9781847356550_Front Cover -- 9781847356550_Contents -- Preface -- Contributors -- Chapter 01 -- 1 Pulmonary Drug Delivery, Concepts and Practice -- 1.1 History and Rationale of Pulmonary Drug Delivery -- 1.2 Diseases and Inhaled Products -- 1.2.1 Asthma -- 1.2.2 Chronic Obstructive Pulmonary Disease -- 1.2.3 Cystic Fibrosis -- 1.3 Rationale for Developing Polymer-based Pulmonary Delivery Systems -- 1.3.1 Drug Protection -- 1.3.2 Drug Release and Targeting -- 1.3.3 Vaccines [41] -- 1.4 Physiological Barriers to Lung Delivery -- 1.4.1 Aerodynamics -- 1.4.2 Mucociliary Clearance -- 1.4.3 Alveolar Macrophages -- 1.4.4 Drug Absorption Rates -- 1.5 Summary -- References -- Chapter 02 -- 2 Polymers for Pulmonary Drug Delivery based on their Interactions with the Lung: Biodegradation, C -- 2.1 Introduction -- 2.1.1 Rationale for the Use of Polymeric Carriers for Pulmonary Drug Delivery -- 2.1.2 Selection Criteria of a Polymeric Carrier for Inhalation Therapy -- 2.1.3 Biodegradable Polymeric Particle Carriers for Pulmonary Drug Delivery -- 2.1.3.1 Biodegradable Polymer-based Nanoparticles for Pulmonary Delivery -- 2.1.3.2 Biodegradable Polymer-based Microparticles for Pulmonary Delivery -- 2.1.4 Biocompatible Polymeric Particle Carriers for Pulmonary Drug Delivery -- 2.1.5 Bioadhesive Polymeric Particle Carriers for Pulmonary Drug Delivery -- References -- Chapter 03 -- 3 The Influence of Polymers on Alveolar Macrophage Uptake -- 3.1 Introduction -- 3.2 Poly(lactic-co-glycolic acid) -- 3.3 Poly(ethylene glycol) -- 3.4 Mannosylated-gelatin -- 3.5 Mannan-Poly(ethylene glycol)-Poly(ethylene) Bioadhesive Poly(lactide-co-glycol acid) -- 3.6 Summary -- References -- Chapter 04 -- 4 Polymer Drug-delivery Systems for Sustained Alveolar Delivery -- 4.1 The Anatomy and Physiology of the Alveolar Region -- 4.2 Aerosol Targeting of the Alveoli.

4.3 Clearance Mechanisms in the Alveolar Region -- 4.4 Review of Particle and Polymer Approaches to Achieve Sustained Alveolar Delivery -- 4.4.1 Achieving Controlled Pulmonary Drug Delivery Using Particle Size -- 4.4.1.1 Large Porous Particles -- 4.4.1.2 Swellable Particles -- 4.4.2 Achieving Controlled Pulmonary Drug Delivery Using Surface Chemistry -- 4.4.2.1 Poly(ethylene glycol) Coating of Particles -- 4.4.2.2 PEGylation of Molecules -- 4.4.3 Achieving Controlled Pulmonary Drug Delivery Using Shape -- 4.5 Summary -- References -- Chapter 05 -- 5 Polymer Drug-delivery Systems for Sustained Mucoadhesion in the Respiratory Tract -- 5.1 Introduction -- 5.2 Physiological Considerations Relevant to the Mucoadhesive Theory -- 5.2.1 Nasal Mucosa -- 5.2.2 Pulmonary Structure -- 5.2.3 Mucus and the Mucoadhesive Phenomenon -- 5.2.4 Mucoadhesion Fundamentals -- 5.2.5 Theories of Mucoadhesion -- 5.2.5.1 Electronic Theory -- 5.2.5.2 Adsorption Theory -- 5.2.5.3 Wetting Theory -- 5.2.5.4 Diffusion Theory - Interpenetration Mechanism -- 5.2.5.5 Fracture Theory -- 5.3 Drug-delivery Systems for Sustained Mucoadhesion -- 5.4.1 Nasal Delivery -- 5.4.2 Pulmonary Delivery -- 5.4.3 Thiomers -- 5.4 Conclusion -- References -- Chapter 06 -- 6 Manufacture of Polymer Particles for Pulmonary Drug Delivery -- 6.1 Introduction -- 6.1.1 Manufacture of Polymer Carrier Particles for Enhanced Pulmonary Drug Delivery -- 6.1.1.1 Milling -- 6.1.1.2 Spray Drying -- 6.1.1.3 Spray Freezing into Liquid -- 6.1.1.4 Emulsion-solvent Evaporation -- 6.1.1.5 Supercritical Fluid Technology -- 6.1.1.6 Spray Gelation (Aerosol-mediated) Method -- 6.1.1.7 Electrohydrodynamic Atomisation -- 6.1.1.8 Other Particle Engineering Methods -- References -- Chapter 07 -- 7 Physical and Chemical Characterisation of Polymers for Pulmonary Drug Delivery -- 7.1 Molecular Weight Determination.

