Dry topical formulation for rehydration and use

Abstract

One or more techniques, systems, and articles of manufacture are described that relate to products that can be dried and then rehydrated to produce a cosmetic or pharmaceutical product. The molded dry formulation has a moisture content of greater than 0 and less than 50% by weight. The dry formulation is formed by drying a liquid formulation that includes a base material, an active ingredient, and an inactive ingredient. The molded dry formulation is configured to be rehydrated with water or another aqueous-based solution or emulsion. The formulation may be rapidly dissolved in a solvent to yield a liquid or semi-solid product that is ready for use as a topical cosmetic or pharmaceutical product.

Description

[Background technology]

[0001] Cosmetics and medicines are commonly used in daily routines. Travel and general daily activities, such as going to the gym or work, can require the availability of cosmetics and maintaining a cosmetic routine, such as a skin care routine, throughout the day or week. Carrying cosmetics and medicines while traveling or otherwise going about one's day can be cumbersome for users. Furthermore, most active ingredients found in liquid products lose up to 50% of their efficacy in just 60 days. Due to this loss of efficacy, cosmetics and medicines may be discarded or replaced frequently, which can lead to increased waste. Summary of the Invention [Means for solving the problem]

[0002] This Summary is intended to introduce in a simplified form some of the concepts described below in the Detailed Description. It is not intended to identify key elements or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0003] In one embodiment, the shaped article may contain one or more active substances and one or more inactive substances. The shaped article may be configured to be rehydrated with water or another aqueous-based solution or emulsion. The shaped article may be configured to be rapidly dissolved in a solvent or at least converted into a mixture, suspension, or the like to obtain a ready-to-use liquid or semi-solid product for topical cosmetic or pharmaceutical use. The shaped article may be formed by removing water from a base formulation, for example, by lyophilization, freeze drying, or other forms of drying. For example, freeze drying may include multiple freezing stages, multiple primary drying stages, and at least one secondary drying stage. In this example, the multiple freezing stages may include a ramping substage in which the temperature is gradually decreased over a set time interval, followed by a holding substage in which the target temperature is maintained for a set time interval. Similarly, the multiple primary drying stages and at least one secondary drying stage may include a ramping substage in which the temperature is gradually increased over a set time interval, followed by a holding substage in which the target temperature is maintained for a set time interval. The primary drying stages and at least one secondary drying stage may be carried out under vacuum pressure.

[0004] To the accomplishment of the foregoing and related ends, the following description and the annexed drawings set forth certain illustrative aspects and implementations, which are indicative of but a few of the various ways in which one or more aspects may be employed. Other aspects, advantages and novel features of the present disclosure will become apparent from the following detailed description when considered in conjunction with the accompanying drawings.

[0005] The subject matter disclosed herein may take physical form in specific parts and arrangements of parts, as described in detail herein and illustrated in the accompanying drawings which form a part hereof. [Brief explanation of the drawings]

[0006] [Figure 1]1 is a process flow of a first embodiment of the method for producing freeze-dried cosmetic tablets disclosed in the present specification.

[0007] [Figure 2] 1 is a process flow of a second embodiment of the method for producing freeze-dried cosmetic tablets disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0008] The claimed subject matter will now be described with reference to the drawings, wherein like reference numerals are generally used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the claimed subject matter. It may be evident, however, that the claimed subject matter may be practiced without these specific details. In other instances, structures and devices are shown in block diagram form to facilitate description of the claimed subject matter.

[0009] The disclosed molded and dried articles may provide precise doses of active ingredients in cosmetics and pharmaceuticals that are compact, easy to handle, and portable. After drying, the articles may contain 0-50% residual moisture. For example, the articles may contain less than 1% to 40%, or 5-30%, 5-20%, 5-15%, 5-10%, or less than 10% by weight of residual moisture. For use as topical cosmetics and pharmaceuticals, the articles may be rapidly dissolved in water or another aqueous-based solution or emulsion to obtain a ready-to-use liquid or semi-solid final product. The dissolution time may range from 1 second to 60 minutes. After rehydration and dissolution, the final product may have a pH value of less than 9. The final product, a dissolvable tablet, provides maximum efficacy with minimal waste compared to traditional bottled products.

[0010] The fast-dissolving article may contain at least one active ingredient and may also contain inactive ingredients. Prior to drying (e.g., lyophilization), the at least one active ingredient and inactive ingredients may be in a liquid formulation, such as an aqueous-based solution or suspension. The liquid formulation may use a carrier such as alginic acid, chitosan, collagen, sodium hyaluronate (hyaluronic acid), trehalose, or other excipients, alone or in combination with each other. To form the fast-dissolving article, the liquid formulation may be lyophilized. In its dried (e.g., lyophilized) form, the fast-dissolving article may contain a single dose of at least one active ingredient. The dried article can be dissolved in water or another aqueous-based solution or emulsion to rehydrate the active and inactive ingredients. Once rehydrated, the final product may be a ready-to-use liquid or semi-solid topical cosmetic or pharmaceutical product containing a single dose of at least one active ingredient. Once rehydrated, the final product may provide a single dose of the active ingredient, representing a single application or use of the final cosmetic or pharmaceutical product. Alternatively, the final product may provide multiple single doses of the active ingredient. Once rehydrated, the final product may provide multiple applications or uses of the formulation as a cosmetic or pharmaceutical product, and may be packaged in a container.

