Soluble pharmaceutical compositions comprising salts of disubstituted 1, 2, 4-triazine compound
AssigneesMineralys Therapeutics, Inc., Tanabe Pharma Corporation
InventorsRobert McKean, Roch Thibert, Elizabeth Vadas, Yoshinori Ohashi, Fuminori Ozaki, Hiroki Ohshima, Hiroomi Nagata
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Abstract
Disclosed are pharmaceutical compositions comprising a salt of a compound having the formula: and one or more excipients, wherein the pharmaceutical composition avoids inducing disproportionation of the salt of the compound.
Claims21
A pharmaceutical composition comprising a halogen anion salt of a compound having the formula:
- and one or more excipients, wherein the one or more excipients do not comprise a metal salt, and wherein the pharmaceutical composition avoids inducing disproportionation of the halogen anion salt of the compound.
A pharmaceutical composition comprising a halogen anion salt of a compound having the formula:
- and one or more excipients, wherein the one or more excipients do not comprise a metal salt, and wherein the pharmaceutical composition has a dissolution profile such that more than 70% of the compound is dissolved in 15 minutes in an in vitro dissolution test of the pharmaceutical composition using USP Apparatus 2 Paddle Method at 50 rpm in a dissolution medium of water at 37° C.
A process for making a pharmaceutical composition comprising a halogen anion salt of a compound having the formula:
- and one or more excipients, wherein the one or more excipients do not comprise a metal salt, wherein the pharmaceutical composition avoids inducing disproportionation of the halogen anion salt of the compound and/or the pharmaceutical composition has a dissolution profile such that more than 70% of the compound is dissolved in 15 minutes in an in vitro dissolution test of the pharmaceutical composition using USP Apparatus 2 Paddle Method at 50 rpm in a dissolution medium of water at 37° C., comprising:
- a) obtaining a halogen anion salt of a compound having the formula:
- and
- b) mixing the salt with the one or more excipients to thereby produce the pharmaceutical composition.
Dependencies are inferred from the claim text.