Fabrication, Optimization and Evaluation of An Extended-Release Tablet For The Treatment In Epilepepsy

Abstract

Oral drug delivery products dominate the global drug delivery market, because they are the easiest to use, the most affordable to produce, and the most convenient with patients, The objective of the present study is to fabricate and evaluate the extended-release tablets for the treatment of epilepsy, bipolar disorder, and migraine. Also, this study focuses on the role of different lipid polymers and its hydrophobic effect on choice to control hygroscopicity and retard release of drug belongs to BCS class I by using a solvent free hot melt granulation technique. And, wet granulation of lipid coated drug to further retard the drug release. The Quality by design (Qbd) and Design of experiment(DoE) approach has been used to evaluate the challenges and critical process parameter affecting the dissolution of the drug. All the different batches prepared by different lipid polymers were evaluated for the physical characteristics, in vitro dissolution, and stability. The release of drug from the tablet is compared with the marketed formulation which gives promising results for a period up to 24 hours was recorded as controlled manner.