lab midterm Flashcards
It is a tablet property related to hardness. It is the ability to withstand abrasion in packaging, handling and shipping.
FRIABILITY
It determines the percentage loss on tablet in packaging, handling and shipping.
FRIABILITY TEST
Makes use of a tumbling apparatus where tablets are exposed to rolling and repeated shocks from free fall within the apparatus.
ROCHE FRIABILATOR
Conditions of Roche Friabilator
100 REVOLUTIONS IN 4 MINUTES
Number of samples if weight is > 650mg per tablet
10 SAMPLES
Number of samples if weight is ≤ 650mg per tablet.
20 SAMPLES
Required weight loss percentage
NOT MORE THAN 1%
Apparatus used in weighing the samples
ANALYTICAL BALANCE
select this mode if the weight of the tablets to be entered manually
MANUAL
select this mode if the balance is connected to the instrument.
BALANCE
select this mode if the test is to be performed by setting rotation.
ROTATION
select this mode if the test is to be performed by setting the time.
TIMER
This term means actual rotations.
ACT ROTATION
Formula for % Wt. loss
% Wt Loss = IW - FW/ IW x 100
A test that measures the time required, under a given set of conditions, for a group of solid dosage forms to disintegrate.
DISINTEGRATION TEST
Based on USP definition, it is the state in which any residue of the unit, except, fragments of insoluble coating or capsule shell remaining is a soft mass having no palpably firm core.
COMPLETE DISINTEGRATION
Disintegration Apparatus
- Basket-rack assembly
- 1000 mL low form beaker
- A thermostatic arrangement for heating fluid
- A device for raising and lowering the basket
Disintegration Media
- Maintained at a temperature of 37 +_ 2C
- Examples: Distilled Water, Simulated Gastric Fluid TS, Simulated Intestinal Fluid TS
Criteria for Disintegration Test
- If 1 or 2 tablets fail, repeat the test using 12 additional tablets
- Not less than 16 of the total 18 tablets should disintegrate completely
Materials used in Disintegration Test
- Disintegration apparatus
- Distilled water
- Uncoated tablets, Any brand
To select the test and to start the test
TEST
To validate the ROTATION/STROKE
VALIDATION
To enter the current date and time
CLOCK SETTINGS
To enter the product name, temperature, and alarm time
PRODUCT
To print product data, test report, and validation report
DATA PRINTING
Tablet hardness is also known as __
CRUSHING STRENGTH
It refers to the resistance of the tablet to chipping, abrasion or breakage under conditions of storage, transportation and handling before usage.
HARDNESS
The test is done by application of a load to the edges of a tablet across a diameter. The load is gradually increased until the tablet fractures or break. The value of the load at this point (crushing force) gives a measure of the hardness of the tablet.
HARDNESS TEST
How many samples are used in hardness test to determine the mean value?
3 SAMPLES
Mechanism of Stokes-Monsanto Hardness Tester
SPRING
Mechanism of Strong Cobb Hardness Tester
AIR PUMP
Mechanism of Pfizer Hardness Tester
HARD PLIERS
Mechanism of Erweka Hardness Tester
SUSPENDED WEIGHT
Most widely used because it eliminates the operator variability
SCHLEUNIGER HARDNESS TESTER
Most primitive and practical test for hardness of tablets.
RULE OF THUMB
It refers to the depth or extent from one surface to another surface.
TABLET THICKNESS
Equipment used for Tablet Hardness and Thickness tests
VERNIER CALIPER
THICKNESS GAUGE
Criteria for Tablet Hardness and Thickness Test
Average thickness ‡ 5% deviation
Stokes-Monsanto Hardness Tester Acceptable Range for Ordinary compressed tablets
4 to 10 kg
Stokes-Monsanto Hardness Tester Acceptable Range for Sublingual tablets
2 kg
Stokes-Monsanto Hardness Tester Acceptable Range for Chewable Tablets
2 kg
Stokes-Monsanto Hardness Tester Acceptable Range for Buccal Tablets
10 kg
1.6 times better than Stokes
STRONG COBB HARDNESS TESTER
