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Development and Use of a Residence Time Distribution (RTD) Model Control Strategy for a Continuous Manufacturing Drug Product Pharmaceutical Process [PDF]

open access: yesPharmaceutics, 2022
Residence-time-distribution (RTD)-based models are key to understanding the mixing dynamics of continuous manufacturing systems. Such models can allow for material traceability throughout the process and can provide the ability for removal of non ...
Samantha Hurley   +4 more
doaj   +2 more sources

Towards the Continuous Manufacturing of Liquisolid Tablets Containing Simethicone and Loperamide Hydrochloride with the Use of a Twin-Screw Granulator [PDF]

open access: yesPharmaceutics, 2023
Continuous manufacturing is becoming the new technological standard in the pharmaceutical industry. In this work, a twin-screw processor was employed for the continuous production of liquisolid tablets containing either simethicone or a combination of ...
Daniel Zakowiecki   +9 more
doaj   +2 more sources

Process Development for the Continuous Manufacturing of Carbamazepine-Nicotinamide Co-Crystals Utilizing Hot-Melt Extrusion Technology [PDF]

open access: yesPharmaceutics
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 Recombinant Drugs: Comprehensive Analysis of Cost Reduction Strategies, Regulatory Pathways, and Global Implementation [PDF]

open access: yesPharmaceuticals
The biopharmaceutical industry is undergoing a fundamental transformation from traditional batch manufacturing to continuous manufacturing (CM) for recombinant drugs and biosimilars, driven by regulatory support through the International Council for ...
Sarfaraz K. Niazi
doaj   +2 more sources

Continuous Multi-Material Additive Manufacturing

open access: yesResearch
Slice-based additive manufacturing has been intensively investigated due to its potential in complex 3-dimensional (3D) structure construction across various fields.
Jiawei Sun   +5 more
doaj   +2 more sources

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

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