Composition and method of preparing a composition

Description

1 / 22 COMPOSITION AND METHOD OF PREPARING A COMPOSITION Cross-reference to related request

[0001] The present application claims the benefit of priority of U.S. non-provisional patent application serial number 18 / 378,069 filed on October 9, 2023, which is incorporated herein in its entirety. Technical field

[0002] This disclosure is directed to the field of pharmaceutical products. More particularly, this disclosure is directed to topical compositions for the treatment of inflammatory skin conditions and methods of preparing such compositions. State of the art

[0003] Many people suffer from inflammatory skin conditions that are often the result of insect bites. Many compositions intended to help alleviate the negative symptoms of insect bites fail to provide relief. The following composition and method address this. Dissemination of the invention

[0004] In general, in a first aspect, the disclosure presents a composition. The composition may include an aqueous solution of iodopovidone, hydrocortisone, diphenhydramine, an emulsifier and a hydrophobic carrier, wherein the aqueous solution of iodopovidone is emulsified in the hydrophobic carrier.

[0005] In general, in a second aspect, the disclosure presents a method of preparing a composition. The method may include adding an aqueous solution of iodopovidone to a hydrophobic carrier and adding an emulsifier to the Petition 870250088538, dated 09 / 30 / 2025, p. 8 / 79 2 / 22 hydrophobic carrier at a concentration that emulsifies the aqueous iodopovidone solution in the hydrophobic carrier after mixing.

[0006] The characteristics of the method and composition may include the following. The composition may additionally include lidocaine. The emulsifier may be polysorbate 80. The hydrophobic carrier may be a cream, lotion, or ointment. The hydrophobic carrier may include one or more ingredients chosen from petrolatum, mineral oil, and a wax. Aqueous iodopovidone solution may be present in the composition at a concentration of 0.1% to 20% (w / w) or higher. Hydrocortisone may be present in the composition at a concentration of 0.1% to 1.0% (w / w) or higher. Diphenhydramine may be present in the composition at a concentration of 0.1% to 2% (w / w) or higher. Polysorbate 80 may be present in the composition at a concentration of 0.1% to 8.0% (w / w) or higher. Lidocaine may be present in the composition at a concentration of 0.1% to 4.0% (w / w) or higher.The hydrophobic carrier may include petrolatum or it may be an anhydrous ointment base including mineral oil, white petrolatum, and emulsifying wax that is capable of preparing water-in-oil emulsions.

[0007] It should be understood that the methods and compositions should not be considered limitations of the invention defined by the claims. The methods and compositions presented can be implemented in one or more ways using one or more features represented in the drawings, described in the detailed description, and presented in the claims. Brief description of the drawings Petition 870250088538, dated 09 / 30 / 2025, page 9 / 79 3 / 22

[0008] The attached drawings illustrate certain aspects and principles of the implementations presented, and should not be interpreted as limiting.

[0009] FIGS. 1A to E are chemical structures of iodopovidone (FIG. 1A), polysorbate 80 (FIG. 1B), hydrocortisone (FIG. 1C), diphenhydramine HCl (FIG. 1D), lidocaine (FIG. 1E).

[0010] FIGS. 2 to 5 are tables showing the results of ointment formulation experiments of a 20% BETADINE® ointment in MEDISCA® emulsifying base testing three different emulsifiers (polysorbate 80, sorbitan monooleate, polysorbate 20).

[0011] FIG. 6 is an image showing the formulations resulting from the experiments in FIGS. 2 to 5 (control - upper left formulation, polysorbate 20 upper right formulation, sorbitan monooleate lower left formulation and polysorbate 80 - lower right formulation).

[0012] FIG. 7 is a table showing the results of an ointment formulation experiment comparing 20% ​​BETADINE® formulations using different bases (MEDISCA® emulsifying ointment base or white petrolatum) and, for white petrolatum, two different emulsifier concentrations (polysorbate 80 at 4% w / w vs. polysorbate 80 at 8% w / w).

[0013] FIGS. 8 and 9 are tables showing summaries of ointment formulation experiments using different concentrations (10%, 15%, 20% w / w) of BETADINE® in petrolatum (FIG. 8) and 20% w / w of BETADINE® in different bases (base Petition 870250088538, dated 09 / 30 / 2025, page 10 / 79 4 / 22 emulsifier, 50% emulsifying base / 50% petrolatum, 25% emulsifying base / 75% petrolatum, FIG. 9).

[0014] FIG. 10A is a formula sheet showing an exemplary ointment formulation ingredient list. The ingredient list is for an ointment containing 20% ​​w / w BETADINE®, 2% w / w diphenhydramine HCl, 1% w / w hydrocortisone and 8% w / w polysorbate 80, combined in a MEDISCA® emulsifying ointment base.

