This comprehensive guide presents the principles underlying the formation, properties and manufacturing of solid dosage forms. Developed by a leading pharmaceutical expert with 25 years of experience, this book is a precise handbook to powder dosage forms, hard shell capsules, milling, tablet, granulation and drying, stability, crystalline solids, DSC and amorphates, hygroscopicity, packaging, micromeritics, sustained release, and more. Designed for use by development pharmacists, analytical chemists, production pharmacists, and pharmacy professors and students, this book emphasizes U.S. validation principles; the interrelationship between formulation, manufacturing and existing USP and FDA guidelines; and aspects of pharmaceutics important to IND and NDA submission and subsequent supplements.
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A pharmacist's guide to the principles underlying the formation, properties, and manufacturing of solid dosage forms. Discusses biopharmaceutical principles, pharmaceutical operations, micro-attributes, and the physics and chemistry of solids at semi-micro and micro levels. Focuses on US validation principles, and how they affect the processes of f
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