Download or read online books in PDF, EPUB and Mobi Format. Click Download or Read Online button to get book now. This site is like a library, Use search box in the widget to get ebook that you want.

Essentials of Pharmaceutical Preformulation

Essentials of Pharmaceutical Preformulation Author Simon Gaisford
ISBN-10 9781118423240
Release 2012-10-22
Pages 272
Download Link Click Here

Essentials of Pharmaceutical Preformulation is a study guide which describes the basic principles of pharmaceutical physicochemical characterisation. Successful preformulation requires knowledge of fundamental molecular concepts (solubility, ionisation, partitioning, hygroscopicity and stability) and macroscopic properties (physical form, such as the crystalline and amorphous states, hydrates, solvates and co-crystals and powder properties), familiarity with the techniques used to measure them and appreciation of their effect on product performance, recognising that often there is a position of compromise to be reached between product stability and bioavailability. This text introduces the basic concepts and discusses their wider implication for pharmaceutical development, with reference to many case examples of current drugs and drug products. Special attention is given to the principles and best-practice of the analytical techniques that underpin preformulation (UV spectrophotometry, TLC, DSC, XRPD and HPLC). The material is presented in the typical order that would be followed when developing a medicine and maps onto the indicative pharmacy syllabus of the Royal Pharmaceutical Society of Great Britain Undergraduate-level pharmacy students and R&D / analytical scientists working in the pharmaceutical sector (with or without a pharmaceutical background) will find this text easy to follow with relevant pharmaceutical examples. Essential study guide for pharmacy and pharmaceutical science students Covers the pharmaceutical preformulation components of the Royal Pharmaceutical Society of Great Britain’s indicative syllabus Easy to follow text highlighted with relevant pharmaceutical examples Self-assessment assignments in a variety of formats Written by authors with both academic and industrial experience Companion website with further information to maximise learning

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation Author Mark Gibson
ISBN-10 9781420073188
Release 2016-04-19
Pages 560
Download Link Click Here

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Author Yihong Qiu
ISBN-10 9780128026373
Release 2016-11-08
Pages 1176
Download Link Click Here

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Pharmaceutical Suspensions

Pharmaceutical Suspensions Author Alok K. Kulshreshtha
ISBN-10 1441910875
Release 2009-11-05
Pages 327
Download Link Click Here

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.

Essentials of Pharmaceutical Chemistry

Essentials of Pharmaceutical Chemistry Author Donald Cairns
ISBN-10 9780853699798
Release 2012-01-01
Pages 308
Download Link Click Here

An introduction to pharmaceutical chemistry for undergraduate pharmacy, chemistry and medicinal chemistry students. Essentials of Pharmaceutical Chemistry is a chemistry introduction that covers all of the core material necessary to provide an understanding of the basic chemistry of drug molecules. Now a core text on many university courses, it contains numerous worked examples and problems. The 4th edition includes new chapters on Chromatographic Methods of Analysis, and Medicinal Chemistry - The Science of Drug Design.

Aulton s Pharmaceutics

Aulton s Pharmaceutics Author Michael E. Aulton
ISBN-10 9780702042904
Release 2013
Pages 894
Download Link Click Here

Pharmaceutics is one of the most diverse subject areas in all of pharmaceutical science. In brief, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms or medicines. An understanding of pharmaceutics is therefore vital for all pharmacists and those pharmaceutical scientists who are involved with converting a drug or a potential drug into a medicine that can be delivered safely, effectively and conveniently to the patient. Now in its fourth edition, this best-selling textbook in pharmaceutics has been brought completely up to date to reflect the rapid advances in delivery methodologies by eye and injection, advances in drug formulations and delivery methods for special groups (such as children and the elderly), nanomedicine, and pharmacognosy. At the same time the editors have striven to maintain the accessibility of the text for students of pharmacy, preserving the balance between being a suitably pitched introductory text and a clear reflection of the state of the art. provides a logical, comprehensive account of drug design and manufacture includes the science of formulation and drug delivery designed and written for newcomers to the design of dosage forms New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Author Feroz Jameel
ISBN-10 9780470595879
Release 2010-07-13
Pages 976
Download Link Click Here

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.

Pharmaceutical Preformulation

Pharmaceutical Preformulation Author J. Wells
ISBN-10 OCLC:969394138
Release 1999
Download Link Click Here

Pharmaceutical Preformulation has been writing in one form or another for most of life. You can find so many inspiration from Pharmaceutical Preformulation also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Pharmaceutical Preformulation book for free.

