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Chapter 1

Introduction of Pharmaceutical Microbiology

PowerPointLecture Slide Presentation

REFERENCESREFERENCES

Tortora GJ, Funke BR, Case CL, 2007, Microbiology anIntroduction, 9th edition, Benjamin Cummings, SanFrancisco, CA 94111, USA

Madigan MT, Martinko JM, 2006, Brock Biology ofMicroorganisms, 11th edition, Pearson Education Inc., USA

Denyer SP, Hodges NA, Gorman SP, 2004, Hugo andRussells: Pharmaceutical Microbiology, 7th edition,Blackwell Science Ltd., Blackwell Publishing Company, USA

Doorne H, 2008, Seminar of Course on CurrentPharmaceutical Microbiology: Methods, Harmonizationand Technology, Faculty of Pharmacy UBAYA, Indonesia

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Microbes in Our Lives

Microorganisms are organisms that are too smallto be seen with the unaided eye

Size < 0,1 mm; bacterial cell 1 m

Germ refers to a rapidly growing cell

Microbiology revolves around 2 basic themes:

The basic science of understanding life

The application of science to human needs

Microorganisms play the central role in both humanactivities and the web of life on Earth

Maintaining balance of environment

Human:

Food, Chem., Pharmaceutical, Biotech. industries

A few are pathogenic, disease-causing

Allows humans to:

Prevent food or products spoilage

Prevent disease occurrence

Knowledge of microorganisms

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Characteristic of the cell: living system

Naming and ClassifyingMicroorganisms

1735, Linnaeus established thesystem of scientific nomenclature

Each organism has two names :

the genus and specific epithet

Describe an organism, honor ascientist or identify the habitat ofa species

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Type of Microorganisms

Bacteria

Archaea

Fungi

Protozoa

Algae

Viruses

Multicellular animal parasites

A Brief History of Microbiology

Ancestors of bacteria were the first life on Earth

The first microbes were observed in 1673

THE FIRST OBSERVATION:

1665, Robert Hooke (English): living things werecomposed of little boxes or cells.

Cell Theory. All living things are composed of cells

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The First Observations

1673-1723, Antoni vanLeeuwenhoek (Dutchmerchant)

Observed via teethscrapings, rain water, andfeces

animalcules

The First Observations

300x

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The Debate Over Spontaneous Generation

The hypothesis: spontaneous generation

A vital force forms life (air)

The alternative: biogenesis

Aristoteles (300 BC)

Evidence Pro and Con

1668, Francisco Redi (Italianphysician) filled six jars withdecaying meat.

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Evidence Pro and Con

1745, John Needham (English): Nutrient broth heated,thenpoured in the sealed flask

Microorganisms from the air probably had entered

1765, Lazzaro Spallanzani (Italian scientist): Nutrientbroth heated afterbeing sealed in the flask

Evidence Pro and Con

1861, Louis Pasteur (Frenchscientist)

Microorganisms are present inthe air and can contaminated

sterile solution; but air itself donot create microbe

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The Theory of Biogenesis

a.

b.

PASTEUR SHOWED THAT:PASTEUR SHOWED THAT:

Microorganisms can be present in the non livingmatter on solids, liquids and in the air

Microbial life can be destroyed by heat and thatmethods can be devised to block the access ofairborne microorganisms to nutrient environments.

These discoveries form the basis of aseptictechniques, which are now the standard practicein laboratory, many medical procedure and moreimportant things that a beginning microbiologistlearns

The Theory of Biogenesis

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The Golden Age of Microbiology

1857-1914, beginning with Pasteur and Robert Koch:establishment of microbiology as a science

Discoveries included

Relationship between microbes-disease, immunity,and antimicrobial drugs

Chemical activity of microorganisms, techniquesimprovement for performing microscopy andculturing microorganisms

Fermentation and Pasteurization

Fermentation: yeast convert the sugar to alcohol inthe absence of air

Bacteria use alcohol and produce acetic acid spoilwine by turning into vinegar

The application of a high heat for a short time is calledpasteurization

1876, Robert Koch (German physician): proofs that abacterium causes anthrax and provides theexperimental steps

Kochs postulates: specific microbe causes aspecific disease.

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The Germ Theory of Disease

1928, Alexander Flemingdiscovered the firstantibiotic

Penicilliumfungus madean antibiotic, penicillin,that killed S. aureus

1940, penicillin wastested clinically and massproduced

The Birth of Modern Chemotherapy

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Modern Developments in Microbiology

MICROBIOLOGY

Pharmaceutical Microbiology

PHARMACY

CLINICAL

PRODUCTS

GMP: products (sterile; non-sterile), quality

Efficacy, Safety, Stability, Acceptability

Disease; mechanisms of pathogenicity

Antimicrobial Drugs and Assay

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Pharmaceutical Microbiology

Deterioration or spoilage of the products due tomicrobial growth may results:

LOSS of consistency, organoleptic and preservativequality, package integrity, therapeutic activity

Trigger a disease depends on various factors:

Number of CFUs of the pathogen present and theproperties of particular strain (toxin)

Condition of the patient

Route of administration

Pharmaceutical Microbiology

Microbial limits of pharmaceutical preparations aregiven in relevant monographs of the leadingpharmacopoeias (FI IV, USP, EuP)

Factors related to microbiological quality:

Properly formulated products

The use of microbiologically pure raw materials The strict adherence to cGMP guidelines

Use of adequate primary packaging material

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Pharmaceutical Microbiology

Harmful effects of microorganisms in pharmacy:

May contaminate non-sterile and sterile medicinewith increase of products deterioration

May contaminate non-sterile and sterile medicinewith increase the risk of infection

Cause pyrogenic reactions (fever) when introducedinto the body even in the absence of infection

Provide the reservoir of antibiotic resistance genes

Pharmaceutical relevance to microorganisms

+Protozoa

++++

++++

FungiYeastsMoulds

+

+

++

++

++ (spores)+++

++++

BacteriaGram (-)Gram (+)MycobacteriaStreptomycetesChlamydiaRickettsia

+++Prions

+Viruses

Used in themanufactureof therapeutic

agents

Resistance tosterilizing

agents andprocesses

Resistance toantibiotics

and biocides

PathogensContaminationor spoilage ofraw material

and medicines

Type ofmicroorganism