Essentials of Pharmaceutical Preformulation


Author: Simon Gaisford,Mark Saunders
Publisher: John Wiley & Sons
ISBN: 1118423240
Category: Science
Page: 272
View: 3682

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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: 7129

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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

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: 2147

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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: 972

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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: 3832

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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

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: 1200

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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

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: 7729

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"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

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: 4592

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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.

Instrumentelle Analytik

Grundlagen - Geräte - Anwendungen
Author: Douglas A. Skoog,James J. Leary
Publisher: Springer-Verlag
ISBN: 366207916X
Category: Science
Page: 900
View: 3271

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Mit der deutschsprachigen Ausgabe des Standard-Lehrbuchs zur Instrumentellen Analytik von Skoog und Leary schließt sich endlich eine Lücke im Buchangebot für fortgeschrittene Studenten der Chemie an Universitäten und Fachhochschulen. Aufgrund des multidisziplinären Eindringens der Analytischen Chemie in andere Bereiche richtet sich das Buch auch an Physiker, Ingenieure und Biochemiker. Das Buch führt aktuell und kompetent in die Grundzüge und Feinheiten der heutigen Instrumentellen Analytischen Chemie ein. Über 530 detailreiche, selbsterklärende Abbildungen, Anhänge zu Statistik und Elektronik, Übungsaufgaben mit Lösungen und viele wichtige Originalzitate ergänzen dieses moderne Lehrbuch für Studierende und Praktiker.

Handbook of Modern Pharmaceutical Analysis


Author: Satinder Ahuja,Stephen Scypinski
Publisher: Academic Press
ISBN: 9780123759818
Category: Medical
Page: 598
View: 9337

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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: 7692

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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: 1646

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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.

Scale-up

Modellübertragung in der Verfahrenstechnik
Author: Marko Zlokarnik
Publisher: John Wiley & Sons
ISBN: 3527660461
Category: Science
Page: 295
View: 3812

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Die Übertagung von Verfahren aus dem Labor-bzw. dem Techni-kumsmaßstab in den industriellen maßstab einer Produktiosanlage ist eine der wichtigsten ingenieurstechnischen Aufgaben in der chemischen Industrie. Die einzige zuverlässige Methode dazu basiert auf der Darstellung von Versuchsergebnissen im zutreffenden dimensions-analytischen Raum, der sich als maßstabsinvariant erweist. Das Buch ist in zwei Teile gegliedert: In der ersten Hälfte werden die vertiefte mathematische Vorkenntnisse dieses Themengebiet näherzubringen. Diskutiert werden die Grundlagen der Dimensionsanalyse, die Behandlung von temperaturabhängigen und von rheologischen Stoffwerten und die Modellübertragung bei Nichtverfügbarkeit von Modellstoffsystemen, sowie bei partieller Ähnlichkeit/ All dies wird dem leser anhand von 20 modernen Beispielen aus der heutigen verfahrenstechnischcen Praxis illustriert, der sich mit 25 in dieser Auflage neu hinzugekommenen Übungsaufgaben sein Verständnis aktive erarbeiten und anhand der Lösungen kontrollieren kann. Im zweitem Teil des Buches werden die einzelnen verfahrenstechnischen Grundoperationen aus den Bereichen mechanische, thermische und chemische Verfahrenstechnik aus der Sicht der Dimensionsanalyse und der Modellübertragung beispielhaft behandelt, und es werden für jede Operation die Maßstabsübertragungsregeln vorgestellt und diskutiert. Das vorliegende Buch wendet sich dementsprechend an Studenten wie auch bereits auf dem gebiet tätige Ingenieure, Chemiker und Verfahrenstechniker.