[0015] FIG. 10B is an image that provides instructions for combining the ingredients shown in FIG. 10A. Modes of carrying out the invention

[0016] Reference will now be made in detail to several illustrative implementations. It should be understood that the following discussion of the implementations is not intended to be exhaustive.

[0017] The disclosure relates to compositions for the treatment of insect bites and other dermal conditions involving inflammatory responses. The composition may be implemented as an anti-itch cream, lotion, or ointment that includes an aqueous solution of BETADINE® (or the active pharmaceutical ingredient (API) iodopovidone), diphenhydramine HCl, hydrocortisone, and optionally lidocaine, formulated in a hydrophobic carrier or vehicle. The hydrophobic carrier may be a cream or lotion including carrier oils or a petroleum-derived ointment. The composition may be applied topically to alleviate various conditions involving dermal immune responses, including reducing itching from various dermal problems, including insect bites, athlete's foot (tinea pedis), contact dermatitis (eczema), and reaction to poisonous plants such as poison ivy. These are just a sample of Petition 870250088538, dated 09 / 30 / 2025, page 11 / 79 5 / 22 therapeutic applications and many others will be discussed in this document.

[0018] The compositions are designed to treat the various pharmacological and biochemical pathways involved in the immune response to an insect bite or other skin condition, including histamine response, inflammatory response, antigenic foreign protein response, and sensory response. The specific pharmacological agents in the composition neutralize the complex physiological pathways central to these responses and thus provide a highly effective treatment for individuals suffering from these skin conditions.

[0019] The present inventor has overcome the difficulty in incorporating aqueous solutions of iodopovidone, which is water-soluble or hydrophilic, into oily ointment carriers, which are hydrophobic. After extensive trial and error, the present inventor discovered that certain concentrations of polysorbate will facilitate the mixing of the aqueous iodopovidone solution into a hydrophobic carrier, such as an emulsifying base, and create a stable ointment that retains the liquid as well as all other ingredients of the composition. The present inventor has determined the appropriate amounts of polysorbate, oily ointment base and aqueous solution of iodopovidone, diphenhydramine HCl, hydrocortisone and, optionally, lidocaine that provide an ointment that is stable, absorbable through the skin and effective in stopping itching in less than 10 minutes and eradicating the sequelae of insect bites or other skin conditions.

[0020] The composition may incorporate or include the following ingredients: Petition 870250088538, dated 09 / 30 / 2025, p. 12 / 79 6 / 22

[0021] Iodopovidone is a water-soluble complex of iodine and polyvinylpyrrolidone that has a molecular weight of 364.95 g / mol. On a dry basis, it contains 9.0% to 12.0% available iodine. Its physical appearance is that of a yellowish-brown, amorphous, hygroscopic powder. The complex has broad antimicrobial activity through the release of free iodine that iodizes components of eukaryotic and prokaryotic cell membranes, such as lipids, killing or neutralizing bacteria, fungi, protozoa, and viruses. Iodopovidone is used as a topical antiseptic to prepare for surgery and to treat skin infections. Names of iodopovidone formulations include BETADINE® (Atlantis Consumer Healthcare Inc., Bridgewater, NJ, USA), Isodine, Bridine, and Disphex. Iodopovidone has the IUPAC name 1-ethenylpyrrolidin-2-one; molecular iodine and the CAS registry number 25655-41-8.BETADINE® is formulated as a 10% aqueous solution of iodopovidone and is also formulated as an antiseptic spray (iodopovidone, 5%, in solution or dry powder) or as a surgical exfoliant (7.5% aqueous solution of iodopovidone). The chemical structure of iodopovidone is given in FIG. 1A.

[0022] Polysorbate (e.g., polysorbate 80) is a hydrophilic nonionic surfactant formed by the reaction of sorbitan fatty acid ester with ethylene oxide, forming a polymer with a molecular weight of 604.8 g / mol composed of PEG-ylated sorbitan. Its physical appearance is that of a yellow to orange oily liquid. It is used as a surfactant, solubilizer, and emulsifying agent in multiple industries, including food, soaps, and pharmaceuticals. Polysorbate is marketed under a variety of names, including Monitan, Tween 80, Glycosperse, and polysorbate 80. Petition 870250088538, dated 09 / 30 / 2025, page 13 / 79 7 / 22 Its IUPAC name is 2-[2-[3,4-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl octadec-9-enoate. Polysorbate 80 has CAS registry number 9005-65-6. The chemical structure is given in FIG. 1B.

