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This text is an essential study guide for undergraduates studying microbiology modules on degree courses in pharmacy and the pharmaceutical sciences. Written by two pharmacists each with over 30 years experience of teaching, research and publishing in pharmaceutical microbiology, it distills the subject down into the essential elements that pharmacists and pharmaceutical scientists need to know in order to practice their profession, and it covers all the microbiology components of the Royal Pharmaceutical Society's indicative syllabus that is at the heart of every UK pharmacy degree.
Much of the applied microbiology that a pharmacist or pharmaceutical scientist needs to know is unique: topics like the manufacture of microbiologically sterile medicines and their subsequent protection against microbial contamination and spoilage, the detection of hazardous microorganisms in medicines and antibiotics' manufacture and assay are all covered here. Essential Microbiology for Pharmacy and Pharmaceutical Science Students displays material in an easy to-digest format and concepts are explained using diagrams, tables and pictures wherever possible. The book contains an extensive self-assessment section that includes typical multiple choice, short answer and essay-style examination questions, and a companion website to further test your knowledge from a selection of questions along with further links to relevant sites.
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Seitenzahl: 454
Veröffentlichungsjahr: 2012
Contents
Cover
Companion Website
Title Page
Copyright
Preface
As a Pharmaceutical Scientist or Practicing Pharmacist, What do We Need to Know About Microbiology?
Part I: Characteristics of Microorganisms
Chapter 1: The Microbial World
1.1 Microorganisms Around Us
1.2 The Benefits of, and Problems with, Microorganisms
1.3 The Different Types of Microorganisms
1.4 Naming of Organisms
Acknowledgement
Chapter 2: Handling and Growing Microorganisms
2.1 Sterility and Asepsis – What do They Mean?
2.2 Hazard Categories of Microorganisms
2.3 Sources and Preservation of Microorganisms
2.4 Growth Media and Methods
2.5 The Bacterial Growth Cycle
2.6 Environmental Factors Influencing Microbial Growth
Acknowledgement
Chapter 3: Bacterial Structure and Function
3.1 Bacterial Morphology
3.2 The Cell Wall
3.3 Teichoic Acids
3.4 Lipopolysaccharide (Endotoxin)
3.5 Cytoplasmic Membrane (See Figure 3.7)
3.6 Inclusion Bodies (Storage Granules)
3.7 The Bacterial Chromosome
3.8 Plasmids
3.9 Ribosomes
3.10 Fimbriae (pili)
3.11 Capsules
3.12 Flagella
3.13 Bacterial Endospores
Acknowledgement
Chapter 4: Mycology: The Study of Fungi
4.1 Definitions
4.2 Main Characteristics
4.3 Commercially Important Fungi
4.4 Pathogenic Fungi
Acknowledgement
Chapter 5: Protozoa
5.1 Cultivation of Protozoa
5.2 Protozoal Infections: the Global and Uk Perspectives
5.3 The Characteristics and Transmission of the Major UK Protozoal Infections
5.4 The Transmission, Prophylaxis and Treatment of Malaria
Acknowledgement
Chapter 6: Viruses and Viral Infections
6.1 The Pharmaceutical Importance of Viruses
6.2 Virus Structure and Replication
6.3 Viral Infections
6.4 Virus Survival Outside the Body and Susceptibility to Disinfection
Acknowledgement
Chapter 7: Characteristics of Other Microorganisms and Infectious Agents
7.1 Nonliving infectious particles
7.2 Viruses
7.3 Chlamydiae
7.4 Rickettsiae
7.5 Mycoplasmas
Acknowledgement
Part II: Microorganisms and the Treatment of Infections
Chapter 8: Infection and immunity
8.1 What is an infection?
8.2 Mode of transmission of disease
8.3 Immune response to infection
8.4 Vaccination and vaccines
Chapter 9: The Selection and Use of Antibiotics
9.1 Mechanisms of Antibiotic Action
9.2 Factors to Consider in Selecting an Antibiotic
9.3 Antibiotic Combinations
9.4 Using Antibiotics for Prophylaxis
Acknowledgement
Chapter 10: Antibacterial Antibiotics
10.1 The Frequency of Use of the Major Groups of Antibiotics
10.2 Penicillins
10.3 Cephalosporins
10.4 Other β-Lactam Antibiotics
10.5 Macrolides
10.6 Tetracyclines
10.7 Sulphonamides and Trimethoprim
10.8 Quinolones
10.9 Aminoglycosides
10.10 Glycopeptides
10.11 Other Antibiotics
Acknowledgement
Chapter 11: Antifungal Agents
11.1 Common Fungal Infections
11.2 Agents Used to Treat Fungal Infections
11.3 Treatment of Common Fungal Infections
Acknowledgement
Chapter 12: Antiviral Agents
12.1 Viral Infections
12.2 Targets for Antiviral Agents
12.3 Antiviral Agents Active Against the Herpes Group of Viruses
12.4 Inorganic Pyrophosphate Mimics
12.5 Anti-HIV Drugs
12.6 HIV Treatment: Highly Active Antiretroviral Therapy – HAART (British HIV Association Guidelines)
12.7 Viral Hepatitis
12.8 Influenza
12.9 Respiratory Syncytial Virus
Acknowledgement
Chapter 13: Antibiotic resistance
13.1 Innate (intrinsic) Resistance
13.2 Measurement of Resistance
13.3 Origins of Antibiotic Resistance
13.4 Resistance Mechanisms at the Cellular Level
13.5 β-Lactamases and Extended-Spectrum β-Lactamases (ESBLs)
