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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.


Pharmaceutical Suspensions describes the fundamentals and theoretical concepts of disperse systems. Readers will find a discussion of the development of pharmaceutical suspensions, in addition to nano-suspensions, an emerging area within the field.


Uitgever Alok K. Kulshreshtha

Uitgever G. Michael Wall

Uitgever Onkar N. Singh


DUIN 36I16ES694U

GTIN 9781489984173

Verschijningsdatum 28.11.2014

Taal Engels

Pagina-aantallen 328

Product type Paperback

Maat 235 x 155 x 155  mm

Gewicht van product 528 g

Pharmaceutical Suspensions

From Formulation Development to Manufacturing

Alok K. Kulshreshtha

€ 149,37

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