Modelling of Release-by-Design Tablets

Abstract

Examine the effects of the specific surface area (SSA) on the dissolution profile of an injection moulded tablet with complex geometry is the main aim of the project. This is attainable by adopting a suitable model from literature, which able to incorporate the calculated SSA. This channelled-tablet was obtained by coupling various manufacturing methods, including 3D printing, hot-melt extrusion, and injection moulding. In previous researches, the relationship between (SSA) and the rate of drug dissolution was well established, where the overall drug released is directly proportional to the (SSA) ratio. This approach is critical in the product-by-design of the immediate-release tablet to ensure the rapid dissolution of the dosage form. Additionally, three different simulations were applied using two soluble polymers, e.g., AFFINISOL HPMC HME 4M and EUDRAGIT E PO and three model drugs (Chlorpheniramine malate, Propranolol and Theophylline). They were chosen based on the different assumed diffusion coefficients and solubilities profiles to investigate the impact of various variables alongside the (SSA). The result showed that increasing the channels number from zero to 30 would dramatically increase the (SSA) from 1.06 to 2.03, and therefore, the release rate of the drug is approximately doubled. Even for low soluble drugs and polymers with various viscosity grades, the impact of increasing the SSA was clearly concluded. This retrospective design approach would, therefore, provide a model that describes the relationship between SSA and the resulting dissolution profile. From this, it is possible to select the desired dissolution profile and use the necessary SSA value to design a tablet of specific physical geometry to achieve a release-by-design (RbD)’s goal.