Design And Development Of A Novel Formulation Of Ganaxolone For Treatment Of Seizure

Abstract

people living with epilepsy, the risk of Sudden Unexpected Death in Epilepsy is an important concern. Cases of Sudden Unexpected Death occur during or immediately after a seizure The exact cause is not known, the possible factors are Breathing problem apnea, Heart rhythm or cardiac arrest. The main risk factors for Sudden Unexpected Death in Epilepsy are Uncontrolled or frequent seizures Generalized convulsive (also called tonic-clonic or grand mal) seizures Other possible risk factors may include Seizures that begin at a young age Many years of living with epilepsy Missed doses of medicine, Drinking Alcohol. Modified release and sustained release dosage forms have the advantage over conventional dosage form for better patient compliance and minimum dosing frequency. Although they have a potential threat of dose dumping, several attempts have been made by pharmaceutical scientists to develop sustained and modified-release drug delivery systems. Ganaxolone is a drug of choice for seizures in people with cyclin-dependent kinase-like 5 deficiency disorder¹⁶.Present study involves formulation of Sustained release tablets of Ganaxolone by using various hydrophilic polymers like HPMC 15 CPS, HPMC K4M, HPMC K15M CR and HPMC K100 MCR Spray Drying granulation techniques where a Nano suspension of Ganaxolone used as Solvent. Trials were evaluated for the preparation of tablets. The formulated tablets were subjected to various evaluation tests like weight variation, hardness, assay, disintegration and dissolution tests. Finally, it was concluded that the F14 batch shows the best results, amongst all formulated batches.