Handbook of Pharmaceutical Excipients

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

Publisher: N.A

ISBN: 9780853697947

Category: Medical

Page: 888

View: 7917

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.
Release

Handbook of pharmaceutical excipients

Author: Ainley Wade,Pharmaceutical Society of Great Britain

Publisher: Pharmaceutical Press

ISBN: N.A

Category: Medical

Page: 651

View: 9251

Provides data on the additives used to convert pharmacologically active compounds into dosage forms suitable for administration to patients. Data includes: nonproprietary names, functional category, synonyms, chemical names and CAS Registry number, empirical formula, molecular weight, structural formula, commercial availability, method of manufacture,description, pharmacopeial specifications, typical properties, stability and storage conditions, incompatibilities, safety, handling precautions, regulatory acceptance, applications in pharmaceutical formulation or technology, use, related substances, comments, and specific references.
Release

Handbook of Pharmaceutical Excipients

Author: Arthur H. Kibbe

Publisher: Amer Pharmacists Assn

ISBN: 9780917330964

Category: Medical

Page: 665

View: 960

Describes the chemical and physical properties of pharmaceutical excipients. Each monograph contains nonproprietary names, synonyms, chemical name and CAS registry number, empirical formula and molecular weight, structural formula, functional category, applications in pharmaceutical formulation or technology, description, pharmacopeial specifications, typical propertics, stability and storage conditions, incompatibilities, method of manufacture, safety, handling precautions, regulatory status, pharmacopeias, related substances, comments, specific references, general references, and authors.
Release

Pharmaceutical Excipients 2001

Handbook of Pharmaceutical Excipients

Author: Pharmaceutical Press,Raymond C. Rowe,Paul J Sheskey,Paul J Weller

Publisher: N.A

ISBN: 9780853694977

Category: Medical

Page: N.A

View: 565

Release

Handbook of Pharmaceutical Excipients

Author: Paul J. Sheskey,Walter G. Cook,Colin G. Cable

Publisher: N.A

ISBN: 9780857112712

Category: Excipients

Page: 1216

View: 6845

The Handbook of Pharmaceutical Excipients contains essential data on the physical properties of excipients, their safe use and potential toxicity.
Release

Die Regeln der Arbeit

Author: Richard Templar

Publisher: books4success

ISBN: 3941493132

Category: Self-Help

Page: 250

View: 631

Für manche Menschen ist der Arbeitsalltag das schiere Vergnügen. Scheinbar ohne sich anzustrengen meistern Sie die Fallstricke der Büropolitik. Sie sagen und tun das Richtige, sie bekommen die Gehaltserhöhung, sie werden befördert. Was wissen diese Glücklichen, was alle anderen scheinbar nicht wissen? Sie kennen die Regeln. Die Regeln der Arbeit. Diese Regeln sind überraschend einfach zu lernen - und wenn man sie einmal kennt, dann kann man sie ebenso einfach im täglichen Leben beibehalten. Richard Templar hat sie in einem Buch zusammengefasst: den "Regeln der Arbeit". Erfahren Sie, wie Sie vorankommen, ohne Ihre Prinzipien aufgeben zu müssen; wie Sie das Selbstvertrauen und die Energie ausstrahlen, die Vertrauen und Respekt erzeugen; wie Sie die perfekte Nische für sich schaffen; wie Sie Konflikte lösen ohne die anderen vor den Kopf zu stoßen; und last but not least: wie Sie in den Schlüsselmomenten, die Ihre Karriere beflügeln können, aktiv, präsent und erfolgreich sind.
Release

Arzneimitteltherapie in der Palliativmedizin

Author: Claudia Bausewein,Constanze Rémi,Robert Twycross,Andrew Wilcock,Paul Howard

Publisher: Elsevier Health Sciences

ISBN: 3437183958

Category: Medical

Page: 1048

View: 1475

Dieses Werk bietet praxisorientierte, konkrete Handlungsanweisungen mit exakten Dosierungsangaben und zahlreichen Tipps für die tägliche Praxis. Es liefert präzise Informationen zu Sonderfällen wie z.B. Anwendungen außerhalb der Zulassung (''off-label use''), alternative Applikationsformen sowie Dosierungsanpassung bei Organinsuffizienz. Das ideale Buch zur kompetenten und sicheren Behandlung von Patienten in der Palliativmedizin. Die deutsche Fassung basiert auf dem renommierten englischen Werk ''Palliative Care Formulary'', wurde aber auf die Erfordernisse im deutschen Sprachraum angepasst. Neu in der 3. Auflage: Aktualisiert und auf Stand des englischen PCF6 gebracht Die S3-Leitlinie Palliativmedizin für Patienten mit einer nicht heilbaren Krebserkrankung wurde ergänzt Weitere relevante deutsche Leitlinien berücksichtigt
Release

