Extended-release topiramate capsules
DCFirst Claim
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1. A method of dosing a subject for the treatment of convulsions, the method comprising:
- administering an extended-release topiramate capsule once daily to the subject, wherein the extended-release topiramate capsule comprises;
a capsule shell comprising a single population of coated particles;
wherein each coated particle comprises a core and a coating thereon;
wherein each particle core comprises a homogeneous mixture comprising topiramate throughout its core; and
wherein the coating comprises one or more release controlling agent(s);
wherein the extended-release topiramate capsule, when given as a single-dose to a healthy human subject, achieves an AUC0-inf of 170 to 210 h⋅
μ
g/mL within a 95% confidence interval, and a Cmax of 2 to 4 μ
g/mL within a 95% confidence interval.
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Abstract
An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
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Citations
20 Claims
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1. A method of dosing a subject for the treatment of convulsions, the method comprising:
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administering an extended-release topiramate capsule once daily to the subject, wherein the extended-release topiramate capsule comprises; a capsule shell comprising a single population of coated particles; wherein each coated particle comprises a core and a coating thereon; wherein each particle core comprises a homogeneous mixture comprising topiramate throughout its core; and wherein the coating comprises one or more release controlling agent(s); wherein the extended-release topiramate capsule, when given as a single-dose to a healthy human subject, achieves an AUC0-inf of 170 to 210 h⋅
μ
g/mL within a 95% confidence interval, and a Cmax of 2 to 4 μ
g/mL within a 95% confidence interval. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification