Pharmaceutical Suspensions
From Formulation Development to Manufacturing
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Beschreibung
Suspension dosage form is a preferred and widely accepted dosage forms for insoluble or poorly soluble drugs for various therapeutic applications. The suspension dosage form has long been used for insoluble and poorly soluble drugs for making oral, topical and parenteral products. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides the reader with a broad overview of suspension drug product technology. Individual chapters in this book focus on suspension formulation principles, excipients, analysis, pharmaceutical development, preclinical, clinical and regulatory aspects, as well as the emerging technology of nanosuspensions as nanomedicine. Various chapters in the book are written by authors from academia, regulatory agencies and industries who are experts in their respective fields. The book includes over 600 bibliographic citations, numerous tables and illustrations.
Pharmaceutical Suspensions is the only volumeto date that systematically follows the suspension dosage development approach used widely in the pharmaceutical industries starting with pre-formulation/formulation development, pre-clinical evaluation and critical characterization method development, continuing to clinical trial essentials and ending with technology transfer essentials and regulatory filing guidance.
Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides a useful resource for pharmaceutical scientists, process scientists/engineers involved in the areas of research and development of pharmaceutical suspension dosage forms as well as for advanced pharmacy undergraduate and graduate students who want in-depth knowledge of suspension dosage form.
"Solid useful text on suspension formulation development"
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.
Written by experienced experts in applicable field from academia/industry/regulatory agencies, volume will systematically discuss the development of stable pharmaceutical suspensions
Autor*in
Alok K. Kulshreshtha
Themen in »Pharmaceutical Suspensions«
Formulation Kulshreshtha Singh Suspentions Wall clinical trial development drug kinetics manufacturing pharmaceutical pharmacokinetics research