Deep learning for continuous manufacturing of pharmaceutical solid dosage form.

Continuous Manufacturing (CM) of pharmaceutical drug products is a new approach within the pharmaceutical industry. In the presented paper, a GMP continuous wet granulation line for production of solid dosage forms was investigated. The line was composed of the subsequent continuous unit: operations feeding - twin-screw wet-granulation - fluid-bed drying - sieving and tableting.

Continuous manufacturing process monitoring of pharmaceutical solid dosage form: A case study.

Continuous Manufacturing (CM) of pharmaceutical drug products is a rather new approach within the pharmaceutical industry. In the presented paper, a GMP continuous wet granulation line used for clinical production of solid dosage forms was investigated with a thorough monitoring strategy regarding process performance and robustness. The line was composed of the subsequent continuous unit operations feeding - twin-screw wet-granulation - fluid-bed drying - sieving and tableting; the formulation of a new pharmaceutical entity in development was selected for this study.

Process analytical technology for continuous manufacturing tableting processing: A case study.

The use of Near Infrared Spectroscopy (NIRS) as a fast and non-destructive technique was employed for the control and monitoring of the tableting step during a continuous manufacturing process. Two NIRS methods were optimized in order to in-line control the blend uniformity in the tablet feed frame and the API concentration of freshly pressed tablets prior the ejection. The novelty of this work first lies in the acquisition speed of NIR spectra reaching up to 70,000 tablets/h.

Safety and robustness of coated pellets: self-healing film properties and storage stability.

Purpose: Aim of the study was to verify the safety of chlorpheniramine maleate pellets, coated with blends of poly(vinyl acetate) and poly(vinyl alcohol)-poly(ethylene glycol) graft copolymer. Therefore, the impact of mechanical forces and storage conditions on the drug release was investigated.

Results: Similar release profiles before and after compression of the pellets to tablets underlined the high film robustness.

Modulating pH-independent release from coated pellets: effect of coating composition on solubilization processes and drug release.

The aim of the study was to clarify the influences of three coating parameters on the drug release from chlorpheniramine maleate (CPM) pellets, coated with blends of poly(vinyl acetate) (PVAc) and poly(vinyl alcohol)-poly(ethylene glycol) (PVA-PEG) graft copolymer. A central composite design was implemented to investigate the effect of the polymer blend ratio, the film coat thickness and the plasticizer concentration on the drug release. The solubilization inside the pellets was monitored by EPR spectroscopy.

New insight into modified release pellets - Internal structure and drug release mechanism.

The aim of the study was to explore the drug release mechanism from pellets, coated with blends of poly(vinyl acetate) (PVAc) and polyvinyl alcohol-polyethylene glycol graft copolymer (PVA-PEG). Water influx and drug solubilization inside the pellets were investigated in correlation to drug release. The highly soluble drug Chlorpheniramine maleate (CPM) was used as a model compound.