Hypochlorite-based eyelid cleaner

Abstract

The antibacterial eyelid cleansing composition contains hypochlorous acid, sodium acetate, and purified water. The composition has a free available chlorine (FAC) concentration of about 10 ppm to 300 ppm, a weight osmolality of 40 to 200 mOsm / kg, and a viscosity of 1 cP to 500 cP. The composition has a pH of about 3.5 to 6.5. The eyelid cleansing composition is an ophthalmic or ophthalmic composition that can cleanse the eyelids and eyes, remove excess lipids, debris, and exfoliated skin from the eyelids and surrounding areas, while reducing inflammation and promoting wound healing.

Description

Technical Field

[0001] Field of the Invention The present invention generally relates to eyelid and skin cleansing compositions and methods for preparing and using such compositions.

Background Art

[0002] Eye health includes not only the eye itself but also related structures such as the eyelids. The eyelids play a very important role in maintaining the overall health of the eye, protecting the eye from potential dangers such as approaching objects and airborne contaminants including pollen, dust, and other foreign substances. The eyelids contain important glands, the lacrimal gland and the Meibomian glands, which produce the tear film essential for maintaining a healthy eye. Each blink forms a new tear film, spreading the tears evenly across the cornea and lubricating the surface of the eye. Additionally, this blinking action helps to remove foreign objects from the eye.

[0003] Eyelid problems are common but can be particularly troublesome for contact lens wearers and potentially lead to more serious complications. One notable complication is blepharitis, a chronic inflammatory condition of the eyelids characterized by scaly crusting along the eyelid margins. The underlying causes of blepharitis can include bacterial infections, allergies, and in some cases, an association with seborrhea of the face and scalp. Effective treatment generally requires frequent eyelid cleansing to remove excess lipids, debris, and exfoliated skin, and failure to do so can exacerbate the problem.

[0004] Blepharitis, an inflammation of the eyelid, often accompanies or follows internal styes (bacterial infections affecting the skin surface of the eyelid margin). Another related infection is external styes, more commonly known as eyelid styes, which target small lipid-secreting meibomian glands along the eyelid margin surrounding the eyelashes. Styes typically appear as a red, tender bump, develop fully within three days, and are characterized by pain, redness, and tenderness of the eyelid margin. Regularly cleaning the eyelid margin can help minimize the occurrence of these frequently recurring conditions. A chalazion, an inflammation of the meibomian glands within the eyelid, is another issue to consider. Chalazions usually grow slowly over two to three weeks and are generally painless, but if left untreated, they may require surgical intervention.

[0005] Improving eyelid hygiene through the use of cleansing agents can reduce the severity of various problems, including those mentioned above, as well as other medical complications such as rosacea and seborrhea. Early intervention of these problems may even allow for their complete prevention. Eyelid cleansing agents serve a dual purpose, as they are effective in cleaning not only the eyelashes and eyelids but also the surrounding area. Furthermore, they can be used as pre-operative scrubs to reduce the presence of harmful bacteria, thereby reducing the likelihood of infection, inflammation, or endophthalmitis in patients. [Overview of the Initiative] [Means for solving the problem]

[0006] According to one embodiment, the eyelid cleansing agent composition comprises about 0.005 to about 0.05% by weight of hypochlorous acid; about 0.001 to 2.0% by weight of sodium acetate; and an appropriate amount of purified water to make the total volume 100% by weight. The composition has a free available chlorine (FAC) concentration of about 10 ppm to 300 ppm. The composition has a weight osmolality of 40 to 200 mOsm / kg and a viscosity of 1 cP to 500 cP. The composition has a pH of about 3.5 to 6.5.

[0007] According to one embodiment, the composition further comprises about 0.05% to about 0.75% by weight of sodium lauryl sulfate or sodium laureth sulfate and about 0.001% to about 2.0% by weight of acetic acid.

[0008] According to another embodiment, the composition further comprises about 0.05% to 0.75% by weight of capryl / caprylyl glucoside, about 0.05% to about 1.0% by weight of propylene glycol, about 0.001% to 2.0% by weight of acetic acid, and about 0.05% to about 5.0% by weight of a medium-chain alkane.

[0009] In yet another embodiment, the composition further comprises about 0.05% to about 0.75% by weight of dioctyl sodium sulfosuccinate and about 0.001% to about 2.0% by weight of acetic acid. [Modes for carrying out the invention]

[0010] The terms and phrases "invention," "present invention," and "instant invention," as well as similar terms and phrases used herein, are non-limiting and are not intended to limit the subject matter of the invention to any single embodiment, but rather encompass all possible embodiments described herein.