CRC Handbook of Food, Drug, and Cosmetic Excipients

Author: Susan C. Smolinske

Publisher: CRC Press

ISBN: 9780849335853

Category: Technology & Engineering

Page: 448

View: 6226

CRC Handbook of Food, Drug, and Cosmetic Excipients provides a comprehensive summary of toxicological issues regarding inactive ingredients in pharmaceutical products, cosmetic products, and food additives. Background information on regulations and labeling requirements for each type of product is provided, and 77 articles critically review human and animal data pertinent to a variety of agents and makes judgments regarding the clinical relevance. The book also identifies at-risk populations, such as neonates, patients with renal failure, and atopic patients. Inactive common pharmaceutical agents and/or foods containing certain ingredients are listed to help physicians counsel hypersensitive patients who must avoid products containing these excipients.
Release

Medizinische Mikrobiologie

Author: Ernest Jawetz,Joseph L. Melnick,Edward A. Adelberg

Publisher: Springer-Verlag

ISBN: 3662001551

Category: Science

Page: N.A

View: 1572

Die Autoren haben beabsichtigt, diejenigen Gebiete der medizinischen Mikrobiologie kurz, exakt und in ihrem gegenwärtigen Stand darzustellen, die für die Infektionskrankheiten und ihre Chemotherapie von besonderer Bedeutung sind. Das Buch wendet sich in erster Linie an Medizinstudenten, außerdem an alle Ärzte in Krankenhaus und Praxis. Die Notwendigkeit für ein klares Verständnis der mlkrobiologischen Grundtatsachen ist in den letzten Jahren stärker geworden, da in Biochemie, Virologie und Chemotherapie so wie auf weiteren, die Medizin beeinflussenden Gebieten bedeutende Entwicklungen statt gefunden haben. Ein wesendicher Teil dieses Lehrbuches ist deswegen der Darstellung der Grundlagen gewidmet, wodurch sich das Buch auch für die Einführung des Studenten in den mikrobiologischen Kurs als brauchbar erweisen wird. Für die neue Auflage wurde ein Kapitel über Virus und Krebs neu geschrieben, und das Kapitel über antimikrobielle Chemotherapie wurde von Grund auf neu bearbeitet. Die Autoren freuen sich, bei dem Erscheinen der 7. amerikanischen Ausgabe von einer spanischen, deutschen, italienischen und griechischen Ausgabe, sowie von der Vorbereitung für eine serbokroatische Übersetzung berichten zu können. Die Autoren möchten nochmals allen danken, die ihnen bei der Bearbeitung dieser Auf lage behilflich waren, und die es ihnen durch ihre Kommentare und ihre Kritik ermöglicht haben, die in 2jährigen Abständen erscheinenden Revisionen dieses Buches auf dem neu esten Stand zu halten. ERNEsr JAWETZ JOSEPH L MELNICK San Frandsco, August 1966 EnWARD A AnELBERG III Inhaltsverzeichnis 1 Kapitell Die ~lt der Mikroben 8 Kapitel 2 Cytologie der Bakterien Optische Methoden 8 9 Eukaryote Zellstrukturen Prokaryote Zellstrukturen . 12 14 Cytoplasmatische Strukturen. 27 Färbeverfahren .
Release

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

Author: Satinder Ahuja,Karen Mills Alsante

Publisher: Academic Press

ISBN: 9780120449828

Category: Medical

Page: 414

View: 1789

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Release

Pharmaceutical Powder Compaction Technology, Second Edition

Author: Metin Çelik

Publisher: CRC Press

ISBN: 1420089188

Category: Medical

Page: 344

View: 7213

Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application. This unique reference covers: The physical structure of pharmaceutical compacts Bonding phenomena that occur during powder compaction Compression mechanisms of pharmaceutical particles Theories and basic principles of powder compaction New topics include: Compaction data analysis techniques The migration of powder constituents into commercial manufacture Instrumentation for compaction Compaction functionality testing, which is likely to become a USP requirement Design space for compaction Metrics required for scalability in tablet compression Interactive compaction and preformulation database for commonly used excipients
Release

