Aulton's Pharmaceutics

Description:

 

The essential pharmaceutics textbook

One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees.

Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery.

All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course.

Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation

Designed and written for newcomers to the design and manufacture of dosage forms

Relevant pharmaceutical science covered throughout

Includes the science of formulation and drug delivery

Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines

Key points boxes throughout

Over 400 online multiple choice questions

 

Table of Contents:

 

 

What is ‘pharmaceutics’?

Chapter 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

Manufacture and quality assurance of medicines

Summary

Part 1. Scientific principles of dosage form design

Chapter 2. Dissolution and solubility

Introduction

Definition of terms

Process of dissolution

Dissolution rates of solids in liquids

Solubility

Summary

Chapter 3. Properties of solutions

Introduction

Types of solution

Ionization of solutes

Colligative properties

Diffusion in solution

Summary

Chapter 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)

Chapter 5. Disperse systems

Introduction

Colloids

Gels

Surface-active agents

Coarse disperse systems

Chapter 6. Rheology

Viscosity, rheology and the flow of fluids

Newtonian fluids

Non-Newtonian fluids

The applications of rheology in pharmaceutical formulation

Chapter 7. Kinetics

Introduction

Rate laws and order of reaction

Complex reactions

The Michaelis–Menten equation

Effect of temperature on reaction rate

Summary

Part 2. Particle science and powder technology

Chapter 8. Solid-state properties

Solid state

Crystallization

Polymorphism

Hydrates and solvates

Amorphous state

Crystal habit

Surface nature of particles

Chapter 9. Particle size analysis

Introduction

Particle size

Particle size analysis methods

Selection of a particle size analysis method

Chapter 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

Chapter 11. Mixing

Mixing principles

Mechanisms of mixing and demixing

Mixing of powders

Mixing of miscible liquids and suspensions

Mixing of semisolids

Chapter 12. Powder flow

Introduction

Particle properties

Process conditions: hopper design

Characterization of powder flow

Improvement of powder flowability

Summary

Part 3. Pharmaceutical microbiology and sterilization

Chapter 13. Fundamentals of microbiology

Introduction

Viruses

Reproduction of viruses

Latent infections

Oncogenic viruses

Bacteriophages

Archaea

Bacteria

Fungi

Chapter 14. Pharmaceutical applications of microbiological techniques

Introduction

Measurement of antimicrobial activity

Microbiological quality of pharmaceutical materials

Chapter 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

Chapter 16. Principles of sterilization

Introduction

Need for sterility

Sterilization parameters

Principles of sterilization processes

New technologies

Summary

Chapter 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

Part 4. Biopharmaceutical principles of drug delivery

Chapter 18. Introduction to biopharmaceutics

What is biopharmaceutics?

Concept of bioavailability

Concept of biopharmaceutics

Summary

Chapter 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

Chapter 20. Bioavailability – physicochemical, dosage form and formulation factors

Introduction

Physicochemical factors influencing bioavailability

Physiological factors affecting the dissolution rate of drugs

Drug factors affecting dissolution rate

Factors affecting the concentration of drug in solution in gastrointestinal fluids

Improving the bioavailability of drugs due to poor aqueous solubility

Formulation approaches to improving drug bioavailability

Improving the bioavailability of drugs with poor permeability

Dosage form factors influencing bioavailability

Influence of formulation excipients on drug dissolution and absorption

Summary

Chapter 21. Assessment of biopharmaceutical properties

Introduction

Measurement of key biopharmaceutical properties

Assessment of bioavailability

Bioequivalence

Assessment at site of release in vivo

Biopharmaceutics Classification System

Summary

Chapter 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

Part 5. Dosage form design and manufacture

Chapter 23. Pharmaceutical preformulation

The concept of preformulation

Assay development

Solubility

Molecular dissociation

Partitioning

Dissolution rate

Hygroscopicity

Physical form

Powder properties

Compaction properties

Summary

Chapter 24. Solutions

Introduction

Pharmaceutical solutions

Solution stability

Enhancement of drug solubility

Chapter 25. Clarification

Introduction

Filtration

Filtration equipment

Centrifugation

Chapter 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 considerations

Stability considerations for suspensions

Manufacturing considerations

Summary

Chapter 27. Emulsions and creams

Introduction

Emulsions in pharmacy

Formulation of pharmaceutical emulsions

Emulsifying agents (emulsifiers)