Acknowledgement
Chapter 14: Antibiotic stewardship
14.1 Antibiotics: a Resource to be Protected
14.2 What is Antibiotic Stewardship?
14.3 The Aims of Stewardship Programmes
14.4 Hospital Antibiotic Stewardship Programmes
14.5 Availability of Antibiotics to the Public
Acknowledgement
Part III: Microorganisms and the Manufacture of Medicines
Chapter 15: Bioburdens: Counting, Detecting and Identifying Microorganisms
15.1 What does ‘Bioburden’ Mean?
15.2 Traditional Counting Methods
15.3 Detection of Objectionable Organisms
15.4 Automated Bioburden Determinations
15.5 Bioburden Specifications in the Pharmacopoeias
15.6 Identification of Microorganisms
Acknowledgement
Chapter 16: Antiseptics, Disinfectants and Preservatives
16.1 Definitions
16.2 Classes of Biocidal Agents
16.3 Measurement of Antibacterial Activity
16.4 Preservative Efficacy Testing
16.5 Disinfectant Testing
Acknowledgement
Chapter 17: The Manufacture of Medicines: Product Contamination and Preservation
17.1 Microbiological Standards for Medicines
17.2 Methods of Making Sterile Products
17.3 Strategies to Assure Appropriate Standards
17.4 Sources of Microbial Contamination, and Environmental Monitoring
17.5 Clean-Room Design and Operation
17.6 The Protection of Pharmaceutical Products from Microbial Contamination
Acknowledgement
Chapter 18: The Design of Sterilization Processes
18.1 Survivor Plots and Sterility Assurance Levels
18.2 D-Values
18.3 Inactivation Factor
18.4 Z-Values
18.5 F and F0 Values
Chapter 19: Sterilization Methods
19.1 Choice of Method for Manufacturing a Sterile Product
19.2 Steam Sterilization
19.3 Dry Heat Sterilization
19.4 Radiation Sterilization
19.5 Gaseous Sterilization
19.6 Filtration Sterilization and Aseptic Manufacture
19.7 Biological Indicators
19.8 Tests for Sterility
19.9 Parametric Release
Acknowledgement
Chapter 20: The Use of Microorganisms in the Manufacture of Medicines
20.1 The Cells Themselves
20.2 Enzymes, Proteins and Polysaccharides
20.3 Recombinant Proteins
20.4 Microbial Biotransformation of Steroids
20.5 Microbial Modifications of the Steroid Nucleus
20.6 Primary Metabolic Products
20.7 Secondary Metabolic Products
20.8 Commercial Production of Antibiotics
Acknowledgement
Index
Access to Companion Websites
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Library of Congress Cataloging-in-Publication Data
Hanlon, Geoff.
Essential Microbiology for Pharmacy and Pharmaceutical Science / Geoff Hanlon and Norman Hodges.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-470-66532-9 (cloth) – ISBN 978-0-470-66534-3 (pbk.)
I. Hodges, Norman A. II. Title.
[DNLM: 1. Microbiological Phenomena. 2. Anti-Infective Agents–pharmacology. 3. Infection–drug therapy. 4. Infection–microbiology. 5. Pharmaceutical Preparations. 6. Pharmacological Phenomena. QW 4]
615.7′92–dc23
2012027340
A catalogue record for this book is available from the British Library.
Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.
Preface
Whether you are studying for a degree in pharmacy or a related discipline such as pharmaceutical and chemical sciences, you are, first and foremost, pharmaceutical scientists and need to understand the main function of professionals working in this field. The pharmaceutical sciences are a very broad discipline encompassing everything from the basic sciences to the social sciences; however, the bottom line is that pharmaceutical scientists are the only professionals with an intimate knowledge of the production and use of medicines. They are involved at every stage in the production of medicines – from drug discovery, product formulation and manufacture to regulatory control and quality assurance, while pharmacists are specifically involved in overseeing the safe and effective use of medicines in the community and in hospital. However, regardless of where your specific expertise resides, it is important to have a good knowledge of all stages in the process.
With this in mind we now need to understand where pharmaceutical microbiology fits into the picture.
The diagram above illustrates that pharmaceutical microbiology touches on a number of major aspects in the production and use of medicines and we will briefly deal with each of these in turn.
