Skin barrier protection delivery system and method thereof

Abstract

The present disclosure relates to compositions and methods for treating topical skin conditions. Topically applied compositions and delivery systems are also provided. Methods of using the compositions and delivery systems in cosmetic, personal care, and dermatological applications are also provided. There is also provided a sprayable composition comprising Vaseline.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 333,768, filed on April 22, 2022, and U.S. Provisional Application No. 63 / 434,179, filed on December 21, 2022, the contents of each of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure relates to compositions and methods for treating local skin conditions. Topically applied compositions and delivery systems are also provided. Compositions and methods of delivery systems for use in beauty, personal care and dermatological applications are further provided. Compositions in the form of sprayable gels are also provided. Background Art

[0004] The skin is the largest organ of the body and protects mammals from both aqueous and dry environmental influences. It is now generally accepted that the intercellular lamellar bilayer of stratum corneum lipids is a key constituent of the functional barrier. Maintaining a barrier that prevents excessive transepidermal water loss to the environment is essential for the survival of all terrestrial animals. Local or systemic perturbations of the epidermal barrier occur in a variety of skin and mucosal diseases and conditions. These perturbations not only have a significant effect on the morphology of skin lesions, but also activate certain skin diseases.

[0005] Active agents are used for skin treatment of various dermatological conditions (such as psoriasis, photoaging, age spots, skin aging due to intrinsic and extrinsic reasons, skin wrinkles, acne, pigmentation and skin cancer). Active agents are usually prescription active agents and over-the-counter active agents. The solvent used in the dermatological formulation with skin treatment active agents can be a strong solvent, such as acetone; it can also be a gentle, i.e. mild solvent. However, it is understood that strong solvents can cause skin conditions that require additional treatment (including damage to the skin barrier) and may interfere with the patient's compliance with the skin treatment regimen. On the other hand, mild solvents are known to be ineffective in the delivery of active agents in transdermal and dermal uses. In addition, with the trend of extended use of dermatological preparations in current skin care products, the demand for local preparations of active agents for various skin treatments continues to exist.

[0006] Common moisturizers and emollients also lead to the destruction of barrier function. There is a constant need for an elegant, non-greasy, safe and effective topical composition that not only protects the skin barrier but also effectively and safely delivers other functional and / or pharmaceutical active ingredients to the skin. Summary of the invention

[0007] One of the objects of the present disclosure is to provide a cost-effective composition, such as a smooth and non-sticky sprayable composition, which is easy to apply and is hygienic. In one embodiment, the present composition increases water retention and improves skin roughness (moisturization), repairs and protects the skin from harmful conditions.

[0008] Certain skin care formulations disclosed herein provide surprising, unexpected results. In certain embodiments, the disclosed delivery systems comprise certain components that provide additive or synergistic results.

[0009] The present disclosure provides compositions useful as skin moisturizers, skin softeners, skin debriding agents, and the like, as well as base compositions for cosmetic preparations, compositions for treatment, such as pharmacological preparations. In cosmetic preparations, the compositions may be used with additional ingredients that have only cosmetic effects. Alternatively, cosmetic preparations may contain ingredients that have both cosmetic and therapeutic effects, such as "cosmeceutical" ingredients.

[0010] In one embodiment, disclosed herein are compositions for correcting a defective epidermal barrier in a skin or mucosal disease or condition. The disclosed compositions and methods strengthen the barrier to prevent damage caused by environmental insults. The disclosed compositions can be used as moisturizers for softening and hydrating the epidermis and have a neutral effect on the barrier function, and in some cases improve the barrier function or increase its recovery rate.

[0011] The disclosed compositions also enhance the therapeutic activity of other pharmaceutical agents. Such agents include anti-inflammatory agents, antimicrobial agents, anti-tumor agents, antipruritic agents, antihistamines, analgesics, natural and synthetic vitamin analogs, carboxylic acids and their analogs, and artemisinin and its analogs.

[0012] Due to its effect on the epidermal barrier function, the disclosed compositions improve epidermal hyperproliferation and reduce inflammation. This results in significantly prolonged or complete remission and prevention of recurrence of skin diseases.

[0013] In certain embodiments, the skin barrier protection delivery system includes a sprayable vaseline that can maintain a higher concentration of active ingredients without separation. It was unexpectedly found that a composition comprising at least about 30% by weight of vaseline can be formulated into a spray. It was further unexpectedly found that the preparation with such a high concentration of vaseline in the present disclosure can be easily sprayed and effectively provide uniform coverage on the skin. In certain embodiments, the sprayable formulation does not include a propellant gas as an additive, which may be harmful to the subject. In one embodiment, the composition forms a closed film on the skin.

[0014] In some embodiments, provided herein is a skin barrier protection delivery system comprising (i) a mixture of Coconut Alkane in a concentration range of 30-70wt% and Coco-Caprylate / Caprate in a concentration range of 3-7wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30wt%; wherein the delivery system is sprayable. In some embodiments, petrolatum is present in a concentration of 40wt%. In some embodiments, petrolatum is present in a concentration of 50wt%.

[0015] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkanes in a concentration range of 30-65 wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40 wt%. In some embodiments, the petrolatum is present in a concentration of 50 wt%.

[0016] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkanes in a concentration range of 30-70 wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7 wt%, wherein the combined concentration of coconut alkanes and coconut oil alcohol-caprylate / caprate is up to 70 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40 wt%. In some embodiments, the petrolatum is present in a concentration of 50 wt%.

[0017] In some embodiments, the skin barrier protection delivery system provided herein comprises (i) a mixture of coconut alkanes in a concentration range of 30-70wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%; and (ii) vaseline, wherein the vaseline is present in a concentration of 25-60wt%, wherein the delivery system is sprayable. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%.

[0018] In some embodiments, the skin barrier protection delivery system provided herein comprises (i) a mixture of coconut alkanes in a concentration range of 30-65wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%; and (ii) vaseline, wherein the vaseline is present in a concentration of 25-60wt%, wherein the delivery system is sprayable. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%.

[0019] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkanes in a concentration range of 30-70 wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7 wt%, wherein the combined concentration of coconut alkanes and coconut oil alcohol-caprylate / caprate is up to 70 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of 25-60 wt%, wherein the delivery system is sprayable. In some embodiments, petrolatum is present in a concentration of 40 wt%. In some embodiments, petrolatum is present in a concentration of 50 wt%.

[0020] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one, at least two, at least three, or at least four of ceramide, triglyceride, phytosterol, phytosterol ester, terpene (e.g., squalene), plant-based ester or wax, tocopherol and / or phospholipid. In some embodiments, vaseline is present in a concentration of 25-60wt%. In some embodiments, vaseline is present in a concentration of at least 30wt%. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%.

[0021] In some embodiments, the skin barrier protection delivery system of the present disclosure includes plant-based esters or waxes. In some embodiments, plant-based esters or waxes are selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax, and sunflower wax. In some embodiments, plant-based esters or waxes include jojoba esters.

[0022] In some embodiments, the skin barrier protection delivery system of the present disclosure includes terpenes. In some embodiments, the terpenes are selected from the group consisting of triterpenes, hemiterpenes, monoterpenes, sesquiterpenes, diterpenes, disesquiterpenes and tetraterpenes. In some embodiments, the terpenes are triterpenes, such as squalene.

[0023] In some embodiments, the skin barrier protection delivery system of the present disclosure includes plant sterol esters, which include esters derived from seeds or nut oils. In some embodiments, seeds or nut oils are selected from the group consisting of macadamia oil, almond oil, avocado oil, rapeseed oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine nut oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil and walnut oil. In some embodiments, the plant sterol ester is phytosteryl macadamiate.

[0024] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises ceramide, triglyceride, phytosterol, phytosteryl macadamia oleate, squalene, jojoba ester and tocopherol. In some embodiments, the skin barrier protection delivery system comprises ceramide NP, ceramide AP, jojoba ester, squalene, phytosterol, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglyceride and C12-18 acid triglyceride.

[0025] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one of a polysaccharide, a gum, a buffer (eg, an acid), and a plant extract (eg, a root plant extract).

[0026] In some embodiments, the skin barrier protection delivery system of the present disclosure includes polysaccharides. In some embodiments, the polysaccharide is selected from the group consisting of maltodextrin, cellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid, and mixtures thereof. In some embodiments, the polysaccharide is maltodextrin.

[0027] In some embodiments, the skin barrier protection delivery system of the present disclosure includes gum. In some embodiments, the gum is selected from the group consisting of guar gum, xanthan gum, pullulan gum, agar-agar gum, carrageenan gum, gellan gum, gum arabic gum and tragacanth gum. In some embodiments, the gum is acacia senegal gum.

[0028] In some embodiments, the skin barrier protection delivery system of the present disclosure includes an extract derived from a plant. In some embodiments, the extract is derived from a root plant. In some embodiments, the root plant is selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish and radish. In some embodiments, the root plant extract is a sweet potato root extract.

[0029] In some embodiments, the skin barrier protection delivery system of the present disclosure includes a buffer. In some embodiments, the buffer is an acid. In some embodiments, the acid is citric acid. In some embodiments, the acid is lactic acid.

[0030] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one of sweet potato root extract, citric acid, gum arabic and maltodextrin. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises sweet potato root extract, citric acid, gum arabic and maltodextrin.

[0031] In some embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglycerides, C12-18 acid triglycerides, sweet potato root extract, gum arabic, citric acid and maltodextrin.

[0032] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) at least 30 wt% of petrolatum; (ii) coconut alkanes in the range of 30-70 wt%; (iii) coconut oil alcohol-caprylate / caprate in the range of 3-7 wt%; (iv) ceramide NP in the range of 0.01-0.1 wt%; (v) ceramide AP in the range of 0.01-0.1 wt%; (vi) jojoba esters in the range of 0.1-1.5 wt%; (vii) squalene in the range of 0.1-1 wt%; (viii) phytosteryl macadamia oleate in the range of 0.01-0.1 wt% ; (ix) phytosterols in the range of 0.005-0.1wt%; (x) tocopherols in the range of 0.001-0.1wt%; (xi) C18-36 acid triglycerides in the range of 0.5-5wt%; (xii) C12-18 acid triglycerides in the range of 0.1-1wt%; (xiii) sweet potato root extract in the range of 0.01-0.1wt%; (xiv) citric acid in the range of 0.001-0.01wt%; (xv) gum arabic in the range of 0.001-0.1wt%; and (xvi) maltodextrin in the range of 0.001-0.1wt%. In some embodiments, the delivery system is a sprayable formulation. In some embodiments, petrolatum is present in a concentration of 40wt%. In some embodiments, petrolatum is present in a concentration of 50wt%.

[0033] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) 50 wt% of petrolatum; (ii) 42-43 wt% of coconut alkanes; (iii) 4-5 wt% of coconut oil alcohol-caprylate / caprate; (iv) 0.05 wt% of ceramide NP; (v) 0.05 wt% of ceramide AP; (vi) 0.75 wt% of jojoba esters; (vii) 0.3-0.4 wt% of squalene; (viii) 0.05-0.06 wt% of phytosterol macadamia oleate; ( ix) 0.01-0.02 wt% of phytosterols; (x) 0.0045 wt% of tocopherol; (xi) 1-2 wt% of C18-36 acid triglycerides; (xii) 0.4-0.5 wt% of C12-18 acid triglycerides; (xiii) 0.03-0.04 wt% of sweet potato root extract; (xiv) 0.003-0.004 wt% of citric acid; (xv) 0.03-0.04 wt% of gum arabic; and (xvi) 0.03-0.04 wt% of maltodextrin. In some embodiments, the delivery system is a sprayable formulation.

[0034] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises zinc oxide. In some embodiments, zinc oxide is present in a concentration ranging from about 10 wt % to about 15 wt %. In some embodiments, zinc oxide is present in a concentration ranging from about 10% to about 25%. In some embodiments, zinc oxide is about 15%.

[0035] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) 25-60 wt % of petrolatum; (ii) 10-25 wt % of zinc oxide (ZnO); and (iii) 30-60 wt % of isohexadecane.

[0036] In some embodiments, the skin barrier protection delivery system of the present disclosure includes (i) 40 wt % of petrolatum; (ii) 15 wt % of zinc oxide (ZnO); and (iii) 45 wt % of isohexadecane.

[0037] In some embodiments, the skin barrier protection delivery system of the present disclosure has a viscosity of about 500 cps to about 10,000 cps, such as about 1,000 cps to about 5,000 cps.

[0038] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises an active ingredient as described herein. In some embodiments, the active ingredient is present in an amount of about 0.0001% to about 35% by weight.

[0039] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises a pharmaceutically acceptable carrier or excipient. In some embodiments, the pharmaceutically acceptable carrier or excipient is selected from the group consisting of water and oil emulsions, suspensions, colloids, microemulsions, clear solutions, nanoparticle suspensions, nanoparticle emulsions, and anhydrous compositions.

[0040] In some embodiments, the present disclosure provides a pharmaceutical composition in the form of a spray, comprising the skin barrier protection delivery system described herein. In some embodiments, the composition does not include a propellant.

[0041] In some embodiments, the present disclosure provides a pharmaceutical composition in the form of a sprayable gel, comprising the skin barrier protection delivery system of the present disclosure. In some embodiments, the composition does not contain a propellant, an aerosol, or a bag-on-valve.

[0042] In some embodiments, the compositions of the present disclosure do not include flammable components. In some embodiments, the compositions of the present disclosure do not contain flammable solubilizing agents. In some embodiments, the compositions of the present disclosure do not contain alcohol.

[0043] In some embodiments, the present disclosure provides a device comprising the skin barrier protection delivery system of the present disclosure.

[0044] In some embodiments, the present disclosure provides a device comprising a pharmaceutical composition comprising the skin barrier protection delivery system of the present disclosure.

[0045] In some embodiments, the device does not include a propellant or an aerosol or a bag on a valve. In some embodiments, the device is in the form of an atomizer pump. In some embodiments, the device is a dip tube atomizer pump.

[0046] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising: (i) a mixture of long chain alkanes with a carbon length greater than 10 carbons in a concentration range of 30-70 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable.

[0047] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising (i) a mixture of long chain alkanes with a carbon length greater than 10 carbons in a concentration range of 30-70 wt% and esters of long chain alcohols in a concentration of 3-7 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable. DETAILED DESCRIPTION

[0048] Disclosed are stable, non-irritating formulations containing skin therapeutic active agents and delivery systems for topical application to the skin. The disclosed topical formulations and delivery systems provide controlled, gentle release of active agents into the skin for treating applicable (amenable) skin conditions and for improving aesthetic skin properties. Also provided are methods for the formulation, manufacture and use of the disclosed formulations and delivery systems. Due to its high viscosity, petrolatum was not previously considered to be useful in non-aerosol (non-propellant-based) spray formulations intended to be dispensed by a manual spray pump dispenser. In addition, the percentage of petrolatum necessary to achieve skin protection benefits is too high; therefore, the use of petrolatum will clog the spray pump. The result will be a liquid or semisolid (e.g., gel) composition that cannot be sprayed at all or sprays inefficiently through a nozzle, and leaves very uneven coverage on the skin. If any formulation does contain petrolatum, the formulation does not contain enough petrolatum to provide the necessary skin protectant benefits. It was unexpectedly discovered that formulations of the present disclosure having such high concentrations of petrolatum (e.g., 30% or more by weight) can be easily sprayed and effectively provide even coverage on the skin. In certain embodiments, the sprayable formulations do not include a propellant gas as an additive that may be harmful to the subject.

[0049] In certain embodiments, the formulations disclosed herein: i) allow for a 10- to 50-fold reduction in the amount of the main ingredient used; ii) are thus environmentally friendly; iii) for the same or better therapeutic effect, the formulation leaves a silky, smooth feel on the skin, whereas the use of known formulations and pure petrolatum jelly results in a sticky, greasy, and messy feel; and iv) the formulation is a spray, which significantly provides: 1) increased ease of use (at home and in hospital & nursing home settings (e.g., one nurse vs. two nurses)) and 2) increased protection against cross-bacterial contamination (no finger-scraper required in the can). Sprayable formulations can be applied to the skin surface without touching or rubbing the skin surface. Thus, the risk of infection or contamination is reduced. In certain embodiments, the present invention provides a surprising discovery that compositions containing high concentrations of petrolatum (e.g., 30% or more by weight) in a sprayable form have improved sprayability compared to existing compositions containing petrolatum.

[0050] The present disclosure provides skin care formulations, delivery systems and methods of use thereof for treating, alleviating or improving skin conditions suitable for treatment with active ingredients. Suitable conditions include, but are not limited to, inflammatory skin diseases and skin conditions characterized by increased cell turnover, including psoriasis, photoaging, weathered appearance, yellowing, loss of elasticity, loss of collagen-rich appearance and / or youthfulness, redness, dryness, age spots, skin wrinkles, acne, rosacea, ichthyosis, xerosis, diaper rash, dermatitis, chapped skin on the hands and feet, and skin cancer.

[0051] The compositions of the present disclosure may also be used as a healer for minor scrapes and burns; a moisturizer for use, for example, on the face, hands, or feet, and more; a protective barrier for pet paws; diaper rash; an eye makeup remover; a split-end reducer; to prevent skin staining from hair dye or nail polish; a perfume scent retainer; and a lubricant for stuck objects.

[0052] The disclosed formulations may also be used to improve one or more aesthetic criteria, including, but not limited to, perceived improvements in apparent skin age, skin tone, weathered appearance, yellowing, loss of elasticity, redness, dryness, age spots, skin wrinkles, skin smoothness, brightness, radiance, and less noticeable skin pores.

[0053] As used herein, the term "about" refers to + / - 5% of a specified value.

[0054] As used herein, the term "treatment" or "treatment" with respect to skin conditions generally refers to the application of the purpose to provide a pharmacodynamic effect without regard to the results. In certain embodiments, "treatment" or "treatment" refers to "having a positive effect on skin conditions", and includes reducing, improving and / or alleviating at least one symptom of skin conditions, reducing, improving and / or alleviating the severity of skin conditions, delaying, preventing or inhibiting the progression of skin conditions, or a perceptible improvement or benefit of the treatment results. It can also refer to the use of over-the-counter products to achieve treatment results comparable to or better than prescription drugs. Therefore, the treatment used herein does not require a complete cure of the condition. In certain embodiments, the formulations or delivery systems disclosed herein can reduce the severity of skin conditions, reduce the severity of symptoms associated therewith, provide improvements in the patient's quality of life, or delay, prevent, inhibit the onset of one or more symptoms of skin conditions, or provide perceptible benefits. As used herein, these terms also include aesthetic improvements to the skin after applying a disclosed formulation containing an active agent.

[0055] As used herein, the term "wt %" with respect to an ingredient or combination of ingredients in a disclosed formulation refers to the concentration of the ingredient or combination of ingredients by weight, based on the total weight of the formulation.

[0056] As used herein, the terms "application," "apply," and "applying" with respect to the disclosed topical formulations or methods of using the disclosed topical formulations refer to any manner of applying the topical formulation to the patient's skin that delivers the formulation to the patient's skin surface in medical or cosmetic practice. Smearing, rubbing, spreading, spraying the disclosed topical formulations on the subject's skin with or without the aid of a suitable device are all included within the scope of the term "application" as used herein. The terms "topical" or "topically" with respect to the application or application of the disclosed formulations refer to epidermal administration or application, or application to the skin.

[0057] As used herein, the phrases "effective amount" or "therapeutically effective amount" used interchangeably herein refer to an amount of a formulation or a component thereof that is effective to slow down or improve skin conditions as described above, including a range of effects from detectable local improvement in the area of ​​topical application, to substantial relief of symptoms, to improvement in one or more aesthetic criteria, including but not limited to perceived improvement in free radical damage from sunlight (UVB, UVA, visible light), HEV (blue) light, infrared (IR), pollution, irritants, allergens or various environmental toxins, apparent skin age, radiation damage, sun or UV damage, skin color, weathered appearance, changes in complexion, The present invention relates to the present invention to the invention of the present invention. The present invention relates to the present invention to the invention of the present invention to the invention of the present invention. The present invention relates to the present invention ... Certain disclosed compositions, formulations, delivery systems, and methods of use thereof can reduce, minimize, or eliminate commonly observed skin disorders, including, inter alia, itching, severe skin flaking, skin barrier disruption, discomfort, extreme dryness, skin cracking, and sensitization. In certain embodiments, disclosed compositions, formulations, delivery systems, and methods of use thereof also provide aesthetic improvements to the skin, including, but not limited to, skin that appears younger, skin that exhibits a more even skin tone, skin that has less noticeable pores, and skin that is judged by the user to be smoother, and / or skin that is improved relative to a weathered or aged appearance, yellowing, loss of elasticity, redness, dryness, age spots, and / or skin wrinkles.

[0058] In certain embodiments, the delivery systems disclosed herein can not only maintain product stability, including the stability of the formulated active agents. In certain embodiments, the inventors unexpectedly found that certain disclosed preparations are effective compared to other skin care preparations. Therefore, certain disclosed preparations and methods of use thereof, compared to prescription strength active agents, effectively play a role in skin care treatment at over-the-counter strength. In certain embodiments, the preparations (especially in daily long-term use) cause reduced, minimal or no skin irritation and other possible side effects commonly associated with these preparations.

[0059] Without wishing to be bound by theory, it is conceivable that the unexpected results associated with certain embodiments of the formulations are obtained through the synergistic effect of the delivery systems herein, i.e., the action of the delivery systems results in the controlled release of the active agent. Here, certain embodiments of the disclosed formulations release the active agent with maximum, optimal intensity and release rate with minimal or no irritation to the skin.

[0060] Without wishing to be bound by theory, it is contemplated that, in certain embodiments, the increased efficiency of active agent delivery coupled with the significant reduction in irritation observed upon application of the presently disclosed formulations allows the delivery system to be formulated and used with significantly higher active ingredient concentrations than previously used. Thus, certain disclosed formulations and delivery systems provide effective skin care treatments at over-the-counter strengths while also being mild to the skin and well tolerated by consumers.

[0061] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising vaseline. In some embodiments, vaseline is present at a concentration of at least 30wt%. In some embodiments, vaseline is present in a concentration range of 25-60wt%. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%.

[0062] In some embodiments, provided herein is a skin barrier protection delivery system comprising: (i) a mixture of coconut alkanes in a concentration range of 30-70wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%; and (ii) vaseline, wherein vaseline is present at a concentration of at least 30wt%. In some embodiments, vaseline is present at a concentration of 40wt%. In some embodiments, vaseline is present at a concentration of 50wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable liquid, semi-liquid or gel.

[0063] In some embodiments, a skin barrier protection delivery system is provided herein, comprising: (i) a mixture of coconut alkanes in a concentration range of 30-70wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%; and (ii) vaseline, wherein vaseline is present in a concentration of 25-60wt%, wherein the delivery system is sprayable. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0064] In some embodiments, the skin barrier protection delivery system comprises: (i) a mixture of coconut alkanes in a concentration range of 30-65wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%; and (ii) vaseline, wherein the vaseline is present in a concentration of at least 30wt%. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0065] In some embodiments, the skin barrier protection delivery system comprises: (i) a mixture of coconut alkanes in a concentration range of 30-65wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%; and (ii) vaseline, wherein the vaseline is present in a concentration of 25-60wt%, wherein the delivery system is sprayable. In some embodiments, vaseline is present in a concentration of 40wt%. In some embodiments, vaseline is present in a concentration of 50wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0066] It is understood that in the composition of the present disclosure, the mixture of coconut alkanes and coconut oil alcohol-caprylate / caprate is present in a concentration of up to about 70% by weight of the formulation. In some embodiments, the present disclosure comprises (i) a mixture of coconut alkanes and coconut oil alcohol-caprylate / caprate, wherein the combined concentration of coconut alkanes and coconut oil alcohol-caprylate / caprate is up to 70wt%; and (ii) petrolatum, wherein petrolatum is present in a concentration of at least 30wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0067] In some embodiments, the skin barrier protection delivery system comprises: (i) a mixture of coconut alkanes in a concentration range of 30-70wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7wt%, wherein the combined concentration of coconut alkanes and coconut oil alcohol-caprylate / caprate is up to 70wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of 25-60wt%, wherein the delivery system is sprayable. In some embodiments, petrolatum is present in a concentration of 40wt%. In some embodiments, petrolatum is present in a concentration of 50wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0068] In some embodiments, the skin barrier protection delivery system comprises: (i) a mixture of coconut alkanes in a concentration range of 30-70 wt% and coconut oil alcohol-caprylate / caprate in a concentration range of 3-7 wt%, wherein the combined concentration of coconut alkanes and coconut oil alcohol-caprylate / caprate is up to 70 wt%; and (ii) petrolatum, wherein the petrolatum is present at a concentration of at least 30 wt%. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0069] Vaseline

[0070] Vaseline is a composition of hydrocarbons obtained in semi-solid form from dewaxed paraffin residue oil. Vaseline mainly includes saturated crystalline and liquid hydrocarbons, which mainly have carbon chain lengths of C25 and above.