[0011] Where used herein, all weight percentages (W%) are based on the total weight percentage of the skincare composition unless otherwise specified. Furthermore, all compositional percentages are based on a total amount equal to 100% by weight unless otherwise specified.

[0012] The compositions and methods of use thereof may "comprise," "essentially consist of," or "consist of" any of the components or processes disclosed throughout this Spec. As used herein and in the claims, the terms "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include"), or "containing" (and any form of containing, such as "contains" and "contain") are inclusive or non-limiting and may include the components of the present invention and do not exclude other components or elements described herein. The use of the terms “a” or “an” in conjunction with the term “comprising” in the claims and / or specification may mean “one,” but is also consistent with the meanings of “one or more,” “at least one,” and “one or more than one.” As used herein, “essentially consisting of” means that the present invention may include other components in addition to those listed in the claims, provided that such additional components do not substantially alter the basic and novel features of the claimed invention. Generally, such additional substances may be absent or present only in trace amounts. However, it may be possible to include up to about 10% by weight of a substance that substantially alters the basic and novel features of the invention, provided that the utility (not the degree of utility) of the composition is maintained.

[0013] All ranges enumerated herein include endpoints, including endpoints that enumerate ranges "between" two values. Terms such as "about," "generally," and "substantially" should be interpreted as modifications of a term or value that do not make the term or value absolute. Such terms shall be defined according to the understanding of the modified term by those skilled in the art, given the context and the term they modify. In one non-limiting embodiment, these terms are defined as within 5%. The term "substantially" and its derivatives are defined, as understood by those skilled in the art, as being the majority of, but not necessarily all, of the specified, and in one non-limiting embodiment, "substantially" refers to a range of 0.01% to 5%.

[0014] Where used herein, the term “effective amount” of a composition refers to an amount sufficient to induce a desired biological response. As will be recognized by those skilled in the art, the effective amount of a substance may vary depending on factors such as the desired biological endpoint, the patient, etc. The terms effective amount and clinical effect may be used interchangeably herein. For example, the effective amount / clinically effective amount of a composition is the amount that can be used to promote long-term eyelid hygiene while substantially reducing inflammation and promoting eyelid wound healing.

[0015] This specification concludes with claims that specifically point out and clearly assert the invention, but the present invention is thought to be better understood from the following description.

[0016] The eyelid cleansing composition is an ophthalmic or ophthalmic composition that can cleanse the eyelids and eyes, remove excess lipids, debris, and exfoliated skin from the eyelids and surrounding areas, while reducing inflammation and promoting wound healing. The composition contains an aqueous medium containing hypochlorous acid, a buffer solution consisting of sodium acetate and acetic acid, and a final pH in the range of approximately 3.5 to approximately 6.5.

[0017] Hypohalous acid is an acid in which a halogen is bonded to a hydroxyl functional group. Preferably, the halogen is chlorine, and the hypohalous acid is hypochlorous acid. The composition contains at least 50 to 500 ppm of hypochlorite.

[0018] Free available chlorine, or free active chlorine (FAC), refers to the amount of chlorine available to disinfect or kill microorganisms. Importantly, FAC encompasses many forms of chlorine, including hypochlorous acid and hypohalite anions, in addition to free residual chlorine. FAC is typically measured and quantified by titration or colorimetric methods. In certain embodiments, eyelid cleansing compositions contain 10 to 300 ppm of free available chlorine (FAC).

[0019] Hypohalite compositions require buffering agents to maintain a stable pH during storage and application to the eye area. The composition comprises an acidic buffer solution consisting of sodium acetate and acetic acid. In exemplary embodiments, the concentration of sodium acetate in the composition is 0.001 to 2 wt / wt%, while the concentration of acetic acid is 0.001 to 2 wt / wt%. These concentration ranges allow those skilled in the art to calculate the amount of each buffering agent required to obtain the desired pH value.

[0020] The composition may contain one or more surfactants to improve its cleansing ability by dissolving and removing lipids, debris, and exfoliated skin. The surfactants act by forming micelles upon contact with the skin surface. The micelles can solubilize lipids, capture debris and loose skin, and then wash them away. Some suitable surfactants include sodium lauryl sulfate, capryl / caprylyl glucoside, sodium laureth sulfate, dioctyl sodium sulfosuccinate, polyglyceryl-6 caprylate, polyglyceryl-4 caprate, and mixtures thereof. The total concentration of surfactants in the composition may range from 0.05% to 5% by weight.

[0021] Emaculators are substances that help soften and soothe the skin, making it more supple and smooth. They are typically used in moisturizers, lotions, and balms to improve skin hydration and reduce dryness and a rough appearance. They work by forming a protective barrier on the skin surface, helping to lock in moisture and prevent moisture loss. They may be derived from natural sources such as yucca plant extracts or synthesized in the laboratory. The composition may contain one or more emollients selected from the group consisting of medium-chain alkanes (C9-C12), yucca extracts, and mixtures thereof. The total concentration of one or more emollients is in the range of 0.05-8 wt / wt%.