[0011] Exemplary active ingredients are described in the following paragraphs. Before being dissolved in the liquid formulation, the active ingredient or its derivatives may be in pure, mixed, liposomal, or hydrolyzed form. A non-exhaustive list of types of active ingredients includes: amino acids, enzymes and coenzymes, salts, sugars (including, but not limited to, polysaccharides, monosaccharides, disaccharides, and oligosaccharides), glycols, polyols, nutrients, phenols, plant extracts, proteins, UV filters, vitamins, organic compounds, inorganic compounds, antioxidants, prebiotics, probiotics, postbiotics, fatty acids, glycerol, triglycerides, monoglycerides, diglycerides, phospholipids, steroids, sterols, sphingolipids, and oils. It will be understood that those skilled in the art will recognize that other types of active ingredients may be used in liquid formulations. The minimum and maximum ranges listed below may refer to the percentage amount of the ingredient in the liquid formulation when the ingredient is used in a cosmetic or pharmaceutical formulation. The table below summarizes the ingredients, but it will be understood that many of these ingredients may fall into more than one category of active ingredient below.

[0012] At least one active ingredient may be an alpha hydroxy acid (AHA), beta hydroxy acid (BHA), or polyhydroxy acid. These ingredients may be included in the formulation of the preparation as chemical exfoliants. The following table is a non-exhaustive list of AHAs, BHAs, and PHAs: [Table 1]

[0013] At least one active ingredient may be an amino acid. The following table is a non-exhaustive list of amino acids that may be used in the fast dissolving articles: [Table 2]

[0014] The above amino acids may act as moisturizing agents or humectants in cosmetics or pharmaceuticals.It is understood that the use of amino acids may provide additional benefits.For example, tranexamic acid and tranexamic acid cetyl mesylate may act as whitening agents, and plant collagen is a commonly used amino acid-based protein.

[0015] The at least one active ingredient may also be a probiotic. The following table is a non-exhaustive list of probiotics that may be used in the fast dissolve articles. [Table 3]

[0016] The at least one active ingredient may also be a polysaccharide, monosaccharide, disaccharide, or oligosaccharide. The following table is a non-exhaustive list of sugars that may be used in the fast-dissolving articles. [Table 4]

[0017] Sugars may provide various benefits in cosmetics or pharmaceuticals. For example, fructose, glucose, fructooligosaccharides, galactooligosaccharides, raffinose, glucomannan, and inulin may act as prebiotics. Dextran and trehalose may act as humectants, with trehalose providing additional antioxidant benefits. Chitosan is a derivative of chitin and may act as a healing agent and collagen stimulator. It will be understood that other sugars may be used in cosmetic or pharmaceutical formulations and may provide other or additional benefits.

[0018] The at least one active ingredient may also be a peptide. The peptide may be a neurotransmitter-inhibiting peptide, a signal peptide, a carrier peptide, an enzyme-inhibiting peptide, or an antimicrobial peptide. The following table is a non-exhaustive list of peptides that may be used in the fast-dissolving articles: [Table 5]

[0019] Peptides may provide various benefits in cosmetics or pharmaceuticals. For example, signal peptides may stimulate collagen, elastin, laminin, hyaluronic acid, elafin, epidermal growth factor (EGF), thrombosponge type I (THBS1), decorin, melanocyte-stimulating hormone (MSH), granulocyte-macrophage colony-stimulating factor (GM-CSF), and fibronectin. Enzyme-inhibiting peptides may inhibit enzymes. As an example, these peptides may inhibit enzymes such as tyrosinase, which stimulates skin darkening, and matrix metalloproteinases (MMPs 1, 2, and 9), which can degrade tissue. It will be understood that other peptides may be used in cosmetic or pharmaceutical formulations, and that the peptides may provide other or additional benefits.

[0020] The at least one active ingredient may also be a plant extract or plant extract derivative. The following table is a non-exhaustive list of plant extracts and derivatives that may be used in the fast dissolve articles. [Table 6]

[0021] Plant extracts may provide various benefits in cosmetics or pharmaceuticals. For example, extracts derived from aloe vera may be used as emollients and humectants, providing soothing, moisturizing, and antioxidant benefits. Extracts of asparagus, banana, barley, flaxseed, garlic, oats, onion, and wheat bran, as well as their derivatives, may act as prebiotics. Extracts of Centella asiatica, Gotu kola, green tea, and prickly pear may act as antioxidants and provide soothing, moisturizing, anti-inflammatory, and other antioxidant benefits. Extracts of licorice and licorice root may also act as antioxidants and provide anti-inflammatory and antibacterial benefits. Rambutan extract may act as a plant-based retinol substitute. Finally, extracts of reishi mushroom and snow jelly mushroom may provide anti-aging and moisturizing benefits. It will be appreciated that other plant extracts or derivatives thereof may be used in cosmetic or pharmaceutical formulations, and that the plant extracts and derivatives thereof may provide other or additional benefits.