Preformulation in Solid Dosage Form Development

Preformulation in Solid Dosage Form Development Author Moji Christianah Adeyeye
ISBN-10 9780824758097
Release 2008-01-07
Pages 616
Download Link Click Here

During the onset of any clinical trial there are many factors and variables to consider. Funding, time restraints, and regulatory agency guidelines are factors that often influence which variables will be studied, leaving other important information out of the study. Preformulation in Solid Dosage Form Development covers every topic of critical importance to the preformulation stages of drug development. Serving as a handbook or stand-alone reference, this text equips those in academia and the pharmaceutical industry with both basic and applied principles for the characterization of drugs, excipients, and products, and deals with the issues relating to predictability, identification, and product development during preformulation stages through Phase I of clinical trials. With contributions from an international panel of experts in the field, this guide: outlines an updated preformulation program for modern drug development issues that includes particle morphology, characterization, thermal analysis, and solubility methods contains rational designs for the structure of formulation studies covers the importance of preformulation design using artificial neural networks and computational prediction techniques, and examines the concepts of preliminary-preformulation discusses the typical drug-excipient interactions that could occur during the course of development and methods of characterization includes novel methods to determine the physical and chemical stability of new formulations reviews the structure, content, and format of the preformulation report examines the significance of drug substance physiochemical properties, in regulatory quality by design

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development Author J E Aguilar
ISBN-10 9781908818508
Release 2013-09-30
Pages 304
Download Link Click Here

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

Handbook of Pharmaceutical Salts Properties Selection and Use

Handbook of Pharmaceutical Salts Properties  Selection  and Use Author P. Heinrich Stahl
ISBN-10 3906390586
Release 2008-08-04
Pages 374
Download Link Click Here

This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.

Pharmaceutical Capsules

Pharmaceutical Capsules Author Fridrun Podczeck
ISBN-10 0853695687
Release 2004
Pages 272
Download Link Click Here

Previously published as Hard Capsules, this updated and expanded second edition covers all aspects of capsule technology, including history, standards, methods and equipment used in manufacture, filling, printing, weighing, cleaning and inspecting of both hard and soft capsules. Pharmaceutical Capsules is an essential resource for all those involved in the development, manufacture and testing of capsules. It will also be valuable to pharmaceutical science students and regulatory authorities.

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing Author Steven W. Baertschi
ISBN-10 9781439801802
Release 2016-04-19
Pages 612
Download Link Click Here

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Pharmaceutical Experimental Design

Pharmaceutical Experimental Design Author Gareth A. Lewis
ISBN-10 9780824746889
Release 1998-09-10
Pages 512
Download Link Click Here

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development.Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design!Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design· offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books· reviews screening designs for qualitative factors at different levels· presents designs for predictive models and their use in optimization· highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability· discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer· details nonstandard designs and mixtures· analyzes factorial, D-optimal design, and offline quality assurance techniques· reveals how one experimental design evolves from another· and more!Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

Pharmaceutical Emulsions

Pharmaceutical Emulsions Author Dipak Kumar Sarker
ISBN-10 9781118648360
Release 2013-07-26
Pages 204
Download Link Click Here

Pharmaceutical Emulsions: A Drug Developer's Toolbag covers all the key aspects of pharmaceutical emulsions, starting from the fundamental scientific basics, to the pharmaceutical forms and the chemical tests for its application. The author uses his extensive experience in both industry and academic experience to provide a concise, student friendly guide to the essential fundamentals of physical pharmacy. Divided into three clear sections, the text begins with Section A - Consideration for Product: Medicinal Formulation which includes a historical perspective, explanation of what is an emulsion, stability and instability, and manufacture. Section B - Forms, Use and Application follows, with chapters on creams and ointments, pastes and bases, colloids, transdermal, gels and implants. The final Section, Tests: Chemistry to control the quality, efficacy and fitness for purpose of the product includes chapters on physic-chemical properties, sizing and microscopy, rheology, QC and finally questions, calculations and dilemmas. Throughout the text there are numerous figures, diagrams and tables to engage the reader. This is an invaluable reference for all students of pharmaceutical sciences, pharmacy industrial pharmaceutical sciences, physical pharmacy and pharmaceutical forms as well as industry professionals

Protein Formulation and Delivery Second Edition

Protein Formulation and Delivery  Second Edition Author Eugene J. McNally
ISBN-10 0849379520
Release 2007-10-26
Pages 376
Download Link Click Here

This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.

Integrated Pharmaceutics

Integrated Pharmaceutics Author Antoine Al-Achi
ISBN-10 9781118356715
Release 2013-01-22
Pages 1016
Download Link Click Here

Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.