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 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.

Analyzes construction of experiments, focusing on variables, models, matrices, and reproducibility. This timely reference systematically examines the basic concepts and theoretical issues, methodologies for experiment and measurement, and practical health applications of emulsions and dispersions-describing formulation problems and identifying potential carriers for the delivery or targeting of new drugs. Evaluates anionic, cationic, and nonionic surfactants as dispersing, emulsifying, foaming, penetrating, and wetting agents. Written by more than 20 international researchers, Pharmaceutical Emulsions and Suspensions discusses uses of macroemulsions and (submicron) microemulsions illuminates delivery devices such as microparticles, nanospheres, liposomes, and mixed micelles investigates the application of self-emulsifying drug delivery systems (SEDDS) introduces techniques for increasing drug solubility with nanosuspensions addresses stabilization, flocculation, and coagulation problems in pharmaceutical and cosmetic suspensions surveys drug delivery by way of dermatological, follicular, and ocular routes explains the pharmacodynamics, bioavailability, and pharmacokinetics in the drug formulation development process compares and contrasts monomeric and micellar adsorption at oil-water interfaces and more! Containing over 1800 references, tables, equations, drawings, and micrographs, Pharmaceutical Emulsions and Suspensions is an ideal resource for pharmacists; physical, surface, colloid, cosmetic, food, and agricultural chemists; and upper-level undergraduate and graduate students in these disciplines.

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.