Handbook of Pharmaceutical Controlled Release Technology

Author: Donald L. Wise

Publisher: CRC Press

ISBN: 9780824703691

Category: Medical

Page: 902

View: 8471

The Handbook of Pharmaceutical Controlled Release Technology reviews the design, fabrication, methodology, administration, and classifications of various drug delivery systems, including matrices, and membrane controlled reservoir, bioerodible, and pendant chain systems. Contains cutting-edge research on the controlled delivery of biomolecules! Discussing the advantages and limitations of controlled release systems, the Handbook of Pharmaceutical Controlled Release Technology covers oral, transdermal, parenteral, and implantable delivery of drugs discusses modification methods to achieve desired release kinetics highlights constraints of system design for practical clinical application analyzes diffusion equations and mathematical modeling considers environmental acceptance and tissue compatibility of biopolymeric systems for biologically active agents evaluates polymers as drug delivery carriers describes peptide, protein, micro-, and nanoparticulate release systems examines the cost, comfort, disease control, side effects, and patient compliance of numerous delivery systems and devices and more!
Release

Handbook of Pharmaceutical Manufacturing Formulations

Semisolid Products

Author: Sarfaraz K. Niazi

Publisher: CRC Press

ISBN: 1420081276

Category: Medical

Page: 376

View: 8654

The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations. Highlights from Semisolid Products, Volume Four include: coverage of over 350 formulations valuable information on the difficult area of compliance changes to approved new drug applications and abbreviated new drug applications the evolving guidelines of ICH and when to conduct a regulatory review
Release

Handbook of Pharmaceutical Manufacturing Formulations

Sterile Products

Author: Safaraz K. Niazi

Publisher: CRC Press

ISBN: 1420081314

Category: Medical

Page: 464

View: 5191

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry. Highlights from Sterile Products, Volume Six include: formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications specifications of a manufacturing facility to manufacture compliant sterile products NDA or aNDA filing requirements of sterile products an alphabetical presentation of formulations of pharmaceutical products based on their generic names
Release

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Author: John Geigert

Publisher: Springer Science & Business Media

ISBN: 1461469163

Category: Medical

Page: 338

View: 3059

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Release

Preclinical Development Handbook

ADME and Biopharmaceutical Properties

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

ISBN: 0470249021

Category: Medical

Page: 1352

View: 3641

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
Release

Handbook of Pharmaceutical Granulation Technology

Author: Dilip M. Parikh

Publisher: CRC Press

ISBN: 9780824798826

Category: Medical

Page: 528

View: 464

Integrating the basic principles and industrial practices of pharmaceutical granulation production, this book discusses technologies and demonstrates cost-effective approaches to manufacturing solid-dosage forms with content uniformity and consistent physical properties while complying with regulatory requirements. Specialists from pharmaceutical companies, academia, and the U.S. Drug Regulatory Affairs agency address current and changing practices in industrial drug granulation production. Text, charts, figures, and photographs illustrate the pros and cons of diverse methods and technologies for accurately achieving strong bonding of particles in tablets and capsules.
Release

Handbook of Pharmaceutical Manafacturing Formulations, 2nd Ed, Sarfaraz K. Niazi, 2009

