Polymorphism in the Pharmaceutical Industry. Solid Form and Drug Development (Rolf Hilfiker).

Книга "Polymorphism in the Pharmaceutical industry: Solid Form and Drugs Development" ("Полиморфизм в фармацевтической промышленности: Твердая форма и разработка лекарств") от автора Rolf Hilfiker раскрывает значение полиморфизма в современной фармацевтической химии с акцентом на концепции качества по дизайну (Qbd). Она охватывает все важные вопросы на примере практических примеров, начиная с свойств и кристаллизации, через термодинамику, аналитику и теоретическое моделирование, вплоть до патентных вопросов. Таким образом, книга подчеркивает важность химии твердого состояния в химическом и фармацевтическом развитии. Она подчеркивает, почему проблемы с твердым состоянием важны, подходы, необходимые для избежания проблем, и возможности, предоставляемые свойствами твердого состояния. Авторы включают в себя истинные полиморфы, а также сольваты и гидраты, предоставляя информацию о физико-химических свойствах, термодинамике кристаллизации, квантово-механи

Written and compiled by renowned experts in the subject, Polymorphism In The Pharmaceutical Industry - Solid-Form And Drug Development - provides detailed chapters on all essential areas, from properties and crystal formation via thermo dynamics, analy zed data and theories, and also defendantions from patent authorities. These chapters cover various aspects of ceramics, geometrical building, and chemical structure. This book features true polymorphisms along with gem-ochr rates and proteins as well as giving facts about physical and chemical properties, crystal thermo dynamic models, quantum mechanical builds and scaling up. Reliable analytical means for validating solid states and quantifying mixtures are discussed as wdl as case studies of solid substance development routines in business and industries. This volume is the best reference for academic investigators, project executives, and safety risk officers at pharmaceutical, agrichemical, and high-tech enterprises as wdl.

This book establishes polymorphism as an essential issue in the pharmaceutical industry, with special emphasis on developments regarding the latest Quality by Design (QbD)-concepts. By means of various case-studies on properties, chemistry and controlled crystallization processes, combined with modern analytics (as well as statistical methods), but also through patenting issues, it shows considerable significance to solid state chemistry in today's chemical/pharmaceutical fields. This book beautifully explains the necessity of analysing solid-phase chemistry objectively and, at the same time, offers valuable information that could be advantageous to the creation of solid-form technicalities. Implications for true polymorph arrangement as well as hydrates/solvates are clearly illustrated and their physicochemical features are covered, along with thermodynamic crystallization modeling and quantum mechanical simulations. Additionally, some key methods for analyzing solid states and quantifying mixtures are concisely given, as are a few case examples of industrial solid-solid development applications. Experts of this subject have put together this high quality publication to serve as a reference for pharmaceutical and chemical project leaders, process and QbD professionals, academic analysts and those entering the organic solid state realm.