METHOD OF ADMINISTRATION AND TREATMENT
Provided herein are formulations for topical and/or transdermal administration, and methods of using these formulations for the treatment of proliferative diseases related to cancer such as cancers and related conditions, and solid tumors. Also provided are formulations for topical and/or transdermal administration, and methods of using these formulations for melasma, gout, skin disorders, and other diseases and disorders described herein as well as methods for modulating the pH (e.g. raising) of a tissue or microenvironment proximal to a tumor, modulating pH, or improving the effectiveness of know chemotherapeutic agents, immunotherapy and the like for the prevention, treatment of cancers and related conditions described herein.
1 . A formulation suitable for transdermal delivery of a buffering agent, the formulation comprising the buffering agent and comprising benzyl alcohol and/or steric acid; wherein the buffering agent comprises sodium bicarbonate or sodium carbonate.
2 . The formulation of claim 1 , wherein the formulation further comprises a penetrant or penetration enhancer.
3 . The formulation of claim 2 , wherein the penetrant or penetration enhancer comprises one or more of benzyl alcohol, cetyl alcohol, isododecane, isopropyl palmitate (IPP), isopropyl stearate, menthol, phosphatidyl choline, undecane, and lecithin, wherein the lecithin is selected from an egg lecithin, a soy lecithin, and a synthetic lecithin.
4 . The formulation of claim 3 , wherein the penetrant or penetration enhancer comprises benzyl alcohol and/or wherein the penetrant or penetration enhancer comprises a synthetic lecithin.
5 . The formulation of claim 1 , wherein the formulation further comprises a source of fatty acids comprising one or more of an almond oil, alkanoic acid, caprid acid, diacid, ethyloctadecanoic acid, hexanoic acid, lactic acid, lauric acid, a lecithin, linoelaidic acid, linoleic acid, linolenic acid, neodecanoic acid, oleic acid, palmitic acid, pelargonic acid, propionic acid, stearic acid, and vaccenic acid, wherein the lecithin is selected from an egg lecithin, a soy lecithin, and a synthetic lecithin.
6 . The formulation of claim 5 , wherein the source of fatty acids is almond oil and stearic acid.
7 . The formulation of claim 6 , wherein the source of fatty acids is a lecithin selected from an egg lecithin, a soy lecithin, and a synthetic lecithin.
8 . The formulation of claim 1 , wherein the formulation further comprises menthol.
9 . The formulation of claim 1 , wherein the formulation comprises benzyl alcohol.
10 . The formulation of claim 5 , wherein the formulation comprises benzyl alcohol.
11 . The formulation of claim 1 , wherein the formulation further comprises one or more of a humectant, an emulsifier, a surfactant, and a polar solvent.
12 . The formulation of claim 11 , wherein
the humectant when present comprises propylene glycol;
the emulsifier when present comprises one or more of cetyl alcohol, Durosoft®, and Phospholipon® 90G;
the surfactant when present comprises one or more of a polyoxyethylated castor oil derivative, nonoxynol, octoxynol, phenylsulfonate, a poloxamer, a polyoleates, Rewopal®, sodium laurate, sodium lauryl sulfate (sodium dodecyl sulfate), sodium oleate, sorbitan dilaurate, sorbitan dioleate, a sorbitan monolaurate, a sorbitan monooleate; sorbitan trilaurate, sorbitan trioleate, a sorbitan monopalmitate, a sorbitan stearate; a polyethylene glycol, a nonylphenyl ether, p-(1,1,3,3-tetramethylbutyl)-phenyl ether (Triton™ X-100), or a polysorbate (e.g., a Tween®); and
the polar solvent when present is one or more of ethanol, isopropyl palmitate (IPP), and water.
13 . The formulation of claim 12 , wherein the comprises formulation further comprises a humectant, an emulsifier, a surfactant, and a polar solvent;
wherein the humectant is propylene glycol, the emulsifier is cetyl alcohol and/or Durosoft®, the surfactant is a poloxamer, and the polar solvent is ethanol and/or water.
14 . The formulation of claim 1 , wherein the concentration of the buffering agent is from about 10% to about 50% w/w of the formulation.
15 . The formulation of claim 1 , wherein the formulation comprises about 33% w/w sodium bicarbonate or sodium carbonate.
16 . The formulation of claim 15 , wherein the formulation further comprises about 1% w/w benzyl alcohol and/or from about 1.5% to about 2% w/w stearic acid.
17 . The formulation of claim 16 further comprising about 0.5% w/w menthol.
18 . The formulation of claim 17 further comprising about 3% w/w almond oil.
19 . The formulation of claim 1 which is formulated as a cream, a lotion, or an ointment.
20 . A formulation suitable for transdermal delivery of a buffering agent comprising sodium bicarbonate or sodium carbonate, the formulation comprising about 33% w/w sodium bicarbonate; about 1% w/w benzyl alcohol; about 0.5% w/w menthol; from about 1.5% to about 2% w/w stearic acid; and about 3% w/w almond oil;
wherein the formulation further comprises one or more of cetyl alcohol, lecithin, isopropyl palmitate (IPP), ethanol, propylene glycol, a poloxamer, water, NaOH, and Durosoft®; and
wherein the formulation is formulated as a cream, lotion, or ointment.