[0022] At least one active ingredient may also be sphingolipid.Sphingolipid is a type of naturally occurring lipid, and may be used as an emollient in cosmetics or medicine, thereby providing moisturizing benefits.The following table is a non-exhaustive list of sphingolipid that may be used in fast-dissolving articles. [Table 7]

[0023] The at least one active ingredient may also be an ultraviolet (UV) blocker or filter. UV blockers may be added to cosmetics or pharmaceuticals to protect the skin from harmful UV rays, for example, in sunscreen products. The following table is a non-exhaustive list of UV blockers or filters that may be used in the fast-dissolving article. It will be understood that other UV blockers or filters may be used in the cosmetic or pharmaceutical formulation, and that the UV blocker may provide additional benefits. [Table 8]

[0024] The at least one active ingredient may be a vitamin or nutrient, or a vitamin or nutrient derivative. The following table is a non-exhaustive list of vitamin, nutrient and derivative filters that may be used in the fast dissolving article. [Table 9]

[0025] The above nutrients and vitamins may provide various benefits as part of cosmetic or pharmaceutical formulations.For example, B-panthenol may act as a moisturizing agent and humectant, and vitamin E derivatives may act as skin conditioning agents.It is understood that other vitamins and nutrients and their derivatives may be used in cosmetic or pharmaceutical formulations, and vitamins, nutrients and derivatives may provide additional cosmetic or pharmaceutical benefits.

[0026] The at least one active ingredient may also be an antioxidant. The following table is a non-exhaustive list of antioxidants that may be used in the fast dissolve articles. [Table 10]

[0027] The use of these antioxidants in cosmetic or pharmaceutical formulations may provide skin protection and skin lightening benefits in addition to the benefits of other antioxidants. For example, 4-butylresorcinol and resveratrol may act as tyrosinase inhibitors, and diglucosyl gallate may act as a skin lightening agent. It will be appreciated that other antioxidants and their derivatives may be used in cosmetic or pharmaceutical formulations, and the antioxidants may provide additional cosmetic or pharmaceutical benefits.

[0028] The at least one active ingredient may also be an enzyme or coenzyme. The following table is a non-exhaustive list of enzymes or coenzymes that may be used in the fast dissolve articles. [Table 11]

[0029] The use of these enzymes and coenzymes in cosmetic or pharmaceutical formulations may provide benefits. In a first step, the lysate may act as a postbiotic, and coenzyme Q10 may act as an antioxidant to protect the skin. It will be understood that other enzymes and coenzymes may be used in cosmetic or pharmaceutical formulations, and that the enzymes and coenzymes may provide additional cosmetic or pharmaceutical benefits.

[0030] The at least one active ingredient may also be a protein. The following table is a non-exhaustive list of proteins that may be used in fast-dissolving articles. This table includes amino acid-based proteins that provide cosmetic or pharmaceutical benefits. It will be understood that other proteins may be used in cosmetic or pharmaceutical formulations. [Table 12]

[0031] The at least one active ingredient may also be a polyol. The following table is a non-exhaustive list of polyols that may be used in fast-dissolving articles. The polyol may act as a humectant or moisturizer in the cosmetic or pharmaceutical preparation. It will be understood that other polyols may be used in the cosmetic or pharmaceutical preparation, and that the polyol may provide additional cosmetic or pharmaceutical benefits. [Table 13]

[0032] At least one active ingredient may also be a form of hyaluronic acid.Hyaluronic acid is a polymer that may act as a humectant and provide moisturizing benefits to cosmetics or pharmaceuticals.The following table is a non-exhaustive list of the forms of hyaluronic acid that may be used in fast-dissolving articles. [Table 14]

[0033] The at least one active ingredient may also be a variety of chemical or organic compounds. The following table is a non-exhaustive list of these compounds that may be used in the fast dissolving articles. [Table 15]

[0034] The use of these various compounds in cosmetic or pharmaceutical formulations may provide various benefits. For example, allantoin and its derivatives are plant extracts that may provide soothing benefits. Azeloyl acid, benzoyl peroxide, and azelaic acid may provide anti-inflammatory and antibacterial benefits. Propanediol may serve as a humectant in cosmetics or pharmaceuticals. Hexylresorcinol, hydroquinone, and kojic acid may act as skin lightening agents and antioxidants. Finally, xylitol may act as a probiotic in cosmetics or pharmaceuticals.

[0035] The fast-dissolving article may also contain excipients or inactive ingredients in addition to the active ingredient. Exemplary excipients are described in the following paragraphs. Before being dissolved in the liquid formulation, the excipient or its derivatives may be in pure, mixed, liposomal, or hydrolyzed form. A non-exhaustive list of types of excipients that may be used in lyophilized cosmetics or pharmaceuticals includes amino acids, salts, sugars, polyols, polymers, surfactants, buffers, chelate complexes, and inorganic salts. It will be understood that those skilled in the art will recognize that other types of excipients may be used in liquid formulations. The minimum and maximum ranges listed below may refer to the percentage amount of the excipient in the liquid formulation when the excipient is used in cosmetic or pharmaceutical formulations. While the table below groups ingredients, it will be understood that many of these ingredients may apply to multiple types of active ingredients listed below.

