Formulation and evaluation of levetiracetam orodispersible tablets for pediatric use

ABSTRACTLevetiracetam is an antiepileptic drug used in the management of several seizure disorders. Orodispersible tablets(ODTs) can provide a convenient oral dosage form for pediatric patients who may have difficulty swallowingconventional tablets. In the present project, Levetiracetam ODTs were developed by direct compression usingLevetiracetam, co-processed excipients such as Prosolv ODT and F-melt, superdisintegrants includingCrospovidone and Croscarmellose sodium, and flavoring agents. Preformulation studies included organolepticcharacterization, solubility assessment, drug–excipient interference/compatibility assessment, micromeriticevaluation and melting-point determination. The prepared tablets were evaluated for appearance, dimensions,weight variation, hardness, friability, disintegration, wetting, dissolution, taste masking and drug content.Levetiracetam showed a UV maximum absorbance at 209 nm under the described method. Accelerated stabilitytesting of the optimized F010 formulation was performed in PVDC–Al blister packs at 40°C/75% RH for threemonths. The supplied project data showed no remarkable change in cumulative drug release during the stabilityperiod. These findings support the feasibility of developing Levetiracetam ODTs by direct compression; however,complete numerical batch-wise evaluation data should be inserted before journal submission.