Handbook of Pharmaceutical Manafacturing Formulations

Author: Informa Healthcare

Publisher: Bukupedia

ISBN: N.A

Category: Business & Economics

Page: 2738

View: 2419

The science and the art of pharmaceutical formulation keeps evolving as new materials, methods, and machines become readily available to produce more reliable, stable, and releasecontrolled formulations. At the same time, globalization of sourcing of raw and finished pharmaceuticals brings challenges to regulatory authorities and results in more frequent revisions to the current good manufacturing practices, regulatory approval dossier requirements, and the growing need for cost optimization. Since the publication of the first edition of this book, a lot has changed in all of these areas of importance to pharmaceutical manufacturers. The second edition builds on the dynamic nature of the science and art of formulations and provides an evermore useful handbook that should be highly welcomed by the industry, the regulatory authorities, as well as the teaching institutions. The first edition of this book was a great success as it brought under one umbrella the myriad of choices available to formulators. The readers were very responsive and communicated withmefrequently pointing out to the weaknesses as well as the strengths of the book. The second edition totally revised attempts to achieve these by making major changes to the text, some of which include: 1. Complete, revised errors corrected and subject matter reorganized for easy reference. Whereas this series has six volumes differentiated on the basis of the type of dosage form and a separate inclusion of the U.S. OTC products, ideally the entire collection is needed to benefit from the myriad of topics relating to formulations, regulatory compliance, and dossier preparation. 2. Total number of pages is increased from 1684 to 2726. 3. Total number of formulations is expanded by about 30% with many newly approved formulations. 4. Novel formulations are now provided for a variety of drugs; these data are collected from the massive intellectual property data and suggest toward the future trend of formulations. While some of these formulations may not have been approved in the United States or Europe, these do provide additional choices, particularly for the NDA preparation. As always, it is the responsibility of the manufacturer to assure that the intellectual property rights are not violated. 5. A significant change in this edition is the inclusion of commercial products; while most of this information is culled out from the open source such as the FOIA (http://www.fda.gov/foi/default.htm), I have made attempts to reconstruct the critical portions of it based on what I call the generally acceptable standards. The drug companies are advised to assure that any intellectual property rights are not violated and this applies to all information contained in this book. The freedom of information act (FOIA) is an extremely useful conduit for reliable information and manufacturers are strongly urged to make use of this information. Whereas this information is provided free of charge, the process of obtaining the information may be cumbersome, in which case, commercial sources of these databases can prove useful, particularly for the non-U.S. companies. 6. Also included are the new Good Manufacturing Guidelines (2007) with amendments (2008) for the United States and similar updates for European Union and WHO; it is strongly urged that the companies discontinue using all old documents as there are significant changes in the revised form, and many of them are likely to reduce the cost of GMP compliance. 7. Details on design of clean rooms is a new entry that will be of great use to sterile product manufacturers; whereas the design and flow of personnel and material flow is of critical nature, regulatory agencies view these differently and the manufacturer is advised always to comply with most stringent requirements. 8. Addition of a self-auditing template in each volume of the series. While the cGMP compliance is a complex issue and the requirements diversified across the globe, the basic compliance remains universal. I have chosen the European Union guidelines (as these are more in tune with the ICH) to prepare a self-audit module that I recommend that every manufacturer adopt as a routine to assure GMP compliance. In most instances reading the template by those responsible for compliance with keep them sensitive to the needs of GMP. 9. OTC products cross-referenced in other volumes where appropriate. This was necessary since the regulatory authorities worldwide define this class of drug differently. It is important to iterate that regardless of the prescription or the OTC status of a product, the requirements for compliance with the cGMP apply equally. 10. OTCmonograph status is anew section added to theOTC volume and this should allow manufacturers to chose appropriate formulations that may not require a filing with the regulatory agencies; it is important to iterate that an approved OTC monograph includes details of formulation including the types and quantities of active drug and excipients, labeling, and presentation. To qualify the exemption, the manufacturer must comply with the monograph in its entirety. However, subtle modifications that are merely cosmetic in nature and where there is an evidence that the modification will not affect the safety and efficacy of the products can be made but require prior approval of the regulatory agencies and generally these approvals are granted. 11. Expanded discussion on critical factors in the manufacturing of formulations provided; from basic shortcuts to smart modifications now extend to all dosage forms. Pharmaceutical compounding is one of the oldest professions and whereas the art of formulations has been v vi Preface to the Series—Second Edition relegated to more objective parameters, the art nevertheless remains. An experienced formulator, like an artist, would know what goes with what and why; he avoids the pitfalls and stays with conservative choices. These sections of the book present advice that is time tested, although it may appear random at times; this is intended for experienced formulators. 