7.1.1 Size Exclusion Chromatography -- 7.2 Structural Analysis -- 7.2.1 Fourier-Transform Infrared -- 7.2.2 Ultraviolet-Visible Spectrophotometry -- 7.2.3 Elemental Analysis -- 7.2.4 Nuclear Magnetic Resonance -- 7.2.5 Mass Spectrometry and Gas Chromatography-Mass Spectrometry -- 7.3 Thermal Analysis -- 7.3.1 Thermogravimetric Analysis -- 7.3.2 Differential Scanning Calorimetry -- 7.3.3 Thermomechanical Analysis -- 7.4 Small-angle X-ray Scattering -- 7.5 Microscopic Characterisation -- 7.5.1 Scanning Electron Microscopy -- 7.5.2 Transmission Electron Microscopy -- 7.5.3 Atomic Force Microscopy -- References -- Chapter 08 -- 8 Polymers Used in Inhaler Device Design and Packaging -- 8.1 Introduction -- 8.2 Polymers in Inhalation Device Design -- 8.2.1 Inhalation Device Design -- 8.2.1.1 Nebuliser -- 8.2.1.2 Metered-dose Inhaler -- 8.2.1.3 Dry Powder Inhaler -- 8.2.2 Properties of Polymers in Inhalation Device Design -- 8.2.3 Functions of Polymers in Inhalation Device Design -- 8.2.3.1 Support -- 8.2.3.2 Compatibility -- 8.2.3.3 Moisture Prevention -- 8.2.3.4 Leakage Prevention -- 8.2.3.5 Electrostatic Reduction -- 8.2.3.6 Patient Convenience -- 8.2.4 Manufacturing of Polymers in Inhalation Devices -- 8.3 Polymers in Pharmaceutical Packaging -- 8.4 Regulations and Considerations for Polymers in Pharmaceutical Applications -- 8.4.1 General Regulations for Polymers -- 8.4.2 Considerations for Polymers: Extractables and Leachables -- 8.5 Conclusion -- References -- Chapter 09 -- 9 Regulatory Aspects of Pulmonary Delivery of Polymers -- 9.1 Introduction -- 9.2 An Overview of Regulatory Issues for Polymeric Products -- 9.2.1 Sources of Polymer Material -- 9.2.2 Regulation and Guidance for Polymer Characterisation -- 9.2.2.1 Structure Analysis and Identification Tests -- 9.2.2.2 Particle Shape, Size and Surface Area -- 9.2.2.3 Thermal Analysis.

9.2.2.4 Other Physicochemical Properties: Solubility, Viscosity and Flowability -- 9.2.2.5 Impurity Detection and Purification -- 9.2.2.6 Stability Tests -- 9.2.2.7 Safety Evaluation -- 9.2.3 Regulations and Guidance for Polymer-based Product Characterisation -- 9.3 Issues Specific to Polymers Used in the Lung -- 9.3.1 Accumulation and Clearance -- 9.3.2 Sterilisation of Polymers -- 9.3.2.1 Steam Sterilisation -- 9.3.2.2 Ethylene Oxide Sterilisation -- 9.3.2.3 Irradiation Sterilisation -- 9.3.2.4 Dense Gas Technique -- 9.3.3 Compatibility -- 9.3.4 Chronic versus acute therapies -- References -- Abbrevations -- Abbreviations -- Index -- Index -- 9781847356550_Back Cover.