting surfaces, wherein the substrate is configured for insertion into one or more body cavities selected from the group consisting of the vagina, mouth, or anus; (b) lubricating one or more of the skin-contacting surfaces of the substrate with the antiviral lubricous composition, thereby producing a lubricated substrate; (c) contacting the lubricated substrate with the skin or epithelial tissue located on or within at least one of the vagina, anus, mouth, or penis of one or more of the partners; and (d) transferring the antiviral lubricous composition from the lubricated substrate to the skin or epithelial tissue.
- the substrate is a condom.
- the condom comprises latex.
- the condom comprises polyurethane and/or other synthetic materials.
- the condom is incompatible with oil- based personal lubricants.
- the condom is selected from the group consisting of a male condom and a female condom.
- methods for reducing, inhibiting, ameliorating, or preventing the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between partners engaging in sexual activity further comprise the steps of: lubricating a skin-contacting surface of a condom; contacting the skin or epithelial tissue within mouth, vagina, or anus of one or more of the partners with the lubricated skin-contacting surface of the condom; and transferring the antiviral lubricous composition from the lubricated skin contacting surface of the condom to the skin or epithelial tissue.
- methods for reducing, inhibiting, ameliorating, or preventing the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between partners engaging in sexual activity further comprise the steps of: placing a condom over the finger or penis of one partner; lubricating an external surface of the condom with the antiviral lubricous composition; contacting the skin or epithelial tissue within the mouth, vagina, or anus of one or more additional partners using the lubricated external surface of the condom; and transferring the antiviral lubricous composition from the lubricated external surface of the condom to the skin or epithelial tissue.
- methods for reducing, inhibiting, ameliorating, or preventing the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between partners engaging in sexual activity further comprise the steps of: lubricating the condom; sealing the lubricated condom within a packaging; storing the lubricated condom within the packaging; removing the lubricated condom from the packaging; applying the lubricated condom to the finger or penis of one of the sexual partners; contacting the skin or epithelial tissue within the mouth, vagina, or anus of one or more additional partners using the lubricated condom; and transferring the antiviral lubricous composition from the lubricated condom to the skin or epithelial tissue.
- the substrate is a sexual accessory device including but not limited to sex toys, dildos, vibrators, rings, or beads.
- the method further comprises the steps of sealing the lubricated sexual accessory device within a packaging, storing the lubricated sexual accessory device within the packaging, and removing the lubricated sexual accessory device from the packaging prior to contacting the skin or epithelial tissue of one or more of the partners.
- the antiviral lubricous composition can be applied to any skin-contacting surface of the sexual accessory device, typically prior to contact with the skin of one or more the sexual partners, particularly prior to insertion into the vagina, anus, or mouth.
- a condom lubricated by any of the antiviral lubricous compositions of the present invention can be applied to an unlubricated sexual accessory device to provide lubricity for use during sexual activity.
- an unlubricated condom can be applied to a sexual accessory device lubricated by any of the antiviral lubricous compositions of the present invention.
- an unlubricated condom can be applied to an unlubricated sexual accessory device and subsequently be lubricated by any of the antiviral lubricous compositions of the present invention.
- the substrate is an internal applicator configured for insertion into the vagina, rectum, mouth, or nose, and wherein the internal applicator is selected from the group consisting of a swab, an elongate stick or rod, a wearable insert, an injector, a syringe, a cannula, or a pipette.
- the internal applicator comprises a skin-contacting surface that is configured to contact epithelial tissue within a person’s body cavity, particularly within the vagina, nose, mouth, or rectum.
- the internal applicator comprises a container configured for housing or containing the antiviral lubricous composition prior to transferring the antiviral lubricous composition onto epithelial tissue within a person’s body cavity, particularly the vagina, nose, mouth, or rectum.
- the substrate is a swab of sufficient length for insertion into the mouth or nose, to contact epithelial tissue within the nasal cavity or oral cavity, including the throat.
- a lubricated swab can be inserted into the nose or mouth, to contact epithelial tissue within the nasal cavity or oral cavity, to reduce, inhibit, or ameliorate the transmission, symptoms, or effects of a viral respiratory infection, such as, as non-limiting examples, SARS, COVID-19, Middle East Respiratory Syndrome (MERS), and adenovirus.
- a viral respiratory infection such as, as non-limiting examples, SARS, COVID-19, Middle East Respiratory Syndrome (MERS), and adenovirus.
- kits for reducing, inhibiting, or ameliorating the transmission of a sexually-transmitted virus including but not limited to HPV, HIV, and HSV, between partners engaging in sexual activity
- the kit comprising any of the above-described antiviral lubricous compositions and instructions describing any of the methods disclosed above for contacting the antiviral lubricous composition with the skin of one or more of the partners.
- the kit can further comprise any of the above-described substrates, including condoms, sexual accessory devices, and/or internal applicators.
- Figure 1 shows a plot of the viscosity of antiviral lubricous compositions as a function of the concentration of carrageenan.
- Figure 2 shows a plot of the osmolality of antiviral lubricous compositions as a function of 1,2-propanediol concentration.
- the present disclosure includes aqueous compositions that have antiviral activity against several different taxonomic families, including but not limited to one or both of coronaviridae and papillomaviridae , and which can be utilized as personal lubricants during sexual activity.
- the antiviral lubricous compositions can be contacted with the skin or epithelial tissue anywhere a viral infection is known to be present either inside or outside the body, or in areas that are commonly lubricated during sexual activity, including but not limited to the cervix, vulva, vagina, clitoris, penis, anus, nose, nasal cavity, mouth, and throat.
- the antiviral lubricous compositions are capable of reducing, inhibiting, ameliorating, or preventing the transmission and/or the persistence of sexually- transmitted viruses, including human papillomavirus (HPV), human immunodeficiency virus (HIV), or herpes simplex virus (HSV) between sexual partners, including male-female, male-male, and female-female sexual partnerships.
- human papillomavirus HPV
- human immunodeficiency virus HIV
- HSV herpes simplex virus
- the antiviral activity of the antiviral lubricous compositions of the present invention results from the presence of carrageenan, particularly lambda-carrageenan.
- Carrageenan is a generic term for a broad family of naturally occurring sulfated polysaccharides that are extracted from a wide range of species of seaweed algae, particularly from Chondrus crispus , a red seaweed found on the Atlantic coast of the United States. Extracted carrageenans can typically be obtained in one of ten forms, which differ in terms of sulfation content, sulfation location within each polysaccharide, and acid/base character.
- kappa-carrageenan Three of the forms — kappa-carrageenan, iota-carrageenan, and lambda- carrageenan — are particularly common within compositions used in the food and pharmaceutical industries.
- the structures of kappa-carrageenan, iota-carrageenan, and lambda-carrageenan are shown below:
- kappa-carrageenan, iota-carrageenan, and lambda-carrageenan comprise repeating galactose units.