[0036] The excipient may be an amino acid. The following table is a non-exhaustive list of amino acids that may be used as excipients in fast dissolving articles: [Table 16]

[0037] The use of these amino acids may provide various functions in cosmetic or pharmaceutical formulations. For example, arginine, glycine, histidine, and plant collagen may act as bulking agents. Arginine and potassium acetate may act as buffering agents. It will be understood that other amino acids may be used in cosmetic or pharmaceutical formulations, and that the amino acids may provide additional or alternative functions.

[0038] The excipient may be an alcohol. The following table is a non-exhaustive list of alcohols that may be used as excipients in fast dissolve articles. [Table 17]

[0039] The alcohol may act as a solubilizer or co-solvent in the cosmetic or pharmaceutical formulation. It will be understood that other alcohols may be used in the cosmetic or pharmaceutical formulation and may serve additional or alternative functions.

[0040] The excipient may also be a polysaccharide, monosaccharide, disaccharide, or oligosaccharide. The following table is a non-exhaustive list of sugars that may be used in fast dissolving articles. [Table 18]

[0041] The use of these sugars may serve various functions in cosmetic or pharmaceutical formulations. Lactose, sucrose, glucose, dextran, and raffinose may act as bulking agents. Sucrose and glucose may also act as tonics. α-cyclodextrin and hydroxypropyl-β-cyclodextrin may act as solubilizers and complexing agents. Algin and tara gum may act as thickeners. Dextran may act as a binder. Chitosan may act as a delivery agent. Tara gum may also act as an emulsifier, stabilizer, texturizer, or disintegration or temperature regulator. It will be understood that other sugars may be used in cosmetic or pharmaceutical formulations and may serve additional or alternative functions.

[0042] The excipient may also be a polyol. The following table is a non-exhaustive list of polyols that may be used in fast dissolving articles. [Table 19]

[0043] Polyols may serve a variety of functions in cosmetic or pharmaceutical formulations. Glycerol / glycerin, meglumine, and polyglyceryl-4 caprate (a fatty acid found in coconut milk) may act as solubilizers. Mannitol may act as a cryoprotectant, binder, or pH adjuster. It will be understood that other polyols may be used in cosmetic or pharmaceutical formulations and may serve additional or alternative functions.

[0044] The excipient may also be a glycol. The following table is a non-exhaustive list of glycols that may be used in fast dissolving articles. [Table 20]

[0045] Glycols may serve a variety of functions in cosmetic or pharmaceutical formulations. For example, propanediol may act as a preservative, solvent, or emollient. Propylene glycol may act as a solvent. It will be appreciated that other polyols may be used in cosmetic or pharmaceutical formulations and may serve additional or alternative functions.

[0046] The excipient may also be a polymer. The following table is a non-exhaustive list of polymers that may be used in fast dissolving articles. [Table 21]

[0047] Polymers may serve a variety of functions in cosmetic or pharmaceutical formulations. For example, polyethylene glycol, hyaluronic acid, and dextran may be used as bulking agents. Cellulose gum, a natural polymer, may function as a texturizing agent. Polyethylene glycol, a water-soluble carrier material, may also act as an emulsifier or emollient. It will be understood that other polymers may be used in cosmetic or pharmaceutical formulations, and that the polymers may serve additional or alternative functions.

[0048] The excipient may also be an organic compound or an acid.The following table is a non-exhaustive list of polymers that may be used in fast dissolving articles. [Table 22]

[0049] Organic compounds and acids may serve a variety of functions in cosmetic or pharmaceutical formulations. For example, citric acid, potassium acid, sodium acid, tartaric acid, sodium acetate, sodium lactate, Tris acetate, Tris base, and Tris hydrochloride may act as buffering agents. Tris hydrochloride and M-cresol may act as antimicrobial agents. Methylene chloride and acetone may act as solubilizing agents. It will be understood that other organic compounds may be used in cosmetic or pharmaceutical formulations and may serve additional or alternative functions.

[0050] The excipient may also be a protein. As an example, a cosmetic or pharmaceutical formulation may contain collagen or gelatin in the range of 0.001-50.0% of the liquid formulation. Gelatin may act as a disintegrant or temperature regulator. Collagen may act as a bulking agent. It will be understood that other proteins may be used in cosmetic or pharmaceutical formulations, and that proteins may provide additional or alternative functions.

[0051] The excipient may also be an alpha-hydroxy acid. As an example, a cosmetic or pharmaceutical product may contain lactic acid in the range of 0.001-50.0% of the liquid formulation. Lactic acid may act as a pH balancer or antimicrobial agent. It will be understood that other AHAs may be used in cosmetic or pharmaceutical formulations, and that the AHAs may provide additional or alternative functions.

[0052] The excipient may also be a hydroxybenzoic acid. As an example, a cosmetic or pharmaceutical product may contain ethylparaben or methylparaben in the range of 0.001-50.0% of the liquid formulation to act as an antimicrobial agent. It will be understood that other hydroxybenzoic acids may be used in cosmetic or pharmaceutical formulations, and that the hydroxybenzoic acids may provide additional or alternative functions.

