PHENOBARBITAL SALTS; METHODS OF MAKING; AND METHODS OF USE THEREOF
Disclosed are new phenobarbital salts, methods of preparation, and uses thereof.
1 . A compound which is a crystalline salt of phenobarbital selected from the group consisting of phenobarbital potassium, phenobarbital benzathine, phenobarbital betaine, and corresponding anhydrous forms, hydrates, solvates, or polymorphic forms thereof.
2 . The compound of claim 1 , wherein the salt of phenobarbital is phenobarbital benzathine salt.
3 . The compound of claim 1 , wherein the salt of phenobarbital is phenobarbital betaine salt.
4 . The compound of claim 1 , wherein the salt of phenobarbital is phenobarbital potassium salt.
5 . The compound of claim 1 , wherein the salt of phenobarbital is phenobarbital potassium salt, monohydrate.
6 . Amorphous phenobarbital sodium salt or a corresponding anhydrous form, hydrate, or solvate thereof
7 . A method of preparing a crystalline salt of phenobarbital, comprising:
crystallizing or precipitating a phenobarbital salt from a solution of phenobarbital, a counterion source, and a solvent;
wherein the crystalline salt of phenobarbital is selected from the group consisting of phenobarbital potassium, phenobarbital benzathine, phenobarbital betaine, and corresponding anhydrous forms, hydrates, solvates, or polymorphic forms thereof.
8 . The method of claim 7 , comprising precipitating phenobarbital benzathine from a solution of phenobarbital, benzathine, and tetrahydrofuran by removal of tetrahydrofuran.
9 . The method of claim 7 , comprising
precipitating phenobarbital betaine from a solution of phenobarbital, betaine, and dimethylformamide by removal of dimethylformamide.
10 . The method of claim 7 , comprising
precipitating phenobarbital potassium from a solution of phenobarbital, potassium hydroxide, and isopropanol by removal of isopropanol.
11 . A composition comprising:
a compound which is a crystalline salt of phenobarbital selected from the group consisting of phenobarbital potassium, phenobarbital benzathine, phenobarbital betaine, and corresponding anhydrous forms, hydrates, solvates, or polymorphic forms thereof; and
a pharmaceutically acceptable excipient.
12 . The composition of claim 11 , wherein the composition is an oral or parenteral formulation.
13 . The composition of claim 11 , wherein the composition is an intravenous, transdermal, subcutaneous, subcutaneous depot, or intramuscular formulation.
14 . A method of treating, comprising:
administering to a patient in need of phenobarbital therapy the compound of claim 1 .
15 . A method of treating, comprising:
administering to a patient in need of phenobarbital therapy the composition of claim 11 .
16 . The method of claim 14 , wherein the administering is to treat or control seizures, grand mal seizures, complex or simple partial seizures in adults and children, generalized tonic-clonic seizures, myclonic seizures and neonatal seizures, febrile seizures, status epilepticus; short-term treatment of anxiety; or short-term treatment of insomnia.
17 . The method of claim 15 , wherein the administering is to treat or control seizures, grand mal seizures, complex or simple partial seizures in adults and children, generalized tonic-clonic seizures, myclonic seizures and neonatal seizures, status epilepticus; short-term treatment of anxiety; or short-term treatment of insomnia.