[0071] Petrolatum is generally a safe and effective topical agent suitable for a wide range of topical applications, including but not limited to moisturizing creams and lotions; makeup; hand and foot creams and lotions; skin protectants; wound care agents; lip balms and lipsticks; salves and liniments; baby care agents; hair care agents. In the pharmaceutical industry, petrolatum is used as a medicinal analgesic cream, ointment and cream. Petrolatum protects injured or exposed skin or mucosal surfaces from harmful irritation and can help provide relief to these surfaces. More specifically, such products can help prevent (or temporarily protect; and optionally, help relieve) abraded, chapped or cracked skin.

[0072] Lip products containing petrolatum in concentrations deemed safe and effective by the FDA in its final Skin Protectant Monograph can claim benefits of temporarily preventing dryness and helping to reduce chapped lips on the exposed surfaces.

[0073] Skin and lip products containing more than 30% petrolatum may also claim to help protect the skin / lips from the drying effects of wind and cold weather.

[0074] Despite the long history of safety and efficacy of petrolatum-based topical formulations, they are known to have certain limitations—they can be greasy and cosmetically inelegant. The application of topical products by the user placing their hands or an inanimate applicator (brush, spatula, swab, sponge, puff) into a container can be unhygienic and can have potentially harmful health consequences. Even if "clean" (e.g., free of exogenous contaminants or disease-carrying organisms), hands can contain microorganisms present in the skin microbiome. Applicators are typically not cleaned between uses and can become colonized by microorganisms.

[0075] There has been and remains a need for a sprayable composition that is cosmetically elegant, non-greasy, and in certain embodiments, applies a safe and effective concentration of at least 30% by weight of petrolatum and other ingredients in a manner that not only protects the skin barrier, but also effectively and safely delivers other functional and / or pharmaceutically active ingredients to the skin. The skin barrier protection delivery system of the present disclosure meets those needs. Therefore, one of the goals of the present disclosure is to increase water retention and improve skin roughness (moisturizing).

[0076] In some embodiments, petrolatum is present in the skin barrier protection system of the present disclosure at a concentration of at least about 30% by weight. In some embodiments, petrolatum is present in the skin barrier protection system of the present disclosure at a concentration range of about 25% to about 30%, about 25% to about 60%, about 30% to about 60%, about 30% to about 55%, about 30% to about 50%, about 30% to about 45%, about 30% to about 40%, about 30% to about 35%, about 35% to about 60%, about 35% to about 55%, about 35% to about 50%, about 35% to about 45%, about 35% to about 40%, about 40% to about 60%, about 40% to about 55%, about 40% to about 50%, about 40% to about 45%, about 45% to about 60%, about 50% to about 60%, about 50% to about 55%, or about 55% to about 60%. In some embodiments, petrolatum is present in a skin barrier protection system of the present disclosure at a concentration of at least about 25%, 30%, 35%, 40%, 45%, 50%, 55% or 60%, or even higher by weight. In some embodiments, petrolatum is present at a concentration of 40 wt%. In some embodiments, petrolatum is present at a concentration of 50 wt%.

[0077] Coconut Alkane and Coco-Caprylate / Caprate

[0078] Coconut alkanes are produced by reducing and hydrogenating a mixture of fatty acids derived from coconut oil. Different carbon chain lengths and distributions of different carbon chain lengths are commercially available, including products from Biosynthis Ltd. (Saint-Cyrsous-Dourdan France), ranging from C5-C14, including C8-C10, C9-C12 and C12-C14, and mixtures of the above substances. Coconut alkanes are described in U.S. pre-grant patent application publications 2012 / 0027702, 2017 / 0143610, 2018 / 0256479, 2019 / 0343753, 2019 / 0343753 and 2021 / 0154110, the disclosure of each of which is incorporated herein in its entirety in relevant part.

[0079] Coco-caprylate / caprate (CAS#95912-86-0) is a mixture of coconut alcohol (a mixture of fatty alcohols derived from coconut oil) with esters of caprylic and capric acids. Non-limiting examples of commercially available coconut-caprylate / caprate esters include LC (BASF Corporation, Florham Park, NJ), Dub 810C (Stearinerie Dubois Fils, Boulogne Billancourt, France) and Lanol TM 2681 (Seppic, Paris, France).

[0080] Mixtures of coconut alkanes and coconut caprylate / caprate are commercially available, including those sold under the trade names 1214 (from Biosynthis) and Vesgesil TM 345 (Global Ingredient Solutions, Irvine, CA) for sale.

[0081] In some embodiments, the mixture of coconut alkanes and coconut caprylate / caprate comprises a ratio of coconut alkanes to coconut caprylate / caprate of about 99:1, about 95:5, about 90:10, about 85:15, about 80:20, about 75:25, about 70:30, about 65:35, about 60:40, about 55:45, about 50:50, about 45:55, about 40:60, about 35:65, about 30:70, about 25:75, about 20:80, about 15:85, about 10:90, about 5:95, about 1:99, or any ratio therebetween. In some embodiments, the compositions of the present disclosure comprise a mixture of coconut alkanes and coconut caprylate / caprate of 90%:10%.

[0082] In some embodiments, the compositions of the present disclosure comprise about 30-70 wt % by weight, e.g., 30%-67%, 30%-65%, 30%-60%, 30%-55%, 30%-50%, 30%-45%, 30%-40%, 30%-35%, 35%-70%, 35%-67%, 35%-65%, 35%-60%, 35%-55%, 35%-50%, 35%-45%. %-45%, 41%-42%, 42%-43%, 43%-44%, 44%-45%, 45%-70%, 45%-67%, 45%-65%, 45%-60%, 45%-55%, or 45%-50% coconut alkanes. In some embodiments, the compositions of the present disclosure comprise coconut alkanes at a concentration of about 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, or 70% by weight based on the total weight of the formulation.

[0083] In some embodiments, the compositions of the present disclosure comprise coco-caprylate / caprate in a concentration range of 3-7% by weight, e.g., 3%-6%, 3%-5.5%, 3%-5%, 3%-4.5%, 3%-4%, 3%-3.5%, 3.5%-7%, 4%-7%, 4.5%-7%, 5%-7%, 5.5%-7%, 6%-7%, 6.5%-7%, 4%-7%, 4%-6.5%, 4%-6%, 4%-5.5%, 4%-5%, 4%-4.5%, based on the total weight of the formulation. In some embodiments, the compositions of the present disclosure comprise coco-caprylate / caprate at a concentration of about 3%, 3.5%, 4%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5%, 5.5%, 6%, 6.5%, or 7% by weight based on the total weight of the formulation.

[0084] In some embodiments, the compositions of the present disclosure comprise (i) about 30%-70% by weight of coconut alkanes, and (ii) about 3%-7% by weight of coconut oil alcohol-caprylate / caprate. In some embodiments, the compositions of the present disclosure comprise (i) about 30%-67% by weight of coconut alkanes, and (ii) about 3%-7% by weight of coconut oil alcohol-caprylate / caprate. In some embodiments, the compositions of the present disclosure comprise (i) about 30%-65% by weight of coconut alkanes, and (ii) about 3%-7% by weight of coconut oil alcohol-caprylate / caprate. In some embodiments, the compositions of the present disclosure comprise about 42%-43% by weight of coconut alkanes and about 4%-5% by weight of coconut oil alcohol-caprylate / caprate. In some embodiments, the compositions of the present disclosure comprise about 46.8% of a mixture of coconut alkanes and coconut caprylate / caprate, wherein coconut alkanes comprise about 90% of the mixture (42.12% by weight of the composition) and coconut caprylate / caprate comprises about 10% of the mixture (4.68% by weight of the composition).

[0085] In some embodiments, the present disclosure relates to a skin barrier protection delivery system comprising or consisting essentially of: (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of two or more, the ratio of coconut alkanes to coconut oil alcohol-caprylate / caprate being about 3:1 to about 9:1; and (b) petrolatum at a concentration of at least about 30%. In some embodiments, petrolatum is present at a concentration of 40 wt%. In some embodiments, petrolatum is present at a concentration of 50 wt%.

[0086] In certain embodiments, the skin barrier protection delivery system comprises or consists essentially of: (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of two or more, coconut alkanes to coconut oil alcohol-caprylate / caprate in a ratio of about 3:1 to about 9:1; and (b) petrolatum at a concentration of at least about 30%; and the ratio of (a) to (b) is about 7:3 to about 1:3. In some embodiments, petrolatum is present at a concentration of 40 wt%. In some embodiments, petrolatum is present at a concentration of 50 wt%.

[0087] In some embodiments, the present disclosure relates to a skin barrier protection delivery system, comprising or consisting essentially of: (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of two or more, coconut alkanes and coconut oil alcohol-caprylate / caprate in a ratio of about 3:1 to about 9:1, and (b) petrolatum at a concentration of at least about 30%; and the ratio of (a) to (b) is about 7:3 to about 1:3, and the skin barrier protection delivery system is sprayable. In some embodiments, petrolatum is present at a concentration of 40wt%. In some embodiments, petrolatum is present at a concentration of 50wt%.

[0088] In some embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of the two, to (b) petrolatum is about 7:3 to about 3:7. In some embodiments, petrolatum is present at a concentration of 25-60wt%. In some embodiments, petrolatum is present at a concentration of 40wt%.

[0089] In some embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of the two, to (b) petrolatum is about 2:1 to about 1:2. In other embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of the two, to (b) petrolatum is about 3:2 to about 2:3. In some embodiments, petrolatum is present in a concentration of 25-60wt%. In some embodiments, petrolatum is present in a concentration of 40wt%. In some embodiments, petrolatum is present in a concentration of 50wt%.

[0090] In some other embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of the two, to (b) petrolatum is about 5:4 to about 4:5, and in some embodiments, about 10:9 to about 9:10, and about 1:1. In some embodiments, the ratio of (a) coconut alkanes and / or coconut oil alcohol-caprylate / caprate, optionally, a mixture of the two, to (b) petrolatum is about 1:1. In some embodiments, petrolatum is present in a concentration of 25-60wt%. In some embodiments, petrolatum is present in a concentration of 40wt%. In some embodiments, petrolatum is present in a concentration of 50wt%.

[0091] In these embodiments, the ratio of (i) coconut alkanes to (ii) coconut caprylate / caprate is from about 3:1 to about 9:1.

[0092] Other excipients

[0093] In some embodiments, the skin barrier protection delivery system of the present disclosure further includes at least one of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid. In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least two of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid. In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least three of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid. In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least four of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid. In some embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

[0094] In some embodiments, the skin barrier protection delivery system of the present disclosure includes plant-based esters or waxes. Plant oils, plant-based esters and waxes, sterols, and esters of plant sterols and fatty acids (e.g., derived from plant seed oils) can be used in cosmetics, personal care products, and dermatological products.

[0095] In some embodiments, the plant-based ester or wax is selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax, and sunflower wax. In some embodiments, the plant-based ester or wax is or comprises a jojoba ester. Jojoba seed oil is a fixed oil pressed or extracted from the seeds of the desert shrub Simmondsia chinensis (Jojoba).

[0096] Macadamia Seed Oil is a fixed oil obtained from the kernel of the macadamia nut.

[0097] Jojoba / Macadamia Seed Oil Esters (CAS#97593-46-9) is a mixture of esters formed by the interesterification of jojoba seed oil and macadamia seed oil.

[0098] In certain embodiments, the skin barrier protection delivery system of the present disclosure includes at least one phytosterol and / or terpene (eg, squalene).

[0099] In some embodiments, the skin barrier protection delivery system of the present disclosure includes terpenes. Terpenes are organic compounds composed of isoprene (a five-carbon building block). In some embodiments, the skin barrier protection delivery system of the present disclosure includes triterpenes (C30), hemiterpenes (C5), monoterpenes (C10), sesquiterpenes (C15), diterpenes (C20), disesquiterpenes (C25), tetraterpenes (C40), or any mixture thereof.

[0100] In some embodiments, the terpene is a triterpene. In some embodiments, the triterpene is squalene. Squalene (CAS#111-02-4) is an unsaturated branched isoprenoid (triterpene) hydrocarbon present in various vegetable oils or obtained by fermentation.

[0101] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one phytosterol. 17 H 28 O; CAS#949109-75-5) is a family of alcohols derived from plant steranes (a tetracyclic hydrocarbon without double bonds). In some embodiments, the hydrogen atom at position 3 of the sterane is replaced by a hydroxyl group.

[0102] In some embodiments, the skin barrier protection delivery system of the present disclosure includes plant sterol esters. In some embodiments, the plant sterol esters include esters derived from plants, for example, seed oils or nut oils. In some embodiments, the seed oils or nut oils are selected from the group consisting of macadamia oil, almond oil, avocado oil, rapeseed oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine nut oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil and walnut oil.

[0103] In some embodiments, the phytosterol ester is phytosteryl macadamia oleate. Phytosteryl macadamia oleate (CAS# 68990-51-2) is an ester of phytosterols with fatty acids from macadamia seed oil.

[0104] In some embodiments, the skin barrier protection delivery system of the present disclosure includes tocopherol. Vitamin E is a fat-soluble substance derived from plants, consisting of a chromanol ring with a C2 side chain. Tocopherol (CAS#10191-41-0) is a form of vitamin E—named α, β, γ, and δ based on the number and position of methyl groups on the chromanol ring. Any form of tocopherol can be used in the composition of the present disclosure.

[0105] In certain embodiments of the skin barrier protection delivery system of the present disclosure, at least one ceramide is included. In certain embodiments of the skin barrier protection delivery system of the present disclosure, at least two ceramides are included. In certain embodiments, the ceramide is one or both of ceramide AP and / or ceramide NP. Ceramide is a group of sphingolipids, comprising derivatives of sphingoid bases linked to various fatty acids with amide bonds. Together with other stratum corneum lipids, ceramide plays a vital role in building and maintaining the barrier function of the skin. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises ceramide AP. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises ceramide NP. Ceramide AP is an N-acylated sphingolipid composed of phytosphingosine with a D-erythro structure linked to α-hydroxy saturated or unsaturated fatty acids. Ceramide NP is an N-acylated sphingolipid composed of phytosphingosine with a D-erythro structure linked to normal saturated or unsaturated fatty acids.

[0106] Many skin conditions and disorders in which the skin barrier function is impaired are characterized by reduced ceramide content. Topical formulations that provide lipids identical to or mimicking those in the skin have been reported to improve skin conditions. See, e.g., Coderch, L., López, O., de la Maza A., Parra J. "Ceramides and skin function" Am. J. Clin. Dermatol. 2003; 4(2): 107-29.

[0107] In some embodiments, the skin barrier protection delivery system of the present disclosure includes triglycerides. In some embodiments, the triglycerides are C18-C36 acid triglycerides. In some embodiments, the triglycerides are C12-18 acid triglycerides.

[0108] In some embodiments, the skin barrier protection delivery system of the present disclosure includes a mixture of jojoba esters, squalene, phytosteryl macadamia oleate, phytosterols, tocopherol, C18-C36 triglycerides and C12-C18 triglycerides, sold under the trade name Sold in combination. Designed to mimic the distribution of skin lipids in "younger skin", (Flora Technologies, Ltd., Chandler, AZ) is composed of jojoba / macadamia esters, squalene, phytosteryl macadamia oleate, phytosterols, and tocopherols. The main components of L22 are jojoba / macadamia esters (about 85%) and squalene (12.5%). The combined concentration of phytosteryl macadamia oleate and phytosterols in L22 is about 2.5%.

[0109] In certain embodiments, the skin barrier protection delivery system of the present disclosure includes at least one ceramide, at least two ceramides, or at least one phytosterol and / or squalene.

[0110] In certain embodiments, the skin barrier protection delivery system of the present disclosure includes at least one ceramide, at least two ceramides, or at least one phytosterol and squalene.

[0111] In certain embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one ceramide, triglyceride, phytosterol, phytosteryl macadamia oleate, squalene, jojoba esters, and tocopherol.

[0112] In certain embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglycerides and C12-18 acid triglycerides. Each embodiment can optionally contain one plant-derived ester or a mixture of plant-derived esters.

[0113] In certain embodiments, the plant-derived esters include jojoba / macadamia seed oil esters and / or phytosteryl macadamia oleate.In certain embodiments, the skin barrier protection delivery system of the present disclosure includes jojoba / macadamia seed oil esters and phytosteryl macadamia oleate.

[0114] Plant-based esters (when present) are included in the skin barrier protection delivery system of the present disclosure (alone or in combination with one or more plant oils or waxes) at a combined concentration of up to about 20 wt%, up to about 15 wt%, up to about 10 wt%, up to about 5 wt%, or up to about 1 wt%. For example, based on the total weight of the formulation, the plant-based esters may be present in an amount of about 0.1-0.15 wt%, about 0.15-0.2 wt%, about 0.2-0.25 wt%, about 0.25-0.3 wt%, about 0.3-0.35 wt%, about 0.35-0.4 wt%, about 0.4-0.45 wt%, about 0.45-0.5 wt%, about 0.5-0.55 wt%, about 0.55-0.6 wt%, about 0.6-0.65 wt%, about 0.65-0.7 wt%, about 0.7-0.8 wt%. 0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt%, about 0.95-1wt%, about 1-1.5wt%, about 1.5-2wt%, about 2-3wt%, about 3-4wt%, about 4-5wt%, about 5-6wt%, about 6-7wt%, about 7-8wt%, about 8-9wt%, about 9-10wt%, about 10-15wt% or about 15-20wt%.

[0115] Terpenes (e.g., squalene), when present, are included in the skin barrier protection delivery system of the present disclosure at a concentration of up to 5 wt%, less than about 4 wt%, less than about 3%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt%. For example, based on the total weight of the formulation, terpenes (e.g., squalene) may be present in an amount of about 0.1-0.15 wt%, about 0.15-0.2 wt%, about 0.2-0.25 wt%, about 0.25-0.3 wt%, about 0.3-0.35 wt%, about 0.35-0.4 wt%, about 0.4-0.45 wt%, about 0.45-0.5 wt%, about 0.5-0.55 wt%, about 0.55-0.6 wt%. %, about 0.6-0.65wt%, about 0.65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt%, about 0.95-1wt%, about 1-1.5wt%, about 1.5-2wt%, about 2-3wt%, about 3-4wt% or about 4-5wt%. In some embodiments, squalene is present in an amount of about 0.37% based on the total weight of the formulation.

[0116] In one embodiment, at least one ceramide (when present) is included in the skin barrier protection delivery system of the present disclosure at a concentration ranging from about 0.01% to about 0.5%. For example, ceramide can be present at a concentration of about 0.01% to about 0.1%, about 0.05wt%-0.4wt%, about 0.05-0.3wt%, about 0.05-0.2wt%, about 0.05-0.1wt%, about 0.05wt%-0.06wt%, about 0.06wt%-0.06wt%, about 0.07wt%-0.08wt%, about 0.08wt%-0.09wt%, about 0.09wt%-0.1wt%.

[0117] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises at least one of a polysaccharide, a gum, a buffer (eg, an acid), and a plant root extract.

[0118] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one polysaccharide. In some embodiments, at least one polysaccharide can be, for example, maltodextrin, cellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid and mixtures thereof. In some embodiments, the polysaccharide is maltodextrin.

[0119] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one gum. In some embodiments, at least one gum can be, for example, selected from the group consisting of guar gum, xanthan gum, pullulan gum, agar gum, carrageenan, gellan gum, gum arabic and tragacanth gum. In some embodiments, the gum is gum arabic.

[0120] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one plant extract. In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one plant root extract. In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one fruit extract. In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one vegetable extract. In some embodiments, at least one plant root extract is selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish and radish. In some embodiments, the plant root extract is a sweet potato root extract. In some embodiments, at least one plant extract is derived from cucumber, garlic, pepper, berry (including raspberry, blackberry, strawberry, elderberry, blueberry, bilberry), asparagus, etc. In some embodiments, the plant extract is a bilberry fruit extract. In some embodiments, the plant extract is a cucumber (Cucumis Sativus) (cucumber) extract. In some embodiments, the plant extract is a garlic (plant garlic) (Allium Sativum) extract. The plant extract may be present in the composition of the present disclosure in the range of 0.01-0.1wt%. In some embodiments, the plant extract is present in an amount of about 0.01-0.9 wt%, about 0.01-0.85 wt%, about 0.01-0.8 wt%, about 0.01-0.75 wt%, about 0.01-0.7 wt%, about 0.01-0.65 wt%, about 0.01-0.6 wt%, about 0.01-0.55 wt%, about 0.01-0.5 wt%, about 0.01-0.45 wt%, about 0.01-0.4 wt%, about 0.01-0.35 wt%, about 0.01- 0.3wt%, about 0.01-0.25wt%, about 0.01-0.2wt%, about 0.01-0.15wt%, about 0.01-0.1wt%, about 0.01-0.02wt%, about 0.02-0.03wt%, about 0.03-0.04wt%, about 0.04-0.05wt%, about 0.0-0.06wt%, about 0.06-0.07wt%, about 0.07-0.08wt%, about 0.08-0.09wt% or about 0.09-0.1wt% exists in a concentration range.

[0121] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one buffer. In some embodiments, the buffer is an acid. In some embodiments, the acid is citric acid. In other embodiments, the acid can be a carboxylic acid. In some embodiments, the acid is selected from the group consisting of: citric acid, acetic acid, succinic acid, lactic acid, maleic acid, fumaric acid, palmitic acid, bile acid, pamoic acid, mucic acid, D-glutamic acid, D-camphoric acid, glutaric acid, phthalic acid, tartaric acid, lauric acid, stearic acid, salicylic acid, sorbic acid, benzoic acid and cinnamic acid, and their salts (e.g., their alkali metal salts or alkaline earth metal salts). In some embodiments, the acid is citric acid / sodium citrate. In some embodiments, the buffer is present at about 0.001-1 wt%, about 0.001-0.5 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.01 wt%, about 0.001-0.005 wt%, about 0.001-0.003 wt%, about 0.001-0.002 wt%, about 0.001-0.003 wt%, about 0.001-0.004 wt%, about 0.001-0.005 wt%, about 0.001-0.006 wt%, about 0.001-0.008 wt%, about 0.001-0.009 wt%, about 0.001-0.010 wt%, about 0.001-0.011 wt%, about 0.001-0.013 wt%, about 0.001-0.014 wt%, about 0.001-0.015 wt%, about 0.001-0.016 wt%, about 0.001-0.017 wt%, about 0.001-0.018 wt%, about 0.001-0 About 0.01-5wt%, about 0.01-1wt%, about 0.1-1wt%, about 0.5-1wt%, about 0.01-0.05wt%, about 0.05-0.1wt%, about 0.1-0.15wt%, about 0.15-0.2wt%, about 0.2-0.25wt%, about 0.25-0.3wt%, about 0.3-0.35wt%, about 0.35-0 .4wt%, or about 0.4-0.45wt%, about 0.45-0.5wt%, about 0.5-0.55wt%, about 0.55-0.6wt%, about 0.6-0.65wt%, about 0.65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0. 9-0.95wt%, about 0.95-1wt%, about 1-1.5wt%, about 1.5-2wt%, about 2-3wt%, about 3-4wt%, about 4-5wt%, about 5-6wt%, about 6-7wt%, about 7-8wt%, about 8-9wt%, about 9-10wt%, about 10-15wt%, about 15-20wt% or about 20-30wt%.