[0053] The excipient may also be a mixed ester. As an example, a cosmetic or pharmaceutical product may contain a plant extract or caprylic / capric triglyceride, a natural fatty acid, or coco-caprylate / caprate, an ester of a natural fatty alcohol with caprylic and capric acids, in a range of 0.001-50.0% of the liquid formulation to act as an antimicrobial agent. Caprylic / capric triglyceride may act as an emollient. Coco-caprylate / caprate may act as a solubilizer or texture improver. It will be understood that other mixed esters may be used in cosmetic or pharmaceutical formulations, and that the mixed esters may provide additional or alternative functions.

[0054] Pharmaceuticals or cosmetics may contain various other compounds or solvents as excipients. The following table is a non-exhaustive list of various other compounds or solvents that may be used in fast-dissolving articles. [Table 23]

[0055] Compounds or solvents may serve various functions in cosmetic or pharmaceutical formulations. For example, polysorbate 20 and polysorbate 80 may act as emulsifiers or surfactants. Sodium phosphate and sodium hydroxide may be buffering agents. Sodium phosphate may be a tonic. Sodium hydroxide, hydrochloric acid (a pH adjuster), and ethoxydiglycol may be solubilizing agents. It will be understood that other compounds may be used in cosmetic or pharmaceutical formulations and may serve additional or alternative functions.

[0056] Cosmetic or pharmaceutical formulations for liquid formulations may include any combination of at least one active ingredient and excipients listed above. The following are exemplary formulations of active ingredients and excipients that may be used in liquid formulations. Other formulations may be used in liquid formulations to create fast-dissolving articles.

[0057] The first exemplary formulation may include alpha arbutin and either alginate, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base. One embodiment of the first exemplary formulation may include the components in the first table below in the weight percentages listed before the liquid formulation is lyophilized, and the components in the second table in the weight percentages listed after the liquid formulation is lyophilized. [Table 24] [Table 25]

[0058] The second exemplary formulation may include potassium azeloyldiglycinate (azelaic acid) and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base. One embodiment of the second exemplary formulation may include the components in the first table below in the stated weight percentages before the liquid formulation is lyophilized, and the components in the second table in the stated weight percentages after the liquid formulation is lyophilized. [Table 26] [Table 27]

[0059] A third exemplary formulation may include niacinamide USP and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base. One embodiment of the third exemplary formulation may include the ingredients in the following Table 1 in the weight percent listed before the liquid formulation is lyophilized, and the ingredients in the following Table 2 in the weight percent listed after the liquid formulation is lyophilized. [Table 28] [Table 29]

[0060] A fourth exemplary formulation may include gluconolactone USP, dextran, maltobionic acid, lactobionic acid, Aloe Barbadensis (Aloe Vera) leaf juice, and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base. One embodiment of the fourth exemplary formulation may include the ingredients in the following Table 1 in the weight percentages listed before the liquid formulation is lyophilized, and the ingredients in the following Table 2 in the weight percentages listed after the liquid formulation is lyophilized. [Table 30] [Table 31]

[0061] A fifth exemplary formulation may include sodium hyaluronate (hyaluronic acid), betaine, polyglutamic acid, and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base material.

[0062] A sixth exemplary formulation may include Centella Asiatica (Cica) extract, Camellia Sinensis (Green Tea) extract, and either alginate, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base.

[0063] A seventh exemplary formulation may include tripeptide-1 and copper (copper peptide 1), acetyl hexapeptide-8, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, and either alginate, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base. One embodiment of the seventh exemplary formulation may include the components in the following Table 1 in the weight percentages listed before the liquid formulation is lyophilized, and the components in the following Table 2 in the weight percentages listed after the liquid formulation is lyophilized. [Table 32] [Table 33]

[0064] An eighth exemplary formulation may include glycolic acid (99% hydroxyacetic acid), lactic acid, phytic acid, mandelic acid (99% DL-mandelic acid), salicylic acid, and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base.

[0065] A ninth exemplary formulation may include L-ascorbic acid, DL-alpha tocopherol acetate, ferulic acid, propanediol or ethoxydiglycol, and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base.

[0066] The tenth exemplary formulation may include hydroxypinacolone retinoic acid, DL-alpha tocopherol acetate, a solvent, and either alginic acid, chitosan, sodium hyaluronate (hyaluronic acid), or collagen as a base. One embodiment of the tenth exemplary formulation may include the components in the following Table 1 in the weight percentages listed before the liquid formulation is lyophilized, and the components in the following Table 2 in the weight percentages listed after the liquid formulation is lyophilized. [Table 34] [Table 35]

[0067] Another aspect of the present disclosure includes a method for preparing a cosmetic or pharmaceutical product containing the above-described active ingredient and excipients, particularly in the above-described formulation, as a fast-dissolving product. For example, the fast-dissolving product may be a tablet that can be rehydrated in water to obtain a single dose or use of the cosmetic or pharmaceutical product. It is understood that the formulation may be prepared in accordance with current good practice (CGMP) regulations.

