MXPA06001713A - Emulsive composition containing dapsone. - Google Patents

Abstract

The present invention relates to a topical, emulsive composition containing Dapsone or its derivative. The inventive composition incorporates emollients and Dapsone or its derivative in a stable emulsion. The stability is achieved through the use of a combination of certain surfactant mixtures and an enhancer providing solubility of the Dapsone.

Description

COMPOSITION IN EMULSION CONTAINING DAPSONE DECLARATION OF PRIORITY This patent application claims the priority of the United States provisional patent application serial number 60 / 494,912, filed on August 13, 2003.

BACKGROUND OF THE INVENTION The DDS or 4,4'-diaminodiphenylsulfone has the name USP Dapsone, and is a well-known drug that possesses several beneficial medicinal activities. Dapsone is typically administered as one of the medicinal agents used in the treatment of leprosy. Dapsone and its derivatives are also effective for the treatment of bacterial infections, infections by protozoa, such as malaria, pneumocystis carinii and plasmonic infections, such as toxoplasmosis. Some of the previous publications describing Dapsone and its derivatives include a French patent of 1938 (FR 829,926) and US patent No. 2,385,899. These references explain that Dapsone has an inhibitory effect on the development of bacteria, mycobacteria and plasmodia. According to the 2001 Physicians Desk Reference, Dapsone can be obtained commercially in the form of tablets from Jacobus Pharmaceutical Company. Dapsone is also used as an entanglement agent for epoxy resins. It is also known that Dapsone is useful as an anti-inflammatory agent. It has been used to treat skin diseases characterized by abnormal infiltration of neutrophils, such as dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris and Sweet's syndrome. In all these applications, including topical applications, treatment with Capsone is systemic and the drug is administered orally. There is no commercial topical formulation of Dapsone available for the local treatment of skin diseases; and references that describe the topical administration of Dapsone are not common. Of the few scientists who consider topical administration, Osborne (U.S. Patent Nos. 5,863,560 and 6,060,085) is one that provides a topical formulation of Dapsone. Describes a dermatological gel composition containing Dapsone. One reason for the lack of topical commercial formulations is the solubility character of Dapsone and its derivatives. Dapsone and many of its derivatives are soluble in ethanol, methanol, acetone and dilute aqueous HCl; but they are practically insoluble in water and in oils, such as petroleum jelly, wax and vegetable oils. Consequently, topical formulations of Dapsone in water or oils are difficult to develop. Topical formulations of Dapsone that have been developed typically include salt formers and solubilizing agents that allow the formation of a single phase aqueous solution or gel. The solubilizing agents are miscible with water, and include organic liquids such as ethylene glycol monoethyl ether and ethanol. However, the use of such topical formulations of Dapsone is also problematic. These topical formulations typically act as drying agents for the skin. They remove the skin's essential oils and natural softeners from the skin, causing it to dry, itch and crack. However, the inclusion of exogenous emollients for the skin, oil and the like causes phase separation and precipitation of Dapsone. The use of typical emulsifiers does not solve the Dapsone precipitation due to the decreased solubility of Dapsone and the conflicting physical characteristics of the phases of the resulting composition. Accordingly, there is a need to formulate a water-based, stable, emulsion-based Dapsone composition that does not dry or crack the skin. There is also a need to formulate said composition with ingredients acceptable for pharmaceutical use. There is also a need to include exogenous oils, emollients and the like, in said emulsion, without causing separation or precipitation of Dapsone.

BRIEF DESCRIPTION OF THE INVENTION These and other needs are met by means of the present invention, which provides a stable emulsion composition, containing Dapsone or a Dapsone derivative. The emulsion composition allows the use of a wide variety of oil phase components, such as vehicles for the topical (skin or mucosal) delivery of Dapsone or a Dapsone derivative. The emulsion composition of the invention also allows the use of polar phase components for the increased delivery and better performance of Dapsone or a Dapsone derivative, on the skin or mucosa. Accordingly, the present invention is directed to an emulsion composition having the following components: a) Dapsone or its derivative (hereinafter collectively referred to as Dapsone); b) a solvation medium (polar phase component) for Dapsone; c) an emulsifier system; d) an oil phase component; e) optional water and (f) optional gelation agents or thickeners. Excipients, as well as other additives and dyes, may also be included as additional compounds in the solvation medium (polar phase) and oil phase components. Each of the components of the emulsion composition (except optional water) may consist of one or more individual compounds, which fall within the description of the component. The solvation medium (polar phase) can be an organic solvent that varies in its water solubility from moderately soluble (for example, having a solubility in water of 2 percent to 10 percent by weight), until completely miscible with water , in all proportions. The solvation medium will dissolve the Dapsone, at least partially and, preferably completely. When the optional water is combined with the solvation medium, the combination will also dissolve the Dapsone at least partially and, preferably, completely. In any of those aspects, the solvation medium or the solvation medium plus the water, dissolve or disperse the Dapsone as a stable solution or dispersion. When the combination of solvation medium and water is used, that combination is the polar phase (an aqueous polar phase) and the solvation medium preferably increases the solubility of Dapsone in this aqueous polar phase. Preferred organic solvents that function as a solvation medium, alone or in combination with water, include: a polyglycol, a polyol, a polyglycol ether, a polyol ether, a polyglycol monoether or a polyol monoether, or a combination of they. The oil phase component includes any organic hydrophobic substance, acceptable for pharmaceutical use, which softens and moistens the layers of the skin, such as the epidermis and the dermis. Waxes, oils, fatty acids, polyols and esterified fatty acids are some examples of the oil phase component. The emulsifier system has both ionic and non-ionic properties, so as to stabilize the emulsion composition of the invention, and prevent the separation of Dapsone. Preferably, the ionic properties are anionic properties. The combination of these properties can be obtained by a mixture of surfactant and a saturated and / or unsaturated fatty alcohol. In particular, a mixture of a saturated and / or unsaturated fatty alcohol of 10 to 24 carbon atoms, and one or more of an ester or a saturated and / or unsaturated fatty alcohol phosphate diester, of 8 to 24 atoms of carbon, an ester or a diester of saturated and / or unsaturated fatty alcohol sulphate of 8 to 24 carbon atoms, an ester or a saturated fatty alcohol carbonate diester and / or unsaturated of 8 to 24 carbon atoms, as well as the derivatives of said phosphate, sulfate and / or saturated fatty alcohol carbonate esters and / or unsaturated, it can serve as an emulsifier system according to the invention. Preferably the emulsifier system is a combination of a fatty alcohol of 12 to 18 carbon atoms, a diester phosphate of a fatty alcohol of 12 to 18 carbon atoms, and a monoester phosphate of an unsaturated fatty alcohol of 12 to 18 carbon atoms. According to the invention, the concentrations of the components, by weight with respect to the total weight of the emulsion composition, are as follows: a) Dapsone can vary from about 0.005 percent to about 30 percent, preferably from around 0.1 percent to around 25 percent; more preferable, from around 0.1 percent to around 15 percent; especially, from around 0.1 percent to around 10 percent; very especially from around 0.2 percent to around 8 percent; and most preferably, from about 0.5 percent to about 5 percent by weight of the emulsion composition; being especially preferred modalities those having percentages such as 1, 2, 5 and 7.5 weight percent. b) The solvation medium can vary from about 0.5 percent to about 99 percent; preferably from about 0.5 percent to about 50 percent; more preferable, from about 5 percent to about 40 percent; especially, from around 5 percent to around 35 percent; very preferable, from around 5 percent to around 30 percent. c) The emulsifier system can vary from about 0.1 percent to about 30 percent; preferably, from about 0.5 percent to about 25 percent; more preferable, from about 1 percent to about 25 percent; very preferable, from about 5 percent to about 25 percent; and what is most preferred, from around 5 percent to around 20 percent. d) The oil phase can vary from about 0.1 weight percent to about 75 weight percent; preferably, from about 0.1 percent to about 50 percent; more preferable, from about 1 percent to about 45 percent; and what is most preferred, from around 2 percent to around 40 percent. e) Water can vary from 0 percent to approximately 99 percent; preferably, from zero percent to around 50 percent; more preferable, from 0 percent to about 40 percent; very preferable, from zero percent to around 35 percent; which means that water is optional. f) The quantities are combined to give a total of one hundred percent; and except for water, each of components a) to d) must be included. Each of the four ingredients, components a) to d), may be constituted by one or more individual compounds that fall within the designated category of the component. The emulsion composition of the invention provides therapeutic benefits such as, but not limited to: anti-inflammatory activity, antibacterial activity, antipruritic activity, and emollient properties, so that it is useful in the treatment of dermatological disorders such as: psoriasis, dermatitis and itching associated with the healing of burn injuries, while maintaining skin and / or mucosal integrity, flexibility, traction and moisture.

