Structured rheological solid personal care composition

Abstract

The present invention discloses a rheological solid personal care composition, which comprises a crystallizing agent, a suspending agent, an insoluble active substance and an aqueous phase. The method for manufacturing the rheological solid composition comprises the following steps: providing and heating an aqueous solution of sodium chloride and sodium hydroxide; adding an emulsifier, preferably palmitic acid, so as to obtain a main emulsifier mixture, preferably a main sodium palmitate soap mixture; adding a suspending agent, preferably xanthan gum and glycerol, to the main emulsifier mixture; adding a premix of insoluble active substances to the main emulsifier mixture to obtain a blend, the premix of insoluble active substances being preferably a petrolatum-based premix of topical active substances, the topical active substances being preferably selected from the group consisting of menthol, nutmeg, camphor, eucalyptus, cedar leaf, thymol and any combination thereof; cooling the blend so as to form a crystalline structure of the rheological solid composition; optionally adding a hygroscopic stabilizer to the blend to stabilize the crystalline structure, the hygroscopic stabilizer being preferably sodium lactate.

Description

TECHNICAL FIELD

[0001] The present disclosure describes a rheological solid liquid extruded personal care composition that comprises greater than about 55% water with a crystallizing agent that has an elongated fibrous crystal habit. The rheological solid personal care composition allows for a unique “pinching” skin feel and / or slip when rubbed on the skin; and provides enhanced evaporative cooling for a fresh / cool feel even in the absence of sensates. BACKGROUND OF THE DISCLOSURE

[0002] Consumers routinely use personal care compositions on the chest, back, and / or throat to relieve nasal congestion, dry cough, chest tightness, muscle aches and / or pains, difficulty sleeping caused by colds and / or flu, and / or to provide a soothing feeling on the skin. Current products are formulated as creams, lotions, and / or ointments and are applied to the skin by hand, which can be messy and difficult to control due to their liquid or semi-liquid nature. Such products can also leave a greasy feeling on the user's hands after application and / or can stain clothing and bedding. In addition, some consumers may wish to apply such products multiple times throughout the day or when busy without having to wash their hands after application. Accordingly, there is a need for a more convenient, non-messy delivery system for personal care compositions.

[0003] Conventional soap-type gel sticks are often used as deodorants for underarm application and typically incorporate sodium stearate (C18) gelling agents (which are actually a mixture of various chain lengths from natural sources derived from stearic esters, typically tallow). The use of sodium stearate requires the inclusion of high levels of polyols (such as propylene glycol and glycerin) as solubilizing aids for the gelling agent during processing, even at high process temperatures. Typical compositions contain about 50% propylene glycol, 25% glycerin, and only 25% water (EP2170257 and EP2465487). This eliminates the pinching feel of the solid stick and diminishes the slip and cool feel. Finally, this may require high levels of gelling agents, including gelling agents other than sodium stearate, to prepare the gel stick, particularly a translucent gel stick.

[0004] Attempts have been made to provide rheological solid compositions that are compositionally similar to those specifically embodied in the present invention and that contain insoluble active agents such as fragrance capsules, solid particles, or oil droplets, since rheological solid compositions provide a way for the user to quickly and easily apply the rheological solid composition to a specific surface. However, these products cannot stabilize the insoluble active agents in the composition, resulting in the insoluble active agents floating to the top (i.e., "creaming") or sinking to the bottom (i.e., "settling") before the composition solidifies. If the insoluble active agents are not evenly distributed, the rheological solid composition may have a higher concentration of insoluble active agents in one area than in another, resulting in non-uniform performance during the useful life of the product. In the most extreme cases, it is unacceptable for a consumer product to have a significant amount of insoluble active material at the top and / or bottom of the product; most preferably, the insoluble active material is evenly dispersed throughout the product.

[0005] Accordingly, there is a need to provide a rheological solid personal care composition having a low level of gelling agent that can maintain its shape and contains insoluble active beneficial agents uniformly suspended in the composition. SUMMARY OF THE INVENTION

[0006] Provided herein is a rheological solid personal care composition comprising a crystallizing agent; a suspending agent; an insoluble active material; and an aqueous phase.

[0007] Additionally, provided is a rheological solid composition for use in a method of treating the following symptoms: nasal congestion, cold, flu, cough, dry cough, chest tightness, muscle soreness and pain, or any combination thereof.

[0008] Additionally, provided is a method for manufacturing a rheological solid composition, the method comprising the steps of:

[0009] - providing and heating an aqueous solution of sodium chloride and sodium hydroxide,

[0010] - adding an emulsifier, preferably palmitic acid, to obtain an emulsifier main mixture, preferably a sodium palmitate soap main mixture,

[0011] - adding a suspending agent, preferably xanthan gum and glycerin, to the emulsifier main mixture,

[0012] - adding an insoluble active material premix to the emulsifier main mixture to obtain a blend, the insoluble active material premix preferably being a petrolatum-based premix of topical active materials, the topical active materials preferably being selected from the group consisting of menthol, nutmeg, camphor, eucalyptus, cedar leaf, thymol, and any combination thereof,

[0013] - Cool the blend to form a crystalline structure of the rheological solid composition,

[0014] - Optionally add a moisture stabilizing agent to the blend to stabilize the crystalline structure, the moisture stabilizing agent being preferably sodium lactate. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Although the specification ends with claims that particularly point out and distinctly claim the subject matter regarded as the present disclosure, it is believed that the present disclosure may be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of these figures may have been simplified by omitting selected elements to more clearly show other elements. Such omission of an element in some of the figures does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless it is explicitly described as such in the corresponding written description. The drawings are not drawn to scale.

[0016] Figure 1A . Top view showing separation of the active substance in the absence of a suspending agent.

[0017] Figure 1B . Side view showing separation of the active substance in the absence of a suspending agent.

[0018] Figure 2A . Top view showing no separation of the inactive substance in the presence of a suspending agent.

[0019] Figure 2B . Side view showing no separation of the inactive substance in the presence of a suspending agent.

[0020] Figure 3 . SEM of a crystalline network formed by fibrous particles.

[0021] Figure 4 . An effective gum suspending agent system for stabilizing insoluble active particles.

[0022] Figure 5 . Effect of the gum suspending agent on the effectiveness of different crystallizing agents.

[0023] Figure 6 . Total aroma extrusion (concentration in ppm) versus time (hours). DETAILED DESCRIPTION

[0024] The present invention includes a rheological solid personal care composition containing a crystalline network. The crystalline network ("network") comprises a relatively rigid, three-dimensional, interlocking crystalline framework of fibrous crystalline particles (formed from a crystallizing agent) having voids or openings that contain an aqueous solution and optionally one or more active substances. The network provides a self-supporting structure such that the rheological solid personal care composition can "stand on its own" when placed on a surface. If compressed above a critical stress, the network allows the rheological solid personal care composition to extrude the entrapped aqueous solution and optionally one or more active substances. The rheological solid personal care composition of the present invention comprises a crystallizing agent, a suspending agent, an insoluble active substance, and an aqueous phase, and can be combined with a device for enabling application.

[0025] As used herein, "personal care composition" refers to a composition intended for topical application to the skin, including topical prescription drugs, over-the-counter drugs, behind-the-counter drugs, consumer products, and combinations thereof.

[0026] Crystallizing agent

[0027] In the present invention, the network of the rheological solid personal care composition comprises fibrous crystalline particles formed from a crystallizing agent; wherein the "crystallizing agent" as used herein comprises the sodium salt of a fatty acid having a relatively short chain length (C12 - C20) in a majority of water, such as sodium palmitate (C16). The rheological solid personal care composition is preferably achieved using a "narrow" distribution of the chain length of the crystallizing agent, and further preferably in the absence of very short chain lengths (C12 or shorter) and a measurable amount of unsaturated groups on the chain of the sodium salt of the fatty acid, in combination with controlled crystallization processing. Those skilled in the art recognize that the crystalline particles exhibit sharp scattering peaks between 0.25 degrees - 60 degrees 2θ in powder x-ray diffraction measurements. This is in sharp contrast to compositions in which these substances are used as gelling agents, which show broad amorphous scattering peaks from poorly formed solids.

[0028] The rheological solid personal care composition can comprise greater than about 55% water, alternatively greater than about 60%, alternatively greater than about 65%, alternatively greater than about 70% water, alternatively greater than about 80% water, and is "structured" by a network of interlocking fibrous crystalline particles that are predominantly of a single chain length, as described above (see Figure 3)。 The term "fibrous crystalline particle" refers to a particle in which the length of the particle in the direction of its longest axis is 10 times the length of the particle in any orthogonal direction. Fibrous crystalline particles prepare a network at very low concentrations (about 0.5 wt%), which forms a solid that is produced only under minimal applied stress, i.e., a rheological solid. The suspending agent, the insoluble active substance, and the aqueous phase (water) are mainly present in the open spaces of the network. When preparing these compositions, heat is used to dissolve the crystallizing agent in water. As the mixture cools over several minutes to several hours, fibrous crystalline particles form a network. Without being bound by theory, suspending agents (such as polymeric gums, clay particles, and hydrophobic fat particles) prevent the insoluble active substance from pasting or settling during the formation of the network (see Figure 1A and Figure 1B ); the removal of the suspending agent shows significant (or catastrophic) separation of the insoluble active substance. The preferred compositions have a phase stability rating of "1", and the most preferred phase stability rating is "2", as determined by the phase stability test method described herein.

[0029] Without being limited to theory, it is believed that only the sodium salts of fatty acids with high chain lengths can be used as crystallizing agents in the present invention. Crystallizing agents containing shorter chain lengths (C12 or shorter) can make the composition highly soluble at room temperature, such that fibrous crystalline particles do not form. The inclusion of unsaturation in the chain of the sodium salt of the fatty acid increases the "kinks" of excessive crystallization, such that fibrous crystalline particles do not form, and the composition is pasty or liquid. The crystallizing agent should be present in an amount sufficient to form a rheological solid with a firmness between about 0.1 N and about 50.0 N, more preferably between about 0.5 N - about 40.0 N, more preferably between about 1.0 N - about 30.0 N, and most preferably between about 2.5 N - about 15.0 N, where the lower limit sets the minimum "softness" of the composition and the upper limit sets the maximum "hardness" of the composition, both of which are affected by the consumer product application. In some aspects, the crystallizing agent is present in an amount of about 0.01% to about 10% by weight of the rheological solid personal care composition. The crystallizing agent can be present in an amount of about 0.1% to about 7% by weight of the rheological solid personal care composition, about 1% to about 7% by weight of the rheological solid personal care composition, or about 2% to about 5% by weight of the rheological solid personal care composition.

[0030] The crystallizing agent should form elongated fibrous crystalline particles, where the length of the particles in the direction of their longest axis is preferably 10 times the length of the particles in any orthogonal direction, more preferably 15 times and most preferably 20 times, as evaluated by standard scanning electron microscopy (SEM) methods. Without being bound by theory, it is believed that the longer the crystalline particles, the more effectively they can entangle to form an effective network structure. This is in contrast to the fatty acid crystals of magnesium fatty acid salts (the protonated form of sodium fatty acid salts), which are not elongated and typically exhibit a ratio of 1 to 2 times. The composition of the fibrous crystalline particles should be thermally stable at room temperature, preferably at a temperature higher than about 30 °C, more preferably higher than about 35 °C, more preferably higher than about 40 °C, more preferably higher than about 50 °C, most preferably higher than about 60 °C, as determined by the thermal stability test method as described herein. Finally, the fibrous crystalline particles combine to form a network such that the aqueous phase and the insoluble active material can be extruded from the rheological solid personal care composition with a defined applied stress. The work required to extrude the aqueous phase from 15% of the structural volume of the rheological solid personal care composition is preferably between about 100 J m-3 and about 6000 J m-3, alternatively between about 100 J m-3 and about 3000 J m-3, alternatively between about 300 J m-3 and about 2000 J m-3, alternatively between about 500 J m-3 and about 1500 J m-3, as determined by the water extrusion test method as described herein.

[0031] In some aspects, the crystallizing agent can be a metal salt. Non-limiting examples of metal salts can include sodium stearate, sodium palmitate, potassium stearate, potassium palmitate, sodium myristate. Those skilled in the art will understand that the rheological solid personal care composition can be prepared using the acid form of the salt in combination with a base such as sodium hydroxide to form the metal salt.

[0032] Suspending agent

[0033] The suspending agent prevents the separation of insoluble active substances during the preparation of a rheological solid personal care composition. The composition of the present invention is heated until the crystallizing agent dissolves, leaving the active substances dispersed in a low-viscosity fluid. When the composition cools, the crystallizing agent begins to form fibrous crystalline particles that together weave into a network that ultimately traps the active substances. This process can take from a few minutes to several hours. Without being bound by theory, it is believed that the suspending agent increases the viscosity or forms a yield stress that keeps the active substances from creaming or settling during the crystallization of the crystallizing agent and the formation of the network. Preferred suspending agents are effective at low concentrations to prevent potential negative impacts on the network and the performance of the consumer product. Preferred amounts are less than about 2 wt%, alternatively less than about 1 wt%, alternatively less than about 0.5 wt%, alternatively less than about 0.1 wt%. In some aspects, the rheological solid personal care composition can contain from about 0.01 wt% to about 2 wt%, alternatively from about 0.05 wt% to about 1 wt%, alternatively from about 0.1 wt% to about 0.5 wt%, alternatively from about 0.25 wt% to about 0.35 wt% of the suspending agent, all percentages being based on the weight of the rheological solid personal care composition.

[0034] Suitable suspending agents include gums, polymers, microfiber particles, clay particles, and combinations thereof, and unexpectedly, the composition must be selected such that their addition has no negative impact on the network. For example, the use of a gum can weaken the network structure relative to a composition without the gum that requires an increased amount of crystallizing agent (Example 2). Also, the use of clay (Example 10) and microfibers (Example 9) can be rendered ineffective by the addition of sodium chloride.

[0035] Gum

[0036] The rheological solid personal care composition contains at least one suspending agent to keep insoluble substances (i.e., solids or oils) suspended during preparation. The suspending agent can comprise one or more biopolymers. Non-limiting examples of such biopolymers include polysaccharides, such as polymers of glucose, fructose, galactose, mannose, rhamnose, glucuronic acid, and mixtures thereof.

[0037] The suspending agent can be in the form of a polysaccharide or a polysaccharide mixture. Preferred polysaccharide suspending agents include xanthan gum, glucomannan, galactomannan, and combinations thereof. Glucomannan can be derived from natural gums such as konjac gum. Galactomannan can be derived from natural gums such as locust bean gum. The polysaccharide suspending agent can also include carrageenan. The suspending agent gum can be modified, such as by deacetylation.

[0038] A rheologically solid personal care composition may comprise a polysaccharide suspending agent system that includes at least two polysaccharides, such as a first polysaccharide and a second polysaccharide. The first polysaccharide may be xanthan gum. The second polysaccharide may be selected from the group consisting of glucomannan, galactomannan, and combinations thereof. The second polysaccharide may be selected from the group consisting of konjac gum, locust bean gum, tara gum, and combinations thereof.

[0039] Preferably, the first polysaccharide is xanthan gum and the second polysaccharide is konjac gum.

[0040] The first polysaccharide may be present at a level greater than about 10 wt% and less than about 100 wt%, alternatively from about 40 wt% to about 90 wt%, alternatively from about 40 wt% to about 60 wt%, based on the weight of the polysaccharide suspending agent system.

[0041] The second polysaccharide may be present at a level from about 0 wt% to about 90 wt%, alternatively from about 60 wt% to about 10 wt%, alternatively from about 60 wt% to about 40 wt%, based on the weight of the polysaccharide suspending agent system.

[0042] The total concentration of polysaccharides present in the rheologically solid personal care composition may be between about 0.01 wt% and about 1.0 wt%, or more preferably between about 0.03 wt% and about 1.0 wt%, or more preferably between about 0.05 wt% and about 0.8 wt%, more preferably between about 0.07 wt% and about 0.75 wt%, and most preferably between about 0.09 wt% and about 0.5 wt%, all percentages being based on the weight of the rheologically solid personal care composition. Without being bound by theory, it is believed that minimizing the total polysaccharide level in the composition ensures the stability of the dispersed active agent during preparation while minimizing the impact of the suspending agent on the network structure.