[0068] FIG. 1 shows an example flow diagram and exemplary embodiment of an exemplary method 100 for manufacturing a fast-dissolving article comprising the formulation described above for use as a skin care tablet. At 102, the method includes combining a desired amount of at least one active ingredient, as described above, to form an aqueous solution or suspension. In some embodiments, the formulation may include one or more of the listed excipients in addition to the active ingredient. Determining the desired amount of each ingredient to be combined may include weighing / measuring the ingredients. In some embodiments, the weighed amounts of the ingredients (e.g., at least one active ingredient) provide a cosmetic formulation defined by its component weight percentages. The active ingredient and excipients may be combined with sterile water in a container or processing tank to form a liquid formulation. The active ingredient and excipients may be added individually and stirred / agitated, for example, using a magnetic stirring table and stir bar, until completely dissolved in the sterile water. Once all active and inactive ingredients have been added to the desired weight percent, the liquid formulation is fully formed. The liquid formulation may be recirculated and mixed for additional time to ensure proper dissolution of the ingredients.

[0069] At 104, in one embodiment of the method, the next step may include pouring the liquid formulation into a mold. The mold may be a tray having multiple rows and multiple columns of individual cells configured to receive the liquid formulation. The liquid formulation may be pumped and dispensed into the cells using an automated or robotic process. It will be appreciated that the liquid formulation may also be dispensed into the cells manually. During the dispensing process, continuous monitoring and calibration may be performed to ensure that each cell is filled with a target volume, and therefore a target weight, of the liquid formulation. It will be appreciated that this target weight may vary depending on the ingredients in the formulation and the amount of the ingredients contained in a single dose of the cosmetic or pharmaceutical product.

[0070] At 106, in one embodiment of the method, the next step in the method is lyophilizing the liquid formulation. A tray may be inserted into the freeze-dryer to begin the freeze-drying process. Multiple trays may be placed in the freeze-dryer to perform the freeze-drying steps simultaneously. Once the trays are loaded into the freeze-dryer, the freeze-drying process may include a freezing stage, a vacuum stage, a primary drying or sublimation stage, and a secondary drying or drying stage. The freezing and drying stages may include a ramp stage, in which the temperature and / or pressure is decreased or increased over a set time interval, and a hold stage, in which the temperature and / or pressure is maintained within the freeze-dryer for a set time interval.

[0071] An exemplary freeze-drying process is shown in the table below. It will be understood that parameters such as target temperature, target pressure, ramp time interval, and hold time interval may all vary depending on the formulation and best practices in the liquid formulation. Once the second drying sub-step is complete, the trays are stored in the temperature-controlled freeze-dryer or immediately removed. [Table 36]

[0072] Alternatively, at 106, the freeze-drying process may include multiple freezing sub-stages followed by multiple sublimation or primary drying sub-stages followed by multiple drying or secondary drying sub-stages. During each sub-stage, the freeze-dryer may change temperature and pressure. The sub-stages may include ramp stages, in which the temperature is decreased or increased over a set time interval, and hold stages, in which the temperature within the freeze-dryer is maintained for a set time interval.

[0073] An exemplary freeze-drying process is shown in the table below. It will be understood that the freeze-drying process may include more or fewer freezing sub-steps and more or fewer first and second drying sub-steps. Furthermore, it will be understood that parameters such as target temperature, target pressure, ramp time interval, and hold time interval may all vary depending on the formulation and best practices in the liquid formulation. Once the second drying sub-step is complete, the trays are stored in the temperature-controlled freeze-dryer or immediately removed. [Table 37-1] [Table 37-2]

[0074] At 108, in one embodiment of the method, the next step includes removing the fast-dissolving articles from the trays. The trays may be removed from the freeze-dryer, and the fast-dissolving articles may be removed from one tray at a time. The fast-dissolving articles may be removed from the trays manually or by some automated process.

[0075] 2 is an exemplary embodiment of a flow chart example of a second exemplary method 200 for producing a fast-dissolving article containing the formulation described above for use as a skin care tablet. At 202, the method includes combining a desired amount of at least one active ingredient, as described above, to form an aqueous solution or suspension. This process is substantially the same as 102 described above.

[0076] At 204, a second exemplary method may include pouring the liquid formulation into a container. The liquid formulation may be poured into one large container as opposed to being dispensed into individual cells.

[0077] At 206, a second exemplary method may include lyophilizing the liquid formulation in the container to obtain a lyophilized article. The lyophilization process may be substantially the same as described above at 106. It will be understood that the number of freezing and drying steps, as well as the target temperature, pressure, and time parameters for freezing and drying, may be varied to lyophilize all of the liquid formulation in one batch.

[0078] At 208, a second exemplary method may include producing a lyophilized powder from the lyophilized articles in the container. The lyophilized articles may be removed from the container. The lyophilized articles may be mixed into a lyophilized powder. It will be appreciated that the lyophilized articles may be converted into a lyophilized powder through another process, such as crushing or grinding.

[0079] At 210, a second exemplary method may include compressing the lyophilized powder into a final article form. The lyophilized powder may be placed into a mold and compressed to produce the final article form. For example, the powder may be compressed into a single-dose tablet for a topical cosmetic or pharmaceutical product.

