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Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

Author: Terrence P. Tougas

Publisher: Springer Science & Business Media

Published: 2013-04-10

Total Pages: 443

ISBN-13: 1461462967

The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Author: Anthony J. Hickey

Publisher: CRC Press

Published: 2019-03-26

Total Pages: 784

ISBN-13: 0429619561

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This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

Inhaled Pharmaceutical Product Development Perspectives

Author: Anthony J. Hickey

Publisher: Elsevier

Published: 2017-11-23

Total Pages: 112

ISBN-13: 0128123362

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Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future. Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel

Inhalation Aerosols

Author: Anthony J. Hickey

Publisher: CRC Press

Published: 2019-03-21

Total Pages: 546

ISBN-13: 1351660519

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Inhalation aerosols continue to be the basis for successful lung therapy for several diseases, with therapeutic strategies and the range of technology significantly evolving in recent years. In response, this third edition takes a new approach to reflect the close integration of technology with its application. After briefly presenting the general considerations that apply to aerosol inhalation, the central section of the book uses the focus on disease and therapeutic agents to illustrate the application of specific technologies. The final integrated strategies section draws the major points from the applications for disease targets and drug products.

Communication and Intelligent Systems

Author: Harish Sharma

Publisher: Springer Nature

Published: 2023-07-10

Total Pages: 692

ISBN-13: 9819923220

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This book gathers selected research papers presented at the Fourth International Conference on Communication and Intelligent Systems (ICCIS 2022), organized by the National Institute of Technology, Delhi, India, during December 19–20, 2022. This book presents a collection of state-of-the-art research work involving cutting-edge technologies for communication and intelligent systems. Over the past few years, advances in artificial intelligence and machine learning have sparked new research efforts around the globe, which explore novel ways of developing intelligent systems and smart communication technologies. The book presents single- and multi-disciplinary research on these themes in order to make the latest results available in a single, readily accessible source. The work is presented in two volumes.

Pharmaceutical Powder and Particles

Author: Anthony J. Hickey

Publisher: Springer

Published: 2018-08-13

Total Pages: 108

ISBN-13: 3319912208

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This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance. Drs. Hickey and Giovagnoli have written an essential primer for any scientists involved in powder or particle research and manufacturing. It is appropriate for those just entering the field or as a rapid reference for the experienced pharmaceutical scientist. The authors have both academic and industrial experience and the coverage includes solid state chemistry; crystallization; physical processes; particle size and distribution;particle interaction;manufacturing processes;quality by design;and a general discussion of the industry. Pharmaceutical Powder and Particles is intended to concisely review important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.

Essentials of Aerosol Therapy in Critically ill Patients

Author: Mohamed E. A. Abdelrahim

Publisher: Springer Nature

Published: 2021-10-21

Total Pages: 245

ISBN-13: 3030850269

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This book assesses the most appropriate forms of aerosol therapy for critically ill patients. Aerosol therapy is applied for the treatment of several pulmonary diseases in addition to some promising applications intended for systemic absorption. Nowadays, aerosol delivery to clinically stable patients in the outpatient settings is done easily with a lot of focus on patient counseling and enhancement of lung deposition. A lot of guidelines are available for several diseases and it could offer adequate guidance to the therapists concerning escalation or de-escalation of therapy to enhance treatment efficiency and safety. However, in critically ill patients aerosol delivery is mostly done by the choice of the respiratory therapist only according to his knowledge. The book describes the type of patients requiring aerosol therapy, different aerosol generators available for the treatment of critically ill patients, mechanisms of aerosol lung deposition, and factors affecting aerosol deposition. It also discusses the special needs of neonates and infants, transitioning aerosol from hospital to home, and the methods of aerosol delivery to different patient e.g. nasal delivery patients, ventilated patients, etc. Moreover, it reviews methods of detecting such aerosol delivery to the lung. At the end, it discusses the suggested monitoring plans and weaning protocols to ensure high efficacy and safety of the ventilatory support in such patients. Given its scope, the book can serve as guidelines or specific recommendations to maximize clinical benefits of medicated aerosols in critically ill patients and it represents a valuable resource for intensivists, pulmonologists and healthcare professionals working at ICUs.

Inhaled Medicines

Author: Stavros Kassinos

Publisher: Academic Press

Published: 2021-01-20

Total Pages: 439

ISBN-13: 0128149752

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Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues

Alginate Biomaterial

Author: Sougata Jana

Publisher: Springer Nature

Published: 2023-01-31

Total Pages: 420

ISBN-13: 981196937X

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This book focuses on recent trends of research on alginate-based biomaterials in Drug Delivery strategies and biomedical engineering. It contains the widely used alginate-based biomaterials as micro to nano-controlled drug delivery (oral, ocular delivery, topical delivery, etc.) and its fabrication technology, characterization, and biomedical aspects (such as cancer therapy, tissue engineering, gene delivery, vaccine delivery, enzyme immobilization, wound healing, dental applications, etc.) in a single book. The chapters cover updated information, current research trends, informatics, and all aspects of applications. Alginate is a U.S. Food and Drug Administration (FDA)-approved natural biomaterial and has diverse biomedical applications. In recent years, researchers and scientists are working on the alginate-based drug delivery systems that have been designed and characterized as a matrix, micro to nanocarriers, fibers, composite/scaffolds, etc. Alginate has versatile properties such as biodegradable, biocompatible, nontoxic, and easily available. This book especially highlights both the drug delivery strategies and biomedical engineering aspects such as controlled drug delivery, drug targeting to the site of action, cancer therapy, gene and vaccine delivery, enzyme immobilization, tissue engineering, and regenerative medicine.

Inhaled Medicines

Author: Stavros Kassinos

Publisher: Academic Press

Published: 2021-02-05

Total Pages: 438

ISBN-13: 0128149744

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Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ? Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ? Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ? Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ? Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues