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Author: Ehsan Sheikholeslamzadeh
Publisher:
ISBN:
Category :
Languages : en
Pages : 350
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Book Description
In this project, the aim was to achieve two important objectives and solve some challenges that the pharmaceutical industry is facing. It will be shown that the NRTL-SAC (Non-random Two Liquid Segment Activity Coefficient) model can best predict the solubility of different pharmaceutical and chemical components in pure and mixed solvents by comparing the results with the well-known model of the UNIFAC. The four parameters that are used in the NRTL-SAC model will be found through nonlinear parameter estimation technique. This project also covers the VLE, LLE, and VLLE phase behaviour calculations using the mentioned models to verify their applicability in industries that use solvents as their main process materials (such as pharmaceutical processes). It will be explained that the NRTL-SAC model is efficient and less complex than the UNIFAC model when dealing with multi-component systems of solvents. The solvent screening process is then modeled using a novel method of modeling and optimization which resulted in a significant change in the objective functions from single to binary solvent combinations. The proposed method shows the efficient selection of single, binary, and ternary solvent systems with the optimal crystallization operating conditions to achieve the desired objectives. However, the change from binary to ternary system of solvents did not have a significant effect on the performance functions. The study on the crystallization process of a polymorphic transformation phenomenon is another part of the project which was modeled and optimized. The novel method of modeling for polymorphic transformation of L-glutamic acid enabled us to develop an optimal control strategy of the system consisting of a variety of process conditions (such as seeded and un-seeded crystallization). The outcome of this part of the project gives a detailed understanding of polymorphic transformation systems with optimal conditions that can be implemented for such processes. Finally some useful experimental work that has been done in the area of nucleation and polymorphic transformation of L-glutamic acid using a powerful spectroscopic probe (Lasentec FBRM) will be explained. The nucleation detection and the change from metastable polymorph to the stable one can be performed using the in-situ FBRM which was used in this project.
Author: Ehsan Sheikholeslamzadeh
Publisher:
ISBN:
Category :
Languages : en
Pages : 350
Get Book Here
Book Description
In this project, the aim was to achieve two important objectives and solve some challenges that the pharmaceutical industry is facing. It will be shown that the NRTL-SAC (Non-random Two Liquid Segment Activity Coefficient) model can best predict the solubility of different pharmaceutical and chemical components in pure and mixed solvents by comparing the results with the well-known model of the UNIFAC. The four parameters that are used in the NRTL-SAC model will be found through nonlinear parameter estimation technique. This project also covers the VLE, LLE, and VLLE phase behaviour calculations using the mentioned models to verify their applicability in industries that use solvents as their main process materials (such as pharmaceutical processes). It will be explained that the NRTL-SAC model is efficient and less complex than the UNIFAC model when dealing with multi-component systems of solvents. The solvent screening process is then modeled using a novel method of modeling and optimization which resulted in a significant change in the objective functions from single to binary solvent combinations. The proposed method shows the efficient selection of single, binary, and ternary solvent systems with the optimal crystallization operating conditions to achieve the desired objectives. However, the change from binary to ternary system of solvents did not have a significant effect on the performance functions. The study on the crystallization process of a polymorphic transformation phenomenon is another part of the project which was modeled and optimized. The novel method of modeling for polymorphic transformation of L-glutamic acid enabled us to develop an optimal control strategy of the system consisting of a variety of process conditions (such as seeded and un-seeded crystallization). The outcome of this part of the project gives a detailed understanding of polymorphic transformation systems with optimal conditions that can be implemented for such processes. Finally some useful experimental work that has been done in the area of nucleation and polymorphic transformation of L-glutamic acid using a powerful spectroscopic probe (Lasentec FBRM) will be explained. The nucleation detection and the change from metastable polymorph to the stable one can be performed using the in-situ FBRM which was used in this project.
Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001323
Category : Science
Languages : en
Pages : 645
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Book Description
A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Author: Antonios Fytopoulos
Publisher: Springer Nature
ISBN: 3030909247
Category : Mathematics
Languages : en
Pages : 437
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Book Description
Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.
Author: Andrew Dada Ezekiel
Publisher:
ISBN:
Category : Dissertations, Academic
Languages : en
Pages : 714
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Book Description
A key to be competitive in today's economy is to produce high-quality products at low production cost, to meet or exceed customer's requirements. Product and process variations cost manufacturing industry significant money in terms of high rework cost, scrap, and costly inspections. Reducing product and process variation in a production process is a vital issue in quality improvement programs, because variation grows into hundreds-of-thousands of dollars in added product cost per year. The objectives of this research are (1) to study the variability of a generic pharmaceutical filling process; (2) to generate the process capability and conduct process validation based on statistical process control (SPC); (3) to develop economic optimization models for the filling process; and then (4) to optimize the process mean (e.g., reduce the deviation of the average fill from the target value), as well as minimize the variability around the process mean in a generic liquid pharmaceutical filling operation. This research, motivated by the fact that many production processes are being run at sub-optimal settings, utilizes the combination of control charts and SPC to study the current variability, capability, and validation of our filling process. Then, we developed a model that accounts for both the controllable and uncontrollable factors, and the response variable. Based on the model, we used mixed-level factorial design and robust design methods to effectively determine the optimal level settings of controllable factors that minimize the variability in the fill weights, while keeping the mean fill weight on target. As a result, the response variable (the fill weight) was insensitive or robust to the variations in uncontrollable noise factors. We derived optimum specification limits for the filling process. This research provides consistent methods for process optimization and variation reduction that has been implemented to improve the performance of our filling operations. Consequently, we have decreased the amount of scrap, rework and the cost incurred by the firm. The approach and the models, based on Taguchi's robust design, can be applied to other similar production processes. -- Abstract.