[0023] Hydrocortisone is a corticosteroid that exerts anti-inflammatory effects by binding to the glucocorticoid receptor. It has a molecular weight of 362.5 g / mol. It is also known as the human corticosteroid hormone cortisol, produced by the adrenal cortex. Its physical appearance is that of a white crystalline powder. Hydrocortisone is marketed under a variety of names, including Acticort, Cetacort, Dermacort, and Cortifan. Its IUPAC name is (8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one. Hydrocortisone has CAS registry number 50-23-7. The chemical structure is given in FIG. 1C.

[0024] Diphenhydramine HCl is an antihistamine with a molecular weight of 291.8 g / mol. It is a histamine H1 receptor antagonist used to treat allergic reactions. Its physical appearance is that of a white or almost white crystalline powder. It is most commonly known by its trade name BENADRYL®. Its IUPAC name is 2-benzhydryloxy-N,N-dimethylethanamine hydrochloride. Diphenhydramine HCl has CAS registry number 147-24-0. The chemical structure is given in FIG. 1D.

[0025] Lidocaine is a monocarboxylic acid amide of local anesthesia resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline. The names under which lidocaine is marketed include Lignocaine. Petition 870250088538, dated 09 / 30 / 2025, page 14 / 79 8 / 22 and Xylocaine. Its IUPAC name is 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide. Lidocaine acts by blocking sodium channels, inhibiting nerves in local tissues from signaling pain. The molecular weight of lidocaine is 234.34 g / mol. Lidocaine appears as a white or slightly yellow crystalline powder. Its IUPAC name is 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide. The CAS registry number for lidocaine is 137-58-6. The chemical structure is given in FIG. 1E.

[0026] The ingredients of the composition may be formulated in various hydrophobic carriers, such as creams, lotions, and ointment bases. According to some implementations, the composition is formulated in an ointment base that has one or more ingredients chosen from petrolatum, mineral oil, and wax. Although the hydrophobic carrier may vary in composition, two specific examples are provided below.

[0027] Petrolatum ointment base is a colloidal system of semi-solid hydrocarbons derived from petroleum and used as an ointment base that is most commonly known as petroleum jelly and VASELINE®. Its physical appearance is that of a colorless, white, or yellowish to light amber semi-solid or liquid. The CAS registry numbers for petrolatum are 8009-038, 8063-27-2, and 8027-32-5.

[0028] MEDISCA® ointment base (emulsifier) ​​is an anhydrous ointment base composed of mineral oil, white petrolatum, and emulsifying wax that can be used to prepare water-in-oil emulsions (Medisca Inc., Plattsburgh, NY, USA). It appears as a waxy, white to off-white ointment. It is sold under product number 0937. Petition 870250088538, dated 09 / 30 / 2025, page 15 / 79 9 / 22

[0029] Other ointment bases may also be used to formulate the composition, either as a component base ingredient with other base ingredients or as the entire base ingredient. Several hydrophobic and hydrophilic ointment bases are available. Hydrophobic bases are composed of hydrocarbons (oil compounds) and include white ointment, white petroleum, mineral oil, wax and other paraffins, and VASELINE®. Hydrophilic bases include anhydrous absorption bases such as hydrophilic petrolatum, anhydrous lanolin, POLYSORB®, AQUAPHOR® and AQUABASE®; these will absorb significant amounts of water. Water-in-oil emulsion ointment bases are hydrated bases, such as hydrated lanolin, cold cream, EUCERIN®, HYDROCREAM®, rosewater ointment, and NIVEA®. Other examples of hydrophilic absorption bases include oil-in-water emulsion bases, water-soluble bases, and gels. Formulas for these ointment bases have been described in the pharmacy literature (see De Villiers, Melgardt (2009), “Ointment Bases”, in the book: “A Practical Guide to Contemporary Pharmacy Practice” (pp. 277-290), Edition: 3, Chapter: 23, Publisher: Lippincott). Williams & Wilkins, Editors: Judith E Thompson; and “Remington: The Science and Practice of Pharmacy” (2020), Publisher: Academic Press, each incorporated herein by reference). Ointment bases may be chosen to incorporate the active pharmaceutical ingredients (APIs) of the composition, provide stability and consistency, and deliver them to the affected skin areas. Hydrophilic APIs, such as povidone-iodine in aqueous solution, may be emulsified in the ointment base, as may an ointment base that has one or more hydrophobic ointment base ingredients chosen from Petition 870250088538, dated 09 / 30 / 2025, page 16 / 79 10 / 22 above, using disclosure methods, or otherwise incorporated as water-soluble ingredients if a hydrophilic ointment base is chosen.

