Methods of preparing pharmaceutical compositions comprising eslicarbazepine acetate and methods of use

Abstract

The present disclosure relates to the treatment of various diseases and conditions with eslicarbazepine acetate. The present disclosure also relates to the use of eslicarbazepine acetate in a method for reducing or decreasing epileptic seizures in a patient. The present disclosure also relates to a method for increasing the exposure to eslicarbazepine in a patient. The present disclosure also relates to a method of preparing a pharmaceutical composition comprising eslicarbazepine acetate.

1 - 29 . (canceled) 
     
     
         30 . A method for treating at least one condition or disease in a patient in need thereof, comprising:
 administering to the patient a once-daily dose of a pharmaceutical composition comprising eslicarbazepine acetate in a pharmacologically effective amount,   wherein the at least one condition or disease is chosen from epilepsy, bipolar disorders, neuropathic pain, and neuropathic pain-related disorders.   
     
     
         31 . The method according to  claim 30 , wherein the once-daily dose is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine greater than about 7,400 ng/mL. 
     
     
         32 . The method according to  claim 31 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 12,000 ng/mL. 
     
     
         33 . The method according to  claim 30 , wherein the once-daily dose is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine greater than about 111,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         34 . The method according to  claim 33 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 140,000 ng·h/mL. 
     
     
         35 . The method according to  claim 30 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate. 
     
     
         36 . The method according to  claim 35 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 800 mg to about 2400 mg. 
     
     
         37 . The method according to  claim 30 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         38 . The method according to  claim 30 , wherein the condition or disease is epilepsy. 
     
     
         39 . The method according to  claim 38 , wherein the once-daily dose of the pharmaceutical composition comprising eslicarbazepine acetate is administered concomitantly with at least one other anti-epileptic drug. 
     
     
         40 . The method according to  claim 39 , where the concentration of the at least one other anti-epileptic drug is not significantly decreased by the once-daily dose of the pharmaceutical composition comprising eslicarbazepine acetate. 
     
     
         41 . The method according to  claim 39 , wherein the at least one other anti-epileptic drug is chosen from valproate, lamotrigine, topiramate, and combinations thereof. 
     
     
         42 . The method according to  claim 30 , wherein the condition or disease is chosen from refractory partial epilepsy, diabetic neuropathic pain, post-herpetic neuralgia, and migraine. 
     
     
         43 . The method according to  claim 30 , wherein the pharmaceutical composition is administered in the form of a tablet or an oral suspension. 
     
     
         44 . A method for reducing epileptic seizures in a patient, comprising:
 administering to the patient a once-daily dose of a pharmaceutical composition comprising eslicarbazepine acetate in a pharmacologically effective amount.   
     
     
         45 . The method according to  claim 44 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         46 . The method according to  claim 44 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate. 
     
     
         47 . The method according to  claim 44 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 800 mg to about 2400 mg. 
     
     
         48 . A method for increasing the exposure to eslicarbazepine in a patient, comprising:
 administering to the patient a once-daily dose of a pharmaceutical composition comprising eslicarbazepine acetate.   
     
     
         49 . The method according to  claim 48 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         50 . The method according to  claim 48 , wherein the once-daily dose is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine greater than about 7,400 ng/mL. 
     
     
         51 . The method according to  claim 48 , wherein the once-daily dose is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine greater than about 111,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         52 . The method according to  claim 48 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate. 
     
     
         53 . The method according to  claim 52 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 800 mg to about 2400 mg. 
     
     
         54 . The method according to  claim 48 , wherein the patient is suffering from at least one condition or disease chosen from epilepsy, bipolar disorders, neuropathic pain, and neuropathic pain-related disorders. 
     
     
         55 . The method according to  claim 54 , wherein the condition or disease is chosen from refractory partial epilepsy, diabetic neuropathic pain, post-herpetic neuralgia, and migraine. 
     
     
         56 . A method of preparing a once-daily pharmaceutical composition comprising:
 combining an amount of eslicarbazepine acetate effective for treating at least one condition or disease in a patient in need thereof, with at least one pharmaceutically acceptable excipient, auxiliary substance, carrier material, or combination thereof,   wherein the at least one condition or disease is chosen from epilepsy, bipolar, neuropathic pain, and neuropathic pain-related disorders.   
     
     
         57 . The method according to  claim 56 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         58 . The method according to  claim 56 , wherein the pharmaceutical composition is administered in a form chosen from tablet form and oral suspension form. 
     
     
         59 . A method for treating at least one condition or disease in a patient in need thereof, comprising:
 administering to the patient a pharmaceutical composition comprising eslicarbazepine acetate in a pharmacologically effective amount,   wherein the at least one condition or disease is chosen from bipolar disorders, neuropathic pain, and neuropathic pain-related disorders.   
     
     
         60 . The method according to  claim 59 , wherein the pharmaceutical composition is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine greater than about 7,400 ng/mL. 
     
     
         61 . The method according to  claim 60 , wherein the pharmaceutical composition is administered in an amount resulting in a C max  of eslicarbazepine greater than about 12,000 ng/mL. 
     
     
         62 . The method according to  claim 59 , wherein the pharmaceutical composition is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine greater than about 111,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         63 . The method according to  claim 62 , wherein the pharmaceutical composition is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 140,000 ng·h/mL. 
     
     
         64 . The method according to  claim 59 , wherein the pharmaceutical composition is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate. 
     
     
         65 . The method according to  claim 64 , wherein the pharmaceutical composition is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 800 mg to about 2400 mg. 
     
     
         66 . The method according to  claim 59 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         67 . The method according to  claim 59 , wherein the condition or disease is chosen from diabetic neuropathic pain, post-herpetic neuralgia, and migraine. 
     
     
         68 . The method according to  claim 59 , wherein the pharmaceutical composition is administered in the form of a tablet or an oral suspension. 
     
     
         69 . A method of preparing a pharmaceutical composition comprising:
 combining an amount of eslicarbazepine acetate effective for treating at least one condition or disease in a patient in need thereof, with at least one pharmaceutically acceptable excipient, auxiliary substance, carrier material, or combination thereof,   wherein the at least one condition or disease is chosen from bipolar disorders, neuropathic pain, and neuropathic pain-related disorders.   
     
     
         70 . The method according to  claim 69 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         71 . The method according to  claim 69 , wherein the pharmaceutical composition is administered in a form chosen from tablet form and oral suspension form.