Efnisyfirlit

• Instructions for online access
• Cover image
• Title Page
• Table of Contents
• Copyright
• Preface
• Contributors
• Acknowledgements
• What is ‘pharmaceutics’?
• 1 Design of dosage forms
• Principles of dosage form design
• Biopharmaceutical aspects of dosage form design
• Drug factors in dosage form design
• Therapeutic considerations in dosage form design
• Summary
• Bibliography
• Part 1 Scientific principles of dosage form design
• 2 Dissolution and solubility
• Introduction
• Definition of terms
• Process of dissolution
• Dissolution rates of solids in liquids
• Solubility
• Summary
• Reference
• Bibliography
• 3 Properties of solutions
• Introduction
• Types of solution
• Ionization of solutes
• Colligative properties
• Diffusion in solution
• Summary
• Bibliography
• 4 Surfaces and interfaces
• Introduction
• Surface tension
• Solid wettability
• Adsorption at interfaces
• Solid–vapour adsorption isotherms
• Interactions between powders and water vapour
• Inverse phase gas chromatography (IGC)
• References
• 5 Disperse systems
• Introduction
• Colloids
• Gels
• Surface-active agents
• Coarse disperse systems
• References
• Bibliography
• 6 Rheology
• Viscosity, rheology and the flow of fluids
• Newtonian fluids
• Non-Newtonian fluids
• The applications of rheology in pharmaceutical formulation
• References
• Bibliography
• 7 Kinetics
• Introduction
• Rate laws and order of reaction
• Complex reactions
• The Michaelis–Menten equation
• Effect of temperature on reaction rate
• Summary
• Bibliography
• Part 2 Particle science and powder technology
• 8 Solid-state properties
• Solid state
• Crystallization
• Polymorphism
• Hydrates and solvates
• Amorphous state
• Crystal habit
• Surface nature of particles
• References
• Bibliography
• 9 Particle size analysis
• Introduction
• Particle size
• Particle size analysis methods
• Selection of a particle size analysis method
• Reference
• Bibliography
• 10 Particle size reduction and size separation
• Introduction to size reduction
• Influence of material properties on size reduction
• Influence of size reduction on size distribution
• Size reduction methods
• Selection of the particle size reduction method
• Introduction to size separation
• Size separation methods
• Selection of a size separation process
• Bibliography
• 11 Mixing
• Mixing principles
• Mechanisms of mixing and demixing
• Mixing of powders
• Mixing of miscible liquids and suspensions
• Mixing of semisolids
• References
• Bibliography
• 12 Powder flow
• Introduction
• Particle properties
• Process conditions: hopper design
• Characterization of powder flow
• Improvement of powder flowability
• Summary
• Bibliography
• Part 3 Pharmaceutical microbiology and sterilization
• 13 Fundamentals of microbiology
• Introduction
• Viruses
• Archaea
• Eubacteria
• Fungi
• Bibliography
• 14 Pharmaceutical applications of microbiological techniques
• Introduction
• Measurement of antimicrobial activity
• Microbiological quality of pharmaceutical materials
• References
• 15 Action of physical and chemical agents on microorganisms
• Introduction
• Kinetics of cell inactivation
• Antimicrobial effects of moist and dry heat
• Ionizing radiation
• Ultraviolet radiation
• Gases
• Antimicrobial effects of chemical agents
• References
• 16 Principles of sterilization
• Introduction
• Need for sterility
• Sterilization parameters
• Principles of sterilization processes
• New technologies
• Summary
• References
• Bibliography
• 17 Sterilization in practice
• Sterile products
• Determination of sterilization protocols
• Recommended pharmacopoeial sterilization processes
• High-level disinfection
• Statistical considerations of sterility testing and sterility assurance level
• Test for sterility of the product
• Validation of a sterilization process
• Limitations of sterilization methods
• Summary
• References
• Bibliography
• Part 4 Biopharmaceutical principles of drug delivery
• 18 Introduction to biopharmaceutics
• What is biopharmaceutics?
