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Developing Solid Oral Dosage Forms : Pharmaceutical Theory and Practice.

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Qiu, Yihong
Otros Autores: Chen, Yisheng, Zhang, Geoff G. Z., Yu, Lawrence, Mantri, Rao V.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Saint Louis : Elsevier Science, 2016.
Edición:2nd ed.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover; Developing Solid Oral Dosage Forms; Copyright Page; Dedication; Contents; List of Contributors; I. Theories and Techniques in the Characterization of Drug Substances and Excipients; 1 Solubility of Pharmaceutical Solids; 1.1 Introduction; 1.1.1 Implication of solubility in dosage form development; 1.1.2 Basic concepts of solubility and dissolution; 1.1.2.1 Ionic interactions; 1.1.2.2 van der Waals interactions; 1.1.2.3 Dispersion interactions; 1.1.2.4 Hydrogen bonding; 1.2 Thermodynamics of Solutions; 1.2.1 Volume of mixing; 1.2.2 Enthalpy of mixing; 1.2.3 Entropy of mixing.
  • 1.2.4 Free energy of mixing1.3 Theoretical Estimation of Solubility; 1.3.1 Ideal solutions; 1.3.2 Effect of crystallinity; 1.3.3 Nonideal solutions; 1.3.4 Regular solution theory; 1.3.5 Aqueous solution theory; 1.3.6 General solubility equation; 1.4 Solubilization of Drug Candidates; 1.4.1 Solubility enhancement by pH control and salt formation; 1.4.1.1 Theoretical expressions to describe pH-solubility profiles; 1.4.2 Solubilization using complexation; 1.4.2.1 AL-type phase diagrams; 1.4.2.2 AP-type phase diagrams; 1.4.2.3 BS-type phase diagrams; 1.4.3 Solubilization by cosolvents.
  • 1.4.4 Solubilization by surfactants (micellar solubilization)1.4.5 Solubilization by combination of approaches; 1.4.5.1 Combined effect of ionization and cosolvency; 1.4.5.2 Combined effect of ionization and micellization; 1.4.5.3 Combined effect of ionization and complexation; 1.4.5.4 Combined effect of cosolvency and complexation; 1.4.5.5 Combined effect of complexation and micellar solubilization; 1.5 Experimental Determination of Solubility; 1.5.1 Stability of solute and solvent; 1.5.2 Shakers and containers; 1.5.3 Presence of excess undissolved solute; 1.5.4 Determination of equilibrium.
  • 1.5.5 Phase separation1.5.6 Determination of solute content in the dissolved phase; 1.5.7 Experimental conditions; References; 2 Crystalline and Amorphous Solids; 2.1 Introduction; 2.2 Definitions and Categorization of Solids; 2.3 Thermodynamics and Phase Diagrams; 2.3.1 Polymorphs; 2.3.1.1 Enantiotropy and monotropy; 2.3.1.2 Methods of determining stability relationships between polymorphs; 2.3.1.2.1 Quantitative methods; 2.3.1.2.1.1 Using heat of fusion data; 2.3.1.2.1.2 Using eutectic fusion data; 2.3.1.2.1.3 Using solubility/intrinsic dissolution rate data.
  • 2.3.1.2.1.4 Using solubility/intrinsic dissolution rate and heat of solution data2.3.1.2.2 Qualitative methods; 2.3.1.2.2.1 Using the definition; 2.3.1.2.2.2 Using the heat of fusion rule; 2.3.1.2.2.3 Using the heat of transition rule; 2.3.2 Solvates/Hydrates; 2.3.2.1 Anhydrate/Hydrate equilibrium at constant temperature; 2.3.2.2 Temperature dependence of anhydrate/hydrate equilibrium; 2.3.3 Cocrystals; 2.3.4 Amorphous solids; 2.4 Pharmaceutical Relevance and Implications; 2.4.1 Solubility; 2.4.2 Dissolution rate and bioavailability; 2.4.3 Hygroscopicity.