[0122] In some embodiments, the skin barrier protection delivery system of the present disclosure includes at least one of sweet potato root extract, citric acid, gum arabic and maltodextrin. In some embodiments, the skin barrier protection delivery system of the present disclosure includes sweet potato root extract, citric acid, gum arabic and maltodextrin. The combination of sweet potato root extract, citric acid, gum arabic and maltodextrin is commercially sold under the trade name Natpure Xfine Potato SP313.

[0123] In some embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglycerides, C12-18 acid triglycerides, sweet potato root extract, gum arabic, citric acid and maltodextrin.

[0124] In some embodiments, the skin barrier protection delivery system of the present disclosure also includes zinc oxide. In some embodiments, zinc oxide is present in a concentration range of about 1-23wt%, such as about 5-15%, about 8-10wt%, about 10-12wt%, about 12-14wt%, about 10-15wt%, about 15-20wt%, about 20-25wt% or about 25-30wt%. In some embodiments, zinc oxide is present in a concentration of about 10wt%, about 10.5wt%, about 11wt%, about 11.5wt%, about 12wt%, about 12.5wt%, about 13wt%, about 13.5wt%, about 14wt%, about 14.5wt% or about 15wt%.

[0125] In the skin barrier protection delivery system of the present disclosure, the excipients may be used alone or in a cumulative manner at about 0.001-10 wt%, about 0.001-5 wt%, about 0.001-1 wt%, about 0.001-0.5 wt%, about 0.001-0.4 wt%, about 0.001-0.3 wt%, about 0.001-0.25 wt%, about 0.001-0.2 wt%, about 0.001-0.15 wt%, about 0.001 -0.1wt%, about 0.001-0.05wt%, about 0.001-0.04wt%, about 0.001-0.03wt%, about 0.001-0.01wt%, about 0.001-0.025wt%, about 0.001-0.02wt%, about 0.001-0.015wt%, about 0.005-0.01wt%, about 0.01-0.05wt%, about 0.05-0.1wt%, about 0.1-0.15wt%, about 0 .15-0.2wt%, about 0.2-0.25wt%, about 0.25-0.3wt%, about 0.3-0.35wt%, about 0.35-0.4wt% or about 0.4-0.45wt% to about 0.45-0.5wt%, about 0.5-0.55wt%, about 0.55-0.6wt%, about 0.6-0.65wt%, about 0.65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8- Any one of the concentration ranges of 0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt%, about 0.95-1wt%, about 1-1.5wt%, about 1.5-2wt%, about 2-3wt%, about 3-4wt%, about 4-5wt%, about 5-6wt%, about 6-7wt%, about 7-8wt%, about 8-9wt%, about 9-10wt%, about 10-15wt%, about 15-20wt% or about 20-30wt% exists.

[0126] Exemplary compositions

[0127] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) at least 30 wt% of petrolatum; (ii) coconut alkanes in the range of 30-70 wt%; (iii) coconut oil alcohol-caprylate / caprate in the range of 3-7 wt%; (iv) ceramide NP in the range of 0.01-0.1 wt%; (v) ceramide AP in the range of 0.01-0.1 wt%; (vi) jojoba esters in the range of 0.1-1.5 wt%; (vii) squalene in the range of 0.1-1 wt%; (viii) phytosterol macadamia oleate in the range of 0.01-0.1 wt% Esters; (ix) phytosterols in the range of 0.005-0.1 wt%; (x) tocopherols in the range of 0.001-0.1 wt%; (xi) C18-36 acid triglycerides in the range of 0.5-5 wt%; (xii) C12-18 acid triglycerides in the range of 0.1-1 wt%; (xiii) sweet potato root extract in the range of 0.01-0.1 wt%; (xiv) citric acid in the range of 0.001-0.01 wt%; (xv) gum arabic in the range of 0.001-0.1 wt%; and (xvi) maltodextrin in the range of 0.001-0.1 wt%. In some embodiments, the delivery system is a sprayable formulation.

[0128] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) at least 30 wt% of petrolatum; (ii) coconut alkanes in the range of 30-67 wt%; (iii) coconut oil alcohol-caprylate / caprate in the range of 3-7 wt%; (iv) ceramide NP in the range of 0.01-0.1 wt%; (v) ceramide AP in the range of 0.01-0.1 wt%; (vi) jojoba esters in the range of 0.1-1.5 wt%; (vii) squalene in the range of 0.1-1 wt%; (viii) phytosterol macadamia oleate in the range of 0.01-0.1 wt% Esters; (ix) phytosterols in the range of 0.005-0.1 wt%; (x) tocopherols in the range of 0.001-0.1 wt%; (xi) C18-36 acid triglycerides in the range of 0.5-5 wt%; (xii) C12-18 acid triglycerides in the range of 0.1-1 wt%; (xiii) sweet potato root extract in the range of 0.01-0.1 wt%; (xiv) citric acid in the range of 0.001-0.01 wt%; (xv) gum arabic in the range of 0.001-0.1 wt%; and (xvi) maltodextrin in the range of 0.001-0.1 wt%. In some embodiments, the delivery system is a sprayable formulation.

[0129] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) at least 30 wt% of petrolatum; (ii) coconut alkanes in the range of 30-65 wt%; (iii) coconut oil alcohol-caprylate / caprate in the range of 3-7 wt%; (iv) ceramide NP in the range of 0.01-0.1 wt%; (v) ceramide AP in the range of 0.01-0.1 wt%; (vi) jojoba esters in the range of 0.1-1.5 wt%; (vii) squalene in the range of 0.1-1 wt%; (viii) phytosterol macadamia oleate in the range of 0.01-0.1 wt% Esters; (ix) phytosterols in the range of 0.005-0.1 wt%; (x) tocopherols in the range of 0.001-0.1 wt%; (xi) C18-36 acid triglycerides in the range of 0.5-5 wt%; (xii) C12-18 acid triglycerides in the range of 0.1-1 wt%; (xiii) sweet potato root extract in the range of 0.01-0.1 wt%; (xiv) citric acid in the range of 0.001-0.01 wt%; (xv) gum arabic in the range of 0.001-0.1 wt%; and (xvi) maltodextrin in the range of 0.001-0.1 wt%. In some embodiments, the delivery system is a sprayable formulation.

[0130] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) 50 wt% of petrolatum; (ii) 42-43 wt% of coconut alkanes; (iii) 4-5 wt% of coconut oil alcohol-caprylate / caprate; (iv) 0.05 wt% of ceramide NP; (v) 0.05 wt% of ceramide AP; (vi) 0.75 wt% of jojoba esters; (vii) 0.3-0.4 wt% of squalene; (viii) 0.05-0.06 wt% of phytosterol macadamia oleate; ( (ix) 0.01-0.02wt% phytosterols; (x) 0.0045wt% tocopherol; (xi) 1-2wt% C18-36 acid triglycerides; (xii) 0.4-0.5wt% C12-18 acid triglycerides; (xiii) 0.03-0.04wt% sweet potato root extract; (xiv) 0.003-0.004wt% citric acid; (xv) 0.03-0.04wt% gum arabic; and (xvi) 0.03-0.04wt% maltodextrin.

[0131] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) 25-60 wt % of petrolatum; (ii) 10-25 wt % of zinc oxide (ZnO); and (iii) 30-60 wt % of isohexadecane.

[0132] In some embodiments, the skin barrier protection delivery system of the present disclosure includes (i) 40 wt % of petrolatum; (ii) 15 wt % of zinc oxide (ZnO); and (iii) 45 wt % of isohexadecane.

[0133] In some embodiments, other long chain alkanes can be used to replace coconut alkanes to dissolve vaseline. In some embodiments, the long chain alkanes can have greater than 10 carbons, such as 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 carbon atoms, or even longer carbon lengths. In some embodiments, the long chain alkanes comprise from 10 to 40 carbon atoms, such as 10-25, 10-20, 10-15, 20-30, 25-30, 30-35, 35-40, etc.

[0134] In some embodiments, esters of long-chain alcohols and carboxylic acids (e.g., fatty acids) can be used to replace coconut oil alcohol-caprylate / caprate to dissolve vaseline. For example, these esters can include long-chain alcohols having greater than 10 carbons, such as 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 carbon atoms, or even longer carbon lengths. In some embodiments, long-chain alcohols include 10 to 40 carbon atoms, such as 10-25, 10-20, 10-15, 20-30, 25-30, 30-35, 35-40, etc. Carboxylic acids can include from about 10 to about 30 carbon atoms. Suitable carboxylic acids are fatty acids, including saturated fatty acids and unsaturated fatty acids. Non-limiting examples of fatty acids include oleic acid, linoleic acid, palmitic acid, stearic acid, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). Unsaturated 18-carbon fatty acids with double bonds at C9-C10 (oleic acid); double bonds at C9-C10 and C12-C13 (linoleic acid); and double bonds at C9-C10, C12-C13, and C15-C16 (linolenic acid) may also be used.

[0135] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising (i) a mixture of long chain alkanes with a carbon length greater than 10 carbons, in a concentration range of 30-70 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable.

[0136] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising (i) a mixture of long chain alkanes with a carbon length greater than 10 carbons, in a concentration range of 30-70 wt%, and esters of long chain alcohols in a concentration of 3-7 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable.

[0137] Active ingredients

[0138] Various functional ingredients, including natural ingredients, ingredients including those of plant and algae origin, and active pharmaceutical ingredients can be mixed in the skin barrier protection delivery system of the present disclosure.

[0139] The "active ingredients" may be mixed in (i.e., contained in) the skin barrier protection delivery system of the present disclosure in a concentration range of from about 0.001% to about 20%, from about 0.005% to about 10% (by weight), from about 0.01% to about 5% (by weight), or from about 0.1% to about 2.0%, and include: agents (steroidal and nonsteroidal) for treating inflammatory skin diseases (including but not limited to acne, eczema, psoriasis, rosacea, and inflammatory skin diseases caused by radiation exposure); antimicrobial and antifungal active substances; antipruritic agents; local anesthetics; sunscreens; emollients and skin soothing agents; humectants and moisturizers, including hyaluronic acid; skin barrier protectants (such as the U.S. FDA OTC drug final monograph (FDA OTC Final Monograph); lipids, including oils and butters of vegetable origin; antioxidants and agents that reduce the appearance of fine lines and wrinkles, including vitamins, proteins and peptides; skin bleaching and whitening agents; agents that aid in wound healing / wound beauty; agents that reduce inflammation (including erythema) and / or edema; active pharmaceutical ingredients (over-the-counter or prescription) that are used to prevent or treat (or aid in the prevention or treatment of) pathological conditions (e.g., diseases), including but not limited to ulcerative skin.

[0140] One non-limiting "active" ingredient included in the skin barrier protection delivery system of the present disclosure is a sweet potato root extract, which, when used according to the present disclosure, has been shown to reduce edema in the extremities. The sweet potato root extract may be present in the composition of the present disclosure in a range of 0.01-0.1 wt%. In some embodiments, the sweet potato root extract is present in an amount of about 0.01-0.9 wt%, about 0.01-0.85 wt%, about 0.01-0.8 wt%, about 0.01-0.75 wt%, about 0.01-0.7 wt%, about 0.01-0.65 wt%, about 0.01-0.6 wt%, about 0.01-0.55 wt%, about 0.01-0.5 wt%, about 0.01-0.45 wt%, about 0.01-0.4 wt%, about 0.01-0.35 wt%, about 0.01- 0.3wt%, about 0.01-0.25wt%, about 0.01-0.2wt%, about 0.01-0.15wt%, about 0.01-0.1wt%, about 0.01-0.02wt%, about 0.02-0.03wt%, about 0.03-0.04wt%, about 0.04-0.05wt%, about 0.05-0.06wt%, about 0.06-0.07wt%, about 0.07-0.08wt%, about 0.08-0.09wt% or about 0.09-0.1wt% concentration range exists. In some embodiments, the skin barrier protection delivery system of the present disclosure is applied by spraying or atomization. In one embodiment, the skin barrier protection delivery system of the present disclosure has a viscosity (TE@10) of from about 500cps to 10,000cps. In one embodiment, the skin barrier protection delivery system of the present disclosure has a viscosity (TE@10) of from about 1,000 cps to 5,000 cps.

[0141] In some embodiments, it is unexpectedly found that the skin barrier protection delivery system of the present disclosure can be formulated into a gel with sprayable properties. In some embodiments, the skin barrier protection delivery system of the present disclosure can be formulated into a liquid or gel composition with sprayable properties. It has been found that the composition containing vaseline produces a sprayable gel mixture by, for example, an atomizer (a fine sprayer generally used to produce a fragrant fine mist). In some embodiments, pressure (i.e., an aerosol or a bag on a valve) is not required to spray the gel.

[0142] In some embodiments, the present disclosure provides a pharmaceutical composition in the form of a sprayable gel, comprising the skin barrier protection delivery system of the present disclosure. In some embodiments, the composition does not contain a propellant, an aerosol, or a bag-on-valve.

[0143] In some embodiments, the compositions of the present disclosure do not contain flammable components. In some embodiments, the compositions of the present disclosure do not contain flammable solubilizing agents. In some embodiments, the compositions of the present disclosure do not contain alcohol.

[0144] In some embodiments, the present disclosure provides a device comprising a skin barrier protection delivery system of the present disclosure. In some embodiments, the present disclosure provides a device comprising a pharmaceutical composition, which comprises a skin barrier protection delivery system of the present disclosure. In some embodiments, the device does not include a propellant. In some embodiments, the device does not include an aerosol. In some embodiments, the device does not include a bag on a valve. In some embodiments, the device is in the form of a nebulizer pump. In some embodiments, the device is a dip tube nebulizer pump.

[0145] Devices that can be used for spraying or atomization include pump sprayers, trigger sprayers, nebulizers, aerosol containers (pressurized with propellants, such as non-fluorocarbon propellants, including valve bag dispensers). In some embodiments, the spray composition of the present disclosure can be applied directly to the skin of the subject using a device. The device can be, for example, a metered atomizing spray pump, such as a single, double dose, or multi-purpose spray device. In some embodiments, the device does not contain a propellant.

[0146] The numbers used in describing quantities of ingredients are to be understood as modified in all instances by the term "about".

[0147] Unless otherwise indicated, percentages are understood to be based on the total weight of the skin barrier protection delivery system.

[0148] Numerical ranges are intended to include combinations of numbers within the recited ranges and sub-ranges between given ranges. For example, a range of 1-5 includes 1, 2, 3, 4, and 5, as well as sub-ranges such as 2-5, 3-5, 2-3, 2-4, 1-4, etc.

[0149] "At least one" means one or more and also includes single components as well as mixtures / combinations.

[0150] The disclosed compositions may also be used as a basis for the delivery of other therapeutic agents and, when so used, will enhance the clinical response to these agents.

[0151] Examples of these other therapeutic agents are:

[0152] (1) anti-inflammatory agents, examples of which are corticosteroids, colchicine, sulfasalazine and sulfones;

[0153] (2) antibiotics, examples of which are quinolones, macrolides, penicillins, cephalosporins, sulfonamides and tetracyclines;

[0154] (3) antiviral agents, examples of which are acyclovir, iodoxuridine, zidovudine, dideoxyinosine (ddI), vidarabine and trifluridine;

[0155] (4) antifungal agents, examples of which are ketoconazole, econazole, griseofulvin, cicloprix and naftidine;

[0156] (5) antihistamines, examples of which are diphenhydramine, astemizole, hydroxyzine, doxepin, amitriptyline, cyproheptadine and sodium cromoglycate;

[0157] (6) Antipruritic agents, examples of which are camphor, menthol, phenol, benzocaine, benzyl alcohol, salicylic acid, dyclonine and pramoxine;

[0158] (7) antitumor agents, examples of which are methotrexate, piroxetine, cisplatin, 5-fluorouracil, bleomycin, carmustine, hydroxyurea, azathioprine and nitrogen mustard;

[0159] (8) Carboxylic acid analogs, examples of which are monolaurin, azelaic acid and dodecanedioic acid;

[0160] (9) natural and synthetic vitamins and analogs, examples of which are vitamin D, calcipitriol, 1,25-dihydroxycholecalciferol, retinol, retinyl palmitate, retinyl ascorbate, isotretinoin, etretinate and tretinoin; and

[0161] (10) Artemisinin analogs, examples of which are artesunate, arteether, artemether, dihydroartemisinin and artelenic acid.

[0162] The concentrations of these therapeutic components can vary. A typical range is from about 0.01% to about 10%. The most appropriate concentration will depend on the clinical indication and will be apparent to those skilled in the art.

[0163] Pharmaceutical preparations

[0164] Other cosmetic and / or pharmaceutical agents or excipients may be provided in the formulations of the present disclosure, provided that they are non-toxic and physiologically acceptable and suitable for use in combination with the therapeutically effective amount of the active ingredient provided in the formulation.

[0165] For example, the claimed preparation of the present disclosure may include chemically compatible pharmaceutically acceptable carriers and excipients, such as water and / or alcohol. The preparation may also include an emollient, such as vaseline, zinc oxide, paraffin, mineral oil, glycerine, beeswax, olive oil, coconut oil, jojoba oil, lanolin, cocoa butter, butyl stearate, stearic acid, diethylene glycol laurate, 2-ethylhexanol, almond oil, aloe vera gel, batana oil, caprylic / capric triglyceride, caprylyl-caprylate / caprate, hexadecyl palmitate, chia seed oil, coconut oil caprylate, collodion, dhupe butter, dicaprylyl carbonate, dihydroxyacetone, dimethicone, myristate, shea butter, vegetable oil, fatty acid, fatty alcohol, triglyceride, benzoate, palmitate, squalene and ceramide and their derivatives, compositions and mixtures. The composition can include skin conditioning agents such as butanol, cholesterol, lanolin, fatty acid esters, fatty acid ethers, cetyl acetate, silicone, vegetable oils, panthenol, panthenol triacetate, vitamin B, vitamin C, vitamin D, vitamin E, vitamin D, keratin, lysine, arginine, hydrolyzed wheat protein, hydrolyzed silk protein, colloidal oatmeal, zinc, coal tar, hydrocortisone, sulfides, emollients, and derivatives, combinations and mixtures thereof.

[0166] The formulation may include a pH adjuster such as alpha-hydroxy acids, butylated hydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA), triethanolamine (TEA), cosmetically acceptable salts, glycerin, propylene glycol, and derivatives, combinations and mixtures thereof.

[0167] Other acceptable ingredients include humectants such as glycerin, propylene glycol, sorbitol, hexylene glycol, butylene glycol, urea, alpha-hydroxy acids, polyols, sorbital, hydroxypropyl sorbitol, hexylene glycol, 1,3-dibutylene glycol, 1,2,6-hexanetriol, ethoxylated glycerol, propoxylated glycerol, and their derivatives, compositions and mixtures may be included herein. Pharmaceutically acceptable buffers such as citric acid, sodium citrate, their derivatives, compositions and mixtures are also useful beneficial ingredients.

[0168] Other components that can be included are viscosity modifiers, such as salt, carbomer gelling agent, gum derivatives and their derivatives, compositions and mixtures. Preservatives, such as methylparaben, ethylparaben, butylparaben, formaldehyde, DMDM ​​hydantoin, leucidal liquid, propylparaben, phenoxyethanol and their derivatives, compositions and mixtures are also useful when used in small quantities. The preparation of the present invention can include emulsifiers, such as polysorbate 80, glyceryl distearate, POE (2) stearyl ether, POE10 stearyl ether, ceteareth 20, stearyl alcohol, ceteareth 20, cetearyl alcohol, lecithin and their derivatives, compositions and mixtures. For example, the preparation of the present invention can include chelating agents, such as ethylenediaminetetraacetic acid (EDTA), dihydroxyethylglycine, tartaric acid and their derivatives, compositions and mixtures. These formulations may also include thickeners such as salts, silica, bentonite, magnesium aluminum silicate, carbomer, gums, xanthan gum, gelatin, cetyl alcohol, stearyl alcohol, carnauba wax, stearic acid, polyacrylamide, C13-C14 isoparaffin, laureth, and derivatives, combinations and mixtures thereof.

[0169] Other optional ingredients of the formulations of the present disclosure include antioxidants such as green tea extract, ascorbyl palmitate, tocopheryl acetate, BHT, BHA, alpha-lipoic acid, beta-glucan, coenzyme Q10, grape seed extract, green tea, soy sterols, superoxide dismutase, vitamin C (ascorbyl palmitate and magnesium ascorbyl palmitate) and vitamin E (alpha-tocopherol, tocotrienols, tocopheryl acetate), pomegranate, curcumin, turmeric, butylated hydroxyanisole (BHA), phenylnaphthylamine, hydroquinone, propyl gallate, melatonin, nordihydroquiaretic acid, and derivatives, combinations and mixtures thereof.

[0170] The formulations of the present disclosure may also include anti-aging agents, such as agents for treating wrinkles or preventing their development. Anti-aging, anti-wrinkle, anti-skin atrophy and skin repair active substances can effectively replenish or restore the epidermis. These ingredients generally provide desirable skin care benefits by promoting or maintaining the natural desquamation process. Examples of anti-wrinkle and anti-skin atrophy active substances include those selected from one or more of the following lists: alpha-lipoic acid, lycopene, ergothioneine, resveratrol, grape seed extract, cis-urocaninic acid (see U.S. Pat. No. 5,620,680), compositions containing farnesol and / or bisabolol (see PCT Publication No. WO 20040664). 00 / 62744), 2-amino-1,3-alkanediol, including but not limited to 2-amino-1,3-octadecanediol, 2-N-acetylamino-1,3-octadecanediol, 2-N-octanoylamino-1,3-octadecanediol, 2-N-(2-hydroxyhexadecanoyl)amino-1,3-octadecanediol, 2-N-(2-hydroxydocosanoyl)amino-1,3-octadecanediol, 2-amino-1,3,4-octadecanetriol, 2-N-(2-hydroxyhexadecanoyl)amino-1,3,4-octadecanetriol, 2-N-hexanoylamino-1,3-octadecanediol, 2-N-octanoylamino -1,3,4-octadecanetriol (see U.S. Patent Publication No. 2002 / 0006420 to Philippe et al.), ubiquinone and plastoquinone (coenzyme Qn), in particular coenzyme Q9 and Q10, prasterone, DHEA, dehydroepiandrosterone, containing selected from sterols (such as animal sterols including cholesterol, dihydrocholesterol, 7-dehydrocholesterol, lanosterol, dihydrolanosterol, spongosterol and starfish sterol; plant sterols including ergosterol, sitosterol, stigmasterol, fucosterol, campesterol and campesterol;Preparations of one or more compounds of the group consisting of mycosterol (including ergosterol, mycosterol and zymosterol) and their biochemical precursors (such as mevalonate, farnesol and squalane) in combination with one or more compounds including ubiquinone and its derivatives and plastoquinone and its derivatives (see U.S. Pat. No. 6,261,575), Brazil nut extract, betulinic acid, biotin, blackberry bark extract, blackberry lily extract, black cohosh extract, blue cohosh extract, butyryl betulinic acid, carboxymethyl 1,3-β-glucan, chalcones, chaste tree (chaste tree extract, clover extract, coumestrol, daidzein, angelica extract, darutoside, debromomyrcenol, 1-decanoyl-glycerophosphate, dehydrodicreosol, dehydrodihydroeugenol, dehydroepiandrosterone, dehydroepiandrosterone sulfate, dianethole, diosgenin, dodecanedioic acid, ergosterol, fennel extract, fenugreek seed extract, formononetin, forsythia fruit extract, genistein, genistein, genistein acid, gentiool, ginkgo extract, ginseng extract, ginsenosides, 25-hydroxycholesterol, 7-hydroxysterol, hydroxyethyl isostearyloxyisopropanolamine, hydroxytetramethylpiperidinyloxy, hypotaurine, ibukijakou extract, isoflavones, isoflavone SG10 (available from Barnet Products), kinetin, kohki extract, lectin, lichochalcone LF15 (available from Maruzen), glycyrrhizin extract, lignans, luminosterols, lupene, luteolin, lysophosphatidic acid, naringenin, neotigogenin, o-demethylangiotensin, oat beta-glucan, oleanolic acid, placenta extract, pratensein, pregnenolone, pregnenolone acetate, pregnenolone succinate, soybean extract, spleen extract, tachysterol, sisal sapogenin, vitex extract, yam extract, yam sapogenin, zeatin, hyaluronic acid. ;

[0171] The formulations of the present disclosure may also include one or more anti-acne agents selected from the list consisting of: phenoxyethanol, phenoxypropanol, phenoxyisopropanol, ethyl acetate, sebostats such as flavonoids and bioflavonoids; bile salts such as scymnol sulfate; sulfate and its derivatives, deoxycholate and cholate; allantoin; aloe extract; barberry extract; bearberry extract; Belamcanda chinensis; berberine; BIODERMINE (available from Sederma); bioflavonoids; bisabolol; carrot extract; cinnamon oil; clove extract; citral; citronellal; cucumber extract; ethylhexyl monoglycerol ether; ethyl 2-hydroxyundecanoate; farnesol; farnesol acetate; geranoil; glabridin; glyceryl monocaprate; grapefruit seed extract; gugulipid; hesperidin; hinokitiol; hops extract; hydrogenated rosin; lemongrass oil; linoleic acid; LIPACIDE C8CO (available from Seppic); mukurossi; neem seed oil; panthenol; 1-pentadecanol; peony extract; peppermint extract; phelladendron extract; phloretin; PHLOROGINE (available from Secma); quercetin; red sandalwood extract; rosemary extract; rutin; sage extract; skull cap extract; siber hegner extract; saxifrage extract; sophora flavescens extract (available from Maruzen); sunder vati extract; tea tree oil; thyme extract; trehalose 6-undecenoate; 3-tridecen-2-ol; triclosan; white thyme oil; willow bark extract; wogonin; ylang ylang ylang); zinc glycerate; zinc linoleate; zinc oxide; zinc pyrithione; zinc sulfate; urea; triclosan, phenoxyethanol and phenoxypropanol, ethyl acetate, chlorhexidine and its derivatives, such as chlorhexidine gluconate; sebum regulating agents, such as flavonoids, prasterone and antimicrobial agents of the preservative type and antibacterial agents of the disinfectant type, such as chlorxylenol, chloroxylenol, octowynol and nonoxynol ether (see Martindale's Pharmacopoeia 29th Edition), urea, allantoin, povidone iodine and phenol.

