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Impact of Impurities on Crystallization and Product Quality: A Case Study with Paracetamol

open access: yesCrystals, 2021
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

open access: yesChemistry Proceedings, 2022
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

open access: yesFrontiers in Chemical Engineering, 2022
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

open access: yesCrystals, 2022
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

Effect of Process Conditions on Particle Size and Shape in Continuous Antisolvent Crystallisation of Lovastatin

open access: yesCrystals, 2020
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 Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

open access: yesPharmaceutics, 2021
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

Predictive Model-Based Process Start-Up in Pharmaceutical Continuous Granulation and Drying

open access: yesPharmaceutics, 2020
Continuous manufacturing (CM) is a promising strategy to achieve various benefits in the context of quality, flexibility, safety and cost in pharmaceutical production.
Victoria Pauli   +2 more
doaj   +1 more source

Impact of Vertical Blender Unit Parameters on Subsequent Process Parameters and Tablet Properties in a Continuous Direct Compression Line

open access: yesPharmaceutics, 2022
The continuous manufacturing of solid oral-dosage forms represents an emerging technology among the pharmaceutical industry, where several process steps are combined in one production line.
Marius J. Kreiser   +2 more
doaj   +1 more source

Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting Process

open access: yesPharmaceutics, 2023
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.
Gerald A. Hebbink   +7 more
doaj   +1 more source

Nucleation and Growth Kinetics of Sodium Chloride Crystallization from Water and Deuterium Oxide

open access: yesCrystals, 2023
Despite the ubiquity of the crystallization of sodium chloride (NaCl) throughout history, few detailed, well-controlled quantitative studies of the kinetics of NaCl crystallization have been published.
James M. Flannigan   +4 more
doaj   +1 more source

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