DEFINITIONS As used herein, certain terms have the following meanings. All other terms and other phrases used in this description have the meanings that are ordinarily given to them and understood by those who have experience in the subject. Such ordinary meanings may be obtained by reference to technical dictionaries such as Hawley's Condensed Chemical Dictionary, 11a. edition, by Sax and Lewis, Van Nostrand Reinhold, New York, NY, 1987; The Merck Index, 11th Edition, Merck & Co., Rahway, NJ 1989; The Physician's Desk Reference (PDR), 2001 edition, Medical Economics Company, Montvale, NJ; Stedman's Medical Dictionary, 25a. edition, Williams & Wilkens, Baltimore, MD, 1990. Dapsone is 4,4'-diaminodiphenylsulfone. It has the chemical formula C12H12N2O2S, and is alternatively known as 4,4'-sulfonyldianiline or bis (4-aminophenyl) sulfone) (also with the spelling sulphone in English). See the Merck Index referred to above, in entry No. 2820. "Derivatives of Dapsone" refers to compounds that have a similar chemical structure and, therefore, a therapeutic potential similar to that of Dapsone. These include compounds with two organic substituents (R-i, R2) at the two amino groups (R ^ 2N C6H4SO2C6H4NR1R2). Each of RT and R2 can be hydrogen, alkyl of 1 to 6 carbon atoms, alkoxy of 1 to 6 carbon atoms, as well as an alkyl group substituted with 1 to 6 carbons, where the substituent can be hydroxyl, thio, alkoxy , halo, amido and similar polar or lipophilic substituents. Preferably, R ^ and R2 are the same. When the substitution R1 and R2 is R = CHO, the compound formed is generically called diformil Dapsone. It is alternatively known as bis (4-formaminophenyl) sulfone and like 4,4'-diformildiaminodiphenyl) sulfone. When the substitution R and R2 is R = COCH3, the compound formed is AceDapsone, alternatively referred to as bis (4-acetamidophenyl) sulfone and 4,4'-diacetyldiaminodiphenyl) sulfone. AceDapsone is a known prodrug of Dapsone. Other known derivatives that have an antibacterial and / or anti-inflammatory effect are: sodium glucosulfone, solapsone, diatimosulfone, acediasulfone, monoacetyl dapsone, acetosulfone, succisulfone, aldesulfone sodium and thiazolsulfone. Other derivatives of Dapsone are described in the following journal articles, the descriptions of which are incorporated herein by means of this reference: M. D. Colman and co-authors, J. Pharm. Pharmacol., 1997, 49, 53-57; J. Pharm. Pharmacol., 1996, 48, 945-50; Environmental Toxicology and Pharmacology, 1996, 2, 389-395. An emulsifying agent is a surfactant (defined separately below). However, not all surfactants are emulsifying agents. An emulsifying agent is typically a term used to describe an organic compound that stabilizes a uniform dispersion of one solvent in another; where the two solvents are immiscible. Portions of the emulsifying agent dissolve in the different phases, so that the coalescence of the dispersion to two separate liquids is prevented. A fatty alcohol is a saturated or unsaturated alcohol, 8 to 40 carbon atoms, which may or may not be substituted with additional groups, such as halo, alkoxy of 1 to 6 carbon atoms, alkylketo of 2 to 6 carbon atoms, alkoxycarbonyl of 2 to 6 carbon atoms, alkylamido of 2 to 6 carbon atoms, and alkylamine of 1 to 6 carbon atoms, optionally substituted with 1 or 2 alkyl groups of 1 to 4 carbon atoms. The terms "insoluble" and "immiscible" when applied to two liquids, mean that one liquid exhibits essentially no solubility in the second. While the measurable solubility does not necessarily have to be zero, for the practical purposes of formulating topical products, the level of solubility is negligible if one ingredient is described as insoluble or immiscible in another. The term "miscible", when used in relation to two liquids, means that the two liquids are soluble in one another, at all proportions. A solution is a system in chemical equilibrium, in which a solute (liquid, solid or gas) is dissolved in a liquid solvent. A surfactant or surface active agent is an organic compound that reduces surface tension when dissolved in water or in aqueous solutions. In an emulsion, a surfactant will contain a hydrophilic portion and a lipophilic portion, by means of which it functions to reduce the surface tension of the surfaces between the immiscible phases. Functionally, in dermatological applications, surfactants include: emulsifying agents, wetting agents, cleaning agents, foam enhancers and solubilizing agents. A surfactant is any nonionic, anionic or cationic organic compound of moderate to high molecular weight (such as from about 100 to about 300,000 dalton), for which a significant portion of the molecule is hydrophilic and a significant portion of the molecule is hydrophilic. the molecule is lipophilic. The term "pharmaceutically active agent" is used to refer to a chemical material or a compound that is suitable for topical administration, and which induces a desired physiological effect. The term "topical administration" means supplying a composition or an active agent to the skin or to a mucosal tissue. A topical composition is one that is suitable for topical administration. The term "approximately" or "around" means a variation of 10 percent of the specified value; for example, about 50 percent means a variation of 45 to 55 percent.