[0043] The polysaccharide suspending agent system may have a weight average molecular weight in the range of about 10,000 daltons to about 15,000,000 daltons, alternatively from about 200,000 daltons to about 10,000,000 daltons, alternatively from about 300,000 daltons to about 6,000,000 daltons, alternatively from about 300,000 daltons to about 500,000 daltons.

[0044] The polysaccharide suspending agent system may be characterized by an average acetylation ratio, where the average acetylation ratio is the number of acetylated hydroxyl groups in the polysaccharide divided by the number of free hydroxyl groups in the polysaccharide. The average acetylation ratio may be in the range of about 2.0 to about 0.5, preferably in the range of about 1.5 to about 0.5.

[0045] Clay

[0046] In the present disclosure, suspending agents can be used to provide viscosity and thixotropic properties to the composition, thereby preventing the suspended active agent particles from gelling or settling during preparation. In one or more embodiments, the suspending agent can be a mineral clay mixture, more specifically a mineral clay mixture that is organophilic. In one or more embodiments, the mineral clay mixture can be treated with an alkyl quaternary ammonium compound to render the mineral clay mixture hydrophobic; such clays can also be referred to as organophilic. In one or more embodiments, the mineral clay mixture can comprise: mineral clay (a), which comprises from about 50 wt% to about 95 wt%, or from about 60 wt% to about 95 wt%, or from about 70 wt% to about 90 wt% of the mineral clay mixture, the mineral clay being selected from the group consisting of sepiolite, palygorskite, and mixtures of sepiolite and palygorskite; and mineral clay (b), which comprises the balance of the montmorillonite by weight of the mineral clay mixture. In one or more embodiments, the montmorillonite can be a natural or synthetic clay mineral selected from the group consisting of lithium montmorillonite, synthetic hectorite, montmorillonite, bentonite, beidellite, saponite, stevensite, and mixtures thereof. Suitable clays include synthetic hectorite from the Garamite product line available from BYK Additives, (Gonzalez, TX).

[0047] Microfiber

[0048] Any microcrystalline cellulose can be employed in the compositions of the present invention. Suitable starting materials include, for example, wood pulp such as bleached sulfite and sulfate wood pulp, corn husks, bagasse, wheat straw, cotton, cotton linters, flax, hemp, ramie, fermented cellulose, and the like. The amounts of microcrystalline cellulose and hydrocolloids can vary within a wide range depending on the desired properties in the final composition. Suitable microfibers include Rheocrysta c-2sp (WASE COSFA USA, Inc.).

[0049] Insoluble active substance

[0050] In addition to the fibrous crystalline particles comprising the network, the rheological solid personal care composition can further comprise one or more insoluble active particles. As used herein, "insoluble active particles" comprise at least a portion of a solid, semi-solid, or liquid material, including an amount of insoluble active substance. The insoluble active particles can take various different forms, for example, the insoluble active particles can be 100 wt% solid or can be hollow. The insoluble active particles can include, for example, mesoporous particles, activated carbon, zeolites, beneficial agent delivery particles, waxes, insoluble oils, hydrogels, and / or ground nut shells.

[0051] In some aspects, the rheological solid personal care composition may comprise from about 0.001% to about 35% by weight of insoluble active particles, alternatively from about 0.01% to about 30% by weight of insoluble active particles, alternatively from about 0.01% to about 25%, alternatively from about 0.1% to about 15%, alternatively from about 0.5% to about 12%, alternatively from about 1% to about 10%, alternatively from about 5% to about 10% by weight of insoluble active particles, all percentages being based on the weight of the rheological solid personal care composition.

[0052] In some aspects, the rheological solid personal care composition may comprise from about 0.001% to about 30% by weight, alternatively from about 0.1% to about 30% by weight, alternatively from about 0.1% to about 25%, alternatively from about 0.5% to about 15%, alternatively from about 1% to about 10%, alternatively from about 5% to about 15% by weight of insoluble active agents, all percentages being based on the weight of the rheological solid personal care composition.

[0053] The rheological solid personal care composition may comprise one or more types of insoluble active particles, such as two types of insoluble active particles, wherein one of the first insoluble active particles or the second insoluble active particles (a) is made of a different material from the other; (b) has a wall comprising a different amount of wall material or monomer from the other; (c) contains a different amount of perfume oil component from the other; (d) contains a different perfume oil; (e) has a wall cured at a different temperature; (f) contains a perfume oil having a different cLogP value; (g) contains a perfume oil having a different volatility; (h) contains a perfume oil having a different boiling point; (i) has a wall made of a different weight ratio of wall material; (j) has a wall cured at a different curing time; and / or (k) has a wall heated at a different rate.

[0054] The plurality of insoluble active agent particles may have a diameter of less than about 500 μm, alternatively less than about 400 μm, alternatively less than about 300 μm, alternatively less than about 200 μm, alternatively less than about 100 μm. Those skilled in the art recognize that the ability to suspend particles is a function of the average diameter of the particles (wherein larger particles are more difficult to suspend) and the total amount of particles (wherein a large amount of particles are more difficult to suspend).

[0055] For the former, those skilled in the art also recognize that the concentration of the suspending agent with a given insoluble active agent may have to be increased to accommodate larger insoluble active particles. It is generally preferred to minimize the amount of the suspending agent (e.g., Example 2), such that smaller active agent particles are preferred. For the latter, those skilled in the art also recognize that the concentration of the suspending agent with a given insoluble active agent may have to be increased to accommodate a larger amount of insoluble active particles (e.g., Example 7).

[0056] Encapsulated insoluble beneficial agent

[0057] The insoluble active particles may comprise a wall material encapsulating an insoluble active substance. The insoluble active substance may be selected from the group consisting of: fragrance compositions, fragrance raw materials, fragrances, skin coolants, vitamins, sunscreens, antioxidants, glycerol, bleach encapsulates, chelating agents, antistatic agents, insect and moth repellents, colorants, antioxidants, sanitizing agents, disinfectants, microbial control agents, mold control agents, mildew control agents, antiviral agents, desiccants, antifouling agents, detergents, chlorine bleach odor control agents, dye fixatives, dye transfer inhibitors, color retention agents, optical brighteners, color restorers / revivifiers, anti-fading agents, whiteness enhancers, anti-abrasion agents, anti-wear agents, fabric integrity agents, anti-friction agents, anti-pilling agents, defoaming agents, anti-foaming agents, ultraviolet protectants, photo-fading inhibitors, anti-allergenic agents, enzymes, water repellents, fabric comfort agents, anti-shrink agents, anti-stretch agents, stretch restorers, skin care agents, natural active substances, antibacterial active substances, antiperspirant active substances, cationic polymers, dyes, metal catalysts, non-metal catalysts, activators, preformed peroxycarboxylic acids, diacyl peroxides, hydrogen peroxide sources, enzymes, topical active substances, and combinations thereof. As used herein, "fragrance raw material" refers to one or more of the following components: aromatic essential oils; aromatic compounds; pre-fragrances; materials provided with aromatic essential oils, aromatic compounds, and / or pre-fragrances, including stabilizers, diluents, processing aids, and contaminants; and any materials that typically accompany aromatic essential oils, aromatic compounds, and / or pre-fragrances.

[0058] The wall materials of the insoluble active particles may include melamine, polyacrylamide, silicone, silica, polystyrene, polyurea, polyurethane, polyacrylate-based materials, polyacrylate-based materials, gelatin, styrene maleic anhydride, polyamide, aromatic alcohols, polyvinyl alcohol, and mixtures thereof. The melamine wall materials may include melamine crosslinked with formaldehyde, melamine-dimethoxyethanol crosslinked with formaldehyde, and mixtures thereof. The polystyrene wall materials may include polystyrene crosslinked with divinylbenzene. The polyurea wall materials may include urea crosslinked with formaldehyde, urea crosslinked with glutaraldehyde, polyisocyanate reacted with polyamine, polyamine reacted with aldehyde, and mixtures thereof. The polyacrylate-based wall materials may include polyacrylates formed from methyl methacrylate / dimethylaminoethyl methacrylate, polyacrylates formed from amine acrylates and / or methacrylates with strong acids, polyacrylates formed from carboxylic acid acrylates and / or methacrylates monomers with strong bases, polyacrylates formed from amine acrylates and / or methacrylate monomers with carboxylic acid acrylates and / or carboxymethyl methacrylate monomers, and mixtures thereof.

[0059] The polyacrylate-based wall materials may include polyacrylates formed from alkyl and / or glycidyl esters of acrylic acid and / or methacrylic acid, acrylates and / or methacrylates carrying hydroxyl and / or carboxyl groups, and allyl glucosamide, and mixtures thereof.

[0060] The aromatic alcohol-based wall materials include aryloxyalkanols, arylalkanols, and oligomeric alkanol aryl ethers. It may also contain aromatic compounds having at least one free hydroxyl group, particularly preferably at least two directly aromatic-coupled free hydroxyl groups, which are particularly preferred if at least two free hydroxyl groups are directly coupled to the aromatic ring and more particularly preferably are positioned meta to each other. Preferably, the aromatic alcohol is selected from phenol, cresols (o-cresol, m-cresol, and p-cresol), naphthols (α-naphthol and β-naphthol), and thymol, as well as ethylphenol, propylphenol, fluorophenol, and methoxyphenol.

[0061] The polyurea-based wall material may comprise a polyisocyanate. The polyisocyanate may be an aromatic polyisocyanate containing phenyl, toluoyl, xylyl, naphthyl or diphenyl moieties (e.g., polyisocyanurate of toluene diisocyanate, trimethylolpropane adduct of toluene diisocyanate or trimethylolpropane adduct of xylylene diisocyanate), an aliphatic polyisocyanate (e.g., trimer of hexamethylene diisocyanate, trimer of isophorone diisocyanate and biuret of hexamethylene diisocyanate) or a mixture thereof (e.g., mixture of biuret of hexamethylene diisocyanate and trimethylolpropane adduct of xylylene diisocyanate). In other embodiments, the polyisocyanate may be crosslinked with a polyamine as the crosslinking agent (e.g., diethylenetriamine, bis(3-aminopropyl)amine, bis(hexamethylene)triamine, tris(2-aminoethyl)amine, triethylenetetramine, N,N'-bis(3-aminopropyl)-1,3-propanediamine, tetraethylenepentamine, pentaethylenehexamine, branched polyethyleneimine, chitosan, nisin, gelatin, 1,3-diaminoguanidine monohydrochloride, 1,1-dimethylbiguanide hydrochloride or guanidine carbonate).

[0062] The polyvinyl alcohol-based wall material may comprise crosslinked hydrophobically modified polyvinyl alcohol, which comprises a crosslinking agent comprising i) a first glucuronic acid having a molecular weight of from about 2,000 Da to about 50,000 Da; and ii) a second glucuronic acid having a molecular weight of greater than about 50,000 Da to about 2,000,000 Da.

[0063] Preferably, the insoluble active particles with fragrance have a wall material of a polymer comprising silica or acrylic acid or its derivatives and a benefit agent comprising a fragrance mixture.

[0064] For insoluble active particles, the rheological solid personal care composition may comprise from about 0.001 wt% to about 20 wt% of a benefit agent, based on the weight of the rheological solid personal care composition, the benefit agent being comprised in the wall material of the benefit agent delivery particles. Alternatively, the rheological solid personal care composition may comprise from about 0.01 wt% to about 10 wt%, or most preferably from about 0.05 wt% to about 5 wt% of a benefit agent, based on the weight of the rheological solid personal care composition, the benefit agent being comprised in the wall material of the insoluble active particles.

[0065] These walled particles may be coated with a deposition aid, a cationic polymer, a nonionic polymer, an anionic polymer or a mixture thereof. Suitable polymers may be selected from polyvinyl formaldehyde, partially hydroxylated polyvinyl formaldehyde, polyvinylamine, polyethyleneimine, ethoxylated polyethyleneimine, polyvinyl alcohol, polyacrylate, and combinations thereof.

[0066] Unencapsulated fragrance

[0067] The rheological solid personal care composition may contain unencapsulated fragrance, which contains one or more fragrance ingredients that provide only hedonic beneficial effects (i.e., do not neutralize malodor but provide a pleasant fragrance). Suitable fragrances are disclosed in US 6,248,135. For example, the rheological solid personal care composition may contain a mixture of volatile aldehydes for neutralizing malodor and hedonic fragrance aldehydes.

[0068] When formulating a fragrance other than the volatile aldehyde in the malodor control component into the rheological solid personal care composition, the total amount of the fragrance and the volatile aldehyde may be about 0.015 wt% to about 2 wt%, alternatively about 0.01 wt% to about 1.0 wt%, alternatively about 0.015 wt% to about 0.5 wt% based on the weight of the rheological solid personal care composition.

[0069] Fragrance delivery technology

[0070] The rheological solid personal care composition may contain one or more fragrance delivery technologies that stabilize and enhance the deposition and release of fragrance components from the treated substrate. Such fragrance delivery technologies can also be used to extend the persistence of fragrance release from the treated substrate. Fragrance delivery technologies, methods for preparing certain fragrance delivery technologies, and uses of such fragrance delivery technologies are disclosed in US 2007 / 0275866A1.

[0071] The rheological solid personal care composition may contain about 0.001 wt% to about 20 wt%, or about 0.01 wt% to about 10 wt%, or about 0.05 wt% to about 5 wt%, or even about 0.1 wt% to about 0.5 wt% of the fragrance delivery technology. In one aspect, the fragrance delivery technology may be selected from the group consisting of: pre-fragrance, polymer particles, soluble silicone, polymer-assisted delivery, molecule-assisted delivery, co-delivery, amine-assisted delivery, cyclodextrin, starch encapsulation blend, zeolite, and inorganic carriers, and mixtures thereof.

[0072] Fragrance delivery techniques can include amine reaction products (ARPs) or thio reaction products. One can also use "reactive" polymeric amines and / or polymeric thiols, where the amine and / or thiol functional groups are pre-reacted with one or more PRMs to form reaction products. Generally, the reactive amines are primary and / or secondary amines and can be part of a polymer or a monomer (non-polymer). Such ARPs can also be blended with additional PRMs to provide the beneficial effects of polymer-assisted delivery and / or amine-assisted delivery. Non-limiting examples of polymeric amines include polyalkyleneimine-based polymers such as polyethyleneimine (PEI) or polyvinylamine (PVAm). Non-limiting examples of monomeric (non-polymer) amines include hydroxyamines such as 2-aminoethanol and its alkyl-substituted derivatives, and aromatic amines such as anthranilates. The ARP can be premixed with the fragrance or added separately to leave-on or rinse-off applications. In another aspect, materials containing heteroatoms other than nitrogen and / or sulfur (e.g., oxygen, phosphorus, or selenium) can be used as alternatives to amine compounds. In another aspect, the foregoing alternative compounds can be used in combination with amine compounds. In another aspect, a single molecule can contain an amine moiety and one or more alternative heteroatom moieties such as thiols, phosphines, and selenols. Beneficial effects can include improved delivery of the fragrance and controlled fragrance release. Suitable ARPs and methods for their preparation can be found in USPA 2005 / 0003980 A1 and USP 6,413,920 B1.

[0073] Essential oils and natural oils

[0074] The insoluble active particles can comprise a separate mixture of insoluble oils such as essential oils and natural oils. As used herein, the term "essential oil" refers to an oil or extract distilled or expressed from plants and the components of these oils. Typical essential oils and their main components are, for example, those obtained from thyme (thymol, carvacrol), oregano (carvacrol, terpenes), lemon (limonene, terpinene, phellandrene, pinene, citral), lemongrass (citral, methyl heptenone, citronellal, geraniol), neroli (linalool, beta-pinene, limonene), orange (limonene, citral), anise (anethole, safrole), clove (eugenol, eugenol acetate, caryophyllene), rose (geraniol, citronellol), rosemary (borneol, bornyl acetate, camphor), geranium (geraniol, citronellol, linalool), lavender (linalyl acetate, linalool), citronella (geraniol, citronellol, citronellal, camphene), eucalyptus (cineole); peppermint (menthol, menthyl esters), spearmint (carvone, limonene, pinene), wintergreen (methyl salicylate), camphor (safrole, acetaldehyde, camphor), bay (eugenol, myrcene, chavicol), cinnamon (cinnamaldehyde, cinnamyl acetate, eugenol), tea tree (terpinene-4-ol, cineole), eucalyptus oil, nutmeg oil, turpentine, chamomile oil, neroli oil, cedar leaf (alpha-thujone, beta-thujone, fenchone), and combinations thereof. Essential oils are widely used in perfumery and as flavoring agents, pharmaceuticals, and solvents. Essential oils (their composition and preparation) are described in detail in the 4th edition of the Kirk-Othmer Encyclopedia of Chemical Technology and the 13th edition of The Merck Index.