[0172] Lipstick compositions may contain behenic acid or acexaminc acid, as well as antimicrobial agents in the form of preservatives and antibacterial agents in the form of disinfectants, such as parachlorometaxylenol, chloroxylenol, octylphenol polyethers and nonoxynol ethers (see Martindale's Pharmacopoeia 29th Edition), urea, allantoin, povidone iodine and phenol, menthol, camphor, triclosan, phenoxyethanol, phenoxypropanol, ethyl acetate, chlorhexidine and its derivatives, such as chlorhexidine gluconate.

[0173] The formulations of the present disclosure may also include a skin conditioning agent, such as an agent that can make the skin smooth or soft, selected from one or more of the list consisting of: aloe vera extract, Biocare SA (available from Amerchol); egg white; Flexan 130 (available from National Starch); Gatuline Lifting (available from Gattefosse); Pentacare HP (available from Pentapharm); Vegeseryl (available from Laboratories Serobioloques), candelilla wax, alpha-bisabolol, aloe vera, Manjistha (extracted from the genus Rubia, especially Rubia cordifolia) and Guggal (extracted from the genus Commiphora, especially Commiphora Mukul).

[0174] The formulations of the present disclosure may also include skin barrier repair ingredients that can help repair and replenish the natural moisture barrier function of the epidermis. Non-limiting examples of skin barrier repair actives include Alpha Lipid (available from LucasMeyer); biotin; biotin esters; brassicasterol; caffeine; campesterol; rapeseed-derived sterols; Cennamides (available from Ennagram); Ceramax (available from Alban Muller); CERAMAX (available from Quest in Ashford, UK); CERAMIDE 2 and CERAMIDE HO3 TM(both available from Sederma); CERAMIDE II (available from Quest); CERAMIDE III and IIIB (both available from Cosmoferm in Delft, the Netherlands); CERAMIDE LS 3773 (available from Laboratories Serobiologiques); CERAMINOL (available from Inocosm); Cerasol and Cephalip (both available from Pentapharm); cholesterol; cholesterol hydroxystearate; cholesterol isostearate; 7-dehydrocholesterol; DERMATEIN BRC and DERMATEIN GSL (both available from Hormel); ELDEW CL 301 and ELDEW PS203 (both available from Ajinomoto); Fitobroside (available from Pentapharm); Galactocerebroside; Generol, 122 (available from Henkel); Glycerylserineamide; Hydroxyethylisostearoylisopropanolamine; Lanolin; Lanolin alcohol; Lanosterol; Lauric acid N-lauryl glucamide; Lipoic acid; N-acetylcysteine; N-acetyl-L-serine; N-methyl-L-serine; Net Sterol-ISO (available from Barnet Products); Palmitic acid; Panthenol; Panthetine; PHYTOSPHINGOSINE (available from Gist Brocades, King of Prussia, Pennsylvania); PSENDOFILAGGRIN (available from Brooks Industries, South Plainfield, New Jersey); QUESTAMIDE H (available from Quest); serine; stigmasterol; sitosterol; soy-derived sterols; sphingosine; sphingomyelinase; S-lactoylglutathione; stearic acid; Structurine (available from Silah); SUPER STEROL ESTERS (available from Croda); lipoic acid; THSC CERAMIDE OIL (available from Campo Research); trimethylglycine; tocopheryl nicotinate; vitamin D3; and Y2 (available from Ocean Pharmaceutical).

[0175] The formulations of the present disclosure may also include sebum stimulants, which can increase the production of sebum in the sebaceous glands. These skin care actives are particularly useful for postmenopausal women who are sebum deficient. Examples of sebum stimulating actives include bryonolic acid, completech MBAC-DS, dehydroepiandrosterone (also known as DHEA), orizanol, and mixtures thereof.

[0176] The formulations of the present disclosure may also include sebum inhibitors, which can reduce the production of sebum in the sebaceous glands. Examples of sebum inhibitory active substances include aluminum hydroxychloride, ASEBIOL (available from Laboratories Serobiologiques), BIODERMINE (available from Sederma), cucumber extract, gugulipiu, Lichochalcone LR15 (available from Maruzen), phloretin, PHLOROGINE (available from Secma), S-carboxymethylcysteine, sepicontrol AS, zincidone (UC1B) and mixtures thereof.

[0177] The formulations of the present disclosure may also include a humectant selected from the group consisting of glycerin, propylene glycol, dipropylene glycol, butylene glycol, sorbitol, honey and honey derivatives such as honey quaternary ammonium salts, urea and urea derivatives such as hydroxyethyl urea, ammonium lactate, sodium lactate, potassium lactate, pyroglutamic acid and its salts, sodium malate, polydextrose, triacetin, mannitol, oxidized polyethylene, isomalt, maltitol and maltitol syrup, lactitol, xylitol, erythritol, and combinations thereof.

[0178] The preparation of the present disclosure may also include a pharmaceutically acceptable carrier, which may be any toxicologically and pharmaceutically acceptable cosmetic carrier. Typical pharmaceutically acceptable carriers that can be used for the compositions of the present disclosure include water, ethanol, acetone, isopropanol, stearyl alcohol, freon, polyvinyl pyrrolidone, propylene glycol, polyethylene glycol, fragrances, gel-generating substances, mineral oil, stearic acid, spermaceti, sorbitol, monooleate, polysorbate, "Tween", sorbitol, methylcellulose, petrolatum, mineral oil (petrolatum oil), which may be any petroleum-based product; modified or unmodified vegetable oils, such as peanut oil, wheat germ oil, linseed oil, jojoba oil, almond oil, walnut oil , palm oil, pistachio oil, sesame oil, rapeseed oil, juniper oil, corn germ oil, peach kernel oil, pine oil, castor oil, soybean oil, safflower oil, coconut oil, hazelnut oil, grape seed oil, avocado oil, soybean oil, sweet almond oil, crabapple oil, castor oil, olive oil, sunflower oil, or animal oil, such as whale oil, seal oil, herring oil, halibut liver oil, cod liver oil, codfish oil, tuna oil, tortoise fat, horse hoof oil, sheep hoof oil, mink oil, otter oil, woodchuck oil, etc.; synthetic oils, such as silicone oils such as dimethyl polysiloxane; alkyl groups of fatty acids and alkenyl esters, such as isopropyl myristic acid, palmitic acid and stearic acid and fatty esters solid at room temperature; waxes, such as lanolin wax, candelilla wax, spermaceti, cocoa butter, shea butter, silicone wax, hydrogenated oils solid at room temperature, sucrose glycerides, oleates, myristates, linoleates, stearates, paraffin, beeswax, carnauba wax, ozokerite, candelilla wax, microcrystalline wax; fatty alcohols, such as lauryl alcohol, cetyl alcohol, myristyl alcohol, stearyl alcohol, palmityl alcohol and oleyl alcohol; polyoxyethylated fatty alcohols; and wax esters, lanolin and its derivatives, perhydrosqualene and saturated esters, ethyl palmitate, isopropyl palmitate, alkyl myristates such as isopropyl myristate, butyl myristate and decyl myristate, hexyl stearate, triglycerides, caprylic and capric triglycerides, castor oil cetyl, stearyl caprylate (Purcellin oil), fatty acids, polyols, polyether derivatives, fatty acid monoglycerides, polyethylene glycol, propylene glycol, alkyl ethoxy ether sulfonates, alkyl ammonium sulfates, fatty acid soaps and hydrogenated polyisobutene, and mixtures of waxes and oils.

[0179] The formulation of the present disclosure may also include a solvent. In some embodiments, the solvent is selected from the group consisting of water, ethanol, isopropanol, water, dimethyl ether, diethyl ether, butane, propane, isobutylene, 1,1-difluoroethane, 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,3,3,3-hexafluoropropane, ethyl acetate, acetone, isoamyl acetate, denatured alcohol, methanol, propanol, isobutylene, pentane, hexane, chlorobutanol, turpentine, cyclopentasiloxane, cyclomethicone, methyl ethyl ketone, and combinations thereof. In other embodiments, the solvent is selected from the group consisting of 1,2,6-Hexanetriol, Alkyl Triol, Alkyl Diol, Acetyl Monoglyceride, Tocopherol, Alkyl Dioxolane, Propylene Glycol, Anise Oil, Apricot Oil, Dimethyl Isosorbide, Alkyl Glucoside, Benzyl Alcohol, Beeswax, Benzyl Benzoate, Butylene Glycol, Caprylic / Capric Triglyceride, Caramel, Cinnamon Oil, Castor Oil, Cinnamal, Cinnamon Oil, Clove Oil, Coconut Oil, Cocoa Butter, Coco Glycerides, Coriander Oil, Corn Oil, Coriander Oil, Corn Syrup, Cottonseed Oil, Cresol, Cyclomethicone Oil, diacetin, diacetylated monoglycerides, diethanolamine, diethylene glycol monoethyl ether, diglycerides, ethylene glycol, eucalyptus oil, fat, fatty alcohol, flavor, liquid sugar, ginger extract, glycerin, high fructose corn syrup, hydrogenated castor oil, IP palmitate, lemon oil, lime oil, limonene, milk, monoacetin, monoglycerides, nutmeg oil, octyldodecanol, olive alcohol, orange oil, palm oil, peanut oil, PEG vegetable oil, peppermint oil, petrolatum, phenol, pine needles Oil, polypropylene glycol, sesame oil, spearmint oil, soybean oil, vegetable oil, vegetable shortening, vinyl acetate, wax, 2-(2-octadecyloxy)ethoxy)ethanol, benzyl benzoate, butylated hydroxyanisole, candelilla wax, carnauba wax, ceteareth-20, cetyl alcohol, polyglycerol, dipolyhydroxystearate, PEG-7 hydrogenated castor oil, diethyl phthalate, diethyl sebacate, dimethicone, dimethyl phthalate, PEG fatty acid esters, PEG-stearate, PEG-oleate, PEG laurate, PEG fatty acid diester, PEG-dioleate, PEG-distearate, PEG-castor oil, glyceryl behenate, PEG glyceryl fatty acid esters, PEG glyceryl laurate, PEG glyceryl stearate, PEG glyceryl oleate, hexyl glycerin, lanolin, lauryl diethanolamide, lauryl lactylate, lauryl sulfate, methylene diphosphonic acid (medronic acid), methacrylic acid, polysterol extract, myristyl alcohol, neutral oil, PEG-octylphenyl ether, PEG-alkyl ether, PEG-cetyl ether, PEG-stearyl ether, PEG-sorbitan fatty acid esters, PEG-sorbitan diisostearate, PEG-sorbitan monostearate, propylene glycol fatty acid esters, propylene glycol stearate, propylene glycol, caprylate / caprate, sodium pyrrolidonecarboxylate, sorbitol, squalene, stearic acid (stear-o-wet), triglycerides, alkylaryl polyether alcohols, polyoxyethylene derivatives of sorbitan ethers, saturated polyethylene glycol C8-C10 glycerides, N-methylpyrrolidone, honey, polyoxyethylene glycerides, dimethyl sulfoxide, azone and related compounds, dimethylformamide, N-methylformamide, fatty acid esters, fatty alcohol ethers, alkylamides (N,N-dimethyl alkylamide), N-methylpyrrolidone related compounds, ethyl oleate, polyglycerolated fatty acids, monoolein, monomyristic glyceryl, fatty acid glycerides, serine, PPG-3 benzyl ether myristate, Di-PPG-2 myristyl alcohol ether 10-adipate, honey quaternary ammonium salt, sodium pyroglutamate, Abyssinica oil, dimethicone, macadamia oil, limnanthes alba seed oil, cetearyl alcohol, PEG-50 shea butter, shea butter, aloe juice, phenyl trimethicone, hydrolyzed wheat protein and their combinations. ,

[0180] Based on the total weight of the formulation, the solvent (when present) can be present in an amount of about 0.01-25 wt%, 0.01-20 wt%, 0.01-15 wt%, 0.01-10 wt%, about 0.01-5 wt%, about 0.01-1 wt%, 0.1-25 wt%, 0.1-20 wt%, 0.1-15 wt%, 0.1-10 wt%, about 0.1-5 wt%, about 0.1-1 wt%, about 0.5-1 wt%, about 0.01-0.05 wt%, about 0.05-0.1 wt%, about 0.1-0.15 wt%, about 0.15-0.2 wt%, about 0.2-0.25 wt%, about 0.25-0.3 wt%, about 0.3-0.35 wt%, about 0.35-0.4 wt%, or about 0.4-0.5 wt%. 0.45wt%, about 0.45-0.5wt%, about 0.5-0.55wt%, about 0.55-0.6wt%, about 0.6-0.65wt%, about 0.65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt%, about 0.95-1wt%, about 1-1.5wt%, about 1.5-2wt%, about 2-3wt%, about 3-4wt%, about 4-5wt%, about 5-6wt%, about 6-7wt%, about 7-8wt%, about 8-9wt%, about 9-10wt%, about 10-15wt%, about 15-20wt% or about 20-30wt%.

[0181] Preparations of the present disclosure may include nutrients and amino acids, such as alanine, arginine, asparagine, aspartic acid, cysteine, cystine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, minerals, and vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, vitamin K, and their derivatives, compositions, and mixtures. Preparations of the present invention may include spices, such as eucalyptus oil, synthetic camphor, peppermint oil, clove oil, olive oil, lavender, chamomile, flavor spices such as chocolate, vanilla, mint, and their derivatives, compositions, and mixtures. Preparations of the present disclosure may also include other food additives commonly included in supplements, such as gelatin, rice, flour, wheat, citric acid, natural and artificial flavors, and their derivatives, compositions, and mixtures.

[0182] The present preparations may also include antioxidant ingredients and combinations selected from, but not limited to, ascorbic acid, ascorbic acid derivatives, glucosamine ascorbate, arginine ascorbate, lysine ascorbate, glutathione ascorbate, niacinamide ascorbate, nicotinic acid ascorbate, allantoin ascorbate, creatine ascorbate, creatinine ascorbate, chondroitin ascorbate, chitosan ascorbate, DNA ascorbate, carnosine ascorbate, vitamin E, various vitamin E derivatives, tocotrienols, rutin, quercetin, hesperidin (Citrus sinensis), diosmin (blood orange), mangiferin (mango), mangosteen (mangosteen), anthocyanidins (Vaccinium myrtillus), astaxanthin (Haematococcus algae), lutein (Tagetes erecta), patula), lycopene (tomato), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (turmeric), rosmarinic acid (rosemary), hypericin (Hypericum perforatum), ellagic acid (pomegranate), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, niacinamide lipoate, glutathione, andrographolide (Andrographis paniculata), carnosine, niacinamide, potentilla erecta extract, polyphenols, grape seed extract, Pycnogenol (pine bark extract), pyridoxine, magnolol, honokiol, paeonol, resacetophenone, quinacetophenone, arbutin, kojic acid, and combinations thereof.Based on the total weight of the formulation, the antioxidant can be used alone or in a cumulative manner at about 0.001-0.01 wt%, about 0.01-0.05 wt%, about 0.05-0.1 wt%, about 0.1-0.15 wt%, about 0.15-0.2 wt%, about 0.2-0.25 wt%, about 0.25-0.3 wt%, about 0.3-0.35 wt%, about 0.35-0.4 wt%, or about 0.4-0.45 wt% to about 0.45-0.5 wt%, about 0.5-0.55 wt%, about 0.55-0.6 wt%, about 0.6-0.65 wt%, about 0.75-0.8 wt%, about 0.85-0.9 wt%, about 0.95-0.10 wt%, about 0.96-0.11 wt%, about 0.97-0.12 wt%, about 0.98-0.13 wt%, about 0.99-0.14 wt%, about 0.91-0.15 wt%, about 0.99-0.16 wt%, about 0.91-0.17 wt%, about 0.97-0.18 wt%, about 0.98-0.19 wt%, about 0.99-0 .65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt%, about 0.95-1wt%, about 1-1.5wt%, about 1.5-2wt%, about 2-3wt%, about 3-4wt%, about 4-5wt%, about 5-6wt%, about 6-7wt%, about 7-8wt%, about 8-9wt%, about 9-10wt%, about 10-15wt%, about 15-20wt% or about 20-30wt% is present in a concentration of any one.

[0183] The preparation may also include blood microcirculation improving ingredients and compositions selected from, but not limited to, horse chestnut extract (Aesculus hippocastanum extract), esculin, aescin, yohimbine, capsicum oleoresin, capsaicin, nicotinic acid, nicotinic acid esters, methyl nicotinate, benzyl nicotinate, ruscosapogenin (Butchers Broom extract; Eleutherodactylum extract), diosgenin (fenugreek, fenugreek seed), olea europaea extract (emblica extract), asiatica glycoside (Centella asiatica extract), frankincense extract (Boswellia serrata), ginger root extract (ginger), piperine, vitamin K, meliloti (Oleracea extract), glycyrrhetinic acid, ursolic acid, sericoside (Terminalia extract), dasyphylla (Siegesbeckia extract), Amnivisnaga extract, red grape (grape) leaf extract, apigenin, phytosan, luteolin, and combinations thereof.

[0184] The formulation may also include an anti-inflammatory ingredient or composition selected from, but not limited to, at least one of the following classes of antioxidants: cyclooxygenase (e.g., COX-1 or COX-2) or lipoxygenase (e.g., LOX-5) enzyme inhibitors, such as ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperidin (blood orange (Citrussinensis)), diosmin (blood orange), mangiferin (mango), mangostin (mangosteen), anthocyanidins (European bilberry), astaxanthin (haematococcus), lutein (marigold), lycopene (tomato), resveratrol (knotweed), tetrahydrocurcumin (turmeric), rosmarinic acid (rosemary), hypericin (Hypericum perforatum), ellagic acid (pomegranate), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), europaea), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, Pycnogenol (pine bark extract), white tea extract, black tea extract, (andrographis paniculata), carnosine, niacinamide, and emblica extract. The anti-inflammatory composition may also be selected from, but is not limited to, horse chestnut extract (Aesculus hippocastanum extract), esculin, aescin, yohimbine, capsicum oleoresin, capsaicin, nicotinic acid, nicotinic acid esters, nicotinic acid methyl ester, benzyl nicotinate, ruscosapogenin (butcher's broom extract; hollyhock extract), diosgenin (fenugreek, fenugreek seed), olea oleifera extract (emblica emblica extract), asiatica glycoside (Centella asiatica extract), frankincense extract (Boswellia serrata), sericoside, visnadine, thiocolchicoside, grape seed extract, ginger root extract (ginger), piperine, vitamin K, meliloti (Oleracea extract), glycyrrhetinic acid, ursolic acid, sericoside (Terminalia extract), siegetin (Siegesbeckia extract), Amni visnaga extract, red grape (grape) leaf extract, apigenin, phytosan, luteolin and combinations thereof.

[0185] Certain divalent and multivalent metal ions may also be present in the compositions of the present disclosure. Examples of such metal ions include zinc, copper, manganese, vanadium, chromium, cobalt, and iron.

[0186] The preparation may also include colorants such as zinc oxide (white), titanium dioxide (white), calcium carbonate, kaolin, blue, green, orange, red, purple, yellow and black pigments. The preparation may also include mixtures and compositions of any of the above substances, and one or more active ingredients other than the therapeutically effective dose of the active ingredient, such as, but not limited to, other therapeutic agents for preventing and treating one or more conditions or disease states.

[0187] The formulations of the present disclosure may also include a skin whitening agent selected from the group consisting of hydroquinone, arbutin, a hydroquinone derivative, paper mulberry extract (Broussonetia kazinoke), rough hat berry extract (Mitracarpus scaber), bearberry extract (Arctostaphylos uva ursi), wrinkled yellow syrup extract (Rumex crispus and Rumex occidentalis), glutathione, leukocyte extract, Aspergillus oryzae extract (Aspergillus orizae), licorice root extract (Glycyrrhiza glabra), rosmarinic acid (Rosmarinus officinalis), tetrahydrocurcumin, green tea extract (Camellia sinensis), yohimbe extract (pausinystalia yohimbe), Ecklonia cava (Ecklonia ovata), safflower oil (Safflower oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cinnamon bark extract (Clove oil), cava extract, niacinamide, hydroxytetronic acid, Spondias mombin extract, Maprounea guianensis extract, Walteria indica extract, Gouania blanchetiana extract, Cordia schomburgkii extract, Randia armata extract, Hibiscus furcellatus extract, 2-hydroxyacetophenone, 3-hydroxyacetophenone, 4-hydroxyacetophenone, 2,3-dihydroxyacetophenone, 2,4-dihydroxyacetophenone, 2,5-dihydroxyacetophenone, 2,6-dihydroxyacetophenone, 3,4-dihydroxyacetophenone, 3,5-dihydroxyacetophenone, 2,4,6-trihydroxyacetophenone, 2,3,4-trihydroxyacetophenone, 2,3,5-trihydroxyacetophenone, 2,3,6-trihydroxyacetophenone, 2,4,5-trihydroxyacetophenone, 3,4,5-trihydroxyacetophenone, norpaeonol (r The invention relates to phenol, phenol, esacetophenone, 2-acetylresorcinol, 4-acetylresorcinol, 3,4-dihydroxyacetophenone, acetylquinoline, quinoline acetonide, 1-(3-hydroxy-4-methoxy-5-methylphenyl)ethanone, 1-(3-hydroxy-4-methoxyphenyl)ethanone, paeonol, 5'-bromo-2'-hydroxyacetophenone, 5'-chloro-2'-hydroxyacetophenone, 3',5'-dichloro-2'-hydroxyacetophenone, 3',5'-dibromo-4'-hydroxyacetophenone, 5-chloro-3-bromo-2-hydroxyacetophenone and combinations thereof.The amount of such a composition may be a safe and effective amount as required and is not limited to any particular limitation.

