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Last Updated: October 29, 2020

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Claims for Patent: 9,566,244

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Summary for Patent: 9,566,244
Title:Pharmaceutical composition comprising licarbazepine acetate
Abstract: A pharmaceutical composition comprising licarbazepine acetate, especially eslicarbazepine acetate, in combination with suitable excipients, in particular a binder, and a disintegrant. Also disclosed is a granulation process, especially a wet granulation process, for making the pharmaceutical composition.
Inventor(s): Cardoso de Vasconcelos; Teofilo (S. Mamede do Coronado, PT), dos Santos Lima; Ricardo Jorge (S. Mamede do Coronado, PT), Cerdeira de Campos Costa; Rui (S. Mamede do Coronado, PT)
Assignee: BIAL-PORTELE & CA, S.A. (S. Mamede do Coronado, PT)
Application Number:14/108,615
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,566,244
Patent Claims: 1. A tablet or capsule consisting essentially of: a granular phase comprising licarbazepine acetate and a super-disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and mixtures thereof; an extragranular phase comprising a lubricant and a super-disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and mixtures thereof; and optionally one or more additional excipients selected from the group consisting of (1) a binder selected from the group consisting of povidone, pregelatinized starch, gelatin, and mixtures thereof, (2) a diluent/filler, (3) a disintegrant, (4) a glidant, (5) a lubricant, and (6) mixtures thereof; and wherein the amount of licarbazepine acetate present in the granular phase ranges from 70 to 90 percent by weight relative to the total weight of the tablet or capsule; wherein the total amount of super-disintegrant ranges from 5 to 10 percent by weight relative to the total weight of the tablet or capsule; and wherein 30 to 70 percent by weight of the total amount of super-disintegrant is present in the granular phase.

2. The tablet or capsule according to claim 1, wherein the licarbazepine acetate is eslicarbazepine acetate.

3. The tablet or capsule according to claim 2, wherein the amount of eslicarbazepine acetate ranges from 80 to 90% by weight relative to the total weight of the tablet or capsule, the amount of povidone ranges from 3 to 10% by weight relative to the total weight of the tablet or capsule, and the amount of croscarmellose sodium ranges from 3 to 10% by weight relative to the total weight of the tablet or capsule.

4. A tablet or capsule comprising: a granular phase comprising licarbazepine acetate and a super-disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and mixtures thereof; an extragranular phase comprising a lubricant and a super-disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and mixtures thereof; and povidone; and wherein the amount of licarbazepine acetate present in the granular phase ranges from 55 to 60 percent by weight relative to the total weight of the tablet or capsule; wherein the total amount of super-disintegrant ranges from 5 to 10 percent by weight relative to the total weight of the tablet or capsule; wherein the amount of povidone is 5 to 9 percent by weight relative to the total weight of the tablet or capsule; wherein 30 to 70 percent by weight of the total amount of super-disintegrant is present in the granular phase; and wherein the tablet or capsule exhibits a dissolution percentage of 67.9 to 81.5 at 30 minutes when using a paddle apparatus at a speed of 100 rpm under the following combination of conditions: a dissolution medium temperature of 37.+-.0.5.degree. C. and a dissolution medium pH of 4.5.

5. The tablet or capsule according to claim 4, wherein the licarbazepine acetate is eslicarbazepine acetate.

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