- kappa-carrageenan and iota-carrageenan comprise alternating units of D-galactose and 3,6-anhydro-galactose (3,6-AG), whereas lambda-carrageenan does not comprise any 3,6-AG.
- Each form differs in the number of sulfate groups per disaccharide, where kappa- carrageenan, iota-carrageenan, and lambda-carrageenan comprise one, two, or three sulfate groups, respectively, per alternating unit.
- Carrageenans are commonly used in the food and pharmaceutical industry as thickening agents and/or gelation agents. As carrageenans are hydrated within an aqueous composition, they begin to swell, raising the viscosity of the composition exponentially as a function of the total carrageenan concentration. However, the rate of exponential growth is inversely proportional to the sulfate content within each form of carrageenan, so kappa-carrageenan causes a greater exponential growth in viscosity than iota-carrageenan, which itself has a greater effect on viscosity than lambda-carrageenan.
- compositions comprising kappa- carrageenan and iota-carrageenan are able to form gel networks upon cooling, as the polysaccharides form double-helical, quasi-crystalline networks, particularly in the presence of cations.
- the presence of lambda-carrageenan within a composition partially inhibits the formation of a gel, and in compositions where the lambda-carrageenan is the most abundant, gel formation is pre-empted completely. Without being limited by a particular theory, it is believed that the lack of a 3,6-AG group within lambda-carrageenan drives gel inhibition.
- carrageenan compositions that predominantly contain kappa- and iota-forms of carrageenan are useful for thickening compositions or gels, they are inactive against HPV.
- the lambda-carrageenan form has been shown to be active against HPV both in vitro (see Buck, et al., above) and in vivo.
- Several patents and patent publications similarly discuss the use of carrageenan within medicaments as an antimicrobial or antiviral compound (see U.S. Pat. Nos. 5,208,031 and 8,367,098, and U.S. Pat. Pubs.
- lambda- carrageenan utilizes a “lock and key” type mechanism by which the polysaccharide attracts a virus, interacts with viral capsid, arrests or prevents viral replication, and further inhibits viral activity. This results in significant reduction of the transmission and persistence of viruses, particularly HPV in sexually active men and women.
- a lambda-carrageenan-containing gel was given to sexually-active women that were at high risk of contracting and/or transmitting HPV during sexual activity (see Marais, D., et al., (2011) Antiviral Therapy 16:1219-1226, as well as U.S. Patent 8,367,098, the disclosures of which are incorporated by reference in their entireties).
- the tested composition, Carraguard® comprises a 3% by weight mixture of kappa-carrageenan and lambda-carrageenan, and has a viscosity of between 30,000 and 40,000 cP. Study participants were instructed to apply the gel in conjunction with vaginal intercourse.
- carrageenans (of any form) have historically been used as thickening agents and generally are not preferred in personal lubricant formulations because they cause an exponential increase in the viscosity of the composition.
- gel compositions comprising kappa-carrageenan and/or large amounts of iota-carrageenan are typically very viscous and tend to dry out quickly once applied to the skin or epithelial tissue, causing them to form sticky residues and lose their lubricity.
- most topical carrageenan-containing compositions including the one studied in Marais, et al. as well as the related composition in U.S. Patent No. 8,367,098, are typically gels or creams.
- Carraguard® the viscosity of Carraguard® compared to several common compositions is shown in Table 1, below.
- the viscosity of the Carraguard® gel utilized in the Marais study is in a range between the viscosity of chocolate and the viscosity of ketchup.
- chocolate and ketchup both have shear-thinning properties, and chocolate in particular can comprise edible compositions that can be utilized during sexual activity, the high viscosity of both compositions causes them to perform poorly as personal and sexual lubricants.
- compositions that are commonly used as personal lubricants and don’t contain carrageenan are typically five to ten times less viscous than the gels used in the Marais study and described in the ‘098 patent.
- a personal lubricant composition should have a viscosity such that it can be poured or lightly squeezed from its container, remain on the skin after being applied, and undergo shear thinning in response to a stress, such as during sexual activity.
- Materials commonly found in personal lubricants include, but are not limited to: oils, particularly silicone oils, gums, celluloses, glycerins, polyols, glycols, glycans, polyquatemiums, and other polymers.
- oils particularly silicone oils, gums, celluloses, glycerins, polyols, glycols, glycans, polyquatemiums, and other polymers.
- these lubricants do provide pleasing results during sexual activity, they do not provide any protection against HPV.
- Glycols also commonly known as “polyols,” most commonly comprise glycerol, 1,2- propanediol, and 1,3 -propanediol, and can upset the water-electrolyte balance within epithelial cells.
- the WHO goes on to show that most of the commercially available lubricants have osmolalities that far exceed the osmolality of normal vaginal secretions (260-290 mOsmol/kg) and semen (250-380 mOsmol/kg), and recommends that companies tailor the osmolality of their marketed personal lubricant compositions to be under 1,200 mOsmol/kg, with a goal of being as isosmolal as possible with vaginal secretions and/or semen (between 250 and 400 mOsmol/kg).
- the present invention provides several novel antiviral lubricous compositions that comprise lambda-carrageenan, are active against viruses, including HPV, and have a viscosity similar to commonly-available lubricants that do not contain carrageenan.
- the antiviral lubricous compositions possess a rheological profile that enable to compositions to retain their moisture and lubricity for several hours upon being applied, and which provide a pleasing experience to people engaging in sexual activity.
- the antiviral lubricant compositions are pseudoplastic, non-Newtonian fluid compositions that undergo shear thinning in response to mechanical strain, particularly during sexual activity.
- antiviral lubricant compositions of the present invention can be poured directly from a container, without having to be squeezed or otherwise manually extracted from the container.
- the antiviral lubricous composition is substantially free of a gel network.
- carrageenans of all types can be obtained from sea algae extracts, typically as a mixture of two, three, or more forms of carrageenan.
- Carrageenan mixtures can be obtained as raw extracts, or they can be obtained as powders.
- carrageenans utilized within antiviral lubricous composition are obtained as a carrageenan powder.
- Non-limiting examples of commercially-available carrageenan powders include Viscarin® PC 109, Viscarin® PC 209, Viscarin® PC 515, Gelcarin® PC 379, and Gelcarin® PC 911.
- the carrageenan powder is Viscarin® PC 209.
- the carrageenan powder comprises at least about 85% by weight lambda-carrageenan, including at least about 90% by weight of lambda-carrageenan.
- kappa-carrageenan and iota-carrageenan together can comprise up to about 20% by weight of the carrageenan powder including up to about 15%, 10%, 8%, 6%, 4%, 2%, or up to about 1% by weight of the carrageenan powder.
- kappa-carrageenan and iota-carrageenan together comprise at least about 1% by weight of the carrageenan powder, including at least about 2%, 4%, 6%, 8%, or 10% by weight, up to at least about 15% by weight, of the carrageenan powder.
