SPRITAM is manufactured with US-sourced levetiracetam by Aprecia Pharmaceuticals, LLC in Blue Ash, Ohio USA. The manufacturing facility is the first and only in the world to receive FDA authorization to produce a three-dimensionally printed pharmaceutical product for commercial sale in the United States.

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Bioavailability and Pharmacokinetics

In a crossover study in 33 healthy volunteers, SPRITAM® (levetiracetam) administered with a sip of water, was shown to have an equivalent rate and extent of absorption to levetiracetam immediate-release (IR) tablets, under fasting conditions. 1Boudriau S, Harvey C, Massicotte J, et al. Randomized Comparative bioavailability of a nocel three-dimensional printed fast-melt formulation of levetiracetam following the administration of a single 1000-mg dose to healthy human volunteers under fasting and fed conditions, Drugs R D. 2016;16(2):229–238.

Mean plasma concentation-time curve profiles after oral administration under fasting conditions.

Adapted from Boudriau, et al.

Tmax=Time to maximum observed plasma concentration.

Cmax=Maximum observed plasma concentration.

AUC0–T=Area under the plasma concentration–time curve from time zero to the time of the last measurable concentration.

AUC0–∞=Area under the plasma concentration–time curve from time zero to infinity.

Thalf=Terminal elimination half-life.

c.v.=Coefficient of variation.

*PK=Pharmacokinetics.

Median for Tmax.

Adapted from Boudriau, et al.