[0188] The preparation of the present disclosure may also include a sunscreen ingredient with an SPF of 6-95. Sunscreen ingredients include, but are not limited to, octyl methoxycinnamate (ethylhexyl p-methoxycinnamate), octyl salicylate oxybenzone (benzophenone-3), benzophenone-4, menthyl anthranilate, dioxybenzone, aminobenzoic acid, amyl dimethyl PABA, diethanolamine p-methoxycinnamate, ethyl 4-bis(hydroxypropyl)aminobenzoate, 2-ethylhexyl-1-2-cyano-3,3-diphenylacrylate, high menthyl salicylate, glyceryl aminobenzoate, dihydroxyacetone, octyl dimethyl PABA, 2-phenylbenzimidazole-5-sulfonic acid, triethanolamine salicylate, zinc oxide and titanium dioxide and mixtures thereof. The amount of sunscreen used in the cosmetically acceptable composition of the present disclosure will vary depending on the specific UV absorption wavelength of the specific sunscreen active material used, and may be from about 0.1 to about 10 weight percent, from about 2 to about 8 weight percent. In one embodiment, the active ingredient is present in the formulation of the present disclosure at a concentration of from about 0.1% to about 60.0%. In one embodiment, the active ingredient is present in the formulation of the present disclosure at a concentration of from about 0.1% to about 80.0%. In one embodiment, the active ingredient is present in the formulation of the present disclosure at a concentration of from about 1.0% to about 50.0% (for topical and transdermal applications), and at a concentration of from about 50% to 98% (for oral formulations).

[0189] The formulations of the present disclosure may also include analgesics such as lanocaine, lidocaine, prilocaine, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, capsaicin, camphor, menthol, methyl salicylate, methyl nicotinate, ketamine, and triethanolamine salicylate.

[0190] The formulations of the present disclosure may also include agents for wound healing, such as papain, trypsin, allantoin, chymotrypsin, streptokinase, dornase, ficin, pepsin, carboxypeptidase, aminopeptidase, chymopapain, and bromelain.

[0191] The formulations of the present disclosure may also include anti-infective agents such as bacitracin, polymyxin B, mupirocin, neomycin, tetracyclines (chlortetracycline hydrochloride, oxytetracycline hydrochloride, and tetracycline hydrochloride), clindamycin, gentamicin sulfate, benzalkonium chloride, benzethonium chloride, hexylresorcinol, methylbenzethonium chloride, and phenol.

[0192] Formulations of the present disclosure may also include preservatives such as thymol, menthol, benzalkonium chloride, chlorhexidine gluconate, and natural oils including tea tree oil.

[0193] The formulations of the present disclosure may also include astringents and desiccants, such as calamine, witch hazel, sodium bicarbonate, aluminum hydroxide, and zinc oxide.

[0194] The formulations of the present disclosure may also include antifungal agents such as miconazole, econazole, tolnaftate, ketoconazole, undecylenic acid, amphotericin, carbol-fuchsin, ciclopirox, clotrimazole, haloprogin, mafenide, naftifine, nystatin, oxiconazole, silver, sulfadiazine, sulconazole, terbinafine, tioconazole, undecylenic acid anti-acne salicylic acid, benzoyl peroxide, acne, rosacea, seborheic resorcinol, sulfur, dermatitis sodium sulfacetamide, tretinoin, isotretinoin, erythromycin, zinc, retinol, citric acid and alpha-hydroxy acids.

[0195] In certain embodiments, retinol is included in the delivery system described herein and comprises about 0.01-10 wt%, about 0.01-5 wt%, about 0.01-4 wt%, about 0.01-3%, about 0.01-2 wt%, about 0.01-1 wt%, about 0.1-5 wt%, about 0.1-4 wt%, about 0.1-3 wt%, about 0.1-2 wt%, about 0.1-1 wt%, about 0.1-5 wt%, about 0.1-4 wt%, about 0.1-3 wt%, about 0.1-2 wt%, about 0.1-1 wt%, about 1 -10wt%, about 10-20wt%, about 20-30wt%, about 30-40wt%, about 40-50wt%, about 50-60wt%, about 60-70wt%, about 70-80wt%, about 80-85wt%, about 85-90wt%, about 90-95wt%, about 95-96wt%, about 96-97wt%, about 97-98wt%, about 98-99wt%, about 99-99.5wt% or about 99.5wt% retinol.

[0196] The formulations of the present disclosure may also include antiviral agents such as acyclovir, docosanol, pencyclovir, cidofovir, deciclovir, famciclovir, ganciclovir, lobcavir, PMEA, valacyclovir, 2242, PAA, PFA, H2G, sorivudine, trifluridine, tromantanamine, adenine, cytarabine, adenine arabinoside monophosphate and lobcavir.

[0197] The formulations of the present disclosure may also include immunomodulators such as pimecrolimus, tacrolimus, muramyl dipeptide, cyclosporin, interferons (including alpha, beta and gamma interferons), interleukin-2, cytokines, tumor necrosis factor, pentostatin, thymopentin, transforming growth factor β2 and erythropoietin.

[0198] The formulations of the present disclosure may also include cleansing agents such as ammonium lauryl sulfate, cold cream, glycerin, glycolic or salicylic acid, sodium bicarbonate, calcium carbonate, magnesium hydroxide, aluminum hydroxide, sodium hydroxide, polyethylene beads, alumina, synthetic detergents, baking soda, waxes and minerals containing borax detergents, or combinations thereof.

[0199] In certain embodiments, the composition comprises petrolatum, yellow 5 lake, petrolatum, white petrolatum, or a combination thereof. In certain embodiments, petrolatum is present in a concentration of about 10-15%, 15-20%, 20-30%, 30-40%, 40-50%, 50-60%, 60-70%, 70-80%, 80-90%, 90-95%, 95-98% by weight.

[0200] In certain embodiments, the compositions of the present disclosure include cedarleaf oil, nutmeg oil, special petrolatum, thymol, turpentine, spices, or combinations thereof.

[0201] In certain embodiments, the compositions of the present disclosure comprise 4%-5% camphor (antitussive and topical analgesic), 1-5% eucalyptus oil (antitussive), 1-5% menthol (antitussive and topical analgesic), or a combination thereof.

[0202] In certain embodiments, the composition comprises deionized water, glycerin, petrolatum, distearyl dimethyl ammonium chloride, isopropyl palmitate, cetyl alcohol, dimethicone, allantoin, T36-C5, tea tree oil, benzyl alcohol, or a combination thereof. In certain embodiments, the composition comprises mineral oil, ceresin, lanolin alcohol, panthenol, glycerin, bisabolol, or a combination thereof. In certain embodiments, the composition comprises caprylic / capric triglyceride, avocado (Persea Gratissima) (avocado (Avocado)) oil, microcrystalline wax, beeswax, shea butter (shea) oil, tocopherol, panthenol, glycerin, bisabolol, or a combination thereof. In certain embodiments, based on the total weight of the formulation, the composition comprises hydrocortisone in a concentration range of about 0.5-1.5%, 1.5-3%, 3-5%, 5-10%, 10-15%, 15-20% by weight.

[0203] In certain embodiments, the composition comprises petrolatum, mineral oil, ozokerite, lanolin alcohol, panthenol, glycerin, bisabolol, menthoxypropylene glycol, or a combination thereof.

[0204] In certain embodiments, the composition comprises 500 units of bacitracin: 3.5 mg of the emergency antibiotic neomycin sulfate: 10,000 units of the antibiotic polymyxin B sulfate: 10 mg of the emergency antibiotic pramoxine hydrochloride: a topical analgesic, or a combination thereof.

[0205] In certain embodiments, the composition comprises petrolatum, Gossypium herbaceum (cotton) seed oil, Olea europaea (olive) fruit oil, Theobroma cacao (cocoa) seed oil, tocopheryl acetate, sodium pyruvate, or a combination thereof.

[0206] In certain embodiments, the composition comprises camphor (w / w) (1-5%) (external analgesic), menthol (w / w) (1-5%) (external analgesic), petrolatum (w / w) 10-70% (lip balm), phenol (w / w) (0.5-1%) (external analgesic), or a combination thereof.

[0207] In certain embodiments, the composition comprises beeswax, benzyl alcohol, diisopropyl adipate, flavoring agents, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, Theobroma cacao (cocoa) seed butter, or a combination thereof.

[0208] In certain embodiments, the composition comprises dimethicone (w / w) (1-5%, for example, 1wt%, 1.5wt%, 2wt%, 2.5wt%, 3wt%, 3.5wt%, 4wt%, 4.5wt% or 5wt%) (lip balm), octyl methoxycinnamate (Octinoxate) (w / w) - (1-10%, for example, 1wt%, 1.5wt%, 2wt%, 2.5wt%, 3wt%, 3.5wt%, 4wt%, 4.5wt% or 5wt%) (lip balm), t% or 5wt%, 5.5wt%, 6wt%, 6.5wt%, 7wt%, 7.5wt%, 8wt%, 8.5wt%, 9wt%, 9.5wt% or 10wt%) (sunscreen), Octisalate (w / w) - (1-5%, for example, 1wt%, 1.5wt%, 2wt%, 2.5wt%, 3wt%, 3.5wt%, 4wt%, 4.5wt% or 5wt%) (sunscreen) or a combination thereof.

[0209] In certain embodiments, the composition comprises beeswax, camphor, cetyl alcohol, cetyl palmitate, Euphorbia Cerifera (Candelilla) wax, flavoring agents, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, polybutene, Red 6 Lake, Theobroma cacao (cocoa) seed butter, titanium dioxide, phenoxyethanol, or a combination thereof.

[0210] In certain embodiments, the composition comprises mineral oil, paraffin, ozokerite, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, sodium lauroyl lactylate, proline, cholesterol, phenoxyethanol, tocopheryl acetate, tocopheryl hydrolyzed hyaluronic acid, panthenol, pantolactone, phytosphingosine, xanthan gum, ethylhexylglycerin, or a combination thereof.

[0211] In certain embodiments, the composition comprises mineral oil, paraffin, ozokerite, dimethicone, hyaluronic acid, sodium hydroxide, ceramide 1, ceramide 3, ceramide 6-II, tocopheryl acetate, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, panthenol, water, L-proline, xanthan gum, or a combination thereof.

[0212] In certain embodiments, the composition comprises purified water, glycerin, ceteareth-20 and cetearyl alcohol, caprylic / capric triglyceride, behentrimonium methosulfate and cetearyl alcohol, cetyl alcohol, ceramide 3, ceramide 6-11, ceramide 1, hyaluronic acid, cholesterol, petrolatum, dimethicone, potassium phosphate, dipotassium phosphate, sodium lauroyl lactylate, disodium ethylenediaminetetraacetic acid (EDTA), phenoxyethanol, methylparaben, propylparaben, phytosphingosine, carbomer, xanthan gum, or a combination thereof.

[0213] In certain embodiments, the composition comprises solution / water / aqueous solution (eau), glycerin, petrolatum, caprylic / capric triglyceride, hydrogenated vegetable oil, sucrose distearate, dextrin, helianthus annuus (sunflower) seed oil unsaponifiables, Prunus Domestica Seed extract, or a combination thereof.

[0214] In certain embodiments, the composition comprises mineral oil, Avena Sativa, (Oat) Kernel Flour, Theobroma cacao (Cocoa), seed oil, tocopheryl acetate, or a combination thereof.

[0215] In certain embodiments, the composition comprises water (solution), glycerin, dimethicone, stearic acid, caprylic / capric triglyceride, glycol stearate, PEG-100 stearate, petrolatum, glyceryl stearate, caprylyl glycol, phenoxyethanol, cetyl alcohol, acrylates / C10-30 alkyl acrylate crosspolymer, triethanolamine, helianthus annuus (sunflower) seed oil, triolein, disodium ethylenediaminetetraacetic acid (EDTA), stearamide AMP, carbomer, titanium dioxide (CI77891), or a combination thereof. In certain embodiments, the composition comprises triticum vulgare (wheat germ) oil, tocopheryl pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, allantoin, isopropyl palmitate, liquid paraffin (mineral oil), isopropyl myristate, aloe vera (aloe vera) leaf extract, BHE, or a combination thereof.

[0216] In certain embodiments, the composition comprises petrolatum (10-50%, 25-60%, 50-80%), zinc oxide (5-15%, 10-25%, 15-20%, 20-30%), titanium dioxide (5-15%, 10-25%, 15-20%, 20-30%), octocrylene (5-10%, 10-15%, 15-20%), octinoxate (5-10%, 10-15%, 15-20%), or a combination thereof.

[0217] In certain embodiments, the composition comprises beeswax, birch (white birch) bark extract, shea butter (butyrospermum parkii), calendula oil, corn starch, soya bean (soybean) oil, lanolin, panthenyl ethyl ether, paraffin, propylparaben, tocopheryl acetate, or a combination thereof.

[0218] In certain embodiments, the composition comprises petrolatum, cod liver oil, lanolin, glycerin, beeswax, sorbitan sesquioleate, fragrance, pentaerythritol tetra-di-tert-butyl hydroxyhydrocinnamate, tocopheryl acetate, talc, or a combination thereof.

[0219] In certain embodiments, the composition comprises white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (Avena Sativa) kernel extract, polysorbate 80, or a combination thereof.

[0220] In certain embodiments, the composition comprises alpha-tocopheryl acetate, butylated hydroxytoluene, lanolin, lavender oil, light mineral oil, methylparaben, petrolatum, polysorbate 60, or a combination thereof.

[0221] In certain embodiments, the composition comprises mineral oil, white petrolatum, white wax, or a combination thereof.

[0222] In certain embodiments, the composition comprises alpha-tocopheryl acetate, aloe vera leaf, light mineral oil, paraffin, petrolatum, or a combination thereof.

[0223] In certain embodiments, the composition comprises light mineral oil, white beeswax, white petrolatum, or a combination thereof.

[0224] In certain embodiments, the composition comprises carnauba wax, isopropyl palmitate (and) isopropyl myristate (and) aloe barbadensis leaf extract, lanolin, fragrance, petrolatum, sorbitan sesquioleate, tocopheryl acetate (vitamin E), or a combination thereof.

[0225] In certain embodiments, the composition comprises bismuth oxychloride, C12-15 alkyl benzoate, caprylhydroxamic acid, caprylyl glycol, cetyl PEG / PPG-10 / 1 dimethicone, cyclohexasiloxane, cyclopentasiloxane, dimethicone, dimethicone crosspolymer, dimethicone / vinyl dimethicone crosspolymer, dimethicone alcohol, disodium edetate, glycerin, hydrogenated dimethicone, iron oxides, mica, microcrystalline wax, PEG-10 dimethicone, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, polyhydroxystearic acid, polysorbate 20, sodium chloride, stearyl dimethicone, tetrahexyldecyl ascorbate, tocopheryl acetate, triethanolamine, triethoxycaprylylsilane, water, or a combination thereof.

[0226] In certain embodiments, the composition comprises water, C12-15 alkyl benzoate, styrene / acrylates copolymer, octyldodecyl citrate crosspolymer, phenyl trimethicone, cetyl PEG / PPG-10 / 1 dimethicone, dimethicone, polyhydroxystearic acid, glycerin, ethyl polymethicone, cetyl dimethicone, silica, feverfew (feverfew) flower / leaf / stem juice, glyceryl behenate, phenylethyl alcohol, caprylyl glycol, cetyl dimethicone / bisvinyl dimethicone crosspolymer, acrylates / dimethicone copolymer, sodium chloride, phenoxyethanol, chlorphenesin, or a combination thereof.

[0227] In certain embodiments, the composition comprises octyldodecyl neopentanoate, C12-15 alkyl benzoate, polyethylene, paraffin, silica, neopentyl glycol diethylhexanoate, ozokerite, isopropyl myristate, adipic acid / diethylene glycol crosspolymer, triethoxycaprylylsilane, neopentyl glycol diisostearate, caprylyl glycol, tocopheryl acetate, or a combination thereof.

[0228] In certain embodiments, the composition comprises water, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea Butter), Fragrance, Caprylyl Glycerin / Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Coco-Glucoside, Tocopherol, Microcrystalline Cellulose, Cellulose Gum, Bisabolol, Cetyl Alcohol, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Polyhydroxystearic Acid, Sodium Hyaluronate, Sodium Gluconate, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, or a combination thereof.

[0229] In certain embodiments, the composition comprises water, diisopropyl adipate, ethylhexyl palmitate, ethylhexyl stearate, cetyl PEG / PPG-10 / 1 dimethicone, glycerin, cetyl dimethicone, hydrogenated castor oil, hydrated silica, cyclopentasiloxane, polyethylene, aloe barbadensis leaf extract, tocopheryl acetate, theobroma cacao (cocoa) seed butter, beeswax, cyclohexasiloxane, triethoxycaprylylsilane, sodium chloride, DMDM ​​hydantoin, fragrance, or a combination thereof.

[0230] In certain embodiments, the composition comprises water, dimethicone, isododecane, C12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl polymethicone, butyloctyl salicylate, phenylethyl benzoate, styrene / acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone / PEG-10 / 15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, iron oxides, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, Artemia extract, benzoic acid, C9-15 fluoroalcohol phosphate, PEG-9, or a combination thereof.

[0231] In certain embodiments, the composition comprises allantoin, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl glycol, dimethicone / propyl silsesquioxane / silicate crosspolymer, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isodecyl salicylate, isopropyl isostearate, lecithin, neopentyl glycol diheptanoate, 1,2-hexanediol, polyester-7, polyglyceryl-3 polyricinoleate, propylene glycol, silica silylate, sodium chloride, squalane, glyceryl tribehenate, tridecyl salicylate, water, or a combination thereof.

[0232] In certain embodiments, the composition comprises helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) oil, cera alba (beeswax), ricinus communis (castor) seed oil, raspberry (red raspberry) seed oil, butyrospermum parkii (shea) butter, prunus armeniaca (apricot) kernel oil, argan oil, rosa canina (rosehip) oil, tocopherol, or a combination thereof.

[0233] In certain embodiments, the composition comprises water, cyclopentasiloxane, zinc oxide, propylene glycol, titanium dioxide, butylene glycol dicaprylate / dicaprate, lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone, methyl methacrylate crosspolymer, butyloctyl salicylate, caprylyl polymethicone, citrus aurantium dulcis (orange) oil, citrus mandarin orange (tangerine) peel oil, litsea cubeba fruit oil, 1,2-hexanediol, disteardimonium hectorite, magnesium sulfate, stearic acid, aluminum hydroxide, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, triethoxycaprylylsilane, sorbitan caprylate, glyceryl caprylate, ethylhexylglycerin, tocopherol, or a combination thereof.

[0234] In certain embodiments, the composition comprises water, dimethicone, isododecane, C12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl polymethicone, butyloctyl salicylate, phenethyl benzoate, styrene / acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone / PEG-10 / 15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, diethylhexyl syringylidene malonate, tocopherol, propylene carbonate, cassia leaf extract, maltodextrin, benzoic acid, PEG-9, or a combination thereof.

[0235] In certain embodiments, the composition comprises water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl nonanoate, cetyl PEG / PPG-10 / 1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer, dilinoleate / propylene glycol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, tocopherol, or a combination thereof.

[0236] In certain embodiments, the composition comprises octyldodecyl neopentanoate, C12-15 alkyl benzoate, polyethylene, paraffin, silica, neopentyl glycol diethylhexanoate, ozokerite, isopropyl myristate, adipic acid / diethylene glycol crosspolymer, triethoxycaprylylsilane, neopentyl glycol diisostearate, caprylyl glycol, Avena Sativa (oat) kernel oil, or a combination thereof.

[0237] In certain embodiments, the composition comprises octyldodecyl neopentanoate, C12-15 alkyl benzoate, polyethylene, paraffin, silica, neopentyl glycol diethylhexanoate, ozokerite, isopropyl myristate, adipic acid / diethylene glycol crosspolymer, triethoxycaprylylsilane, neopentyl glycol diisostearate, caprylyl glycol, Avena Sativa (oat) kernel oil, tocopheryl acetate, or a combination thereof.

[0238] In certain embodiments, the composition comprises C12-15 alkyl benzoate, octyldodecyl neopentanoate, dimethicone, paraffin, ozokerite, beeswax, phenyl trimethicone, Euphorbia Cerifera (Candelilla) wax, polyethylene, polyhydroxystearic acid, dipropylene glycol dibenzoate, triethoxycaprylylsilane, PPG-15 stearyl ether benzoate, caprylyl glycol, ethylhexylglycerin, Avena Sativa (Oat) kernel flour, BHT, or a combination thereof.

[0239] In certain embodiments, the composition comprises water, isobutane, isododecane, cetyl PEG / PPG-10 / 1 dimethicone, caprylic / capric triglyceride, butyloctyl salicylate, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, sodium citrate, or a combination thereof.

[0240] In certain embodiments, the composition comprises water, caprylic / capric triglyceride, isohexadecane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, cetyl PEG / PPG-10 / 1 dimethicone, lauryl PEG-8 dimethicone, C30-38 olefin / isopropyl maleate / MA copolymer, sodium chloride, ethylhexyl methoxypolyacrylonitrile, dimethicone, phenoxyethanol, caprylyl glycol, PEG-8, alumina, glycerin, sodium citrate, tocopheryl acetate, or a combination thereof.

[0241] In certain embodiments, the composition comprises arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol, butyloctyl salicylate, butyrospermum parkii (shea) butter, calendula officinalis flower extract, camellia sinensis leaf extract, caprylylhydroxamic acid, caprylylglycerol / sebacic acid copolymer, caprylyl glycol, cellulose gum, cetearyl alcohol, cetyl alcohol, chamomile (matricaria) flower extract, citric acid, citrus aurantium dulcis (orange) peel oil, coco-glucoside, cocos nucifera (coconut) oil, gherkin (cucumber) fruit extract, diheptyl succinate, glycerin, methyl dihydroabietic acid, microcrystalline cellulose, polyhydroxystearic acid, persea gratissima (avocado) fruit extract, prunus armeniaca (prunus Armeniaca) (Apricot) Kernel Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Certified Organic Water, or a combination thereof.

[0242] In certain embodiments, the composition comprises arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol, butyloctyl salicylate, butyrospermum parkii (shea) butter, calendula officinalis flower extract, camellia sinensis leaf extract, caprylylhydroxamic acid, caprylylglyceryl / sebacic acid copolymer, caprylyl glycol, cellulose gum, cetearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, citric acid, citrus aurantium dulcis (orange) peel oil, coco-glucoside, cocos nucifera (coconut) oil, glucosamine (cucumber) fruit extract, diheptyl succinate, glycerin, methyl dihydroabietate, microcrystalline cellulose, polyhydroxystearic acid, persea gratissima (avocado) fruit extract, prunus armeniaca (apricot) kernel oil, sodium gluconate, sodium hyaluronate, sodium stearoyl glutamate, theobroma cacao (cocoa) seed butter, tocopherol, triethyl citrate, vanilla orchid fruit extract, water, or a combination thereof.

[0243] In certain embodiments, the composition comprises purified water, caprylic / capric triglyceride, polyglyceryl-4 isostearate, glycerin, hydrogenated glyceryl rosinate, hexyl laurate, cetyl dimethicone, aloe barbadensis leaf juice, hydrogenated castor oil, magnesium sulfate, helianthus annuus (sunflower) seed oil, jojoba (jojoba) seed oil, tocopherol, Olea Europaea (olive) fruit oil, raspberry (raspberry) seed oil, Vaccinium Macrocarpon (cranberry) seed oil, sodium hyaluronate, Carica Papaya (Papaya) fruit extract, Ribes Nigrum (Black Currant) extract, Citrus grandis (Grapefruit) extract. Paridisi) (pink grapefruit) peel oil, sorbitan sesquioleate, caprylylhydroxamic acid, triethoxycaprylylsilane, glyceryl caprylate, or a combination thereof.

[0244] In certain embodiments, the composition comprises purified water, aloe barbadensis leaf juice, caprylic / capric triglyceride, sorbitan stearate (coconut based), pine resin, vegetable glycerin, cetyl dimethicone, hydrogenated castor oil, magnesium sulfate (Epsom salts), sunflower oil, jojoba oil, ascorbic acid (vitamin C), tocopherol (vitamin E), olive oil, raspberry seed oil, cranberry seed oil, hyaluronic acid (plant-made), glucose & glucose oxidase and lactoperoxidase, papaya, or a combination thereof.

