Daily formulation of lacosamide
AssigneeUCB Pharma S.A.
InventorsWilli CAWELLO, Martin Alexander SCHUBERT
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Abstract
A modified release formulation of lacosamide suitable for once-daily administration.
Claims29
-35. (canceled)
A solid controlled release formulation for oral administration of lacosamide, the formulation comprising a lacosamide-containing matrix and at least one matrix retardation agent, wherein the solid controlled release formulation is configured such that
- a. an amount of about 8.5 wt % to about 41 wt % of lacosamide relative to the total lacosamide content of the formulation is released within 1 h,
- b. an amount of about 15 wt % to about 64 wt % of lacosamide relative to the total lacosamide content of the formulation is released within 2 h, and
- c. an amount of about 28 wt % to about 88 wt % of lacosamide relative to the total lacosamide content of the formulation is released within 4 h,
- when the in-vitro release of lacosamide is measured according to USP (edition 24) method <711>, dissolution apparatus 2, in 900 mL of 0.1N HCl at 75 rpm, and wherein the at least one matrix retardation agent is present in an amount of about 1.5 to about 10 wt % relative to the total weight of the formulation.
A solid controlled release formulation for oral administration of lacosamide, the formulation comprising a lacosamide-containing matrix and at least one matrix retardation agent, wherein the solid controlled release formulation is configured such that
- a. no more than about 41 wt % of lacosamide relative to the total lacosamide content of the formulation is released within 1 h,
- b. no more than about 64 wt % of lacosamide relative to the total lacosamide content of the formulation is released within 2 h, and
- c. no more than about 88 wt % of lacosamide relative to the total lacosamide content of the formulation is released within 4 h,
- when the in-vitro release of lacosamide is measured according to USP (edition 24) method <711>, dissolution apparatus 2, in 900 mL of 0.1N HCl at 75 rpm, and wherein the at least one matrix retardation agent is present in an amount of about 1.5 to about 10 wt % relative to the total weight of the formulation.
Dependencies are inferred from the claim text.