Essentials of Pharmaceutical Preformulation

Author: Simon Gaisford,Mark Saunders

Publisher: John Wiley & Sons

ISBN: 1118423240

Category: Science

Page: 272

View: 5618

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

Handbook of Preformulation

Chemical, Biological, and Botanical Drugs

Author: Sarfaraz K. Niazi

Publisher: CRC Press

ISBN: 9781420006629

Category: Medical

Page: 446

View: 8991

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this handbook provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics

Author: Patrick Augustijns,Marcus Brewster

Publisher: Springer Science & Business Media

ISBN: 0387691545

Category: Medical

Page: 462

View: 5513

Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

Pharmaceutical Preformulation and Formulation

A Practical Guide from Candidate Drug Selection to Commercial Dosage Form

Author: Mark Gibson

Publisher: CRC Press

ISBN: 1420073184

Category: Medical

Page: 560

View: 5674

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.

Theory and Practice of Physical Pharmacy - E-Book

Author: Gaurav Jain,Roop Krishen Khar,Farhan Jalees Ahmad

Publisher: Elsevier Health Sciences

ISBN: 8131232654

Category: Medical

Page: 420

View: 1380

A core subject in pharmaceutics, physical pharmacy is taught in the initial semesters of B. Pharm. The methodical knowledge of the subject is required, and is essential, to understand the principles pertaining to design and development of drug and drug products. Theory and Practice of Physical Pharmacy is unique as it fulfils the twin requirements of physical pharmacy students: the authentic text on theoretical concepts and its application including illustrative exercises in the form of practicals. Covers all the topics included in various existing syllabi of physical pharmacy Provides an integrated understanding of theory and practical applications associated with physicochemical concepts Explore the latest developments in the field of pharmaceutics Reviews the relevance of physicochemical principles in the design of dosage form Ensures proper recapitulation through sufficient end-of-chapter questions Provides valuable learning tool in the form of multiple choice questions Multiple choice questions section especially useful for GPAT aspirants

Chemistry for Pharmacy Students

General, Organic and Natural Product Chemistry

Author: Satyajit Sarker,Lutfun Nahar

Publisher: John Wiley & Sons

ISBN: 0470017805

Category: Science

Page: 396

View: 2290

"This book has succeeded in covering the basic chemistry essentials required by the pharmaceutical science student… the undergraduate reader, be they chemist, biologist or pharmacist will find this an interesting and valuable read." –Journal of Chemical Biology, May 2009 Chemistry for Pharmacy Students is a student-friendly introduction to the key areas of chemistry required by all pharmacy and pharmaceutical science students. The book provides a comprehensive overview of the various areas of general, organic and natural products chemistry (in relation to drug molecules). Clearly structured to enhance student understanding, the book is divided into six clear sections. The book opens with an overview of general aspects of chemistry and their importance to modern life, with particular emphasis on medicinal applications. The text then moves on to a discussion of the concepts of atomic structure and bonding and the fundamentals of stereochemistry and their significance to pharmacy- in relation to drug action and toxicity. Various aspects of aliphatic, aromatic and heterocyclic chemistry and their pharmaceutical importance are then covered with final chapters looking at organic reactions and their applications to drug discovery and development and natural products chemistry. accessible introduction to the key areas of chemistry required for all pharmacy degree courses student-friendly and written at a level suitable for non-chemistry students includes learning objectives at the beginning of each chapter focuses on the physical properties and actions of drug molecules

Developing Solid Oral Dosage Forms

Pharmaceutical Theory and Practice

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

Publisher: Academic Press

ISBN: 9780080932729

Category: Medical

Page: 978

View: 7280

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 Formulation

The Science and Technology of Dosage Forms

Author: Geoffrey D Tovey

Publisher: Royal Society of Chemistry

ISBN: 1849739412

Category:

Page: 409

View: 5759

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.

Morphology Control of Materials and Nanoparticles

Advanced Materials Processing and Characterization

Author: Yoshio Waseda,Atsushi Muramatsu

Publisher: Springer Science & Business Media

ISBN: 9783540009580

Category: Technology & Engineering

Page: 262

View: 2620

This is the first major compilation of new advances covering the current status and topics related to the processing and production of precisely controlled materials. It provides a unique source of information and guidance for specialists and non-specialists alike. This book represents an extended introductory treatise on the fundamental aspects, new methods for the precise control of morphology (size, shape, composition, structure etc.) and accurate materials characterization, from both the basic science and the applied engineering viewpoints.

Handbook of Modern Pharmaceutical Analysis

Author: Satinder Ahuja,Stephen Scypinski

Publisher: Academic Press

ISBN: 9780123759818

Category: Medical

Page: 598

View: 7051

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Polymorphism in Pharmaceutical Solids, Second Edition

Author: Harry G. Brittain

Publisher: CRC Press

ISBN: 1420073222

Category: Medical

Page: 656

View: 1102

Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism and solvatomorphism, while systematically explaining their thermodynamic and structural origins. Topics include: Computational methodologies High-throughput screening methods Pharmaceutical cocrystals Thermally-induced and solution-mediated phase transformations Amorphous solids Crystallography preparation and characterization The amorphous state

Formulating Poorly Water Soluble Drugs

Author: Robert O. Williams III,Alan B. Watts,Dave A. Miller

Publisher: Springer Science & Business Media

ISBN: 9781461411444

Category: Medical

Page: 648

View: 884

This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.

Pharmaceutical Inhalation Aerosol Technology

Author: Anthony J. Hickey

Publisher: Marcel Dekker Incorporated

ISBN: 9780824784645

Category: Medical

Page: 365

View: 2695

This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.

Pharmakokinetik

Eine Einführung

Author: Erich Gladtke,Hans Michael von Hattingberg

Publisher: Springer-Verlag

ISBN: 3662092719

Category: Medical

Page: 164

View: 7273


Pharmaceutical Capsules

Author: Fridrun Podczeck,Brian E. Jones

Publisher: Pharmaceutical Press

ISBN: 9780853695684

Category: Medical

Page: 272

View: 3233

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.

International Pharmaceutical Product Registration, Second Edition

Author: Anthony C. Cartwright,Brian R. Matthews

Publisher: CRC Press

ISBN: 1420081837

Category: Medical

Page: 852

View: 2793

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

Development of Biopharmaceutical Parenteral Dosage Forms

Author: Cosimo Prantera,Burton I. Korelitz

Publisher: CRC Press

ISBN: 0585378002

Category: Medical

Page: 264

View: 3602

This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.