[0245] In certain embodiments, the composition comprises alumina, aluminum stearate, beeswax, C12-15 alkyl benzoate, caprylyl glycol, cetyl dimethicone, cetyl PEG / PPG-10 / 1 dimethicone, chlorphenesin, dimethicone, disodium EDTA, ethylhexyl palmitate, ethylhexyl stearate, hexyl laurate, hydrogenated castor oil, methyl glucose dioleate, octyldodecyl neopentanoate, PEG-7, hydrogenated castor oil, phenoxyethanol, polyglyceryl-4 isostearate, polyhydroxystearic acid, propylene glycol, purified water, sorbitan oleate, stearic acid, tocopheryl acetate, trimethylsiloxysilicate, VP / hexadecene copolymer, or a combination thereof.

[0246] In certain embodiments, the composition comprises dimethicone, caprylic / capric triglyceride, dimethicone crosspolymer, dimethicone / vinyl dimethicone crosspolymer, butyloctyl salicylate, glyceryl isostearate, polyester-8, polysilicone-15, behenic acid, camellia sinensis leaf extract, caprooyl phytosphingosine, ceramide AP, ceramide EOP, ceramide EOS, ceramide NP, ceramide NS, ceteareth-25, cetyl alcohol, cholesterol, glycerin, iron oxides, PEG / PPG-18 / 18 dimethicone, pomegranate extract, silica, tetrahexyldecyl ascorbate, tocopheryl acetate, triethoxycaprylylsilane, Vaccinum Macrocarpon (Cranberry) fruit extract, or a combination thereof.

[0247] In certain embodiments, the composition comprises water, glycerin, C12-15 alkyl benzoate, dimethicone, isododecane, styrene / acrylate copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propylene glycol, stearic acid, aluminum hydroxide, Peg-100 stearate, sorbitan stearate, niacinamide, Peg-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carboxylic acid. Bohm, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethicone, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, palmitic acid, phenoxyethanol, chlorphenesin, tocopherol, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosphingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin, or a combination thereof.

[0248] In certain embodiments, the composition comprises alumina, cyclohexasiloxane, cyclopentasiloxane, dimethicone, dimethicone crosspolymer, dimethicone / vinyl dimethicone crosspolymer, dimethicone, lauryl PEG / PPG-18 / 18 methicone, methicone, PEG-10 dimethicone, or a combination thereof.

[0249] In certain embodiments, the composition comprises water, cocos nucifera (coconut) oil, persea gratissima (avocado oil), cetearyl alcohol / polysorbate 60 (vegetable emulsifying wax NF), butyrospermum parkii (shea butter), raspberry (rubus idaeus seed oil), glyceryl oleate citrate with caprylic / capric triglyceride, glycerin, cera alba (beeswax), ethylhexylglycerin & propylene glycol, polyhydroxystearic acid, sodium gluconate, cocos nucifera (coconut essential oil), vanilla (Vanilla essential oil), or a combination thereof.

[0250] In certain embodiments, the composition comprises organic sunflower oil, organic beeswax, sunflower vitamin E, or a combination thereof.

[0251] In certain embodiments, the composition comprises helianthus annuus (sunflower) seed oil, beeswax (beeswax), tocopherol (sunflower vitamin E), or a combination thereof.

[0252] In certain embodiments, the composition comprises petrolatum, coconut alkanes, coconut oil alcohol-caprylate / caprate and an analgesic. In certain embodiments, the composition comprises petrolatum, coconut alkanes, coconut oil alcohol-caprylate / caprate and lidocaine. In some embodiments, the composition is in the form of a radiation spray.

[0253] In certain embodiments, the composition comprises petrolatum, coconut alkanes, coconut caprylate / caprate, camphor (antitussive and topical analgesic), menthol (antitussive and topical analgesic), and eucalyptus leaf essential oil.

[0254] In certain embodiments, the composition comprises petrolatum, coconut alkanes, coconut oil alcohol-caprylate / caprate, camphor (antitussive and topical analgesic), menthol (antitussive and topical analgesic), eucalyptus leaf essential oil, nutmeg (MyristicaFragrans) (Nutmeg) kernel oil, turpentine, C18-C36 acid triglycerides, jojoba esters, C12-C18 acid triglycerides, squalene, thymol, phytosteryl macadamia oleate, phytosterols and tocopherol. In some embodiments, the composition is in the form of a steam spray.

[0255] In certain embodiments, the composition comprises a polyol or a diol. Exemplary diols may include, but are not limited to, propylene glycol, propanediol, butanediol, butene glycol, pentanediol, hexanediol, octanediol, neopentyl glycol, 2-methyl-1,3-propanediol, diethylene glycol, triethylene glycol, tetraethylene glycol, dipropylene glycol, dibutylene glycol, isoprene glycol, ethoxylated glycol, or a combination thereof. Based on the total weight of the composition, the diol contained in the delivery system described herein is present in a concentration of about 1-25wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-1wt%, about 1-5wt%, about 1-10wt%, about 5-10wt%, about 1-15wt%, about 10-15wt%, about 15-20wt%, about 20-25wt%, about 25-30wt%, about 30-35wt%, about 35-40wt%, about 40-45wt%, about 45-50wt%, about 50-55wt%, about 55-60wt%, about 60-65wt%, about 65-70wt%, about 70-75wt%, about 75-80wt%, about 80-85wt%, about 85-90wt% or about 90-95wt%. For example, the diol can be present in a concentration of about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt%, based on the total weight of the composition.

[0256] In certain embodiments, the composition comprises bakuchiol in an amount of about 0.01-10 wt%, about 0.01-1 wt%, about 0.01-1 wt%, about 0.1-0.3 wt%, about 0.3-0.5 wt%, about 0.5-0.7 wt%, about 0.7-1 wt%, or about 1-3 wt%, about 3-5 wt%, about 5-7 wt%, about 7-10 wt%, about 10-15 wt%, about 15-20 wt%, or about 20-25 wt%, based on the total weight of the composition.

[0257] In some embodiments, based on the weight of the preparation, the composition includes the water (solution) of the amount of about 0.001-25wt%. For example, based on the weight of the preparation, the composition can include the water of the concentration range of about 0.1-25wt%. For example, based on the gross weight of the preparation, the composition can include the water (solution) of about 0.1-20%, about 0.1-15wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or 1-3wt%, about 3-5wt%, about 5-7wt%, about 7-10wt%, about 10-15wt%, about 15-20wt% or about 20-25wt%.

[0258] In certain embodiments, based on the weight of the preparation, the composition includes the caprylic / capric triglyceride of the amount of about 0.001-25wt%.For example, based on the weight of the preparation, the composition can include the caprylic / capric triglyceride of the concentration range of about 0.1-25wt%.For example, based on the gross weight of the preparation, the composition can include the caprylic / capric triglyceride of about 0.1-20%, about 0.1-15wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or 1-3wt%, about 3-5wt%, about 5-7wt%, about 7-10wt%, about 10-15wt%, about 15-20wt% or about 20-25wt%.

[0259] In certain embodiments, based on the weight of the preparation, the composition includes the glycerol of the amount of about 0.001-25wt%.For example, based on the weight of the preparation, the composition can include the glycerol of the concentration range of about 0.1-25wt%.For example, based on the gross weight of the preparation, the composition can include the glycerol of about 0.1-20wt%, about 0.1-15wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or about 1-3wt%, about 3-5wt%, about 5-7wt%, about 7-10wt%, about 10-15wt%, about 15-20wt% or about 20-25wt%.

[0260] In certain embodiments, the composition comprises methyl dihydroabietic acid in an amount of about 0.01-10wt%, based on the weight of the formulation. For example, based on the total weight of the formulation, the composition may comprise methyl dihydroabietic acid in an amount of about 0.01-1wt%, about 0.01-0.5wt%, about 0.01-0.1wt%, about 0.01-0.05wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt%, or about 1-3wt%, about 3-5wt%, about 5-7wt%, or about 7-10wt% of methyl dihydroabietic acid.

[0261] In some embodiments, based on the weight of the preparation, the composition includes the cetearyl alcohol of the amount of about 0.01-10wt%. For example, based on the gross weight of the preparation, the composition can include the cetearyl alcohol of about 0.01-1wt%, about 0.01-0.5wt%, about 0.01-0.1wt%, about 0.01-0.05wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or about 1-3wt%, about 3-5wt%, about 5-7wt% or about 7-10wt%.

[0262] In certain embodiments, the composition comprises bisabolol in an amount of about 0.01-10 wt %, based on the weight of the formulation. For example, based on the total weight of the formulation, the composition may comprise bisabolol in an amount of about 0.01-1 wt %, about 0.01-0.5 wt %, about 0.01-0.1 wt %, about 0.01-0.05 wt %, about 0.1-10 wt %, about 0.1-5 wt %, about 0.1-5 wt %, about 0.1-1 wt %, about 0.1-0.5 wt %, about 0.1-0.3 wt %, about 0.3-0.5 wt %, about 0.5-0.7 wt %, about 0.7-1 wt %, or about 1-3 wt %, about 3-5 wt %, about 5-7 wt %, or about 7-10 wt %.

[0263] In certain embodiments, the composition comprises lactic acid in an amount of about 0.001-10 wt % based on the weight of the formulation. For example, the composition can include about 0.001-1 wt%, about 0.001-0.5 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.01 wt%, about 0.001-0.005 wt%, about 0.001-0.003 wt%, about 0.001-0.002 wt%, 0.1-10 wt%, about 0.1-5 wt%, about 0.1-5 wt%, about 0.1-1 wt%, about 0.1-0.5 wt%, about 0.1-0.3 wt%, about 0.3-0.5 wt%, about 0.5-0.7 wt%, about 0.7-1 wt%, or about 1-3 wt%, about 3-5 wt%, about 5-7 wt%, or about 7-10 wt% lactic acid, based on the total weight of the formulation.

[0264] In certain embodiments, the composition comprises citric acid in an amount of about 0.001-10 wt % based on the weight of the formulation. For example, based on the total weight of the formulation, the composition can include about 0.001-1wt%, about 0.001-0.5wt%, about 0.001-0.1wt%, about 0.001-0.05wt%, about 0.001-0.01wt%, about 0.001-0.005wt%, about 0.001-0.003wt%, about 0.001-0.002wt%, 0.1-10wt%, about 0.1-5wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt%, or about 1-3wt%, about 3-5wt%, about 5-7wt%, or about 7-10wt% of citric acid.

[0265] In certain embodiments, the composition comprises coco-glucoside in an amount of about 0.001-1 wt % based on the weight of the formulation. For example, based on the weight of the formulation, the composition can include about 0.001-0.01 wt%, about 0.001-0.5 wt%, about 0.001-0.4 wt%, about 0.001-0.3 wt%, about 0.001-0.25 wt%, about 0.001-0.2 wt%, about 0.001-0.15 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.04 wt%, about 0.001-0.03 wt%, about 0.001-0.01 wt%, about 0.001-0.025 wt%, about 0.001-0.02 wt%, about 0.001-0.015 wt%, about 0.005-0.01 wt%, about 0.01 %, about 0.05wt%, about 0.05-0.1wt%, about 0.1-0.15wt%, about 0.15-0.2wt%, about 0.2-0.25wt%, about 0.25-0.3wt%, about 0.3-0.35wt%, about 0.35-0.4wt%, or about 0.4-0.45wt%, about 0.45-0.5wt%, about 0.5-0.55wt%, about 0.55-0.6wt%, about 0.6-0.65wt%, about 0.65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt%, or about 0.95-1wt% of coconut oil monoglucoside.

[0266] In some embodiments, the composition comprises glucan. In some embodiments, the composition comprises beta-glucan. In some embodiments, based on the weight of the preparation, the composition comprises carboxymethyl beta-glucan sodium in a concentration range of about 0.01-10wt%. For example, based on the gross weight of the preparation, the composition can comprise about 0.1-10wt%, about 0.1-5wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or about 1-3wt%, about 3-5wt%, about 5-7wt% or about 7-10wt% beta-glucan.

[0267] In some embodiments, based on the weight of the preparation, the composition includes the isohexadecane of the amount of about 0.01-10wt%. For example, based on the gross weight of the preparation, the composition can include about 0.01-1wt%, about 0.01-0.5wt%, about 0.01-0.1wt%, about 0.01-0.05wt%, 0.1-10wt%, about 0.1-5wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or about 1-3wt%, about 3-5wt%, about 5-7wt% or about 7-10wt% isohexadecane. In some embodiments, the composition includes the isohexadecane of 30-60wt%. In some embodiments, the composition includes the isohexadecane of 45wt%.

[0268] In certain embodiments, based on the weight of the preparation, the composition comprises silicon dioxide in an amount of about 0.01-10wt%. For example, based on the gross weight of the preparation, the composition can comprise silicon dioxide in an amount of about 0.01-1wt%, about 0.01-0.5wt%, about 0.01-0.1wt%, about 0.01-0.05wt%, about 0.1-10wt%, about 0.1-5wt%, about 0.1-5wt%, about 0.1-1wt%, about 0.1-0.5wt%, about 0.1-0.3wt%, about 0.3-0.5wt%, about 0.5-0.7wt%, about 0.7-1wt% or about 1-3wt%, about 3-5wt%, about 5-7wt% or about 7-10wt%.

[0269] In some embodiments, the composition comprises any one or more of decanoyl hydroxamic acid, polyhydroxystearic acid, bentonite, ethylhexylglycerin, heptyl undecylenate, hexylene glycol, hexadecyl glyceryl ether, caprylyl glycol, or phenoxyethanol. In certain embodiments, the composition comprises any one or more of decanoyl hydroxamic acid, polyhydroxystearic acid, bentonite, ethylhexylglycerin, heptyl undecylenate, hexylene glycol, hexadecyl glyceryl ether, caprylyl glycol, or phenoxyethanol, and their individual or collective amounts are about 0.001-1 wt % based on the weight of the formulation. For example, based on the weight of the formulation, the composition can include about 0.001-0.01 wt%, about 0.001-0.5 wt%, about 0.001-0.4 wt%, about 0.001-0.3 wt%, about 0.001-0.25 wt%, about 0.001-0.2 wt%, about 0.001-0.15 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.04 wt%, about 0.001-0.03 wt%, about 0.001-0.01 wt%, about 0.001-0.025 wt%, about 0.001-0.02 wt%, about 0.001-0.015 wt%, about 0.005-0.01 wt%, about 0.01-0.05wt%, about 0.05-0.1wt%, about 0.1-0.15wt%, about 0.15-0.2wt%, about 0.2-0.25wt%, about 0.25-0.3wt%, about 0.3-0.35wt%, about 0.35-0.4wt% or about 0.4-0.45wt%, about 0.45-0.5wt%, about 0.5-0.55wt%, about 0.55-0.6wt%, about 0.6-0.65wt%, about 0.65-0.7wt%, about 0.7-0.75wt%, about 0.75-0.8wt%, about 0.8-0.85wt%, about 0.85-0.9wt%, about 0.9-0.95wt% or about 0.95-1wt%.

[0270] In some embodiments, these compositions are packaged into a spray delivery system, which provides mist or spray, such as a can-in-can aerosol system. Optionally, the spray barrier formulation can be packaged into a bag-on-valve aerosol system. In some embodiments, the product is delivered by a system that separates the formulation from the propellant. Those skilled in the art will appreciate that there are several known mixed ingredients to obtain a method for sprayable compositions, and the described process should not be considered to limit the scope of the present disclosure.

[0271] In certain embodiments, the viscosity of the petrolatum used in the formulation is about 150,000 centipoise at 25° C. An exemplary viscosity range of the petrolatum used in the formulations of the present disclosure is about 20,000 centipoise to 600,000 centipoise at 25° C.

[0272] In certain embodiments, the compositions disclosed herein have low viscosity, so that such compositions can be applied to desired body parts in the form of mist from a spray bottle with a spray pump or from a container equipped with an atomizing head, including but not limited to face, lips, legs, face, etc. In certain embodiments, the spray pump bottle is configured to spray the mist of the composition onto the user's skin. In certain aspects, the spray pump bottle is configured to spray mist.

[0273] In certain embodiments, the compositions of the present disclosure have a viscosity of 3 to 500 centipoise ("cP"), 3 to 100 cp, 3 to 75 cp, 3 to 40 cp, 3 to 10 cp, 3 to 5 cp, 500 to 1,000 cp, 1,000-5000 cp, 5,000-7,000 cp at a temperature ranging from 65°F to 100°F, from 70°F to 85°F, and from 72°F to 80°F.

[0274] In certain embodiments, the sprayable formulation has a particle size of from 50 to 100 microns, 10-50 microns, 5-10 microns, or 1-5 microns.

[0275] In certain embodiments, to further aid solubility and dispensability of the composition, for example by reducing the viscosity of the total composition, water is included at a concentration of 1 to 70 wt%, 1 to 15 wt%, 1 to 10 wt%, 2 to 65 wt%, 2 to 8 wt%, 2 to 6 wt%, 3 to 60 wt%, or 3 to 5 wt% of the total composition. In certain embodiments, water helps dissolve the various ingredients and further acts synergistically to moisturize and aid in moisture retention of the user's skin.

[0276] In certain embodiments, in order to provide a sprayable preparation, it is necessary to gradually reduce the viscosity (the limited time required for changing from high viscosity to low viscosity at a constant shear rate) under constant shear. The present disclosure provides a preparation with reduced viscosity and increased shear rate, so as to provide an immediate change proportional to the shear amount, which allows a sprayable preparation while also allowing the preparation to maintain enough viscosity to suspend the composition under low shear or no shear conditions. In certain embodiments, the preparation has minimal cohesiveness and will not condense or otherwise precipitate from the solution when shear is not applied to the preparation. In certain embodiments, when shear is applied to the preparation, it can be sprayed. In certain embodiments, when the preparation touches the skin and shear is not applied, the preparation will thicken again so that it will not flow away from the skin surface, thereby forming a uniform coating on the skin.

[0277] In certain embodiments, the composition exhibits lower viscosity, enhanced processability, and / or improved sprayability compared to existing compositions comprising vaseline. Sprayability refers to the formulation being dispensed by a handheld spray dispenser by pressing a dispense button to spray the formulation onto the skin. Any conventional spray dispenser can be used to dispense the skin protective formulation, including aerosol or pressurized propellant dispensers, electric pump dispensers, or dispensers using a manual spray pump device.

[0278] Also disclosed is a container configured for dispensing mist or aerosol, the container comprising a reservoir containing a formulation disclosed herein; and a nozzle fluidly connected to the reservoir, the nozzle being suitable for dispensing the formulation in the form of mist or aerosol. In certain embodiments, the spray bottle comprises a pump that draws the liquid (i.e., the formulation) from the reservoir onto a siphon and forces it through the nozzle. Depending on the sprayer, the nozzle of the spray bottle may be adjustable or non-adjustable to select between a jet stream or mist. In certain embodiments, the spray container is a multi-angle spray head / dispenser. In certain embodiments, the disclosed formulation may be further packaged, for example, in a moisture-proof, sealed package that can be opened and closed repeatedly. Alternatively, the package may contain a single-use amount of the disclosed formulation.

[0279] Treatment

[0280] The present disclosure provides a method for treating a subject's skin condition by topically treating the skin with the composition. Exemplary diseases that can be treated with topical compositions are radiation dermatitis, thermal burns, dermatomyofibromas, myositis, burns, diaper rash, pruritus, acne, sunburn, windburn, fever herpes, cold sores, insect bites, insect stings, poison ivy, poison oak, poison sumac, dermatitis, other skin conditions, skin spots. In certain embodiments, topical compositions are used to treat stretch marks, wrinkles, age spots, facial and body scars, thermal burns or thermal burns, radiation (sun) burns, rosacea, chapped lips (dryness) and other skin conditions.

[0281] In certain embodiments, the method comprises topically applying the composition to the affected area of ​​the subject and repeating one to three times daily throughout the course of treatment.

[0282] The present disclosure provides a method of strengthening the epidermal barrier to prevent occupationally or environmentally induced or genetically predisposed skin disorders.

[0283] In most cases, effective results are obtained by topical application of a thin layer over the affected area or areas where the desired effect is desired. Effective results may be obtained with application frequencies ranging from once every two or three days to four or more times per day, depending on the condition being treated, its stage or extent, and whether the application is for therapeutic or preventive reasons.

[0284] The present invention is generally applicable to the treatment of mammalian skin, including, for example, humans, domestic pets, and livestock and other farm animals.

[0285] Conditions Treatable by the Disclosed Compositions

[0286] The disclosed compositions will successfully treat and prevent skin and mucosal diseases and conditions that result in epidermal barrier disruption or dysfunction. Thus, these formulations can be effectively applied to any of the following conditions and skin conditions:

[0287] Aging, wrinkles, photodamage, stretch marks, scars, age spots, sunburn, thermal burns or heat injuries, ice damage and frostbite. In one embodiment, the composition can be used to treat bedsores.

[0288] Important causes of morbidity and mortality in preterm infants younger than 33 weeks of gestation are fluid and electrolyte abnormalities, hypothermia, and infections through the skin. The development of a mature barrier function is associated with the deposition of adequate amounts of the three major epidermal lipids in appropriate proportions.

[0289] Eczematous dermatitis is a group of inflammatory hyperproliferative skin diseases characterized by ill-defined, scaly, itchy or tender patches that may involve a wide range of areas of the body. The two most common types are atopic and seborrheic dermatitis. Both have a genetic predisposition and show abnormalities in stratum corneum lipids and barrier function even in clinically uninvolved skin. Other major eczematous dermatitis is caused by environmental or occupational insults (insult) of solvents, chemicals, detergents, hot water, low ambient humidity, ultraviolet rays or X-rays. These conditions include allergic or irritant contact dermatitis, eczema craquele, photoallergy, phototoxicity or phytophotodermatitis, radiation and stasis dermatitis. Eczema craquele begins with dehydrated or dry skin, which reaches such severity that the complete destruction of the epidermal barrier occurs, resulting in inflammation and excessive proliferation. The main treatments for eczematous dermatitis include topical use of corticosteroids and systemic antihistamines, with or without antibiotics. Unfortunately, after clinical resolution of overt lesions, the skin remains hypersensitive for months, which leads to rapid recurrence of lesions when environmental insults are significantly less severe. Therefore, there is a great need for effective therapeutic agents that normalize the barrier of clinically uninvolved and involved skin to prevent disease progression and / or limit disease extent.

[0290] Ulcers and erosions are caused by trauma or ischemia to the skin or mucous membranes. These injuries include chemical or thermal burns, as well as damaged blood vessels in veins, arteries, emboli, or diabetic ulcers. Lesions are not only painful, but also form a portal of entry for pathogenic microorganisms. Current treatments mainly include antibiotics, occlusive dressings, and vascular compression bandages.

[0291] Ichthyoses are a group of incurable, disfiguring, common to rare genetic disorders characterized by abnormal epidermal keratinization with or without associated barrier dysfunction and epidermal hyperproliferation. Conservative treatment of these disorders consists of systemic and topical retinoids, as well as topical alpha-hydroxy acids and salicylates. These modalities may produce significant local irritation, and both systemic retinoids and topical salicylates carry a significant risk of severe systemic toxicity.

[0292] Epidermolysis bullosa is a group of rare genetic disorders caused by a loss or defect in epidermal / dermal adhesion. Skin trauma to normal skin during daily activities can lead to complete or partial loss of the epidermis, producing blisters, erosions, and ulcers. The only treatment for one type is phenytoin and / or systemic tretinoin. Both treatments produce a number of serious systemic side effects when used long-term.

[0293] Psoriasis is a prominent hyperproliferative, inflammatory papulosquamous disease characterized by well-defined scaly plaques most often located on sites of the body that have been traumatized, particularly the knees, elbows, hands, feet, and scalp. Almost all currently available local and systemic therapies carry a significant risk of systemic and / or skin toxicity. In addition, they are often accompanied by a rapid rebound of the disease, usually when these treatments are stopped. None of these treatments can repair the barrier, and some actually make it worse. Current medications include retinoids, corticosteroids, sulfones, antineoplastic agents, anthralin, tar, psoralen, and ultraviolet A or B light. Recently, it has been reported that 60% of lesions treated weekly with occlusive tape over a 10-week period achieved long-term remission. This approach artificially restores epidermal barrier function to a certain extent.

