Formulation Tools For Pharmaceutical Development

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Formulation Tools for Pharmaceutical Development

J E Aguilar

Author : J E Aguilar
Publisher : Elsevier
Page : 304 pages
File Size : 41,7 Mb
Release : 2013-09-30
Category : Medical
ISBN : 9781908818508

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Formulation Tools for Pharmaceutical Development by J E Aguilar Pdf

A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines Development of drugs and medicines using mathematical tools Compilation of expert system developed around the world

Pharmaceutical Formulation Design

Usama Ahmad,Juber Akhtar

Author : Usama Ahmad,Juber Akhtar
Publisher : BoD – Books on Demand
Page : 166 pages
File Size : 42,9 Mb
Release : 2020-02-05
Category : Medical
ISBN : 9781789856620

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Pharmaceutical Formulation Design by Usama Ahmad,Juber Akhtar Pdf

Pharmaceutical formulations have evolved from simple and traditional systems to more modern and complex novel dosage forms. Formulation development is a tedious process and requires an enormous amount of effort from many different people. Developing a stable novel dosage form and further targeting it to the desired site inside the body has always been a challenge. The purpose of this book is to bring together scholarly articles that highlight recent developments and trends in pharmaceutical formulation science. Each article has been written by authors specializing in the subject area and hailing from top institutions around the world. The book has been written in a systematic and lucid style explaining all basic concepts and fundamentals in a very simple way. This book aims to serve the need of all individuals involved at any level in the pharmaceutical dosage form development. I sincerely hope that the book will be liked by inquisitive students and learned colleagues.

Pharmaceutical Formulation

Geoffrey D Tovey

Author : Geoffrey D Tovey
Publisher : Royal Society of Chemistry
Page : 432 pages
File Size : 51,6 Mb
Release : 2018-06-25
Category : Science
ISBN : 9781849739412

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Pharmaceutical Formulation by Geoffrey D Tovey Pdf

Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

Computer-aided applications in pharmaceutical technology

Ljiljana Djekic,Dragana Vasiljevic,Marija Primorac

Author : Ljiljana Djekic,Dragana Vasiljevic,Marija Primorac
Publisher : Elsevier Inc. Chapters
Page : 300 pages
File Size : 51,5 Mb
Release : 2013-04-10
Category : Technology & Engineering
ISBN : 9780128091883

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Computer-aided applications in pharmaceutical technology by Ljiljana Djekic,Dragana Vasiljevic,Marija Primorac Pdf

This chapter introduces the concept of formulation development assisted by computer applications. Development and optimization of various types of pharmaceutical emulsions microemulsions, self-microemulsifying systems, and double emulsions are presented. Illustrative examples are presented to demonstrate the ability of computer-aided tools to facilitate formulation development. Various techniques, such as design of experiments and artificial neural networks, are implemented for optimization of the formulation and/or processing parameters. Furthermore, some of the critical quality attributes and processing parameters are optimized simultaneously. The examples presented should serve as the foundation for the future quality-by-design development of pharmaceutical emulsion and (self) microemulsion formulations.

Pharmaceutical Suspensions

Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall

Author : Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
Publisher : Springer Science & Business Media
Page : 337 pages
File Size : 41,6 Mb
Release : 2009-11-05
Category : Medical
ISBN : 9781441910875

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Pharmaceutical Suspensions by Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall Pdf

The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

Lars Hovgaard,Sven Frokjaer,Marco van de Weert

Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
Publisher : CRC Press
Page : 395 pages
File Size : 42,7 Mb
Release : 2012-11-14
Category : Medical
ISBN : 9781439853887

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Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition by Lars Hovgaard,Sven Frokjaer,Marco van de Weert Pdf

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Innovative Dosage Forms

Yogeshwar Bachhav

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Page : 470 pages
File Size : 47,7 Mb
Release : 2019-12-04
Category : Science
ISBN : 9783527343966

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Innovative Dosage Forms by Yogeshwar Bachhav Pdf

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Feroz Jameel,Susan Hershenson

Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Page : 986 pages
File Size : 48,8 Mb
Release : 2010-07-13
Category : Science
ISBN : 9780470595879

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Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Feroz Jameel,Susan Hershenson Pdf

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Developing Solid Oral Dosage Forms

Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter

Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Page : 978 pages
File Size : 43,9 Mb
Release : 2009-03-10
Category : Medical
ISBN : 008093272X

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Developing Solid Oral Dosage Forms by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter Pdf

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Pharmaceutical, Cosmetic and Personal Care Formulations

Tharwat F. Tadros

Author : Tharwat F. Tadros
Publisher : Walter de Gruyter GmbH & Co KG
Page : 362 pages
File Size : 44,6 Mb
Release : 2018-05-22
Category : Science
ISBN : 9783110587982

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Pharmaceutical, Cosmetic and Personal Care Formulations by Tharwat F. Tadros Pdf

Volume 3 of Formulation Science and Technology is a survey of the applications of formulations in a variety of fields, based on the theories presented in Volumes 1 and 2. It offers in-depth explanations and a wealth of real-world examples for research scientists, universities, and industry practitioners in the fields of Pharmaceuticals, Cosmetics and Personal Care.

Pediatric Formulations

Daniel Bar-Shalom,Klaus Rose

Author : Daniel Bar-Shalom,Klaus Rose
Publisher : Springer Science & Business Media
Page : 429 pages
File Size : 49,8 Mb
Release : 2014-01-30
Category : Medical
ISBN : 9781489980113

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Pediatric Formulations by Daniel Bar-Shalom,Klaus Rose Pdf

Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

High-Throughput Formulation Development of Biopharmaceuticals

Vladimir I. Razinkov,Gerd Kleemann

Author : Vladimir I. Razinkov,Gerd Kleemann
Publisher : Woodhead Publishing
Page : 132 pages
File Size : 40,7 Mb
Release : 2016-09-29
Category : Medical
ISBN : 9781908818768

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High-Throughput Formulation Development of Biopharmaceuticals by Vladimir I. Razinkov,Gerd Kleemann Pdf

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

Biopharmaceutics

Hannah Batchelor

Author : Hannah Batchelor
Publisher : John Wiley & Sons
Page : 324 pages
File Size : 49,7 Mb
Release : 2021-12-20
Category : Medical
ISBN : 9781119678281

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Biopharmaceutics by Hannah Batchelor Pdf

Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.

Formulation and Analytical Development for Low-Dose Oral Drug Products

Jack Zheng

Author : Jack Zheng
Publisher : John Wiley & Sons
Page : 506 pages
File Size : 41,9 Mb
Release : 2009-02-09
Category : Medical
ISBN : 9780470056097

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Formulation and Analytical Development for Low-Dose Oral Drug Products by Jack Zheng Pdf

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Handbook of Pharmaceutical Granulation Technology

Dilip M. Parikh

Author : Dilip M. Parikh
Publisher : CRC Press
Page : 905 pages
File Size : 41,6 Mb
Release : 2021-05-11
Category : Medical
ISBN : 9781000366389

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Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf

Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Formulation Tools For Pharmaceutical Development

Formulation Tools for Pharmaceutical Development by J E Aguilar Pdf

Pharmaceutical Formulation Design by Usama Ahmad,Juber Akhtar Pdf

Pharmaceutical Formulation by Geoffrey D Tovey Pdf

Computer-aided applications in pharmaceutical technology by Ljiljana Djekic,Dragana Vasiljevic,Marija Primorac Pdf

Pharmaceutical Suspensions by Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall Pdf

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition by Lars Hovgaard,Sven Frokjaer,Marco van de Weert Pdf

Innovative Dosage Forms by Yogeshwar Bachhav Pdf

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Feroz Jameel,Susan Hershenson Pdf

Developing Solid Oral Dosage Forms by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter Pdf

Pharmaceutical, Cosmetic and Personal Care Formulations by Tharwat F. Tadros Pdf

Pediatric Formulations by Daniel Bar-Shalom,Klaus Rose Pdf

High-Throughput Formulation Development of Biopharmaceuticals by Vladimir I. Razinkov,Gerd Kleemann Pdf

Biopharmaceutics by Hannah Batchelor Pdf

Formulation and Analytical Development for Low-Dose Oral Drug Products by Jack Zheng Pdf

Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf

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