Optimisation of Ondansetron Orally Disintegrating Tablets Using Artificial Neural Networks

Abstract

Purpose: To investigate the impact of critical quality attributes (CQAs) and critical process parameters (CPPs) on quality target product profile (QTPP) attributes of orally disintegrating tablet (ODT) containing ondansetron (OND) using two artificial neural network (ANN) programs.Methods: Different amounts of two different commercial superdisintegrants commonly used in ODT formulations (Ludiflash® and Parteck®) were examined as CQAs, while three different tablet-pressing forces were evaluated as CPPs for an orally disintegrating tablet (ODT) formulation. The impact of CQAs, and CPPs on the target product profile (tablet hardness, friability and disintegration time) were analysed using gene expression programming (GEP) and neuro-fuzzy logic (NFL) models.Results: NFL model defined the relations between CQAs, CPPs and QTPP, while GEP model favoured the use of an ODT formulation with suitable QTPP features which contained 4 mg ondansetron, 21.30 mg Parteck®, and 119 mg Avicel, fabricated with a compression force of 515 psi. In this regard, the tablet formulation demonstrated the required specifications.Conclusion: ANN programs are a useful tool for research and development (R&D) studies in the pharmaceutical industry and the use of ANNs can be beneficial in terms of raw materials, time and cost, as demonstrated for ondansetron ODT tablets.Keywords: Ondansetron, Critical quality attributes, Critical process parameters, Quality target product profile, Gene expression programming, Neuro-fuzzy logic, Artificial neural network