DETAILED DESCRIPTION OF THE INVENTION The present invention solves the problems of formulation and treatment associated with the topical administration of Dapsone and its derivatives (hereinafter collectively collectively as Dapsone). These compounds are aromatic, are substituted with diamino groups and are difficult to formulate as topical water-based compositions. The compounds themselves are easily separated and / or easily precipitated from said aqueous phase compositions. When solvating enhancers are used, the resulting compositions typically can not conveniently include oil-based skin conditioning agents. Such skin conditioning agents, however, are common formulation ingredients for topical compositions because without them, topical compositions often dry, redden and are detrimental to the skin. In accordance with the invention, it has been discovered that combinations of solvating medium ingredients and emulsifiers allow the formulation of topical compositions of Dapsone including oil-based skin conditioning agents. In particular, the emulsion composition of the invention includes Dapsone, a solvation medium, an emulsifier system and one or more oil-based skin conditioning agents. An alternative emulsion composition, of the invention, includes water with the solvation medium, in order to provide a polar aqueous phase. The emulsion composition of the present invention may exhibit a consistency and tactile characteristic of the products suitable for application to the skin, or to a mucous membrane. The consistency of the composition can be a free-flowing liquid. This consistency allows a quick distribution on the skin and facilitates the application. Alternatively, the consistency of the composition may vary to a rigid or firm semi-solid. A rigid consistency may be suitable for a stronger application of the composition to a limited site on the skin, or on a mucous membrane. Additionally, the rigid consistency that is the result of a high oil phase may contribute to the occlusive property of the composition on the skin or on a mucous membrane. The feeling of the composition on the skin can vary from a moist, thin sensation, to a stiff, waxy sensation. With the adjustment of the various ingredients, the composition can be formulated to exhibit an optimum consistency and feel for the delivery of Dapsone for an intended indication.

COMPOSITION OF THE INVENTION Many dermatological products are described as emulsions, but the two immiscible phases forming said products often do not form colloidal mixtures. Rather, the internal phases are dispersed as drops within the continuous phases to create temporarily stable systems. The chemical equilibria in these systems go towards the separation of the immiscible phases. It can be said that a system is in chemical equilibrium when it is theoretically stable indefinitely, as a result of random molecular motion. In contrast, a physically stable topical emulsion system often implies practical and limited stability. An emulsion can be classified as physically stable when it exhibits no change or exhibits only insignificant changes in phase dispersion for a defined period of time. For a dermatological product in emulsion, a physically stable system is typically that which shows no significant change in the dispersion of the phase during the commercial warehouse life span. In dermatological or topical products, the common emulsions are oil-in-water emulsions and water-in-oil emulsions. In the former, the oil phase is the internal phase, dispersed in the continuous aqueous phase. In the second, the oil phase can be the continuous phase. More complex emulsion systems have been described and formulated as dermatological products. Water-in-oil-in-water emulsions and other complex combinations can be formed between immiscible phases. In many topical emulsions an internal oil phase contains oily or fatty excipients that are solid at room temperature, thereby causing a point of confusion over the definition of an emulsion as a dispersion of liquid into liquid. This point is clarified when it is understood that at the time of formation, the emulsion is a dispersion of liquid in liquid, because the oil phase may have been heated or manipulated in another way to make it liquid. It can also be noted that, at the water / oil interface, the precise nature of the physical state of the oil phase, either as a liquid or as a solid, is not a simple characterization. The oil phase of a topical emulsion may contain oily or fatty materials, which are miscible or compatible with each other, but which either have miscibility or solubility in water, or have only negligible. Since many of the oil phase excipients are solid at normal temperature, miscibility with the excipients in their liquid states is commonly evaluated. In topical or dermatological products, the water phase, or water phase, often contains a quantity of water and, optionally, a variety of liquids or solids that are soluble, miscible or dispersible in water. Many of these properties are present in the emulsion composition of the present invention. However, water must not necessarily be present in combination with the solvation medium according to the invention. In the following discussion, the use of the term "Dapsone" shall mean Dapsone or its derivatives, unless otherwise indicated. The present invention provides a physically stable emulsion composition, containing Dapsone in a solvation medium (polar phase) in combination with at least one oil phase component (oil phase) and an emulsifier system. The solvation medium (polar phase) includes an organic solvent to solvate Dapsone. Optionally, the solvation medium can contain additional compounds, such as common excipients, coloring agents and the like. Also optionally, the solvation medium can form a combination with water to act as the polar phase. The emulsifier system can be a combination of a fatty alcohol and a surfactant. The emulsion composition can be formulated within a scale of topical compositions ranging from light lotions, not fats, even emollient, heavy creams. According to the invention, the concentration of Dapsone can be any amount that provides effective antibacterial and / or anti-inflammatory properties to the emulsion composition. In particular, the concentration of Dapsone in the emulsion composition of the invention can vary from about 0.05 percent to about 30 percent by weight of the emulsion formulation. Preferably, this concentration can be from about 0.1 percent to about 25 percent; more preferable, from around 0.1 percent to around 15 percent; especially, from around 0.1 percent to around 10 percent; very special and preferably, from about 0.2 percent to about 8 percent and, most preferably, from about 0.5 to about 5 percent by weight of the emulsion composition. The concentration of Dapsone in the especially preferred embodiments can be at percentages such as 1, 2, 5 and 7.5. According to the invention, the solvation medium can be an organic solvent that is from moderately soluble to water miscible, and dissolves Dapsone or allows the dissolution of Dapsone in the combination of the solvation medium and the optional water. The solvation medium or its combination with water acts as the polar phase of the emulsion composition. Preferably, in any of the alternatives, that is, the use of one or more organic solvents alone as a solvation medium, or the use of the combination of one or more organic water solvents, allows the complete dissolution of Dapsone in the composition in emulsion. However, the amount of organic solvent used, alone, as a solvation medium, or the concentration of the organic solvent in the combination of water and solvation medium, may also allow partial dissolution of Dapsone in the emulsion composition. In this latter situation, the portion of undissolved Dapsone in the solvation medium, or in the combination, such as a dispersion of microparticles or micronized particles and the like, in the emulsion composition can be suspended. Alternatively, the portion of undissolved Dapsone can be suspended as a dispersion of crystalline Dapsone. The size of the suspended Dapsone particles can be controlled by the preparation of the Dapsone raw material, or by the process by which the emulsion composition is composed. The size of the suspended particles can vary from less than 10 microns (microparticles or micronized particles) to palpable particles, of more than about 100 microns. The emulsifier system participates in the maintenance of the dispersion. Alternatively, the portion of undissolved Dapsone in the oil phase of the emulsion composition can be dissolved when it is formed by the combination of the solvation medium, the oil phase and the emulsification system. The partial dissolution of Dapsone may be the result of one or more of various formulation designs. Firstly, the organic solvent may not allow the complete dissolution of the desired concentration of Dapsone in the solvation medium, even when minor amounts of Dapsone are completely dissolved. Secondly, the volume of the oil phase may be insufficient to dissolve this portion of undissolved Dapsone in the solvation medium. Third, the formation of the emulsion composition can decrease the solubility of Dapsone in the solvation medium, due to the interaction of the oil phase, the emulsifier system and the solvation medium.