[0030] More broadly, individual carrier ingredients in various combinations, representing hydrophobic and / or hydrophilic carrier substances, examples not limited to including white petrolatum, white wax, mineral oil, vegetable oils, animal fats, mineral wax, beeswax, cholesterol, parabens, methylparaben, propylparaben, triethanolamine, propylene glycol, polyethylene glycol, wool wax alcohol, cetyl alcohol, stearyl alcohol, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, butyl stearate, and butyl palmitate, stearic acid, glycerin, cetyl ester wax, almond oil, rose oil, pine needle oil, purified water, rose water, carbomer 934, poloxamer 407, ethyl alcohol, isopropyl alcohol, high molecular weight alcohols and chain fats or oils branched, they can be used to provide a basis for formulating the inventive composition.The inventive composition of the disclosure preferably incorporates one or more of the above-mentioned hydrophobic or non-polar ingredients as carrier substances, in combination with an emulsifier, as well as other ingredients such as stabilizers, penetration enhancers, antioxidants, pigments or fragrances.

[0031] The ingredients can be formulated in the composition at the following concentrations:

[0032] BETADINE® (e.g., aqueous solution of iodopovidone at 5%, 7.5% or 10%) may be included in Petition 870250088538, dated 09 / 30 / 2025, p. 17 / 79 11 / 22 composition in a concentration of 0.1% to 20% (w / w), including 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.2%, 1.4%, 1.6%, 1.8%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18% and 19%, as well as values ​​between them, as well as in any range encompassing these values, such as 0.1% 1%, 1% to 10%, 2% to 10%, 3% to 10%, 4% to 10%, 5% to 10%, 1% to 5%, 2% to 8%, 3% to 7%, 8% to 10%, 10% to 20%, 10% to 15%, 12% to 18%, 15% to 20%, 16% to 20%, 14% to 18%, 15% to 18%, 5% to 20%, 8% to 20%, 1% to 20%, 12% to 20%, 16% to 20%, and so on. In other implementations, BETADINE® concentrations greater than 20% (w / w), including 21%, 22%, 23%, 24% and 25%, or more, such as 30%, 35% or 40%, are included in the composition.

[0033] In other implementations, the composition may incorporate generic forms of aqueous iodopovidone solution instead of such solutions specifically marketed under the trade name BETADINE®. The composition may incorporate generic aqueous solutions of 1% to 20% iodopovidone, including 2%, 2.5%, 3%, 4%, 5%, 6%, 7%, 7.5%, 8%, 9%, 10%, 12%, 12.5%, 15%, 17.5% and 20% iodopovidone, as well as values ​​in between, and in any range encompassing these values, such as 5% to 10%, 2.5% to 10%, 2.5% to 12.5%, 5% to 17.5%, 7.5% to 12.5%, 7.5% to 15%, 15% to 20% of iodopovidone, and so on, with an amount of aqueous iodopovidone solution incorporated into the composition in the range of a concentration of 0.1% to 20% (w / w), as mentioned above for BETADINE®. For example, the composition may be an ointment that includes 200 mg / gram (or 20% w / w) of a 10% iodopovidone solution, or 100 mg / gram (or 10% w / w) of a Petition 870250088538, dated 09 / 30 / 2025, p. 18 / 79 12 / 22 10% iodopovidone solution, or 150 mg / gram (15% w / w) of a 10% iodopovidone solution, or including 200 mg / gram (or 20% w / w) of a 5% iodopovidone solution, or 100 mg / gram (or 10% w / w) of a 5% iodopovidone solution, or 150 mg / gram (15% w / w) of a 5% iodopovidone solution, or including 200 mg / gram (or 20% w / w) of a 20% iodopovidone solution, or 100 mg / gram (or 10% w / w) of a 20% iodopovidone solution, or 150 mg / gram (15 % w / w) of a 20% iodopovidone solution, or including 200 mg / gram (or 20% w / w) of a 7.5% iodopovidone solution, or 100 mg / gram (or 10% w / w) of a 7.5% iodopovidone solution, or 150 mg / gram (15% w / w) of a 7.5% iodopovidone solution. 7.5%, or including 200 mg / gram (or 20% w / w) of a 15% iodopovidone solution, or 100 mg / gram (or 10% w / w) of a 15% iodopovidone solution, or 150 mg / gram (15% w / w) of a 15% iodopovidone solution, or the composition may be an ointment including 100 to 200 mg / gram (10 to 20% w / w) of a 5 to 10% iodopovidone solution. Generic aqueous solutions of iodopovidone may be from generic manufacturers or prepared directly from dried iodopovidone powder in a suitable aqueous vehicle, such as sterile distilled water.

