PHA6114

PHARMACEUTICAL MICROBIOLOGY AND

PARASITOLOGY

INTRODUCTION TO PHARMACEUTICAL MICROBIOLOGY

(MODERN APPLICATIONS)
ASST. PROF. RHONA P. RAMOS, MSc.
Course Facilitator
 CONTENTS
APPLICATIONS OF MICROBIOLOGY

1. Modern medicine
2. Sterile products
3. Disinfection
4. Antibiotic Production
5. Understanding infections
6. Applications to Pharmacy
 health improvement of world’s population

death due to AIDS reached its peak in 2006

new HIV infections down 16% from 2000 to 2008

life expectancy rose in 157 out of the 193

countries
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better nutrition and sanitation

improved health care and the greater

availability of effective medicines

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 Global Eradication

smallpox in 1977 rinderpest in 2011

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 Global Eradication

polio guinea worm infection

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 MODERN MEDICINE

development of many vaccines

and other medicines contribute to
the improvement of world health

large investment of
pharmaceutical companies

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 MODERN MEDICINE

worldwide sales of medicine has

been tremendously increasing

growth of the pharmaceutical

industry is paralleled by rising
standards for product quality

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 MODERN MEDICINE

medicines: effective, safe, high quality

active ingredient + excipients: ensure that

the medicine is effective and remains
stable, palatable and safe during storage
and use
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 MODERN MEDICINE

ensuring that the components of the

medicine are present in the correct
physical form and concentration
microorganisms also have the potential
to influence efficacy and safety

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 STERILE PRODUCTS

for sterile products,

contamination with
pathogenic
microorganisms is a
safety hazard

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 STERILE PRODUCTS
for sterile products,
contamination with infection,
pathogenic product spoilage
microorganisms is a
safety hazard

under-strength
physically or chemically unstable
possibly contaminated with toxic materials
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 STERILE PRODUCTS

sterilization preservation against

microbial spoilage
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 DISINFECTION

pharmacist
must be familiar with
disinfection and properties of
antiseptics, disinfectants and
preservatives

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 DISINFECTION
two perspectives of antiseptics/
disinfectans/preservatives
1. as an additive - for their biocide property

2. as a pharmaceutical product

concerns on antibiotics as
preservatives

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 ANTIBIOTIC PRODUCTION
1940s commercial antibiotic production began with the manufacture of
penicillin

1950s microorganisms are used to facilitate the manufacture of steroids

1970s-1990s development of recombinant DNA technology

2000 more than 100 biotechnology-derived products are on the market

with another 300 or more in clinical trials

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 ANTIBIOTIC PRODUCTION

benefits and uses hazards and problems

manufacture of antibiotics, steroids, therapeutic
may contaminate non-sterile and sterile medicines
enzymes, polysaccharides, products of recombinant
with a risk of infection
DNA technology

use in the production of vaccines cause infections and other diseases

as assay organisms to determine antibiotic, vitamin cause pyrogenic reactions (fever) when introduced
and amino acid concentrations into the body even in the absence of infection

to detect mutagenic or carcinogenic activity provide a reservoir of antibiotic resistance genes

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 UNDERSTANDING INFECTIONS
physiology and genetics

important not only in the

production of new therapeutic
agents but also in the
understanding of infections
and other diseases

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 UNDERSTANDING INFECTIONS

ribotyping
used to identify cross-
infection

to reduce transmission

optimize management of
hospital-acquired
infections

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 UNDERSTANDING INFECTIONS

re-emergence of resistant form

posing problems with antibiotic
resistance

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 UNDERSTANDING INFECTIONS

microorganisms
taking advantage of changing practices
and procedures in medicine and
surgery

urinary and venous catheters, heart

valves, pacemakers and hip
prostheses help them to attach
and grow as biofilms

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 APPLICATIONS TO OUR PROFESSION

knowledge not only on drugs

but of the infectious disease
are the factors that might
influence the success of
antibiotic therapy

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 APPLICATIONS TO OUR PROFESSION

identify the organism present

detect those that are prohibited from

particular product categories

enumerate microbial contaminants in

the manufacturing environment, raw
materials and finished product

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 APPLICATIONS TO OUR PROFESSION

non-sterile medications

must have familiarity with the

characteristics of antimicrobial
preservatives to minimize the risk of
microbial growth and spoilage
during storage and use by the
patient
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 APPLICATIONS TO OUR PROFESSION

sterile products
there should be no detectable
microorganisms whatsoever

able to pass a test for sterility

injections are subject to a test

for pyrogens/endotoxins

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 APPLICATIONS TO OUR PROFESSION

sterile products
manufacturing with two different strategies:

1. terminal sterilization - make the product, pack it in its final

container and sterilize it by heat, radiation or other means

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 APPLICATIONS TO OUR PROFESSION

sterile products
manufacturing with two different strategies:

2. aseptic manufacture - manufacture the product from

sterile ingredients under conditions that do not permit the
entry of contaminating organisms (for heat- or radiation-
sensitive)

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 APPLICATIONS TO OUR PROFESSION

infectious disease as a problem

approx 23% of the global 58 million deaths/year

respiratory infection, HIV/AIDS, diarrheal

disease, tuberculosis and malaria

development of resistance

increased in all categories of pathogenic

microorganisms

prevalence of infections that may soon

have no treatment
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 APPLICATIONS TO OUR PROFESSION

infectious disease as a problem

As of Aug. 8, 2020
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 APPLICATIONS TO OUR PROFESSION
hospital-acquired infection
cost of treatment exceeded £1 billion in 2007

attention is given to infection control procedures to minimize transfer

of infection from one patient to another within the hospital

focused on disinfectants and antiseptics, measurement of their

antimicrobial activity and selection

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 APPLICATIONS TO OUR PROFESSION

microorganisms in our ecosystem, daily life,

industry
carbon and nitrogen cycles - recycling dead
plant and animal material, fixation of
atmospheric nitrogen

present in our food, dairy and brews

genetics, immunology and biotechnology

uses in pharmaceutical industry

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 APPLICATIONS TO OUR PROFESSION
enzyme-mediated production of antibiotics
steroids

fungi enzymes for cortisone synthesis used to treat rheumatoid

arthritis

enzymes for treatment

asparaginase (cancer chemotherapy)

streptokinase (to digest blood clots)

polysaccharides for treatment

dextran (as plasma expander)
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 APPLICATIONS TO OUR PROFESSION
recombinant DNA technology
allows insertion of human genes to microorganisms to
manufacture gene products

insulin

human growth hormone

interferon

erythropoietin

blood clotting factors, etc

development of vaccines (hepatitis B)

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 CONTENTS
APPLICATIONS OF MICROBIOLOGY

1. Modern medicine
2. Sterile products
3. Disinfection
4. Antibiotic Production
5. Understanding infections
6. Applications to Pharmacy