Despite the dissolution characteristics of Dapsone in the solvation medium and in the emulsion composition, in a preferred embodiment of the invention the amounts of Dapsone and organic solvent are selected to completely dissolve Dapsone in the organic solvent. While the solution of Dapsone in the organic solvent may be complete, the subsequent formation of the emulsion composition may result in the partial precipitation of Dapsone or may maintain the complete dissolution of Dapsone. Both possibilities are within the invention. According to the invention, the concentration of the solvation medium as an organic solvent alone, with respect to the total weight of the emulsion composition, ranges from about 0.5 percent to about 99 percent by weight. More preferably, the concentration of the solvation medium is about 0.5 percent to about 50 percent by weight. It is especially preferred that the concentration of the solvation medium be from about 5 percent to about 40 percent, most especially from about 5 percent to about 35 percent by weight and, most preferred, from about 5 percent to about 30 weight percent of the emulsion composition. When water is combined with one or more organic solvents as the solvation medium, the concentration of the solvation medium relative to the weight of the water plus the solvation medium varies from 0.005 weight percent to 98 weight percent. In this case, the ingredients are the solvent or organic solvents and water. The concentration of the organic solvent in the emulsion will vary, depending on the desired concentration of Dapsone, the solubility of Dapsone in the solvation medium, and the desired degree to which Dapsone is dissolved in the emulsion composition. The solubility of Dapsone in some organic solvents exceeds 30 percent by weight of the solution. Their solubility in other organic solvents may be less than one percent by weight. Suitable emulsion compositions can be formulated with an organic solvent calculated to dissolve an effective amount of Dapsone. Additionally, the concentration and proportion of two or more organic solvents can be selected for optimal effect, depending on the synergistic solubility of Dapsone. Organic solvents that are suitable for use as a solvation medium in the present invention, and which are moderately soluble in miscible with water, can be classified into several broad groups. One group is that of glycol ethers. A glycol ether is an ether formed from at least one glycol and at least one lower alkyl alcohol. Preferably, the glycol of the alkylene glycols, such as ethylene glycol, propylene glycol or butylene glycol, is selected. The ether portion the glycol ether is a radical of a lower alkyl alcohol, such as an alcohol of 1 to 6 carbon atoms. Preferably, the alcohol portion of the ether is selected from: methyl alcohol, ethyl alcohol, propyl alcohol, isopropyl alcohol, butyl alcohol or isobutyl alcohol. The glycol ethers have a generalized formula CxHyOz; where x is from 4 to 10; and it's around 10 to 22; and z is from 2 to 5. According to the present invention, the glycol ethers are soluble or miscible with water and vary in molecular formula from 4 to about 10 carbon atoms. Examples of glycol ethers, under the classification of ethylene glycol ethers, include: ethylene glycol monopropyl ether (propoxyethanol); ethylene glycol monobutyl ether (butoxyethanol), diethylene glycol monomethyl ether (methoxydiglycol), diethylene glycol monoetyl ether (ethoxydiglicol), diethylene glycol monobutyl ether (butoxidig licol), diethylene glycol monoisopropyl ether (isopropyl diglycol) and diethylene glycol monoisobutyl ether (isobutyl-di-ig) licol). The glycol ethers that fall into the classification of propylene glycol ethers, include: propylene glycol monomethyl ether, dipropylene glycol monomethyl ether (PPG-2 methyl ether), tripropylene glycol monomethyl ether (PPG-3 methyl ether), propylene glycol n-propyl ether, dipropylene glycol n-propyl ether (propyl ether) of PPG-2), propylene glycol monobutyl ether, dipropylene glycol monobutyl ether (PPG-2 butyl ether), propylene glycol monoisobutyl ether and dipropylene glycol dimethyl ether. In one embodiment of the invention, the solvation enhancer is ethoxydiglycol. In another embodiment, the solvation enhancer is butoxydiglycol. A second group of organic solvents useful in the present invention include compounds classified as diols. A diol is an organic compound with two hydroxyl groups. It will be understood that a glycol ether, such as those presented above, can contain two hydroxyl groups and, therefore, can be classified as a diol. Diols suitable for use in the present invention include: diethylene glycol, triethylene glycol, propylene glycol, propanediol, dipropylene glycol, butylene glycol, hexylene glycol, pentylene glycol and isopentyldiol. Other organic solvents suitable for use in the present invention, which are from moderately soluble to water miscible, include monoalcohols of 1 to 10 carbon atoms and their esters, including, but not limited to: dimethylisosorbide, benzyl alcohol, triacetin, diacetin, ethanol, butyl alcohol, propylene carbonate, butylene carbonate, ethoxydiglycol acetate, 1-methyl-2-pyrrolidone, dimethyl sulfoxide, ethoxydiglycol acetate and isopropyl alcohol. Another group of suitable organic solvents includes ethylene oxide polymers, of a molecular weight up to about 700. Under the international classification nomenclature for cosmetic ingredients, these compounds are known as PEG-4 to PEG-16. The oil phase component of the emulsion composition of the invention may include a general class of compounds that will dissolve Dapsone. Although these do not constitute a means of solvation for Dapsone, they allow the complete or additional dissolution of Dapsone in the two phases of the emulsion composition. These compounds include liquids that are insoluble in the organic solvent, or in the combination of organic solvent and water, or that have insufficient solubility in the organic solvent, or in combination with water, at a concentration selected for use. Many of these compounds are oily liquids that can be combined with water and / or with organic solvent to form an emulsion. When said compound is selected as a component of the oil phase, it is selected for the solubility of Dapsone. It can also constitute the entire oil phase of the emulsion. A broad grouping of said oil phase compounds, for the further dissolution of Dapsone, includes the diesters formed between a dicarboxylic acid, for example, oxalic acid, succinic acid, maleic acid, glutaric acid, adipic acid, sebacic acid, and an alcohol alkyl, for example: isopropyl alcohol, isobutyl alcohol, butyl alcohol, ethyl alcohol, hexyl alcohol, isodecyl alcohol, isononyl alcohol, ethylhexyl alcohol, propyl alcohol. Common examples include: diethyl sebacate, diisopropyl adipate, diisobutyl adipate, diisopropyl sebacate, diethyl succinate, and dipropyl adipate. A second group of said oil phase compounds includes the monoesters formed between a monocarboxylic acid and an alkyl or aralkyl alcohol. Examples of the monoacids include: palmitic acid, lauric acid, oleic acid, myristic acid, isostearic acid, linoleic acid, linolenic acid, ricinoleic acid and benzoic acid. Examples of alkyl or aralkyl alcohol include: isopropyl alcohol, ethyl alcohol, propyl alcohol, butyl alcohol, isobutyl alcohol, 2-ethylhexyl alcohol, isodecyl alcohol or benzyl alcohol. Common examples include: ethyl oleate, ethyl palmitate, isopropyl myristate, isopropyl palmitate, isobutyl palmitate, benzyl benzoate and octyl palmitate. Several of these ester and other similar compounds are commercially available from Croda (Oleochemicals) under the general trademark Crodamol, and by Scher Chemicals under the general trademark Schercemol. Other compounds that may constitute the oil phase of the emulsion include, but are not limited to: oleic acid, oleyl alcohol, oleyl oleate, caprylic / capric triglyceride, propylene glycol dicaprylate / dicaprate, propylene glycol dilaurate, propylene glycol dipelargonate, myristate myristyl, myristyl lactate, PPG-2 myristyl ether propionate, ethoxydiglycol oleate, octyldodecanol, bisabolol and isostearic acid. Of particular interest is the selection of the combination of an organic solvent and a component of the oil phase, where the two have at least some compatibility. This combination is illustrated by the compatibility shown between some organic solvents soluble in water and some organic liquids insoluble in water. Many oil phase compounds, such as: isopropyl myristate, isopropyl palmitate and ethoxydiglycol oleate, are immiscible with water, but will form homogeneous solutions with water-soluble organic solvents. The ethoxydiglicol, the butoxidiglicol and the dimetilisosorbide, for example, are all water-miscible liquids that will act as solvents for many oil-phase liquids, in the absence of water, to form heterogeneous mixtures. According to a preferred embodiment of the invention, the physical compatibility described between the organic solvents that constitute the solvation medium and the oil phase, allows the selection of formulations where the organic liquids of the oil phase and the organic solvents of the polar phase of the emulsion composition, can be combined in the absence of water, to form a homogeneous solvent mixture for Dapsone. According to the invention, the emulsion