[0080] The word "exemplary" is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "exemplary" is not necessarily to be construed as advantageous over other aspects or designs. Rather, use of the word "exemplary" is intended to present concepts in a concrete manner. As used in this application, the term "or" is intended to mean an inclusive "or" rather than an exclusive "or." That is, unless otherwise specified or apparent from the context, "X employs A or B" is intended to mean any of the natural inclusive permutations. That is, if X employs A, if X employs B, or if X employs both A and B, then "X employs A or B" is satisfied in each of the foregoing cases. Furthermore, the articles "a" and "an," as used in this application and the appended claims, may be construed generally to mean "one or more" unless otherwise specified or apparent from the context to be directed to the singular form.

[0081] Although the present subject matter has been described in language specific to structural features and / or methodological acts, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims. Of course, those skilled in the art will recognize that many modifications may be made to this configuration without departing from the scope or spirit of the claimed subject matter.

[0082] Moreover, while the present disclosure has been shown and described with respect to one or more embodiments, equivalent changes and modifications will occur to those skilled in the art upon reading and understanding this specification and the accompanying drawings. The present disclosure includes all such changes and modifications, and is limited only by the scope of the following claims. In particular, with regard to the various functions performed by the above-described components (e.g., elements, resources, etc.), the terms used to describe such components, unless otherwise indicated, are intended to correspond to any component that performs the specified function of the described component (e.g., is functionally equivalent), even if it is not structurally equivalent to the disclosed structure that performs that function in the exemplary embodiments described herein of the present disclosure.

[0083] Additionally, while a particular feature of the present disclosure may be disclosed with respect to only one of several embodiments, such feature may be combined with one or more other features of other embodiments, as may be desirable and advantageous for any given or particular application. Furthermore, to the extent that the terms "includes," "having," "has," "with," or variations thereof are used in either the detailed description or the claims, such terms are intended to be inclusive in the same manner as the term "comprising."

[0084] Having described the above embodiments, it will be apparent to those skilled in the art that the above methods and apparatus may incorporate changes and modifications without departing from the general scope of the invention. The present invention is intended to include all such changes and modifications insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. 1. An article for use as a cosmetic or pharmaceutical product comprising a shaped dry preparation containing more than 0% and up to 50% by weight of water, said dry preparation being formed by drying a liquid preparation, said liquid preparation being a base comprising one or more of alginate, chitosan, collagen, sodium hyaluronate, and trehalose; active ingredients including one or more of amino acids, enzymes and coenzymes, salts, sugars, glycols, polyols, nutrients, phenols, plant extracts, peptides, proteins, ultraviolet (UV) filters, vitamins, organic compounds, inorganic compounds, antioxidants, prebiotics, probiotics, postbiotics, fatty acids, glycerol, triglycerides, monoglycerides, diglycerides, phospholipids, steroids, sterols, sphingolipids, alpha-hydroxy acids (AHA), beta-hydroxy acids (BHA), or polyhydroxy acids (PHA), and oils; and Inactive ingredients including one or more of amino acids, alcohols, salts, sugars, polyols, glycols, polymers, acids, esters, solvents, proteins, surfactants, buffers, chelate complexes, and inorganic salts. Including, wherein the dry formulation is adapted to be rehydrated with an aqueous-based solvent, solution or emulsion to form a ready-to-use liquid or semi-solid topical product.

2. 10. The article of claim 1, wherein the substrate of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and the active ingredient comprises alpha arbutin, and wherein the dry formulation comprises 5-15% by weight water, 50-70% by weight active ingredient, and 15-40% by weight substrate.

3. 10. The article of claim 1, wherein the substrate of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and the active ingredient comprises potassium azeloyldiglycinate, and wherein the dry formulation comprises 5-15% by weight water, 60-80% by weight active ingredient, and 10-30% by weight substrate.

4. 10. The article of claim 1, wherein the substrate of the liquid formulation comprises one or more of alginate, chitosan, sodium hyaluronate, or collagen, and the active ingredient comprises potassium niacinamide USP, and wherein the dry formulation comprises 5-15% by weight water, 50-70% by weight active ingredient, and 15-40% by weight substrate.

5. 10. The article of claim 1, wherein the substrate of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising gluconolactone USP, dextran, maltobionic acid, lactobionic acid, and aloe barbadensis leaf juice, and wherein the dry formulation comprises 5-15% by weight water, 70-90% by weight active ingredient, and 5-20% by weight substrate.

6. 10. The article of claim 1, wherein the substrate of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising tripeptide-1 (and) copper peptide-1, acetyl hexapeptide-8, palmitoyl tripeptide-1, and palmitoyl tetrapeptide-7, and wherein the dry formulation comprises 5-15% by weight water, 30-50% by weight active ingredients, and 40-60% by weight substrate and / or inactive ingredient materials.

7. 10. The article of claim 1, wherein the substrate of the liquid formulation comprises one or more of alginate, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising hydroxypinacolone retinoic acid and DL-α-tocopherol acetate, and wherein the dry formulation comprises 10-30% by weight water, 50-70% by weight active ingredient, 1-10% by weight substrate, and 10-20% by weight dextran.

8. 10. The article of claim 1, comprising sodium hyaluronate, betaine, or polyglutamic acid as an active ingredient and any of alginic acid, chitosan, sodium hyaluronate, or collagen as a base.

9. 10. The article of claim 1, comprising Centella asiatica extract, camellia sinensis extract, and any of alginic acid, chitosan, sodium hyaluronate, and collagen as a base.