[0075] In some aspects, the rheological solid personal care composition can comprise from about 0.1 wt% to about 20 wt%, alternatively from about 0.5 wt% to about 15 wt%, alternatively from about 1 wt% to about 12 wt%, alternatively from about 4 wt% to about 15 wt%, alternatively from about 5 wt% to about 10 wt% of the insoluble oil, all percentages being based on the weight of the rheological solid personal care composition.

[0076] Waxes and oils

[0077] The insoluble active particles can comprise a separate mixture of wax and oil as a non-aqueous binder. A non-aqueous binder is generally any chemical substance in any physical form that does not contain water. The non-aqueous binder can be selected from the group consisting of liquid petrolatum, petrolatum, mineral oil, glycerin, natural and synthetic oils, fats, silicones and silicone derivatives, polyvinyl acetate, natural and synthetic waxes such as animal waxes like beeswax, lanolin, and shellac, hydrocarbons, hydrocarbon derivatives, vegetable waxes such as carnauba wax, candelilla wax, and bayberry wax, vegetable oils such as triglyceride caprylate / caprate, and combinations thereof. In some aspects, the non-aqueous binder can be selected from the group consisting of liquid petrolatum, petrolatum, mineral oil, vegetable oils such as almond oil, canola oil, squalane, squalene, coconut oil, corn oil, jojoba oil, jojoba wax, lecithin, olive oil, safflower oil, sesame oil, shea butter, soybean oil, sweet almond oil, sunflower oil, tea tree oil, shea butter, palm oil, and animal oils such as fish oil and oleic acid, and mixtures thereof. In some aspects, the non-aqueous binder can be mineral oil. In some aspects, the non-aqueous binder can be pentaerythritol tetra(isostearate).

[0078] Preferably, the non-aqueous binder is hydrophobic. One advantage of adding a hydrophobic non-aqueous binder such as petrolatum is thermal stability. Without being bound by theory, it is believed that adding a hydrophobic non-aqueous binder can provide better partitioning between the oil phase and the water phase, which can provide thermal stability. In addition, the hydrophobic non-aqueous binder can improve the hardness and spreadability of the rheological solid personal care composition.

[0079] In some aspects, the rheological solid personal care composition can comprise from about 1 wt% to about 15 wt%, alternatively from about 3 wt% to about 12 wt%, alternatively from about 5 wt% to about 10 wt% of the non-aqueous binder, all percentages being based on the weight of the rheological solid personal care composition.

[0080] In some aspects, the rheological solid personal care composition can comprise a ratio of insoluble active substance to non-aqueous binder of from about 1 to about 2, alternatively from about 1.5 to about 1.9.

[0081] Deodorant

[0082] The rheological solid personal care composition can comprise other malodor reduction techniques. This can include, but is not limited to, amine-functional polymers, metal ions, cyclodextrins, cyclodextrin derivatives, polyols, oxidants, activated carbon, zeolites, and combinations thereof.

[0083] Touch modifier

[0084] The rheological solid personal care composition may also contain an insoluble active agent that is designed to change the tactile properties of the composition when applied to a surface such as the skin. This can include starches (e.g., tapioca starch, rice starch, etc.), talc, pyrogenic silica ( 200), titanium dioxide, polydimethylsiloxane, iron oxide, mica, charcoal, colloidal oatmeal, colloidal cellulose, kaolin, and combinations thereof.

[0085] Skin care agent

[0086] Skin care agents can be added to deliver therapeutic and / or skin-protecting benefits. It should be recognized that among the many materials available for delivery to the skin, those that are considered safe and effective skin care agents and their mixtures are the logical materials for use herein. Such materials include Class I active substances as defined by the Tentative Final Monograph for Over-the-Counter Human Drug Products for Skin Protectants of the U.S. Food and Drug Administration (21 C.F.R. § 347), which currently includes: allantoin, aluminum hydroxide gel, calamine, cocoa butter, polydimethylsiloxane, cod liver oil (combination), glycerin, kaolin, petrolatum, lanolin, mineral oil, shark liver oil, white petrolatum, talc, topical starch, zinc acetate, zinc carbonate, zinc oxide, etc. Other potentially available materials are Class DI active substances as defined by the Tentative Final Monograph for Over-the-Counter Human Drug Products for Skin Protectants of the U.S. Food and Drug Administration (21 C.F.R. § 347), which currently includes: live yeast cell derivatives, aluminum allantoin, aluminum acetate, microcrystalline cellulose, cholecalciferol, colloidal oatmeal, cysteine hydrochloride, dexpanthenol, Peru balsam oil, protein hydrolysates, racemic methionine, sodium bicarbonate, vitamin A, buffer mixtures of cationic and anionic exchange resins, corn starch, triethanolamine, etc. Additionally, other possible materials are Class II active substances as defined by the Tentative Final Monograph for Over-the-Counter Human Drug Products for Skin Protectants of the U.S. Food and Drug Administration (21 C.F.R. § 347), which includes: bismuth subnitrate, boric acid, ferric chloride, polyvinylpyrrolidone-vinyl acetate copolymer, sulfur, tannic acid, etc. The skin care agent can be selected from these materials and their mixtures. As mentioned above, the materials used should be safe. The rheological solid personal care composition may contain a skin care agent in an amount between about 0.001 wt% and about 20 wt% based on the weight of the rheological solid personal care composition. The concentration range of the skin care agent in the composition varies depending on the material.

[0087] Hair treatment active substance

[0088] Pyrithione anti-dandruff granules, especially 1-hydroxy-2-pyrithione salts, are suitable particulate anti-dandruff agents. Based on the total weight of the composition, the concentration of pyrithione anti-dandruff microparticles typically ranges from about 0.01% to about 5% by weight, generally from about 0.1% to about 3% by weight, and usually from about 0.1% to about 2% by weight. Suitable pyrithione salts include those formed from heavy metals such as zinc, tin, cadmium, magnesium, aluminum, and zirconium, generally zinc, and typically the zinc salt of 1-hydroxy-2-pyrithione (referred to as "zinc pyrithione" or "ZPT"), usually in the form of flaky particles, where the particles have an average size of at most about 20 μm, typically at most about 5 μm, and usually at most about 2.5 μm. Salts formed from other cations such as sodium may also be suitable. Pyrithione anti-dandruff agents are described, for example, in U.S. Patent 2,809,971; U.S. Patent 3,236,733; U.S. Patent 3,753,196; U.S. Patent 3,761,418; U.S. Patent 4,345,080; U.S. Patent 4,323,683; U.S. Patent 4,379,753; and U.S. Patent 4,470,982. As described above, ZPT is the preferred pyrithione salt.

[0089] In addition to the anti-dandruff active substance, the composition may further comprise one or more anti-fungal or anti-microbial active substances in addition to the metal pyrithione salt active substance. Suitable anti-microbial active substances include coal tar, sulfur, charcoal, Whitfield's ointment, Castellani's paint, aluminum chloride, gentian violet, octopirox (octopirox ethanolamine), ciclopirox olamine, undecylenic acid and its metal salts, potassium permanganate, selenium sulfide, sodium thiosulfate, propylene glycol, bitter orange oil, urea preparations, griseofulvin, 8-hydroxyquinoline chloroiodoquine, thiodibazole, thiocarbamate, haloprogin, polyene, hydroxypyridone, morpholine, benzylamine, allylamine (such as terbinafine), tea tree oil, clove leaf oil, coriander, palmarosa, berberine, thyme red, cinnamon oil, cinnamaldehyde, citronellic acid, hinokitiol, sulfonated shale oil, Sensiva SC-50, Elestab HP-100, azelaic acid, lysol, iodopropargyl butylcarbamate (IPBC), isothiazolinones such as octyl isothiazolinone and azoles, and combinations thereof. Typical anti-microbial agents include itraconazole, ketoconazole, selenium sulfide, and coal tar.

[0090] Underarm treatment active substance

[0091] The rheological solid personal care composition may comprise from about 0.1% to about 50% by weight, based on the weight of the rheological solid personal care composition, of a soluble antiperspirant active substance suitable for application to human skin. The concentration of the antiperspirant active substance in the composition should be sufficient to provide the desired sweating humidity and odor control for the finished antiperspirant product.

[0092] The rheological solid personal care composition may contain a soluble antiperspirant active substance in a concentration of from about 0.1% to about 35% by weight, preferably from about 3% to about 20% by weight, even more preferably from about 4% to about 19% by weight of the composition, or provide a finished product containing the soluble antiperspirant active substance. All these weight percentages are calculated based on the anhydrous metal salt, excluding water and any complexing agent or buffer, such as glycine, glycinate or other complexing agent or buffer.

[0093] The soluble antiperspirant active substances used in the compositions of the present invention include any compound, composition or other substance having antiperspirant activity. Preferred antiperspirant active substances include astringent metal salts, especially inorganic and organic salts of aluminum, zirconium and zinc, and mixtures thereof. Particularly preferred are aluminum salts and zirconium salts, such as aluminum halides, hydrated aluminum chloride, hydroxyaluminum halide, zirconium oxyhalide, hydroxyzirconium oxyhalide and mixtures thereof.

[0094] Preferred aluminum salts for use in antiperspirant compositions include those conforming to the following formula:

[0095] Al2(OH) a Cl b ·x H2O

[0096] where a is from about 2 to about 5; the sum of a and b is about 6; x is from about 1 to about 6; and where a, b and x can have non-integer values. Particularly preferred is hydroxyaluminum chloride, which is called "5 / 6 basic hydroxyaluminum chloride" when a = 5, and which is called "2 / 3 basic hydroxyaluminum chloride" when a = 4.

[0097] Preferred zirconium salts for use in antiperspirant compositions include those conforming to the following formula:

[0098] ZrO(OH) 2-a Cl a ·x H2O

[0099] where a is any number having a value of from about 0 to about 2; x is from about 1 to about 7; and where both a and x can have non-integer values. Particularly preferred zirconium salts are those complexes that also contain aluminum and glycine, commonly referred to as ZAG complexes. These ZAG complexes contain hydroxyaluminum chloride and hydroxyzirconium chloride conforming to the above formula.

[0100] Tooth treatment active substance

[0101] The composition may contain a water-soluble fluoride in an amount sufficient to provide a fluoride ion concentration of from about 0.0025% to about 5.0% by weight, preferably from about 0.005% to about 2.0% by weight, in the composition and / or when in use, so as to provide an anti-caries effect. A variety of fluoride ion-generating materials can be used as the soluble fluoride source in the composition of the present invention. Examples of suitable fluoride ion-generating materials can be found in U.S. Patent No. 3,535,421, issued to Briner et al. on October 20, 1970, and U.S. Patent No. 3,678,154, issued to Widder et al. on July 18, 1972. Representative fluoride ion sources include stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, indium fluoride, etc. Stannous fluoride and sodium fluoride and mixtures thereof are preferred.

[0102] Topical active substance

[0103] The rheological solid personal care composition may contain an insoluble topical active substance. In some aspects, the rheological solid personal care composition may contain from about 0.01% to about 20% by weight, alternatively from about 0.025% to about 10% by weight, alternatively from about 0.1% to about 7% by weight, alternatively from about 0.25% to about 5% by weight, alternatively from about 1% to about 3% by weight of the topical active substance, all percentages being based on the weight of the rheological solid personal care composition. Non-limiting examples of the topical active substance may include pain relievers such as methyl salicylate, ibuprofen and diclofenac sodium, melatonin, capsaicin, chili peppers, camphor, menthol, anesthetics such as benzocaine, corticosteroids such as hydrocortisone and hydrocortisone acetate, and combinations thereof.

[0104] Aqueous phase

[0105] The rheological solid personal care composition contains a large amount of water. However, other components may optionally be dissolved in the water to form an aqueous phase. These components are referred to as soluble active agents. Such soluble active agents may include, but are not limited to, catalysts, activators, peroxides, enzymes, antimicrobial agents, preservatives, salts (such as sodium chloride), polyols, soluble drug active substances, and combinations thereof. Crystallizing agents and insoluble active agents are dispersed in the aqueous phase. The suspending agent may be dissolved in the aqueous phase (such as gums and other soluble polymers) or may be dispersed in the aqueous phase (such as clay particles).

[0106] Catalyst

[0107] In some aspects, the soluble surfactant may comprise one or more metal catalysts. In some aspects, the metal catalyst may include one or more of the following: manganese(II) dichloro-1,4-diethyl-1,4,8,11-tetraazabicyclo[6.6.2]hexadecane; and manganese(II) dichloro-1,4-dimethyl-1,4,8,11-tetraazabicyclo[6.6.2]hexadecane. In some aspects, the non-metal catalyst may include one or more of the following: 2-[3-[(2-hexyldodecyl)oxy]-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 3,4-dihydro-2-[3-[(2-pentylundecyl)oxy]-2-(sulfonyloxy)propyl]isoquinolinium, inner salt; 2-[3-[(2-butyldecyl)oxy]-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 3,4-dihydro-2-[3-(octadecyloxy)-2-(sulfonyloxy)propyl]isoquinolinium, inner salt; 2-[3-(hexadecyloxy)-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 3,4-dihydro-2-[2-(sulfonyloxy)-3-(tetradecyloxy)propyl]isoquinolinium, inner salt; 2-[3-(dodecyloxy)-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 2-[3-[(3-hexyldecyl)oxy]-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 3,4-dihydro-2-[3-[(2-pentylnonyl)oxy]-2-(sulfonyloxy)propyl]isoquinolinium, inner salt; 3,4-dihydro-2-[3-[(2-propylheptyl)oxy]-2-(sulfonyloxy)propyl]isoquinolinium, inner salt; 2-[3-[(2-butyloctyl)oxy]-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 2-[3-(decyloxy)-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt; 3,4-dihydro-2-[3-(octyloxy)-2-(sulfonyloxy)propyl]isoquinolinium, inner salt; and 2-[3-[(2-ethylhexyl)oxy]-2-(sulfonyloxy)propyl]-3,4-dihydroisoquinolinium, inner salt.

[0108] Activator

[0109] In some aspects, the soluble surfactant may comprise one or more activators. In some aspects, the activator may include one or more of the following: tetraacetylethylenediamine (TAED); benzoylcaprolactam (BzCL); 4-nitrobenzoylcaprolactam; 3-chlorobenzoylcaprolactam; benzoyloxybenzenesulfonate (BOBS); nonanoyloxybenzenesulfonate (NOBS); phenyl benzoate (PhBz); decanoyloxybenzenesulfonate (C 10-OBS); Benzoylvalerolactam (BZVL); Octanoyloxybenzenesulfonate (C8-OBS); Hydrolyzable esters; Sodium 4-[N-(nonanoyl)aminohexanoyloxy]-benzenesulfonate (NACA-OBS); Dodecanoyloxybenzenesulfonate (LOBS or C 12 -OBS); 10-Undecenoyloxybenzenesulfonate (UDOBS or C with unsaturation at the 10-position 11 -OBS); Decanoyloxybenzoic acid (DOBA); (6-Octanoylaminohexanoyl)oxybenzenesulfonate; (6-Nonanoylaminohexanoyl)oxybenzenesulfonate; and (6-Decanoylaminohexanoyl)oxybenzenesulfonate.

[0110] Peroxycarboxylic acid

[0111] In some aspects, the soluble active agent may comprise one or more preformed peroxycarboxylic acids. In some aspects, the peroxycarboxylic acids may include one or more of the following: peroxymonosulfuric acid; perimidic acid; percarbonic acid; peroxycarboxylic acids and salts of said acids; phthalimidopercaproic acid; aminoperoxy acids; 1,12-diperoxydodecanedioic acid; and monoperoxyphthalic acid (magnesium salt hexahydrate), wherein the aminoperoxy acids may include N,N'-terephthaloyl-bis(6-aminohexanoic acid), monononanamide of peroxysuccinic acid (NAPSA) or peroxyladipic acid (NAPAA), or N-nonanoylaminoperoxycaproic acid (NAPCA).

