INTRODUCTION TO INDUSTRIAL
PHARMACY
Definition of Industrial Pharmacy
The conversion of raw materials into
certain dosage forms.
Or it is manufacturing, development,
marketing and distribution of drug products
including quality assurance of these activities
.
E.g.: Tablets, capsules, suspensions and
ampoules.
Properties of Dosage Form
Requirements to Formulate Dosage Form
Physicochemical properties of
active ingredient and additives
Physical properties Chemical properties
Appearance, Texture, Oxidation,
Color, Odor, Taste, Decomposition,
Melting point, Boiling Crystal structure,
point, Density, Toxicity,
Solubility. Thermodynamic
properties
Department of Drug Industry
1. Research and development department
A- Small Scale B- Responsible for
department (pilot formulation of a new
plant) dosage forms.
C- Need Wikipedia
pharmacist
E.g.: Discover new drug
likeEvotaz(atazanavirandcobicistat) tablets for
HIV and check its pharmacological properties
then transfer to development department to
develop the new drug
2- Production department
(A) Large scale department (full-scale
plant).
(B) Responsible for production of
dosage form in large scale department.
(C) Need skilled workers.
E.g. Area for production of tablets,
capsules, ampoules and solutions.
3- Quality control department:
Evaluation department.
Responsible for evaluation of
dosage form before going to
the market and following up
the product from the market
to ensure the stability.
E.g.: Ensure no differences
between batches for the same
company within accepted
evaluations.
4- Marketing department:
Responsible for marketing of drugs to pharmacies
and hospitals.
5- Non-laboratory department:
Responsible for finding markets for dispense,
management, accounting and personnel.
Drug Factories Requirements
1- Compatible with
theGMP
specificationslikeclean,
sterilization, and all
personnel should wear
certain protective work
outfits.
2- Departments
separation
E.g.: Antibiotics
department should be
separated from other
departments.
Equipments used in laboratory
1st: Tablet equipment
Cubic mixer
Ribbon Double cone
mixer • Dense powder mixer
and granules
• Wet • Dry and
granulatio free
n flowing
powders
(1)
Mixers
V-Shaped
Suppository mixer
mixer Z-Shaped • Non
mixer viscous
• Powder granules or
and powder
granules
(2) Sieves
Get uniform particle size
Coulter counter Sub-sievesizer
Measure number of Separate particles
particles and size according to their
(< size (0.2 to 50µm
1µm). range).
Dry
granulator
granulate
slugs and
pellets.
(3)
Homogenizer
[Granulator]
Wet
granulatorg
ranulate
suspensions,
emulsions
and
dispersions.
(4) Tablet machine
(5) Coating pan:
produce uniform coating
on tablet by either sugar
or thin film.
(6) Polishing drum:
add polishing materials
during operating the
drum.
Quality control
department to determine
the manufactured tablet
(7)Evaluatio fall within required
n equipment standards.
• (A)Flow meter: measure
the flowability of the tablets.
• (B)Flame
photometer: measure the
concentration or amount of
ions such as K and Na.
• (C)Hardness tester:
measure the hardness of the
tablet
Manual
hardness Hardness
tester
tester:
such
asMonsatoha
rdness tester.
Electrical
hardness tester
such
asErwekahardness
tester.
(D) 2- very solid
1- very friable
tablet
tablet Tabletfriabilat
or:
measures the
tablet friability will not crack
crack rapidly.
that means easily.
(E)Disintegration
apparatus:
measure the time required for
disintegration and evacuation from
the stomach.
The disintegration time is
between 15-30 minutes.
consist of 2-4 baskets each has 6 cylinders, the
dosage form placed in the cylinder, which will
be immersed in buffer and placed in water bath
operating at 37° C.
Exception:(Hard tablet) with higher
quantity of binder will require
> 30 min. to
disintegrate.
(f) Dissolution rate
apparatus
In vitro method to measure the
dissolution of drugs inside the body.
Consist of 2-6 jars filled with buffer
(0.1NHCl, phosphate) and the (Tablet,
film or In-situ gel) is placed in the jar
and a sample is taken every 10 min.
2nd: Semi solid dosage form
equipment:
Ointment
agitator (Filler).
Three roller
mill.
Collapsible
closer (to close
the tubes).
3rd: Ampoules equipment:
(A) Ampoule (B) Ampoule
filling filling and sealing
machine(consist machine(connect
of manual tool fills
ed with other
the ampoule in
device that control
every push is 1
it’s operation).
ml).
(C) Ampoule (D) Millipore
sealing machine filter
(utilize high (sterilization of
temperature heat liquid because
to seal the tip of of small pores
the ampoule). (0.3 – 0.5 µ)).
Devices for
evaluation of
ampoules:
(2) Leaker
(1) Clarity (3) Sterility test
test device. test. apparatus.
4th: Drying equipment:
Dry oven
for dry heat or heat sterilization that require long time.
Autoclave
for moist heat sterilization.
Temperature Pressure Time for sterilization
121° C 15 PSI 15 minutes
184° C 30 PSI 3 minutes
Tray dryer
which operates by passing hot streams of air.
Freeze dryer
for substances affected by heat or moisture especially
hormones.
