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 menthol; 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.
6 . The formulation of claim 1 , wherein the source of fatty acids comprises one or more of an 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.
7 . The formulation of claim 1 , wherein the formulation further comprises a polar solvent.
8 . The formulation of claim 7 , wherein the polar solvent is one or more of ethanol, isopropyl palmitate (IPP), and water.
9 . The formulation of claim 1 , wherein the formulation further comprises one or more of a humectant, an emulsifier, a surfactant, and an emollient.
10 . The formulation of claim 9 , wherein the emulsifier comprises one or more of cetyl alcohol, Durosoft®, and Phospholipon® 90G.
11 . The formulation of claim 9 , wherein the humectant comprises propylene glycol.
12 . The formulation of claim 11 , wherein the surfactant 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®).
13 . The formulation of claim 12 , wherein the poloxamer is a Pluronic®.
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 and about 0.5% w/w menthol.
16 . The formulation of claim 15 , wherein the formulation further comprises benzyl alcohol, isopropyl palmitate (IPP), and a lecithin, wherein the lecithin is selected from an egg lecithin, a soy lecithin, and a synthetic lecithin; and
the formulation further comprises one or more of ethanol, cetyl alcohol, almond oil, propylene glycol, a poloxamer, and Durosoft®.
17 . The formulation of claim 1 which is formulated as a cream, a lotion, or an ointment.
18 . A formulation suitable for transdermal delivery of a buffering agent, the formulation comprising: the buffering agent comprising sodium bicarbonate or sodium carbonate, menthol, a penetrant or penetration enhancer, a source of fatty acids, and a polar solvent, and one or more of a humectant, an emulsifier, a surfactant, and an emollient;
wherein the formulation is formulated as a cream, lotion, or ointment.
19 . The formulation of claim 20 , wherein the formulation comprises about 33% sodium bicarbonate or sodium carbonate and about 0.5% menthol.
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 and about 0.5% w/w menthol;
wherein the formulation further comprises one or more of ethanol, benzyl alcohol, cetyl alcohol, almond oil, lecithin, isopropyl palmitate (IPP), propylene glycol, a poloxamer, water, and Durosoft®; and
wherein the formulation is formulated as a cream, lotion, or ointment.