[0112] In some aspects, the water-based and / or water-soluble beneficial agent may include one or more diacyl peroxides. In some aspects, the diacyl peroxides may include one or more of di-nonanoyl peroxide, di-decanoyl peroxide, di(undecanoyl) peroxide, dilauroyl peroxide, dibenzoyl peroxide, di-(3,5,5-trimethylhexanoyl) peroxide, wherein the diacyl peroxides may be encapsulated.

[0113] Peroxide

[0114] In some aspects, the soluble active agent may comprise one or more hydrogen peroxides. In some aspects, the hydrogen peroxide source may include one or more of perborates, percarbonates, peroxyhydrates, peroxides, persulfates, and mixtures thereof. In one aspect, the hydrogen peroxide source may include sodium perborate. In one aspect, the sodium perborate may include the monohydrate or the tetrahydrate, sodium pyrophosphate peroxyhydrate, urea peroxyhydrate, trisodium phosphate peroxyhydrate, and sodium peroxide.

[0115] Enzyme

[0116] In some aspects, the soluble surfactant may comprise one or more enzymes. In some aspects, the enzymes may include one or more of the following: peroxidase, protease, lipase, phospholipase, cellulase, cellobiohydrolase, cellobiose dehydrogenase, esterase, cutinase, pectinase, mannanase, pectate lyase, keratinase, reductase, oxidase, phenol oxidase, lipoxygenase, ligninase, pullulanase, tannase, pentosanase, glucanase, arabinosidase, hyaluronidase, chondroitinase, laccase, amylase, DNase, and combinations thereof.

[0117] Sensory agent

[0118] In some aspects, the soluble surfactant may comprise one or more components that provide a sensory benefit, commonly referred to as sensates. Sensates may have sensory attributes such as a warming, tingling, or cooling sensation. Suitable sensates include, for example, menthol, menthyl lactate, leaf alcohol, camphor, clove bud oil, eucalyptus oil, anethole, methyl salicylate, cineole, cinnamon, 1-8 menthyl acetate, eugenol, oxazolidinone, α-ionone, allyl ethyl guaiacol, thymol, linalool, benzaldehyde, cinnamaldehyde glycerol acetal referred to as "CGA", N-[(ethoxycarbonyl)methyl]-p-menthane-3-carboxamide referred to as "WS-5" supplied by Renessenz-Symrise, and mixtures thereof.

[0119] In some aspects, the sensates include cooling agents. The cooling agent can be any of a variety of substances. Those substances included in the present invention are amides, menthol, ketals, diols, and mixtures thereof. Some examples of amide cooling agents include, for example, p-menthane carboxamide reagents such as N-ethyl-p-menthane-3-carboxamide (commercially known as "WS-3"), N,2,3-trimethyl-2-isopropylbutyramide (referred to as "WS-23"), and N-(4-cyanomethylphenyl)-p-menthane carboxamide (referred to as G-180 and supplied by Givaudan). G-180 is typically provided in the form of a 7.5% solution in flavor oils such as spearmint oil or peppermint oil. Examples of menthol cooling agents include, for example, menthol; 3-1-menthoxypropane-1,2-diol referred to as TK-10 and manufactured by Takasago; menthone glycerol acetal referred to as "MGA" and manufactured by Haarmann and Reimer; and menthyl lactate manufactured by Haarmann and Reimer. As used herein, the terms menthol and menthyl include the dextrorotatory and levorotatory isomers of these compounds and their racemic mixtures.

[0120] In some aspects, the sensate comprises a cooling agent selected from the group consisting of menthol; 3-1-menthoxypropane-1,2-diol; menthyl lactate; N,2,3-trimethyl-2-isopropylbutyramide; N-ethyl-p-menthane-3-carboxamide; N-(4-cyanomethylphenyl)-p-menthane carboxamide; ethyl aminomethyl oxalate; and combinations thereof. In some aspects, the sensate comprises menthol; N,2,3-trimethyl-2-isopropylbutyramide; N-(4-cyanomethylphenyl)-p-menthane carboxamide; ethyl aminomethyl oxalate; and combinations thereof.

[0121] In some aspects, the sensate includes a warming sensate. Non-limiting examples of warming sensates can include vanillyl butyl ether (sold by Takasago International under the trade name TK-1000), vanillyl butyl ether (commercially available from Corum, Inc., Taipei, Taiwan, CN), capsaicin, nonivamide, ginger, capsicum (which can be commercially obtained under the trade name Capsicum LC481 from Gattefossé, Lyon, France), and combinations thereof.

[0122] In some aspects, the sensate includes a tingling sensate. Non-limiting examples of tingling sensates can include Zanthoxylum bungeanum, hydroxy-α-sanshool, Spilanthes acmella extract, milliamide, and combinations thereof. Suitable sensate enhancers can include nerve soothers such as Mariliance obtained from Givaudan (Vernier, Switzerland) TM .

[0123] One advantage of including a sensate is that they can provide a local sensory effect. When a rheological solid personal care composition having one or more sensates is applied to the skin, it can provide a sensation on the skin that can act in concert with the odor to provide an enhanced perception of the product strength.

[0124] The rheological solid personal care composition can comprise from about 0.001 wt% to about 1.5 wt%, alternatively from about 0.01 wt% to about 1 wt%, alternatively from about 0.1 wt% to about 0.75 wt%, alternatively from about 0.2 wt% to about 0.5 wt% of the sensate, all percentages being based on the weight of the rheological solid personal care composition.

[0125] Surfactant

[0126] In some aspects, the soluble active agent can comprise one or more surfactants. These include cationic, anionic, and non-surfactants. This includes fabric conditioning softening surfactants and cleansing surfactants.​

[0127] Antimicrobial compound

[0128] In some aspects, the soluble active agent can include an effective amount of a compound for reducing the number of viable microorganisms in the air or on inanimate surfaces. The antimicrobial compound is effective against Gram-negative or Gram-positive bacteria or fungi commonly present on indoor surfaces that come into contact with human skin or pets, such as sofas, pillows, pet bedding, and carpets. Such microbial species include Klebsiella pneumoniae, Staphylococcus aureus, Aspergillus niger, Klebsiella pneumoniae, Steptococcus pyogenes, Salmonella choleraesuis, Escherichia coli, Trichophyton mentagrophytes, and Pseudomonoas aeruginosa. The antimicrobial compound is also capable of effectively reducing the number of viable viruses, such as H1-N1, rhinovirus, respiratory syncytial virus, poliovirus type 1, rotavirus, influenza A virus, herpes simplex virus types 1 and 2, hepatitis A virus, and human coronavirus.

[0129] The antimicrobial compound suitable for the rheological solid composition can be any organic material that does not cause damage to the appearance of the fabric (e.g., decolorization, coloring such as yellowing, bleaching). Water-soluble antimicrobial compounds include organic sulfur compounds, halogenated compounds, cyclic organic nitrogen compounds, low molecular weight aldehydes, quaternary compounds, dehydroacetic acid, phenyl and phenoxy compounds, or mixtures thereof.

[0130] Quaternary compounds can be used. Examples of commercially available quaternary compounds suitable for use in rheological solid compositions are those obtained from Lonza Corporation under the name and the quaternary compound didecyldimethylammonium chloride obtained from Lonza Corporation under the trade name 2250.

[0131] The antimicrobial compound can be present in an amount of from about 500 ppm to about 7000 ppm, alternatively from about 1000 ppm to about 5000 ppm, alternatively from about 1000 ppm to about 3000 ppm, alternatively from about 1400 ppm to about 2500 ppm, based on the weight of the rheological solid personal care composition.

[0132] Preservative

[0133] In some aspects, the soluble surfactant may include a preservative. The preservative may be present in an amount sufficient to prevent spoilage or prevent the growth of inadvertently added microorganisms over a particular period of time, but not sufficient to contribute to the odor-neutralizing properties of the rheological solid composition. In other words, the preservative is not used as an antimicrobial compound to kill the microorganisms on the surface on which the rheological solid composition is deposited, thereby eliminating the odor produced by the microorganisms. Instead, it is used to prevent spoilage of the rheological solid personal care composition to extend the shelf life of the rheological solid personal care composition.

[0134] The preservative can be any organic preservative material that does not cause damage to the appearance of the fabric (e.g., decolorization, coloring, bleaching). Suitable water-soluble preservatives include organic sulfur compounds, halogenated compounds, cyclic organic nitrogen compounds, low molecular weight aldehydes, parabens, propylene glycol materials, isothiazolinones, quaternary compounds, benzoates, low molecular weight alcohols, dehydroacetic acid, phenyl and phenoxy compounds, or mixtures thereof.

[0135] Non-limiting examples of commercially available water-soluble preservatives include a mixture of about 77% 5-chloro-2-methyl-4-isothiazolin-3-one and about 23% 2-methyl-4-isothiazolin-3-one, which is a broad-spectrum preservative sold by Rohm and Haas Co. under the trade name CG as a 1.5% aqueous solution; 5-bromo-5-nitro-1,3-dioxane, which is sold under the trade name Bronidox purchased from Henkel; 2-bromo-2-nitropropane-1,3-diol, which is sold under the trade name purchased from Inolex; 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide) (commonly known as chlorhexidine) and its salts, such as salts with acetic acid and digluconic acid; a 95:5 mixture of 1,3-bis(hydroxymethyl)-5,5-dimethyl-2,4-imidazolidinedione and 3-butyl-2-iodopropargyl carbamate, which is sold under the trade name Glydant purchased from Lonza; N-[1,3-bis(hydroxymethyl)2,5-dioxo-4-imidazolidinyl]-N,N'-bis(hydroxy-methyl)urea, which is commonly known as diazolidinyl urea, sold under the trade name II purchased from Sutton Laboratories, Inc.; N,N"-methylenebis{N'-[1-(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl]urea}, which is commonly known as imidazolidinyl urea, e.g., sold under the trade name purchased from 3V-sigma, sold under the trade name Unicide purchased from Induchem, sold under the trade name Ger-mall Purchased from Sutton Laboratories, Inc.; polymethoxy bicyclic oxazolidine, which is sold under the trade name C was purchased from Hüls America; formaldehyde; glutaraldehyde; polyaminopropyl biguanide, which is sold under the trade name Cosmocil purchased from ICI Americas, Inc., or sold under the trade name purchased from Brooks, Inc; dehydroacetic acid; and benzisothiazolinone, which is sold under the trade name Koralone TM B-119 was purchased from Rohm and Hass Corporation; 1,2-benzisothiazolin-3-one; Acticide MBS.

[0136] A suitable content of the preservative is about 0.0001% to about 0.5% by weight, alternatively about 0.0002% to about 0.2% by weight, alternatively about 0.0003% to about 0.1% by weight, based on the weight of the rheological solid personal care composition.

[0137] The rheological solid personal care composition may contain an aqueous carrier. The aqueous carrier used may be distilled water, deionized water or tap water. Water may be present in any amount to make the rheological solid personal care composition an aqueous solution. Water may be present in an amount of about 85% to 99.5% by weight, alternatively about 90% to about 99.5% by weight, alternatively about 92% to about 99.5% by weight, alternatively about 95% by weight, based on the weight of the rheological solid personal care composition. Alternatively, water may be present in an amount of about 55% to about 99.5% by weight, alternatively about 60% to about 99.5% by weight, alternatively about 65% to about 95% by weight, alternatively about 70% to about 95% by weight, alternatively about 75% to about 90% by weight, all percentages being based on the weight of the rheological solid personal care composition.

[0138] Water containing a small amount of low molecular weight monohydric alcohols (e.g., ethanol, methanol and isopropanol) or polyhydric alcohols (such as ethylene glycol and propylene glycol) may also be used. However, volatile low molecular weight monohydric alcohols such as ethanol and / or isopropanol should be restricted because these volatile organic compounds will cause flammability problems and environmental pollution problems. If a small amount of low molecular weight monohydric alcohols is present in the rheological solid composition (due to adding these alcohols to such substances as fragrances or stabilizers for some preservatives), the content of the monohydric alcohol may be about 1% to about 5% by weight, alternatively less than about 6% by weight, alternatively less than about 3% by weight, alternatively less than about 1% by weight, based on the weight of the rheological solid personal care composition.

[0139] Adjuvant

[0140] Adjuvants can be added to the rheological solid personal care compositions herein for their known purposes. Such adjuvants include, but are not limited to, water-soluble metal salts, including zinc salts, copper salts, and mixtures thereof; antistatic agents; insect and moth repellents; colorants; antioxidants; aromatherapy agents, and mixtures thereof.

[0141] The compositions of the present invention may also contain any additives commonly used in the art under study. For example, unencapsulated pigments, film formers, dispersants, antioxidants, essential oils, preservatives, fragrances, fat-soluble polymers dispersible in the medium, fillers, neutralizing agents, silicone elastomers, cosmetic and skin care oil-soluble active agents such as emollients, humectants, vitamins, anti-wrinkle agents, essential fatty acids, sunscreens, and mixtures thereof can be added.

[0142] Solvent

[0143] The rheological solid personal care compositions may contain a solvent. Non-limiting examples of the solvent may include ethanol, glycerin, propylene glycol, polyethylene glycol 400, polyethylene glycol 200, and mixtures thereof. In some aspects, the rheological solid personal care compositions may contain from about 0.5 wt% to about 15 wt% of the solvent, alternatively from about 1.0 wt% to about 10 wt% of the solvent, alternatively from about 1.0 wt% to about 8.0 wt% of the solvent, alternatively from about 1 wt% to about 5 wt% of the solvent, all percentages being based on the weight of the rheological solid personal care composition.

[0144] Vitamin

[0145] As used herein, "xanthine compound" means one or more xanthines, their derivatives, and mixtures thereof. Xanthine compounds useful herein include, but are not limited to, caffeine, xanthine, 1-methylxanthine, theophylline, theobromine, their derivatives, and mixtures thereof. Among these compounds, caffeine is preferred in view of its solubility in the composition. The composition may contain from about 0.05 wt%, preferably from about 2.0 wt%, more preferably from about 0.1 wt%, still more preferably from about 1.0 wt%, and to about 0.2 wt%, preferably to about 1.0 wt%, more preferably to about 0.3 wt% of the xanthine compound by weight.

[0146] As used herein, "vitamin B3 compound" refers to one or more compounds having the following formula:

[0147]

[0148] wherein R is —CONH2 (i.e., nicotinamide), —COOH (i.e., nicotinic acid) or —CH2OH (i.e., nicotine alcohol); their derivatives; their mixtures; and salts of any one of the foregoing substances.

[0149] Exemplary derivatives of the foregoing vitamin B3 compounds include nicotinic acid esters, which include non-vasodilatory nicotinic acid esters (such as tocopheryl nicotinate and myristyl nicotinate), nicotinoyl amino acids, nicotine alcohol esters of carboxylic acids, nicotinic acid N-oxides and nicotinamide N-oxides. The composition may comprise from about 0.05% by weight, preferably from about 2.0% by weight, more preferably from about 0.1% by weight, still more preferably from about 1.0% by weight, and up to about 0.1% by weight, preferably up to about 0.5% by weight, more preferably up to about 0.3% by weight of the vitamin B3 compound.

[0150] As used herein, the term "panthenol compound" is broad enough to include panthenol, one or more derivatives of pantothenic acid, and mixtures thereof. Panthenol and its derivatives may include D-panthenol ([R]-2,4-dihydroxy-N-[3-hydroxypropyl]-3,3-dimethylbutyramide), DL-panthenol, pantothenic acid and its salts (preferably the calcium salt), panthenol triacetate, royal jelly, pantethine, pantoyl mercaptoethylamine, panthenyl ethyl ether, pantothenyl lactose, vitamin B complex or mixtures thereof. The composition may comprise from about 0.01% by weight, preferably from about 0.02% by weight, more preferably from about 0.05% by weight, and up to about 3% by weight, preferably up to about 1% by weight, more preferably up to about 0.5% by weight of the panthenol compound.

[0151] Salt

[0152] In some aspects, the rheologically solid personal care composition may comprise salts that contribute to thermal stability. Non-limiting examples of salts may include sodium chloride, sodium sulfate, and combinations thereof. In some aspects, the rheologically solid personal care composition may comprise from about 0.1% by weight to about 10% by weight, alternatively from about 1% by weight to about 7% by weight, alternatively from 3% by weight to about 5% by weight of the salt, all percentages being based on the weight of the rheologically solid personal care composition.