composition includes a polar phase and an oil phase, which can be made physically stable by including an emulsifier system. According to the invention, the emulsifier system includes at least one fatty alcohol and a surfactant. This combination of a fatty alcohol and a surfactant can be self-emulsifying and can act as an emulsifier to disperse other oily or graded compounds and Dapsone in an emulsion with the solvating medium. According to the invention, the surfactant portion of the emulsifier system includes nonionic, anionic and cationic surfactants. Preferably the surfactant portion of the emulsifier system is a nonionic or anionic surfactant. It is especially preferred that the surfactant portion of the emulsifier system be a nonionic surfactant. Nonionic surfactants include those belonging to the following groups: polyoxyethylene sorbitan esters, for example, Polysorbate 20 and Polysorbate 80; sorbitan esters, for example, sorbitan stearate and sorbitan sesquioleate; polyoxyethylene glycol esters, for example, PEG-4 dioleate and PEG-20 palmitate; polyoxyethylene ethers, for example, cetech-20, laureth-4 and steareth-10; polyoxyethylene alkoxylated alcohols, for example, hydrogenated castor oil of PEG-40 and lanolin of PEG-5; polyoxyethylene / polyoxypropylene block polymers, for example, Poloxamer 217 and Poloxamer 237; polyoxyethylene phenolic ethers, for example, Nonoxynol 10. Also included in the group of nonionic surfactants are the sulfate, phosphate and carbonate of mono-, di- and triesters of fatty alcohols. Suitable ionic surfactants for use include the sodium and potassium salts of higher sulphated primary aliphatic alcohols. Examples include sodium capryl sulphonate, sodium cetyl sulfate, sodium cetearyl sulfate, sodium decyl sulfate, sodium lauryl sulfate, sodium myristyl sulfate, sodium oleyl sulfate, sodium octyl sulfate, sodium tridecylsulfate and potassium lauryl sulfate. A second group of compatible anionic surfactants is formed by those described as sodium salts of sulphated and ethoxylated fatty alcohols. Examples include: decethra sulfate, sodium myreth sulfate, sodium laureth sulfates, sodium laneth sulfate and sodium tridecethsulfate. Another group of common anionic surfactants is formed by the salts of the polyoxyethylene ether surfactants which form esters with the phosphoric acid. Examples include: sodium pareth-8-butyl phosphate of 13 to 15 carbon atoms, sodium diketeareth-10-phosphate, sodium dioleth-8-phosphate, sodium oleth-7-phosphate and sodium steareth-4-phosphate . Similar groups of surfactants can be formed by replacing the phosphate with sulfate, carboxylate or tartrate. It will be understood that for all the above anionic surfactants, a simple replacement of the cation, the fatty alcohols, the ethoxylated chains or the complex anion allows to produce an enormous formation of surfactants. The above is intended as an explanation for the possible agents; in no way is it a definitive list of them, nor is it intended to limit the range of surfactants suitable for use in an emulsion system. A third group of surfactants suitable for use as an emulsifying agent are cationic surfactants. A prominent group of cationic surfactants, suitable for this function, is formed by the quaternary ammonium salts. Examples include: behentrimonium chloride, behentrimonium methosulfate, benzalkonium chloride, cetrimonium chloride, cetrimonium methosulfate, dicetildimonium chloride, distearyldimonium chloride, lapyrium chloride, lauralconium chloride, stearalkonium chloride and PEG-3 methosulfate. diesteroylamidoethylmonium, quaternium-24 (decylmethyloctylammonium chloride). Surfactants can be individually incorporated into the emulsifier system of the invention, or they can be used in combination of two or more, to allow the development of an emulsifier system according to the invention. According to the invention, a surfactant can be mixed with a fatty alcohol to form the emulsifier system of the emulsion composition. Said mixtures can be synergistic combinations of at least one fatty alcohol and at least one surfactant. The surfactant may be anionic and / or nonionic. The fatty alcohol / surfactant mixture can be self-emulsifying and can also act as an emulsifying agent for other components of the oil phase. A wide variety of commercial mixtures of fatty alcohol and surfactant are available. Croda, Inc. manufacture Emulsifying Wax N. F., under the brands Polawax® and Polawax® A-31. Croda also provides a series of mixtures of cetearyl alcohol and cereareth-20, under the Cosmowax® brand. Croda also manufactures an anionic self-emulsifying wax, Crodafos® CES, which is a mixture of cetearyl alcohol, dioctyl phosphate and ceteth-10 phosphate. Gattefosse also manufactures several suitable mixtures. Emulcire 61® by Gattefosse is a mixture of cetyl alcohol, cetech-20 and steareth-20. According to the invention, a preferred scale for the concentration of Crodafos® CES as the emulsifier system of the present invention is from 1 to 20 weight percent, with a more preferred scale being from 4 weight percent to 12 weight percent. Similarly, a formulation useful in accordance with the present invention is Emulium Delta® from Gattefosse, which is a mixture of cetyl alcohol, glyceryl stearate, PEG-75 stearate, ceteth-20 and steareth-20. Preferred concentrations for Emulium Delta® are from about 3 percent to about 10 percent by weight. In another embodiment of the present invention, the emulsifier system is chosen from among the acrylic acid copolymers entangled with allylpentaerythritol. The designation INCI for those emulsifying agents is crosslinked polymers of acrylates / alkyl acrylate of 10 to 30 carbon atoms. The monograph of the National Formulary for this material has it under the designation Copolymer of Carbomer. These materials are sold by Noveon, Inc., of Cleveland, OH, E. U. A., under the Pemulen TR1 and Pemulen TR2 brands. These agents can be used alone as the emulsifier system, or they can be used in combination with one or more surfactants to constitute the emulsifier system of the invention. Although the oil phase component of the emulsion can be constituted by a liquid organic compound that dissolves Dapsone, additional oil-free ingredients can be incorporated to provide a range of emulsion products. As understood in the art of formulating topical products, these excipients may include various oils, waxes, emollients, thickening agents, occlusives and skin conditioning agents. The excipients of the oil phase may include: cetyl alcohol, stearyl alcohol, cetyl palmitate, cetyl citrate, white wax, white petrolatum, paraffin, microcrystalline wax, stearyl citrate, ethoxydiglycol behenate, stearyldimethicone, myristyl myristate, wax of cetyl esters, dimethiconol stearate, octyl stearate, aluminum stearate, sodium stearate, ozokerite wax, shea butter, octyl stearate. Whoever has ordinary experience in the art will understand that many groups of excipients, useful for topical formulations, can be added to the emulsion composition of the invention. One such group of excipients, suitable for addition to the aqueous phase, is constituted by water-soluble or water-dispersible gelling agents. Examples of such agents include polyacrylic acid polymers, guar gum, polyquaternium-10, hyaluronic acid, sodium hyaluronate, xanthan gum, polyvinyl alcohol, hydroxyethylcellulose, xanthan gum, hydroxypropylmethylcellulose and sodium carboxymethylcellulose. Groups of excipients well known in the formulation can be added to increase the oil phase of the emulsion composition of the invention. These groups include: antioxidants, represented by tocopherol, butylated hydroxytoluene, butylated hydroxyanisole, propyl gallate, tocopherol, tocopherol acetate, ascorbic acid, ascorbyl palmitate and citric acid; and preservatives, represented by potassium sorbate, sorbic acid, benzoic acid, potassium benzoate, methylparaben, propylparaben, butylparaben, benzyl alcohol, dimethylol-dimethylhydantoin, imidazolidinylurea, diazolidinylurea and methylisothiazolinone. Other groups of excipients, useful for inclusion in the emulsion composition of the present invention, include regulatory agents, neutralizing agents, humectants, chelating agents, colorants and opacifying agents. fragrances, skin conditioning agents, solubilizing agents, such as cyclodextrins and biological additives. The pH value of the composition can be adjusted by the addition of an acid or a base, alone or in combination. A particular value basis for the invention can be added to neutralize the embodiments of the composition containing a polyacrylic acid polymer or other acid component. Said polymer may be present as a thickening agent or as a gelling agent, or it may be present as an emulsifier. In addition, more than one polyacrylic acid polymer may be present in the composition. A base can be added to neutralize the composition so that it is within a pH range that allows the desired operation of the polyacrylic acid polymer. A suitable base can be selected from an inorganic base, such as sodium hydroxide and potassium hydroxide; or it may be selected from an organic base, such as diethanolamine, triethanolamine and diisopropylamine. Likewise, an organic acid can be used to neutralize a basic component, such as an amine-containing surfactant. The following examples are intended to further illustrate, but not limit, the invention.

