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 . 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.    
   
   
       2 . The method according to  claim 1 , 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.  
   
   
       3 . The method according to  claim 2 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 12,000 ng/mL.  
   
   
       4 . The method according to  claim 1 , 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.  
   
   
       5 . The method according to  claim 4 , 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.  
   
   
       6 . The method according to  claim 1 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate.  
   
   
       7 . The method according to  claim 6 , 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.  
   
   
       8 . The method according to  claim 1 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate.  
   
   
       9 . The method according to  claim 1 , wherein the at least one disease or condition is chosen from epilepsy, central and peripheric nervous system disorders, affective disorders, schizoaffective disorders, bipolar disorders, attention disorders, anxiety disorders, neuropathic pain and neurophratic pain-related disorders, sensorimotor disorders, vestibular disorders, and nervous function alterations in degenerative and post-ischemic diseases.  
   
   
       10 . The method according to  claim 9 , wherein the disease is epilepsy.  
   
   
       11 . The method according to  claim 10 , wherein the once-daily dose of the pharmaceutical composition comprising eslicarbazepine acetate is administered concomitantly with at least one other anti-epileptic drug.  
   
   
       12 . The method according to  claim 11 , 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.  
   
   
       13 . The method according to  claim 11 , wherein the at least one other anti-epileptic drug is chosen from valproate, lamotrigine, topiramate, and combinations thereof.  
   
   
       14 . The method according to  claim 1 , wherein the disease is bipolar disorder, refractory partial epilepsy, or trigeminal neuralgia.  
   
   
       15 . 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.    
   
   
       16 . The method according to  claim 15 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate.  
   
   
       17 . The method according to  claim 15 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate.  
   
   
       18 . The method according to  claim 17 , 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.  
   
   
       19 . 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.    
   
   
       20 . The method according to  claim 19 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate.  
   
   
       21 . The method according to  claim 19 , 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.  
   
   
       22 . The method according to  claim 21 , 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.  
   
   
       23 . The method according to  claim 19 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate.  
   
   
       24 . The method according to  claim 23 , 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.  
   
   
       25 . A method of preparing a pharmaceutical composition comprising: 
 combining an amount of eslicarbazepine acetate effective for treating at least one disease or condition 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 disease or condition is chosen from epilepsy, central and peripheric nervous system disorders, affective disorders, schizoaffective disorders, bipolar disorders, attention disorders, anxiety disorders, neuropathic pain and neurophratic pain-related disorders, sensorimotor disorders, vestibular disorders, and nervous function alterations in degenerative and post-ischemic diseases.    
   
   
       26 . The method according to  claim 25 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate.  
   
   
       27 . The method according to  claim 25 , wherein the pharmaceutical composition is administered in a form chosen from tablet form and oral suspension form.  
   
   
       28 . 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 disease and/or condition is chosen from epilepsy, central and peripheric nervous system disorders, affective disorders, schizoaffective disorders, bipolar disorders, attention disorders, anxiety disorders, neuropathic pain and neurophratic pain-related disorders, sensorimotor disorders, vestibular disorders, and nervous function alterations in degenerative and post-ischemic diseases.    
   
   
       29 . 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 sufficient to result in a maximum observed plasma concentration, C max , of eslicarbazepine greater than about 7,400 ng/mL,    wherein the at least one disease and/or condition is chosen from epilepsy, central and peripheric nervous system disorders, affective disorders, schizoaffective disorders, bipolar disorders, attention disorders, anxiety disorders, neuropathic pain and neurophratic pain-related disorders, sensorimotor disorders, vestibular disorders, and nervous function alterations in degenerative and post-ischemic diseases.