The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion.

Continuous processing is superseding conventional batch processing as a means of manufacturing within the pharmaceutical research/industry. This paradigm shift has led to the implementation of Process Analytical Technology (PAT) as a semi-automatic, predictive tool offering real-time quality control that can be built into the production line. However, PAT tools have been mainly utilised to monitor a single process (e.

Metformin Hydrochloride and Sitagliptin Phosphate Fixed-Dose Combination Product Prepared Using Melt Granulation Continuous Processing Technology.

The development of oral solid dosage forms, such as tablets that contain a high dose of drug(s), requires polymers and other additives to be incorporated at low levels as possible, to keep the final tablet weight low, and, correspondingly, the dosage form size small enough to be acceptable from a patient perspective. Additionally, a multi-step batch-based manufacturing process is usually required for production of solid dosage forms. This study presents the development and production, by twin-screw melt granulation technology, of a high-dose immediate-release fixed-dose combination (FDC) product of metformin hydrochloride (MET) and sitagliptin phosphate (SIT), with drug loads of 80% w/w and 6% w/w, respectively.

A predictive integrated framework based on the radial basis function for the modelling of the flow of pharmaceutical powders.

This study presents a modelling framework to predict the flowability of various commonly used pharmaceutical powders and their blends. The flowability models were trained and validated on 86 samples including single components and binary mixtures. Two modelling paradigms based on artificial intelligence (AI) namely, a radial basis function (RBF) and an integrated network were employed to model the flowability represented by the flow function coefficient (FFC) and the bulk density (RHOB).