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DFE Pharma
Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting…
Abstract
Modern pharmaceutical manufacturing based on Quality by Design and digitalisation is revolutionising the pharmaceutical industry. Continuous processes are promoted as they increase efficiency and improve quality control. Compared to batch blending, continuous blending is easier to scale…
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A dry powder formulation for peripheral lung delivery and absorption of an anti-SARS-CoV-2 ACE2…
One of the strategies proposed for the neutralization of SARS-CoV-2 has been to synthetize small proteins able to act as a decoy towards the virus spike protein, preventing it from entering the host cells. In this work, the incorporation of one of these proteins, LCB1, within a spray-dried…
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Polyenylphosphatidylcholines as bioactive excipient in tablets for the treatment of liver fibrosis
Liver fibrosis is a condition characterized by the accumulation of extracellular matrix (ECM) arising from the myofibroblastic transdifferentiation of hepatic stellate cells (HSCs) occurring as the natural response to liver damage. To date, no pharmacological treatments have been specifically…
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Microstructural insight into inhalation powder blends through correlative multi-scale X-ray computed…
Dry powder inhalers (DPI) are important for topical drug delivery to the lungs, but characterising the pre-aerosolised powder microstructure is a key initial step in understanding the post-aerosolised blend performance. In this work, we characterise the pre-aerosolised 3D microstructure of an…
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Indices for the brittleness of pharmaceutical tablets: a reassessment
Brittleness is an important mechanical property. In the classical sense, a material is considered brittle if, during loading, it behaves elastically until failure. Nevertheless, it is also sometimes understood as the fact to be resistant to breakage. In the case of pharmaceutical tablets, three…
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Effect of geometrical features on the capping behavior of biconvex tablets
Abstract
Capping is a common industrial issue during the manufacturing of pharmaceutical tablets. It is influenced by both process and formulation parameters. In this work, a systematic study of the influence of the geometrical features of biconvex tablets on capping occurrence was performed on a…
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3D powder bed tablet printing: From a R&D printer to a scalable GMP printer
Powder bed-based 3D printing has been used to produce pharmaceutical tablets mainly under laboratory conditions. To advance the technology for commercial use, laboratory's proof of principles should be translated to and validated under good manufacturing practice (GMP) conditions. In this study,…
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Spray drying robot for high-throughput combinatorial fabrication of multicomponent solid dispersions
During the development of pharmaceutical spray-dried formulations, many samples must be prepared for physico-chemical characterisation and dissolution testing by systematically varying parameters such as drug loading or the grades and ratios of excipients (polymers, surfactants, etc.). When spray…
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Process intensification using a semi-continuous mini-blender to support continuous direct…
The production of pharmaceutical tablets is shifting towards continuous manufacturing. Therefore, individual unit operations such as powder blending need to be re-designed. Continuous powder blending has been implemented successfully, but for low-dose formulations this is challenging due to…
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
Abstract
Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and…
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