Development and Formulation of Veterinary Dosage Forms, Second Edition

Author: Gregory E. Hardee,J. Desmond Baggo

Publisher: CRC Press

ISBN: 9781420001860

Category: Medical

Page: 504

View: 6512

This up-to-the-minute Second Edition of an incomparable resource describes in detail the bases for developing dosage forms for use in animals-highlighting the data necessary to meet regulatory approval. Demonstrates the successful characterization, control, and registration of new veterinary medicines! Thoroughly rewritten and enlarged to reflect the technical advances that have occurred since the previous edition, Development and Formulation of Veterinary Dosage Forms, Second Edition discusses the reasons for dosage form selection explains the latest available technologies examines new drug therapeutics reveals up-to-date techniques and applications for pharmacokinetic data covers the formulation of products derived from biotechnology elucidates recent analytical methods shows how to determine the type of dosage form appropriate for particular species and more! Written by a team of international authorities from North America and Europe and containing over 1100 bibliographic citation, figures, and tables, Development and Formulation of Veterinary Dosage Forms, Second Edition is an essential reference for pharmaceutical, animal, and quality control scientists; research pharmacists and pharmacologists; veterinarians; drug quality assurance and regulatory personnel in government and industry; pathologists; microbiologists; virologists; physiologists; toxicologists; and upper-level undergraduate and graduate students in these disciplines.
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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: 1060

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.
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Oral Formulation Roadmap from Early Drug Discovery to Development

Author: Elizabeth Kwong

Publisher: John Wiley & Sons

ISBN: 1118907906

Category: Medical

Page: 272

View: 3841

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
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ADMET for Medicinal Chemists

A Practical Guide

Author: Katya Tsaioun,Steven A. Kates

Publisher: John Wiley & Sons

ISBN: 9780470922811

Category: Medical

Page: 512

View: 4004

This book guides medicinal chemists in how to implement early ADMET testing in their workflow in order to improve both the speed and efficiency of their efforts. Although many pharmaceutical companies have dedicated groups directly interfacing with drug discovery, the scientific principles and strategies are practiced in a variety of different ways. This book answers the need to regularize the drug discovery interface; it defines and reviews the field of ADME for medicinal chemists. In addition, the scientific principles and the tools utilized by ADME scientists in a discovery setting, as applied to medicinal chemistry and structure modification to improve drug-like properties of drug candidates, are examined.
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Pharmaceutical Dosage Forms and Drug Delivery

Author: Ram I. Mahato,Ajit S. Narang

Publisher: CRC Press

ISBN: 1420009206

Category: Medical

Page: 336

View: 2867

Integrating aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, Pharmaceutical Dosage Forms and Drug Delivery elucidates basic physicochemical principles and their application in the design of dosage forms. The author addresses the relevance of these principles to the biopharmaceutical aspects of drugs. He explores the latest developments in the application of biomaterials, including polymers and biotechnology-based agents, to the development of novel dosage forms. The book covers physicochemical principles of dosage design, biopharmaceutical and physiological considerations, types of commonly used pharmaceutical dosage forms, introduction to polymeric biomaterials, protein and nucleic acid-based dosage forms, and novel and targeted drug delivery systems. It highlights the physicochemical parameters used for the design, development, and evaluation of biotechnological dosage forms and describes the biological barriers to drug absorption. Containing the right blend of mathematics, equations, diagrams, pictorials, and other pertinent information, this book provides a unified perspective that creates a greater overall understanding of basic science and cutting-edge technology.
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Pharmaceutical Suspensions

From Formulation Development to Manufacturing

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

Publisher: Springer Science & Business Media

ISBN: 9781441910875

Category: Medical

Page: 327

View: 8002

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.
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Pharmaceutical Stress Testing

Predicting Drug Degradation, Second Edition

Author: Steven W. Baertschi,Karen M. Alsante,Robert A. Reed

Publisher: CRC Press

ISBN: 1439801800

Category: Medical

Page: 612

View: 2457

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).
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Generic Drug Product Development

Solid Oral Dosage Forms, Second Edition

Author: Leon Shargel,Isadore Kanfer

Publisher: CRC Press

ISBN: 1420086367

Category: Medical

Page: 397

View: 9645

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
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Generic Drug Product Development

Bioequivalence Issues

Author: Isadore Kanfer,Leon Shargel

Publisher: CRC Press

ISBN: 1420020013

Category: Medical

Page: 288

View: 2791

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
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Photostability of Drugs and Drug Formulations, Second Edition

Author: Hanne Hjorth Tonnesen

Publisher: CRC Press

ISBN: 9781420023596

Category: Medical

Page: 448

View: 7842

Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features Assists non-experts in this field design a test protocol and interpret the results Covers in vitro and in vivo aspects of interactions between drugs and light Explores the kinetic and chemical aspects of drug photodecomposition Discusses the problems frequently encountered in photochemical stability testing Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint Offers specific guidance in photostability testing and screening of drug photoreactivity
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Handbook of Pharmaceutical Manufacturing Formulations

Liquid Products (Volume 3 of 6)

Author: Sarfaraz K. Niazi

Publisher: CRC Press

ISBN: 9781420048452

Category: Medical

Page: 256

View: 5456

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs and the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.
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Pharmaceutical Dosage Forms - Parenteral Medications

