Back to results
US 2023/0398098 A1Published application
Topical detomidine formulations
AssigneeClexio Biosciences Ltd.
InventorsMark ZAMANSKY, Anton FRENKEL
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to a purified detomidine HCl pharmaceutical product and to methods of preparation, validation of pharmaceutically acceptable product and use thereof.
Claims20
A method for providing prolonged, non-systemic treatment of a condition in a human subject in need thereof, comprising
- topically administering to the skin of the human subject a formulation comprising
- detomidine or a salt thereof in an amount of about 0.001 to about 3 wt %, based on the weight of the formulation, and
- a carrier that is suitable for topical administration to human skin,
- wherein the carrier optionally comprises a water-miscible solubilizer that is present in an amount of 0.1 to 40 wt %, based on the weight of the formulation,
- wherein the formulation has a pH of 4.5 to 9, and,
- wherein the formulation comprises less than about 1 wt % of 3-((1H-Imidazol-4-yl)methyl)-2-methylbenzaldehyde at least 6 months after its manufacture.
3 more elements
A method for providing prolonged, non-systemic treatment of a condition in a human subject in need thereof, comprising
- topically administering to the skin of the human subject a pharmaceutical formulation comprising
- detomidine or a salt thereof in an amount of about 0.001 to about 3 wt %, based on the weight of the formulation, and
- a carrier that is suitable for topical administration to human skin,
- wherein the carrier optionally comprises a water-miscible solubilizer that is present in an amount of 0.1 to 40 wt %, based on the weight of the formulation,
- wherein the formulation has a pH of 4.5 to 9, and,
- wherein the formulation is substantially free of 3-((1H-Imidazol-4-yl)methyl)-2-methylbenzaldehyde.
3 more elements
A method for providing prolonged, non-systemic treatment of a condition in a human subject in need thereof, comprising
- topically administering to the skin of the human subject a pharmaceutical formulation comprising
- detomidine or a salt thereof in an amount of about 0.001 to about 3 wt %, based on the weight of the formulation, and
- a carrier that is suitable for topical administration to human skin,
- wherein the carrier optionally comprises a water-miscible solubilizer that is present in an amount of 0.1 to 40 wt %, based on the weight of the formulation,
- wherein the formulation has a pH of 4.5 to 9, and,
- wherein the topical formulation comprises less than 4% of the total detomidine content as crystalline detomidine base.
3 more elements
Dependencies are inferred from the claim text.