Basic Tests for Pharmaceutical Dosage Forms
Author: World Health Organization
Publisher: World Health Organization
Published: 1991
Total Pages: 144
ISBN-13: 9789241544184
DOWNLOAD EBOOKPosts
Basic Tests for Drugs
Author: World Health Organization
Publisher: World Health Organization
Published: 1998
Total Pages: 104
ISBN-13: 9789241545136
DOWNLOAD EBOOKThis book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabeled, substandard, or counterfeit products when the labeling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry. The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis. The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances, and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO is also provided. Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications "Basic Tests for Pharmaceutical Substances" and "Basic Tests for Pharmaceutical Dosage Forms".
In Vitro Drug Release Testing of Special Dosage Forms
Author: Nikoletta Fotaki
Publisher: John Wiley & Sons
Published: 2019-12-31
Total Pages: 312
ISBN-13: 1118341473
DOWNLOAD EBOOKGuides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.
Dosage Form Design Parameters
Author:
Publisher: Academic Press
Published: 2018-07-25
Total Pages: 816
ISBN-13: 012814422X
DOWNLOAD EBOOKDosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
How to Develop Robust Solid Oral Dosage Forms
Author: Bhavishya Mittal
Publisher: Academic Press
Published: 2016-10-05
Total Pages: 192
ISBN-13: 0128047321
DOWNLOAD EBOOKHow to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. - Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more - Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin - Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues
Sample Preparation of Pharmaceutical Dosage Forms
Author: Beverly Nickerson
Publisher: Springer Science & Business Media
Published: 2011-08-05
Total Pages: 400
ISBN-13: 1441996311
DOWNLOAD EBOOKThis book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.
Compounded Topical Pain Creams
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2020-07-21
Total Pages: 353
ISBN-13: 030967218X
DOWNLOAD EBOOKPain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.
Essential Chemistry for Formulators of Semisolid and Liquid Dosages
Author: Vitthal S. Kulkarni
Publisher: Academic Press
Published: 2015-10-15
Total Pages: 256
ISBN-13: 012801072X
DOWNLOAD EBOOKA needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations. - Unique coverage of the underlying chemistry that makes possible stable dosages - Quality content written by experienced experts from the drug development industry - Valuable information for academic and industrial scientists developing topical and liquid dosage formulations for pharmaceutical as well as skin care and cosmetic products
ICH Quality Guidelines
Author: Andrew Teasdale
Publisher: John Wiley & Sons
Published: 2017-09-29
Total Pages: 624
ISBN-13: 1118971132
DOWNLOAD EBOOKExamining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Oral Drug Absorption
Author: Jennifer B. Dressman
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 432
ISBN-13: 1420077341
DOWNLOAD EBOOKOral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
