1 Introduction To Pharmaceutical Microbiology 1 PDF

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
rpramos2020
better nutrition and sanitation
improved health care and the greater

availability of effective medicines
rpramos2020
Global Eradication
smallpox in 1977 rinderpest in 2011

rpramos2020
Global Eradication
polio guinea worm infection

rpramos2020
MODERN MEDICINE
development of many vaccines

and other medicines contribute to
the improvement of world health
large investment of
pharmaceutical companies
rpramos2020
MODERN MEDICINE
worldwide sales of medicine has

been tremendously increasing
growth of the pharmaceutical

industry is paralleled by rising
standards for product quality
rpramos2020
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
rpramos2020
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
rpramos2020
STERILE PRODUCTS
for sterile products,

contamination with
pathogenic
microorganisms is a
safety hazard
rpramos2020
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
rpramos2020
STERILE PRODUCTS
sterilization preservation against

microbial spoilage
rpramos2020
DISINFECTION
pharmacist
must be familiar with
disinfection and properties of
antiseptics, disinfectants and
preservatives
rpramos2020
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
rpramos2020
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
rpramos2020
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
rpramos2020
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
rpramos2020
ribotyping
used to identify cross-
infection
to reduce transmission
optimize management of
hospital-acquired
infections
rpramos2020
re-emergence of resistant form

posing problems with antibiotic
resistance
rpramos2020
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
rpramos2020
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
rpramos2020
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
rpramos2020
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
rpramos2020
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
rpramos2020
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
rpramos2020
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)
rpramos2020
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
rpramos2020
infectious disease as a problem
As of Aug. 8, 2020
rpramos2020
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
rpramos2020
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
rpramos2020
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)
rpramos2020
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)

rpramos2020
CONTENTS
APPLICATIONS OF MICROBIOLOGY
1. Modern medicine
2. Sterile products
3. Disinfection
4. Antibiotic Production
5. Understanding infections
6. Applications to Pharmacy

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PHA6114

PHARMACEUTICAL MICROBIOLOGY AND

INTRODUCTION TO PHARMACEUTICAL MICROBIOLOGY

death due to AIDS reached its peak in 2006

life expectancy rose in 157 out of the 193

improved health care and the greater

smallpox in 1977 rinderpest in 2011

polio guinea worm infection

development of many vaccines

worldwide sales of medicine has

growth of the pharmaceutical

medicines: eﬀective, safe, high quality

active ingredient + excipients: ensure that

ensuring that the components of the

for sterile products,

sterilization preservation against

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

benefits and uses hazards and problems

use in the production of vaccines cause infections and other diseases

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

important not only in the

re-emergence of resistant form

urinary and venous catheters, heart

knowledge not only on drugs

identify the organism present

detect those that are prohibited from

enumerate microbial contaminants in

must have familiarity with the

able to pass a test for sterility

injections are subject to a test

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

2. aseptic manufacture - manufacture the product from

infectious disease as a problem

respiratory infection, HIV/AIDS, diarrheal

increased in all categories of pathogenic

prevalence of infections that may soon

infectious disease as a problem

attention is given to infection control procedures to minimize transfer

focused on disinfectants and antiseptics, measurement of their

microorganisms in our ecosystem, daily life,

present in our food, dairy and brews

genetics, immunology and biotechnology

fungi enzymes for cortisone synthesis used to treat rheumatoid

enzymes for treatment

streptokinase (to digest blood clots)

polysaccharides for treatment

human growth hormone

blood clotting factors, etc

development of vaccines (hepatitis B)

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