[0034] Diphenhydramine HCl may be included in the composition at a concentration of 0.1% to 2% (w / w), including 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8% and 1.9%, as well as values ​​between them, as well as any range encompassing these values, such as 0.1% to 1.0%, 0.2% to 1.0%, 0.3% to 1.0%, 0.4% to 1.0%, 0.5% to 1.0%, 0.5% to 1.5%, 0.5% to 2.0%, 1.0% to 2.0%, 1.2% to 2.0%, 1.5% to 2.0%, Petition 870250088538, dated 09 / 30 / 2025, p. 19 / 79 13 / 22 1.6% to 2.0%, 0.8% to 1.2%, 0.4% to 1.6%, 1.1% to 1.9%, and so on. In other implementations, diphenhydramine HCl concentrations greater than 2% (w / w), including 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9% and 3.0%, or more, such as 3.5% or 4.0%, are included in the composition.

[0035] Hydrocortisone may be included in the composition at a concentration of 0.1% to 1.0% (w / w), including 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8% and 0.9%, as well as values ​​between them, and any range encompassing those values, including 0.1% to 1.0%, 0.2% to 1.0%, 0.3% to 1.0%, 0.4% to 1.0%, 0.5% to 1.0%, 0.6% to 1.0%, 0.2% to 0.8%, 0.4% to 0.8%, 0.5% to 0.8%, 0.1% to 0.9%, 0.5% to 0.9%, 0.3% to 0.9%, 0.6% to 0.9%, and so on. In other implementations, hydrocortisone concentrations greater than 1.0% (w / w), including 1.1%, 1.2%, 1.3%, 1.4% and 1.5%, or more, such as 1.6%, 1.7%, 1.8%, 1.9% or 2.0%, are included in the composition.

[0036] Lidocaine may be included in the composition at a concentration of 0.1% to 4.0% (w / w), including 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3.0%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, as well as values ​​between them, as well as any range encompassing these values, such as 1.0% to 4.0%, 0.5% to 4.0%, 1.5% to 4.0%, 2.0% to 4.0%, 2.5% to 4.0%, 3.0% to 4.0%, 1.0% to 3.0%, 1.5% to 3.5%, 1.2% to 3.8%, 0.5% to 3.5%, 1.4% to 3.8%, 0.5% to 3.9%, 2.2% to 4.0%, and so on. In other implementations, lidocaine concentrations greater than 4.0% (w / w), including 4.1%, 4.2%, 4.3%, 4.4 Petition 870250088538, dated 09 / 30 / 2025, p. 20 / 79 14 / 22%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9% and 5.0%, or more, such as 6%, 7% or 8%, are included in the composition.

[0037] Polysorbate 80 may be included in the composition at a concentration of 0.1% to 8.0% (w / w), including 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, as well as values ​​between them, as well as in any range encompassing these values, including 2.0% to 4.0%, 2.0 % to 6.0%, 3.0% to 5.0%, 6.0% to 8.0%, 4.0% to 8.0%, 5.0% to 8.0%, 5.0% to 7.0%, 3.0% to 6.0% and 2.0% to 8.0%. In other implementations, polysorbate 80 concentrations greater than 8.0% (w / w), including 8.2%, 8.4%, 8.6%, 8.8%, 9.0%, 9.5%, 10.0%, 10.5%, 11.0% and 12.0%, or more, such as 13%, 14%, 15% or 16%, are included in the composition.

[0038] The ingredients may be formulated as an emulsion using an oil-based ointment (e.g., petrolatum), a water-in-oil emulsifying ointment base (e.g., MEDISCA® emulsifying ointment base), or a combination thereof. The ingredients may also be formulated in other hydrophobic carriers, such as other ointments, lotions, and creams. In other implementations, the ingredients are formulated as pastes, gels, or impregnated substances. The ingredients may be formulated by weighing an appropriate amount of each ingredient to achieve a desired concentration and mixing using a mortar and pestle or mechanical pharmaceutical mixer or blender until a homogeneous composition is achieved. For example, in one implementation, an aqueous solution of iodopovidone is first added to a Petition 870250088538, dated 09 / 30 / 2025, page 21 / 79 15 / 22 hydrophobic carrier at a desired concentration, and then an appropriate amount of emulsifier, such as polysorbate 80, is gradually and incrementally added and mixed into the hydrophobic carrier until the aqueous iodopovidone solution is completely emulsified in the hydrophobic carrier. Example 4 illustrates a list of ingredients with appropriate weights for combination to achieve a particular embodiment of the inventive composition.

