Baclofen formulations and methods for making same

An injectable baclofen solution comprising:

• baclofen in a concentration greater than 2 mg/mL;
• sulfate or phosphate in a concentration of from 5 mM to 25 mM;
• and
• NaCl and/or KCl;
• wherein:
• the solution has a pH between about 5.0 and 7.0;
• a combined ionic strength of the solution is equivalent to the ionic strength of from about 0.1 M to 0.2 M NaCl or KCl;
• and
• the solution is configured to comprise less than 1.3% of 4-(4-chlorophenyl)-2-pyrrolidinone (4-CPP) based on an initial concentration of baclofen after at least 30 days of storage at room temperature.

An injectable baclofen solution comprising:

• baclofen in a concentration greater than 2 mg/mL;
• and
• sulfate or phosphate in a concentration of from 5 mM to 25 mM;
• wherein:
• the solution has a pH between about 5.0 and 7.0;
• a combined ionic strength of the solution is equivalent to the ionic strength of from about 0.1 M to 0.2 M NaCl or KCl;
• and
• the solution is configured to comprise less than 1.3% of 4-(4-chlorophenyl)-2-pyrrolidinone (4-CPP) based on an initial concentration of baclofen after at least 30 days of storage at room temperature.