US2014288058A1PendingUtilityA1

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

Assignee: BIAL PORTELA & CA SAPriority: May 6, 2005Filed: Feb 21, 2014Published: Sep 25, 2014
Est. expiryMay 6, 2025(expired)· nominal 20-yr term from priority
A61P 25/18A61P 25/00A61P 25/08A61P 25/06A61K 45/06A61K 31/55A61K 31/19
63
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 29 . (canceled) 
     
     
         30 . A method for treating epilepsy 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.   
     
     
         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 110,000 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 240,000 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 once-daily dose of the pharmaceutical composition comprising eslicarbazepine acetate is administered as adjunctive therapy to a patient being treated with at least one other anti-epileptic drug. 
     
     
         39 . The method according to  claim 38 , wherein the serum 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. 
     
     
         40 . The method according to  claim 38 , wherein the at least one other anti-epileptic drug is chosen from valproate, lamotrigine, topiramate, and combinations thereof. 
     
     
         41 . The method according to  claim 30 , wherein the epilepsy is refractory partial epilepsy. 
     
     
         42 . The method according to  claim 30 , wherein the pharmaceutical composition is administered in the form of a tablet or an oral suspension. 
     
     
         43 . 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.   
     
     
         44 . The method according to  claim 43 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         45 . The method according to  claim 43 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate. 
     
     
         46 . The method according to  claim 45 , 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. 
     
     
         47 . 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 up to about 58,800 ng/mL. 
     
     
         48 . The method according to  claim 32 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 22,700 ng/mL. 
     
     
         49 . The method according to  claim 48 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 36,500 ng/mL. 
     
     
         50 . The method according to  claim 49 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 45,200 ng/mL. 
     
     
         51 . 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 up to about 67,800 ng/mL. 
     
     
         52 . 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 up to about 885,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         53 . 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 up to about 1,000,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         54 . The method according to  claim 34 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 375,000 ng·h/mL. 
     
     
         55 . The method according to  claim 54 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 595,000 ng·h/mL. 
     
     
         56 . The method according to  claim 55 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 790,000 ng·h/mL. 
     
     
         57 . The method according to  claim 35 , wherein the once-daily dose is administered in a dosage comprising at least about 800 mg of eslicarbazepine acetate. 
     
     
         58 . The method according to  claim 57 , wherein the once-daily dose is administered in a dosage comprising at least about 1200 mg of eslicarbazepine acetate. 
     
     
         59 . 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 1200 mg. 
     
     
         60 . 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 400 mg to about 1200 mg. 
     
     
         61 . The method according to  claim 42 , wherein the oral suspension comprises at least one excipient, auxiliary substance or carrier material. 
     
     
         62 . The method according to  claim 61 , wherein the at least one excipient, auxiliary substance or carrier material is selected from the group consisting of xanthan gum, macrogol stearate, methylparaben, propylparaben, saccharin sodium, sorbitol, buffers, flavourings and combinations thereof. 
     
     
         63 . The method according to  claim 30 , wherein upon administration of the pharmaceutical composition, the number, duration, or frequency of epileptic seizures in a patient decreases relative to the number, duration or frequency of epileptic seizures in a patient without treatment. 
     
     
         64 . The method according to  claim 30 , wherein the frequency of epileptic seizures is reduced by 50% or more. 
     
     
         65 . The method according to  claim 30 , wherein upon administration of the pharmaceutical composition patients become seizure-free relative to a patient without treatment. 
     
     
         66 . The method according to  claim 30 , wherein the patient is an adult. 
     
     
         67 . The method according to  claim 30 , wherein the patient is aged 18 to 65 years. 
     
     
         68 . The method according to  claim 30 , wherein the pharmaceutical composition is administered orally. 
     
     
         69 . The method according to  claim 43 , 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. 
     
     
         70 . The method according to  claim 69 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 12,000 ng/mL. 
     
     
         71 . The method according to  claim 43 , wherein the once-daily dose is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine up to about 58,800 ng/mL. 
     
     
         72 . The method according to  claim 70 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 22,700 ng/mL. 
     
     
         73 . The method according to  claim 72 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 36,500 ng/mL. 
     
     
         74 . The method according to  claim 73 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 45,200 ng/mL. 
     
     
         75 . The method according to  claim 43 , wherein the once-daily dose is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine up to about 67,800 ng/mL. 
     
     
         76 . The method according to  claim 43 , wherein the once-daily dose is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine up to about 885,000 ng/mL, wherein τ is the dosing interval. 
     