[0039] The inventive compositions are useful for the treatment of inflammatory skin conditions and rashes, including bites and stings, infections, autoimmune diseases, and allergies. Examples of inflammatory skin conditions that can be treated include insect bites or stings, such as those from mosquitoes, flies (e.g., horseflies, black flies, deer flies, sandflies), bees, yellow wasps, hornets, spiders, scorpions, ants, wasps, fleas, ticks, trombiculids, lice, scabies mites, kissing bugs, and bed bugs. Other examples include animal bites or scratches, including those from rodents, cats, dogs, and reptiles. Other examples include skin rashes from contact with poisonous plants, such as poison oak, poison ivy, poison sumac, and common nettle.Other examples include drug-induced skin rashes, such as those produced by systemic allergic reactions to medications like antibiotics, allopurinol, antiepileptic drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), and vaccines. Other examples include direct contact dermatitis resulting from topical exposures to certain substances, such as antibiotics, antiseptics, preservatives, rubber products, detergents, or metals. Petition 870250088538, dated 09 / 30 / 2025, page 22 / 79 16 / 22 Other examples include viral skin infections, such as those caused by herpes simplex viruses 1 and 2 or herpes zoster. Other examples include fungal skin infections, such as tinea pedis and tinea versicolor. Other examples include autoimmune conditions, such as psoriasis. These are merely illustrative examples, and more will become apparent to the expert. Inflammatory skin conditions may present as skin rashes (e.g., erythema multiforme, erythema nodosum), hives, welts, blisters, itchy areas, and / or combinations thereof. An appropriate amount of the composition (e.g., 0.1 grams to 5 grams) can be applied dermally to the site of the inflammatory skin condition until the symptoms of the inflammatory skin condition, such as itching, pain, swelling, and redness, are reduced or eliminated, as applied for 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 12 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes or more.

[0040] Examples 1 to 3 below describe experiments performed to determine the correct ingredients and quantities of ingredients for inventive compositions that provide an ointment with homogeneity, consistency, stability, and other material properties suitable for medical applications for the treatment of inflammatory skin conditions. The experiments also determined a suitable emulsifying agent and the appropriate concentration of the emulsifying agent for the formulation of BETADINE® (10% aqueous solution of iodopovidone), which is water-soluble, in a fat-soluble ointment base. Example 1 describes experiments testing the effectiveness of three emulsifiers. Petition 870250088538, dated 09 / 30 / 2025, page 23 / 79 Example 1 describes experiments testing the efficacy of two different concentrations of polysorbate 80 (4% w / w, 8% w / w) and two different ointment bases in the consistency of a 20% (w / w) BETADINE® ointment. Example 2 provides results from experiments testing different ointment implementations with fixed amounts of polysorbate 80, hydrocortisone, and diphenhydramine, and different concentrations of BETADINE® (10% w / w, 15% w / w, 20% w / w) using different ointment bases. Example 4 describes a particular embodiment of the inventive compositions. Example 1: BETADINE® ointment at 20% in an emulsifying base; experiment with three different emulsifiers

[0041] FIGS. 2 to 5 are tables showing the results of ointment formulation experiments of a 20% w / w BETADINE® ointment in MEDISCA® emulsifying base testing three different emulsifiers (polysorbate 80, sorbitan monooleate, polysorbate 20). FIG. 6 is an image showing the resulting formulations (control formulation - top left, polysorbate 20 - top right, sorbitan monooleate - bottom left and polysorbate 80 - bottom right). The experimental protocol is provided below. Base: MEDISCA® emulsifying ointment base. Materials: 1. 3 glass mortars and pestles 2. Existing BETADINE® ointment 20% w / w 3. Emulsifiers: polysorbate 80, NF Petition 870250088538, dated 09 / 30 / 2025, page 24 / 79 18 / 22 sorbitan monooleate (Span 80) polysorbate 20 NF 4. 3 syringes Procedure: 1. Gather the compound and try to combine it first in small amounts. 2. Weigh the compound, then divide the weight by 4 (control and 3 test emulsifiers), each weighing 7 g. The total weight is 28 g. Record the weight of each below: Weight of the controller: 7.09 g 3. Place ¼ of the compound in the corresponding mortar and pestle. One emulsifier per mortar and pestle. 4. Drop a drop (0.1 mL) of the first emulsifier and write a description of its consistency (an image is acceptable). a. Draw up 0.1 mL with a syringe and wipe clean before placing it on a scale for measurement. b. Measure the syringe with emulsifier. c. Inject 0.1 mL into the mortar containing the compound. d. Measure the empty syringe. e. Mix the first emulsifier with the compound. 5. Continue until consistent (estimated amounts until consistent 0.5 to 6% ~ 0.3 mL) 6. Repeat steps 4 and 5 with other emulsifiers. Beaker 28.85 grams Syringe 2.61 grams Example 2: BETADINE® 20% ointment base; experiment comparing polysorbate 80 concentrations. Petition 870250088538, dated 09 / 30 / 2025, page 25 / 79 19 / 22

