Apparatus and method for preparing cosmeceutical ingredients containing epi-dermal delivery mechanisms

Abstract

The skin serves as a barrier that protects the body from the external environment and prevents water loss. This barrier function also prevents most hydrophilic or hydrophobic and large molecular weight ingredients (>500 kDa) from penetrating intact skin. Until recently, methods to increase stratum corneum permeability were generally not effective enough to make the stratum corneum so permeable that the barrier posed by the viable epidermis mattered. However, that has now changed with the development of the present embodiment's physical methods and highly optimized chemical formulations, such that we revisited the permeability of the full epidermis with the example embodiment's constructs and not focus only on the stratum corneum. This example embodiment therefore tests the hypothesis that the viable epidermis offers a significant permeability barrier to both small molecules and macromolecules that becomes the rate limiting step.

What is claimed is: 
     
         1 . A method for the construction of cosmeceutically bioactive compositions including elastic niosome vesicle epi-dermal delivery vehicles without use of supercritical CO 2  and in a continuously operating process, the method comprising:
 forming a solution or mixture of cosmeceutically benevolent phospholipids, the solution being hydrophobic or hydrophilic with an aqueous phase;   removing any constituent attributes of water-insolubility from the solution, while operating under conditions to preserve activity of labile biomolecules;   loading the solution and desired hydrophobic bio-actives into an organic solvent residing in a pressure reactor, the pressure reactor having been previously driven to a pre-determined working temperature;   pressurizing the reactor with compressed CO 2  until reaching a pre-determined working pressure to produce a resulting CO 2 -expanded solution;   depressurizing the resulting CO 2 -expanded solution over an aqueous phase to form vesicular conjugates, the resulting solution containing water soluble cationic or non-ionic surfactants and hydrophilic or hydrophobic bio-actives; and   forming nano and macro carriers as either unimolecular or multi-molecular carriers of beneficial cosmeceutical ingredients.   
     
     
         2 . The method of  claim 1  wherein the pre-determined working temperature is less than 31.1° C. and the pre-determined working pressure is less than 73.8 bar. 
     
     
         3 . The method of  claim 1  including using a neutral lipid species, selected from the group consisting of phosphatidylethanolamine, phosphatidylcholine, sphingomyelin, and cholesterol. 
     
     
         4 . The method of  claim 1  including forming nano and macro carriers as unimolecular carriers, having dendrimers, carbon nanotubes, polymer-conjugate drug/protein, or multimolecular carriers. 
     
     
         5 . The method of  claim 1  wherein the nano and macro carriers are based on molecular self-assemblies having nanoshells, vesicles, micelles, elastic vesicles, liquid crystal phases, and Langmuir monolayers by surfactant molecules in aggregate structures having a translation aggregate, a glide aggregate, and a screw aggregate. 
     
     
         6 . The method of  claim 1  wherein the nano and macro carriers have an effective diameter of between 30 and 1500 nanometers, between 150 to 4000 nanometers, between 50 to 380 nanometers or 1 to 35 microns. 
     
     
         7 . The method of  claim 1  wherein the nano and macro carriers have a polydispersity of between 0.001 to 1, between 0.01 to 0.9, or between 0.1 to 0.6. 
     
     
         8 . The method of  claim 1  wherein the nano and macro carriers have an ingredient lipid content % w/w of between 25 to 200, 50 to 100, or 60 to 90. 
     
     
         9 . The method of  claim 1  wherein the nano and macro carriers have residual solvent levels % v/v between 0.01 to 10, 0.1 to 6, or 0.3 to 5. 
     
     
         10 . The method of  claim 1  including forming a cosmeceutical agent preparation, incorporated into particles having a diameter of 0.5 to 100 microns, the preparation comprising a core, the core comprising at least one member selected from the group consisting of a hydrophilic material and a hydrophobic material and at least first and second layers, each member comprising at least one member selected from the group consisting of hydrophilic material and hydrophobic material wherein an interface between the core and the first layer and between adjacent layers is an interface between hydrophobic and hydrophilic material. 
     
     
         11 . The method of  claim 1  including introducing a cosmeceutically active agent into a cell of a plant or animal, the method further including: preparing lipid vesicles comprising a cationic, anionic, or non-ionic lipid and containing the cosmeceutically active agent; and contacting the cell with the elastic lipid vesicles whereby the cosmeceutically active agent is taken up into the cell. 
     
     
         12 . The method of  claim 1  including introducing a cosmeceutically active agent into a cell of a plant or animal, the method further including: preparing lipid vesicles comprising a cationic, anionic, or non-ionic lipid and containing the cosmeceutically active agent; and contacting the cell with a bioactive agent in the presence of the lipid vesicles, whereby the bioactive agent is taken up into the cell. 
     
     
         13 . The method of  claim 1  wherein a final arrangement of the liposome solution or mixture is governed by the nature of the initial components and the methodology used in their preparation. 
     
     
         14 . The method of  claim 10  wherein at least one of the layers is an emulsion. 
     
     
         15 . The method of  claim 10  wherein the core comprises an emulsion of a hydrophobic material and a hydrophilic material as an oil-in-water emulsion. 
     
     
         16 . The method of  claim 10  wherein the core comprises an emulsion of a hydrophilic material and a hydrophobic material as a water-in-oil emulsion. 
     
     
         17 . The method of  claim 1  including forming a combination of the liposome solution or mixture, a hydrophobic or hydrophilic cosmeceutical ingredient, and an aqueous phase and a low-pressure fluid, the combination being decompressed to separate the low pressure, critical fluid, from the phospholipid and aqueous medium, to form one or more liposomes or elastic vesicles, the rate of depressurization influences the size of the liposomes formed. 
     
     
         18 . The method of  claim 1  including loading the liposome solution and desired hydrophobic bio-actives in an organic solvent into the high-pressure reactor. 
     
     
         19 . The method of  claim 1  wherein the nano and macro carriers enable the incorporation of cosmeceutical essential oils into carrier materials by facilitating the diffusion of the essential oil due to the swelling and opening of the pores of carrier material particles. 
     
     
         20 . The method of  claim 1  including forming unilamellar liposome or niosome vesicles, the size of the liposome or niosome being determined by the rate of decompression.