Topical formulations for the treatment of depression with S adenosyl methionine
AssigneeJames L. Schaller, P.A.
InventorsJames Schaller, Ben Briggs
Life of this patent
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Abstract
Disclosed herein are topical formulations for treating depression with S adenosyl methionine (SAM-e) The topical formulations contain at least 35% wt/wt of SAM-e partially dissolved in aqueous and lipophilic phases of an emulsion and the emulsion is stable from separation of phases for a period of at least 30 days despite the high concentration of SAM-e. Also provided are methods for making such compositions and methods of treating depression using the same.
Claims23
A composition for treating depression of a subject, comprising a base emulsion that includes a lipophilic component and an aqueous component;
- S-adenosyl methionine at least partially dissolved in the base and present in an amount of at least 35% wt/wt of the composition;
- a pH adjusting component to bring the pH of the composition between 6.5 and 7.5;
- and
- the composition being formulated to be stable against separation of the emulsion for a period of at least 30 days when stored at room temperature.
A composition for treating depression of a subject, comprising a base emulsion that includes a 15%-45% wt/wt of a lipophilic component and 55%-85% wt/wt of an aqueous component;
- S-adenosyl methionine present in a total amount of at least 35% wt/wt of the composition;
- a buffering agent to maintain the pH of the composition between about 6.5 and about 7.5;
- and
- the composition being formulated to be stable against separation of the emulsion for a period of at least 30 days when stored at room temperature.
A composition for treating depression of a subject, comprising a base emulsion that includes a lipophilic component and an aqueous component;
- S-adenosyl methionine partially dissolved in a first portion of the lipophilic component, partly dissolved in a first portion of the aqueous component, partly encapsulated in micelles comprising a second portion of the lipid component surrounding a second portion of the aqueous component and present in a total amount of at least 35% wt/wt of the composition;
- a pH adjusting component to bring the pH of the composition between 6.5 and 7.5;
- and
- the composition being formulated to be stable against separation of the emulsion for a period of at least 30 days when stored at room temperature.
A method of making a composition for treatment of depression by topical administration of SAM-e comprising;
- mixing a weight of SAM-e calculated to be at least 35% wt/wt of the final composition into a base emulsion comprising 15%-45% wt/wt of a lipophilic component and 55%-85% wt/wt of an aqueous component, to form a paste comprising partially dissolved and partially suspended SAM-e milling the paste until the partially suspended SAM-e is not detectable in the paste by unaided visual inspection;
- diluting the milled paste with a diluent, wherein the base and diluent are selected to provide an emulsion that is stable from separation when stored for at least 30 days at room temperature.
Dependencies are inferred from the claim text.