Author: Marianthi G. Ierapetritou
Publisher: Humana Press
ISBN: 9781493949960
Category : Medical
Languages : en
Pages : 393
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Book Description
This thorough volume aims to provide pharmaceutical engineers with an introduction to the current state of the art in modeling and simulation of pharmaceutical processes and to summarize a number of practical applications of relevant methodologies in drug product development. Chapters include explorations of simulation and modeling methodologies, data collection and analysis, development of novel sensing techniques, development and integration of individual unit models, optimization approaches for data-based models, design space evaluation techniques, informatics-based methodologies, and emerging topics in pharmaceutical process development. As a part of the Methods in Pharmacology and Toxicology series, the chapters contain the kind of detail and implementation advice that will make the transition into the laboratory as smooth as possible. Authoritative and cutting edge, Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture seeks to promote research into process systems methodologies and their application in pharmaceutical product and process development, which will undoubtedly become an increasingly important area in the future.
Author: Efstratios N. Pistikopoulos
Publisher: John Wiley & Sons
ISBN: 1118965590
Category : Technology & Engineering
Languages : en
Pages : 326
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Book Description
Shows the newest developments in the field of multi-parametric model predictive control and optimization and their application for drug delivery systems This book is based on the Modelling, Control and Optimization of Biomedical Systems (MOBILE) project, which was created to derive intelligent computer model-based systems for optimization of biomedical drug delivery systems in the cases of diabetes, anaesthesia, and blood cancer. These systems can ensure reliable and fast calculation of the optimal drug dosage without the need for an online computer—while taking into account the specifics and constraints of the patient model, flexibility to adapt to changing patient characteristics and incorporation of the physician’s performance criteria, and maintaining the safety of the patients. Modelling Optimization and Control of Biomedical Systems covers: mathematical modelling of drug delivery systems; model analysis, parameter estimation, and approximation; optimization and control; sensitivity analysis & model reduction; multi-parametric programming and model predictive control; estimation techniques; physiologically-based patient model; control design for volatile anaesthesia; multiparametric model based approach to intravenous anaesthesia; hybrid model predictive control strategies; Type I Diabetes Mellitus; in vitro and in silico block of the integrated platform for the study of leukaemia; chemotherapy treatment as a process systems application; and more. Introduces readers to the Modelling, Control and Optimization of Biomedical Systems (MOBILE) project Presents in detail the theoretical background, computational tools, and methods that are used in all the different biomedical systems Teaches the theory for multi-parametric mixed-integer programming and explicit optimal control of volatile anaesthesia Provides an overview of the framework for modelling, optimization, and control of biomedical systems This book will appeal to students, researchers, and scientists working on the modelling, control, and optimization of biomedical systems and to those involved in cancer treatment, anaesthsia, and drug delivery systems.
Author: Ravendra Singh
Publisher: Elsevier
ISBN: 0444639667
Category : Technology & Engineering
Languages : en
Pages : 700
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Book Description
Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing
Author: Cenk Undey
Publisher: CRC Press
ISBN: 1439829454
Category : Medical
Languages : en
Pages : 330
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Book Description
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Author: Ahmad Taher Azar
Publisher: Academic Press
ISBN: 0128211954
Category : Technology & Engineering
Languages : en
Pages : 410
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Book Description
Modeling and Control of Drug Delivery Systems provides comprehensive coverage of various drug delivery and targeting systems and their state-of-the-art related works, ranging from theory to real-world deployment and future perspectives. Various drug delivery and targeting systems have been developed to minimize drug degradation and adverse effect and increase drug bioavailability. Site-specific drug delivery may be either an active and/or passive process. Improving delivery techniques that minimize toxicity and increase efficacy offer significant potential benefits to patients and open up new markets for pharmaceutical companies. This book will attract many researchers working in DDS field as it provides an essential source of information for pharmaceutical scientists and pharmacologists working in academia as well as in the industry. In addition, it has useful information for pharmaceutical physicians and scientists in many disciplines involved in developing DDS, such as chemical engineering, biomedical engineering, protein engineering, gene therapy. Presents some of the latest innovations of approaches to DDS from dynamic controlled drug delivery, modeling, system analysis, optimization, control and monitoring Provides a unique, recent and comprehensive reference on DDS with the focus on cutting-edge technologies and the latest research trends in the area Covers the most recent works, in particular, the challenging areas related to modeling and control techniques applied to DDS
Author: Guido Grüne
Publisher: Springer Science & Business Media
ISBN: 3642117171
Category : Business & Economics
Languages : en
Pages : 183
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Book Description
As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP’s consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants’ profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.
