Quality-by-Design Optimization of Intraperitoneal Drug Delivery with Pressurized Aerosols PDF Download

Author: Iaroslav Sautkin
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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Book Description

Author: Iaroslav Sautkin
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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Book Description
Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a minimally invasive treatment mode for local chemotherapy of Peritoneal Metastasis (PM). PIPAC has demonstrated promising results in the first clinical studies. Optimization of the current drug-devices combinations requires functional models. The currently used in vivo, in vitro and ex vivo models cannot deliver real-time information on tissue drug uptake. Moreover, alternatives should be developed to limit research on living animals. This study focuses on the development and validation of an ex vivo model for optimizing intraperitoneal drug delivery, the enhanced Inverted Bovine Urinary Bladder Model (eIBUB). The research builds up on the IBUB model proposed by Schnelle et al in 2017, by connecting a second vessel to the bladder. A list of specifications and requirements for an ex-vivo model was created. The eIBUB model takes advantage of the principle of communicating vessels by connecting the base of the bladder to a second, hermetic container kept under an identical pressure. This design allows continuous collection of the aerosol falling down, and real-time assessment of the tissue liquid uptake (i.e., the portion of the therapeutic aerosol effectively taken up by the tissue) vs. the liquid falling down (which, by definition, can only have a limited therapeutic effect). This study details the technical setup of the eIBUB model and its feasibility, in particular concerning real-time measurements. The verification process showed that the eIBUB model meets the majority of the specifications. The usability and safety of the eIBUB model was confirmed under real laboratory conditions using toxic drugs. The validation process, involving two drugs commonly used during PIPAC (doxorubicin and cisplatin), showed that the depth of tissue penetration and the tissue drug concentration are in line with the gold standard (measurements in the human patient) and available comparators (ex-vivo and animal models). The variability of the results was at least comparable to the comparators. The eIBUB model meets the ARRIVE criteria (replacement, reduction, refinement) in animal research. Thus, the eIBUB model is a significant advance in peritoneal pharmacological research.

Author: Ranjita Shegokar
Publisher: Elsevier
ISBN: 9780128178706
Category : Business & Economics
Languages : en
Pages : 250

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Drug Delivery Trends: Expectations and Realities of Multifunctional Drug Delivery Systems, Volume Three explores new trends in market and drug delivery therapy. Nanowires, 3D printing, Minitablets, EU regulations on registrations, and GMP scale up challenges of nanocarriers are selected topics. Written by a diverse range of international researchers from industry and academia, the book's chapters examine specific aspects of characterization and manufacturing for pharmaceutical applications and regulatory and policy aspects. Users will find the topics covered spur discussions on opportunities and challenges in the development of micro-nanomedicine and other drug delivery systems. This book connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stakeholders. This level of discussion makes it a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about the status of drug delivery systems. Investigates current and new trends in micro-nano pharmaceuticals Examines drug delivery trends in OSDFs, including minitablet, nano-micro OSDFs Includes regulatory discussions regarding quality and legal guidelines Contains in-depth investigations on the specific aspects of drug delivery systems

Author: Ajit S Narang
Publisher: Springer
ISBN: 3319202065
Category : Medical
Languages : en
Pages : 700

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Book Description
In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Author: Philip Chi Lip Kwok
Publisher: CRC Press
ISBN: 131531195X
Category : Medical
Languages : en
Pages : 201

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Book Description
The respiratory tract has been used to deliver biologically active chemicals into the human body for centuries. However, the lungs are complex in their anatomy and physiology, which poses challenges to drug delivery. Inhaled formulations are generally more sophisticated than those for oral and parenteral administration. Pulmonary drug development is therefore a highly specialized area because of its many unique issues and challenges. Rapid progress is being made and offers novel solutions to existing treatment problems. Advances in Pulmonary Drug Delivery highlights the latest developments in this field.

Author: Tol S. Purewal
Publisher: CRC Press
ISBN: 9781574910650
Category : Technology & Engineering
Languages : en
Pages : 280

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Book Description
Metered Dose Inhaler Technology explores the technologies of pressurized metered dose inhalation (MDI) delivery systems and provides practical, easy-to-use guidance to effective product formulation. With contributions from an international panel of authors, the book addresses the global phase-out of chloroflurocarbon chemicals (CFCs), the generation of propellant systems to replace them, and their associated new medications and therapies. Topics include the manufacture of metered dose inhalers, particle size analysis in inhalation therapy, development and testing, pharmcokinetics and metabolism of propellants, toxicology, and more.

Author: Binghe Wang
Publisher: John Wiley & Sons
ISBN: 1118833368
Category : Science
Languages : en
Pages : 740

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Book Description
Following its successful predecessor, this book covers the fundamentals, delivery routes and vehicles, and practical applications of drug delivery. In the 2nd edition, almost all chapters from the previous are retained and updated and several new chapters added to make a more complete resource and reference. • Helps readers understand progress in drug delivery research and applications • Updates and expands coverage to reflect advances in materials for delivery vehicles, drug delivery approaches, and therapeutics • Covers recent developments including transdermal and mucosal delivery, lymphatic system delivery, theranostics • Adds new chapters on nanoparticles, controlled drug release systems, theranostics, protein and peptide drugs, and biologics delivery

Author: Ana Patricia Ferreira
Publisher: Academic Press
ISBN: 012811066X
Category : Medical
Languages : en
Pages : 465

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Book Description
Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Author: Ashok Katdare
Publisher: CRC Press
ISBN: 1420004131
Category : Medical
Languages : en
Pages : 474

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Book Description
To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Author: Padma V. Devarajan
Publisher: Springer
ISBN: 3319113550
Category : Medical
Languages : en
Pages : 788

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Book Description
This authoritative volume explores the fundamental concepts and numerous applications of targeted delivery of drugs to the body. This compilation has been divided into eight sections comprised of the basic principles of drug targeting, disease and organ/organelle-based targeting, passive and active targeting strategies, and various advanced drug delivery tools such as functionalized lipidic, polymeric and inorganic nanocarriers. Together, the twenty-three chapters cover a wide range of topics in the field, including tumor and hepatic targeting, polymer-drug conjugates, nanoemulsion, physical and biophysical characteristics of nanoparticles, and in vivo imaging techniques, among others. The book also examines advanced characterization techniques, regulatory hurdles and toxicity-related issues that are key features for successful commercialization of targeted drug delivery system products. Targeted Drug Delivery is a comprehensive reference guide for drug delivery researchers, both beginners and those already working in the field.