EXAMPLE 1 The following formulation was prepared: Excipient% w / w Dapsone 5.0 White Petrolatum 10.0 Isopropyl Palmitate 5.0 Crodafos® CES1 10.0 Purified Water, c. s. p. 100 Ethoxydiglycol 25.0 Methylparaben 0.2 Propylparaben 0.05 1Crodafos® CES is manufactured by Croda, Inc. It is a mixture of cetearyl alcohol, diethyl phosphate and ceteth-10. Procedure: 1) White petrolatum, isopropyl palmitate and Croda®CES, and melt at 70 ° C. 2 Methylparaben and propylparaben are dissolved in ethoxydiglycol. 3) Dapsone is dissolved in the ethoxydiglycol solution from step 2). 4) The purified water is heated to 70 ° C. 5) The oil phase from step 1) is added with high speed mixing to the water phase of step 3). The emulsion was mixed to form the uniform dispersion of the oil phase. 6) The Dapsone solution is added to the emulsion of step 5) with continuous mixing. The emulsion is cooled.

EXAMPLE 2 The following formulation was prepared: Excipient% w / w Dapsone 3.0 White Petrolatum 5.0 Isopropyl Palmitate 5.0 Emulium Delta®1 10.0 Purified Water, c. s. p. 100 Carbopol 980 0.25 Ethoxydiglycol 15.0 Methylperaben 0.2 Propylparaben 0.05 Sodium hydroxide solution, 10% 0.25 1Emulium Delta® is manufactured by Gattefosse. It is a mixture of cetyl alcohol, glyceryl stearate, PEG-75 stearate, ceteth-20 and steareth-20. Procedure: 1) White petrolatum, isopropyl palmitate and Emulium Delta® were combined and melted at 70 ° C. 2) Methylparaben and propylparaben were dissolved in the ethoxydiglycol. 3) Dapsone was dissolved in the ethoxydiglycol solution from step 2). 4) Carbopol 980 was dispersed in the purified water with agitation by propellant. The mixture was heated to 70 ° C. 5) The water phase from step 4 was added to the phase with high speed mixing, the oil phase of step 1. The emulsion was mixed to form a uniform dispersion of the oil phase. 6) The Dapsone solution was added to step 5, with continued mixing. The emulsion was cooled.

EXAMPLE 3 The following formulations were prepared:% by weight / weight Excipient 4-A 4-B 4-C Dapsone 2.0 1.0 1.0 Isopropyl myristate 30.0 20.0 20.0 Octyldodecanol - - 10.0 Cetyl Palmitate - 10.0 5.0 Pemulen TR2 0.3 0.3 0.3 Carbopol 980 0.2 0.4 0.2 Propylene glycol __ 10.0 10.0 Ethoxydiglycol 10.0 Benzyl Alcohol 1.0 Methylparaben 0.15 0.15 - Butylated hydroxytoluene 0.05 0.05 0.05 Purified water, c. s. p. 100 100 100 Sodium hydroxide, 10% 0.5 0.5 0.5 Procedure: 1) The oil phase (isopropyl myristate, octyldodecanol, cetyl palmitate) was heated at 60 ° C. 2) Dapsone was added to step 1) and stirred to wet it. 3) Pemulen TR2 and Carbopol 980 were dispersed in the purified water, with mixing by means of propellant. The dispersion was heated to 65 ° C. 4) The preservative (methylparaben or benzyl alcohol) and BHT were added to ethoxydiglycol or to propylene glycol. 5) The solution from step 4 was added to the water phase of step 3). 6) The oil phase of step 1) was added with high speed mixing to the water phase of step 5). 7) Sodium hydroxide was added, with mixing. 8) The cream was cooled to room temperature.