• Concept of bioavailability
• Concept of biopharmaceutics
• Summary
• Bibliography
• 19 Gastrointestinal tract – physiology and drug absorption
• Introduction
• Physiological factors influencing oral drug absorption
• Physiology of the gastrointestinal tract
• Transit of pharmaceuticals in the gastrointestinal tract
• Barriers to drug absorption
• Summary
• References
• Bibliography
• 20 Bioavailability – physicochemical and dosage form factors
• Introduction
• Physicochemical factors influencing bioavailability
• Dosage form factors influencing bioavailability
• Reference
• Bibliography
• 21 Assessment of biopharmaceutical properties
• Introduction
• Measurement of key biopharmaceutical properties
• Assessment of bioavailability
• Assessment of site of release in vivo
• Biopharmaceutics classification system
• Summary
• References
• Bibliography
• 22 Dosage regimens
• Dosage regimens: influence on the plasma concentration-time profile of a drug in the body
• One-compartment open model of drug disposition in the body
• Important factors influencing steady-state plasma concentrations of a drug
• Summary
• Bibliography
• Part 5 Dosage form design and manufacture
• 23 Pharmaceutical preformulation
• The concept of preformulation
• Assay development
• Solubility
• Molecular dissociation
• Partitioning
• Dissolution rate
• Salt selection
• Hygroscopicity
• Physical form
• Powder properties
• Compaction properties
• Summary
• References
• Bibliography
• 24 Solutions
• Introduction
• Pharmaceutical solutions
• Solution stability
• Enhancement of drug solubility
• Bibliography
• 25 Clarification
• Introduction
• Filtration
• Filtration equipment
• Centrifugation
• Bibliography
• 26 Suspensions
• Introduction
• Definition of a suspension
• Solid particle–liquid vehicle interactions
• Particle movement in suspensions
• Dispersibility issues – surface wetting
• Dissolution issues
• Ostwald ripening
• General suspension formulation 1considerations
• Stability considerations for suspensions
• Manufacturing considerations
• Summary
• Bibliography
• 27 Emulsions and creams
• Introduction
• Emulsions in pharmacy
• Formulation of emulsions
• Emulsifying agents (emulsifiers)
• Creams
• Manufacture and processing of emulsions and creams
• Emulsion properties
• Emulsion stability
• Stability testing
• Bibliography
• 28 Powders, granules and granulation
• Introduction to powders and granules
• Powdered and granulated products as dosage forms
• Granules used as an intermediate in tablet manufacture
• Pharmaceutical technology of granule production
• Granulation mechanisms
• Pharmaceutical granulation equipment and processes
• Bibliography
• 29 Drying
• Introduction
• Drying of wet solids
• Types of drying method
• Convective drying of wet solids
• Conductive drying of wet solids
• Radiation drying of wet solids
• Drying of solutions and suspensions
• Freeze-drying (lyophilization)
• Solute migration during drying
• Bibliography
• 30 Tablets and compaction
• Introduction
• Quality attributes of tablets
• Tablet manufacturing
• Tablet excipients
• Tablet types
• Tablet testing
• Fundamental aspects of the compression of powders
• Fundamental aspects of the compaction of powders
• Relationships between material properties and tablet strength
• References
• Bibliography
• 31 Modified-release oral drug delivery
• Modified-release oral drug delivery
• Designing a modified-release formulation: factors to consider
• Conclusions
• References
• Bibliography
• 32 Coating of tablets and multiparticulates
• Introduction
• Film coating
• Sugar coating
• Compression coating
• Coating of tablets
• Coating of multiparticulates
• References
• Bibliography
• 33 Hard capsules
• Introduction
• Raw materials
• Manufacture
• Formulation
• References
• Bibliography
• 34 Soft capsules
• Introduction
• Description of the soft gelatin capsule dosage form (softgels)
• Rationale for the selection of softgels as a dosage form
• Manufacture of softgels
• Formulation of softgels
