Formulation and Development of Pellet Base Oral Suspension for Once a Day Treatment of Epilepsy

Abstract

As a chronic neurological illness marked by recurring seizures, epilepsy is difficult to manage since medication must be taken consistently to control seizures and stop them from happening again. Oftentimes, the traditional immediate-release formulations are unable to maintain therapeutic medication levels, which causes variations in plasma concentration and insufficient control over seizures. The creation of an innovative oral suspension formulation based on pellets with the goal of achieving extended-release properties for the treatment of epilepsy is the main emphasis of this thesis. The main functional polymer in the formulation technique is Aquacoat ECD 30. The purpose of the study is to determine how different Aquacoat ECD 30 concentrations affect the active pharmaceutical ingredient's (API) in vitro release profiles when used to treat epilepsy. The creation of pellet-based oral solutions with an acceptable drug dose and different Aquacoat ECD 30 and binder concentrations is one of the experimental approaches. Techniques for characterization are carried out, including in vitro release, drug content, and micromeritics characteristics. Findings show a clear relationship between the amount of extended release attained and the concentration of Aquacoat ECD 30 in the formulation, with larger polymer concentrations resulting in lower in vitro release rates. On the other hand, there is an inverse link between drug release and binder concentration; larger binder concentrations lead to slower initially and constant for larger period of time kind of release kinetics. The extent of extended release attained is directly correlated with the concentration of Aquacoat ECD 30 in the formulation, as evidenced by the results, where larger polymer concentrations result in lower in vitro release rates. On the other hand, the drug release and binder concentration show an inverse connection.