     
         77 . The method according to  claim 43 , wherein the once-daily dose is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine up to about 1,000,000 ng/mL, wherein τ is the dosing interval. 
     
     
         78 . The method according to  claim 43 , 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 110,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         79 . The method according to  claim 78 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 240,000 ng·h/mL. 
     
     
         80 . The method according to  claim 79 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 375,000 ng·h/mL. 
     
     
         81 . The method according to  claim 80 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 595,000 ng·h/mL. 
     
     
         82 . The method according to  claim 81 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 790,000 ng·h/mL. 
     
     
         83 . The method according to  claim 45 , wherein the once-daily dose is administered in a dosage comprising at least about 800 mg of eslicarbazepine acetate. 
     
     
         84 . The method according to  claim 83 , wherein the once-daily dose is administered in a dosage comprising at least about 1200 mg of eslicarbazepine acetate. 
     
     
         85 . The method according to  claim 45 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 800 mg to about 1200 mg. 
     
     
         86 . The method according to  claim 45 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 400 mg to about 1200 mg. 
     
     
         87 . The method according to  claim 43 , wherein the once-daily dose of the pharmaceutical composition comprising eslicarbazepine acetate is administered as adjunctive therapy to a patient being treated with at least one other anti-epileptic drug. 
     
     
         88 . The method according to  claim 87 , where the serum 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. 
     
     
         89 . The method according to  claim 87 , wherein the at least one other anti-epileptic drug is chosen from valproate, lamotrigine, topiramate, and combinations thereof. 
     
     
         90 . The method according to  claim 43 , wherein the pharmaceutical composition is administered in the form of a tablet or an oral suspension. 
     
     
         91 . The method according to  claim 90 , wherein the oral suspension comprises at least one excipient, auxiliary substance or carrier material. 
     
     
         92 . The method according to  claim 91 , wherein the at least one excipient, auxiliary substance or carrier material is selected from the group consisting of xanthan gum, macrogol stearate, methylparaben, propylparaben, saccharin sodium, sorbitol, buffers, flavourings and combinations thereof. 
     
     
         93 . The method according to  claim 43 , wherein the epilepsy is refractory partial epilepsy. 
     
     
         94 . The method according to  claim 43 , wherein upon administration of the pharmaceutical composition, the number, duration, or frequency of epileptic seizures in a patient decreases relative to the number, duration or frequency of epileptic seizures in a patient without treatment. 
     
     
         95 . The method according to  claim 43 , wherein the reduction in frequency of epileptic seizures is 50% or more. 
     
     
         96 . The method according to  claim 43 , wherein upon administration of the pharmaceutical composition patients become seizure-free relative to a patient without treatment. 
     
     
         97 . The method according to  claim 43 , wherein the patient is an adult. 
     
     
         98 . The method according to  claim 43 , wherein the patient is aged 18 to 65 years. 
     
     
         99 . The method according to  claim 43 , wherein the pharmaceutical composition is administered orally. 
     
     
         100 . A pharmaceutical composition comprising eslicarbazepine acetate in a pharmacologically effective amount for use in treating epilepsy in a patient in need thereof in a once-daily dose. 
     
     
         101 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine greater than about 7,400 ng/ml. 
     
     
         102 . The pharmaceutical composition according to  claim 101 , wherein the composition is in a form for administration in an amount resulting in a C max  of eslicarbazepine greater than about 12,000 ng/ml. 
     
     
         103 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in a maximum observed plasma concentration, C max  of eslicarbazepine up to about 58,800 ng/mL. 
     
     
         104 . The pharmaceutical composition according to  claim 102 , wherein the composition is in a form for administration in an amount resulting in a C max  of eslicarbazepine greater than about 22,700 ng/mL. 
     
     
         105 . The pharmaceutical composition according to  claim 104 , wherein the composition is in a form for administration in an amount resulting in a C max  of eslicarbazepine greater than about 36,500 ng/mL. 
     
     
         106 . The pharmaceutical composition according to  claim 105 , wherein the composition is in a form for administration in an amount resulting in a C max  of eslicarbazepine greater than about 45,200 ng/mL. 
     
     
         107 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in a maximum observed plasma concentration, C max  of eslicarbazepine up to about 67,800 ng/mL. 
     
     
         108 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine up to about 885,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         109 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine up to about 1,000,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         110 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine greater than about 110,000 ng·h/ml, wherein τ is the dosing interval. 
     
     
         111 . The pharmaceutical composition according to  claim 110 , wherein the composition is in a form for administration in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 240,000 ng·h/ml. 
     
