Ready to use non-aqueous solutions of lamotrigine
Disclosed are ready to use non-aqueous solutions of lamotrigine. The lamotrigine is dissolved in a solvent, wherein the solvent comprises propylene glycol and optionally at least one co-solvent, and wherein if water is present in the ready to use non-aqueous solution, the water is not at least one co-solvent. Also disclosed are methods for treating a neurological disorder or a mental disorder by administering the ready to use non-aqueous solutions of lamotrigine, processes for preparing ready to use non-aqueous solutions of lamotrigine, and kits containing lamotrigine to prepare ready to use non-aqueous solutions of lamotrigine.
1 . A ready to use solution, comprising lamotrigine dissolved in a solvent,
wherein the solvent comprises propylene glycol and at least one co-solvent comprising glycerin,
wherein the ready to use solution has a water content of equal to or less than about 20% w/w of the ready to use solution, and
wherein water is not the at least one co-solvent.
2 . The ready to use solution of claim 1 , wherein a concentration of lamotrigine in the ready to use solution is about 0.01 mg/mL to about 40 mg/mL.
3 . The ready to use solution of claim 1 , wherein a concentration of lamotrigine in the ready to use solution is about 20 mg/mL.
4 . The ready to use solution of claim 1 , wherein the water content is equal to or less than about 1% w/w of the ready to use solution.
5 . The ready to use solution of claim 1 , wherein the at least one co-solvent further comprises at least one selected from the group consisting of polypropylene glycol, polyethylene glycol, and ethanol.
6 . The ready to use solution of claim 1 , wherein water is not present in the ready to use solution.
7 . The ready to use solution of claim 1 , wherein a weight ratio of propylene glycol to glycerin is 80:20 to 20:80.
8 . The ready to use solution of claim 1 , wherein a propylene glycol content is about 45% to about 87% w/w of the ready to use solution.
9 . The ready to use solution of claim 1 , wherein a glycerin content is about 11% to about 60% w/w of the ready to use solution.
10 . The ready to use solution of claim 1 , wherein a propylene glycol content is about 45% to about 55% w/w of the ready to use solution and a glycerin content is about 45% to about 55% w/w of the ready to use solution.
11 . The ready to use solution of claim 1 , further comprising ethyl maltol.
12 . The ready to use solution of claim 1 , wherein the ready to use solution has a pH meter reading from about 7.5 to about 7.8.
13 . The ready to use solution of claim 1 , wherein the ready to use solution has a viscosity from 200 centipoise to about 300 centipoise.
14 . The ready to use solution of claim 1 , wherein the ready to use solution has a density from about 1.1 g/mL to about 1.2 g/mL.
15 . A ready to use solution, comprising:
about 15 mg/mL to about 25 mg/mL of lamotrigine; and
a solvent, the solvent comprising:
about 45% to about 55% w/w of propylene glycol; and
about 45% to about 55% w/w of glycerin,
wherein the ready to use solution has a water content of equal to or less than about 20% w/w of the ready to use solution, and
wherein water is not the solvent.
16 . The ready to use solution of claim 15 , wherein a concentration of lamotrigine in the ready to use solution is about 20 mg/mL.
17 . A method for treating a disorder, comprising administering orally to a human subject in need thereof a ready to use solution, wherein the ready to use solution includes about 2 mg to about 700 mg of lamotrigine dissolved in a solvent, wherein the solvent comprises propylene glycol and at least one co-solvent comprising glycerin, wherein the ready to use solution has a water content of equal or less than about 20% w/w of the ready to use solution, wherein water is not the at least one co-solvent, and wherein the disorder is epilepsy or bipolar disorder.
18 . The method of claim 17 , wherein the disorder is epilepsy.
19 . The method of claim 17 , wherein the disorder is bipolar disorder.
20 . The method of claim 18 , wherein the epilepsy disorder includes partial seizures, tonic-clonic seizures, and/or seizures of Lennox-Gastaut syndrome.
21 . The method of claim 19 , wherein the bipolar disorder is a bipolar I disorder.
22 . The method of claim 17 , comprising administering about 2 mg to about 500 mg of lamotrigine.
23 . The method of claim 17 , wherein the administering results in a C max value from about 800 ng/ml to about 1,000 ng/ml of lamotrigine in the subject.
24 . The method of claim 17 , wherein the administering results in an AUC value from about 35,000 ng/mL*hr to about 40,000 ng/mL*hr of lamotrigine in the subject.
25 . The method of claim 21 , wherein the therapeutically effective amount is administered after fasting.
26 . The method of claim 21 , wherein the therapeutically effective amount is administered after a meal.
27 . The method of claim 17 , wherein a concentration of lamotrigine in the ready to use solution is about 0.01 mg/mL to about 40 mg/mL.
28 . The method of claim 17 , wherein a concentration of lamotrigine in the ready to use solution is about 20 mg/mL.
29 . The method of claim 17 , wherein water is not present in the ready to use solution.
30 . The method of claim 17 , wherein a propylene glycol content is about 45% to about 55% w/w of the ready to use solution and a glycerin content is about 45% to about 55% w/w of the ready to use solution.