[0042] FIG. 7 is a table showing the results of an ointment formulation experiment comparing BETADINE® ointment formulations at 20% w / w using different bases (MEDISCA® emulsifying ointment base or white petrolatum) and, for white petrolatum, two different emulsifier concentrations (polysorbate 80 at 4% w / w vs. Polysorbate 80 at 8% w / w). The experimental protocol is provided below. Materials: Base: MEDISCA® emulsifying ointment base or white petrolatum. Emulsifier: polysorbate 80 Active pharmaceutical ingredient (API): BETADINE® Procedure: 1. Place an empty bottle (emp) on a scale and zero its weight. 2. Weigh 14.4 g of emulsifying base into the emulsifying bottle. Record the actual weight. a. Base (emulsifying ointment): 14.446 g 3. Zero the bottle containing the base. Add 4 g of BETADINE® to the zeroed bottle that already contains the base. Record the actual weight: a. IFA (BETADINE®): 4.01 g 4. Zero the empty vial containing the base and the API one last time. 5. Using a syringe, measure 1.6 g (~1.6 mL) of polysorbate 80. This will be the last ingredient to be added to the vial. Record the actual weight. a. Polysorbate 80: 1.6 g Petition 870250088538, dated 09 / 30 / 2025, page 26 / 79 20 / 22 6. Take the empty bottle containing all the ingredients to be mixed. Settings: a. Speed: 2 b. Time: 1 minute 7. Remove the bottle from the mixer and record a description of the compound. 8. Repeat steps 1 through 7 using petrolatum as the base. Record the weights at each step. a. Base (petrolatum): 14.41 g b. IFA (BETADINE®): 4.02 g c. Polysorbate 80: 1.61 g 9. Repeat steps 1 to 7 with polysorbate 80 (0.8 g), petrolatum 15.2 g, and API 4 g. Record the weights. a. Base (petrolatum): 15.23 g b. IFA (BETADINE®): 4.01 g c. Polysorbate 80: 0.83 g Example 3: Ointment formulation experiments with different concentrations of BETADINE® and different bases.

[0043] FIGS. 8 and 9 are tables showing summaries of ointment formulation experiments using different concentrations (10%, 15%, 20% w / w) of BETADINE® in petrolatum (FIG. 8) and 20% w / w of BETADINE® in different bases (emulsifying base, 50% emulsifying base / 50% petrolatum, % emulsifying base / 75% petrolatum, FIG. 9). The ointment formulations include fixed amounts of polysorbate 80 (8% w / w), hydrocortisone (1% w / w) and diphenhydramine (2% w / w). The tables show each of the ingredients, the calculated and actual concentrations and weights, and an image of the resulting ointment obtained after combination. Petition 870250088538, dated 09 / 30 / 2025, page 27 / 79 21 / 22 Example 4: Formula for an ointment (emulsifier) ​​of 20% BETADINE® / 2% diphenhydramine HCl / 1% hydrocortisone for combination

[0044] FIG. 10A is a formula sheet showing an exemplary ointment formulation ingredient list. The ingredient list is for an ointment containing 20% ​​w / w BETADINE® (10% aqueous iodopovidone solution), 2% w / w diphenhydramine HCl, 1% w / w hydrocortisone, and 8% w / w polysorbate 80, combined in a MEDISCA® emulsifying ointment base. FIG. 10B is an image providing instructions for combining the ingredients shown in FIG. 10A.

[0045] This disclosure has described particular implementations with various features. In light of the disclosure provided above, it will be evident to those skilled in the art that various modifications and variations can be made without departing from the scope or spirit of the disclosure. A person skilled in the art will recognize that the disclosed features can be used singularly, in any combination, or omitted based on the requirements and specifications of a particular application or design. When an implementation refers to comprising certain features, it should be understood that the implementations may alternatively consist of, or consist essentially of, any one or more of the features. Other implementations will be evident to those skilled in the art from consideration of the descriptive report and practice of the disclosure.

