Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology [PDF]
Objectives: Hot-melt extrusion (HME) offers a solvent-free, scalable approach for manufacturing pharmaceutical co-crystals (CCs), aligning with the industry’s shift to continuous manufacturing (CM).
Lianghao Huang +6 more
doaj +2 more sources
Continuous Manufacturing of Ketoprofen Delayed Release Pellets Using Melt Extrusion Technology: Application of QbD Design Space, Inline Near Infrared, and Inline Pellet Size Analysis. [PDF]
Delayed-release dosage forms are mainly manufactured as batch processes and include coated tablets, pellets, or particles with gastric resistant polymers.
Vo AQ +5 more
europepmc +2 more sources
Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk
Pharmaceutical manufacturing is evolving from traditional batch processes to continuous ones. The new global competition focused on throughput and quality of drug products is certainly the driving force behind this transition which, thus, represents the ...
Antonello A. Barresi +2 more
exaly +2 more sources
Impact of Impurities on Crystallization and Product Quality: A Case Study with Paracetamol
A thorough, systematic study into the effect that structurally related impurities have on both the process and product quality during the crystallization of an active pharmaceutical ingredient is presented.
Stephanie J. Urwin +3 more
doaj +1 more source
Targeting Desired Particle Size for Improved Dissolution and Manufacturability of Mefenamic Acid
This work aims at the production of uniformly sized, equant shaped crystals using a direct nucleation control (DNC) strategy to help achieve enhanced manufacturability and bioavailability of the active pharmaceutical ingredients (API).
Wei Li, Chris D. Rielly, Brahim Benyahia
doaj +1 more source
Continuous crystallisation of organic salt polymorphs
Organic salt crystallisation is of great importance to the pharmaceutical industry as many pharmaceutical products are marketed as salts with salt formation being an essential step in drug development.
John McGinty +5 more
doaj +1 more source
Phase Diagram Determination and Process Development for Continuous Antisolvent Crystallizations
The development of an antisolvent crystallization process requires the construction of an accurate phase diagram for this ternary system of compound, solvent and antisolvent, preferably as a function of temperature.
Corin Mack +3 more
doaj +1 more source
Therapeutic proteins treat many acute and chronic diseases that were until recently considered untreatable. However, their high development cost keeps them out of reach of most patients around the world. One plausible solution to lower-cost manufacturing
Sarfaraz K. Niazi, Matthias Magoola
semanticscholar +1 more source
Lovastatin crystals often exhibit an undesirable needle-like morphology. Several studies have shown how a needle-like morphology can be modified in antisolvent crystallisation with the use of additives, but there is much less experimental work ...
John McGinty +5 more
doaj +1 more source
The drying unit of a continuous from-powder-to-tablet manufacturing line based on twin-screw granulation (TSG) is a crucial intermediate process step to achieve the desired tablet quality.
Alexander Ryckaert +6 more
doaj +1 more source

