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Pharmaceutics

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Pharmaceutics Books

Pharmaceutical Preformulation

Contents

  1. The Innovator Company
    • Patent Considerations
    • Biological Equivalence and the Principle of (Patent) Equivalence
    • Pharmaceutical Preformulation
    • Molecular Investigation in Later Phases
    • Macroscopic Property Determination in Later Phases
    • Statistics and Optimization of Protocols
    • Computer Programs
    • Analytical Techniques
  2. Solubility
    • Aqueous Solubility of Non-Ionized Drugs
    • Solubility Determinations by RH-Relations
    • Solubility in mixed solvents
    • Solubility of Drug Substances which Ionize in Solution
    • Ionic Strength
    • Solubility Determinations when Adequate Supplies of Drug Substance are Available
    • Solubility of Poorly Stable Compounds
    • Effect of Surfactants
    • Mixed Solvent Systems as a Formulation Aid in Solubilization
    • Partition Coefficients
    • Dielectric Constant and Solubility Parameters
    • Solubility and pH
    • Curved Van't Hoff Plots
    • Preformulation Tasks in the Area of Solubility
  3. pH and pK
    • Definition of pH
    • Obtaining pKa with small Amounts of Drug
    • Approximate Relation between pKa and pK(c)
    • Spectrophotometric Determination of pK
    • Solubility of a Weak Electrolyte as a Function of pH
    • Partition Coefficients of Weak Electrolytes
    • Preformulation Tasks
  4. Surface Tension and Critical Micelle Concentration
    • Instrument Properties
    • Surface Tension
    • Critical Micelle Concentration
    • Effect of Temperature on CMC-Values
    • Effect of Counter Ion on Surface Tension
    • Effect of Temperature on Surface Tension
    • General Impact of Amphiphilic
  5. Solution Kinetics
    • Preliminary Task
    • Reaction Order
    • Fractional Lives
    • Temperature Effects
    • Effect of Reaction Mechanisms
    • Calorimetric Methods
    • pH Profiles and Buffer Effect
    • Oxidation
    • Kinetic Salt Effect
    • Amphiphilic Drugs
    • Optimization
    • Preformulation Check Sheet
  6. Suspensions
    • Solubility
    • Rationale for Suspensions
    • Taste
    • Stability
    • Viscosity
    • Settling of Suspensions
    • Sedimentation Kinetics
    • Density Matching
    • Particle Growth
    • Rheograms
    • Yield Diameter of Suspensions
    • Protective Colloids
    • Adsorption Isotherms
    • Coascervates
    • Surfactants
    • Preservation and Surface Adsorption
    • Dissolution of Suspensions
    • Content Uniformity
    • Pre-NDA and Pre-ANDA Testing
    • Initial Specifications
    • Test Post-NDA and Post-ANDA
    • Production Problems
  7. Crystalline Solids
    • Crystal Systems
    • Drug Purification
    • Crystal Habit
    • Vapor Pressure of Solids
    • Solubility Measurements
    • Polymorphism by Solubility Measurements
    • Metastable Solutions
    • Differential Scanning Calorimetry (DSC)
    • Preformulation Tasks
  8. Drug Substance Considerations
    • Salt Selection
    • Purifacation by Perticipation
    • Purity Assessment by Means of Phase Solubility
    • Differential Scanning Calorimetry (DSC)
    • Eutectic Diagrams
    • Preformulation Tasks
  9. Moisture Isotherms
    • Water Adsorption
    • Classifacation of Solids in Regards to Moisture
    • Critical Moisture Content(RH*)
    • Moisture Uptake below the Critical RH
    • Automated Equipment
    • Isotherms of "Soluble" Compounds
    • Hydrates
    • Hygroscopicity
    • Solubilities from Moisture Isotherms
    • Preformulation Tasks
    • Nomenclature
  10. Principles of Dissolution
    • The Noyes-Whitney Equation
    • The Dissolution Rate "Constant"
    • Particulate Dissolution
    • Multiparticulates
    • Equivalent "Diameters"
    • Preformulation Tasks
  11. Micromeritics
    • Microscopy
    • Geometric Surface Areas
    • Sieve Analysis
    • Surface Areas
    • Preformulation Tasks
  12. Shape Factors
    • Geometric Surface Area and Rugosity
    • Microscopically Determined shape Factors
    • The Ridgeway-Rupp Experiments
    • Shape Factors in General
    • Dimensional Microscopic Shape Factors
    • Fractal Geometry
    • Fractal Analysis and Pharmaceutical Parameters
    • Preformulation Tasks
  13. Physical Testing
    • Pharmaceutical Equipment for Solid Dosage Forms
    • Hard Shell Capsules
    • Dissolution of Capsules
    • Routine Task with Hard Shell Capsules
    • Soft Shell Capsules
    • Tablets
    • Mechanical Testing of Solid Dosage Forms
    • Disintegration Test
    • Tablets-Dissolution
    • Physical Compatibility
    • Some Routine Tests
    • Weight and Content Uniformity
    • Apparent Density of Mixtures
    • Cohesion-Repose Angles
    • Sieve Analysis
    • Effects of Polymorphism
    • Preformulation Tasks
  14. Compatibility Testing
    • Compatibility Test for Solid Dosage Forms
    • Hydrates
    • Dissolution Compatibility
    • Vapor Pressure
    • Aqueous Solution Compatibility
    • Non-Aqueous Liquids
    • Preformulation Task
  15. Dissolution Test Design
    • In vitro Dissolution of Solid Dosage Forms
    • Blood Level Equations
    • In vivo Dissolution
    • Calculating the Correlating in vitro Curve
    • Calculating the Correlating in vitro Curve
    • One Point Methods and Deconvolution
    • Symbols



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