LIQUID NIMODIPINE COMPOSITIONS
Liquid compositions comprising nimodipine having improved nimodipine concentrations are provided herein. Methods of improving neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms with the liquid compositions of the present invention are also detailed herein.
1 - 15 . (canceled)
16 . A method of improving neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms comprising enterally administering to a patient in need thereof an effective amount a liquid composition comprising:
nimodipine, wherein the nimodipine is present in the liquid composition at a concentration of about 6 mg/mL; and
a solvent system comprising about 50% to about 97% (w/v) polyethylene glycol (PEG), and about 1% to about 15% (w/v) water, and
optionally about 1% to about 50% (w/v) glycerin,
wherein about 10% or less nimodipine degradation is observed over a period of at least three months when exposed to 25° C. and 60% relative humidity.
17 . The method of claim 16 , wherein the composition is administered orally, via nasogastric tube or via gastric tube.
18 . The method of claim 16 , wherein a first unit dose of the composition is administered to the patient within about 100 hours of the subarachnoid hemorrhage.
19 . The method of claim 16 , wherein the duration of treatment is continued for at least 7 days.
20 . The method of claim 16 , wherein the duration of treatment is continued for at least 14 days.
21 . The method of claim 16 , wherein the composition is administered about every four hours.
22 . The method of claim 16 , wherein the composition is administered multiple times per day.
23 . The method of claim 16 , wherein nimodipine is present in an amount about 10 mg to about 100 mg per dosage unit.
24 . The method of claim 23 , wherein nimodipine is present in an amount of about 60 mg per dosage unit.
25 . The method of claim 23 , wherein nimodipine is present in an amount of about 30 mg per dosage unit
26 . The method of claim 16 , wherein the polyethylene glycol is PEG 300, PEG 400, or a mixture thereof.
27 . The method of claim 16 , wherein the solvent system comprises about 50% to about 75% (w/v) PEG.
28 . The method of claim 16 , wherein the solvent system comprises about 65% to about 97% (w/v) PEG.
29 . The method of claim 16 , wherein the solvent system comprises about 1% to about 10% (w/v) water.
30 . The method of claim 16 , wherein the solvent system comprises about 40% to about 50% (w/v) glycerin.
31 . The method of claim 16 , wherein the solvent system further comprises an alcohol that is ethanol, benzyl alcohol, or a combination thereof.
32 . The method of claim 16 , wherein the liquid composition further comprises one or more preservatives.
33 . The method of claim 32 , wherein the one or more preservatives is a paraben preservative.
34 . The method of claim 33 , wherein the paraben preservative is methylparaben, propylparaben, ethylparaben, butylparaben, isobutylparaben, isopropylparaben, benzylparaben, or any combination thereof.
35 . The method of claim 16 , wherein the liquid composition comprises about 10% or less nimodipine degradation is observed over a period of at least six months when exposed to 25° C. and 60% relative humidity.