Modelling amorphous solid dispersions behaviour

Abstract

The pharmaceutical industries focus on developing new active pharmaceutical ingredients (APIs) and developing the formulation for the nal drug product. Most recently developed APIs present low solubility and this can be a challenge for oral drug products. There are several strategies to increase the solubility of the API and one of them is producing an amorphous solid dispersion (ASD). The behaviour of ASDs can be described by three processes: dissolution, supersaturation and precipitation. Biorelevant dissolution is used to predict how ASDs will behave in human body. Predicting the behavior of ASDs will reduce the number of laboratory experiments, the product development time, the number of formulations tested in vivo and, consequently, the time for the nal drug product to reach the market. This work presents the development of a mathematical model that describes the behaviour of ASDs through ordinary di erential equations and using Python for numerical its numerical study. Describing the behaviour of ASDs in biorelevant media can help predicting the absorption in the human body , when applied with a PBPK (Physiologically based pharmacokinetic modelling) model. In this report we study three ordinary di erential equations which describe the phenomenon of dissolution, supersaturation and precipitation. In order to approximate the results to the experimental values and obtain a good description of the data, the rates for each phenomenon were optimized. The main conclusions of these work are although there is still a lot of work to be developed the model describes well the behavior of an ASD, it ts the experimental data.