Therapeutic Salt Compositions and Methods
OwnerMark P. Rubino, Gyorgy F. Ambrusinventors
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Abstract
Therapeutic salt compositions and methods are disclosed herein.
Claims21
A method of converting a carboxylic acid to a salt comprising, adding an aqueous solution of a strong base to an aqueous mixture containing said carboxylic acid,
- while maintaining the pH of the said aqueous mixture at no more than about 10,
- wherein said carboxylic acid consists of
A composition consisting of an essentially pure pharmaceutically acceptable salt of
- wherein said composition contains no ethyl hexanoic acid or acetonitrile.
The composition of claim 9 consisting essentially of pure
A dosage form prepared by a process comprising reacting a carboxylic acid form of a therapeutically active agent with an aqueous solution of a strong base to form the corresponding salt form, wherein the therapeutically active agent is maintained in an aqueous mixture having a pH which is no more than about 10;
- and
- combining said salt form with a pharmaceutically acceptable excipient;
- wherein said carboxylic acid form has a formula chosen from
A dosage form comprising a salt form of a therapeutically active agent having a structure chosen from
- wherein said dosage form contains less than 107 parts per million of acetonitrile.
A dosage form comprising a salt form of a therapeutically active agent having a structure chosen from
- wherein said dosage form contains no ethyl hexanoic acid.
The dosage form of claim 17, which contains no acetonitrile.
A dosage form comprising a salt form of a therapeutically active agent having a structure chosen from
- wherein the salt is greater than 96% pure on an anhydrous basis when it is used in the dosage form.
A method of converting a carboxylic acid to a salt comprising, adding an aqueous solution of a strong base to an aqueous mixture containing said carboxylic acid,
- while maintaining the pH of the said aqueous mixture at no more than about 10,
- wherein said carboxylic acid is a prodrug of a proton pump inhibitor having an arylsulfonyl leaving group, wherein said leaving group also has a substituent having a carboxylic acid functional group.
A composition, said composition having a mass of from about 1 kg to about 10,000 kg, wherein said composition consists essentially of
Dependencies are inferred from the claim text.