1. Under guidance of
Dr. Rashmei Mathews
Ass.Professor
Dep: of pharmaceutics
Presented by: Abdallah abdalmalk
Email: abdallahabdalmalk@yahoo.com
Phone no: 7899406897/+249 900126821
KARNATAKA COLLEGE OF PHARMACY
SEMINAR TOPIC IS
QUALITY CONTROL TEST OF TABLET
15/12/2019
2. INTRODUCTION
• TABLETS can be defined as solid dosage form of
medicaments with or without excipients which are
prepared by compression or moulding method and
intended for oral administration for local and
systemic effect.
• They may vary in size shape weight depending upon
the medicament and it’s mode of administration.
3. SIGNIFICANTS OF QUALITY CONTOL TEST (QCT)
I. To ensure safety , potency. Efficacy ,stability, patient
acceptability and patient compliance.
II.To whether a pharmaceutical tablet satisfy certain
standards to claim it to be a quality drug or not .
III.To check the quality parameters are within the
acceptance limits or not.
4. QUALITY CONTROL
• Quality control is a small part of QA and it is concerned with
sampling, testing and documentation during manufacturing and also
after completion of manufacturing.
• It the monitoring process through which manufacturer measures
actual quality performance, compares it with standards and find out
the causes of deviation from standard to ensure quality product not
once but every time.
• In general term quality control refers to a procedure or a set of
steps taken during the manufacturing of product to ensure that it
meets requirements and the product is reproducible.
5. TYPES OF QUALITY CONTROL TEST
1.OFFICIAL TESTS
I. Weight variation test
II.Disintegration time test
III.Dissolution test
IV.Drug content
2.UNOFFICIAL TESTS
I. Thickness
II.Hardness
III.Friability
IV.Organoleptic characters
6. EQUIPMENTS USED IN THICKNESS TEST
A.Micrometer: put the tablet between
two anvils and read it’s Thickness by scale .
It’s measured in micrometer(mm).
B.Vernier caliper: tablet is placed between
two jaws of Vernier caliper and measure
thickness of tablet by reading scale .
It’s measured in centimeter(cm).
7. EQUIPMENTS USED IN HARDNESS TEST
a)Monsanto hardness tester
b)Pfizer hardness tester
c)Strong cobb hardness tester
d)Erweka hardness tester
8. a)Monsanto hardness tester
• Tablet is put between moving jaw
and fixed jaw is moved and
pressure is applied on tablet by
means of screw knob.
• The point where the tablet break
down it’s recorded by means of
scale.
• The hardness is measured in
kg/cm2
9. b). Pfizer hardness tester
• the Pfizer tester compresses tablet
between a holding anvil and a piston
connected to a force-reading gauge
when it’s plier-like handle are gripped.
• The point where tablet gets break
down it’s noted by reading gauze.
10. FRIABILITY TEST
• It means surface erosion by certain mechanical
shock and lost of martial from intact tablet.
• Friability is phenomenon where the surface of
the tablet is damage or shown a stir of damage
due to mechanical shock.
• Tablet friability is measured by the uses of Roche
friabilator.
• This method employed to determine physical
strength of uncoated tablet upon exposure to
mechanical shock and attrition.
11. PROCEDURE OF FRIABILITY TEST
1. Take amount of tablet say 20 tablets and take initial weight of it and put
it into friabliator.
2. Now rotate the drum at 25 rpm per min or 100 rpm for 4 mins.
3. During this tablet get dropped on plastic from 6 inches it will pass
through mechanical shocks.
4. After 4 minutes, calculate final weight of tablets and that of %friability.
5. %friability can be calculate by the following formula :
% friability= W1-W2/W1*100
W1= weight of tablets before testing.
W2= weight of tablets after testing.
12. DISINTEGRATION TEST
• Disintegration is process in which tablet are breaks up into
granular or smaller particles.
• The time is taken to disintegrate the tablet and measured in a
device described in USP/NF so disintegration test is measure of
the time required for a group of tablets to breaks up into
particles under a given set of conditions.
• The test is essential for tablets intended for administration by
mouth.
• E.g.: lozenges, glyceryl trinitrate.
PROCEDURE OF DIS INTEGRATION TEST
1. The time of one tablet is placed in each tube and the basket
rack is positional in 1-L beaker of water stimulated gastric fluid
or stimulated intestinal fluid at 37c such that tablet remains
2.5cm below the surface of liquid on their upward movement
and descend not closer than 2.5vm from the bottom of beaker.
13. 2. A standard motor-driven is used to move the basket assembly
contains the tablet up and down through a distance of 5-6 cm at
frequency of 28-32 cycles per minutes.
In this way we can note the time required to complete
disappearance from glass tube.
15. DISSOLUTION TEST
• The test intended to measure the times required for a
given drug in oral solid dosage form into solution under
specific set of conditions and all particles to pass through
mesh 10 screen.
• This test performed in two ways such as :
1) In vivo dissolution test is performed in healthy living
subjects.
2) In vitro dissolution test is performed in dissolutions
apparatus under stimulate biological conditions.
• Generally two apparatus have been using for dissolution
test
1) Rotating basket apparatus
2) Rotating raddle apparatus.
Fig: rotating basket apparatus
16. Rotating paddle apparatus:
ASSEMBLY CONSIST OF :
• A covered vessel
• Metallic drive shaft
• Stainless steel paddle
• Motor
• Sinker to prevent floating tablet
• Water bath holding temperature at 37c -
+ 0.5c.
• Acidic media or alkaline media.
17. RESOURSES
• Theory and practice of industrial pharmacy by Lachman/Lieberman’s
• A text book of industrial pharmacy-1 by prof.(Dr.) Mahesh Prasad and
Dr. antesh kummar jha .
Presented by: malk’s Son