- the carrageenan powder comprises at least about 90% by weight lambda-carrageenan and up to about 10% by weight iota-carrageenan. In further embodiments, the carrageenan powder comprises about 90% by weight lambda-carrageenan and about 10% by weight iota-carrageenan.
- the carrageenan powder comprises at least about 90% by weight lambda-carrageenan and up to about 10% by weight kappa-carrageenan. In further embodiments, the carrageenan powder comprises about 90% by weight lambda-carrageenan and about 10% by weight kappa-carrageenan.
- carrageenan mixtures comprising lambda-carrageenan are substantially homogenized within the antiviral lubricous composition, wherein a majority of the carrageenan polysaccharides within the composition are present as free molecules within an aqueous solvent.
- the carrageenan mixtures are fully homogenized within the antiviral lubricous composition.
- homogeneous antiviral lubricous compositions have a substantially uniform appearance and density.
- the antiviral lubricous composition is a solution in which the ratio of carrageenan to the solvent is substantially uniform.
- the antiviral lubricous composition is substantially free of particulates, aggregates, clumps, or other solids that are visible either to the naked eye and/or under 10X magnification under a microscope. In still further embodiments, the antiviral lubricous composition is translucent. In even still further embodiments, the antiviral lubricous composition is transparent.
- carrageenan comprises at least about 0.001% by weight of the antiviral lubricous composition, including at least about 0.01, 0.1, 0.5, 1, 2, 2.5, or 3% by weight, up to at least about 5% by weight of the antiviral lubricous composition. In further embodiments, carrageenan comprises 0.5% to about 2.3% by weight of the antiviral lubricous composition. In even further embodiments, carrageenan comprises 0.8% to about 2.0% by weight of the antiviral composition. In still further embodiments, carrageenan comprises 1.5% to about 1.7% by weight of the antiviral lubricous composition.
- the viscosity, rheology, sensation, and overall performance of the lambda- carrageenan-containing, antiviral lubricous composition can be controlled by the addition of a minor concentration of a polymer, particularly a polyol, to the antiviral lubricous composition.
- a polymer particularly a polyol
- polyols are one class of compounds that are commonly found in commercially-available products as bulking agents, flavor retainers/maskers, humectants, stabilizers, anti-crystallizing agents, and for systemic and oral health benefits.
- polyols are typically added to enhance the solubility of other polymers that might be present in commercial personal lubricant products, polyols can also be added in small quantities to antiviral lubricous compositions of the present invention to decrease the viscosity, reduce irritation, provide a secondary source of lubricity, and/or to provide a stimulating “warming” or “tingling” feeling that is often pleasing to the user during sexual activity.
- Non-limiting examples of polyols that can be added can include: glycerol; propylene glycol (1,2-propanediol); 1,3-propanediol; 1,3-butanediol; 1,4-butanediol; 2,3-butanediol; xylitol; sorbitol; erythritol; isomalt; lactitol; maltitol; mannitol; polyethylene glycol; and polypropylene glycol; including combinations thereof.
- the identity and concentration of the polyol(s) included in an antiviral lubricous composition can be controlled to obtain a desired property.
- mannitol and xylitol are regulated as food additives for special dietary needs, while polyols are otherwise ‘generally regarded as safe’ (GRAS).
- Xylitol also has been used for oral cavity prevention, and mannitol has also been used as a preventative for urinary tract infections.
- 1,3- butanediol, 1,4-butanediol, 2,3-butanediol has been shown to reduce irritation in topical application of ointment, cream, and gel compositions.
- Sugar-based polyols can provide some sweetness, while maltitol can mimic fat textures in edible products.
- the polyol can comprise less than about 50% by weight of the antiviral lubricous composition, including less than about 25, 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2% by weight, down to less than about 1% by weight of the antiviral lubricous composition.
- the antiviral lubricous composition comprises at least about 1% by weight of the polyol, including at least about 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 25% by weight, including at least about 35% by weight.
- the polyol comprises about to about 10% by weight of the antiviral lubricous composition.
- the polyol is propylene glycol (1,2-propanediol).
- the antiviral lubricous composition comprises up to 8% by weight of propylene glycol. In even further embodiments, the antiviral lubricous composition comprises 0.5% to about 5% by weight of propylene glycol. In still further embodiments, the antiviral lubricous composition comprises about 4% to about 5% by weight of propylene glycol. In some embodiments, the antiviral lubricous composition comprises between about 4.0% and about 4.5% by weight of propylene glycol. In yet still further embodiments, the antiviral lubricous composition comprises between about 2.0% and about 2.5% by weight of propylene glycol.
- the presence of a polyol results an antiviral lubricous composition that is superior to known personal lubricant compositions because it maintains all of the sexual performance benefits of the commercially-available personal lubricants, while also having the ability to inhibit the transmission and/or persistence of HPV.
- the antiviral lubricous compositions are thin enough to provide the tactile benefits of a personal lubricant composition, while also thick enough to remain on the skin or epithelial tissue, particularly the vagina, anus, penis, or mouth prior to initiating sexual contact.
- the personal lubricant composition has a viscosity of less than about 10,000 cP, including less than about 8,000, 6,000, 4,000, or 2,000 cP, down to less than about 1,000 cP.
- the antiviral lubricous composition has a viscosity of at least about 500 cP, including at least about 1,000, 2,000, 4,000, or 6,000 cP, up to at least about 8,000 cP.
- the antiviral lubricous composition has a viscosity of about 500 cP to about 8,000 cP, particularly about 1,000 cP to about 4,000 cP, and more particularly about 2,000 cP to about 3,000 cP.
- the antiviral lubricous composition has a viscosity between about 1,500 cP and 2,500 cP. In some embodiments, the antiviral lubricous composition has a viscosity of about 2,000 cP.
- the amount of polyol within the antiviral lubricous composition is limited, in order to provide an osmolality that is within WHO-recommended levels.
- the antiviral lubricous composition has an osmolality that is less than about 1,200 mOsm/kg, including less than about 1000, 900, 800, 700, 600, 500, 400, 300, or 200 mOsmol/kg, down to less than about 100 mOsmol/kg.
- the osmolality of the antiviral lubricous composition is about 250 to about 800 mOsmol/kg.
- the osmolality of the antiviral lubricous composition is about 650 to about 850 mOsmol/kg.
- the osmolality of the antiviral lubricous composition is isosmolal with the osmolality of human plasma.
- the antiviral lubricous composition is isosmolal with semen.
- the antiviral lubricous composition is isosmolal with vaginal secretions.
- the osmolality of the antiviral lubricous composition is about 250 mOsmol/kg to about 400 mOsmol/kg.
- supplemental components can be added to the antiviral lubricous composition to complement the antiviral activity of the composition and/or to enhance the composition’s performance during sex.
- the pH of the antiviral lubricous composition can be controlled by the addition of a pH-adjusting agent.
- the pH of the composition once carrageenan is solubilized into water is around 7 to 9.