Pharmakokinetik

Eine Einführung
Author: Erich Gladtke,Hans Michael von Hattingberg
Publisher: Springer-Verlag
ISBN: 3662092727
Category: Medical
Page: 148
View: 6179

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Die Herausgeber dieses Büchleins sind bzw. waren meine langjährigen Mitarbeiter und haben sich überwiegend mit der praktischen und ange wandten Pharmakokinetik beschäftigt. Aus der gemeinsamen Arbeit ergab sich, daß unsere Arbeitsgruppe immer wieder zu Fortbildungsvor trägen und Einführungskursen über das Gebiet der Pharmakokinetik gebeten wurde. Diese Veranstaltungen waren vor allem für jene gedacht, die sich bisher noch nicht mit der Pharmakokinetik beschäftigt hatten, die also wissen wollten, um was es sich bei dieser Materie überhaupt handelt. Beim ersten Hinsehen erscheinen manchem Mediziner und Biologen die Formulierungen und mathematischen Ableitungen, wie sie in einigen diesbezüglichen Arbeiten verwendet werden und wie ich sie in meinen Grundlagen der Pharmakokinetik ausführlich immer wieder bringen mußte, vielleicht zu kompliziert und zu abschreckend. Deshalb begrüße ich es, daß Herr Gladtke und Herr von Hattingberg bewegt werden konnten, den Inhalt dieser Kurse niederzuschreiben. Es soll eine Orientierung und Einführung sein. Sicher werden einige Leser dadurch angeregt, tiefer in jene Materie einzudringen, die ich seinerzeit (1953) Pharmakokinetik genannt habe, ohne zu wissen, daß diese Be zeichnung inzwischen weltweite Bedeutung erlangt haben würde. Damit wäre das Büchlein von Nutzen. Ich darf dies den Autoren wünschen. Gießen, Dezember 1972 F.H. DOST V Vorwort Diese Schrift ist als Einführung in die Pharmakokinetik gedacht und darf damit nicht als Lehrbuch, Nachschlagewerk oder erschöpfende Dar stellung verstanden werden. Der Vorsteher der Sektion antimikrobielle Chemotherapie der Paul Ehr lich-Gesellschaft und Leiter der Abteilung für antimikrobielle Therapie der Universitäts-Kinderklinik München, Herr Professor Dr. med.

Biophysical Methods for Biotherapeutics

Discovery and Development Applications
Author: Tapan K. Das
Publisher: John Wiley & Sons
ISBN: 1118354680
Category: Medical
Page: 376
View: 526

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With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Pharmaceutical Capsules


Author: Fridrun Podczeck,Brian E. Jones
Publisher: Pharmaceutical Press
ISBN: 9780853695684
Category: Medical
Page: 272
View: 7240

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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.

Taschenatlas Pharmakologie


Author: Lutz Hein,Heinz Lüllmann,Klaus Mohr
Publisher: Georg Thieme Verlag
ISBN: 3131516577
Category: Medical
Page: 416
View: 659

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Wirkt sofort! Dieser Taschenatlas hilft. Beschwerden der Verwirrung und Überforderung werden sofort gemildert und weichen dem Gefühl des Verstehens und Begreifens. Die Wirkstoffe Visualisierung und Kompaktheit sind in großen Mengen aktiv. - Über 170 brillante Infografiken illustrieren die Pharmakologie und erleichtern dir den Zugang zu pharmakologischen Sachverhalten. Die kompakten Lerneinheiten eignen sich als Ergänzung zu einem Lehrbuch, zum Vertiefen und Wiederholen. Alle relevanten Informationen zu Wirkstoffgruppen kannst du rasch und gut verständlich nachlesen. Das sinnvolle arzneimitteltherapeutische Vorgehen bei wichtigen Erkrankungen kompakt und auf dem aktuellen Stand. Arzneimittel-Konvertierungslisten helfen dir auf der Suche nach dem Wirkstoff- oder Handelsnamen. Dank Daumenregister und Farbleitsystem kannst du dich schnell orientieren. Du verstehst Zusammenhänge und schaust über den ein oder anderen Tellerrand.

Pharmaceutical Formulation

The Science and Technology of Dosage Forms
Author: Geoffrey D Tovey
Publisher: Royal Society of Chemistry
ISBN: 1849739412
Category:
Page: 409
View: 4920

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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.

Pharmaceutical Inhalation Aerosol Technology


Author: Anthony J. Hickey
Publisher: Marcel Dekker Incorporated
ISBN: 9780824784645
Category: Medical
Page: 365
View: 9813

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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.