Liquid topical pharmaceutical nano-emulsion formulations

Abstract

Aspects of the present invention are directed to compositions that are useful for delivery of an active ingredient to a subject. Some embodiments are formulated with an active ingredient, including, for example, a non-steroidal anti-inflammatory drug (NSAID), such as aspirin, ibuprofen, ketoprofen, or naproxen, acetaminophen, or a polypeptide or protein, such as insulin, wherein the active ingredient is stabilized and greater than 90% of the particles of the active ingredient have a particle size that is less than or equal to or any number in between 100, 90, 80, 70, 60, 50, 40, 30, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, or 4 nanometers, or smaller, as determined by Dynamic Light Scattering (DLS), using a volume-weighted particle size distribution calculation method.

What is claimed is: 
     
         1 . A transdermal and/or dermal composition comprising:
 (a) an ethoxylated oil,   (b) an alcohol, and   (c) an active ingredient, wherein greater than 90% of the particles of the active ingredient have a particle size that is less than or equal to or any number in between 100, 90, 80, 70, 60, 50, 40, 30, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, or 4 nanometers, as determined by Dynamic Light Scattering, using a volume-weighted particle size distribution calculation method.   
     
     
         2 - 157 . (canceled) 
     
     
         158 . The transdermal and/or dermal composition of  claim 1 , further comprising water. 
     
     
         159 . The transdermal and/or dermal composition of  claim 158 , further comprising one or more viscosity-increasing agents selected from the group consisting of hydroxyethylcellulose, methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose (E464), and hydroxyethyl methyl cellulose. 
     
     
         160 . The transdermal and/or dermal composition of  claim 1 , wherein the active ingredient is selected from the group consisting of a Non-Steroidal Anti-Inflammatory Drug (or NSAID); a protein, a dietary supplement, an antioxidant, an amino acid, a sugar containing compound, a hormone precursor, a hormone mimic, and an antibiotic. 
     
     
         161 . The transdermal and/or dermal composition of  claim 160 , wherein said active ingredient is a Non-Steroidal Anti-Inflammatory Drug (NSAID) selected from the group consisting of aspirin (acetylsalicylic acid), naproxen (2-(6-methoxynaphthalen-2-yl)propanoic acid), diclofenac (2-(2,6-dichloranilino) phenylacetic acid) (sodium and/or epolamine), ibuprofen (iso-butyl-propanoic-phenolic acid), or ketoprofen ((RS)2-(3-benzoylphenyl)-propionic acid), and acetaminophen (N-acetyl-para-aminophenol). 
     
     
         162 . The transdermal and/or dermal composition of  claim 160 , wherein said active ingredient is a hormone, hormone precursor, or a hormone mimic selected from the group consisting of insulin, dehydroepiandrosterone (DHEA), a human growth hormone (hGH), and erythropoietin (EPO). 
     
     
         163 . The transdermal and/or dermal composition of  claim 1 , wherein said active ingredient comprises one or more opiods, anti-depressants, anti-epileptic drugs, adjuvant medications, muscle relaxers, nerve ablation drugs, spinal cord stimulators, nutraceuticals, vitamins, minerals, neuropathy therapy drugs, male hormonal balancing drugs, female hormonal balancing drugs, or bio-identical hormones. 
     
     
         164 . The transdermal and/or dermal composition of  claim 1 , wherein said ethoxylated oil is present at 2%-25% by total weight or total volume of the transdermal and/or dermal composition. 
     
     
         165 . The transdermal and/or dermal composition of  claim 1 , wherein said ethoxylated oil is an ethoxylated macadamia nut oil having 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 ethoxylations per molecule. 
     
     
         166 . The transdermal and/or dermal composition of  claim 1 , wherein said alcohol is present at 30%-70% by total weight or total volume of the transdermal and/or dermal emulsion composition. 
     
     
         167 . The transdermal and/or dermal composition of  claim 1 , further comprising a fragrance. 
     
     
         168 . The transdermal and/or dermal composition of  claim 1 , wherein said ethoxylated oil is an ethoxylated macadamia nut oil having 16 ethoxylations per molecule. 
     
     
         169 . A method for reducing pain, fever, and/or inflammation in a subject, said method comprising administering to said subject the transdermal and/or dermal composition of  claim 1 . 
     
     
         170 . A method for inhibiting a bacterial infection or hormonal imbalance, said method comprising administering to said subject the transdermal and/or dermal composition of  claim 1 . 
     
     
         171 . A method of making the transdermal and/or dermal composition of  claim 1  comprising the following steps in order:
 (a) mixing an amount of an active ingredient with an alcohol; and 
 (b) adding an ethoxylated oil, which is present at a final concentration of 2%-25% by total weight or total volume of the transdermal and/or dermal composition, to the mixture of (a). 
 
     
     
         172 . The method of  claim 171 , further comprising adding one or more viscosity-increasing agents selected from the group consisting of hydroxyethylcellulose, methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose (E464), and hydroxyethyl methyl cellulose. 
     
     
         173 . The method of  claim 171 , wherein the active ingredient is selected from the group consisting of an Non-Steroidal Anti-Inflammatory Drug (or NSAID); a protein, a dietary supplement, an antioxidant, an amino acid, a sugar containing compound, a hormone precursor, a hormone mimic, and an antibiotic. 
     
     
         174 . The method of  claim 171 , wherein said ethoxylated oil is an ethoxylated macadamia nut oil having 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 ethoxylations per molecule. 
     
     
         175 . The method of  claim 171 , wherein said alcohol is present at 30%-70% by total weight or total volume of the transdermal and/or dermal emulsion composition.