- the effectiveness of the antiviral lubricous composition can be supplemented by controlling the pH of the composition to either match or be similar to the target surface to which the composition is applied.
- the pH of a healthy vagina typically ranges from about 3.5 to about 5.5, whereas the pH of other epithelial cells, including those located within the rectum, is closer to a neutral pH.
- the pH-adjusting agent is an acid that is capable of reducing the pH to a range that is complementary to the intended epithelial surface, particularly below a pH of about 8.0, including less than about 7.0, 6.5, 6.0, 5.5, 5.0, 4.5, or 4.0, down to less than about 3.5.
- the pH of the antiviral lubricous composition is at least about 3.5, including at least about 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, or 7.0, up to at least about 8.0. In further embodiments, the pH of the antiviral lubricous composition is about 3.5 to about 5.5, particularly about 4.5. In other further embodiments, the pH of the antiviral lubricous composition is about 5.5 to about 7.0. In still other further embodiments, the pH of the antiviral lubricous composition is about 6.25 to about 6.75. [0094] In some embodiments, the pH-adjusting agent is a strong acid, including, but not limited to, hydrochloric acid or sulfuric acid.
- the pH-adjusting agent is a weak acid, in order to create a buffered antiviral lubricous composition.
- Weak acids can be selected based on their buffering capacity, pKa, and availability.
- Non-limiting examples of weak acids that can be utilized as pH-adjusting agents can include citric acid, lactic acid, and acetic acid.
- the antiviral lubricous composition comprises between about 0.01% and about 1.0% by weight of a pH-adjusting agent, particularly between about 0.04% and about 0.06% by weight of the pH-adjusting agent.
- the pH-adjusting agent is citric acid.
- the antiviral lubricous composition can optionally further comprise one or more preservatives, which can be added to prevent microbial growth within the antiviral lubricous composition during storage.
- preservatives Any one or more of several preservatives may be selected from preservatives known to those of skilled in the art, including but not limiting to one or more of the following: methylparaben, benzoic acid, salicylic acid, sorbic acid, propylparaben, and sodium dehydroacetate, including combinations thereof.
- the preservative may be present in the compositions of this invention in an amount of up to about 1% by weight of the composition.
- the antiviral lubricous composition can optionally further comprise one or more sweeteners that enhance the flavor the composition when it comes in contact with a person’s mouth.
- the sweetener is an artificial sweetener, the presence of which can also inhibit bacterial growth within the antiviral lubricous composition during storage.
- artificial sweeteners include, but are not limited to aspartame, saccharin, sucralose, neotame, and acesulfame potassium.
- the sweetener is saccharin.
- the antiviral lubricous composition further comprises up to about 0.005% by weight of saccharin.
- the antiviral lubricous composition comprises about 0.125% saccharin.
- the antiviral lubricous composition can optionally further comprise other aromatic agents or fragrances that can mask either the scent of the composition itself or the skin or epithelial tissue to which the antiviral lubricous composition is applied.
- fragrances include vanilla, lavender, oregano, thyme, lemongrass, lemons, oranges, anise, cloves, aniseed, cinnamon, geraniums, roses, mint, peppermint, citronella, eucalyptus, sandalwood, cedar, rosmarin, pine, vervain fleagrass, or ratanhiae, including combinations thereof, although any essential oil-based fragrance can be chosen.
- the antiviral lubricous composition can optionally further comprise one or more chemical, aroma-causing compounds that cause the odor or fragrance within an essential oil-based fragrance.
- chemical, aroma-causing compounds that can be comprised in any of the antiviral lubricous compositions include carvacrol, eugenol, linalool, thymol, /i-cymene, myrcene, borneol, camphor, caryophillin, cinnamaldehyde, geraniol, nerol, citronellol, and menthol, including combinations thereof.
- the antiviral lubricous composition can optionally further comprise one or more metal salts.
- the addition of a metal salt can have several effects, including controlling the ionic strength of the composition, enhancing its antimicrobial or antiviral activity, or adding in the solubilization of one or more components.
- Metal salts that can be added include, but are not limited to, zinc, silver, copper, alkali, or alkaline earth metal salts.
- the metal salt is a zinc salt or a sodium salt.
- the antiviral lubricous composition can optionally further comprise one or more pharmaceutical antiviral, antifungal, or antimicrobial compounds.
- the present invention also provides several methods for reducing, inhibiting, or ameliorating the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between two or more partners engaging in sexual activity, using the antiviral lubricous compositions made by the processes described below.
- the method comprises the step of contacting the antiviral lubricous composition with the skin or epithelial tissue of one or more of the partners, wherein the skin or epithelial tissue located on or within at least one of the vagina, anus, mouth, or penis.
- vagina includes skin or epithelial tissue located within the vagina itself and/or surrounding the vagina, including but not limited to the vulva, labia, clitoris, vaginal opening, and the cervix.
- at least one partner is male and at least one partner is female.
- at least two partners are male.
- at least two partners are female.
- the antiviral lubricous composition can be contacted with the skin, particularly skin located on or within at least one of the vagina, anus, mouth, or penis, of one or more of the sexual partners prior to sexual activity, in order to prophylactically inhibit the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, from one sexual partner to another.
- the antiviral lubricous composition can be contacted with the skin of one or more of the sexual partners less than about 8 hours, 4 hours, 2 hours,
- the antiviral lubricous composition can be contacted with the skin of one or more of the sexual partners at least about 30 seconds, 1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, or about 8 hours prior to sexual activity.
- the antiviral lubricous composition can be contacted with the skin, particularly skin located on or within at least one of the vagina, anus, mouth, or penis, of one or more of the sexual partners after sexual activity, in order to reduce the spread of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, from cell to cell after HPV has been transmitted through skin-to-skin contact.
- a sexually-transmitted virus including but not limited to HPV, HIV, and HSV
- the antiviral lubricous composition can be contacted with the skin of one or more of the sexual partners less than about 8 hours, 4 hours,
- the antiviral lubricous composition can be contacted with the skin of one or more of the sexual partners at least about 30 seconds, 1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, or about 8 hours after sexual activity.
- Substrates suitable for use in conjunction with methods of the present invention include any object, device, or accessory that can be used to contact internal or external surfaces on or within the vagina, anus, mouth, or penis during sexual activity.
- substrates that can be utilized in accordance with methods of the present invention include condoms; sexual accessory devices such as sex toys, dildos, vibrators, rings, and beads; and internal applicators; comprising materials including but not limited to rubber, latex, plastic, wood, and/or metal.
- Such examples are described in U.S. Patent Nos. 6,983,751 and 9,119,763; U.S. Design Patent No. D599486, and U.S.
- Patent Publication 2006/0178602 the disclosures of which are included by reference in their entireties. Those skilled in the art would understand that there are countless other examples of substrates, both commercially available and improvised, sexually-themed or not, which can be utilized during sexual activity and to which antiviral lubricous compositions of the present invention can be applied.
