Aulton’s Pharmaceutics: The Design and Manufacture of Medicines 5th Edition

Aulton’s Pharmaceutics: The Design and Manufacture of Medicines 5th Edition:

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

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