Physical chemical properties and design of pharmaceutical suspensions PDF Download

Author: Beatriz Millan-Hernandez
Publisher:
ISBN:
Category : Suspensions (Chemistry)
Languages : en
Pages : 422

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Author: Stephen R. Byrn
Publisher: John Wiley & Sons
ISBN: 1118145305
Category : Science
Languages : en
Pages : 420

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Book Description
Presents a detailed discussion of important solid-state properties, methods, and applications of solid-state analysis Illustrates the various phases or forms that solids can assume and discussesvarious issues related to the relative stability of solid forms and tendencies to undergo transformation Covers key methods of solid state analysis including X-ray powder diffraction, thermal analysis, microscopy, spectroscopy, and solid state NMR Reviews critical physical attributes of pharmaceutical materials, mainly related to drug substances, including particle size/surface area, hygroscopicity, mechanical properties, solubility, and physical and chemical stability Showcases the application of solid state material science in rational selection of drug solid forms, analysis of various solid forms within drug substance and the drug product, and pharmaceutical product development Introduces appropriate manufacturing and control procedures using Quality by Design, and other strategies that lead to safe and effective products with a minimum of resources and time

Author: Alok K. Kulshreshtha
Publisher: Springer Science & Business Media
ISBN: 1441910875
Category : Medical
Languages : en
Pages : 337

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Book Description
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.

Author: Antoine Al-Achi
Publisher: John Wiley & Sons
ISBN: 1119574188
Category : Medical
Languages : en
Pages : 820

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Book Description
This work is an examination of all aspects of the science in developing effective dosage form for drug delivery Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. Integrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. Readers of the second edition of Integrated Pharmaceutics will also find: A glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter Earlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products” Supplementary instructor guide with questions and solutions available online for registered professors Updated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols Integrated Pharmaceutics is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide.

Author: Alexander T Florence
Publisher: Pharmaceutical Press
ISBN: 0857111744
Category : Medical
Languages : en
Pages : 665

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Book Description
This 6th edition of the established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body.

Author: Humphrey Moynihan
Publisher: Oxford University Press, USA
ISBN: 0199232849
Category : Business & Economics
Languages : en
Pages : 316

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Book Description
What are the physical and chemical properties that determine how a drug interacts with the body? What determines which dosage form is best, if it will reach its intended target, and how it will be metabolised once it has entered the body? The Physicochemical Basis of Pharmaceuticals explores the phenomena which affect the formulation and bio-availability of drug substances to give a straightforward, accessible treatment of the essential concepts affecting the absorption and distribution of drugs. It provides the reader with the conceptual 'tool-kit' necessary to understand the physicochemical aspects of drug design and action, and shows how these concepts apply in practice. The book introduces key underlying physical chemistry principles before exploring pharmaceutical solutions, the pharmaceutical solid phase, solid - liquid dispersal systems, biological interfaces, absorption, distribution, metabolism and excretion, to give a complete view of the field. Focusing at all times on the essential principles and concepts, The Physicochemical Basis of Pharmaceuticals avoids excessive detail, presenting the key facts, backed up with pertinent examples and easy-to-digest illustrations, making it the ideal primer for those who need to understand physicochemical issues in the context of their broader field of study. Online Resource Centre For registered adopters of the text: · Figures from the book in electronic format, ready to download For students: · A hyperlinked bibliography of references given in the text.

Author: Gregory K. Webster
Publisher: CRC Press
ISBN: 1315340860
Category : Medical
Languages : en
Pages : 578

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Book Description
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.

Author: Philip Denton
Publisher: Oxford University Press
ISBN: 0199655316
Category : Medical
Languages : en
Pages : 288

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Book Description
Pharmaceutics: the science of medicine design explores the different forms that medicines can take, and demonstrates how being able to select the best form - be it a tablet, injectable liquid, or an inhaled gas - requires an understanding of how chemicals behave in different physical states.

Author: Dipak Kumar Sarkar
Publisher: John Wiley & Sons
ISBN: 1118648366
Category : Science
Languages : en
Pages : 182

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Book Description
Pharmaceutical Emulsions: A Drug Developer's Toolbag covers all the key aspects of pharmaceutical emulsions, starting from the fundamental scientific basics, to the pharmaceutical forms and the chemical tests for its application. The author uses his extensive experience in both industry and academic experience to provide a concise, student friendly guide to the essential fundamentals of physical pharmacy. Divided into three clear sections, the text begins with Section A - Consideration for Product: Medicinal Formulation which includes a historical perspective, explanation of what is an emulsion, stability and instability, and manufacture. Section B - Forms, Use and Application follows, with chapters on creams and ointments, pastes and bases, colloids, transdermal, gels and implants. The final Section, Tests: Chemistry to control the quality, efficacy and fitness for purpose of the product includes chapters on physic-chemical properties, sizing and microscopy, rheology, QC and finally questions, calculations and dilemmas. Throughout the text there are numerous figures, diagrams and tables to engage the reader. This is an invaluable reference for all students of pharmaceutical sciences, pharmacy industrial pharmaceutical sciences, physical pharmacy and pharmaceutical forms as well as industry professionals

Author: Ann Newman
Publisher: John Wiley & Sons
ISBN: 111890138X
Category : Science
Languages : en
Pages : 505

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Book Description
Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations • Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach • Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world