Volume 2: Facility Design, Sterilization and Processing

Author: Sandeep Nema,John D. Ludwig

Publisher: CRC Press

ISBN: 1420086464

Category: Medical

Page: 406

View: 5917

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume two presents: • Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. • A comprehensive chapter on pharmaceutical water systems. • A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. • A detailed chapter on processing of parenteral drug products (SVPs and LVPs). • Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat. • An in-depth chapter on lyophilization.
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Handbook of Pharmaceutical Salts Properties, Selection, and Use

Author: P. Heinrich Stahl,Camille G. Wermuth

Publisher: John Wiley & Sons

ISBN: 9783906390581

Category: Science

Page: 374

View: 3338

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.
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Pharmaceutical Manufacturing Handbook

Production and Processes

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

ISBN: 9780470259801

Category: Science

Page: 1384

View: 2048

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
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Oral Drug Absorption

Prediction and Assessment

Author: Jennifer B. Dressman,Hans Lennernas

Publisher: CRC Press

ISBN: 9780824702724

Category: Medical

Page: 352

View: 7767

A practical, hands-on guide for successfully developing oral drug products, this comprehensive reference runs the gamut from theoretical stages of computer-based calculations to practical guidelines for establishing in vitro/in vivo correlations. Coverage details the interrelationship between the physiology of the gastrointestinal tract and oral drug formulations and absorption, and progresses to the latest applications of pharmacokinetic analysis. Includes chapters by the innovators of the Biopharmaceutical Classification Scheme (BCS), human perfusions, and biorelevant dissolution testing! With over 600 literature references, equations, drawings, and photographs, Oral Drug Absorption offers multiple methods for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence facilitates selection of appropriate drug candidates for development fully elaborates on the experimental and data analysis techniques of in vitro/in vivo correlations provides guidance to the Federal Drug Administration's BCS and its applications appends helpful case studies to the concepts discussed and much more! Contributions by more than 20 international specialists on the latest research make Oral Drug Absorption an invaluable tool and useful reference in the hands of pharmaceutical scientists, medicinal chemists, pharmacists, pharmacologists, toxicologists, biochemists, gastroenterologists, regulatory personnel, and graduate school students in these disciplines.
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Remington

The Science and Practice of Pharmacy

Author: David B. Troy,Paul Beringer

Publisher: Lippincott Williams & Wilkins

ISBN: 9780781746731

Category: Medical

Page: 2393

View: 9323

For over 100 years, Remington has been the definitive textbook and reference on the science and practice of pharmacy. This Twenty-First Edition keeps pace with recent changes in the pharmacy curriculum and professional pharmacy practice. More than 95 new contributors and 5 new section editors provide fresh perspectives on the field. New chapters include pharmacogenomics, application of ethical principles to practice dilemmas, technology and automation, professional communication, medication errors, re-engineering pharmacy practice, management of special risk medicines, specialization in pharmacy practice, disease state management, emergency patient care, and wound care. Purchasers of this textbook are entitled to a new, fully indexed Bonus CD-ROM, affording instant access to the full content of Remington in a convenient and portable format.
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Mechanisms of Transdermal Drug Delivery

Author: Russel O. Potts

Publisher: CRC Press

ISBN: 9781420002249

Category: Medical

Page: 376

View: 9379

Provides an up-to-date and critical examination of biophysical techniques used in the analysis of molecular mechanisms underlying transdermal drug delivery as well as a physical and chemical evaluation of the stratum corneum necessary for the enhancement of percutaneous drug transport. Reflects the hands-on experience of established and novel researchers in the field.
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Bentley's Textbook of Pharmaceutics - E-Book

Author: Sanjay Kumar Jain,Vandana Soni

Publisher: Elsevier Health Sciences

ISBN: 8131232662

Category: Medical

Page: 776

View: 8925

This adaptation of Bentley's Textbook of Pharmaceutics follows the same goals as those of the previous edition, albeit in a new look. The content of the old edition has been updated and expanded and several new chapters, viz. Complexations, Stability Testing as per ICH Guidelines, Parenteral Formulations, New Drug Delivery Systems and Pilot Plant Manufacturing, have been included, with an intention to make the book more informative for the modern pharmacists. The book has six sections: Section I deals with the physicochemical principles. Two new chapters: Complexations and ICH Guidelines for Stability Testing, have been added to make it more informative. Section II conveys the information regarding pharmaceutical unit operations and processes. Section III describes the area of pharmaceutical practice. Extensive recent updates have been included in many chapters of this section. Two new chapters: Parenteral Formulations and New Drug Delivery Systems, have been added. Section IV contains radioactivity principles and applications. Section V deals with microbiology and animal products. Section VI contains the formulation and packaging aspects of pharmaceuticals. Pilot Plant Manufacturing concepts are added as a new chapter, which may be beneficial to readers to understand the art of designing of a plant from the pilot plant model.
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Handbook of Pharmaceutical Excipients

Author: Raymond C. Rowe,Paul J. Sheskey,Marian E. Quinn

Publisher: Amer Pharmacists Assn

ISBN: 9781582121352

Category: Medical

Page: 888

View: 2410

An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.
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