[0022] The composition may further contain a wetting agent. The wetting agent is a substance that helps maintain moisture by attracting water molecules from the environment and retaining them within the composition. In topological application, the wetting agent will attract moisture to the skin surface and retain water molecules just below the skin surface. According to one embodiment, propylene glycol is used as a wetting agent in the eyelid cleansing composition at a concentration of 0.05 to 1 wt / wt%.

[0023] The aqueous medium may be deionized water or USP purified water. The composition is physiologically suitable for viscosity, osmolality, and pH within a suitable range. Osmolality can be adjusted using sugars, glycerin, propylene glycol, and similar components. The osmolality of the composition can be adjusted from about 40 mOsm / kg to about 200 mOsm / kg. Viscosity is similarly adjusted using viscosity modifiers (but not limited to carboxymethylcellulose, hydroxypropylmethylcellulose, Carbopol®, etc.). The viscosity of the composition is preferably higher in the range of 1 to 500 cP.

[0024] In one embodiment, the eyelid cleanser composition contains hypochlorous acid, sodium lauryl sulfate, an acidic buffer consisting of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleanser contains 0.005 to 0.05 wt / wt% hypochlorous acid, 0.05 to 0.75 wt / wt% sodium lauryl sulfate, an acidic buffer consisting of 0.001 to 2.0 wt / wt% sodium acetate and 0.001 to 2.0 wt / wt% acetic acid, and a suitable amount (q.s.) of purified water to make the total amount 100 w / w.

[0025] In another embodiment, the eyelid cleanser composition contains hypochlorous acid, capryl / caprylyl glucoside, propylene glycol, medium-chain alkane, an acidic buffer consisting of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleanser contains 0.005 to 0.05 wt / wt% hypochlorous acid, 0.05 to 0.75 wt / wt% capryl / caprylyl glucoside, 0.05 to 1.0 wt / wt% propylene glycol, 0.05 to 5.0 wt / wt% medium-chain alkane, an acidic buffer consisting of 0.001 to 2.0 wt / wt% sodium acetate and 0.001 to 2.0 wt / wt% acetic acid, and a suitable amount of purified water to make the total amount 100 w / w.

[0026] In one embodiment, the eyelid cleanser composition contains hypochlorous acid, sodium lauryl sulfate, capryl / caprylyl glucoside, medium-chain alkane, an acidic buffer consisting of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleanser contains 0.005 to 0.05 wt / wt% hypochlorous acid, 0.05 to 0.75 wt / wt% sodium lauryl sulfate, 0.05 to 0.75 wt / wt% capryl / caprylyl glucoside, 0.05 to 5.0 wt / wt% medium-chain alkane, an acidic buffer consisting of 0.001 to 2.0 wt / wt% sodium acetate and 0.001 to 2.0 wt / wt% acetic acid, and a suitable amount of purified water to make the total amount 100 w / w.

[0027] In one embodiment, the eyelid cleanser composition contains hypochlorous acid, sodium lauryl sulfate, an acidic buffer solution composed of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleanser contains 0.005 to 0.05 wt / wt% hypochlorous acid, 0.05 to 0.75 wt / wt% sodium lauryl sulfate, an acidic buffer solution composed of 0.001 to 2.0 wt / wt% sodium acetate and 0.001 to 2.0 wt / wt% acetic acid, and an appropriate amount of purified water to make the total amount 100 w / w.

[0028] In one embodiment, the eyelid cleanser composition contains hypochlorous acid, sodium dioctyl sulfosuccinate, an acidic buffer solution composed of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleanser contains 0.005 to 0.05 wt / wt% hypochlorous acid, 0.05 to 0.75 wt / wt% sodium dioctyl sulfosuccinate, an acidic buffer solution composed of 0.001 to 2.0 wt / wt% sodium acetate and 0.001 to 2.0 wt / wt% acetic acid, and an appropriate amount of purified water to make the total amount 100 w / w.

[0029] In one embodiment, the eyelid cleanser composition contains hypochlorous acid, polyglyceryl-6 caprylate and polyglyceryl-4 caprate, yucca extract, an acidic buffer solution composed of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleanser contains 0.005 to 0.05 wt / wt% hypochlorous acid, 0.05 to 5 wt / wt% polyglyceryl-6 caprylate and polyglyceryl-4 caprate, 0.05 to 3.0 wt / wt% yucca extract, an acidic buffer solution composed of 0.001 to 2.0 wt / wt% sodium acetate and 0.001 to 2.0 wt / wt% acetic acid, and an appropriate amount of purified water to make the total amount 100 w / w.