A large number of medicines and medical devices are manufactured as sterile products – for example, injections and infusions, eye drops and eye ointments, some dressings, catheters and cannulas. Going back in time, there were a number of horrific incidents where products that had not been properly sterilized were given to patients, some of whom subsequently died. It is our responsibility as pharmaceutical scientists to understand the processes of sterilization and aseptic manufacture so that patients' lives are not put at risk.
Even if a medicine is not a sterile product, there are still requirements for it to be manufactured in such a way as to restrict microbial contamination, and quality control procedures including bioburden determination and environmental monitoring are pivotal to achieve this. Many products, such as creams, lotions and liquid oral products, are opened and used on a number of separate occasions. In order to protect the product and the patient we need to incorporate antimicrobial preservatives into these medicines and understand what influences their efficacy.
While we spend a lot of time trying to eliminate microorganisms from our environment and the products we make, it should not be forgotten that they are also responsible for the production of a number of very useful materials. These include antibiotics, steroids, insulin and other recombinant proteins, amino acids, organic acids, enzymes and polysaccharides.
It is not the role of a pharmaceutical scientist to diagnose infections; that is the job of the clinician, but it is important that we have a clear understanding of viral, fungal and bacterial diseases. The reason this is important is because it critically influences the choice of medication to be used in the management of the disease. Knowing the characteristics of different pathogens, the diseases they cause and the most suitable management protocols is critical for our role in the infection control team. Part of our daily professional routine may be to discuss treatment options with clinical colleagues and we have to be able to speak their language.
We also need to understand how the body reacts to infectious agents so that we can advise patients on how to deal with their symptoms. Many patients will present with minor conditions such as coughs and colds, skin infections, gastro-intestinal problems such as diarrhoea and vomiting and we need to understand what is going on in order to give them the best advice. Moreover, we are seeing increasing numbers of patients with compromised immune systems and so it is necessary to understand why these are more susceptible to infection and how this might be managed.
An understanding of the control of microbes is relevant in terms of patient treatment and also control of microbes in the environment. From a patient perspective probably the most important role of the pharmacist is to understand the use of antibiotics – what they can do and what they can't. For instance, an antibiotic such as amoxicillin would be of no use in treating a patient with a viral sore throat or a fungal lung infection. Indeed we need to go further and understand why an antibacterial antibiotic such as benzylpenicillin would be ineffective in treating a patient with a Gram-negative bacteraemia. An increasingly important issue and one that will play a major part in the career of any pharmacist or pharmaceutical scientist is that of antibiotic resistance. Many of the antibiotics that we have come to rely upon are losing their usefulness as certain pathogens develop mechanisms to resist their effects. Some clinical isolates of Pseudomonas aeruginosa, Acinetobacter baumannii and Mycobacterium tuberculosis have been found which are resistant to virtually all of the standard antibiotic therapies. How these infections can be managed in the future requires a clear understanding of the basics of microbiology.
Controlling microorganisms in the environment by the use of disinfectants and antiseptics has become increasingly crucial as we understand more about the role of microbes in infection. The use of alcohol gels in hospitals has become the norm and the public has become more aware of the importance of disinfection around the home. Disinfectants are the main tool in deep cleaning procedures applied following outbreaks of infections such as MRSA and Clostridium difficile in hospitals. Pharmacists will play a role in implementing these strategies and will need to be in a position to provide advice on all of these scenarios.
This book covers the microbiology content of the Royal Pharmaceutical Society's syllabus for Pharmacy degrees in the UK which is equally relevant to those studying the pharmaceutical and chemical sciences. It is not intended to give a comprehensive coverage of the whole subject but instead to be an easily digestible outline of the most important features. If the reader requires further information on any of the subjects, the website associated with this book gives examples of where this may be found, and in addition it contains a range of multiple choice questions to allow a reader to check their understanding of the material.
Geoffrey Hanlon and Norman Hodges
Part I
Characteristics of Microorganisms
Chapter 1
The Microbial World
A mixture of bacteria, protozoa and algae in a water sample from a stream
Microorganisms are present in almost every location and environment on earth. They are in the air, soil and water, on all plants and animals and in such extreme environments as Antarctic ice and rocks 3 km below the earth's surface where the temperature is 60° C or more. Besides growing at extremes of temperature and pH, many bacteria survive and grow in the absence of oxygen; for these bacteria, described as anaerobes, oxygen is toxic. Microorganisms are present, too, in huge numbers and variety. The bacteria in the average human gut are estimated to comprise about 500 different species, and their total number, approximately 1014 (one hundred trillion), is about 10 times the number of human cells in the body and more than 10 000 times the human population of the earth. It is impossible to obtain precise data on the relative numbers of harmless and disease-causing (pathogenic) organisms for two main reasons: because new species are being identified all the time, and because of the difficulty of deciding what is harmless and what is not. Organisms that present no threat to a healthy individual might be pathogenic for a person with impaired immunity. Nevertheless, despite the extensive media attention on bioterrorism organisms and the so-called hospital ‘superbugs’, the harmless bacteria, together with those that are actually beneficial, grossly outnumber the pathogens; one estimate is by a ratio of more than 200 000 to 1.
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