     
         112 . The pharmaceutical composition according to  claim 111 , wherein the composition is in a form for administration in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 375,000 ng·h/ml. 
     
     
         113 . The pharmaceutical composition according to  claim 112 , wherein the composition is in a form for administration in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 595,000 ng·h/ml. 
     
     
         114 . The pharmaceutical composition according to  claim 113 , wherein the composition is in a form for administration in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 790,000 ng·h/ml. 
     
     
         115 . The pharmaceutical composition according to  claim 100 , wherein the composition comprises at least about 400 mg of eslicarbazepine acetate. 
     
     
         116 . The pharmaceutical composition according to  claim 115 , wherein the composition comprises at least about 800 mg of eslicarbazepine acetate. 
     
     
         117 . The pharmaceutical composition according to  claim 116 , wherein the composition comprises at least about 1200 mg of eslicarbazepine acetate. 
     
     
         118 . The pharmaceutical composition according to  claim 115 , wherein the composition comprises an amount of eslicarbazepine acetate ranging from about 800 mg to about 2400 mg. 
     
     
         119 . The pharmaceutical composition according to  claim 115 , wherein the composition comprises an amount of eslicarbazepine acetate ranging from about 800 mg to about 1200 mg. 
     
     
         120 . The pharmaceutical composition according to  claim 115 , wherein the composition comprises an amount of eslicarbazepine acetate ranging from about 400 mg to about 1200 mg. 
     
     
         121 . The pharmaceutical composition according to  claim 100 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         122 . The pharmaceutical composition according to  claim 100 , wherein the composition comprising eslicarbazepine acetate is administered as adjunctive therapy to a patient being treated with at least one other anti-epileptic drug. 
     
     
         123 . The pharmaceutical composition according to  claim 122 , where the serum 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. 
     
     
         124 . The pharmaceutical composition according to  claim 122 , wherein the at least one other anti-epileptic drug is chosen from valproate, lamotrigine, topiramate, and combinations thereof. 
     
     
         125 . The pharmaceutical composition according to  claim 100 , wherein the pharmaceutical composition is in the form of a tablet or an oral suspension. 
     
     
         126 . The pharmaceutical composition according to  claim 125 , wherein the oral suspension comprises at least one excipient, auxiliary substance or carrier material. 
     
     
         127 . The pharmaceutical composition according to  claim 126 , wherein the at least one excipient, auxiliary substance or carrier material is selected from the group consisting of xanthan gum, macrogol stearate, methylparaben, propylparaben, saccharin sodium, sorbitol, buffers, flavourings and combinations thereof. 
     
     
         128 . The pharmaceutical composition according to  claim 100 , wherein the epilepsy is refractory partial epilepsy. 
     
     
         129 . The pharmaceutical composition according to  claim 100 , wherein upon administration of the pharmaceutical composition, the number, duration, or frequency of epileptic seizures in a patient decreases relative to the number, duration or frequency of epileptic seizures in a patient without treatment. 
     
     
         130 . The pharmaceutical composition according to  claim 100 , wherein upon administration of the pharmaceutical composition, the frequency of epileptic seizures is reduced by 50% or more. 
     
     
         131 . The pharmaceutical composition according to  claim 100 , wherein upon administration of the pharmaceutical composition patients become seizure-free relative to a patient without treatment. 
     
     
         132 . The pharmaceutical composition according to  claim 100 , wherein the patient is an adult. 
     
     
         133 . The pharmaceutical composition according to  claim 100 , wherein the patient is aged 18 to 65 years. 
     
     
         134 . The pharmaceutical composition according to  claim 100 , wherein the pharmaceutical composition is administered orally. 
     
     
         135 . A method for treating a patient with partial-onset seizures, comprising:
 administering to the patient a once-daily dose of a pharmaceutical composition comprising eslicarbazepine acetate in a pharmacologically effective amount.   
     
     
         136 . The method according to  claim 135 , 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. 
     
     
         137 . The method according to  claim 136 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 12,000 ng/mL. 
     
     
         138 . The method according to  claim 135 , wherein the once-daily dose is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine up to about 58,800 ng/mL. 
     
     
         139 . The method according to  claim 137 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 22,700 ng/mL. 
     
     
         140 . The method according to  claim 139 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 36,500 ng/mL. 
     
     
         141 . The method according to  claim 140 , wherein the once-daily dose is administered in an amount resulting in a C max  of eslicarbazepine greater than about 45,200 ng/mL. 
     
     
         142 . The method according to  claim 135 , wherein the once-daily dose is administered in an amount resulting in a maximum observed plasma concentration, C max , of eslicarbazepine up to about 67,800 ng/mL. 
     