- the substrate is a condom.
- the term “condom,” includes devices designed to be worn by either a male or female, within or on the penis, vagina, anus, or finger. Condoms can also be applied over sexual accessory devices, described below.
- the antiviral lubricous composition can be applied to a skin-contacting surface located on at least one of an internal surface of the condom or an external surface of the condom, either prior to placing the condom on or within the penis, fmger(s), vagina, anus, mouth, or other body part or obj ect, or afterward.
- a condom pre-lubricated with any of the antiviral lubricous compounds of the present invention can be provided in a packaging that encloses the lubricated condom and seals it from an external environment outside of the packaging.
- the packaging comprises a watertight seal, thereby preventing loss of the antiviral lubricous composition before opening the packaging and applying the pre-lubricated condom over the penis or an analogous sexual accessory device and engaging in sexual activity.
- methods for reducing, inhibiting, ameliorating, or preventing the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between partners engaging in sexual activity further comprise the steps of: lubricating a skin-contacting surface of a condom; contacting the skin or epithelial tissue within mouth, vagina, or anus of one or more of the partners with the lubricated skin-contacting surface of the condom; and transferring the antiviral lubricous composition from the lubricated skin contacting surface of the condom to the skin or epithelial tissue.
- methods for reducing, inhibiting, or ameliorating the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between two or more partners engaging in sexual activity further comprise the steps of: placing a condom over the finger or penis of one partner; lubricating an external surface of the condom with the antiviral lubricous composition; contacting the skin or epithelial tissue within the mouth, vagina, or anus of one or more additional partners using the lubricated external surface of the condom; and transferring the antiviral lubricous composition from the lubricated external surface of the condom to the skin or epithelial tissue.
- a sexually-transmitted virus including but not limited to HPV, HIV, and HSV
- methods for reducing, inhibiting, or ameliorating the transmission of a sexually-transmitted virus, including but not limited to HPV, HIV, and HSV, between two or more partners engaging in sexual activity further comprise the steps of: lubricating the condom; sealing the lubricated condom within a packaging; storing the lubricated condom within the packaging; removing the lubricated condom from the packaging; applying the lubricated condom to the finger or penis of one of the sexual partners; contacting the skin or epithelial tissue within the mouth, vagina, or anus of one or more additional partners using the lubricated condom; and transferring the antiviral lubricous composition from the lubricated condom to the skin or epithelial tissue.
- a sexually-transmitted virus including but not limited to HPV, HIV, and HSV
- the substrate is an internal applicator.
- Internal applicators suitable for use in conjunction with methods of the present invention include can any object, device, or accessory that can be configured to be inserted into a person’s body cavity and is capable of transferring the antiviral lubricous composition to epithelial tissue within the person’s body cavity.
- Non-limiting examples of internal applicators that can be utilized in accordance with methods of the present invention include syringes, pipettes, swabs, cannulas, elongate sticks or rods, and wearable inserts, comprising materials including but not limited to rubber, latex, plastic, wood, and/or metal. Such examples are described in U.S. Patent Nos.
- the internal applicator comprises a skin-contacting surface that is configured to contact epithelial tissue within a person’s body cavity, particularly within the vagina or rectum.
- the internal applicator comprises a container configured for housing or containing the antiviral lubricous composition prior to transferring the antiviral lubricous composition onto epithelial tissue within a person’s body cavity.
- the internal applicator can be provided in a packaging either with or without the antiviral lubricous composition.
- the internal applicator is pre-lubricated with the antiviral lubricous composition and sealed within the packaging, protecting the lubricated internal applicator from the external environment and preventing loss of the antiviral lubricous composition before transfer to epithelial tissue within the person’s body cavity.
- Methods for applying lubricants or therapeutic substances to internal applicators and packaging them are well known in the art.
- the present invention also provides methods for reducing, inhibiting, or ameliorating the transmission, symptoms, or effects of a virus, not associated with sexual activity.
- Methods include the steps of: (a) providing any of the antiviral lubricous compositions above, and (b) contacting the skin or epithelial tissue where a viral infection is known, or is presumed, to be present, either inside or outside the body.
- the antiviral lubricous composition can be applied to the skin or epithelial tissue using one’s finger or any of the applicators described above.
- a lubricated swab, stick, or rod can be inserted into any of the body cavities described above, as well as and including the mouth and nose to contact epithelial tissue inside the nasal cavity or throat.
- Non-limiting examples of viral taxonomic families that can be treated with any of the antiviral lubricous compositions of the present invention include orthomyxoviridae,paramyxoviridae , pneumoviridae , coronaviridae , retroviridae , herpesviridae , papdlomaviridae , picornaviridae , reoviridae , and adenoviridae , andcombinations thereof.
- viruses within these taxonomic families include, but are not limited to: severe acute respiratory disease (SARS) strains 1 and 2 (COVID-19); influenza A, B, and C; enterovirus, rhinovirus, poliovirus, adenovirus, rotavirus and viruses causing measles, mumps, and chicken pox.
- SARS severe acute respiratory disease
- influenza A, B, and C enterovirus, rhinovirus, poliovirus, adenovirus, rotavirus and viruses causing measles, mumps, and chicken pox.
- the antiviral lubricous composition can be applied to the skin or epithelial of a human having a viral infection, or as prophylaxis to prevent receiving a viral infection.
- the antiviral lubricous composition can be applied to the skin or epithelial of an animal having a viral infection, or as prophylaxis to prevent receiving a viral infection.
- the antiviral lubricous compositions made by processes of the present invention are unique in that they have the ability to inhibit viral activity, including the viral activity of sexually- transmitted viruses such as HPV, HIV, and HSV, and have an optimized viscosity, lubricity, and sensation that enhance their performance as lubricants during sexual activity, while at the same time minimizing the osmolality of the composition.
- the processes to form antiviral lubricous compositions of the present invention can comprise the steps of: (a) providing a carrageenan powder comprising carrageenan, the carrageenan comprising at least about 90% by weight lambda carrageenan and up to about 10% by weight iota carrageenan; (b) combining, while mixing, the carrageenan powder with an aqueous solution comprising a polyol to form a turbid carrageenan suspension; and (c) heating the turbid carrageenan suspension up to a temperature of at least 60 °C and mixing for a time sufficient to transform the turbid carrageenan suspension into a clarified homogeneous solution, thereby forming the antiviral lubricous composition; wherein (i) the antiviral lubricous composition comprises about 0.5% to about 2.3% by weight carrageenan, and up to about 10% by weight polyol; (ii) the antiviral lubricous composition has a viscos
- processes to form antiviral lubricous compositions of the present invention can additionally comprise a pre-mixing step in which the carrageenan powder and the polyol are first combined to form a wet carrageenan mixture comprising carrageenan and polyol.
- a pre-mixing step in which the carrageenan powder and the polyol are first combined to form a wet carrageenan mixture comprising carrageenan and polyol.