[0030] In one embodiment, the eyelid cleansing agent composition comprises hypochlorous acid, a medium-chain alkane, a yucca extract, an acidic buffer consisting of sodium acetate and acetic acid, and purified water. For example, in an exemplary embodiment, the eyelid cleansing agent comprises 0.005 to 0.05 wt / w% hypochlorous acid, 0.05 to 5.0 wt / w% medium-chain alkane, 0.05 to 3.0 wt / w% yucca extract, 0.001 to 2.0 wt / w% sodium acetate and 0.001 to 2.0 wt / w% acetic acid, and an appropriate amount of purified water to make the total volume 100 w / w.

[0031] According to one embodiment, an applicator is used to deliver a therapeutically effective amount of one embodiment of a cleansing composition to the eye area. The applicator can take various forms, including wipes, cloths, pads, sponges, brushes, swabs, puffs, roll-on applicators, and other similar devices. In one particular embodiment, the applicator comprises a hypoallergenic nonwoven hydrophilic material, which is preferred due to its flexible and absorbent properties. The term "pad" refers to a thick cloth piece capable of absorbing the active ingredient, such as cotton, cellulose derivatives, polyester, rayon, polypropylene, bamboo, or other suitable materials. The present invention encompasses a range of materials and fabrics that can be used for applicators, including natural or synthetic fibers and nonwoven fabrics made from a variety of materials. Overall, the applicator is designed to provide a comfortable and effective method for delivering a cleansing composition to the eye area.

[0032] In one embodiment, the present invention provides a kit for delivering a therapeutically effective amount of one embodiment of a cleansing composition to the ocular region. The kit may include one or more sealed packaging bodies, such as sealed pouches, each packaging body containing a disposable, single-use applicator impregnated with one embodiment of the composition. As described herein, the applicator may include a material impregnated with one embodiment of the composition. Furthermore, the kit may include a case for the packaging bodies, along with clear and concise instructions for use.

[0033] Experimental data

[0034] Table 1 shows a comparison of the stability of hypochlorous acid in the presence of various components. The inventors determined that only the specific components disclosed are compatible with hypochlorous acid in the embodiments of the disclosure. For example, in a solution containing sodium laureth sulfate, the FAC concentration decreased by approximately 4% per day after 7 days. In contrast, immediate decomposition of hypochlorous acid was observed when decyl glucoside was used.

[0035] [Table 1]

[0036] While various embodiments of the present invention have been described above, other further embodiments of the present invention can be devised without departing from the basic scope of the present invention. The present invention is not limited to the embodiments, modifications, or examples described, which are included to enable those skilled in the art to practice and use the present invention in combination with information and knowledge available to those skilled in the art.

Claims

1. An eyelid cleansing agent composition, 0.005 to 0.05% by weight of hypochlorous acid; 0.001 to 2.0% by weight of sodium acetate; and An appropriate amount of purified water to bring the total volume to 100% by weight. Includes, An eyelid cleansing composition having a free available chlorine (FAC) concentration of about 10 ppm to 300 ppm.

2. The eyelid cleansing composition according to claim 1, wherein the composition further comprises 0.05% to 0.75% by weight of sodium lauryl sulfate or sodium laureth sulfate.

3. The eyelid cleansing composition according to claim 2, wherein the composition further comprises 0.001% to 2.0% by weight of acetic acid.

4. The eyelid cleansing composition according to claim 1, wherein the composition further comprises 0.05% to 0.75% by weight of capryl / caprylyl glucoside.

5. The eyelid cleansing composition according to claim 4, wherein the composition further comprises 0.05% to 1.0% by weight of propylene glycol.

6. The eyelid cleansing composition according to claim 5, wherein the composition further comprises 0.001% to 2.0% by weight of acetic acid.

7. The eyelid cleansing composition according to claim 6, wherein the composition further comprises 0.05% to 5.0% by weight of a medium-chain alkane.

8. The eyelid cleansing composition according to claim 1, wherein the composition further comprises 0.05% to 0.75% by weight of dioctyl sodium sulfosuccinate.

9. The eyelid cleansing composition according to claim 8, wherein the composition further comprises 0.001% to 2.0% by weight of acetic acid.

10. The eyelid cleansing composition according to claim 1, wherein the composition has a weight osmolality of 40 to 200 mOsm / kg.

11. The eyelid cleansing composition according to claim 1, wherein the composition has a viscosity of 1 cP to 500 cP.

12. The eyelid cleansing composition according to claim 1, wherein the composition has a pH of about 3.5 to 6.5.

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