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Showing posts with label Pharmaceutics. Show all posts

Showing posts with label Pharmaceutics. Show all posts

Saturday, January 22, 2011

Photostability Of Drugs And Drug Formulations, 2nd Edition

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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Absorption and Drug Development: Solubility, Permeability, and Charge State

Many times drugs work fine when tested outside the body, but when they are tested in the body they fail. One of the major reasons a drug fails is that it cannot be absorb by the body in a way to have the effect it was intended to have. Permeability, Solubility, Dissolution, and Charged State of Ionizable Molecules:

Helps drug discovery professionals to eliminate poorly absorbable molecules early in the drug discovery process, which can save drug companies millions of dollars.
Extensive tabulations, in appendix format, of properties and structures of about 200 standard drug molecules.

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Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition

Thoroughly updated and expanded, this new 3^rd edition provides the latest information on dosage, forms, film defects, and polymer characterization. Written by renowned leaders in the field, Aqueous Polymeric Coatings for Pharmaceutical Dosage Formsis easily the most comprehensive book available on the market today.

New to the 3^rd Edition:

· the interaction of drugs with functional polymers

· the influence of processing parameters on coating quality

· the stabilization of polymeric film coats

· plastisizers and their applications in pharmaceutical coatings

· adhesion of polymeric films to solid substrates

· basic properties of latex and pseudolatex colloidal dispersions

Key topics included:

· polymer interactions with drugs and excipients

· physical aging of polymeric films.

· A complete overview and in-depth analysis of recent advances in the field, which includes information on the latest equipment used to apply polymers to a pharmaceutical system

· illustrated examples explaining the appropriate steps to be taken in order to solve formulation, processing and stability problems to achieve an optimized dosage form.

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Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs

Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come.

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Microencapsulation: Methods and Industrial Applications, Second Edition

Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.

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Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition

Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition, is a comprehensively updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume III describes technologies for yielding liposomes that can function in a targeted fashion, and highlights methods for studying the interaction of liposomes within the biological environment to be applied in the detection, therapy, or prevention of disease. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.

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Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, 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 manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.

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British National Formulary 56

Compiled with the advice of clinical experts, the British National Formulary (BNF) provides up-to-date guidance on prescribing, dispensing and administering medicines.

The BNF details medicines prescribed in the UK, with special reference to their uses, cautions, contra-indications, side-effects, dosage and relative costs.

Updated every six months, the BNF reflects current best practice as well as legal and professional guidelines relating to the use of medicines. It is intended for use by prescribers, pharmacists and other healthcare professionals.

Designed for rapid reference
Authoritative, impartial and, where available, evidence-based advice on prescribing, dispensing and administering medicines
Updated twice a year to reflect promptly changes in product availability as well as emerging safety concerns and shifts in clinical practice

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Cosmetic Formulation of Skin Care Products

Specifically written to meet the needs of the cosmetic chemist and engineer, this reference outlines the latest technologies and issues pertinent to the development novel skin care products including advances in formulation and development, raw materials and active ingredients, compound testing, and clinical assessment. Organized by product category, then by body application area, this guide supplies all one needs to know to create effective skin care products for men and women in a diverse range of ethnic populations.

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Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form

Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features.

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Pharmaceutical Compounding and Dispensing

This is a revision guide for students giving bullet points of basic information on pharmaceutical compounding and dispensing followed by questions and answers."Fast Track" is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Pharmaceutical Compounding and Dispensing", this book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing.A Fast Track website will also be live at time of publication and will include MCQs, sample online content and much more.

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The Veterinary Formulary

The sixth edition of The Veterinary Formulary has been updated and revised by 51 expert contributors and reviewed by an advisory committee of veterinarians and pharmacologists. Features of this edition include: Revision of over 780 drug monographs from the fifth edition Some 55 new drug monographs Over 1650 UK veterinary preparations Preparation and dosage details for over 700 human-authorised products Existing sections re-arranged to reflect current veterinary practice Many new sections, eg Prescribing for rabbits, Canine pheromonatherapy, and Teat sealants New table giving husbandry requirements for common pet terrestrial invertebrates Revised BVA code of practice on medicines - includes essential legislation and information New easy-to-read appendix on Drug interactions.