[0046] It is noted, in particular, that when a range of values ​​is provided in this descriptive report, Petition 870250088538, dated 09 / 30 / 2025, page 28 / 79 22 / 22 Each value between the upper and lower limits of this range is also specifically disclosed. The upper and lower limits of these smaller ranges may be independently included in or excluded from the range as well. The singular forms a, an, oea include plural referents unless the context clearly indicates otherwise. The descriptive report and examples are intended to be illustrative in nature and variations that do not depart from the essence of the disclosure are within the scope of the disclosure. Furthermore, all references cited in this disclosure, including patents, published applications and non-patent literature, are each individually incorporated by reference herein in their entirety and, as such, are intended to provide an efficient way to supplement the enabling disclosure as well as to provide background detailing the common skill level in the art. Industrial application

[0047] The disclosed invention would be valuable for those suffering from inflammatory responses to insect bites or other causes. Petition 870250088538, dated 09 / 30 / 2025, page 29 / 79

Claims

1 / 4 CLAIMS 1. Composition, characterized by comprising: an aqueous solution of iodopovidone; hydrocortisone; diphenhydramine; an emulsifier; and a hydrophobic carrier; wherein the aqueous solution of iodopovidone is emulsified in the hydrophobic carrier.

2. Composition according to claim 1, characterized by further comprising lidocaine.

3. Composition according to claim 1, characterized in that the emulsifier is polysorbate 80.

4. Composition according to claim 1, characterized in that the hydrophobic carrier is a cream, lotion or ointment.

5. Composition according to claim 3, characterized in that: the aqueous solution of iodopovidone is present in the composition at a concentration of 0.1% to 20% (w / w); hydrocortisone is present in the composition at a concentration of 0.1% to 1.0% (w / w); diphenhydramine is present in the composition at a concentration of 0.1% to 2% (w / w); and polysorbate 80 is present in the composition at a concentration of 0.1% to 8.0% (w / w).

6. Composition according to claim 3, characterized in that: an aqueous solution of iodopovidone is present in the composition at a concentration of 20% (w / w); hydrocortisone is present in the composition at a concentration of 1% (w / w); diphenhydramine is present in the composition at a concentration of 2% (w / w); and polysorbate 80 is present in the composition at a concentration of 8% (w / w).

7. Composition according to claim 3, characterized in that: the aqueous solution of iodopovidone is present in the composition at a concentration greater than 20% (w / w); or hydrocortisone is present in the composition at a concentration greater than 1% (w / w); or diphenhydramine is present in the composition at a concentration greater than 2% (w / w); or polysorbate 80 is present in the composition at a concentration greater than 8% (w / w).

8. Composition according to claim 1, characterized in that the hydrophobic carrier is an anhydrous ointment base comprising mineral oil, white petrolatum and emulsifying wax and is capable of preparing water-in-oil emulsions.

9. Composition according to claim 1, characterized in that the hydrophobic carrier comprises petrolatum.

10. Composition according to claim 5, characterized in that the hydrophobic carrier is an anhydrous ointment base comprising mineral oil, white petrolatum and emulsifying wax and is capable of preparing water-in-oil emulsions.

11. Composition, according to claim 5, characterized by the hydrophobic carrier comprising petrolatum. Petition 870250088538, dated 09 / 30 / 2025, page 31 / 79 3 / 4 12. Composition according to claim 2, characterized in that lidocaine is present in the composition at a concentration of 0.1% to 4.0%.

13. Composition according to claim 2, characterized in that lidocaine is present in the composition at a concentration of 4.0%.

14. Composition according to claim 2, characterized in that lidocaine is present in the composition at a concentration greater than 4.0%.

15. A method for preparing a composition, characterized by comprising: adding an aqueous solution of iodopovidone to a hydrophobic carrier; and adding an emulsifier to the hydrophobic carrier at a concentration that emulsifies the aqueous solution of iodopovidone in the hydrophobic carrier after mixing.

16. Method according to claim 15, characterized in that the emulsifier is polysorbate 80.

17. Method according to claim 16, characterized in that an aqueous solution of iodopovidone is added at a concentration of 0.1% to 20% (w / w) and polysorbate 80 is added at a concentration of 0.1% to 8.0% (w / w).

18. Method according to claim 16, characterized in that an aqueous solution of iodopovidone is added at a concentration of 20% (w / w) and polysorbate 80 is added at a concentration of 8.0% (w / w).

19. Method, according to claim 15, characterized by the hydrophobic carrier being an anhydrous ointment base comprising mineral oil, white petrolatum and emulsifying wax and capable of preparing water-in-oil emulsions.

20. Method according to claim 15, characterized in that the hydrophobic carrier comprises petrolatum. Petition 870250088538, dated 09 / 30 / 2025, p. 33 / 79

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