Roll compaction integrated work stream

This thesis focuses on the study of powder and granule characterization in order to improve the formulations and properties of solid oral dosage forms as final products. The main goal is to investigate the effect of excipients on formulation, granule properties and morphology and on the active pharmaceutical ingredient (API) release rate of final products. Release rate and controlled release behaviour of drugs are considered as the main quality attributes of products in this project. A natural biopolymer, Alcell lignin is used as an excipient to modify formulations and granule properties in order to improve the final quality of products. In addition, the effect of lignin on drug release and controlled release behaviour is studied. Firstly, powder and granule properties are investigated using dry granulation by the roll compaction process considering various formulations and process parameters. Then, tablet properties are studied using dry granulation via the roll compaction process, considering lignin as excipient and acetylsalicylic acid as API. The influence of lignin on the drug release rate is assessed using gastric fluid (pH 1.2). Subsequently, artificial neural network (ANN) is applied for the prediction of drug release. ANN is developed considering the following parameters: roll pressure, screw speed and lignin content. The model was developed and validated through comparison with obtaind experimental data. Compatibility was observed, thereby confirming the model as a predictive model tool for release rate determination. Finally, the controlled release behaviour of drugs are investigated considering modified lignin as an excipient using varying formulations. Here, paracetamol is considered as an API in all formulations. The results show the positive influence of adding modified lignin as an excipient, as it increases the drug release rate. Moreover, controlled release behaviour of drugs is investigated at different pH, gastric (pH 1.2) and intestine fluid (pH 7.2) and results show pH-sensitive behaviour when modified lignin is utilised in the formulation lignin.