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Pharmaceutical Formulation Development of Peptides and Proteins

This comprehensive volume brings the different aspects of peptide and protein formulation into focus, beginning with the fundamentals of the production of peptides and proteins, ranging from synthesis to protein purification.

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Delivery System Handbook for Personal Care and Cosmetic Products : Technology, Applications and Formulations

Novel delivery systems designed to facilitate the use of “fountain of youth” and other functional actives is an idea whose time has come. In a rapidly growing global market eager for products that really work, accelerating market pull and technology push forces have set the stage for this Foundation text. This “must have” book is the first volume of a new series entitled “Breakthroughs in Personal Care and Cosmetic Technology.” It has been carefully designed for training, development, and the empowerment of synergistic technology transfer across the personal care, cosmetic, and pharmaceutical industries.

This book is intended to cause a breakthrough in effective communication and interaction among technology and marketing functions. It is a showcase for understanding, using, and marketing the technology of why and how delivery systems work, as well as current, emerging/potential applications and working formulations. Each chapter is written by one or more experts in the field. A wide range of companies serving the global marketplace are represented. These companies offer numerous types of delivery systems containing highly desirable functional actives, delivery system technology development services, and opportunities for technology licensing, mergers, and acquisitions. A unique feature of the book is the use of Mind Map™ technology to capture and present the essence of the inner-thinking of over 80 authors in a Book-at-a-Glance Executive Overview section. This section has been specifically designed to powerfully impact decision making leading to the development of innovative product differentiation in a global context.

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Pharmaceutical Emulsions and Suspensions: Second Edition, Revised and Expanded

University Montpellier, France. Covers fundamental and applied knowledge of emulsions and suspensions. Assists those working in all spheres of pharmacy in solving the problems posed by by emulsion and suspension formulations and applications. Diagrams, charts.

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Intelligent Software for Product Formulation

The process of formulating pharmaceuticals, agrochemicals, speciality chemicals or any of the other many formulated products is a highly formulated task. Intelligent software tools are a means of capturing this knowledge to enable all users to benefit from expert advice, as well as providing the means for more consistent decision making. The implementation of intelligent software can also lead to significant improvements in knowledge protection, cost reduction, training consistency and improved communication. Many applications ranging from agrochemicals and aluminium alloys to pharmaceuticals and textile finishing are reviewed.; This is an account of the applicability of expert systems, neural networks, genetic algorithms and other intelligent software in product formulation, which includes an explanation of the technology involved and examples of two commerical software packages specifically developed for product formulation.

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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

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Developing Solid Oral Dosage Forms: Pharmaceutical Theory&Practice

This book 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.

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Protein Formulation and Delivery

Protein Formulation and Delivery (Drugs and the Pharmaceutical Sciences)
By Mcnally

* Publisher: Informa Healthcare
* Number Of Pages: 278
* Publication Date: 1999-09-21
* Sales Rank: 878225
* ISBN / ASIN: 0824778839
* EAN: 9780824778835
* Binding: Hardcover
* Manufacturer: Informa Healthcare
* Studio: Informa Healthcare

This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development. Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability! Organized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Delivery · includes a discussion of accelerated stability testing and its limitations in identifying stable formulations · details analytical methods commonly used in stability assessment and formulation development · stresses the importance of demonstrating the stability-indicating nature of an assay · describes the drug substance manufacturing process succinctly · examines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administration · covers aseptic processing in drug development and the potential development of a freeze-drying cycle · explores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage forms · discusses the physical and chemical characteristics of proteins in microsphere delivery systems · analyzes protein degradation mechanisms, and methods of detecting and monitoring degradation · explores formulations intended for injection, inhalation, and controlled delivery · and more! Presenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers; and upper-level undergraduate and graduate students in these disciplines.

Pharmaceutical Suspensions: From Formulation Development to Manufacturing

amazon review

Pharmaceutical Suspensions: From Formulation Development to Manufacturing

Publisher: Springer | Pages: 323 | 2009-10-16 | ISBN 1441910867 | PDF | 5 MB

The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of suspension 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, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of themanufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, 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 active dispersed in a suitable vehicle.

After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in thistextbook systematically detail the development of pharmaceutical suspensions, from pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to pharmaceutical filed is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists skilled in their specific areas. Contributing authors represent a cross-sections of scholars from Academic Institutions, Pharmaceutical Industries and Regulatory Agency.

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