12. Expanded details on critical steps in the manufacturing processes provided but to keep the size of the book manageable, and these are included for prototype formulations. The reader is advised to browse through similar formulations to gain more insight. Where multiple formulations are provided for the same drug, it intended to show the variety of possibilities in formulating a drug and whereas it pertains to a single drug, the basic formulation practices can be extended to many drugs of same class or even of diversified classes. Readers have often requested that more details be provided in the Manufacturing Direction sections. Whereas sufficient details are provided, this is restricted to prototype formulations to keep the size of the book manageable and to reduce redundancy. 13. Addition of a listing of approved excipients and the level allowed by regulatory authorities. This new section allows formulators a clear choice on which excipients to choose; the excipients are reported in each volume pertaining to the formulation type covered. The listing is drawn from the FDA-approved entities. For the developers of an ANDA, it is critical that the level of excipients be kept within the range generally approved to avoid large expense in justifying any unapproved level. The only category for which the listing is not provided separately is theOTCvolume since it contains many dosage forms and the reader is referred to dosage form–specific title of the series. The choice of excipients forms keeps increasing with many new choices that can provide many special release characteristics to the dosage forms. Choosing correct excipients is thus a tedious exercise and requires sophisticated multivariate statistical analysis. Whereas the formulator may choose any number of novel or classical components, it is important to know the levels of excipients that are generally allowed in various formulations to reduce the cost of redundant exercises; I have therefore included, as an appendix to each volume, a list of all excipients that are currently approved by the U.S. FDA along their appropriate levels. I suggest that a formulator consult this table before deciding on which level of excipient to use; it does not mean that the excipient cannot be used outside this range but it obviates the need for a validation and lengthy justification studies in the submission of NDAs. 14. Expanded section on bioequivalence submission was required to highlight the recent changes in these requirements. New entries include a comprehensive listing of bioequivalence protocols in abbreviated form as approved by the U.S. FDA; these descriptions are provided in each volume where pertinent. To receive approval for an ANDA, an applicant must generally demonstrate, among other things, equivalence of the active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug [21 USC 355(j)(2)(A); 21 CFR 314.94(a)]. Bioequivalent drug products show no significant difference in the rate and extent of absorption of the therapeutic ingredient [21 U.S.C. 355(j)(8); 21 CFR 320.1(e)]. BE studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. The regulations governing BE are provided at 21 CFR in part 320. The U.S. FDA has recently begun to promulgate individual bioequivalence requirements. To streamline the process for making guidance available to the public on how to design product-specific BE studies, the U.S. FDA will be issuing product-specific BE recommendations (www.fda.gov/cder/ogd/index.htm). To make this vital information available, an appendix to each volume includes a summary of all currently approved products by the U.S. FDA where a recommendation on conducting bioequivalence studies is made available by the U.S. FDA. When filing an NDA or an ANDA, the filer is faced with the choice of defending the methods used to justify the bioavailability or bioequivalence data. The U.S. FDA now allows application for waiver of bioequivalence requirement; a new chapter on this topic has been added along with details of the dissolution tests, where applicable, approved for various dosage forms. 15. Dissolution testing requirements are included for all dosage forms where this testing is required by the FDA. Surrogate testing to prove efficacy and compliance is getting more acceptance at regulatory agencies; in my experience, a well-designed dissolution test is the best measure of continuous compliance. Coupled with chapters on waivers of bioequivalence testing, this information on dissolution testing should be great value to all manufacturers; it is recommended that manufacturers develop their own in-house specifications, more stringent than those allowed in these listings and the USP. 16. Best-selling products (top 200 prescription products) are identified with an asterisk and a brand name where applicable; in all instances, composition of these products is provided and formulation of generic equivalents. Despite the vast expansion of pharmaceutical sales and shifting of categories of blockbuster drugs, basic drugs affecting gastrointestinal tract, vascular system, and brain remain most widely prescribed. 17. Updated list of approved coloring agents in the United States, Canada, European Union, and Japan is included to allow manufactures to design products for worldwide distribution. 18. Tablet-coating formulations that meet worldwide requirements of color selection are included in the Volume 1 (compressed solids) and Volume 5 (OTC) because these represent the products often coated. 19. Guidelines on preparing regulatory filings are now dispersed throughout the series depending on where these guidelines are more crucial. However, the reader would, as before, need access to all volumes to benefit from the advice and guidelines provided. As always, comments and criticism from the readers are welcomed and these can be sent to me at [email protected] .com or [email protected] I would try to respond to any inquiries requiring clarification of the information enclosed in these volumes. I would like to express deep gratitude to Sherri R. Niziolek and Michelle Schmitt-DeBonis at Informa, the publisher of Preface to the Series—Second Edition vii this work, for seeing an immediate value to the readers in publishing the second edition of this book and allowing me enough time to prepare this work. The diligent editing and composing staff at Informa, particularly Joseph Stubenrauch, Baljinder Kaur and others are highly appreciated. Regardless, all errors and omissions remain altogether mine. In the first edition, I had dedicated each volume to one of my mentors; the second edition continues the dedication to these great teachers. Sarfaraz K. Niazi, Ph.D. Deerfield, Illinois, U.S.A
Release