Evaluation of Different Types of Paracetamol Active Pharmaceutical Ingredients' Effect on the Release System

The primary purpose of this study was to investigate the effect of active pharmaceutical ingredients (APIs) with varying particle sizes and properties on drug release and to develop matrix-type tablets based on poly(acrylic acid sodium salt) (PAANa) with different gelatin ratios for enhanced paracetamol release. Micronized, superfine, and purified paracetamol APIs were selected as model drugs to assess the impact of these APIs on drug release. Paracetamol is a frequently used medication in healthcare, so it is crucial to select the API with the optimal release rate and an economical, environmentally friendly production method. The direct compression method was employed in the preparation of the tablets due to its simplicity and ease of integration on an industrial scale. The release studies, release kinetics, scanning electron microscope (SEM), Fourier transform infrared spectroscopy (FT-IR), physical properties, and microbial analyses (Escherichia coli, total mold, yeast) were investigated. The release studies at pH 1.2 and pH 7.4 revealed that the type of active pharmaceutical ingredient, especially micronized paracetamol API and superfine API, affects the paracetamol release ratio. Microbial analyses showed that produced tablets were convenient for health. In addition, prepared tablets with added gelatine can be used to deliver paracetamol with the desired release profile.