• Product quality considerations
• References
• 35 Dissolution testing of solid dosage forms
• The relevance of drug dissolution and dissolution testing
• Dissolution testing
• Dissolution testing for quality control
• Predictive dissolution testing
• Conclusions
• References
• Bibliography
• 36 Parenteral drug delivery
• Introduction
• Routes of parenteral administration
• Pharmacopoeial requirements
• Absorption from injection sites
• Excipients
• Containers
• Bibliography
• 37 Pulmonary drug delivery
• Inhaled drug delivery
• Formulating and delivering therapeutic inhalation aerosols
• Methods of aerosol size analysis
• Reference
• Bibliography
• 38 Nasal drug delivery
• Introduction
• Anatomy and physiology
• Drug delivery
• Nasal delivery systems
• Summary
• Bibliography
• 39 Ocular drug delivery
• Introduction
• Anatomy and physiology of the eye
• Some common ocular conditions and pharmacological interventions
• Topical ophthalmic preparations
• Formulating ophthalmic preparations
• Topical, liquid ophthalmic preparations
• Barriers to topical ocular drug absorption
• Increasing drug solubility and absorption in topical ophthalmic preparations
• Sterility of ophthalmic preparations
• Ocular drug pharmacokinetics
• Targeting the posterior segment of the eye
• Problems with traditional and new ocular drug delivery systems
• Patient adherence and instillation of eye drops
• References
• Bibliography
• 40 Topical and transdermal drug delivery
• Introduction
• Skin structure and function
• Transport through the skin
• Experimental methods for studying transdermal drug delivery
• Transdermal and topical preparations
• Enhancement of transdermal and topical drug delivery
• Nail delivery
• Bibliography
• 41 Rectal and vaginal drug delivery
• Introduction
• Rectal drug delivery
• Vaginal drug delivery
• Manufacture of rectal and vaginal dosage forms
• Quality control of rectal and vaginal dosage forms
• References
• Bibliography
• 42 The formulation and manufacture of plant medicines
• Introduction
• Plant-based products in medicinal use
• Quality control of crude plant drugs
• Production methods used to obtain plant-derived active constituents
• Formulation and manufacture of plant-based medicines
• Summary
• References
• Bibliography
• 43 Delivery of biopharmaceuticals
• Introduction
• Protein and peptide drugs
• Vaccines
• Nucleic acid drugs
• Summary
• References
• Bibliography
• 44 Pharmaceutical nanotechnology and nanomedicines
• Introduction
• Applications of pharmaceutical nanotechnology
• Polymer–drug conjugates
• Antibodies and antibody-drug conjugates
• Dendrimers
• Micelle systems
• Solid nanoparticles
• Liposomes and bilayer vesicles
• Microcapsules and microspheres
• Ongoing developments
• Bibliography
• 45 Design and administration of medicines for paediatric and geriatric patients
• Human development, ageing and drug administration
• Formulation design for paediatric and geriatric patients
• Adaptation of existing dosage forms
• Future developments in the formulation of paediatric and geriatric medicines
• Summary
• References
• Bibliography
• Part 6 Packaging and stability of pharmaceutical products
• 46 Packaging
• Introduction
• The pharmaceutical pack
• Packaging materials
• Packaging and regulatory bodies
• Repackaging
• References
• Bibliography
• 47 Chemical stability in dosage forms
• Introduction
• Chemical degradation reactions
• Stability of proteins and peptides
• Bibliography
• 48 Microbial contamination, spoilage and preservation of medicines
• The need to protect medicines against microbial spoilage
• Products and materials vulnerable to spoilage
• Sources and control of microbial contamination
• Selection and use of preservatives
• Preservative interactions with formulation components and containers
• References
• 49 Product stability and stability testing
• Introduction
• Mechanisms of degradation
• Stability testing of pharmaceutical products
• Concluding comments
• References
• Bibliography
• Index