Digital Design of Filtration and Washing of Active Pharmaceutical Ingredients via Mechanistic Modeling.

Org Process Res Dev

EPSRC Future Manufacturing Hub in Continuous Manufacturing and Advanced Crystallisation, University of Strathclyde, GlasgowG1 1RD, U.K.

Published: December 2022

To facilitate integrated end-to-end pharmaceutical manufacturing using digital design, a model capable of transferring material property information between operations to predict product attributes in integrated purification processes has been developed. The focus of the work reported here combines filtration and washing operations used in active pharmaceutical ingredient (API) purification and isolation to predict isolation performance without the need of extensive experimental work. A fixed Carman-Kozeny filtration model is integrated with several washing mechanisms (displacement, dilution, and axial dispersion). Two limiting cases are considered: case 1 where there is no change in the solid phase during isolation (no particle dissolution and/or growth), and case 2 where the liquid and solid phases are equilibrated over the course of isolation. In reality, all actual manufacturing conditions would be bracketed by these two limiting cases, so consideration of these two scenarios provides rigorous theoretical bounds for assessing isolation performance. This modeling approach aims to facilitate the selection of most appropriate models suitable for different isolation scenarios, without the requirement to use overly complex models for straightforward isolation processes. Mefenamic acid and paracetamol were selected as representative model compounds to assess a range of isolation scenarios. In each case, the objective of the models was to identify the purity of the product reached with a fixed wash ratio and minimize the changes to the crystalline particle attributes that occur during the isolation process. This was undertaken with the aim of identifying suitable criteria for the selection of appropriate filtration and washing models corresponding to relevant processing conditions, and ultimately developing guidelines for the digital design of filtration and washing processes.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9764418PMC
http://dx.doi.org/10.1021/acs.oprd.2c00165DOI Listing

Publication Analysis

Top Keywords

filtration washing
16
digital design
12
isolation
9
design filtration
8
active pharmaceutical
8
isolation performance
8
limiting cases
8
selection appropriate
8
isolation scenarios
8
filtration
5

Similar Publications

Sterilization and Filter Performance of Nano- and Microfibrous Facemask Filters - Electrospinning and Restoration of Charges for Competitive Sustainable Alternatives.

Macromol Rapid Commun

December 2024

Empa, Swiss Federal Laboratories for Materials Science and Technology, Laboratory for Biomimetic Membranes and Textiles, St. Gallen, 9014, Switzerland.

Facemask materials have been under constant development to optimize filtration performance, wear comfort, and general resilience to chemical and mechanical stress. While single-use polypropylene meltblown membranes are the established go-to material for high-performing mask filters, they are neither sustainable nor particularly resistant to sterilization methods. Herein an in-depth analysis is provided of the sterilization efficiency, filtration efficiency, and breathing resistance of selected aerosol filters commonly implemented in facemasks, with a particular focus on the benefits of nanofibrous filters.

View Article and Find Full Text PDF

Background: Schistosoma spp. and other intestinal parasites are common in Ethiopia. During pregnancy, SCH increases the risk of adverse birth outcomes.

View Article and Find Full Text PDF

Dual-Stage Cross-Flow Filtration: Integrated Capture and Purification of Virus-Like Particles.

Biotechnol Bioeng

December 2024

Institute of Process Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe Institute of Technology (KIT), Karlsruhe, Germany.

Virus-like particles (VLPs) are a versatile technology for the targeted delivery of genetic material through packaging and potential surface modifications for directed delivery or immunological issues. Although VLP production is relatively simple as they can be recombinantly produced using microorganisms such as Escherichia coli, their current downstream processing often relies on individually developed purification strategies. Integrating size-selective separation techniques may allow standardized platform processing across VLP purification.

View Article and Find Full Text PDF

Microplastics fibers shed from washing synthetic textiles are released directly into the waters and make up 35% of primary microplastics discharged to the aquatic environment. While filtration devices and regulations are in development, safe disposal methods remain absent. Herein, we investigate catalytic hydrothermal carbonization (HTC) as a means of integrating this waste (0.

View Article and Find Full Text PDF

Unlabelled: Autologous blood obtained during hardware reinfusion can be bacterially contaminated with skin microflora in most cases (up to 90%) regardless of the area of surgical intervention. Increased volume of washing solution for red blood cell management, white blood cell filtration and X-ray irradiation do not always provide complete decontamination.

Objective: To analyze the effectiveness of adding cefuroxime to extracorporeal circuit during hardware blood reinfusion.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!