- Pre-mixing is believed to have several advantages, including but not limited to: mixing at lower speeds and under lower shear conditions; heating at lower temperatures to homogenize the carrageenan within the aqueous solution; speeding up each mixing step, particularly mixing to homogenize the carrageenan within the aqueous solution; and preserving the carrageenan polysaccharides from breaking into smaller segments, which can negatively affect the viscosity and performance of the composition as a personal lubricant (see below).
- processes to form antiviral lubricous compositions of the present invention can comprise the steps of: (a) providing a carrageenan powder comprising carrageenan, the carrageenan comprising at least about 90% by weight lambda-carrageenan and up to about 10% by weight iota-carrageenan; (b) mixing the carrageenan powder with a polyol to form a wet carrageenan mixture, wherein the weight ratio of the glycol to the carrageenan is about 1 : 1 to about 10:1; (c) combining, while mixing, the wet carrageenan mixture with an aqueous solution to form a turbid carrageenan suspension, wherein the volume ratio of the aqueous solution to the carrageenan is about 45:1 to about 8:1; (d) heating the turbid carrageenan suspension up to a temperature of at least 60 °C and mixing for a time sufficient to transform the turbid carrageenan suspension into a clarified homogen
- the viscosity of the antiviral lubricous composition is an important factor in its performance as a personal lubricant that can be used in conjunction with sexual activity.
- personal lubricants have a viscosity thick enough to be applied onto the skin or epithelial tissue and remain there until sexual activity is initiated, while also having a rheological profile that the lubricity and moisture from the composition is retained throughout the entire duration of the sexual activity.
- the presence of carrageenan in a composition is typically antithetical to sexual lubricant performance because the viscosity of the composition exponentially increases as a function of carrageenan concentration (see Example 3, below).
- the viscosity of the antiviral lubricous composition is sensitive to the balance of several factors in addition to total carrageenan concentration, including but not limited to: the identity and relative concentration of the kappa-, iota-, and lambda-forms of the carrageenan; the concentration and identity of additional components, particularly polyols; and the weight ratio of the carrageenan to the polyol, where the polyol is present.
- the viscosity is also dependent on the processing steps themselves, including but not limited to: the heating of one or more of the wet carrageenan mixture, the carrageenan suspension, and/or the antiviral lubricous composition; the rate of addition of any of the composition components; the rate and duration of any of the mixing steps; and the type of rotor used for mixing. In sum, all the factors above must be tuned to optimize the performance of the antiviral lubricant compositions during sexual activity.
- the viscosity of the antiviral lubricous composition depends not only on the total carrageenan concentration but also the relative concentration of the kappa-, iota-, and lambda-forms of carrageenan differentially affect the rate of exponential growth of the viscosity of the antiviral lubricous composition.
- the presence and increasing concentration of kappa-carrageenan causes the steepest increase in the composition’s viscosity, whereas the rate of exponential growth caused by the presence and increasing concentration of iota-carrageenan is less than that of kappa-carrageenan, and the rate of exponential growth caused by the presence and increasing concentration of lambda-carrageenan is less than both kappa-carrageenan and iota-carrageenan.
- a composition that is predominantly lambda-carrageenan will have a lower viscosity than a composition that is predominantly kappa-carrageenan and/or iota-carrageenan.
- antiviral lubricous compositions of the present invention can comprise greater than or equal to about 90% lambda-carrageenan and up to about 10% of one or both of kappa- carrageenan or iota-carrageenan.
- the antiviral lubricous compositions comprise about 90% of lambda-carrageenan and about 10% of kappa-carrageenan.
- the antiviral lubricous compositions comprise about 90% of lambda- carrageenan and about 10% of lambda-carrageenan.
- carrageenan mixtures also affects how they must be processed.
- carrageenans are obtained as raw extracts, they are already in a predominantly liquid state.
- shelf life of raw carrageenan extracts is typically reduced relative to solid powders, and carrageenan extracts can include components that are unwanted or even harmful. Consequently, obtaining dried carrageenans in powder form for use in the food or pharmaceutical industry is common, but comes with the trade-off that the carrageenans must be re solubilized in order to be utilized in a liquid composition.
- the carrageenan powders can be solubilized simply by high-sheer and high-speed mixing conditions for an extended period of time, often also under aggressive heating conditions.
- carrageenan powders cannot be processed in the same way to produce the antiviral lubricous compositions of the present invention because such conditions cause the resulting compositions to lose their lubricity over time, particularly upon undergoing the shear-thinning stress that occurs during sexual activity.
- the length of the carrageenan polysaccharides is directly correlated with the lubrication and moisture of the resulting composition. As the average length of the polysaccharides increase, the lubricity of the composition also increases.
- solubilizing carrageenan powders under high-shear and high-stress conditions causes the resulting compositions to prematurely dry out.
- the solubilization of carrageenan powders can be assisted by the addition of the powders to a polyol.
- polyols are commonly included in personal lubricant compositions because of the pleasing properties their presence provides during sexual activity.
- the multiple hydroxyl groups in each polyol molecule have an added benefit because they provide intermolecular contacts with which individual sugars within the larger carrageenan polysaccharide can interact in solution.
- processes to form the antiviral lubricous compositions of the present invention can include a step of first mixing carrageenan powders with at least one polyol to form a wet carrageenan mixture, prior to the addition of the carrageenans.
- first solubilizing the carrageenan powder into the polyol facilitates the complete homogenization of the carrageenan polysaccharides within the antiviral lubricous composition.
- the identity of the polyol and the weight ratio of the polyol to carrageenan also has an effect on the viscosity of the antiviral lubricous composition.
- 1,2-propanediol is approximately 50 times more viscous than water, but glycerol is approximately 23 times more viscous than 1,2-propanediol.
- an antiviral lubricous composition can comprise a much greater concentration of 1,2-propanediol than a second composition comprising glycerol, while having the same viscosity.
- the weight ratio of the polyol to the carrageenan within the wet carrageenan mixture is at least 1:10, including at least 1:5, 1:1, 2:1, 4:1, 6:1, 8:1, 10:1, 20:1, 30:1, or 40:1, up to at least 50:1.
- the weight ratio of the polyol to the carrageenan is about 1 : 1 to about 10:1.
- the polyol is 1,2-propanediol.
- the weight ratio of the aqueous solution mixed with the wet carrageenan mixture to form the carrageenan suspension also affects the viscosity of the antiviral lubricous composition. In some embodiments, as the weight ratio of the aqueous solution relative to the wet carrageenan mixture increases, the viscosity of the antiviral lubricous composition decreases. In further embodiments, the weight ratio of the aqueous solution mixed with the wet carrageenan mixture to form the carrageenan suspension is about 3:1 to about 60:1. In even further embodiments, the weight ratio of the aqueous solution mixed with the wet carrageenan mixture to form the carrageenan suspension is about 8 : 1 to about 45:1.
