Pharmaceutical Suspensions

Pharmaceutical Suspensions
Author: Alok K. Kulshreshtha
Publisher: Springer Science & Business Media
Total Pages: 337
Release: 2009-11-05
Genre: Medical
ISBN: 1441910875

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.

Suspension Concentrates

Suspension Concentrates
Author: Tharwat F. Tadros
Publisher: Walter de Gruyter GmbH & Co KG
Total Pages: 362
Release: 2017-02-20
Genre: Science
ISBN: 3110486873

Suspension Concentrates is a survey into the theory of the formulation and stabilization of suspensions, elaborating on the breaking of aggregates and agglomerates and the role of dispersing agents on flocculation and electrostatic and steric stabilization. Practical analysis by rheology is discussed. Suspension Concentrates is ideal for research scientists and Ph.D. students investigating chemistry, chemical engineering and colloidal science.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
Author: Herbert Lieberman
Publisher: CRC Press
Total Pages: 558
Release: 2020-08-26
Genre: Medical
ISBN: 1000148416

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.

Drug Stability for Pharmaceutical Scientists

Drug Stability for Pharmaceutical Scientists
Author: Thorsteinn Loftsson
Publisher: Academic Press
Total Pages: 170
Release: 2014-01-25
Genre: Medical
ISBN: 0124115624

Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. - Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material - Provides answers and explanations to test your knowledge - Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more - Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability

Physicochemical Principles of Pharmacy

Physicochemical Principles of Pharmacy
Author: Alexander Taylor Florence
Publisher:
Total Pages: 485
Release: 1988
Genre: Biopharmaceutics
ISBN: 9780333449950

This book provides the physicochemical background to the design and use of pharmaceutical dosage forms. It goes beyond the introductory aspects of the subject to show how basic physicochemical principles are essential to an understanding of every aspect of drug action, from the dosage form to the site of action in the body. This is not a textbook of physical chemistry for pharmacists, but is a book which bridges the gap between basic first-year physical chemistry and the more applied practice of later years. This extensively revised second edition includes much new material, illustrations and references to take into account recent scientific developments and curriculum changes.

Early Drug Development, 2 Volume Set

Early Drug Development, 2 Volume Set
Author: Fabrizio Giordanetto
Publisher: John Wiley & Sons
Total Pages: 810
Release: 2018-12-10
Genre: Science
ISBN: 3527341498

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Essential Chemistry for Formulators of Semisolid and Liquid Dosages

Essential Chemistry for Formulators of Semisolid and Liquid Dosages
Author: Vitthal S. Kulkarni
Publisher: Academic Press
Total Pages: 256
Release: 2015-10-15
Genre: Science
ISBN: 012801072X

A 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

Dispersion of Powders

Dispersion of Powders
Author: Tharwat F. Tadros
Publisher: John Wiley & Sons
Total Pages: 285
Release: 2012-04-24
Genre: Science
ISBN: 3527656618

Teaching the fundamental knowledge required for successful dispersion of powders in a liquid, this book covers a host of topics -- from recent advances to industrial applications. In 15 chapters it supports formulation chemists in preparing a suspension in a more rational way, by applying the principles of colloid and interface science, while at the same time enabling the research scientist to discover new methods for preparing stable suspensions. Essential reading for those working in the pharmaceutical, cosmetic, food, paint, ceramic and agricultural industries.