EXAMPLE 4 The following formulation was prepared: Excipient% w / w Dapsone 1.0 White Petrolatum 5.0 Isopropyl Palmitate 5.0 Emulium Delta® 6.0 Purified Water, c. s. p. 100 Carbopol 980 0.2 Dimethylisosorbide 5.0 Ethoxydiglycol 5.0 Methylparaben 0.2 Propylparaben 0.05 Sodium hydroxide solution, 10% 0.2 The procedure for obtaining the composition was the same as in step 2. The dimethyl-isosorbide was combined with the ethoxydiglycol to form the solvent in the process for Dapsone.

EXAMPLE 5 The following composition was prepared: Excipient% w / w Dapsone 1.0 Stearyl alcohol 7.0 Cetyl alcohol 1.5 Caprylic / capric triglyceride 10.0 Diisopropyl sebacate 5.0 Sorbitan monostearate 2.0 Polyoxyethylene-40 stearate 2.5 Purified water, c. s. p. 100 Dimethylisosorbide 10.0 Polyethylene glycol 400 10.0 Benzyl alcohol 1.2 Phosphate regulator, pH 7 Procedure: 1) Stearyl alcohol, cetyl alcohol, caprylic / capric triglyceride, diisopropyl sebacate, sorbitan monostearate and polyoxyethylene stearate were combined. , and melted at 70 ° C. 2) Dimethylisosorbide, polyethylene glycol 400 and benzyl alcohol were combined. Dapsone was added and wetted with mixing. 3) The purified water was combined with the phosphate buffer and heated to 70 ° C. 4) The oil phase was added to the aqueous phase with high speed mixing. 5) The drug phase of step 2) was added with mixing. 6) The cream was cooled to room temperature, while mixing.

EXAMPLE 6 The following formulation was prepared: Excipient% w / w Dapsone 0.5 Octyldodecanol 10.0 Cetostearyl alcohol 5.0 Purified water, c. s. p. 100 Pemulen TR2 0.3 Carbomer 980 0.3 Propylene glycol 15.0 Ethoxydiglycol 20.0 Benzyl alcohol 1.5 Sodium hydroxide solution, 10% 0.5 Procedure: 1) The octyldodecanol and the cetostearyl alcohol were combined and heated to 70 ° C to melt them. 2) Propylene glycol, ethoxydiglycol and benzyl alcohol were combined. Dapsone was added and dissolved. 3) The purified water was heated to 70 ° C. 4) Pemulen TR2 and Carbopol 980 were added to the oil phase of step 1) and stirred to disperse. 5) The oil phase was added to the water phase with high speed mixing. 6) The drug phase from step 2) was added, with continued mixing. 7) The sodium hydroxide solution was added and mixed. 8) The cream was cooled to room temperature.

EXAMPLE 7 The following formulation was prepared: Excipient% w / w Dapsone 2.0 White Petrolatum 5.0 Emulsifying Wax, NF 10.0 Isopropyl Myristate 10.0 Diisopropyl Adipate 10.0 Butylated Hydroxytoluene 0.05 Propylene Glycol 10.0 Benzyl Alcohol 1.5 Purified Water, c. s. p. 100 Procedure: 1) White petrolatum, emulsifying wax, isopropyl myristate, diisopropyl adipate and BHT were combined and melted at 70 ° C. 2) Dapsone was added to the mixture of propylene glycol and benzyl alcohol, and mixed to wet it; 3) The purified water was heated to 70 ° C. 4) The oil phase was added to the water, with high speed mixing. 5) Dapsone solution was added with continued mixing. 6) The product was cooled to room temperature, with mixing.

EXAMPLE 8 The following formulation was prepared: Excipient% w / w Dapsone 3.0 Cetyl alcohol 0.5 Stearic acid 7.0 Mineral oil 7.0 PPG-2 myristyl ether propionate 4.0 Laureth-4 2.0 Sodium Laureth-sulfate 0.5 Purified water, c. s. p. 100 Propylene glycol 15.0 Ethoxydiglycol 15.0 Carbopol 980 0.4 Triethanolamine, c. s. p. pH 6 Methylparaben 0.15 Propylparaben 0.03 Procedure: 1) Cetyl alcohol, stearic acid, mineral oil, PPG-2 myristyl ether propionate, and laureth-4 were combined and melted at 70 ° C. 2) Carbopol 980 was dispersed in the purified water, with high speed mixing. 3) Sodium laureth sulfate was added to the aqueous phase, and the aqueous phase was heated to 70 ° C. 4) Parabens and Dapsone were dissolved in the mixture of propylene glycol and ethoxydiglycol. 5) The oil phase was added to the aqueous phase, with high speed mixing. 6) The Dapsone solution was added with continued mixing. 7) The triethanolamine was added to neutralize, and the product was cooled to room temperature while mixing.

EXAMPLE 9 The following formulations were prepared: General procedure: 1) The ingredients of the oil phase are combined in a vessel and heated to 65 ° C to 75 ° C, to melt them.

The ingredients of the oil phase include: white petrolatum, cetostearyl alcohol, cetyl palmitate, isopropyl myristate and laureth-23. 2) Prepare the active phase in a separate vessel, adding methylparaben, propylparaben and Dapsone to ethoxydiglycol and stirring to dissolve. 3) The aqueous phase is prepared by adding carbomer to the purified water with high speed mixing to form the uniform dispersion. The resulting dispersion is heated to 65 ° C-75 ° C. 4) 4-Trilaureth phosphate is added, when present, to the aqueous phase. 5) The emulsion is composed by adding the oil phase to the aqueous phase, with high speed mixing. 6) The active phase is added slowly to the emulsion, with continuous high-speed mixing. 7) Sodium hydroxide (as an aqueous solution) is added to the emulsion and mixed to combine them. 8) The emulsion is cooled while stirring, up to room temperature.

EXAMPLE 10 The following formulations were prepared: Arlacel 165 is a blend brand of glyceryl stearate and POE 100 stearate. It can be obtained from ICI Surfactants. General procedure: 1) For the active phase, Dapsone is added to propylene glycol or ethoxydiglycol and mixed to combine and wet. 2) For the base, the remaining ingredients are combined and heated to 55 ° C to 60 ° C to completely melt. 3) The active phase is added to the base with mixing. It is stirred to combine uniformly. 4) The mixture is cooled with continued mixing. It cools to room temperature.

REFERENCES a) Barabas US Patent 4,853,439 b) Cho and co-inventors US Patent 4,920, 145 c) Vichroski and co-inventors US Patent 5,437,867 d) Kompis and co-inventors US Patent 5,721, 242 e) Osborne Patent US 5,863,560 f) Preuilh and co-inventors Patent US 6, 1 06,848 g) Castro and co-inventors Patents US 6, 1 13,888 and 6, 214,322 h) Fischetti and co-inventors Patents US 6, 056,955, 6,277,399, 6,248,324, 6, 432,444 i) Stroud and co-inventors Patent US 6,231, 837 All the descriptions of all the Patents, patent applications, publications, and references cited in this specification are incorporated herein by this reference, as if they were reproduced complete in this description. Although the foregoing description of this invention has been described in connection with certain preferred embodiments thereof, and many details have been given for illustrative purposes, it will be apparent to those of ordinary skill in the art that the invention is amenable to additional modalities. , and that some of the details described herein can be varied considerably, without departing from the basic principles of the invention.

