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Publication Number
US-11052152-B2
Publication Date
2021-07-06
Expiration Date
Abstract
Improved formulations for topical treatment that ensure at least localized transdermal or systemic delivery of an active agent through skin, nails or hair follicles are disclosed.
Core Innovation
The disclosed invention provides an improved multi-component topical/transdermal penetrant for administering an active agent through the skin of a subject, with the goal of impeding lactic acidosis. The formulation is based on a penetrant that provides lecithin at 5%-15% w/w of the formulation and sodium bicarbonate at 20%-40% w/w. The penetrant composition further includes isopropyl palmitate, benzyl alcohol at 0.5%-20% w/w, propylene glycol at about 1%-5% w/w, and poloxamer 407 at 1%-15% w/w.
The document explains that penetration is expected to be driven by micelle formation, including wormlike micelles when bile salts are present, and that micelle density can correlate with biological outcomes such as pain attenuation. It also describes optional micelle enhancement by milling and discusses formulation aspects including nonionic detergent and polar solvent options and bile-salt variants, including essentially anhydrous variants. The document further discusses optional buffering to a high pH range.
In addition to lactic-acidosis treatment, the document states broad applicability of the penetrant platform to many categories of active agents for topical and transdermal delivery, including local anesthetics, fat-dissolving bile salts, nutrients for lactic acidosis, hair growth modulators, and nail/skin antifungals. It links the platform’s performance to measurable outcomes described in the experimental examples, including effects such as pain attenuation and tissue improvement, and extends to both local and systemic delivery contexts.
Claims Coverage
The relevant material provided includes one independent claim. It contains a core formulation definition (lecithin and sodium bicarbonate in specified ranges) paired with defined transdermal formulation components, directed to a method of treating an individual to impede lactic acidosis.
Transdermal treatment to impede lactic acidosis with sodium bicarbonate
A method for treating an individual to impede lactic acidosis by administering a topical formulation for transdermal delivery of an active agent through the skin, wherein the active agent comprises sodium bicarbonate.
Penetrant formulation with lecithin and sodium bicarbonate ratios
A topical formulation that comprises a penetrant that provides a lecithin at 5%-15% w/w of the formulation and sodium bicarbonate at 20%-40% w/w of the formulation.
Specific multi-component penetrant composition
The topical formulation further comprises isopropyl palmitate, benzyl alcohol at 0.5%-20% w/w, propylene glycol at about 1%-5% w/w, and poloxamer 407 at 1%-15% w/w.
Overall, the claim coverage centers on a transdermal topical method to impede lactic acidosis using sodium bicarbonate as the active agent, implemented through a defined penetrant formulation defined by lecithin and sodium bicarbonate content and specific multi-component formulation ingredients.
Stated Advantages
Impedes lactic acidosis.
Documented Applications
Treatment to impede lactic acidosis by administering a topical formulation for transdermal delivery of sodium bicarbonate through the skin of an individual.
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