     
         143 . The method according to  claim 135 , wherein the once-daily dose is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine up to about 885,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         144 . The method according to  claim 135 , wherein the once-daily dose is administered in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine up to about 1,000,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         145 . The method according to  claim 135 , 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 110,000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         146 . The method according to  claim 145 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 240,000 ng·h/mL. 
     
     
         147 . The method according to  claim 146 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 375,000 ng·h/mL. 
     
     
         148 . The method according to  claim 147 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 595,000 ng·h/mL. 
     
     
         149 . The method according to  claim 148 , wherein the once-daily dose is administered in an amount resulting in a AUC 0-τ  of eslicarbazepine greater than about 790,000 ng·h/mL. 
     
     
         150 . The method according to  claim 135 , wherein the once-daily dose is administered in a dosage comprising at least about 400 mg of eslicarbazepine acetate. 
     
     
         151 . The method according to  claim 150 , wherein the once-daily dose is administered in a dosage comprising at least about 800 mg of eslicarbazepine acetate. 
     
     
         152 . The method according to  claim 151 , wherein the once-daily dose is administered in a dosage comprising at least about 1200 mg of eslicarbazepine acetate. 
     
     
         153 . The method according to  claim 150 , 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. 
     
     
         154 . The method according to  claim 150 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 800 mg to about 1200 mg. 
     
     
         155 . The method according to  claim 150 , wherein the once-daily dose is administered in a dosage comprising an amount of eslicarbazepine acetate ranging from about 400 mg to about 1200 mg. 
     
     
         156 . The method according to  claim 135 , wherein the active ingredient in the pharmaceutical composition consists essentially of eslicarbazepine acetate. 
     
     
         157 . The method according to  claim 135 , wherein the once-daily dose of the pharmaceutical composition comprising eslicarbazepine acetate is administered as adjunctive therapy to a patient being treated with at least one other anti-epileptic drug. 
     
     
         158 . The method according to  claim 157 , where the serum 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. 
     
     
         159 . The method according to  claim 157 , wherein the at least one other anti-epileptic drug is chosen from valproate, lamotrigine, topiramate, and combinations thereof. 
     
     
         160 . The method according to  claim 135 , wherein the pharmaceutical composition is administered in the form of a tablet or an oral suspension. 
     
     
         161 . The method according to  claim 160 , wherein the oral suspension comprises at least one excipient, auxiliary substance or carrier material. 
     
     
         162 . The method according to  claim 161 , wherein the at least one excipient, auxiliary substance or carrier material is selected from the group consisting of xanthan gum, macrogol stearate, methylparaben, propylparaben, saccharin sodium, sorbitol, buffers, flavourings and combinations thereof. 
     
     
         163 . The method according to  claim 135 , wherein upon administration of the pharmaceutical composition, the number, duration, or frequency of seizures in a patient decreases relative to the number, duration or frequency of seizures in a patient without treatment. 
     
     
         164 . The method according to  claim 135 , wherein the frequency of seizures is reduced by 50% or more. 
     
     
         165 . The method according to  claim 135 , wherein upon administration of the pharmaceutical composition patients become seizure-free relative to a patient without treatment. 
     
     
         166 . The method according to  claim 135 , wherein the patient is an adult. 
     
     
         167 . The method according to  claim 135 , wherein the patient is aged 18 to 65 years. 
     
     
         168 . The method according to  claim 135 , wherein the pharmaceutical composition is administered orally. 
     
     
         169 . The method according to  claim 30 , wherein the once-daily dose is administered in a dosage comprising about 200 mg of eslicarbazepine acetate. 
     
     
         170 . The method according to  claim 43 , wherein the once-daily dose is administered in a dosage comprising about 200 mg of eslicarbazepine acetate. 
     
     
         171 . The pharmaceutical composition according to  claim 100 , wherein the composition comprises about 200 mg of eslicarbazepine acetate. 
     
     
         172 . The method according to  claim 135 , wherein the once-daily dose is administered in a dosage comprising about 200 mg of eslicarbazepine acetate. 
     
     
         173 . The method according to  claim 30 , wherein the once-daily dose is administered in a dosage comprising about 400 mg of eslicarbazepine acetate. 
     
     
         174 . The method according to  claim 43 , wherein the once-daily dose is administered in a dosage comprising about 400 mg of eslicarbazepine acetate. 
     
     
         175 . The pharmaceutical composition according to  claim 100 , wherein the composition comprises about 400 mg eslicarbazepine acetate. 
     
