Extended-release topiramate capsules
DCFirst Claim
Patent Images
1. An extended-release topiramate capsule comprising:
- 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 throughout its core,the mixture comprising components including;
topiramate;
one or more filler(s); and
one or more binder(s);
wherein the coating comprises components including;
one or more release controlling agent(s);
one or more pore former(s); and
one or more plasticizer(s);
wherein the components in the particle core and coating are present in amounts that provide extended release of topiramate;
wherein, when a single dose is given to a healthy human subject, 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 are achieved in the subject'"'"'s plasma.
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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).
356 Citations
30 Claims
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1. An extended-release topiramate capsule comprising:
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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 throughout its core, the mixture comprising components including; topiramate; one or more filler(s); and one or more binder(s); wherein the coating comprises components including; one or more release controlling agent(s); one or more pore former(s); and one or more plasticizer(s); wherein the components in the particle core and coating are present in amounts that provide extended release of topiramate; wherein, when a single dose is given to a healthy human subject, 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 are achieved in the subject'"'"'s plasma. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. An extended-release topiramate capsule comprising:
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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 throughout its core, the mixture comprising components including; topiramate; one or more filler(s) selected from the group of microcrystalline cellulose, dibasic calcium phosphate, lactose, tribasic calcium phosphate, mannitol, and combinations thereof; and one or more binder(s) selected from the group of hydroxypropyl methylcellulose, methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, hydroxyethylcellulose, polyvinyl pyrrolidine, starch, natural gum, and combinations thereof; wherein the coating comprises components including; one or more release control agent(s) selected from the group of ethylcellulose, polyvinyl acetate, polyacrylate and polymethacrylate, copolymers thereof, and combinations thereof; one or more pore former(s) selected from the group of hypromellose, hydroxypropyl cellulose, methylcellulose, hydroxyethylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, polyethylene glycol, guar gum, xanthan gum, sodium alginate, polyvinylpyrrolidone, crospovidone, sodium starch glycolate, croscarmellose sodium, starch, mannitol, glucose, sucrose, fructose, mannose, galactose, sorbitol, dextran, sodium chloride, potassium chloride, calcium chloride, and combinations thereof; and one or more plasticizer(s) selected from the group of diethyl phthalate, triethyl citrate, dibutyl sebacate, polyethylene glycol, triacetin, tributyl citrate, glycerol, propylene glycol, and combinations thereof; wherein the particle core components and coating components are present in amounts that provide extended release of topiramate; wherein, when a single dose is given to a healthy human subject, 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 are achieved in the subject'"'"'s plasma. - View Dependent Claims (28, 29, 30)
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Specification