Creams

Manufacture and processing of emulsions and creams

Emulsion properties

Emulsion stability

Stability testing

Chapter 28. Ointments, pastes, gels, cutaneous patches and topical sprays

Introduction

Topical semisolid preparations

Ointments

Pastes

Gels

Emulgels

Cutaneous patches/medicated plasters

Topical sprays

Small-scale manufacturing (compounding) of ointments and pastes

Large-scale manufacturing of topical semisolid preparations

Regulatory requirements and testing for topical semisolid preparations

Summary

Chapter 29. 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

Chapter 30. 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

Chapter 31. 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

Chapter 32. Modified-release oral drug delivery

Modified-release oral drug delivery

Designing a modified-release formulation: factors to consider

Conclusions

Chapter 33. Coating of tablets and multiparticulates

Introduction

Film coating

Sugar coating

Compression coating

Coating of tablets

Coating of multiparticulates

Chapter 34. Continuous manufacturing of tablets

Introduction

Batch versus continuous manufacturing

Advantages of continuous manufacturing

Drawbacks of continuous manufacturing

Continuous manufacturing processes

Process Analytical Technology (PAT)

Summary

Chapter 35. Hard capsules

Introduction

Raw materials

Manufacture

Formulation

Chapter 36. Soft capsules

Introduction

Soft capsule manufacturing

Shell polymer systems

Fill formulation

Quality considerations

Summary

Chapter 37. 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

Chapter 38. Parenteral drug delivery

Introduction

Routes of parenteral administration

Pharmacopoeial requirements

Absorption from injection sites

Excipients

Containers

Chapter 39. Pulmonary drug delivery

Inhaled drug delivery

Formulating and delivering therapeutic inhalation aerosols

Methods of aerosol size analysis

Chapter 40. Nasal drug delivery

Introduction

Anatomy and physiology

Drug delivery

Nasal delivery systems

Summary

Chapter 41. 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

Chapter 42. Otic drug delivery

Introduction

Anatomy and physiology of the ear

Barriers to otic drug delivery

Major ear diseases and therapies

Administration routes for otic drug delivery

Formulations for otic drug delivery systems

Progress and challenges in otic drug delivery

Summary

Chapter 43. 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

Chapter 44. Rectal and vaginal drug delivery

Introduction

Rectal drug delivery

Rectal dosage forms

Vaginal drug delivery

Vaginal dosage forms

Manufacture of rectal and vaginal dosage forms

Quality control of rectal and vaginal dosage forms

Chapter 45. Preparation and delivery of biopharmaceuticals

Biopharmaceuticals

Protein and peptide drugs

Vaccines

Nucleic acid drugs

Cell-based therapies

Summary

Chapter 46. Pharmaceutical nanotechnology and nanomedicines

Introduction

Applications of pharmaceutical nanotechnology

Polymer–drug conjugates

Antibodies and antibody–drug conjugates

Dendrimers

Micelle systems

Solid nanoparticles

Liposomes, bilayer vesicles and lipid nanoparticles

Microcapsules and microspheres

Ongoing developments

Chapter 47. Radiopharmaceuticals

Introduction

Design of radiopharmaceuticals

Delivery and localization of radiopharmaceuticals

Formulation of radiopharmaceuticals

Radionuclide production: cyclotrons, reactors and radionuclide generators

Functions of a radiopharmacy facility

Summary

Chapter 48. 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

Chapter 49. 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

Part 6. Packaging, stability and pharmaceutical regulation

Chapter 50. Packaging

Introduction

The pharmaceutical pack

Packaging materials

Packaging and regulatory bodies

Repackaging

Designing packaging for safe medicine use

Chapter 51. Chemical stability in dosage forms

Introduction

Chemical degradation reactions

Stability of proteins and peptides

Stability of antibody–drug conjugates

Chapter 52. 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 antimicrobial preservatives

Preservative interactions with formulation components and containers

Chapter 53. Product stability and stability testing

Introduction

Mechanisms of degradation

Stability testing of pharmaceutical products

Summary

Chapter 54. Pharmaceutical quality: the application of pharmaceutics in medicines regulation

Quality, safety and efficacy

Pharmaceutical quality

Medicines regulation

Common Technical Document (CTD)

Drug substance

Drug product

Regulatory applications for generic medicinal products (abridged applications)

Good Manufacturing Practice (GMP)

Unlicensed medicines and off-label use of licensed medicines

Summary

Self Assessment Answers

Index

 

An aparitie	05/05/2021
Autor	Kevin M. G. Taylor, Michael E. Aulton
Dimensiuni	19.05 x 23.5 cm
Editura	Elsevier
Format	Paperback
ISBN	9780702081545
Limba	Engleza
Nr pag	968