Midterm Flashcards
A test that measures the time required, under a given set if 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 Media
1. Maintained at a temperature of
37 +- 2C
Disintegration Media
- Examples:
a. Distilled water
b. Simulated Gastric Fluid TS
c. Simulated Intestinal Fluid TS
Dissolve 2g sodium chloride and 3.2g pepsin in 7 ml of HCL and sufficient water to make 1 L, with a pH of 1.2
b. Simulated Gastric Fluid TS
Dissolve 6.8g of monobasic potassium phosphate in 250 ml water, mix and add 190 ml of 0.2N NaOH and 400 ml water. Add 10g pancreatin and mix and adjust the resulting solution with 0.2N NaOH to a pH of 7.4 to 7.6. dilute with water to make 1L.
c. Simulated Intestinal Fluid TS
Criteria
1. All tablets should disintegrate completely. T or F
True
- If 1 or 2 tablets fail, repeat the test using ___ additional tablets.
12
Not less than __ of the total 18 tablets tested should disintegrate completely.
16
III. MATERIALS:
Disintegration apparatus
Uncoated tablets, Any brand
Distilled Water
test settings
Test method
Test report
Temperature
Lamp
Circulation pump
Heater
- Enter the temperature required for the test. The press “ENTER” key. The instrument can be adjusted between_______. an audio signal will sound when the temperature of the tank will reach the required temperature.
20 °C to 40°C
- Press starts me u key to display the following:
Where:
Test Validation
Clock settings
Product settings
Data Printing
- 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
PRECAUTIONS:
1. Do not try to remove the baskets till they are disengaged from the hook.
2. Do not start the heater till the water in the bath is filled up to the marked level.
3. Do not clean the bath with any strong solvent. Use mild detergent for cleaning. 4. Lift the machine from the base while lifting or installing.
5. Switch OFF the power supply of the instrument before removing water from the bath.
It is a tablet property related to hardness. It is the ability to withstand abrasion in packaging, handling and shipping.
Friability
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. Conditions: 100 revolutions in 4 minutes.
Roche Friabilator
The following are reminders:
1. Use the specified number of samples.
a. If weight is > 650mg per tablet, use ____samples.
10
b. If weight is ≤ 650mg per tablet, use ______samples.
20
Place the tablets on a ______sieve and remove any loose dust with the aid of air pressure or soft brush.
10
The weight loss should not be more than ____. The test should be repeated twice.
1%
III. MATERIALS:
Friability test on tablets
Friabilator
Paracetamol tablets
- Weigh at least 20 tablets using an analytical balance.
- Remove the locking nut from shaft of the friabilator
- Slide drum off of shaft then remove cover.
- Place tablets of a total known weight into the drum.
- Replace cover. Rotate the drum 100 times, equivalent to 4 minutes.
- Weigh and calculate the percent weight loss of the tablets
A. Friability Test Operating Procedure (Vanderkamp Friabilator)
- 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
- if the test is to be performed by setting
the time.
Timer
means actual rotations. The actual rotations will be 0.001 and so forth. The drums will start rotating with fixed speed carrying the tablets to a fixed height along with the arc(in drums) and drop them to the bottom of the drum. Hence without any hard impact the tablets
ACT ROTATION
Also known as “crushing strength”. Hardness refers to the resistance of the tablet to chipping, abrasion or breakage under conditions of storage, transportation and handling before usage.
Tablet 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. _______ are used and the mean value is determined.
Hardness Test
3 samples
Instruments: Test for hardness and thickness of different tablets
- Stokes-Monsanto Hardness Tester
- Strong Cobb Hardness Tester
- Schleuniger Hardness Tester
4.Erweka Hardness Tester
5.Pfizer Hardness Tester
- Stokes-Monsanto Hardness Tester
OMechanism:
Spring
- Stokes-Monsanto Hardness Tester
OMechanism: Spring
o Acceptable Range
a. kg for ordinary compressed tablets
4 to 10 kg
- Stokes-Monsanto Hardness Tester
OMechanism: Spring
o Acceptable Range
b. kg for sublingual tablets
2 kg
c. kg for chewable tablets
2 kg
d. for buccal tablets
10 kg
- Strong Cobb Hardness Tester
o Mechanism -
о _______timesbetter than Stokes
Air pump
1.6
- Pfizer Hardness tester
o Mechanism -
hard pliers
- Erweka Hardness Tester
o Mechanism -
suspended weight
o Most widely used because it eliminates the operator variability
Schleuniger Hardness Tester
Most primitive and practical test for hardness of tablets.
Rule of thumb
refers to the depth or extent from one surface to another surface.
Tablet thickness
To determine the need for pressure adjustment in tableting machines
Importance
Equipment
Vernier caliper
thickness gauge
Average thickness
± 5% deviation
MATERIALS: Hardness and thickness for diff tablet
Stokes-Monsato Hardness Tester
Uncoated tablet, any brand
Micrometer caliper
Forcep
Evaporating dish
Watch glass
IV. OPERATING PROCEDURES FOR:
A. DETERMINATION OF TABLET HARDNESS
- Stokes-Monsanto Tablet Hardness Tester
- Tablet Hardness Tester
- LIH-1 Tablet Hardness Tester
determine the hardness of the different tablets supplied. Use an average of three (3) measurements for each determination and comment on your results.
- Stokes-Monsanto Tablet Hardness Tester
Using the Stokes-Monsanto hardness tester
a. Turn switch to power ON and preheat the tester.
b. Adjust the zero adjustment knob.
c. Place the tablet on the test plate, begin test.
d. Read and record the hardness reading.
e. Same with above portion repeat 2-4 steps for another batch of test. f. Turn off the tester after test is completed.
- Tablet Hardness Tester
a. Plug the tablet hardness tester at a 220 volts wall outlet.
b. Turn on the instrument by pressing the [ON/OFF] key.
c. Move the adjustment knob to tare the instrument at its zero display.
d. Place the tablet in the sample holder.
e. Move the adjustment knob until the tablet breaks or fractures.
f. Read the measurement of the load in the LCD and record result.
g. Brush any tablet residue and repeat the procedures using other sample.
- LIH-1 Tablet Hardness Tester
determine the thickness of the different tablets supplied. Use an average of three (3) measurements for each determination and comment on your result.
micrometer caliper,
