Rapid Disperse Dosage Form Containing Levetiracetam
AssigneeAprecia Pharmaceuticals LLC
InventorsJules JACOB, Norman COYLE, Thomas G. WEST, Donald C. MONKHOUSE, Henry L. SURPRENANT, Nemichand B. JAIN
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Abstract
A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of levetiracetam in a porous matrix that disperses in water within a period of less than about 10 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to levetiracetam.
Claims23
A rapidly dispersible solid dosage form comprising levetiracetam in a bound matrix that disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva.
A rapidly dispersible solid dosage form comprising levetiracetam in a bound porous matrix that disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva, wherein the dosage form provides a Cmax within the ranges listed below when respective doses of levetiracetam are administered to a subject in the fasting state:
- Dose
- Cmax
- (mg)
- (micrograms/ml)
- 1000
- 13-53
- 750
- 9-37
- 500
- 5-20
- 250
- 4-7.
A rapidly dispersible solid dosage form comprising levetiracetam in a bound porous matrix that disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva, wherein the dosage form provides a Cmax within the ranges listed below when respective doses of levetiracetam are administered to a subject in the fed state:
- 3DP Dose
- Cmax
- (mg)
- (microg/ml)
- 1000
- 14-27
- 750
- 10-19
- 500
- 5-10
- 250
- 4-7.
A rapidly dispersible solid dosage form comprising levetiracetam in a bound porous matrix that disperses in about 15 sec or less in a volume of about 15 ml or less of water or saliva, wherein the dosage form provides a fed/fasted ratio for Cmax in the range of 0.55 to 0.74 and for Tmax in the range of 5 to 21.
Dependencies are inferred from the claim text.