4. MICROORGANISMS:
Eukaryotic or prokaryotic organisms which are too small to be seen by naked aye and
require microscopic visualization.
Among Eukaryotes, Fungi and protists are included.
Among prokaryotes, bacteria, shigella and rickettsia include.
Acellular microorganisms include Viruses and Prions.
Let‘s look their role in Pharmaceutical science; The art of searching,producing, and
validating pharmaceutical drugs.
5. APPLICATIONS:
Antibiotics:
Microbes produce antibiotics as natural defense system against other microbes living
in their vicinity.
Man has manipulated this phenomenon to produce hundreds of natural and semi
synthetic antibiotics.
Source
microbe
Antibiotic Action
Streptomyce
s
Moditerranei
Rifamycin Against Tuberculosis
Bacillus
subtilis
Bacitracin G+ bacteria
6. HORMONES:
Chemical Messengers used to regulate body functions in many organisms.
Their deficiency in body produces difference conditions.
To overcome this situation, microbes are added with gene of interest into to express
that gene and hence making the hormone; Insulin being the most famous produced by
E.coli along with growth hormones etc.
7. Biological catalysts produced by bacteria for their own functions are extracted for
pharmaceutical and other uses.
Enzyme Source
@-amylase Bacillus coagulans
Lipase Rhizopus sp.
ENZYMES:
9. ANTIBODIES:
Y-shaped globulins acting as effector of humoral immunity produced by activated-B
cells(plasma cells)
IgM, IgG, IgE, IgD, IgA
Commercially available as antiserum or antitoxin. Eg
Microbe × Host… Time… Antibodies.
Obtaining blood, serum extraction, antibody purification, end product.
10. PROBIOTICS:
Live bacteria that confer a health benefit on the host.
Bacillus coagulans: Improves abdominal pain
Lactobacollus acidophilus: Reduces side effects of
antibiotic therapy.
11. BACTERIOCINS:
Peptide toxins produced by bacteria to inhibit the growth of similar or closely related
bacterial strains.
Can be used as narrow-spectrum antibiotic.
Used as Food Preservatives, eg Nisin.
12. VALIDATING NEW DRUGS:
Antibiotic efficacy can be validated using different species of microorganisms.
Disc diffusion method is practical approach in this case.
13. VACCINES:
Biologics inducing immunity against specific pathogen in susceptible host.
Killed, Attenuated , Toxoid, subunit, conjugate.
Microbes introduced into host; host ‘remembers’ the microbes and induces immunity
upon subsequent exposure.
14. MICROBIOLOGICAL TEST
METHODS
Microbiological tests for pharmaceuticals fall into several
categories.
The Growth Promotion test
The growth promotion test is an important quality control
function in the pharmaceutical industry. It is imperative for establishing the ability and
nutritive property of any media used to support growth when the inoculum contains a
small number of microorganisms.
Sterility Testing.
Sterility testing is done on wide range of pharmaceutical
products as parental preparations, ophthalmic & other non-injectable preparations, bulk
solids and liquid solutions, antibiotic solids, and medical consumables and devices.
15. Microbial Limits Test
This test is used to estimate the total number of viable microorganisms or specific
pathogens present in pharmaceutical products as tablets, capsules, oral suspensions,
injectables, ophthalmic and nasal solutions and other medical devices.
It is based on the principle that any viable microbial cell present in a sample will
produce a single colony when provided with a growth medium and favourable growth
conditions.
The enumeration of these colony-forming units (cfu) gives an estimate of the microbial
population of the product. The microbial content of the product includes the total
bacterial count (TBC), total yeast and mold count (TYMC). These tests are mandatory
for the release of drug products.
16. Bioburden Testing
Bioburden of raw materials and finished pharmaceutical products helps to determine
whether the product complies with the requirements of the US Pharmacopeia.
Bioburden is the total number of microorganisms present on a product prior to
sterilisation.
Water Testing
Water is one of the major commodities consumed by the pharmaceutical industry.
Total viable count is studied to rule out microbial contamination. Tests for presence of
coliforms, E. coli and any other pathogens as Pseudomonas sp. Clostridia,
Salmonella, Staphylococcus etc.are performed.