10. 10. The article of claim 1, comprising glycolic acid, lactic acid, phytic acid, mandelic acid, salicylic acid, and any of alginic acid, chitosan, sodium hyaluronate, and collagen as a base.

11. 2. The article of claim 1, comprising L-ascorbic acid, DL-α-tocopherol acetate, ferulic acid, and propanediol or ethoxydiglycol, and any of alginic acid, chitosan, sodium hyaluronate, and collagen as a base.

12. 1. A method for producing a dry shaped article adapted to be rehydrated for cosmetic or pharmaceutical use, said method comprising: mixing at least one active ingredient from a selection of active ingredients with an aqueous-based solvent to form an active aqueous solution or suspension, wherein the selection of active ingredients includes amino acids, enzymes and coenzymes, salts, sugars, glycols, polyols, nutrients, phenolics, plant extracts, peptides, proteins, ultraviolet (UV) filters, vitamins, organic compounds, inorganic compounds, antioxidants, prebiotics, probiotics, postbiotics, fatty acids, glycerol, triglycerides, monoglycerides, diglycerides, phospholipids, steroids, sterols, sphingolipids, alpha hydroxy acids (AHA), beta hydroxy acids (BHA), or polyhydroxy acids (PHA), and oils; mixing a substrate with the active aqueous solution or suspension, wherein the substrate comprises one or more of alginic acid, chitosan, collagen, sodium hyaluronate, and trehalose; mixing at least one inactive ingredient with the active aqueous solution or suspension to form a liquid formulation, wherein the inactive ingredient comprises one or more of amino acids, alcohols, salts, sugars, polyols, glycols, polymers, acids, esters, solvents, proteins, surfactants, buffers, chelate complexes, and inorganic salts; and producing a shaped dry formulation containing more than 0% and up to 40% water by weight, wherein said dry formulation is produced by drying said liquid formulation; Including, wherein the dry preparation is adapted to be rehydrated with an aqueous-based solvent, solution or emulsion to form a ready-to-use liquid or semi-solid topical product.

13. 13. The method of claim 12, wherein producing the shaped dried preparation comprises lyophilizing the liquid formulation.

14. 13. The method of claim 12, wherein the base of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, the active ingredient comprises alpha arbutin, and the dry formulation comprises 5-15% by weight water, 50-70% by weight active ingredient, and 15-40% by weight base.

15. 13. The method of claim 12, wherein the base of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, the active ingredient comprises potassium azeloyldiglycinate, and the dry formulation comprises 5-15% by weight water, 60-80% by weight active ingredient, and 10-30% by weight base.

16. 13. The method of claim 12, wherein the substrate of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, the active ingredient comprises potassium niacinamide USP, and the dry formulation comprises 5-15% by weight water, 50-70% by weight active ingredient, and 15-40% by weight substrate.

17. 13. The method of claim 12, wherein the substrate of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising gluconolactone USP, dextran, maltobionic acid, lactobionic acid, and aloe barbadensis leaf juice, and the dry formulation comprises 5-15% by weight water, 70-90% by weight active ingredient, and 5-20% by weight substrate.

18. 13. The method of claim 12, wherein the base of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising tripeptide-1 (and) copper peptide-1, acetyl hexapeptide-8, palmitoyl tripeptide-1, and palmitoyl tetrapeptide-7, and the dry formulation comprises 5-15% by weight water, 30-50% by weight active ingredients, and 40-60% by weight base and / or inactive ingredient materials.

19. 13. The method of claim 12, wherein the base of the liquid formulation comprises one or more of alginic acid, chitosan, sodium hyaluronate, or collagen, and active ingredients comprising hydroxypinacolone retinoic acid and DL-α-tocopherol acetate, and the dry formulation comprises 10 to 30% by weight of water, 50 to 70% by weight of the active ingredient, 1 to 10% by weight of the base, and 10 to 20% by weight of dextran.

20. a base comprising one or more of alginate, chitosan, collagen, sodium hyaluronate, and trehalose; active ingredients including one or more of amino acids, enzymes and coenzymes, salts, sugars, glycols, polyols, nutrients, phenols, plant extracts, peptides, proteins, ultraviolet (UV) filters, vitamins, organic compounds, inorganic compounds, antioxidants, prebiotics, probiotics, postbiotics, fatty acids, glycerol, triglycerides, monoglycerides, diglycerides, phospholipids, steroids, sterols, sphingolipids, alpha-hydroxy acids (AHA), beta-hydroxy acids (BHA), or polyhydroxy acids (PHA), and oils; and Inactive ingredients including one or more of amino acids, alcohols, salts, sugars, polyols, glycols, polymers, acids, esters, solvents, proteins, surfactants, buffers, chelate complexes, and inorganic salts.

1. A formulation for use as a topical cosmetic or pharmaceutical product, comprising: wherein the liquid formulation is lyophilized to form a shaped dry preparation containing more than 0% and up to 30% water by weight; and wherein the dry formulation is adapted to be rehydrated with an aqueous-based solvent, solution or emulsion to form a ready-to-use liquid or semi-solid topical formulation. Formulations for use as topical cosmetics or pharmaceuticals.

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