- heating one or more of the wet carrageenan mixture, the carrageenan suspension, and/or the antiviral lubricous composition enables the solubilization and homogenization of the carrageenans in water.
- heating the carrageenans causes at least a partial unfolding of each carrageenan polysaccharide as well as a disruption of intermolecular interactions between polysaccharides, both of which increases the viscosity of the composition.
- the carrageenan polysaccharides begin to solubilize within the aqueous solution, decreasing the viscosity and forming a homogenous antiviral lubricous composition.
- the viscosity of the composition can continue to decrease, and the polysaccharides themselves can dissociate into smaller and smaller oligosaccharides that have lower molecular weights and chain lengths.
- the carrageenan suspension is heated until an antiviral lubricous composition is formed that has a viscosity of less than about 5,000 cP. In even further embodiments, the carrageenan suspension is heated until an antiviral lubricous composition is formed that has a viscosity of about 1,000 cP to about 4,000 cP.
- compositions comprising carrageenans, such as the carrageenan suspension, that have not been homogenized are typically cloudy, hazy, or turbid, comprising large numbers of carrageenan particles that are visible by the naked eye.
- turbidity of the carrageenan suspension results from aggregate formation between two or more carrageenan polysaccharides before they have been fully unwound and exposed to the aqueous solvent.
- the carrageenan suspension is heated until a translucent antiviral lubricous composition is formed.
- the carrageenan suspension is heated until a transparent antiviral lubricous composition is formed.
- the translucent and/or transparent properties of the antiviral lubricous composition is maintained even after packaging and/or storage for an extended period of time.
- the fully homogenized antiviral lubricous composition is a solution.
- turbidity of any of the mixtures, suspensions, or antiviral lubricous compositions disclosed herein can be described quantitatively based on the method of determining the concentration of suspended particles in the sample, including but not limited to: Formazin Nephelometric Units (FNU), Jackson Turbidity Units (JTU), NTU, optical density, Helms Units, parts per million (PPM), and others.
- FNU and NTU are widely used to describe the turbidity of compositions having a uniform distribution of small particles, and are determined by measuring the amount of light that is scattered at 90 degrees relative to an incident light beam.
- NTU is measured using visible light as the incident light beam, typically between about 400 nm and about 680 nm
- FNU is measured using infrared light as the incident light beam, typically between about 780 nm and about 900 nm.
- the turbidity of any of the mixtures, suspensions, or antiviral lubricous compositions described herein are characterized as a function of NTU.
- the turbidity of the carrageenan suspension upon the addition of carrageenan to the aqueous solution is at least about 100 NTU, including at least about 200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, or 3000 NTU, up to at least about 4000 NTU.
- the turbidity of the homogenized antiviral lubricous composition is less than about 25 NTU, including less than about 20, 15, 10, 8, 6, 5, 4, 3, or 2 NTU, down to less than about 1 NTU.
- the turbidity of the homogenized antiviral lubricous composition is less than or equal to about 5 NTU.
- antiviral lubricous compositions can be homogenized until it has a turbidity that is approximately equal to the turbidity of drinking water.
- Governments, health organizations, and other regulatory bodies have described safety standards to protect people and animals from potentially dangerous health conditions from agents that increase the turbidity of a solution, including but not limited to: polymers and other macromolecules; insoluble small molecules; and bacteria and other microorganisms.
- the WHO has determined that drinking water should not be more than 5 NTU, and should ideally be below 1 NTU. In the United States, systems that utilize conventional or direct filtration methods must decrease the turbidity of drinking water to less than 1 NTU, and several localities strive to achieve turbidity levels less than 0.1 NTU.
- the type of mixing apparatus, the rotational speed, and the mixing time can be optimized to control the viscosity of the resulting antiviral lubricous composition, and to disperse and homogenize the carrageenan into the aqueous solution.
- mixing can be conducted under low-shear conditions for an extended and sufficient time to homogenize the composition, while preserving the length of each carrageenan polysaccharide and maintaining their lubricity prior to applying the composition to the skin or epithelial tissue, particularly before or in conjunction with sexual activity.
- mixing can be conducted under high-shear conditions for a minimum period of time, but mixing beyond a minimum time can irreparably disrupt the carrageenan polysaccharides, decrease the viscosity of the composition, and diminish the composition’ s performance as a lubricant during sexual activity.
- mixers include, but are not limited to, screw mixers, tumble mixers, ribbon mixers, and paddle mixers.
- a paddle mixer can be used for each of the mixing steps for forming the antiviral lubricous composition.
- mixing at relatively low speeds also preserves the structural integrity of each polysaccharide.
- each of the mixing steps is conducted with a mixing speed of equal or less than about 500 RPM.
- mixing of the antiviral lubricous composition after homogenizing the carrageenan within the aqueous solution can occur at speeds less than or equal to about 250 RPM.
- processes for forming the antiviral lubricous composition can further comprise several steps, including: (e) cooling the homogenized antiviral lubricous composition until the temperature of the antiviral lubricous composition is less than about 30 °C; (f) mixing one or more pH-adjusting agents into the cooled antiviral lubricous composition, at a weight sufficient to adjust the antiviral lubricous composition to a pH of about 3.5 to about 7.0; (g) optionally mixing one or more sweeteners into the carrageenan suspension or the cooled antiviral lubricous composition, at up to 0.5% by weight of the antiviral lubricous composition; and (h) optionally mixing one or more preservatives into the carrageenan suspension or the cooled antiviral lubricous composition, at up to 1% by weight of the antiviral lubricous composition.
- each of the additional components can be included within the antiviral lubricant composition to supplement its anti-HPV activity and/or enhance its performance during sexual activity.
- Composition properties as a result of adding pH-adjusting agents, sweeteners, and preservatives are described above.
- the processes described above can be utilized to homogenize carrageenan mixtures having different lambda-, kappa, and iota-carrageenan ratios into an aqueous solvent at any desired viscosity.
- lambda-carrageenan comprises at least about 50% by weight of the carrageenan powder, including at least about 60 or 70% by weight, up to about 80% by weight of the carrageenan powder. In other embodiments, lambda-carrageenan comprises less than about 85, 80, or 70% by weight, down to less than about 60% by weight of the carrageenan powder.
- the amount of kappa- and iota-carrageenans can increase such that when present, kappa-carrageenan and iota-carrageenan together comprise up to about 50% by weight of the carrageenan powder, including up to 40%, 30%, or up to 20% by weight of the carrageenan powder.
- the carrageenan suspension was heated to 70 °C and allowed to mix under the same mixing conditions until the carrageenan powder was completely homogenized within the water. Homogenization was achieved upon a transition from a turbid suspension into a clarified solution, after about 90 minutes. Mixing continued for 10 more minutes after homogenization took place. The mixer was paused and the composition was cooled to less than 30 °C. Once cooled, the preservatives, citric acid, and remaining water were added to the composition, with mixing at 250 RPM for 20 minutes. The resulting antiviral lubricous composition was translucent and has a pH of about 6.5, +/- 0.25.
