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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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Tekade, Rakesh K. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London, United Kingdom : Academic Press, an imprint of Elsevier, [2018]
Colección:Advances in pharmaceutical product development and research series.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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