Solid State Development and Processing of Pharmaceutical Molecules

Salts, Cocrystals, and Polymorphism

Michael Gruss, Raimund Mannhold, Helmut Buschmann, Jörg Holenz

• Publisher: Wiley-VCH
• Year: 2021
• Print ISBN:
  9783527346356
• eBook ISBN:
  9783527823062
• Edition: 1
• Topic: Physical Sciences
• Subtopic: Organic Chemistry

Solid State Development and Processing of Pharmaceutical Molecules

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.

Table of contents

• Cover
• Table of Contents
• Series Page
• Title Page
• Copyright
• Series Editors Preface
• Preface
• 1 Aspects for Developing and Processing Solid Forms
• 2 Determination of Current Knowledge
• 3 Systematic Screening and Investigation of Solid‐State Landscapes
• 4.1 Solid‐State Characterization Techniques: Microscopy
• 4.2 Standards and Trends in Analytical Characterization – X‐ray Diffraction (XRD)
• 4.3 Standards and Trends in Solid‐State Characterization Techniques – Thermal Analysis
• 4.4 Standards and Trends in Solid‐State Characterization Techniques: Infrared (IR) Spectroscopy
• 4.5 Transmission Raman Spectroscopy – Implementation in Pharmaceutical Quality Control
• 4.6 Solid‐state Characterization Techniques: Particle Size
• 4.7 Micro Computational Tomography
• 4.8 In Situ Methods for Monitoring Solid‐State Processes in Molecular Materials
• 4.9 Application of Process Monitoring and Modeling
• 4.10 Photon Density Wave (PDW) Spectroscopy for Nano‐ and Microparticle Sizing
• 5 Impact of Solid Forms on API Scale‐Up
• 6 Impact on Drug Development and Drug Product Processing
• 7 Workflow Management
• 8 Digitalization in Laboratories of the Pharmaceutical Industry
• 9.1 Polymorphs and Patents – the US Perspective
• 9.2 Polymorphs and Patents – The EU Perspective
• 10 Regulatory Frameworks Affecting Solid‐State Development
• 11 Opportunities and Challenges for Generic Development from a Solid‐state Perspective
• Index
• End User License Agreement