- Each of the primary forms of carrageenan comprises a different repeating disaccharide structure — iota-carrageenan comprises alternating disaccharides of D-galactaose-4-sulfate and 2- sulfo-3,6-anhydro-D-galactose; kappa-carrageenan comprises alternating disaccharides of D- galactose-4-sulfate and 3,6-anyhdro-D-galactose; and lambda-carrageenan comprises alternating disaccharides of D-galactose-2-sulfate (1-3 linked) and D-galactose-2, 6-disulfate (1,4 linked).
- lambda-carrageenan typically contains more sulfate groups per polymer and substantially fewer anhydrogalactose residues, which are commonly found in iota-carrageenan and kappa- carrageenan.
- the relative ratio of lambda- to iota- to kappa-carrageenan in an antiviral lubricous composition can be determined by several analytical techniques, including but not limited to infrared spectroscopy (IR), nuclear magnetic resonance (NMR) spectroscopy (see de Araujo, C.A., et ah, (2013) Carbohydrate Polymers 91:483-491, and liquid chromatography coupled to mass spectroscopy (LC-MS) (see Diez, F., et ah, (2017) “Development of an Analytical Method to Determine the amount of e Carrageenan in HPMC Capsules by LCMS,” American Association of Pharmaceutical Principles Poster submission, obtained from the internet at http://abstracts.aaps.org/Verify/AAPS2017/PosterSubmissions/M8109.pdf on May 3, 2018).
- IR infrared spectroscopy
- NMR nuclear magnetic resonance
- LC-MS liquid chromatography coupled
- IR spectrum of antiviral lubricous composition can be utilized to determine both a profile of the composition that can be compared against other lambda-carrageenan- containing compositions, as well as a relative molar ratio of the lambda-, iota-, and kappa-carrageenan forms within the composition (see Volery, P., et ah, (2004) ./. Agric. Food Chem. 52 (25):7457-7463).
- carrageenan has several strong, broad absorption bands for residues or functional groups commonly found within each polymer, as well as a strong absorption maximum between about 1065 cm 1 and about 1020 cm 1 , particularly about 1050 cm 1 .
- the intensity of the absorbance of a particular band corresponding to a residue or functional group, relative to the intensity of the major absorption band at 1050 cm 1 can be used to determine the relative abundance of a particular form of carrageenan with the IR sample. Characteristic absorption bands and their intensities relative to the major absorption band at 1050 cm 1 are illustrated below in Table 4. Table 4: Common IR absorption bands in carrageenan
- a sample of the antiviral lubricous composition is subjected to IR spectroscopic analysis according to the procedure described in the Food and Agricultural Organization of the United Nations/ World Health Organization joint compendium of food additive specifications (see “Carrageenan, Compendium of Food Additive Specifications FAO JEFCA Monographs 16; FAO/WHO Publications; Rome, Italy; pp. 7-12). It is expected that antiviral lubricous compositions of the present invention possess a unique and characteristic IR spectrum that can be compared against other compositions that contain lambda-carrageenan.
- the IR spectrum for the antiviral lubricous composition possesses peaks between 810 cm 1 and 820 cm 1 as well as 825 cm 1 and 830 cm 1 , indicating the presence of lambda-carrageenan within the antiviral lubricous composition. It is further expected that the molar ratio of lambda-carrageenan in the antiviral lubricous composition is greater relative to the molar ratio of kappa-carrageenan and iota-carrageenan.
- Example 6 Antiviral Efficacy of the Antiviral Lubricous Composition against Respiratory
- a study is conducted in accordance with principles of the present invention to determine the efficacy of an antiviral lubricous composition in human subjects who have an active viral respiratory infection, such as COVID-19, or are in close contact with someone who has an active viral respiratory infection. Participants are asked to apply the antiviral lubricous composition of Example 2 to the tip of a swab, and to insert the swab through the nose and until contact is made with epithelial tissue inside the nose and nasal cavity. Alternatively, a participant is asked to dispense a volume of antiviral lubricous composition into the mouth, and to swish, swirl, or gargle the composition within the mouth before swallowing.
- the volume of the composition administered by either method is between 0.1 mL and 5 mL.
- the antiviral lubricous composition of Example 2 can be administered in its neat form, or diluted, prior to administration. Participants are asked to administer the antiviral lubricous composition to the nasal cavity 1-4 times a day. Additionally, participants can be asked to administer the composition before and/or after coming into close contact with another person or going out into public. It is expected that for those with an active infection, the progression of symptoms is either abated or reduced until being eliminated completely, on a dose- dependent basis. It is also expected that the viral load of the virus transmitted to subjects who are not sick, but who are in close contact with a sick patient, is either delayed, reduced, or eliminated.
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US20050239742A1 (en) * | 2004-04-08 | 2005-10-27 | Vivus, Inc. | Carrageenan-based formulations and associated methods of use |
KR20080070482A (en) * | 2007-05-31 | 2008-07-30 | (주)디딤바이오텍 | A lubricating composition comprising agents which induce the mucosal immunity and a preparation method thereof |
US20110229446A1 (en) * | 2010-03-02 | 2011-09-22 | Roman Stephen B | Method and composition to relieve sexual discomfort and improve vaginal health |
EP2734262B1 (en) * | 2011-07-20 | 2018-02-28 | Patrick F. Kiser | Intravaginal rings for drug delivery |
US20180369137A1 (en) * | 2017-06-27 | 2018-12-27 | Lifestyles Healthcare Pte. Ltd. | Natural Lubricant |
EP4342539A3 (en) * | 2018-05-10 | 2024-05-01 | Lanvira, LLC | Lubricated substrates comprising lambda-carrageenan |
-
2020
- 2020-06-22 JP JP2022580078A patent/JP2023538798A/en active Pending
- 2020-06-22 KR KR1020237002595A patent/KR20230042020A/en unknown
- 2020-06-22 BR BR112022026026A patent/BR112022026026A2/en unknown
- 2020-06-22 AU AU2020454698A patent/AU2020454698A1/en active Pending
- 2020-06-22 EP EP20942177.5A patent/EP4167956A4/en active Pending
- 2020-06-22 WO PCT/US2020/038991 patent/WO2021262141A1/en unknown
- 2020-06-22 CN CN202080103325.6A patent/CN115942941A/en active Pending
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WO2021262141A1 (en) | 2021-12-30 |
JP2023538798A (en) | 2023-09-12 |
MX2022016267A (en) | 2023-03-31 |
CN115942941A (en) | 2023-04-07 |
KR20230042020A (en) | 2023-03-27 |
CA3183518A1 (en) | 2021-12-30 |
AU2020454698A1 (en) | 2023-02-23 |
EP4167956A4 (en) | 2024-02-21 |
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