Pharmaceutical Suspensions: From Formulation Development to Manufacturing
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Click to show screenshotPharmaceutical Suspensions: From Formulation Development to Manufacturing
Publisher: Springer | Pages: 323 | 2009-10-16 | ISBN 1441910867 | PDF | 5 MB
The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.
A good understanding of fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of suspension 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, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, 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 active dispersed in a suitable vehicle.
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