Dosage form design parameters. Volume 2 /

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and...

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Bibliographic Details
Corporate Authors: Elsevier Science & Technology.
Group Author: Tekade, Rakesh K.
Published: Academic Press, an imprint of Elsevier,
Publisher Address: London, United Kingdom :
Publication Dates: [2018]
Literature type: eBook
Language: English
Series: Advances in pharmaceutical product development and research series
Subjects:
Online Access: https://www.sciencedirect.com/science/book/9780128144213
Summary: Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
Carrier Form: 1 online resource.
Bibliography: Includes bibliographical references and index.
ISBN: 9780128144220
012814422X
Index Number: RS200
CLC: R94
Contents: Front Cover; Dosage Form Design Parameters; Copyright Page; Dedication; Contents; List of Contributors; About the Editor; 1 Levels of Solid State Properties: Role of Different Levels During Pharmaceutical Product Development; 1.1 Introduction; 1.2 Solids and its Forms; 1.2.1 Amorphous; 1.2.2 Polymorphs; 1.2.2.1 Solvates/Hydrates; 1.2.2.2 Salts/Cocrystals; 1.3 Levels of SSP; 1.3.1 Molecular Level; 1.3.2 Particle Level; 1.3.3 Bulk Level; 1.4 Solid State Thermodynamics; 1.5 Bioavailability of Solids; 1.6 Polymorphism and its Types; 1.6.1 Enantiotropy and Monotropy; 1.6.1.1 Density Rule
1.6.1.2 Infrared Rule1.7 Formulation Methods of Polymorphs; 1.7.1 Solvent Evaporation Method; 1.7.2 Slow Cooling Approach; 1.7.3 Solvent Diffusion Technique; 1.7.4 Vapor Diffusion Method; 1.7.5 Sublimation; 1.8 Characterization of Polymorphs; 1.9 Evaluation Technique; 1.9.1 Dissolution; 1.9.2 The Temperature-Dependent Solubility of Polymorphs: van't Hoff Plot; 1.9.3 Biological Studies; 1.10 Importance of SSP in Pharmaceutical Product Development; 1.10.1 Importance of Particle Size; 1.10.1.1 Biopharmaceutical Aspect of Particle Size; 1.11 Conclusion; Acknowledgments; References
Further Reading2 Polymorphism and its Implications in Pharmaceutical Product Development; 2.1 Introduction; 2.1.1 Solids; 2.1.2 Industrial Perspectives; 2.2 Potential Solid Polymorphic Forms; 2.2.1 Crystal; 2.2.2 Crystal Solvates or Hydrates; 2.2.3 Crystal Desolvated Solvates (Dehydrated Hydrates); 2.2.4 Amorphous; 2.3 Formation of Polymorphs: Theoretical Considerations; 2.3.1 Ostwald's Rule of Stages; 2.3.2 Cross-Nucleation; 2.3.3 Heterogeneous Two-Dimensional Nucleation: Chemotaxy, Ledge-Directed Epitaxial Growth, and Two-Dimensional Lattice Mat ...
2.3.4 Additive-Induced Polymorph Selection2.4 Effect of Polymorphism on Different Drug Properties; 2.4.1 Physical and Thermodynamic Properties; 2.4.1.1 Morphology; 2.4.1.2 Density and Refractive Index; 2.4.1.3 Wettability; 2.4.1.4 Melting Point; 2.4.1.5 Solubility; 2.4.1.6 Thermal Stability; 2.4.2 Kinetic Properties; 2.4.2.1 Dissolution; 2.4.2.2 Kinetics of Solid-State Reaction; 2.4.2.3 Stability; 2.4.3 Surface Properties; 2.4.3.1 Surface Free Energy; 2.4.3.2 Crystal Habit; 2.4.3.3 Surface Area; 2.4.3.4 Particle Size Distribution; 2.4.4 Mechanical Properties
2.4.4.1 Compressibility and Hardness2.4.5 Chemical Properties; 2.4.5.1 Reactivity; 2.5 Techniques of Polymorph Preparation; 2.5.1 Solvent Evaporation Technique; 2.5.2 Slow Cooling Technique; 2.5.3 Solvent Diffusion Technique; 2.5.4 Vapor Diffusion Technique; 2.5.5 Vacuum Sublimation Technique; 2.5.6 Crystallization in the Presence of Tailor-Made Additives; 2.6 Characterization Techniques of Polymorphs; 2.6.1 Differential Scanning Calorimetry; 2.6.2 Thermogravimetric Analysis; 2.6.3 Infrared (FT-IR) Spectroscopy; 2.6.4 Raman Spectroscopy; 2.6.5 Powder X-Ray Diffraction