Details

Solid State Development and Processing of Pharmaceutical Molecules


Solid State Development and Processing of Pharmaceutical Molecules

Salts, Cocrystals, and Polymorphism
Methods & Principles in Medicinal Chemistry 1. Aufl.

von: Michael Gruss, Raimund Mannhold, Helmut Buschmann, Jörg Holenz

160,99 €

Verlag: Wiley-VCH
Format: EPUB
Veröffentl.: 14.09.2021
ISBN/EAN: 9783527823062
Sprache: englisch
Anzahl Seiten: 576

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Beschreibungen

<p><b>A guide to the latest industry principles for optimizing the production of solid state active pharmaceutical ingredients </b> </p> <p><i>Solid State Development and Processing of Pharmaceutical Molecules</i> 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. </p> <p>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: </p> <ul style="margin-bottom: 0in; font-size: medium; margin-top: 0in; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; cursor: text; overflow: visible;" type="disc"> <li style="margin: 0in 0in 0in 0.75in; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; cursor: text; overflow: visible;">Provides a guide for the effective development of solid drug forms </li> <li style="margin: 0in 0in 0in 0.75in; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; cursor: text; overflow: visible;">Compares different characterization methods for solid state APIs  </li> <li style="margin: 0in 0in 0in 0.75in; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; cursor: text; overflow: visible;">Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs </li> <li style="margin: 0in 0in 0in 0.75in; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; cursor: text; overflow: visible;">Includes information on automation, process control, and machine learning as an integral part of the development and production workflows </li> <li style="margin: 0in 0in 0in 0.75in; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; cursor: text; overflow: visible;">Covers in detail the regulatory and quality control aspects of drug development </li> </ul> <p>Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers,<i> Solid State Development and Processing of Pharmaceutical Molecules</i> reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production. </p>
Aspects for Developing and Processing Solid Forms<br> Determination of Current Knowledge<br> Systematic Screening and Investigation of Solid State Landscapes<br> Microscopy<br> X-ray Diffraction<br> Thermal Analysis<br> Infrared Spectroscopy<br> Raman Spectroscopy<br> Particle Size Distribution<br> Micro Computational Tomography<br> In situ Methods for Monitoring Solid-State Processes in Molecular Materials<br> Application of Process Monitoring and Modeling<br> Photon Density Wave (PDW) Spectroscopy for Nano- and Microparticle Sizing<br> Impact of Solid Forms on API Scale-Up<br> Impact on Drug Development and Drug Product Processing<br> Workflow Management<br> Digitalization in Laboratories of the Pharmaceutical Industry<br> Polymorphs & Patents - the US Perspective<br> Polymorphs & Patents - the EU Perspective<br> Regulatory Frameworks Affecting Solid-State Development<br> Opportunities and Challenges for Generic Development from a Solid State Perspective<br>
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 PhD in chemistry from Giessen University in 1998. In 2000, he joined Grunenthal GmbH, 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. <br>

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