A guide to the lastest 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.
Зміст
Aspects for Developing and Processing Solid Forms
Determination of Current Knowledge
Systematic Screening and Investigation of Solid State Landscapes
Microscopy
X-ray Diffraction
Thermal Analysis
Infrared Spectroscopy
Raman Spectroscopy
Particle Size Distribution
Micro Computational Tomography
In situ Methods for Monitoring Solid-State Processes in Molecular Materials
Application of Process Monitoring and Modeling
Photon Density Wave (PDW) Spectroscopy for Nano- and Microparticle Sizing
Impact of Solid Forms on API Scale-Up
Impact on Drug Development and Drug Product Processing
Workflow Management
Digitalization in Laboratories of the Pharmaceutical Industry
Polymorphs & Patents – the US Perspective
Polymorphs & Patents – the EU Perspective
Regulatory Frameworks Affecting Solid-State Development
Opportunities and Challenges for Generic Development from a Solid State Perspective
Про автора
Michael Gruss, owner and founder of Solid State Concepts, works as an independent scientific consultant for the pharmaceutical, chemical and nutrition industry. He earned a Ph D in chemistry from Giessen University in 1998. In 2000, he joined Grünenthal Gmb H, where he established and developed a solid-state investigation laboratory for drug substances and intermediates. He is author or co-author of more than 15 patent applications in the field of salts, cocrystals and polymorphs.
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