[0153] Soluble drug active substance

[0154] The rheological solid personal care composition may contain a soluble pharmaceutical active substance. In some aspects, the rheological solid personal care composition may contain from about 0.1% to about 5% by weight, alternatively from about 0.25% to about 3% by weight, alternatively from 0.5% to about 1.5% by weight of the soluble pharmaceutical active substance, all percentages being based on the weight of the rheological solid personal care composition. Non-limiting examples of the soluble pharmaceutical active substance may include antihistamines such as diphenhydramine hydrochloride and tripelennamine hydrochloride, anesthetics such as lidocaine hydrochloride, dibucaine, propamocaine, and tetracaine, and combinations thereof.

[0155] Consumer product / rheologically solid personal care composition

[0156] In one aspect, the rheological solid personal care composition may provide at least a temporary suppression of coughing due to, for example, minor throat and bronchial irritation associated with a cold. In one aspect, the rheological solid personal care composition may provide at least a temporary relief of minor aches and / or pains of muscles and / or joints. In one aspect, the rheological solid personal care composition may provide relief of nasal congestion.

[0157] The rheological solid personal care composition may be applied to the skin of the user's back, throat, forehead, and / or chest. The user may place a desired amount of the rheological solid personal care composition on his or her skin and rub it in for about 5 seconds to about 3 minutes, alternatively about 20 seconds to about 90 seconds, alternatively about 30 seconds to about 60 seconds. In one example, the rheological solid personal care composition may be covered with a warm dry cloth after application to the skin.

[0158] One dose of the rheological solid personal care composition may be applied to the skin and / or clothing once, or twice, or three times a day. In one aspect, one dose of the rheological solid personal care composition may be applied to the skin up to three times a day. The rheological solid personal care composition may be applied to the skin and / or clothing daily or only as needed. Preferably, the rheological solid personal care composition is applied to clothing or other objects and allowed to dry before, for example, contacting the clothing or other objects. The rheological solid personal care composition is preferably applied to a dry or pre-dried desired area.

[0159] One dose of the rheological solid personal care composition may contain from about 0.5 g to about 10 g, alternatively from about 1 g to about 8 g, alternatively from about 1.5 g to about 6 g, alternatively from about 3 g to about 4.5 g, alternatively about 7.5 g.

[0160] Another aspect of the present invention includes a method of providing one or more health benefits, cosmetic benefits, and / or consumer benefits by administering a rheological solid personal care composition to a user in need thereof. Non-limiting examples of one or more health benefits can include providing nasal congestion relief, suppressing cough, providing muscle soreness and pain relief, improving the sleep quality of a user suffering from a cold or the flu, providing topical analgesic effects, providing relief from rashes, pain, and / or dermatitis, and combinations thereof. Non-limiting examples of one or more cosmetic benefits can include moisturizing, cleansing, beautifying, and combinations thereof. Non-limiting examples of one or more consumer benefits can include providing soothing vapors, providing aromatherapy, promoting sleep, providing stress relief, empowering, providing calming and / or relaxing scents, and combinations thereof.

[0161] The compositions of the present invention can achieve excellent consumer aesthetics without compromising stability. The above preferred ratios and weight percentages provide sufficient medium coverage of the product without feeling dry or flaking, and provide a good smooth / uniform effect on the skin. When the compositions are applied, they also provide a pleasant fresh feeling on the skin.

[0162] The present invention also contemplates consumer-friendly kits and / or prepackaged materials containing one or more compositions according to the present specification. The packaging and application devices for any subject matter of the present invention can be selected and manufactured by those skilled in the art based on their common knowledge; and adjusted according to the nature of the composition to be packaged. In fact, the type of device used can be specifically related to the consistency of the composition, specifically its viscosity; it can also depend on the nature of the components present in the composition, such as the presence of volatile compounds.

[0163] Considering the soft solid nature of the materials, the rheological solid personal care compositions of the present invention can also be combined with devices such as containers, non-woven sheets, or rollers. Such composition / device combinations can be used as consumer products for various applications such as skin cooling or vapor applicators (e.g., sticks, balls), non-woven fiber webs (e.g., surface wipes, mops, toilet paper), and fabric enhancers (e.g., fabric dryer sheets, fabric stain removers, fabric wrinkle reducers, fabric softeners).

[0164] Properties

[0165] Phase stability

[0166] As used herein, phase stability is a measure of the effectiveness of a suspending agent in preventing the settled or creamed of the dispersed active particles. A hot mixture of a crystallizing agent dissolved at the processing temperature has a viscosity of about several millipascal-seconds in water. At this stage, the active substance is added and dispersed as particles in the mixture. During the time before the crystallizing agent crystallizes, the active particles tend to cream (i.e., rise) or sediment (i.e., settle), resulting in unacceptable material separation for consumers. The suspending agent prevents the overall separation of the dispersed active particles during crystallization and allows the network of fibrous crystalline particles to entrap the dispersed active particles. Without being bound by theory, it is believed that the suspending agent increases the viscosity of the suspension or gives the mixture a yield stress that prevents the separation of the active particles. A phase stability value of "0" is not preferred, a value of "1" is a preferred value, and a value of "2" is the most preferred value. Phase stability is determined using the phase stability test method described below.

[0167] Stability temperature

[0168] As used herein, the stability temperature is the temperature at which most or all of the crystallizing agent is completely dissolved in the aqueous phase such that the composition no longer exhibits a stable solid structure and can also be considered a liquid. In some aspects, the minimum stability temperature can be from about 30 °C to about 95 °C, from about 40 °C to about 90 °C, from about 50 °C to about 80 °C, or from about 60 °C to about 70 °C, as these temperatures are typical in the supply chain. The stability temperature can be determined using the thermal stability test method described below.

[0169] Firmness

[0170] Depending on the intended application, such as a stick, the firmness of the composition can also be considered. The firmness of the composition can be expressed, for example, in Newton force. For example, the compositions of the present invention containing 1 wt% - 3 wt% of a crystallizing agent can give values of about 4 to 12 N in the form of a coating on a solid stick or sheet. It is evident that the firmness of the compositions according to the embodiments of the present invention can be such that the composition is advantageously self-supporting and can easily release liquid and / or active substances to form a satisfactory deposit on a surface, such as the skin and / or body surface growths such as horny fibers. In addition, the firmness can impart good impact strength to the compositions of the present invention, which can be molded or cast into, for example, stick or sheet form, such as wipes or dryer paper products. The rheological solid personal care compositions can also be transparent or clear, including, for example, compositions without pigments. The preferred firmness is between about 0.1 N and about 50.0 N, more preferably between about 0.5 N to about 40.0 N, more preferably between about 1.0 N to about 30.0 N, and most preferably between about 2.5 N to about 15.0 N. The firmness can be measured using the firmness test method described below.

[0171] Liquid extrusion

[0172] Depending on the intended application, such as for a stick, liquid extrusion of the composition may also be considered. This is a measure of the amount of work required per unit volume to squeeze water out of the composition, and a higher value means it is more difficult to squeeze out the water. For example, when the composition is applied to the skin, a low value may be preferred. For example, when applied to a substrate that requires "touch dry but wipe wet" properties, a high value may be preferred. Preferred values are between about 100 J m-3 and about 6000 J m-3, alternatively between about 100 J m-3 and about 3000 J m-3, alternatively between about 300 J m-3 and about 2000 J m-3, alternatively between about 500 J m-3 and about 1500 J m-3. Liquid extrusion can be measured using the water extrusion test method as described herein.

[0173] Firmness test method

[0174] Before and during testing, all samples and procedures were maintained at room temperature (25 ± 3 °C), taking care to ensure little or no water loss.

[0175] All measurements were performed using a TA-XT2 texture analyzer (Texture Technology Corporation, Scarsdale, N.Y., U.S.A.) equipped with a standard 45° angle penetration cone tool (Texture Technology Corp., part number TA-15).

[0176] To operate the TA-XT2 texture analyzer, the tool was attached to the probe carrier arm and cleaned with a low-lint wipe. The sample was positioned and held firmly such that the tool would contact a representative area of the sample. The tool was reset to be about 1 cm above the product sample.

[0177] The sample was repositioned such that the tool would contact a second representative area of the sample. The run was performed by precisely moving the tool 10 mm into the sample at a rate of 2 mm / second. The measurement could be executed by pressing the "Run" button on the texture analyzer. On another representative area of the sample, at a sufficient distance from the previous measurement (such that they would not affect the second run), a second run was performed by the same procedure. On another representative area of the sample, at a sufficient distance from the previous measurement (such that they would not affect the third run), a third run was performed by the same procedure.

[0178] The following firmness values were returned from this measurement:

[0179] If the mixture does not fully crystallize at room temperature (e.g., remains clear or pasty), return the value "not solid"; if the mixture exceeds 48 N and is too hard to measure, return the value "too hard"; otherwise, return the value that is the average of the maximum of three measurements.

[0180] Thermal stability test method

[0181] Before testing, all samples and procedures were maintained at room temperature (25 ± 3 °C).

[0182] Sampling was carried out in two steps at a representative area on the sample. First, clean the spatula with a laboratory wipe and remove and discard a small amount of the sample from the top of the sample at this area to make a small square hole about 5 mm deep. Second, clean the spatula again with a clean laboratory wipe and collect a small amount of the sample from the square hole and load it into the DSC pan.

[0183] Load the sample into the DSC pan. All measurements were carried out in a high-capacity stainless steel pan set (TA part number 900825.902). Weigh the pan, lid, and washer and balance them on a Mettler Toledo MT5 analytical microbalance (or equivalent). Load the sample into the pan according to the manufacturer's instructions, with a target weight of 20 mg (+ / - 10 mg), taking care to ensure that the sample contacts the bottom of the pan. Then seal the pan with a TA high-capacity mold set (TA part number 901608.905). Measure the final assembly to obtain the sample weight.

[0184] Load the sample into the TA Q Series DSC according to the manufacturer's instructions. The DSC program uses the following settings: 1) Equilibrate at 25 °C; 2) Mark the end of cycle 1; 3) Ramp up to 90.00 °C at 1.00 °C / min; 4) Mark the end of cycle 3; then 5) End of the method; click Run.

[0185] The stability temperature was determined as the maximum peak of the highest temperature peak. If the stability temperature cannot be measured because the sample is liquid or has too low / high thermal stability, assign the value "NM" to the sample.

[0186] Water extrusion test method

[0187] Before testing, all samples and procedures were maintained at room temperature (25 ± 3 °C).

[0188] Measurements for determining water extrusion were performed using a TA Discovery HR-2 Hybrid Rheometer (TA Instruments, New Castle, Delaware, U.S.A.) with the accompanying TRIOS software version 3.2.0.3877 or equivalent. The instrument was equipped with a DHR Fixed Cell (TA Instrument) and a 50 mm flat steel plate (TA Instrument). Calibration was performed according to the manufacturer's recommendations, paying particular attention to measuring the bottom of the DHR Fixed Cell to ensure that it was determined as gap = 0.

[0189] Samples were prepared according to the example procedure. It is important to prepare the sample in a Speed Mixer container (Flak-Tech, Max 60 translucent cup, catalog number 501222t) such that the diameter of the sample matches the diameter of the HR-2 Fixed Cell. The sample was released from the container by running a thin spatula between the edge of the container and the sample. The container was gently flipped and placed on a flat surface. A gentle force was applied to the center of the bottom of the flipped container until the sample released and slid out gently. The sample was carefully placed in the center ring of the DHR Fixed Cell. Care was taken to ensure that the sample did not deform and reform during the entire process. The diameter of the sample should be slightly smaller than the inner diameter of the ring. This ensures that the force applied to the sample in the subsequent steps does not significantly deform the cylindrical shape of the sample, but allows the fluid to escape through the bottom of the sample. This also ensures that any change in the height of the sample used for the experiment is equal to the amount of aqueous phase extruded during the test. At the end of the measurement, it should be confirmed that the aqueous phase was indeed extruded from the sample by measuring by looking for water in the outflow tube connected to the fixed cell. If no aqueous phase was observed, the sample was considered not to extrude water and not to be inventive.

[0190] Set the instrument settings as follows. Select the axial test geometry. Then, set the "Geometry" options: diameter = 50 mm; gap = 45000 um; loading gap = 45000 um; trim gap offset = 50 um; material = "steel"; environmental system = "Peltier plate". Set the "Process" options: temperature = 25 °C; soak time = 0 seconds; duration = 2000 seconds; motor direction = "compress"; constant linear rate = 2 um sec-1; maximum gap change = 0 um; torque = 0 uN·m; data acquisition = "Save Image" every 5 seconds.

[0191] Manually move the steel tool within approximately 1000 um of the sample surface, taking care that the tool does not touch the surface. In the "Geometry" options, reset the gap to this distance.

[0192] Start the run.

[0193] The data is presented as two curves:

[0194] 1) Curve 1: Axial force (N) on the left y-axis and step time (s) on the x-axis;

[0195] 2) Curve 2: Gap (um) on the right y-axis and step time (s) on the x-axis.

[0196] The contact time - T(contact) is obtained from Curve 1. T(contact) is defined as the time when the tool touches the top of the sample. T(contact) is the step time when the first axial force data point exceeds 0.05 N.

[0197] The sample thickness - L is the gap distance at the contact time and is expressed in meters.

[0198] The compression time - T(compression) is the step time when the gap is 0.85*L or 15% of the sample.

[0199] The work required to squeeze water out of the structure is the area under the axial force curve between T(contact) and T(compression) in Figure 1 multiplied by a constant linear rate, or 2e-6 m s-1 normalized by dividing by the total volume of the extruded fluid, and is expressed in joules per cubic meter (J m-3).

[0200] If water extrusion cannot be measured because the sample is a rheological solid but too soft to handle for testing, a "soft" value is assigned to the sample.

[0201] Phase stability test method

[0202] Samples are prepared according to the example procedure.

[0203] For examples containing beads (Examples 1 - 6), the sample is divided into two parts, and each part is placed in a container (Flak-Tech, Max 60 translucent cup, catalog number 501222t). The two containers are placed in an oven (Yamato, DKN 400; Yamato Scientific Co., Ltd., Tokyo, Japan, or equivalent), which is set to 60 °C for one hour. Then the containers are placed on a workbench at room temperature (25 °C ± 3 °C). "Separation" in the sample describes the pasting and / or sedimentation of the microspheres.

[0204] Visually inspect the phase stability of each sample and grade it based on the following:

[0205] · (Most preferred) If the composition appears stable without distinguishable bead separation (i.e., uniform), a grade of "2" is given;

[0206] · (Preferred) If the preparation appears to have no more than 25%

[0207] If the number of tracer beads is given, grade "1" is assigned.

[0208] · (Not preferred) If the composition appears unstable, as evidenced by almost complete separation with more than 75% of the beads at the top and bottom of the composition, grade "0" is assigned.

[0209] For bead-free examples (Examples 7-10), the entire sample was placed in a container (Flak-Tech, Max60 translucent cup, catalog number 501222t) and placed in an oven (Yamato, DKN 400; Yamato Scientific Co., Ltd., Tokyo, Japan, or equivalent), which was set to 60 °C for one hour. The container was placed on a workbench at room temperature (25 ± 3 °C). "Separation" in the sample describes the pasting and / or sedimentation of insoluble active particles.

[0210] Visually inspect the phase stability of each sample and grade based on the following:

[0211] · (Most preferred) If the composition appears stable without discernible or visual separation of insoluble active particles, grade "2" is assigned.

[0212] · (Preferred) If the preparation appears to have only a few drops (estimated to be less than 25 wt% of the total amount of insoluble active agent added) at the top and / or bottom of the composition, grade "1" is assigned. In some compositions, this may result in a "smooth" appearance on the surface;

[0213] · (Not preferred) If the composition appears unstable, as evidenced by almost complete separation of the insoluble active agent at the top or bottom of the composition (estimated to be less than 75 wt% of the total amount of insoluble active agent added), grade "0" is assigned. In terms of oil, this amount is sufficient for the oil to flow visually when the sample is rotated laterally.