     
         176 . The method according to  claim 135 , wherein the once-daily dose is administered in a dosage comprising about 400 mg of eslicarbazepine acetate. 
     
     
         177 . The method according to  claim 30 , wherein the once-daily dose is administered in a dosage comprising about 600 mg of eslicarbazepine acetate. 
     
     
         178 . The method according to  claim 43 , wherein the once-daily dose is administered in a dosage comprising about 600 mg of eslicarbazepine acetate. 
     
     
         179 . The pharmaceutical composition according to  claim 100 , wherein the composition comprises about 600 mg eslicarbazepine acetate. 
     
     
         180 . The method according to  claim 135 , wherein the once-daily dose is administered in a dosage comprising about 600 mg of eslicarbazepine acetate. 
     
     
         181 . The method according to  claim 30 , wherein the once-daily dose is administered in a dosage comprising about 800 mg of eslicarbazepine acetate. 
     
     
         182 . The method according to  claim 43 , wherein the once-daily dose is administered in a dosage comprising about 800 mg of eslicarbazepine acetate. 
     
     
         183 . The pharmaceutical composition according to  claim 100 , wherein the composition comprises about 800 mg eslicarbazepine acetate. 
     
     
         184 . The method according to  claim 135 , wherein the once-daily dose is administered in a dosage comprising about 800 mg of eslicarbazepine acetate. 
     
     
         185 . The method according to  claim 30 , wherein the once-daily dose is administered in a dosage comprising about 1200 mg of eslicarbazepine acetate. 
     
     
         186 . The method according to  claim 43 , wherein the once-daily dose is administered in a dosage comprising about 1200 mg of eslicarbazepine acetate. 
     
     
         187 . The pharmaceutical composition according to  claim 100 , wherein the composition comprises about 1200 mg eslicarbazepine acetate. 
     
     
         189 . The method according to  claim 135 , wherein the once-daily dose is administered in a dosage comprising about 1200 mg of eslicarbazepine acetate. 
     
     
         190 . The method according to  claim 30 , wherein the once-daily dose is administered in an initial dosage comprising about 400 mg of eslicarbazepine acetate and increased at weekly intervals to a dosage of about 800 mg. 
     
     
         191 . The method according to  claim 190 , wherein the once-daily dose is further increased at weekly intervals to a dosage of about 1200 mg. 
     
     
         192 . The method according to  claim 43 , wherein the once-daily dose is administered in an initial dosage comprising about 400 mg of eslicarbazepine acetate and increased at weekly intervals to a dosage of about 800 mg. 
     
     
         193 . The method according to  claim 192 , wherein the once-daily dose is further increased at weekly intervals to a dosage of about 1200 mg. 
     
     
         194 . The method according to  claim 135 , wherein the once-daily dose is administered in an initial dosage comprising about 400 mg of eslicarbazepine acetate and increased at weekly intervals to a dosage of about 800 mg. 
     
     
         195 . The method according to  claim 194 , wherein the once-daily dose is further increased at weekly intervals to a dosage of about 1200 mg. 
     
     
         196 . The method according to according to  claim 30 , wherein the once-daily dose is administered in an amount resulting in a maximum plasma concentration, C max , of eslicarbazepine greater than about 22,700 ng/mL and up to about 36,500 ng/mL. 
     
     
         197 . The method according to  claim 43 , wherein the once-daily dose is administered in an amount resulting in a maximum plasma concentration, C max , of eslicarbazepine greater than about 22,700 ng/mL and up to about 36,500 ng/mL. 
     
     
         198 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in a maximum plasma concentration, C max , of eslicarbazepine greater than about 22,700 ng/mL and up to about 36,500 ng/mL. 
     
     
         199 . The method according to  claim 135  wherein the once-daily dose is administered in an amount resulting in a maximum plasma concentration, C max , of eslicarbazepine greater than about 22,700 ng/mL and up to about 36,500 ng/mL. 
     
     
         200 . The method according to 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 375,000 ng·h/mL and up to about 595,000 000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         201 . The method according to  claim 43 , 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 375,000 ng·h/mL and up to about 595,000 000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         202 . The pharmaceutical composition according to  claim 100 , wherein the composition is in a form for administration in an amount resulting in an area under the concentration curve, AUC 0-τ , of eslicarbazepine greater than about 375,000 ng·h/mL and up to about 595,000 000 ng·h/mL, wherein τ is the dosing interval. 
     
     
         203 . The method according to  claim 135 , 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 375,000 ng·h/mL and up to about 595,000 000 ng·h/mL, wherein τ is the dosing interval.

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