05531nam 2200685 450 991045969960332120200520144314.01-118-90141-X1-118-90138-X(CKB)3710000000361281(EBL)1895726(SSID)ssj0001438522(PQKBManifestationID)11916980(PQKBTitleCode)TC0001438522(PQKBWorkID)11377128(PQKB)10697108(MiAaPQ)EBC1895726(PPN)189834587(Au-PeEL)EBL1895726(CaPaEBR)ebr11027518(CaONFJC)MIL770056(OCoLC)881518557(EXLCZ)99371000000036128120150312h20152015 uy 0engur|n|---|||||txtccrPharmaceutical amorphous solid dispersions /edited by Ann Newman, Seventh Street Development Group Lafayette, Indiana, USA ; contributors, Patrick Augustijns [and forty seven others]Hoboken, New Jersey :Wiley,2015.©20151 online resource (1218 p.)Description based upon print version of record.1-118-45520-7 Includes bibliographical references at the end of each chapters and index.Cover; Title Page; Copyright; Dedication; Preface; Contributors; 1.1 Introduction; 1.2 Formation of the Amorphous State and the Glass Transition Temperature; 1.3 Structure of Amorphous Solids; 1.4 Molecular Mobility in Amorphous Solids; 1.5 Solid-State Crystallization from the Amorphous State; 1.6 Supersaturation of API in Aqueous Media from the Amorphous State; 1.7 Mixtures of Amorphous Solids; 1.8 Formation and Properties of Amorphous Solid Dispersions; 1.9 Solid-State Crystallization from Amorphous Dispersions; 1.10 Dissolution and Supersaturation of API from Amorphous Solid Dispersions1.11 Pharmaceutical Development of Amorphous Solid DispersionsReferences; Chapter 1: Introduction to Amorphous Solid Dispersions; 2.1 Polymers Commonly Used in Amorphous Solid Dispersions; 2.2 Surfactants Commonly Used in Solid Dispersions; 2.3 Synergies between Surfactants and Polymers in Solid Dispersion Systems; 2.4 Physical Properties of Materials and Considerations in Designing Solid Dispersions; References; Chapter 2: Polymers and Surfactants; 3.1 Introduction; 3.2 Amorphous Dispersion Screening; 3.3 Amorphous Solid Dispersion Selection; 3.4 Case Study; 3.5 Conclusions; ReferencesChapter 3: Amorphous Solid Dispersion Screening4.1 Introduction; 4.2 Thermal Analysis Methods; 4.3 Dielectric Relaxation Methods; 4.4 Moisture Sorption Methods; 4.5 Vibrational Spectroscopy and Microspectroscopy; 4.6 Solid-State NMR Spectroscopy; 4.7 Other Molecular Spectroscopic Methods; 4.8 X-Ray Diffractometry; 4.9 Microscopic and Surface Analysis Methods; 4.10 Other Emerging Analytical Methods; 4.11 Computational Models; 4.12 Conclusions; Acknowledgments; References; Chapter 4: Solid-State Characterization of Amorphous Dispersions; 5.1 Introduction5.2 Theory of Crystallization in the Solid State5.3 Factors Impacting the Crystallization Tendency of Active Pharmaceutical Compounds; 5.4 Role of Additives in Modifying Solid-State Crystallization; 5.5 Assessment of Physical Stability; 5.6 Crystallization in Aqueous Environments; 5.7 Summary and Outlook; References; Chapter 5: Physical Stability and Crystallization Inhibition; 6.1 Solubility and Dissolution: An Overview; 6.2 Differences Between Crystalline API, Amorphous Materials, and Amorphous Dispersions as it Pertains to Solubility and Dissolution6.3 The Relationship of Polymer Properties with Solubility, Dissolution, and Supersaturation6.4 Solubility and Dissolution Factors to Consider for Dispersions; 6.5 Solubility and Dissolution Measurements for Amorphous Dispersions: Summary, Conclusions, and Recommendations; Acknowledgments; References; Chapter 6: Solubility and Dissolution Considerations for Amorphous Solid Dispersions; 7.1 Introduction: Translational Drug Development; 7.2 Translational Development at the Discovery Stage; 7.3 Translational Development After Discovery; 7.4 Conclusions; ReferencesChapter 7: Translational Development of Amorphous DispersionsProviding a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology - a leading platform to deliver poorly water soluble drugs, a major hurdle in today's pharmaceutical industry. Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations Has an appendix with structure and property information for polymers commonly used in drug developmPharmaceutical technologyAbsorptionSolubilityElectronic books.Pharmaceutical technology.Absorption.Solubility.615.7Newman Ann(Pharmaceutical scientist),Augustijns PatrickMiAaPQMiAaPQMiAaPQBOOK9910459699603321Pharmaceutical amorphous solid dispersions2023596UNINA