[0214] Examples

[0215] List of materials

[0216] (1) Euxyl PE 9010 (EP) – Schülke & Mayr GmbH, Norderstedt, Germany, PE 9010 preservative, batch number 1501226

[0217] (2) SymDiol 68 (S68) – Symrise, Holzminden, Germany, 68 preservative, batch number 10300094

[0218] (3) Water - Millipore, Burlington, MA (18 m - ohm resistance)

[0219] (4) Sodium myristate (NaM) – TCI Chemicals, Cambridge, MA, Catalog No. M0483

[0220] (5) Xanthan gum (x - gum) – CPK, Denmark, Keltrol 1000, LOT 6J3749K

[0221] (6) Konjac gum (k - gum) - FMC Corporation, Philadelphia, PA, XP 3464, FMC, Lot No. 1192605

[0222] (7) Probe particle microspheres – Cospheric LLC, Santa Barbra, CA, UVPMS - BG - 1.00500 - 600um

[0223] (8) Sodium palmitate (NaP) - TCI Chemicals, Cambridge, MA, Catalog No. P0007

[0224] (9) Sodium stearate (NaS) - TCI Chemicals, Cambridge, MA, Catalog No. S0081

[0225] (10) Starch - Spectrum, New Brunswick, NJ, Catalog No. 9005 - 25 - 8

[0226] (11) Peppermint oil – MFR Ungerer, Bethlehem, PA, Lot No.: 10059257SP - 006

[0227] (12) Coconut oil - Nature’s Oil, Streetsboro, Ohio, Bulk Apothecary, SKU:

[0228] bna - 513

[0229] (13) PMC – Encapsys, Wisconsin, USA, Heavenly Powder PA PMCSlurry, Lot No.: 201810456

[0230] (14) L - menthol

[0231] (15) Nutmeg oil

[0232] (16) Camphor

[0233] (17) Eucalyptus oil

[0234] (18) Cedar leaf oil FCC

[0235] (19) Pine resin containing antioxidant

[0236] (20) Thymol NF

[0237] (21) Sodium chloride (NaCl) - VWR, catalog number BDH9286 - 500G

[0238] (22) Petroleum jelly - Calumet Specialty Products, Indianapolis, IN, catalog number PEN1722 - 00 - C

[0239] (23) Glycerol - Alfa Aesar, catalog number A16205

[0240] (24) Rheocrysta c - 2sp – Iwase Csofa USA Inc., Fort Lee, NJ, catalog number 7UA / 56203

[0241] (25) Synthetic hectorite suspension - Laponite XlG, BYK Additives & Instruments, Louisville, KY, catalog number 13 - 235

[0242] Stock solution

[0243] (A1) Preparation of 1 wt% xanthan gum stock solution (X-gum stock solution)

[0244] Add 0.202 g of Euxyl PE 9010 (1), 0.305 g of SymDiol 68 (2) and 49.007 g of water (3) to a Max 60 Speed Mixer cup (Flak - Tech, Max 60 translucent cup, catalog number 501222t). Add 0.502 g of xanthan gum (5) to the cup. Place the cup in a Speed Mixer (Flak - Tech) at 2700 rpm for 150 seconds. Let the sample stand for 2 hours and then mix again in the SpeedMixed at 2700 rpm for 150 seconds.

[0245] (A2) Preparation of 1 wt% konjac gum stock solution (K-gum stock solution)

[0246] Add 0.201 g of Euxyl PE 9010 (1), 0.301 g of SymDiol 68 (2) and 49.001 g of water (3) to a Max 60 Speed Mixer cup (Flak-Tech, Max 60 translucent cup, catalog number 501222t). Add 0.503 g of konjac gum (6) to the cup. Place the cup in a Speed Mixer at 2700 rpm for 150 seconds. Let the sample stand for 2 hours and then mix again in the Speed Mixer at 2700 rpm for 150 seconds.

[0247] Examples

[0248] Example 1

[0249] Sample A-AE uses a suspending agent made of a gum blend to stabilize suspended insoluble active particles ( Figure 4 ). In these compositions, the suspending agent consists of different amounts of x-gum and k-gum, which is 5 wt% of the crystallizing agent sodium myristate. Figure 4 Plot the total weight of the gums (i.e., x-gum weight + k-gum weight) along the x-axis and the weight percentage of x-gum (i.e., x-gum weight / (x-gum weight + k-gum weight)) along the y-axis, where each point in the graph represents the phase stability results of the compositions in Tables 1 - 8 below. The "X" markers represent compositions with a stability grade of "0" as determined by the phase stability test method and are comparative compositions; the "" markers represent compositions with a stability grade of "1" as determined by the phase stability test method and are the preferred compositions of the present invention; the "O" markers represent compositions with a stability grade of "2" as determined by the phase stability test method and are the most preferred compositions. The data indicate that certain suspending agent compositions are more preferably used to stabilize insoluble active substances. Excluding the suspending agent from the composition always results in a stability grade of "0". Without being bound by theory, this is due to the presence of a yield stress in the preparation formed by the suspending agent during the cooling process. Surprisingly, many compositional limitations vary significantly due to the presence of the crystallizing agent. Tables 1 - 8 also contain data on the firmness (firmness test method), temperature (thermal stability test method), and work (water extrusion test method) of representative comparative compositions and compositions of the present invention. These data indicate that even in the presence of the suspending agent, the prototypes exhibit the desired properties of these rheological solid personal care compositions.

[0250] Preparation of the composition

[0251] A composition is prepared using a heated mixing device. Assemble an overhead mixer (IKA Works Inc, Wilmington, NC, model RW20 DMZ) and a three-blade impeller design. Heat all preparations on a heating pad assembly (VWR, Radnor, PA, 7×7 CER Hotplate, catalog number NO97042 - 690), where heating is controlled with the attached probe. All preparations are carried out in a 250 ml stainless steel beaker (Thermo Fischer Scientific, Waltham, MA).

[0252] First, add preservatives (1, 2) to prepare the NaM / aqueous solution. Then add water (3) and sodium myristate (4) to the beaker. Place the beaker on the heating pad assembly. Place the overhead stirrer in the beaker and set it to rotate at 100 rpm. Set the heater to 80 °C. Heat the preparation to 80 °C. Turn off the heating and allow the preparation to cool to 60 °C.

[0253] The final composition is prepared by adding 1% xanthan gum solution (A1) to the Na - M / aqueous solution, and increasing the stirring rate to 300 rpm - 350 rpm. Once the xanthan gum is completely added and mixed, add 1% konjac gum solution (A2) to the Na - M / water / xanthan gum solution, and increase the stirring rate to 500 rpm - 550 rpm. Then add the solid beneficial agent to the beaker under continuous stirring and allow it to disperse completely. Then divide the composition into three 60 g plastic jars (Flak - Tech, Max 60 translucent cups, catalog number 501222t): fill one jar to 50 ml and two jars to 25 ml. Hold the samples at 60 °C for one hour, then cool at room temperature (25 ± 3 °C) until solid. Perform firmness measurements on the 50 ml sample using a firmness test method, and perform thermal stability measurements on the 50 ml sample using a thermal stability test method. Perform water extrusion measurements on the two 25 ml samples using a water extrusion test method. Representative data show that even in the presence of a suspending agent, the prototype exhibits the desired properties of these rheological solid compositions.

[0254] Table 1

[0255]

[0256] Table 2

[0257]

[0258]

[0259] Table 3

[0260]

[0261] Table 4

[0262]

[0263]

[0264] Table 5

[0265]

[0266] Table 6

[0267]

[0268]

[0269] Table 7

[0270]

[0271] Table 8

[0272]

[0273] Example 2

[0274] Example AF-BO uses a fixed gum suspension system with crystallizing agents of different contents and compositions. The suspending agent is made of 65 wt% x-gum and 35 wt% k-gum, totaling 0.05 wt%, which is the optimal blend described in Example 1. The compositions of the crystallizing agents sodium myristate, sodium palmitate, and sodium stearate are plotted on the x-axis; the contents of the crystallizing agents are plotted on the y-axis( Figure 5)。The "X" mark indicates a composition with a stability level of "0" as determined by the phase stability test method and is a comparative composition; the "" mark indicates a composition with a stability level of "1" as determined by the phase stability test method and is a preferred composition of the present invention; the "O" mark indicates a composition with a stability level of "2" as determined by the phase stability test method and is the most preferred composition. Surprisingly, these data show that the suspending agent can significantly affect the stability of the composition. In these examples, even a moderate amount of the suspending agent can liquefy the composition, and an increase in the content of the crystallizing agent is required to form a stable composition. Also surprisingly, the suspending agent affects the shorter-chain crystallizing agent (i.e., sodium myristate) to a greater extent than the longer-chain crystallizing agent (i.e., sodium stearate), as evidenced by the fact that more crystallizing agent is required for the former. Tables 9 - 17 also contain data on the firmness (firmness test method), temperature (thermal stability test method), and work (water extrusion test method) of representative compositions of the present invention, indicating that even in the presence of the suspending agent, the prototype exhibits the desired properties of these rheological solid compositions.

[0275] Preparation of the composition

[0276] Samples were prepared using a heated mixing device. Assemble an overhead mixer (IKA, model RW20DMZ) with a three-blade impeller design. Heat all preparations on a heating pad assembly (VWR, 7x7 CER Hotplate, catalog number NO97042 - 690), where heating is controlled with the attached probe. All preparations were carried out in a 250 ml stainless steel beaker (Fischer Scientific).

[0277] First, add the preservatives (1,2) to prepare the NaM / aqueous solution. Then add water (3) and sodium myristate (4) to the beaker. Place the beaker on the heating pad assembly. Place the overhead stirrer in the beaker and set it to rotate at 100 rpm. Set the heater to 80 °C. Heat the preparation to 80 °C. Turn off the heating and allow the preparation to cool to 60 °C.

[0278] The final preparation was made by adding 1% xanthan gum solution (A1) to the Na-M / aqueous solution, and increasing the stirring rate to 300 rpm - 350 rpm. Once the xanthan gum was completely added and mixed, 1% konjac gum solution (A2) was added to the Na-M / water / xanthan gum solution, and the stirring rate was increased to 500 rpm - 550 rpm. Then the solid beneficial agent was added to the beaker under continuous stirring and completely dispersed. Then the composition was dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml, and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured by the firmness test method, and the thermal stability of the 50 ml sample was measured by the thermal stability test method. The water extrusion of the two 25 ml samples was measured by the water extrusion test method. Representative data showed that even in the presence of the suspending agent, the prototype exhibited the desired properties of these rheological solid compositions.

[0279] Table 9

[0280]

[0281]

[0282] Table 10

[0283]

[0284] Table 11

[0285]

[0286]

[0287] Table 12

[0288]

[0289] Table 13

[0290]

[0291]

[0292] Table 14

[0293]

[0294] Table 15

[0295]

[0296]

[0297] Table 16

[0298]

[0299]

[0300] Table 17

[0301]

[0302] Example 3

[0303] This example demonstrates the use of Figure 4 and Figure 5 in a composition that effectively suspends perfume capsules (PCs), which are considered representative of insoluble encapsulated active agents. The perfume capsules have an oil core surrounded by a thin solid shell. Without being bound by theory, since the density of the perfume is less than that of the aqueous phase, the capsules would float to the top of the composition in the absence of a suspending agent. The inventive sample with the suspending agent (Sample BP) was shown to have a stability rating of "2" as determined by the phase stability test method, while the comparative sample without the suspending agent (Sample BQ) was shown to have a stability rating of "0" as determined by the phase stability test method.

[0304] Preparation of the composition

[0305] The composition of the present invention was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (Beaker Griffin 250 mL stainless-steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which point the x-gum (A1) and k-gum (A2) solutions were added together with PC (13). For each component added, the mixer was increased by 100 rpm. The solution was then dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured using the firmness test method, and the thermal stability of the 50 ml sample was measured using the thermal stability test method. The water extrusion of the two 25 ml samples was measured using the water extrusion test method. Representative data show that even in the presence of a suspending agent, the prototype exhibits the desired properties of these rheological solid compositions.

[0306] A comparative composition was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (Beaker Griffin 250 mL stainless-steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which point PC (13) was added. For each component added, the mixer speed was increased by 100 rpm. The solution was then dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. Firmness measurements were made on the 50 ml sample using a firmness test method, and thermal stability measurements were made on the 50 ml sample using a thermal stability test method. Water extrusion measurements were made on the two 25 ml samples using a water extrusion test method.

[0307] Table 18

[0308]

[0309]

[0310] Example 4

[0311] This example demonstrates the use of Figure 4 and Figure 5 described in the suspension agent to effectively suspend starch in the composition. Starch is considered a representative of the sedimented insoluble active particles. Starch was added to give the skin and surface a smooth feel. Without being bound by theory, since starch is denser and insoluble than the aqueous phase, it will settle in the aqueous phase. The inventive sample with the suspension agent (Sample BR) was shown to have a stability rating of "2" as determined by the phase stability test method, while the comparative sample without the suspension agent (Sample BS) was shown to have a stability rating of "0" as determined by the phase stability test method.

[0312] Preparation of the composition

[0313] The sample of the present invention was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) into a stainless steel beaker (Beaker Griffin 250 mL stainless steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which time the X-gum (A1) and K-gum (A2) solutions were added together with starch (10). For each component added, the mixer was increased by 100 rpm. Then the composition was dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured by a firmness test method, and the thermal stability of the 50 ml sample was measured by a thermal stability test method. The water extrusion of the two 25 ml samples was measured by a water extrusion test method. Representative data indicate that the prototype exhibits the desired properties of these rheological solid compositions even in the presence of a suspending agent.

[0314] A comparative sample was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (Beaker Griffin 250 mL stainless-steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which time starch (10) was added. For each ingredient added, the mixer speed was increased by 100 rpm. The composition was then dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured using a firmness test method, and the thermal stability of the 50 ml sample was measured using a thermal stability test method. The water extrusion of the two 25 ml samples was measured using a water extrusion test method.

[0315] Table 19

[0316]

[0317]

[0318] Example 5

[0319] This example demonstrates the use of Figure 4 and Figure 5 described in the suspending agents to effectively suspend coconut oil in a composition, coconut oil is considered to be representative of a liquid-solid insoluble active agent. Coconut oil is used as an emollient on the skin and hair. During the preparation of these compositions, coconut oil melts into a liquid and then emulsifies in the stirred composition. After cooling, the oil hardens into solid particles. Without being bound by theory, since the oil is less dense than the composition, the oil would float to the top of the mixture in the absence of a suspending agent. The inventive sample with the suspending agent (sample BT) was shown to have a stability rating of "2" as determined by a phase stability test method, while the comparative sample without the suspending agent (sample BU) was shown to have a stability rating of "0" as determined by a phase stability test method.

[0320] Preparation of the composition

[0321] The sample of the present invention was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (Beaker Griffin 250 mL stainless-steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which time the x-gum (A1) and k-gum (A2) solutions were added together with coconut oil (12). For each ingredient added, the mixer was increased by 100 rpm. The composition was then dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured using a firmness test method, and the thermal stability of the 50 ml sample was measured using a thermal stability test method. The water extrusion of the two 25 ml samples was measured using a water extrusion test method. Representative data indicate that the prototype exhibits the desired properties of these rheological solid compositions even in the presence of suspending agents.

[0322] A comparative sample was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (Beaker Griffin 250 mL stainless-steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the composition was cooled to 60 °C, at which point coconut oil (12) was added. For each ingredient added, the mixer speed was increased by 100 rpm. The composition was then dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured using the firmness test method, and the thermal stability of the 50 ml sample was measured using the thermal stability test method. The water extrusion of the two 25 ml samples was measured using the water extrusion test method.

[0323] Table 20

[0324]

[0325] Example 6

[0326] This example demonstrates a composition using Figure 4 and Figure 5 described suspending agents to effectively suspend peppermint oil, which is considered representative of a liquid-insoluble active agent. Peppermint oil is a natural essential oil used for natural treatment of skin and hair. The oil remains liquid throughout the preparation process. Without being bound by theory, since it is less dense than the aqueous phase, it would float to the top of the composition in the absence of a suspending agent. Surprisingly, these oils also "interfere" with the crystallization process of the crystallizing agent, so the content of the crystallizing agent needs to be adjusted for the presence of the oil. Embodiments of the present invention with a suspending agent were shown to have a stability rating of "2" (samples BV and BX) as determined by the phase stability test method, while a comparative example without a suspending agent (sample BZ) had a stability rating of "0" as determined by the phase stability test method. Sample BY containing a suspending agent showed a stability rating of "0" as determined by the phase stability test method due to a high amount of peppermint oil, which led to failure of stability and firmness.

