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Solid State Development and Processing of Pharmaceutical Molecules. Salts, Cocrystals, and Polymorphism. Edition No. 1. Methods and Principles in Medicinal Chemistry

  • ID: 5186251
  • Book
  • April 2021
  • 400 Pages
  • John Wiley and Sons Ltd
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A guide to the latest industry principles for optimizing the production of solid state active pharmaceutical ingredients  

Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors - noted experts on the topic - examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. 

The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: 

  • Provides a guide for the effective development of solid drug forms 
  • Compares different characterization methods for solid state APIs  
  • Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs 
  • Includes information on automation, process control, and machine learning as an integral part of the development and production workflows 
  • Covers in detail the regulatory and quality control aspects of drug development 

Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production. 

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Impact of solid state on the industrial and academic landscape
Salts, cocrystals, solvates, and polymorphism
Determination of the state of the art
Systematic screening and investigation of solid state landscapes
Recent developments in solid state characterization techniques
Workflow management
Digitalisation strategies and resources
Stability aspects
Impact of solid forms on drug development
Impact of solid forms on scale-up
Large-scale production
Successful implementation of process analytical technology
Application of industry 4.0 systems
Strategies and approaches for industrial implementation of simulation technologies
Life Cycle Management
Patents and IP Aspects
Regulatory frameworks affecting the solid state
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Michael Gruss
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