Claims (27)

1. CLAIMS 1. - An emulsion composition, characterized in that it comprises the components: a) Dapsone or its derivative; b) a solvation medium; c) an emulsifier system; and d) an oil phase component. 2. An emulsion composition according to claim 1, further characterized in that it additionally comprises water, as component e). 3. An emulsion composition according to claim 2, further characterized in that the water and the solvation medium at least partially dissolve Dapsone or its derivative. 4. An emulsion composition according to claim 1, further characterized in that the percentages by weight of the components, with respect to the total weight of the composition in emulsion, comprise: a) Dapsone or its derivative, of about 0.005 per one hundred to about 30 percent; b) the solvation medium, from about 0.5 percent to about 99 percent; c) the emulsifier system, from about 0.1 percent to about 30 percent; d) the oil phase component, from about 0.1 percent to about 75 percent. 5. - An emulsion composition according to claim 2, further characterized in that the weight percentage of the water varies up to about 99 percent. 6. An emulsion composition according to claim 4, further characterized in that it additionally includes water, in a percentage by weight that varies up to about 99 percent. 7. An emulsion composition according to claim 1, further characterized in that the percentages by weight of the components with respect to the total weight of the emulsion composition comprise: a) Dapsone or its derivative, of about 0.1 percent a around 25 percent; b) the solvation medium, from about 0.5 percent to about 50 percent; c) the emulsifier system, from about 0.5 percent to about 25 percent; d) the oil phase component, from about 0.1 weight percent to about 50 percent. 8. An emulsion composition according to claim 1, further characterized in that it optionally comprises water; and wherein the percentages by weight of the components, with respect to the total weight of the emulsion composition are selected from the following scales, such that the total amounts are equal to 100 percent; and each successive scale for each component is preferred with respect to the preceding scale: a) the selections of the scale for the Dapsone are from about 0.005 percent to about 30 percent; from around 0.1 percent to around 25 percent; around 0. 1 percent to around 15 percent; from around 0.1 percent to around 10 percent; from around 0.2 percent to around 8 percent; from about 0.5 percent to about 5 percent, by weight of the emulsion composition; b) the selections of the scale for the solvation medium are: from about 0.5 percent to about 99 percent; from around 0.5 percent to around 50 percent; from around 5 percent to around 40 percent; from around 5 percent to around 35 percent; from around 5 percent to around 30 percent; c) the selections of the scale for the emulsifier system are: from about 0.1 percent to about 30 percent; from around 0.5 percent to around 25 percent; from around 1 percent to around 25 percent; from around 5 percent to around 25 percent; from around 5 percent to around 20 percent; d) the selections of the scale for the oil phase component are: from about 0.1 weight percent to about 75 percent; from around 0.1 to around 50 percent; from about 1 percent to around 45 percent; from around 2 to around 40 percent; and e) the selections of the scale for the optional water are: from 0 percent to around 99 percent; from 0 percent to around 50 percent; from 0 percent to around 40 percent; from 0 percent to around 35 percent. 9. An emulsion composition according to claim 1, further characterized in that the emulsifier system comprises a combination of a fatty alcohol and a surfactant. 10. An emulsion composition according to claim 9, further characterized in that the surfactant comprises a nonionic or anionic surfactant, or a combination thereof. 11. An emulsion composition according to claim 9, further characterized in that the fatty alcohol comprises an alcohol of 8 to 30 carbon atoms, optionally substituted with additional hydroxyl groups, alkoxy groups of 1 to 6 carbon atoms, or groups alkoxycarbonyl of 2 to 6 carbon atoms; or alkylamido groups of 2 to 6 carbon atoms, or any combination thereof. 12. An emulsion composition according to claim 1, further characterized in that the solvation medium comprises an organic solvent in which Dapsone or its derivative is soluble. 13. - An emulsion composition according to claim 12, further characterized in that the organic solvent comprises a glycol, a polyol, a glycol ether or a polyol, or any combination thereof. 14. An emulsion composition according to claim 1, further characterized in that the Dae is dissolved totally or partially in the solvation medium. 15. An emulsion composition according to claim 1, further characterized in that the Dae is dissolved totally or partially in the solvation medium and the oil phase component. 16. An emulsion composition according to claim 1, further characterized in that the emulsifier system comprises a carbomer copolymer. 17. An emulsion composition, characterized in that it comprises: a) Dae; b) a glycol ether; c) an emulsifier system; d) an oil phase component; and e) optional water. 18. An emulsion composition according to claim 17, further characterized in that the glycol ether is ethoxydiglycol. 19. An emulsion composition according to claim 18, further characterized in that it includes a carbomer copolymer. 20. An emulsion composition according to claim 18, further characterized in that the emulsifier system comprises a fatty alcohol and a surfactant. 21. An emulsion composition according to claim 17, further characterized in that the Dae is at a concentration of about 2 percent to about 5 percent by weight of the composition. 22. An emulsion composition according to claim 17, further characterized in that the ratio of the concentration of Dae to the concentration of the glycol ether is such that Dae is soluble in the glycol ether. 23. An emulsion composition according to any of the preceding claims, further characterized in that the acidic and / or basic components are neutralized or regulated at a pH of about 4 to 8, preferably 5 to 8, in particular, from 5 to 7. 24.- An emulsion composition, characterized in that it comprises: Dae, wax or petrolatum, alcohol of 10 to 20 carbon atoms, alkanoate of 10 to 20 carbon atoms, alkyl of 10 to 20 carbon atoms; alkanoate of 10 to 20 carbon atoms, alkyl of 2 to 6 carbon atoms; phosphated surfactant, ethoxydiglycol, polyacrylic acid or its copolymer; preservative, optional neutralizing agent and optional water. 25. An emulsion composition according to claim 24, further characterized in that it has the component scales according to claim 8. 26. - An emulsion composition according to claim 24, further characterized in that the scales are: Dae, from 2 percent to 5 percent; wax or petrolatum, from 5 percent to 10 percent; alcohol of 10 to 20 carbon atoms, from 0 percent to 5 percent; alkanoate of 10 to 20 carbon atoms, of alkyl of 10 to 20 carbon atoms, from 0 percent to 5 percent; alkanoate of 10 to 20 carbon atoms, alkyl of 2 to 6 carbon atoms, 5 to 8 percent; phosphated surfactant, from 0 percent to 5 percent; ethoxydiglycol, 10 percent to 30 percent; polyacrylic acid or its copolymer, from 0.1 percent to 0.2 percent; conservative, from 0.04 percent to 0.2 percent; neutralizing agent and optional water, up to 100 percent; the percentages by weight with respect to the total weight of the composition being. 27. An emulsion composition according to claim 24, further characterized in that it comprises: Dae, wax or petrolatum, cetostearyl alcohol, cetyl palmitate, isopropyl myristate, trilaureth-4 phosphate, ethoxydiglycol, carbomer copolymer, carbomer 940 , preservative, optional neutralizing agent and optional water.