[0327] Preparation of the composition

[0328] The sample of the present invention was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (Beaker Griffin 250 mL stainless-steel beaker, VWR catalog number: 74360-008, or equivalent). The beaker was placed on a heating pad assembly (VWR hot plate with thermocouple, SN: 160809002), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which time the x-gum (A1) and k-gum (A2) solutions were added together with peppermint oil (11). For each component added, the mixer speed was increased by 100 rpm. Then the composition was dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. Firmness measurements were made on the 50 ml sample using a firmness test method, and thermal stability measurements were made on the 50 ml sample using a thermal stability test method. Water extrusion measurements were made on the two 25 ml samples using a water extrusion test method. Representative data show that the prototype exhibits the desired properties of these rheological solid compositions even in the presence of suspending agents. Representative data show that the prototype exhibits the desired properties of these rheological solid compositions even in the presence of suspending agents.

[0329] A comparative sample was prepared by adding Euxyl PE 9010 (1), Symdiol 68 (2), water (3), and sodium myristate (4) to a stainless-steel beaker (VWR hot plate with thermocouple, SN: 160809002). The beaker was placed on a heating pad assembly (details), and a overhead stirrer (IKA RW20DZM.n overhead mixer, SN: 03.153609) was placed in the beaker and set to rotate at 100 rpm. The heater was set to 80 °C. The preparation was heated to 80 °C. Once the solution reached 80 °C, the solution was cooled to 60 °C, at which time peppermint oil (11) was added. For each component added, the mixer was increased by 100 rpm. The composition was then dispensed into three 60 g plastic jars (Flak-Tech, Max 60 translucent cups, catalog number 501222t): one jar was filled to 50 ml and two jars were filled to 25 ml. The samples were held at 60 °C for one hour and then cooled at room temperature (25 ± 3 °C) until solid. The firmness of the 50 ml sample was measured using a firmness test method, and the thermal stability of the 50 ml sample was measured using a thermal stability test method. The water extrusion of the two 25 ml samples was measured using a water extrusion test method.

[0330] Table 21

[0331]

[0332] Example 7

[0333] This example shows that stable compositions of very complex mixtures with a large amount of insoluble active agents can be formed and sometimes the compositions can be modified. All compositions contain approximately 10 wt% of insoluble active agents, and all compositions contain a blend of seven different oils (see oil blend). Those skilled in the art consider this to be a very large amount of dispersed insoluble active agents. Samples CA, CB, and CC utilize a suspension agent system of 0.09 wt% of x-gum and k-gum blend (see Example 1). As previously mentioned, some oils require adjustment of the amount of crystallization agent. In this example, it was increased to approximately 5 wt% to compensate for the weakening effect associated with the presence of the oil. Relative to the previous examples with 0.3 wt% - 2.0 wt% of insoluble active agent particles, the suspension dose of sample CA was still too small to stabilize the composition. In samples CB and CC, NaCl was added to improve the thermal stability of the composition, causing the crystallization agent to crystallize faster than otherwise. Comparative sample CD omitted the suspension agent, which resulted in the oil separating almost completely in a thick layer on top of the composition, making it unsuitable for consumer use.

[0334] (A3) Preparation of the oil blend

[0335] Weigh the following ingredients and add them to a 1-liter beaker: L-menthol (14), nutmeg oil (15), camphor (16), eucalyptus oil (17), cedar leaf oil (18), antioxidant-containing rosin (19), thymol NF (20). Mix them using a overhead mixer device rotating at 100 rpm until the solution is completely clear, and then mix for another 10 minutes.

[0336] Preparation of the composition

[0337] Add deionized water (3) to a 16-oz wide-mouth glass bottle (VWR, catalog number: glc-01700). Add sodium chloride (21) to the wide-mouth bottle. Vortex the wide-mouth bottle until the sodium chloride is completely dissolved. Then place it in a 90 °C controlled water bath (Insta-therm 2600 mL, controlled by a Staco INC Variable autotransformer) and bring the mixture to the bath temperature. Place a large magnetic stir bar in the wide-mouth bottle and rotate it at 200 rpm. Add sodium palmitate (8) to the wide-mouth bottle. Loosely cover it to prevent water loss and prevent pressurization. Stir the mixture until the sodium palmitate is completely dissolved. Remove the wide-mouth bottle from the water bath and place it in a second 80 °C controlled water bath (VWR 7x7 Stir PRO, with a temperature probe). Replace the first lid with a second lid containing two 8-mm holes: one hole is in the center to accommodate the impeller shaft, and one hole is offset midway between the edge and the center of the jar to allow the addition of the remaining ingredients. Install a 4-blade impeller by passing the shaft through the center hole in the lid and placing the blade into the mixture when tightening the lid. Set the impeller to rotate at 450 rpm (Caframo BDC 3030). Add Euxyl PE (1) and Symdiol 68 (2) through the second hole in the lid, and also add the stock solutions of x-gum (A1) and k-gum (A2) dropwise through the second hole using a 1-ml positive displacement syringe. After mixing for one minute, add the oil blend (A3) through the same hole. Increase the impeller speed to 750 rpm and hold for another two minutes. Pour the final mixture into a 60-ml cup (Flak-Tech, Max 60 translucent cup, catalog number 501222t) to cool and crystallize. Perform firmness measurements using a firmness test method, and perform thermal stability measurements on a 50-ml sample using a thermal stability test method; perform water extrusion measurements on two 25-ml samples using a water extrusion test method

[0338] Table 22

[0339]

[0340]

[0341] Example 8

[0342] This example shows that by increasing the amount of suspending agent, a stable composition of a very complex mixture with a large amount of insoluble active agent can be formed. All compositions contain approximately 10 wt% - 12 wt% of insoluble active agent, and all compositions contain a blend of six different oils (Sample CF) and petrolatum (Sample CE) (see petrolatum / oil blend), where x-gum is used as the suspending agent at an elevated concentration. A higher concentration of x-gum is particularly important because petrolatum is liquid at the process temperature and transforms into a solid at room temperature. Each composition uses approximately 0.30 wt% of x-gum as the suspending agent. This is a significantly higher concentration than when x-gum and k-gum were combined as a mixture in Example 1 and emphasized in Example 7. Without being bound by theory, compared to the gum blend, x-gum alone increases the viscosity of the composition before forming a network. Additionally, the amount of crystallizing agent is increased to approximately 5 wt% to compensate for the weakening effect associated with the presence of oil in the composition. The greater the content of the suspending agent, the higher the stability.

[0343] (A4) Preparation of X-gum stock solution in glycerol

[0344] The x-gum stock solution was prepared by adding 9.001 g of glycerol (9) to a 60 ml Speed Mixer cup (Flak-Tech, Max 60 translucent cup, order number: 501222t). 1.007 g of x-gum (5) was added to the cup. It was placed in a Speed Mixer (Flacktek, Inc.) and run at 3500 rpm for one minute. The mixture was allowed to stand for one hour, at which point it was remixed at 3500 rpm for 10 seconds.

[0345] (A5) Preparation of the oil blend

[0346] The following substances were weighed and added to a 1 L beaker: L-menthol (14), nutmeg oil (15), camphor (16), eucalyptus oil (17), cedar leaf oil (18), thymol NF (20). They were mixed using a overhead impeller mixing device at 100 rpm until the solution was completely clear, and then mixed for an additional 10 minutes.

[0347] (A6) Petroleum jelly / oil blend

[0348] 10.227 g of the oil mixture (A5) and 14.02 g of petrolatum (22) were preheated to 40 °C in a glass vial on a hot plate (VWR digital heating block, catalog number 12621-088). Then, prior to preparing the example compositions, it was vortexed at maximum speed for 10 seconds and returned to the 40 °C hot plate for no more than 60 minutes.

[0349] Preparation of the composition

[0350] Add deionized water (3) to a 16 oz wide-mouth glass bottle (VWR). Add sodium chloride (21) to the wide-mouth bottle. Vortex the wide-mouth bottle until the salt is completely dissolved. Then place it in a 90 °C controlled water bath (Insta-therm 2600 mL, controlled by a Staco INC Variable autotransformer) and bring the mixture to the bath temperature. Place a large magnetic stir bar in the wide-mouth bottle and rotate it at 200 rpm. Add sodium palmitate (8) to the wide-mouth bottle. Cap it loosely to prevent water loss while preventing pressurization. Stir the mixture until the sodium palmitate is completely dissolved. Remove the wide-mouth bottle from the water bath and place it in a second 80 °C controlled water bath (VWR 7x7 Stir PRO, with a temperature probe). Replace the first cap with a second cap that contains two 8 mm holes: one hole is in the center to accommodate the impeller shaft, and one hole is offset midway between the edge and the center of the jar to allow the addition of the remaining ingredients. Install a 4-blade impeller by passing the shaft through the center hole in the cap and placing the blades in the mixture when tightening the cap. Set the impeller to rotate at 450 rpm (Caframo BDC 3030). Then, add Euxyl PE (1) and Symdiol 68 (2) through the second hole in the cap. Use a 1 ml positive displacement syringe to also drip the glycerol stock solution of x-gum (A4) through the second hole. After mixing for one minute, add the oil / vaseline blend (A6) through the same hole. Increase the impeller speed to 750 rpm and hold for two more minutes. Pour the final mixture into a 60 ml cup (Flak-Tech, Max 60 translucent cup, order number: 501222t) to cool and crystallize. Perform firmness measurements using the firmness test method, and perform thermal stability measurements on a 50 ml sample using the thermal stability test method; perform water extrusion measurements on two 25 ml samples using the water extrusion test method. Representative data show that even in the presence of a suspending agent, the prototype exhibits the desired properties of these rheological solid compositions.

[0351] Table 23

[0352]

[0353] Example 9

[0354] These samples show that using microfibers as a suspending agent allows for the formation of the compositions of the present invention, which are very complex mixtures having a large weight percentage of an insoluble active agent in a blend with about 10 wt% of seven different oils and petrolatum (Samples CG and CH). Without being bound by theory, it is believed that the microfibers increase the viscosity of the composition before forming a network. With or without sodium chloride (Sample CG or CH, respectively) to improve the thermal stability of the composition such that the crystallizing agent crystallizes faster than otherwise, both compositions are stable. More than 0.2 wt% - 0.27 wt% of microfibers are able to effectively suspend the insoluble active agent, similar to Example 7.

[0355] (A7) Petroleum jelly / oil blend

[0356] 10.227 g of the oil mixture (A5) was preheated to 40 °C in a glass vial on a hot plate (VWR digital heating block, catalog number 12621-088) together with 14.02 g of petrolatum (22). The vial was then vortexed for 10 seconds at maximum speed and returned to the 40 °C hot plate for no more than 60 minutes before use in preparing the Example compositions.

[0357] Preparation of the composition

[0358] Add deionized water (3) to a 16 oz wide-mouth glass bottle (VWR). Use a 1 ml positive displacement syringe to add the Rheocrysta c-2sp solution (24) dropwise. Add sodium chloride (21) to the wide-mouth bottle. Vortex the wide-mouth bottle until the salt is completely dissolved. Then place it in a 90 °C controlled water bath (Insta-therm 2600 mL, controlled by a Staco INC Variable autotransformer) and bring the mixture to the bath temperature. Place a large magnetic stir bar in the wide-mouth bottle and rotate it at 200 rpm. Add sodium palmitate (8) to the wide-mouth bottle. Cap it loosely to prevent water loss while preventing pressurization. Stir the mixture until the sodium palmitate is completely dissolved. Remove the wide-mouth bottle from the water bath and place it in a second 80 °C controlled water bath (VWR 7x7 Stir PRO, with a temperature probe). Replace the first cap with a second cap that contains two 8 mm holes: one hole is in the center device for the impeller shaft, and one hole is offset midway between the edge and the center of the tank device for adding the remaining ingredients. Install a 4-blade impeller by passing the shaft through the center hole in the cap and placing the blade in the mixture when tightening the cap. Set the impeller to rotate at 450 rpm (Caframo BDC 3030). Then, add Euxyl PE (1) and Symdiol 68 (2) through the second hole in the cap. After mixing for one minute, add the oil / Vaseline blend (A7) or the oil mixture (A3) through the same hole. Increase the impeller speed to 750 rpm and hold for another two minutes. Pour the final mixture into a 60 ml cup (Flak-Tech, Max 60 translucent cup, order number: 501222t) to cool and crystallize.

[0359] Table 24

[0360]

[0361] Example 10

[0362] These samples demonstrate that the inventive compositions of the present invention, which form very complex mixtures containing a large weight percentage of insoluble active agents, can be formed using synthetic hectorite clay as a suspending agent, and the mixtures have a blend of seven different oils and petrolatum at about 10 wt% (Samples CI and CJ). Without being bound by theory, it is believed that the electrostatic attraction between synthetic hectorite clay particles produces a cartridge structure that generates a yield stress in the composition before forming a network. As in Examples 8 and 9, higher levels of the suspending agent result in a stable composition (Sample CI). Surprisingly, compared to the previous Examples 7-9, the addition of sodium chloride (Sample CJ) results in an unstable product. In this case, those skilled in the art recognize that the addition of sodium chloride eliminates the electrostatic attraction between synthetic hectorite clay particles and no cartridge structure is formed.

[0363] (A8) Preparation of synthetic hectorite solution

[0364] Prepare a 5% Laponite XLG stock solution using 2.500 g of Laponite XLG (c4039229) and 47.512 g of DI water, mix at high speed for 1 minute at 3500 rpm, and let stand overnight. Then add water to a wide-mouth bottle. Then add the synthetic hectorite stock solution and stir it into a solution using a 134:1 type Q-line stirrer set to 25 on a dial with a 4-blade impeller. Then add salt. Then, cap the wide-mouth bottle. Then place it in a 90 °C water bath, add sodium palmitate, and stir in the water bath using a stir bar until a turbid homogeneous solution is formed. Then place it in a second container at 80 °C.

[0365] (A9) Petroleum jelly / oil blend

[0366] Weigh the following substances and add them to a 1 L beaker: L-menthol (14); nutmeg oil (15); camphor (16); eucalyptus oil (17); cedar leaf oil (18); thymol (20). Heat 10.227 g of this oil mixture and 14.02 g of petrolatum (22) to 40 °C in a glass vial on a hot plate (VWR digital heating block, catalog number 12621-088). Then vortex the vial at maximum speed for 10 seconds before using it to prepare the example composition and return it to the 40 °C hot plate for no more than 60 minutes.

[0367] (A10) Petroleum jelly / oil blend

[0368] Heat 5.040 g of the oil mixture (A5) and 5.046 g of petrolatum (22) to 40 °C in a glass vial on a hot plate (VWR digital heating block, catalog number 12621-088). Then vortex the vial at maximum speed for 10 seconds before using it to prepare the example composition and return it to the 40 °C hot plate for no more than 60 minutes.

[0369] Preparation of the composition

[0370] Add deionized water (3) to a 16 oz wide-mouth glass bottle (VWR). Using a 1 ml positive displacement syringe, also add the synthetic hectorite solution (25) dropwise through the second hole and mix for another minute. Add sodium chloride (21) to the wide-mouth bottle. Vortex the wide-mouth bottle until the salt is completely dissolved. Then place it in a 90 °C controlled water bath (Insta-therm 2600 mL, controlled by a Staco INC Variable autotransformer) and allow the mixture to reach the bath temperature. Place a large magnetic stir bar in the wide-mouth bottle and rotate it at 200 rpm. Add sodium palmitate (8) to the wide-mouth bottle. Loosely cap it to prevent water loss while preventing pressurization. Stir the mixture until the sodium palmitate is completely dissolved. Remove the wide-mouth bottle from the water bath and place it in a second 80 °C controlled water bath (VWR 7x7 Stir PRO, with a temperature probe). Replace the first cap with a second cap that contains two 8 mm holes: one hole in the center device for the impeller shaft and one hole offset midway between the edge and the center of the tank device for adding the remaining ingredients. Install a 4-blade impeller by passing the shaft through the center hole in the cap and placing the blades into the mixture when tightening the cap. Set the impeller to rotate at 450 rpm (Caframo BDC 3030). Finally, add the oil / Vaseline blend (A9) or (A10) through the same hole. Increase the impeller speed to 750 rpm and hold for another two minutes. Pour the final mixture into a 60 ml cup (Flak-Tech, Max 60 translucent cup, order number: 501222t) to cool and crystallize.