[0294] Skin changes of intrinsic aging and photoaging (dermatoheliosis) are caused by a combination of environmental insults and intrinsic changes, which produce atrophy, fragility, inelasticity, decreased cell cohesion, reduced proliferation, and delayed healing after barrier damage. Stratum corneum lipids show a decrease in ceramides and non-polar lipid species, with a relative increase in cholesterol. Current treatments consist of topical application of retinoic acid or alpha-hydroxy acids, both of which often cause irritation, especially in the elderly.

[0295] In certain embodiments, the disclosed compositions are used to prevent or treat dry skin, rash, diaper rash, irritation and itching relief, chapped lips, poison ivy, poison oak and poison sumac, sunburn, windburn, frostbite. In certain embodiments, the disclosed compositions are used to relieve cough, wound healing, skin healing, cosmetics and beauty products, baby care products, lip balm, sunscreen.

[0296] The limiting factor for professional or athletic performance, even for the occasional recreational athlete, is the mechanical shear forces that cause frictional blistering of the skin. Wearing multiple layers of clothing or using synthetic membranes are currently the only available, marginally helpful remedies.

[0297] The major limitation to the use of topical corticosteroids, especially in the young and elderly, is skin atrophy, which predisposes to infection and slows healing. Topical retinoids and alpha-hydroxy acids may partially reverse atrophy, but the irritation potential of these agents is significantly increased.

[0298] There are many known or potential therapeutic compounds whose effectiveness is hampered or impaired due to skin irritation or barrier disruption. Formulations containing these compounds in combination with the lipids of the present disclosure will expand the potential therapeutic armamentarium available to the physician.

[0299] It is known that the integrity of the epidermal barrier is a major factor in regulating epidermal DNA synthesis. It is also known that maintaining a normal epidermal barrier will inhibit epidermal hyperproliferation. Therefore, the findings of the present disclosure lead to the treatment of hyperproliferative skin diseases, of which prominent examples are papulosquamous and eczematous diseases.

[0300] In some embodiments, the benefits of the treatment of the present disclosure include other areas outside the skin of the treated subject. In some embodiments, the compositions of the present disclosure treat the respiratory system of the subject. Common respiratory disorders and diseases that can be treated include chronic obstructive pulmonary disease, asthma, bronchitis, respiratory distress, occupational lung disease, pulmonary hypertension. The present composition can also treat symptoms related to the effects of tobacco smoke irritation, air pollution, occupational chemicals and dust, and upper and lower respiratory infections. In some embodiments, the present composition can also treat synovial infusion, edema and inflammation in the joints, including but not limited to arthritis.

[0301] Method for preparing the preparation

[0302] All preparation, filling and storage procedures follow cGMP requirements. All equipment and tools that come into contact with individual ingredients are cleaned, sterilized and dried before use. All ingredients are stored in a clean, dry and temperature-controlled (15°C to 25°C) area. Ingredients are set up in the main mixing area. They are approved for use, weighed, measured and placed in individual, clean, properly labeled, tared containers of appropriate size.

[0303] Step 1: Add Snow White Vaseline USP to the main reaction vessel equipped with a propeller stirrer. The power and temperature of the main reaction vessel are controlled by variable speed control. Mix Snow White Vaseline USP at high speed and heat to 50°C-55°C and maintain at this temperature.

[0304] Step 2: In a separate container, mix the other ingredients of the formulation and heat to 85°C-90°C until homogeneous. After the other ingredients are melted and well mixed, slowly add the mixture to the main reaction vessel of step 1 and stir until homogeneous. The temperature is maintained at 50°C-55°C.

[0305] Step 3: In a separate container, mix the other ingredients of the formulation until uniform and keep at 50°C-55°C. Then slowly add the mixture to the main reaction vessel in step 1 and stir until uniform. Then remove the mixture in the main reaction vessel from the heat source and homogenize until uniformly dispersed.

[0306] Step 4: In a separate container, mix the other ingredients of the formulation until uniform and add to the main reaction vessel in step 1 and stir until uniform. Repeat this process until all ingredients are combined.

[0307] Step 5: Continue stirring the mixture in the main reaction vessel and cool the mixture to 35° C. A sample of the mixture is then tested and approved.

[0308] Example

[0309] The following examples are illustrative. Obvious and readily accessible modifications may be made by those skilled in the art without departing from the spirit and scope of the present disclosure. The scope of the appended claims is not limited to these examples.

[0310]

[0311]

[0312] Example 1 - Skin Protective Spray Example 2 - Skin Protective Spray

[0313]

[0314] Example 3 - Skin Protective Spray

[0315]

[0316]

[0317] Example 4 - Skin Protective Spray

[0318]

[0319]

[0320] Example 5 - Skin Protective Spray

[0321]

[0322]

[0323] In a separate example, the above formulation contains 15% ZnO; 40% petrolatum, and the coconut alkanes and coconut-caprylate / caprate are substituted with 45% isohexadecane.

[0324] Example 6 - Skin Protective Spray

[0325]

[0326]

[0327] In a separate example, the above formulation contains 15% ZnO; 40% petrolatum, and the coconut alkanes and coconut-caprylate / caprate are substituted with 45% isohexadecane.

[0328] Example 7 - Skin Protective Spray

[0329] INCI name / wt% range Minimum wt% Specific wt% Maximum wt% Vaseline USP 30 50 70 Coconut Alkane and Coco-Caprylate / Caprate 30 46 70 C18-36 Acid Triglycerides 0.5 1.5 5 Ceramide 0.02 0.1 0.5 Jojoba / Macadamia Seed Oil Esters 0.1 1 2.5 Squalene 0.1 0.5 1 Phytosteryl Macadamia Oleate 0.01 0.06 0.1 Phytosterols 0.05 0.15 0.2 Tocopherol 0.01 0.0045 0.25 Sweet Potato Root Extract 0.01 0.05 5 C12-18 Acid Triglycerides 0.1 0.5 1 Gum Arabic 0.001 0.02 0.1 Maltodextrin 0.001 0.03 0.1 Citric Acid 0.001 0.03 0.1

[0330] Example 8 - Skin Protective Spray

[0331]

[0332]

[0333] Example 9 - Skin Protective Spray

[0334]

[0335]

[0336] Example 10 - Skin Protective Spray

[0337] INCI name / specific wt% Minimum wt% Specific wt% Maximum wt% Snow White Vaseline USP 30 65 50 Coconut Alkane and Coco-Caprylate / Caprate 65 30 45-47.5 Ceramide 0.05-0.5 0.05-0.5 0.05-0.5 Jojoba / Macadamia Seed Oil Esters <5.0 <5.0 2.5 Squalene <2.0 <1.0 <0.5 Phytosteryl Macadamia Oleate 0.01-0.1 0.01-0.1 0.01-0.1 Phytosterols 0.05-0.3 0.05-0.3 <0.2 Tocopherol 0.01-0.25 0.01-0.25 <0.05 Sweet Potato Root Extract 0.01-5 0.01-5 <0.1

[0338] Example 11 - Radiation Spray

[0339]

[0340]

[0341] Example 12 - Steam Spray

[0342]

[0343] Example 13 - Method of Preparing Formulations

[0344] The individual ingredients are weighed and measured and placed in separate, clean, properly labeled, appropriately sized tared containers.

[0345] Step 1: Add Snow White Vaseline USP to the main reaction vessel equipped with a propeller stirrer. The power and temperature of the main reaction vessel are controlled by variable speed control. Mix Snow White Vaseline USP at high speed and heat to 50°C-55°C and maintain at this temperature.

[0346] Step 2: In a separate container, Vegesil and ceramide are mixed and heated to 85°C-90°C until homogeneous. After Vegesil and ceramide are melted and well mixed, slowly add the mixture to the main reaction vessel in step 1 and stir until homogeneous. The temperature is maintained at 50°C-55°C.

[0347] Step 3: In a separate container, mix L22 and Natpure Xfine Potato until uniform and keep at 50℃-55℃. Then slowly add the mixture to the main reaction vessel in step 1 and stir until uniform. Then remove the mixture in the main reaction vessel from the heat source and homogenize until Natpure Xfine Potato SP313 is evenly dispersed.

[0348] Step 4: Continue stirring the mixture in the main reaction vessel and cool the mixture to 35° C. Samples of the mixture are then tested and approved.

[0349] The following items list exemplary products, systems, and methods:

[0350] 1. A skin barrier protection delivery system, comprising:

[0351] (i) a mixture of coconut alkanes in a concentration range of 30-70 wt% and coconut caprylate / caprate in a concentration range of 3-7 wt%; and

[0352] (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt %,

[0353] Wherein the delivery system is sprayable.

[0354] 2. The skin barrier protection delivery system according to item 1, wherein the mixture of coconut alkane and coconut oil alcohol-caprylate / caprate is present in a concentration range of 30 wt%-65 wt%.

[0355] 3. The skin barrier protection delivery system according to item 1, wherein the mixture of coconut alkane and coconut alcohol-caprylate / caprate is present in a concentration of up to 70 wt%.

[0356] 4. The skin barrier protection delivery system according to item 1, wherein petrolatum is present in a concentration of about 40%.

[0357] 5. The skin barrier protection delivery system according to item 1, wherein petrolatum is present in a concentration of about 50%.

[0358] 6. The skin barrier protection delivery system according to item 1, further comprising at least one of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

[0359] 7. The skin barrier protection delivery system according to item 6, comprising at least two of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

[0360] 8. The skin barrier protection delivery system according to item 6, comprising at least three of ceramide, triglyceride, phytosterol, phytosterol ester, isohexadecane, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

[0361] 9. The skin barrier protection delivery system according to any one of items 4 to 8, wherein the plant-based ester or wax is selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax and sunflower wax.

[0362] 10. The skin barrier protection delivery system according to item 9, wherein the plant-based ester or wax comprises jojoba ester.

[0363] 11. The skin barrier protection delivery system according to any one of items 4 to 8, wherein the terpene is selected from the group consisting of triterpenes, hemiterpenes, monoterpenes, sesquiterpenes, diterpenes, sesquiterpenes and tetraterpenes.

[0364] 12. The skin barrier protection delivery system according to item 10, wherein the terpene is a triterpene.

[0365] 13. The skin barrier protection delivery system according to item 12, wherein the triterpene is squalene.

[0366] 14. The skin barrier protection delivery system according to any one of items 4 to 8, wherein the phytosterol ester comprises an ester derived from seed or nut oil.

[0367] 15. The skin barrier protection delivery system according to item 14, wherein the seed or nut oil is selected from the group consisting of macadamia oil, almond oil, avocado oil, rapeseed oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine nut oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil and walnut oil.

[0368] 16. The skin barrier protection delivery system according to item 15, wherein the phytosterol ester is phytosteryl macadamia oleate.

[0369] 17. The skin barrier protection delivery system according to item 1, comprising ceramide, triglyceride, phytosterol, phytosteryl macadamia oleate, squalene, jojoba ester and tocopherol.

[0370] 18. The skin barrier protection delivery system according to item 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglyceride and C12-18 acid triglyceride.

[0371] 19. The skin barrier protection delivery system according to any of the preceding items, further comprising at least one of a polysaccharide, a gum, a buffer and a root plant extract.

[0372] 20. The skin barrier protection delivery system according to item 19, wherein the polysaccharide is selected from the group consisting of maltodextrin, cellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid and a mixture thereof.

[0373] 21. The skin barrier protection system according to item 19 or 20, wherein the polysaccharide is maltodextrin.

[0374] 22. The skin barrier protection delivery system according to item 19, wherein the gum is selected from the group consisting of guar gum, xanthan gum, pullulan gum, agar gum, carrageenan, gellan gum, gum arabic and tragacanth gum.

[0375] 23. The skin barrier protection system according to item 19, wherein the gum is gum arabic.

[0376] 24. The skin barrier protection delivery system according to item 19, wherein the root plant extract is derived from a root plant selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish and radish.

[0377] 25. The skin barrier protection delivery system according to item 24, wherein the root plant extract is sweet potato root extract.

[0378] 26. The skin barrier protection delivery system according to item 19, wherein the acid is citric acid.

[0379] 27. The skin barrier protection delivery system according to item 19, comprising at least one of sweet potato root extract, citric acid, gum arabic and maltodextrin.

[0380] 28. The skin barrier protection delivery system according to item 19, comprising sweet potato root extract, citric acid, gum arabic and maltodextrin.

[0381] 29. The skin barrier protection delivery system according to item 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglyceride, C12-18 acid triglyceride, sweet potato root extract, gum arabic, citric acid and maltodextrin.

[0382] 30. The skin barrier protection delivery system according to item 1, wherein the ratio of the mixture of coconut alkanes and / or coconut alcohol-caprylate / caprate to petrolatum is about 1:1.

[0383] 31. The skin barrier protection delivery system according to item 1, comprising:

[0384] (i) at least 30 wt % of petrolatum;

[0385] (ii) coconut alkanes in the range of 30-70 wt %;

[0386] (iii) Coco-caprylate / caprate in the range of 3-7 wt %;

[0387] (iv) ceramide NPs in the range of 0.01-0.1 wt %;

[0388] (v) ceramide AP in the range of 0.01-0.1 wt %;

[0389] (vi) jojoba esters in the range of 0.1-1.5 wt %;

[0390] (vii) squalene in the range of 0.1-1 wt %;

[0391] (viii) phytosteryl macadamia oleate in the range of 0.01-0.1 wt %;

[0392] (ix) phytosterols in the range of 0.005-0.1 wt %;

[0393] (x) tocopherol in the range of 0.001-0.1 wt %;

[0394] (xi) C18-36 acid triglycerides in the range of 0.5-5 wt %;

[0395] (xii) C12-18 acid triglycerides in the range of 0.1-1 wt%;

[0396] (xiii) sweet potato root extract in the range of 0.01-0.1 wt %;

[0397] (xiv) citric acid in the range of 0.001-0.01 wt %;

[0398] (xv) gum arabic in the range of 0.001-0.1 wt %; and

[0399] (xvi) 0.001-0.1 wt% maltodextrin,

[0400] Wherein the delivery system is a sprayable formulation.

[0401] 32. The skin barrier protection delivery system according to item 31, comprising:

[0402] (i) 50 wt% of petrolatum;

[0403] (ii) 42-43 wt% coconut alkanes;

[0404] (iii) 4-5 wt% of coconut oil caprylate / caprate;

[0405] (iv) 0.05 wt % ceramide NPs;

[0406] (v) 0.05 wt% ceramide AP;

[0407] (vi) 0.75 wt % jojoba esters;

[0408] (vii) 0.3-0.4 wt% squalene;

[0409] (viii) 0.05-0.06 wt % phytosteryl macadamia oleate;

[0410] (ix) 0.01-0.02 wt % of phytosterols;

[0411] (x) 0.0045 wt % tocopherol;

[0412] (xi) 1-2 wt% C18-36 acid triglyceride;

[0413] (xii) 0.4-0.5 wt% C12-18 acid triglyceride;

[0414] (xiii) 0.03-0.04 wt % of sweet potato root extract;

[0415] (xiv) 0.003-0.004 wt % citric acid;

[0416] (xv) 0.03-0.04 wt% of gum arabic; and

[0417] (xvi) 0.03-0.04 wt% maltodextrin.

[0418] 33. The skin barrier protection delivery system according to any one of the preceding items, further comprising zinc oxide.

[0419] 34. A skin barrier protection delivery system, comprising:

[0420] (i) 25-60 wt % of petrolatum;

[0421] (ii) 10-25 wt% zinc oxide (ZnO); and

[0422] (iii) 30-60 wt% of isohexadecane.

[0423] 35. A skin barrier protection delivery system, comprising:

[0424] (i) 40 wt% of petrolatum;

[0425] (ii) 15 wt% zinc oxide (ZnO); and

[0426] (iii) 45 wt% of isohexadecane.

[0427] 36. The skin barrier protection delivery system according to any of the preceding items, having a viscosity of about 500 cps to about 10,000 cps.

[0428] 37. The skin barrier protection delivery system according to any of the preceding items, having a viscosity of about 1,000 cps to about 5,000 cps.

[0429] 38. The skin barrier protection delivery system according to any one of the preceding items, further comprising an active ingredient.

[0430] 39. The skin barrier protection delivery system according to item 35, wherein the active ingredient is present in an amount of about 0.0001% to about 35% by weight.

[0431] 40. The skin barrier protection delivery system according to item 35 or 36, wherein the active ingredient is selected from the group consisting of antifungal agents, antibacterial agents, antiviral agents, anti-acne agents, anti-aging agents, antipruritic agents, ultraviolet absorbers, sunscreens, skin pigment regulators, skin whitening agents, skin darkening agents, hair growth promoters, hair growth inhibitors, antidandruff agents, anti-seborrheic agents, antipsoriatic agents, depilatories, exfoliants, wound healing agents, anti-inflammatory agents, blood microcirculation improvers, sebum regulators, hormones, immunomodulators, plant extracts, moisturizers, emollients, astringents, antiperspirants, vitamins, retinoic acid, cleansing agents, Cleansing agents, sensual agents, color-changing agents, antibiotics, anti-irritants, anesthetics, analgesics, steroids, tissue healing agents, tissue regeneration agents, collagen or elastin promoters, skin protectants, agents that promote the reduction of excess fat or control of subcutaneous cellulite or body benefits, amino acids, peptides, minerals, hydroxy acids, antiemetics, anti-anginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, anti-migraine agents, smoking cessation agents, antidiarrheal agents, anti-ulcer agents, mood disorder agents, anti-obesity agents, erectile dysfunction control agents, anti-Parkinson's agents, MAO inhibitors, sleep disorder agents, anti-diabetic agents and combinations thereof.

[0432] 41. The skin barrier protection delivery system according to any of the preceding items, further comprising a skin whitening agent selected from the group consisting of hydroquinone, arbutin, a hydroquinone derivative, paper mulberry extract (paper mulberry), rough cap extract (rough cap), bearberry extract (ursi), sorrel extract (curly and western), glutathione, leukocyte extract, Aspergillus oryzae extract (Aspergillus oryzae), licorice root extract (Glycyrrhiza uralensis), rosmarinic acid (Rosemary), tetrahydrocurcumin, green tea extract (Camellia sinensis), yohimbe extract (Yohimbe), Ecklonia cava extract, niacinamide, hydroxytetracycline, yellow betel nut extract, Guyana head order extract, snakewort, Gouania blanchetiana extract, Cordiaschomburgkii extract, blueberry extract, Hibiscus furcellatus extract, and combinations thereof.

[0433] 42. The skin barrier protection delivery system according to any of the preceding items, further comprising an antioxidant selected from the group consisting of ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperidin (blood orange (Citrus sinensis)), diosmin (blood orange), mangiferin (mango), mangostin (mangosteen), anthocyanidin (European bilberry), astaxanthin (haematococcus), lutein (marigold), lycopene (tomato), resveratrol (knotweed), tetrahydrocurcumin (turmeric), rosmarinic acid (rosemary), hypericin (Hypericum perforatum), ellagic acid (pomegranate), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, Pycnogenol (pine bark extract), white tea extract, black tea extract, (andrographis paniculata), carnosine, niacinamide, emblica emblica extract, and combinations thereof.

[0434] 43. The skin barrier protection delivery system according to any of the preceding items, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl benzoate, avobenzone, artemisia quinone, sulisobenzone, triethanolamine salicylate, artemisia quinone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof.

[0435] 44. The skin barrier protection delivery system according to any of the preceding items, further comprising a pharmaceutically acceptable carrier selected from the group consisting of aqueous and oil emulsions, suspensions, colloids, microemulsions, clear solutions, nanoparticle suspensions, nanoparticle emulsions or anhydrous compositions.

[0436] 45. The skin barrier protection delivery system according to any one of items 1 to 44, comprising no flammable components.

[0437] 46. ​​The skin barrier protection delivery system according to item 45, without flammable solubilizer or alcohol.

[0438] 47. A pharmaceutical composition comprising any one of the aforementioned skin barrier protection delivery systems.

[0439] 48. A pharmaceutical composition in the form of a sprayable gel comprising any of the aforementioned skin barrier protection delivery systems.

[0440] 49. A device comprising the pharmaceutical composition according to item 47 or 48.

[0441] 50. The device according to item 49, wherein the device does not comprise a propellant, an aerosol or a bag-on-valve.

[0442] 51. The device according to item 49 or item 50, wherein the device is in the form of an atomizing pump.

[0443] 52. The device according to item 51, wherein the device is a dip tube atomizing pump.

[0444] 53. A method for protecting the skin of a subject in need thereof, comprising applying to the subject's skin a skin barrier protection delivery system according to any one of items 1 to 46, a pharmaceutical composition according to item 47 or 48, or a device according to any one of items 49 to 52.

[0445] 54. A skin barrier protection delivery system comprising: (i) a mixture of long chain alkanes having a carbon length greater than 10 carbons, wherein the long chain alkanes are present in a concentration range of 30-70 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt%, wherein the delivery system is sprayable.

[0446] 55. A skin barrier protection delivery system comprising: (i) a mixture of long chain alkanes with a carbon length greater than 10 carbons in a concentration range of 30-70wt% and esters of long chain alcohols in a concentration of 3-7wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30wt%, wherein the delivery system is sprayable.

[0447] 56. The skin barrier protection delivery system according to item 54 or 55, which is in the form of a sprayable gel.

[0448] 57. A skin barrier protection delivery system consisting of: (a) a mixture of coconut alkanes and coconut caprylate / caprate and (b) petrolatum, wherein the petrolatum is present in a concentration of at least 30% and the ratio of (a) to (b) is 7:3 to 1:3.

[0449] 58. A skin barrier protection delivery system consisting essentially of: (a) a mixture of coconut alkanes and coconut oil caprylate / caprate and (b) petrolatum, wherein the petrolatum is present in a concentration of at least 30% and the ratio of (a) to (b) is 7:3 to 1:3.

[0450] 59. The skin barrier protection delivery system according to any of the preceding items, wherein the ratio of coconut alkanes to coconut caprylate / caprate is from about 7:3 to about 1:3.

[0451] 60. The skin barrier protection delivery system according to any of the preceding items, further comprising at least two of ceramides, phytosterols, squalene, plant-based esters or waxes and / or phospholipids.

[0452] 61. An emulsion comprising any of the preceding skin barrier protection delivery systems.

[0453] 62. The skin barrier protection delivery system according to any of the preceding items, which is sprayable.

[0454] 63. The skin barrier protection delivery system according to any of the preceding items, having a viscosity of about 500 cps to about 10,000 cps.

[0455] 64. A skin barrier protection delivery system consisting of a mixture of coconut alkane and coconut caprylate / caprate (at least 30% concentration) and a ratio of coconut alkane to coconut caprylate / caprate of 7:3 to 1:3.

[0456] 65. A skin barrier protection delivery system consisting essentially of a mixture of coconut alkane and coconut caprylate / caprate, and the ratio of coconut alkane to coconut caprylate / caprate is 7:3 to 1:3.

[0457] 66. The skin barrier protection delivery system according to any of the preceding items, wherein the ratio of coconut alkanes to coconut-caprylate / caprate is from about 7:3 to about 1:3.

[0458] 67. The skin barrier protection delivery system according to any of the preceding items, further comprising at least two of ceramides, phytosterols, squalene, plant-based esters or waxes and / or phospholipids.

[0459] 68. An emulsion comprising any of the preceding skin barrier protection delivery systems.

[0460] 69. The skin barrier protection delivery system according to any one of the preceding items, which is sprayable.

[0461] 70. The skin barrier protection delivery system according to any one of the preceding items, having a viscosity of about 500 cps to about 10,000 cps.

[0462] 71. The skin barrier protection delivery system according to any of the preceding items, further comprising an active ingredient.

[0463] 72. The skin barrier protection delivery system according to any of the preceding items, wherein the active ingredient is from about 0.0001% to about 95% by weight.

