http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
the science and technology of dosage forms
Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry.
Intro; Title Page; Copyright Page; Preface; Contents; Chapter 1 Preformulation Studies; 1.1 Introduction; 1.2 Solubility; 1.2.1 Absolute (Intrinsic) Solubility; 1.2.2 Molecular Dissociation pKa; 1.2.3 Solubility in Various Solvents; 1.2.4 Solubility Rate (Dissolution); 1.3 Diffusion; 1.4 Partition Coefficient; 1.5 Permeability; 1.6 The Biopharmaceutical Classification System; 1.7 Moisture Uptake/Sorption; 1.7.1 Classification of Hygroscopicity; 1.8 Polymorphism and Crystallinity; 1.8.1 Differential Scanning Calorimetry (DSC); 1.8.2 Thermogravimetric Analysis (TGA)
1.8.3 Powder X-ray Diffraction1.8.4 Crystallinity; 1.9 Stability; 1.9.1 Chemical Degradation in Solution; 1.9.2 Hydrolytic Degradation; 1.9.3 Stability in Solvents Used in Formulation and/or Manufacture; 1.9.4 Dimerization and Polymerisation; 1.9.5 Photostability; 1.9.6 pH-dependent Stability; 1.9.7 Oxidative Stability; 1.9.8 Stability-Compatibility; 1.10 Solid-state Physico-Technical Properties; Further Reading; References; Chapter 2 Hard Capsules in Modern Drug Delivery; 2.1 Introduction; 2.2 Hard Capsules-Types, Characteristics and Applications
2.2.1 Hard Capsules as a Pharmaceutical Excipient2.2.2 Hard Capsules for Special Applications; 2.3 Selection of Capsules in Formulation Development; 2.4 Hard Capsule Drug Delivery Addressing Pharmaceutical Needs; 2.4.1 Hard Capsule Powder Blend Formulation and Processing; 2.4.2 Highly Potent and Low-dose Drug Formulations; 2.4.3 Enhancing Bioavailability of Poorly Aqueous Soluble Drugs; 2.4.4 Physical Modification of the Drug Substance; 2.5 Targeted Drug Delivery; 2.5.1 Capsules with Solid Formulation; 2.5.2 Abuse Deterrent; 2.6 Manufacture of Commercial Hard Capsules Products
2.6.1 Powder and Granule Blends2.6.2 Multiparticulates and Mini-tablets; 2.6.3 Tablet Filling; 2.6.4 Liquid and Semi-solid Formulation; 2.6.5 Powder Micro-dosing; 2.7 Conclusions; Acknowledgements; References; Chapter 3 Soft Capsules; 3.1 Introduction; 3.2 Background; 3.3 Technology Strengths/Limitations; 3.4 Description; 3.5 Equipment and Facilities; 3.6 Shell Components; 3.7 Fill Formulation; 3.8 Product Development; 3.8.1 Fill Formulation Development Processes; 3.8.2 Shell Compatibility; 3.8.3 Prototype Manufacture; 3.8.4 Process Development; 3.9 Clinical Supply
3.10 Analytical Considerations3.11 Excipient Considerations; 3.11.1 Gelatin; 3.11.2 Plasticizers; 3.11.3 Water; 3.11.4 Colors, Opacifiers etc.; 3.11.5 Ingredient Specifications; 3.12 Packaging and Stability Considerations; 3.13 Manufacturing Process; 3.14 Key Process and Product Parameters; 3.14.1 In-process Testing; 3.14.2 Set up (Pre-start); 3.14.3 During Encapsulation; 3.14.4 During Drying; 3.14.5 Finished Product; 3.15 Recent Technology Advances; 3.15.1 Film Coating; 3.15.2 Non-gelatin Shell and Controlled Release Fill; 3.15.3 Vaginal Dosage Forms; 3.16 Trends in Patent Activity