[0371] Table 25

[0372]

[0373] Example 11

[0374] This example shows that even at slightly higher levels of suspending agent, a stable, commercially viable composition can be produced having a large, highly complex mixture of about 25 wt% insoluble active agent. It is believed that higher levels of insoluble active material (IA%) such as petrolatum and insoluble oils allow for better consumer recognition of sensory experiences such as the "feel" and "odor" of the composition when applied to the skin. In the absence of a suspending agent, both petrolatum and insoluble oils would separate from the water during formation. Without being bound by theory, it is believed that the suspending agent increases the viscosity of the composition during preparation (e.g., Example 1), prevents separation of the insoluble active material and requires even higher levels of suspending agent. Example 1 shows that suspension of the insoluble active material requires a minimal level of suspending agent, consisting only of x-gum, provided its level is high enough. Example 2 shows that increasing the level of suspending agent can significantly soften the composition (some do not crystallize at all) and requires additional crystallizing agents and salts. This example shows that a composition having 25 wt% insoluble active material meeting the desired criteria of stability, thermal stability, firmness and water extrusion can be produced using up to 0.30 wt% of x-gum.

[0375] (A11) Preparation of X-Gum in glycerol stock solution

[0376] An x-gum stock solution was prepared by adding 36.024 grams of glycerol (9) to a 60 ml Speed Mixer cup (Flak-Tech, Max 60 translucent cup, order number: 501222t). 4.015 grams of x-gum (5) was added to the cup. It was placed in a Speed Mixer (Flacktek, Inc.) and run at 3500 rpm for one minute. The mixture was allowed to stand for one hour, at which time it was remixed for 10 seconds at 3500 rpm.

[0377] Preparation of the composition

[0378] Part 1: Oil / petrolatum mixture: The oil mixture (A3) was added to a glass vial and placed in a heating block set at 60°C. The petrolatum (22) was heated to a liquid state and then added to the vial. The vial was stirred and kept in the heating block at 55°C until use.

[0379] Part 2: Sample Preparation: Add deionized water (3) to a 16 oz wide-mouth glass bottle (VWR). For sample CK-CR, add all of the sodium chloride (21) to the wide-mouth bottle; add a portion of the sodium chloride (21) in Example CS (First). Vortex the wide-mouth bottle until the salt is completely dissolved. Then place it in a water bath (VWR 7x7 Stir PRO, with temperature probe), and control the temperature at 90 °C. Add a magnetic stir bar to the mixture and set it to rotate at 200 rpm to create a vortex in the mixture. Add sodium palmitate (8) to the mixture. Loosely cover the wide-mouth bottle to prevent water loss and prevent pressurization. Stir the mixture until the sodium palmitate is completely dissolved. Then remove the wide-mouth bottle from the first bath and place it in a second controlled water bath (VWR 7x7 Stir PRO, with temperature probe) where the temperature is controlled at 80 °C. Replace the first lid with a second lid that contains two 8 mm holes: one hole is centered for the impeller shaft, and one hole is offset midway between the edge and the center of the tank device for adding the remaining ingredients. Install a 4-blade impeller by passing the shaft through the center hole in the lid and placing the blades into the mixture when tightening the lid. Rotate the impeller at 500 rpm (Caframo BDC 3030). Slowly add xanthan gum solution (A11) through the second hole using a syringe. Finally, for sample CK-CR, add the oil / vaseline mixture (Part 1) and preservative (1) through the same hole; for sample CS, add the oil / vaseline mixture (Part 1), preservative (1), and the remaining sodium chloride (21) (Second) through the same hole. Increase the impeller speed to 1,000 rpm and hold for another two minutes. Pour the final mixture into a 60 ml cup (Flak-Tech, Max 60 translucent cup, order number: 501222t) to cool and crystallize. Then divide the solution into three 60 g plastic jars (Flak-Tech, Max 60 translucent cup, catalog number 501222t): fill one jar to 50 ml and fill two jars to 25 ml. Hold the samples at 60 °C for one hour, then cool at room temperature (25 ± 3 °C) until solid. Measure the firmness of the 50 ml sample using the firmness test method, and measure the thermal stability of the 50 ml sample using the thermal stability test method. Measure the water extrusion of the two 25 ml samples using the water extrusion test method.

[0380] Table 26

[0381]

[0382] Table 27

[0383]

[0384] Table 28

[0385]

[0386]

[0387] Example 12

[0388] This example demonstrates a method for preparing a rheological solid personal care composition. A 5 kg batch of the rheological solid personal care composition is prepared according to the following process:

[0389] First, water, NaCl, and NaOH are added to the main mixing vessel (a 2 gallon Ross mixer with planetary and high shear mixing elements). The heating and mixing of the main mixing vessel are turned on to provide an aqueous phase. Once the main mixing vessel reaches 70 ± 5 °C, palmitic acid, used as an emulsifier, is added to the main mixing vessel and mixed for about 10 minutes to ensure neutralization to sodium palmitate. The main mixing vessel continues to be heated to 80 ± 5 °C. Then, phenoxyethanol, used as a preservative, and NaCl, which improves the thermal stability of the final rheological solid personal care composition, are added to the main mixing vessel.

[0390] Xanthan gum and glycerol are added to the first premixing vessel (a stainless steel vessel with an overhead mixer equipped with pitched blade mixing elements) and mixed to ensure that the xanthan gum is dispersed within the glycerol. Then this suspending agent premix is added to the main mixing vessel to increase the dispersion structure of the hydrophobic components.

[0391] Vaseline and fragrance are added to the second premixing vessel (a stainless steel vessel with an overhead mixer equipped with pitched blade mixing elements) and heated to 40 ± 5 °C while mixing to form a vaseline - fragrance premix. The vaseline - fragrance premix may contain insoluble active substances, preferably topical active substances selected from the group consisting of menthol, nutmeg, camphor, eucalyptus, cedar leaf, thymol, and any combination thereof.

[0392] The main mixing vessel is cooled to 65 ± 5 °C, and the vaseline - fragrance premix is added to the main mixing vessel. Sodium lactate, used as a hygroscopic component, is further added to the main mixing vessel to stabilize the final crystalline structure of the rheological solid personal care composition. Then the main mixing vessel is mixed for about 10 minutes. Cooling causes the sodium palmitate to crystallize, thereby encapsulating the hydrophilic and hydrophobic components.

[0393] The rheological solid personal care composition manufactured by the method may contain the following components:

[0394] Table 29

[0395] Ingredient name Ingredient function % w / w Water Solvent 61.52 Sodium lactate Humectant stabilizer 3.33 Sodium chloride Temperature stabilizer 3.00 Sodium hydroxide Base 1.44 Palmitic acid Palmitate precursor / emulsifier 4.61 Glycerol X-gum dispersant 2.70 Xanthan gum Structuring agent 0.30 Petroleum jelly Stabilizer 8.00 Fragrance Fragrance 15.00 Phenoxyethanol Preservative 0.10

[0396] Without being bound by theory, it is believed that the basic unit operations described in the 5 kg method can scale with the batch size. Accordingly, it is expected that the same preparation methods described in the 5 kg method are applicable to commercial scale batches such as 1,000 kg using a specific mixing tank. Additionally, although described as a batch method, it is expected that such compositions can also be prepared by a continuous method.

[0397] Accordingly, further, the order of addition of components to the 5 kg batch method is not limiting. Laboratory scale batches have shown that the order of addition can be adjusted (e.g., salt addition in Examples CR and CS). It is believed that the order of addition can also be adjusted in commercial scale preparation methods.

[0398] Release of fragrance compounds from the rheological solid personal care compositions of the invention was evaluated using selected ion flow tube mass spectrometry (SIFT-MS). The concentration profile describes the consumer experience, which includes a "burst" or intense release of the fragrance upon application, followed by fragrance release at a concentration above the odor detection threshold for at least 15 minutes for a given fragrance. These data are shown in Figure 6 a plot of concentration (ppm) of the fragrance compounds provided in

[0399] Combination

[0400] A. A rheological solid personal care composition, the rheological solid personal care composition comprising: (a) a crystallizing agent; (b) a suspending agent; (c) an insoluble active substance; and (d) an aqueous phase.

[0401] B. The rheological solid personal care composition according to paragraph A, wherein the crystallizing agent is present in an amount of from 0.01% to 10% by weight, preferably from 0.1% to about 7% by weight, more preferably from 1% to about 7% by weight, based on the weight of the rheological solid personal care composition.

[0402] C. The rheological solid personal care composition according to paragraph A or B, the rheological solid personal care composition comprising from 0.01% to 2% by weight, preferably from 0.05% to 1% by weight, more preferably from 0.1% to 0.5% by weight, of a suspending agent, based on the weight of the rheological solid personal care composition.

[0403] D. The rheological solid personal care composition according to any one of the preceding paragraphs, the rheological solid personal care composition comprising from 0.1% to 30% by weight, preferably from 0.1% to 25% by weight, more preferably from 0.5% to 15% by weight, of an insoluble active substance, based on the weight of the rheological solid personal care composition.

[0404] E. A rheological solid personal care composition according to any one of the preceding paragraphs, wherein the crystallizing agent comprises a salt of a fatty acid containing from about 12 to about 20 carbon atoms.

[0405] F. A rheological solid personal care composition according to any one of the preceding paragraphs, wherein the crystallizing agent is a metal salt.

[0406] G. A rheological solid personal care composition according to paragraph F, wherein the metal salt is at least one of sodium stearate, sodium palmitate, and sodium myristate.

[0407] H. A rheological solid personal care composition according to any one of the preceding paragraphs, wherein the insoluble active substance is insoluble active particles comprising an insoluble oil.

[0408] I. A rheological solid personal care composition according to paragraph H, wherein the insoluble active particles further comprise a hydrophobic non-aqueous binder.

[0409] J. A rheological solid personal care composition according to paragraph I, wherein the rheological solid personal care composition comprises from about 1% to about 15%, preferably from 3% to 12%, more preferably from 5% to 10% by weight of the hydrophobic non-aqueous binder based on the weight of the rheological solid personal care composition.

[0410] K. A rheological solid personal care composition according to paragraph H, wherein the rheological solid personal care composition comprises from about 4% to about 10% by weight of the insoluble oil.

[0411] L. A rheological solid personal care composition according to any one of the preceding paragraphs, wherein the suspending agent comprises a polysaccharide.

[0412] M. A rheological solid personal care composition according to any one of the preceding paragraphs, wherein the suspending agent comprises a first polysaccharide and a second polysaccharide, wherein the first polysaccharide is xanthan gum and the second polysaccharide is selected from the group consisting of konjac gum, locust bean gum, and combinations thereof.

[0413] N. A rheological solid personal care composition according to any one of the preceding paragraphs, the rheological solid personal care composition having a stability rating of 1 or greater as determined by a phase stability test method.

[0414] O. A rheological solid personal care composition according to any one of the preceding paragraphs, the rheological solid personal care composition having a thermal stability of higher than about 30 °C as determined by a thermal stability test method.

[0415] The dimensions and values disclosed herein should not be construed as being strictly limited to the exact numerical values recited. Instead, each such dimension is intended to represent the recited value and a range functionally equivalent around that value, unless otherwise specified. For example, a dimension disclosed as "40 mm" is intended to represent "about 40 mm".

[0416] The values disclosed herein as the end values of a range should not be construed as being strictly limited to the exact numerical values recited. Instead, each numerical range is intended to represent the recited value and any real number within the recited range, including integers, unless otherwise specified. For example, a range disclosed as "1 to 10" is intended to represent "1, 2, 3, 4, 5, 6, 7, 8, 9, and 10", and a range disclosed as "1 to 2" is intended to represent "1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, and 2".

[0417] Every document cited herein, including any cross-referenced or related patent or patent application and any patent application or patent to which this application claims priority or for which the benefit of priority is claimed, is hereby incorporated by reference in its entirety. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any one or more other references, teaches, suggests, or discloses any such invention. Further, when any meaning or definition of a term in this invention conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to the term in this invention shall govern.

[0418] Although specific embodiments of the invention have been illustrated and described, it will be apparent to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is intended that all such changes and modifications that fall within the scope of the invention be covered by the appended claims.

Claims

1. A rheological solid personal care composition, the rheological solid personal care composition comprising: a. A crystallizing agent, wherein the crystallizing agent comprises a salt of a fatty acid containing 12 to 20 carbon atoms and is present in an amount of 2% to 7% by weight based on the weight of the rheological solid personal care composition; b. A suspending agent, wherein the suspending agent is present in an amount of 0.01% to 1% by weight based on the weight of the rheological solid personal care composition and comprises a first polysaccharide and a second polysaccharide, wherein the first polysaccharide is xanthan gum and is present at a level of 40% to 90% by weight based on the weight of the polysaccharide suspending agent system, and the second polysaccharide is konjac gum; c. An insoluble active substance, wherein the insoluble active substance is present in an amount of 0.1% to 30% by weight based on the weight of the rheological solid personal care composition; and d. An aqueous phase.

2. The rheological solid personal care composition according to claim 1, the rheological solid personal care composition having a firmness between 0.1 N and 50.0 N as determined by a firmness test method, and / or having a thermal stability higher than 30 °C as determined by a thermal stability test method, and / or having a liquid extrusion between 100 J m-3 and 6000 J m-3 as determined by a water extrusion test method, and / or having a stability rating of 1 or greater as determined by a phase stability test method, and / or having a stability rating of 2 or greater as determined by a phase stability test method.

3. The rheological solid personal care composition according to any one of the preceding claims, wherein the crystallizing agent is a metal salt.

4. The rheological solid personal care composition according to claim 3, wherein the metal salt is at least one of sodium stearate, sodium palmitate, and sodium myristate.

5. The rheological solid personal care composition according to claim 1 or 2, wherein the insoluble active substance is a topical active substance.

6. The rheological solid personal care composition according to claim 5, wherein the topical active substance is selected from the group consisting of menthol, nutmeg, camphor, eucalyptus, cedar leaf, thymol, and any combination thereof.

7. The rheological solid personal care composition according to claim 1 or 2, wherein the insoluble active substance is an insoluble active particle comprising an insoluble oil.

8. The rheological solid personal care composition according to claim 7, wherein the rheological solid personal care composition comprises 4% to 15% by weight of the insoluble oil.

9. The rheological solid personal care composition according to claim 1 or 2, wherein the rheological solid personal care composition further comprises a hydrophobic non-aqueous binder.

10. The rheological solid personal care composition according to claim 9, wherein the rheological solid personal care composition comprises 1% to 15% by weight of the hydrophobic non-aqueous binder based on the weight of the rheological solid personal care composition.

11. The rheological solid personal care composition according to claim 1 or 2, wherein the rheological solid personal care composition is used in a method for treating the following symptoms: nasal congestion, cold, flu, cough, dry cough, chest tightness, muscle soreness and pain, or any combination thereof.

12. A method for manufacturing the rheological solid personal care composition according to any one of claims 1-11, the method comprising the following steps: - Providing and heating an aqueous solution of sodium chloride and sodium hydroxide, - Adding an emulsifier, which is palmitic acid, so as to obtain a main emulsifier mixture, which is a main sodium palmitate soap mixture, - Adding a suspending agent to the main emulsifier mixture, - Adding a premix of insoluble active substances to the main emulsifier mixture to obtain a blend, - Cooling the blend so as to form a crystalline structure of the rheological solid personal care composition, - Optionally adding a hygroscopic stabilizer to the blend to stabilize the crystalline structure, wherein the suspending agent is present in an amount of 0.01% to 1% by weight based on the weight of the rheological solid personal care composition and comprises a first polysaccharide and a second polysaccharide, wherein the first polysaccharide is xanthan gum and is present at a level of 40% to 90% by weight based on the weight of the polysaccharide suspending agent system, and the second polysaccharide is konjac gum.

13. The method according to claim 12, wherein the premix of insoluble active substances is a petrolatum-based premix of topical active substances.

14. The method according to claim 13, wherein the topical active substances are selected from the group consisting of menthol, nutmeg, camphor, eucalyptus, cedar leaves, thymol, and any combination thereof.

15. The method according to claim 12, wherein the hygroscopic stabilizer is sodium lactate.

16. The method according to claim 12, the method further comprising: - Adding a preservative to the main emulsifier mixture, - Optionally further adding sodium chloride to the main emulsifier mixture to improve the thermal stability of the crystalline structure.

17. The method according to claim 16, wherein the preservative is phenoxyethanol.

18. The method according to any one of claims 12-17, the method further comprising: - Manufacturing the premix of insoluble active substances by metering petrolatum, heating the petrolatum, and adding and dissolving the insoluble active substances.

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