[0464] 73. A skin barrier protection delivery system according to any of the preceding items, wherein the active ingredient is selected from the group consisting of antifungal agents, antibacterial agents, antiviral agents, anti-acne agents, anti-aging agents, antipruritic agents, ultraviolet absorbers, sunscreens, skin pigment regulators, skin whitening agents, skin darkening agents, hair growth promoters, hair growth inhibitors, antidandruff agents, anti-seborrheic agents, anti-psoriatic agents, depilatories, exfoliants, wound healing agents, anti-inflammatory agents, blood microcirculation improvers, sebum regulators, hormones, immunomodulators, plant extracts, moisturizers, emollients, astringents, antiperspirants, vitamins, retinoic acid, cleansing agents. agents, sensory agents, color-changing agents, antibiotics, anti-irritants, anesthetics, analgesics, steroids, tissue healing agents, tissue regeneration agents, collagen or elastin promoters, skin protectants, agents that promote the reduction of excess fat or control of subcutaneous cellulite or body benefits, amino acids, peptides, minerals, hydroxy acids, antiemetics, anti-anginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, anti-migraine agents, smoking cessation agents, antidiarrheal agents, anti-ulcer agents, mood disorder agents, anti-obesity agents, erectile dysfunction control agents, anti-Parkinson's agents, MAO inhibitors, sleep disorder agents, anti-diabetic agents, or a combination thereof.

[0465] 74. The skin barrier protection delivery system according to any of the preceding items, further comprising a skin whitening agent selected from the group consisting of hydroquinone, arbutin, a hydroquinone derivative, paper mulberry extract (paper mulberry), rough cap extract (rough cap), bearberry extract (ursi), sorrel extract (curly and western), glutathione, leukocyte extract, Aspergillus oryzae extract (Aspergillus oryzae), licorice root extract (Glycyrrhiza uralensis), rosmarinic acid (Rosemary), tetrahydrocurcumin, green tea extract (Camellia sinensis), yohimbe extract (Yohimbe), Ecklonia cava extract, niacinamide, hydroxytetracycline, yellow betel nut extract, Guyana head order extract, snakewort extract, Gouania blanchetiana extract, Cordiaschomburgkii extract, blueberry extract, Hibiscus furcellatus extract, and combinations thereof.

[0466] 75. The skin barrier protection delivery system according to any of the preceding items, further comprising an antioxidant selected from the group consisting of ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperidin (blood orange), diosmin (blood orange), mangiferin (mango), mangosteen (mangosteen), anthocyanidins (European bilberry), astaxanthin (haematococcus), lutein (marigold), lycopene (tomato), resveratrol (knotweed), tetrahydrocurcumin (turmeric), rosmarinic acid (rosemary), hypericin (Hypericum perforatum), ellagic acid (pomegranate), chlorogenic acid (bilberry), oleuropein (olivine), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, Pycnogenol (pine bark extract), white tea extract, black tea extract, (andrographis paniculata), carnosine, niacinamide, emblica extract, and combinations thereof.

[0467] 76. The skin barrier protection delivery system according to any of the preceding items, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl benzoate, avobenzone, artemisia quinone, sulisobenzone, triethanolamine salicylate, artemisia quinone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof.

[0468] 77. The skin barrier protection delivery system according to any of the preceding items, wherein the formulation form of the skin barrier protection delivery system is selected from the group consisting of: lotion, cream, gel, spray, thin liquid, body spray, facial mask, serum, solid beauty stick, lipstick, shampoo, liquid soap, bar soap, bath oil, cologne, conditioner, salve, collodion, impregnated patch, impregnated strip or skin surface implant.

[0469] 78. The skin barrier protection delivery system according to any of the preceding items, further comprising a pharmaceutically acceptable carrier selected from the group consisting of aqueous and oil emulsions, suspensions, colloids, microemulsions, clear solutions, nanoparticle suspensions, nanoparticle emulsions and anhydrous compositions.

[0470] 79. A skin barrier protection delivery system comprising: (i) at least 30 wt% petrolatum; (ii) coconut alkanes in the range of 30-70 wt%; (iii) coconut oil alcohol-caprylate / caprate in the range of 3-7 wt%; (iv) ceramide NP in the range of 0.01-0.1 wt%; (v) ceramide AP in the range of 0.01-0.1 wt%; (vi) jojoba esters in the range of 0.1-1.5 wt%; (vii) squalene in the range of 0.1-1 wt%; (viii) phytosteryl macadamia oleate in the range of 0.01-0.1 wt%; (ix) 0.00 5-0.1wt% phytosterols; (x) 0.001-0.1wt% tocopherol; (xi) 0.5-5wt% C18-36 acid triglycerides; (xii) 0.1-1wt% C12-18 acid triglycerides; (xiii) 0.01-0.1wt% sweet potato root extract; (xiv) 0.001-0.01wt% citric acid; (xv) 0.001-0.1wt% gum arabic; and (xvi) 0.001-0.1wt% maltodextrin, wherein the delivery system is a spray formulation.

[0471] 80. A skin barrier protection delivery system according to any of the preceding items, comprising: (i) 50 wt% of petrolatum; (ii) 42-43 wt% of coconut alkanes; (iii) 4-5 wt% of coconut oil alcohol-caprylate / caprate; (iv) 0.05 wt% of ceramide NP; (v) 0.05 wt% of ceramide AP; (vi) 0.75 wt% of jojoba esters; (vii) 0.3-0.4 wt% of squalene; (viii) 0.05-0.06 wt% of phytosteryl macadamia oleate; ( (ix) 0.01-0.02wt% phytosterols; (x) 0.0045wt% tocopherol; (xi) 1-2wt% C18-36 acid triglycerides; (xii) 0.4-0.5wt% C12-18 acid triglycerides; (xiii) 0.03-0.04wt% sweet potato root extract; (xiv) 0.003-0.004wt% citric acid; (xv) 0.03-0.04wt% gum arabic; and (xvi) 0.03-0.04wt% maltodextrin.

[0472] 81. The skin barrier protection delivery system according to any of the preceding items, having a viscosity of about 500 cps to about 10000 cps.

[0473] 82. The skin barrier protection delivery system according to any of the preceding items, having a viscosity of about 1000 cps to about 5000 cps.

[0474] 83. The skin barrier protection delivery system according to any of the preceding items, further comprising an active ingredient.

[0475] 84. The skin barrier protection delivery system according to any of the preceding items, wherein the active ingredient is from about 0.0001% to about 70% by weight.

[0476] 85. A skin barrier protection delivery system according to any of the preceding items, wherein the active ingredient is selected from the group consisting of antifungal agents, antibacterial agents, antiviral agents, anti-acne agents, anti-aging agents, antipruritic agents, ultraviolet absorbers, sunscreens, skin pigment regulators, skin whitening agents, skin darkening agents, hair growth promoters, hair growth inhibitors, antidandruff agents, anti-seborrheic agents, anti-psoriatic agents, depilatories, exfoliants, wound healing agents, anti-inflammatory agents, blood microcirculation improvers, sebum regulators, hormones, immunomodulators, plant extracts, moisturizers, emollients, astringents, antiperspirants, vitamins, retinoic acid, cleansing agents. agents, sensory agents, color-changing agents, antibiotics, anti-irritants, anesthetics, analgesics, steroids, tissue healing agents, tissue regeneration agents, collagen or elastin promoters, skin protectants, agents that promote the reduction of excess fat or control of subcutaneous cellulite or body benefits, amino acids, peptides, minerals, hydroxy acids, antiemetics, anti-anginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, anti-migraine agents, smoking cessation agents, antidiarrheal agents, anti-ulcer agents, mood disorder agents, anti-obesity agents, erectile dysfunction control agents, anti-Parkinson's agents, MAO inhibitors, sleep disorder agents, anti-diabetic agents, or a combination thereof.

[0477] 86. The skin barrier protection delivery system according to any of the preceding items, further comprising a skin whitening agent selected from the group consisting of hydroquinone, arbutin, a hydroquinone derivative, paper mulberry extract (paper mulberry), rough cap extract (rough cap), bearberry extract (ursi), sorrel extract (curly and western), glutathione, leukocyte extract, Aspergillus oryzae extract (Aspergillus oryzae), licorice root extract (Glycyrrhiza uralensis), rosmarinic acid (Rosemary), tetrahydrocurcumin, green tea extract (Camellia sinensis), yohimbe extract (Yohimbe), Ecklonia cava extract, niacinamide, hydroxytetracycline, yellow betel nut extract, Guyana head order extract, snakewort extract, Gouania blanchetiana extract, Cordiaschomburgkii extract, blueberry extract, Hibiscus furcellatus extract, and combinations thereof.

[0478] 87. The skin barrier protection delivery system according to any of the preceding items, further comprising an antioxidant selected from the group consisting of ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperidin (blood orange), diosmin (blood orange), mangiferin (mango), mangosteen (mangosteen), anthocyanidins (European bilberry), astaxanthin (haematococcus), lutein (marigold), lycopene (tomato), resveratrol (knotweed), tetrahydrocurcumin (turmeric), rosmarinic acid (rosemary), hypericin (Hypericum perforatum), ellagic acid (pomegranate), chlorogenic acid (bilberry), oleuropein (olivine), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, Pycnogenol (pine bark extract), white tea extract, black tea extract, (andrographis paniculata), carnosine, niacinamide, emblica extract, and combinations thereof.

[0479] 88. The skin barrier protection delivery system according to any of the preceding items, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl benzoate, avobenzone, artemisia quinone, sulisobenzone, triethanolamine salicylate, artemisia quinone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof.

[0480] 89. The skin barrier protection delivery system according to any of the preceding items, wherein the formulation form of the skin barrier protection delivery system is selected from the group consisting of: emulsion, cream, gel, spray, thin liquid, body spray, facial mask, serum, solid beauty stick, lipstick, shampoo, liquid soap, bar soap, bath oil, cologne, conditioner, ointment, collodion, impregnated patch, impregnated strip or skin surface implant.

[0481] 90. The skin barrier protection delivery system according to any of the preceding items, further comprising a pharmaceutically acceptable carrier selected from the group consisting of aqueous and oil emulsions, suspensions, colloids, microemulsions, clear solutions, nanoparticle suspensions, nanoparticle emulsions and anhydrous compositions.

[0482] 91. A method for preparing the skin barrier protection delivery system of claim 1, comprising: (a) mixing petrolatum, a long-chain alkane and / or an ester of a long-chain alcohol in a reactor to produce a mixture; (b) heating the mixture until a melt is obtained; and (c) cooling the mixture.

[0483] 92. A method for preparing the skin barrier protection delivery system of claim 1, comprising: (a) heating petrolatum in a reactor; (b) adding an ester of a long-chain alkane and a long-chain alcohol to the reactor to produce a mixture; (c) heating the mixture until a melt is obtained; and (d) cooling the mixture.

[0484] The above description of the specific embodiments will fully reveal the general nature of the present disclosure, so that others can easily modify and / or adjust this specific embodiment for various applications without excessive experimentation and without departing from the general concept of the present disclosure by applying the knowledge of the relevant fields (including the contents of the documents listed and incorporated herein by reference) without excessive experimentation and without departing from the general concept of the present disclosure. Therefore, such adjustments and modifications are intended to fall within the equivalent meanings and scopes of the disclosed embodiments based on the teachings and guidance presented herein. It should be understood that the wording or terminology herein is for the purpose of description rather than limitation, so that the terms or wording of this specification should be interpreted by those skilled in the art based on the teachings and guidance presented herein, combined with the knowledge of those skilled in the relevant art.

[0485] Although various embodiments of the present disclosure have been described above, it should be understood that they are presented by way of example and not limitation. It will be apparent to those skilled in the art that various changes can be made to its form and details without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure should not be limited by any of the above exemplary embodiments, but should only be defined according to the attached claims and their equivalents.

[0486] All references cited herein are incorporated by reference in their entirety and for all purposes to the same extent as if each individual publication or patent or patent application was specifically and individually indicated to be incorporated by reference in its entirety for all purposes.

Claims

1. A skin barrier protection delivery system, comprising: (i) a mixture of coconut alkanes in a concentration range of 30-70 wt% and coconut caprylate / caprate in a concentration range of 3-7 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt %, wherein the delivery system is sprayable.

2. The skin barrier protection delivery system according to claim 1, wherein the mixture of coconut alkanes and coconut oil alcohol-caprylate / caprate is present in a concentration range of 30 wt% to 65 wt%.

3. The skin barrier protection delivery system according to claim 1, wherein the mixture of coconut alkanes and coconut oil-caprylate / caprate is present in a concentration of up to 70 wt%.

4. The skin barrier protection delivery system of claim 1, wherein the petrolatum is present at a concentration of about 40%.

5. The skin barrier protection delivery system of claim 1, wherein the petrolatum is present at a concentration of about 50%.

6. The skin barrier protection delivery system according to claim 1, further comprising at least one of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

7. The skin barrier protection delivery system according to claim 6, comprising at least two of ceramide, triglyceride, phytosterol, phytosterol ester, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

8. The skin barrier protection delivery system according to claim 6, comprising at least three of ceramide, triglyceride, phytosterol, phytosterol ester, isohexadecane, terpene, plant-based ester or wax, tocopherol and / or phospholipid.

9. The skin barrier protection delivery system according to any one of claims 4 to 8, wherein the plant-based ester or wax is selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax and sunflower wax.

10. The skin barrier protection delivery system according to claim 9, wherein the plant-based ester or wax comprises jojoba esters.

11. The skin barrier protection delivery system according to any one of claims 4 to 8, wherein the terpene is selected from the group consisting of triterpenes, hemiterpenes, monoterpenes, sesquiterpenes, diterpenes, sesquiterpenes and tetraterpenes.

12. The skin barrier protection delivery system according to claim 11, wherein the terpene is a triterpene.

13. The skin barrier protection delivery system according to claim 12, wherein the triterpene is squalene.

14. The skin barrier protection delivery system according to any one of claims 5 to 8, wherein the phytosterol ester comprises an ester derived from seed or nut oil.

15. The skin barrier protection delivery system according to claim 14, wherein the seed or nut oil is selected from the group consisting of macadamia oil, almond oil, avocado oil, rapeseed oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine nut oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil and walnut oil.

16. The skin barrier protection delivery system according to claim 15, wherein the phytosterol ester is phytosteryl macadamia oleate.

17. The skin barrier protection delivery system according to claim 1, comprising ceramide, triglyceride, phytosterol, phytosteryl macadamia oleate, squalene, jojoba esters and tocopherol.

18. The skin barrier protection delivery system according to claim 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglyceride and C12-18 acid triglyceride.

19. The skin barrier protection delivery system according to any one of the preceding claims, further comprising at least one of a polysaccharide, a gum, a buffer and a root plant extract.

20. The skin barrier protection delivery system according to claim 19, wherein the polysaccharide is selected from the group consisting of maltodextrin, cellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid and mixtures thereof.

21. The skin barrier protection system according to claim 19 or 20, wherein the polysaccharide is maltodextrin.

22. The skin barrier protection delivery system according to claim 19, wherein the gum is selected from the group consisting of guar gum, xanthan gum, pullulan gum, agar gum, carrageenan, gellan gum, gum arabic and tragacanth gum.

23. The skin barrier protection system of claim 19, wherein the gum is gum arabic.

24. The skin barrier protection delivery system according to claim 19, wherein the root plant extract is derived from a root plant selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish and radish.

25. The skin barrier protection delivery system according to claim 24, wherein the root plant extract is a sweet potato root extract.

26. The skin barrier protection delivery system according to claim 19, wherein the acid is citric acid. 27 . The skin barrier protection delivery system according to claim 19 , comprising at least one of sweet potato root extract, citric acid, gum arabic, and maltodextrin.

28. The skin barrier protection delivery system according to claim 19, comprising sweet potato root extract, citric acid, gum arabic and maltodextrin.

29. The skin barrier protection delivery system according to claim 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterols, phytosteryl macadamia oleate, tocopherol, C18-C36 acid triglyceride, C12-18 acid triglyceride, sweet potato root extract, gum arabic, citric acid and maltodextrin.

30. The skin barrier protection delivery system according to claim 1, wherein the ratio of the mixture of coconut alkanes and / or coconut alcohol-caprylate / caprate to petrolatum is about 1:

1.

31. The skin barrier protection delivery system according to claim 1, comprising: (i) at least 30 wt % of petrolatum; (ii) coconut alkanes in the range of 30-70 wt %; (iii) Coco-caprylate / caprate in the range of 3-7 wt %; (iv) ceramide NPs in the range of 0.01-0.1 wt %; (v) ceramide AP in the range of 0.01-0.1 wt %; (vi) jojoba esters in the range of 0.1-1.5 wt %; (vii) squalene in the range of 0.1-1 wt %; (viii) phytosteryl macadamia oleate in the range of 0.01-0.1 wt %; (ix) phytosterols in the range of 0.005-0.1 wt %; (x) tocopherol in the range of 0.001-0.1 wt %; (xi) C18-36 acid triglycerides in the range of 0.5-5 wt %; (xii) C12-18 acid triglycerides in the range of 0.1-1 wt%; (xiii) sweet potato root extract in the range of 0.01-0.1 wt %; (xiv) citric acid in the range of 0.001-0.01 wt %; (xv) gum arabic in the range of 0.001-0.1 wt %; and (xvi) 0.001-0.1 wt% maltodextrin, wherein the delivery system is a sprayable formulation.

32. The skin barrier protection delivery system according to claim 30, comprising: (i) 50 wt% of petrolatum; (ii) 42-43 wt% coconut alkanes; (iii) 4-5 wt% of coconut oil caprylate / caprate; (iv) 0.05 wt % ceramide NPs; (v) 0.05 wt% ceramide AP; (vi) 0.75 wt % jojoba esters; (vii) 0.3-0.4 wt% squalene; (viii) 0.05-0.06 wt % phytosteryl macadamia oleate; (ix) 0.01-0.02 wt % of phytosterols; (x) 0.0045 wt % tocopherol; (xi) 1-2 wt% C18-36 acid triglyceride; (xii) 0.4-0.5 wt% C12-18 acid triglyceride; (xiii) 0.03-0.04 wt % of sweet potato root extract; (xiv) 0.003-0.004 wt % citric acid; (xv) 0.03-0.04 wt% of gum arabic; and (xvi) 0.03-0.04 wt% maltodextrin.

33. The skin barrier protection delivery system according to any one of the preceding claims, further comprising zinc oxide.

34. A skin barrier protection delivery system, comprising: (i) 25-60 wt % of petrolatum; (ii) 10-25 wt% zinc oxide (ZnO); and (iii) 30-60 wt% of isohexadecane.

35. The skin barrier protection delivery system according to claim 34, comprising: (i) 40 wt% of petrolatum; (ii) 15 wt% zinc oxide (ZnO); and (iii) 45 wt% of isohexadecane.

36. The skin barrier protection delivery system according to any one of the preceding claims, having a viscosity of about 500 cps to about 10,000 cps.

37. The skin barrier protection delivery system according to any one of the preceding claims, having a viscosity of about 1,000 cps to about 5,000 cps.

38. The skin barrier protection delivery system according to any one of the preceding claims, further comprising an active ingredient.

39. The skin barrier protection delivery system according to claim 38, wherein the active ingredient is present in an amount of about 0.0001% to about 35% by weight.

40. The skin barrier protection delivery system according to claim 38 or 39, wherein the active ingredient is selected from the group consisting of antifungal agents, antibacterial agents, antiviral agents, anti-acne agents, anti-aging agents, antipruritic agents, ultraviolet absorbers, sunscreens, skin pigment regulators, skin whitening agents, skin darkening agents, hair growth promoters, hair growth inhibitors, anti-dandruff agents, anti-seborrheic agents, anti-psoriatic agents, depilatories, exfoliants, wound healing agents, anti-inflammatory agents, blood microcirculation improvers, sebum regulators, hormones, immunomodulators, plant extracts, moisturizers, emollients, astringents, antiperspirants, vitamins, retinoic acid , cleansers, sensates, color-changing agents, antibiotics, anti-irritants, anesthetics, analgesics, steroids, tissue healing agents, tissue regeneration agents, collagen or elastin promoters, skin protectants, agents that promote the reduction of excess fat or control of subcutaneous cellulite or body benefits, amino acids, peptides, minerals, hydroxy acids, antiemetics, anti-anginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, anti-migraine agents, smoking cessation agents, antidiarrheal agents, anti-ulcer agents, mood disorder agents, anti-obesity agents, erectile dysfunction control agents, anti-Parkinson's agents, MAO inhibitors, sleep disorder agents, anti-diabetic agents, and combinations thereof.

41. The skin barrier protection delivery system according to any one of the preceding claims, further comprising a skin whitening agent selected from the group consisting of hydroquinone, arbutin, a hydroquinone derivative, paper mulberry extract (paper mulberry), crassa chinensis extract (crassa chinensis), bearberry extract (ursi), sorrel extract (Rumex crispus and Rumex occidentalis), glutathione, leukocyte extract, Aspergillus oryzae extract (Aspergillus oryzae), licorice root extract (Glycyrrhiza uralensis), rosmarinic acid (Rosemary), tetrahydrocurcumin, green tea extract (Camellia sinensis), yohimbe extract (Yohimbe), Ecklonia cava extract, niacinamide, hydroxytetronic acid, yellow betel nut extract, guianensis extract, snakewort extract, Gouania blanchetiana extract, Cordia schomburgkii extract, blueberry extract, Hibiscus furcellatus extract, and combinations thereof.

42. The skin barrier protection delivery system according to any one of the preceding claims, further comprising an antioxidant selected from the group consisting of ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperidin (blood orange), diosmin (blood orange), mangiferin (mango), mangosteen (mangosteen), anthocyanidin (European bilberry), astaxanthin (haematococcus), lutein (marigold), Lycopene (tomato), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (turmeric), rosmarinic acid (rosemary), hypericin (Hypericum perforatum), ellagic acid (pomegranate), chlorogenic acid (bilberry), oleuropein (olivine), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, pycnogenol (pine bark extract), white tea extract, black tea extract, (andrographis paniculata), carnosine, niacinamide, emblica extract, and combinations thereof.

43. The skin barrier protection delivery system according to any one of the preceding claims, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl anthranilate, avobenzone, artemisia quinone, sulisobenzone, triethanolamine salicylate, artemisia quinone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof.

44. The skin barrier protection delivery system according to any one of the preceding claims, further comprising a pharmaceutically acceptable carrier selected from the group consisting of water and oil emulsions, suspensions, colloids, microemulsions, clear solutions, nanoparticle suspensions, nanoparticle emulsions or anhydrous compositions.

45. The skin barrier protection delivery system according to any one of claims 1 to 44, comprising no flammable components.

46. ​​The skin barrier protection delivery system according to claim 45, which does not contain a flammable solubilizer or alcohol.

47. A pharmaceutical composition comprising the skin barrier protection delivery system of any one of the preceding claims.

48. A pharmaceutical composition in the form of a sprayable gel comprising the skin barrier protection delivery system of any one of the preceding claims.

49. A device comprising a pharmaceutical composition according to claim 47 or 48.

50. The device of claim 49, wherein the device does not comprise a propellant, an aerosol, or a bag-on-valve.

51. A device according to claim 49 or 50, wherein the device is in the form of an atomising pump.

52. The device of claim 51, wherein the device is a dip tube atomizing pump.

53. A method for protecting the skin of a subject in need thereof, the method comprising applying to the subject's skin the skin barrier protection delivery system of any one of claims 1-46, the pharmaceutical composition of claim 47 or 48, or the device of any one of claims 49-52.

54. A skin barrier protection delivery system, comprising: (i) a mixture of long chain alkanes having a carbon length greater than 10 carbons, wherein the long chain alkanes are present in a concentration range of 30-70 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt %, wherein the delivery system is sprayable.

55. A skin barrier protection delivery system, comprising: (i) a mixture of a long chain alkane having a carbon length greater than 10 carbons in a concentration range of 30-70 wt% and an ester of a long chain alcohol in a concentration range of 3-7 wt%; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30 wt %, wherein the delivery system is sprayable.

56. The skin barrier protection delivery system according to claim 54 or 55, which is in the form of a sprayable gel.

57. A method for preparing the skin barrier protection delivery system of claim 1, the method comprising: (a) mixing petrolatum, a long-chain alkane and / or an ester of a long-chain alcohol in a reactor to produce a mixture; (b) heating the mixture until a melt is obtained; and (c) cooling the mixture.

58. A method for preparing the skin barrier protection delivery system of claim 1, the method comprising: (a) heating vaseline in a reactor; (b) adding a long chain alkane and / or an ester of a long chain alcohol to the reactor to produce a mixture; (c) heating the mixture until a melt is obtained; and (d) cooling the mixture.

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