Essential Microbiology for Pharmacy and Pharmaceutical Science - Geoff Hanlon - E-Book

Essential Microbiology for Pharmacy and Pharmaceutical Science E-Book

Geoff Hanlon

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Beschreibung

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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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

Companion Website
This book is accompanied by a companion website at:
www.wiley.com/go/hanlon/essentialmicrobiology
Visit the website for:
Figures and tables from the bookInteractive multiple choice questionsLinks to more detailed reference sources, both printed and electronic

This edition first published 2013 © 2013 by John Wiley & Sons, Ltd

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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

As a Pharmaceutical Scientist or Practicing Pharmacist, What do We Need to Know About Microbiology?

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.

Production of Medicines

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.

Understanding Infection

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.

Control of Microbes

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.

The Scope of this Book

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

Key Facts
Microorganisms are all around us in enormous numbers and are present both on and within our bodies. Some, termed pathogens, cause disease; others are beneficial and are of commercial importance but the vast majority are harmless.Infectious diseases can be caused by agents which are not living microorganisms: prions are simply ‘rogue’ protein molecules, and viruses usually consist of nucleic acid and protein but have no cellular structure.Bacteria represent the simplest living cells. Most of those of pharmaceutical interest can be grown easily in the lab.Fungi and protozoa are more complex than bacteria and most of them can exhibit sexual reproduction.Relatively few fungi are pathogenic; most are important as contaminants and spoilage organisms in manufactured medicines.Protozoa are only of pharmaceutical interest as pathogens; they are not spoilage organisms.

1.1 Microorganisms Around Us

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.

1.2 The Benefits of, and Problems with, Microorganisms

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