INDUSTRIAL PHARMACY - I
Topic :- Quality Control test for Tablet
Name :- BAGWAN ABUSAAD MOHAMMAD FIROZ
Roll no :- 09
Class :- T. Y B pharm
Quality Control test for Tablet
Quality control tests for tablet production ensure the final product meets
required standards for safety, efficacy, and stability. Here are common tests
conducted:
• Appearance and Physical Testing
•Size and Shape
• Weight Variation.
• Hardness Test
• Friability Test
• Disintegration Test
• Dissolution Test
• Assay Test
• Moisture Content
• Stability Testing
• Identification Test
General appearance
Size and shape
This is important to facilitate packaging and to decide which
tablet compressing machine to use.
Weight Variation
This test is based on the fact that, if the weight variation is within
the limits then it can be said that the amount of medicament will
uniform considerably. Conversely, if the weight variation is not in
limits then it can be concluded that the active medicament will
uninform considerably.
Sources of weight variation
Weight variation is solely dependent on the poor flow property of granules
and filling of die cavity. Poor flow properties arise from: (a) improper
lubrication, (b) size of granules and (c) adjustment of lower punch.
Weight variation test
The U.S.P. weight variation test is run by weighing 20 tablets individually,
calculating the average weight, and comparing the individual tablet
weights to the average. The tablets meet the USP test if “not more than 2
tablets are outside the percentage limit and if no tablet differs by more
than 2 times the percentage limit.”
Hardness Test
Tablet Hardness
The resistance of the tablet to chipping, abrasion or breakage
under conditions of storage, transportation and handling
before usage depends on its hardness.
Method:
A tablet is taken between the 2nd and 3rd finger and pressing it
with the thumb as fulcrum. If the tablet breaks with a “sharp
snap”, yet, it does not break when it falls on the floor – is said
to possess proper hardness.
Why do we measure hardness?
To determine the need for pressure adjustments on the tableting
machine.
To withstand the mechanical shocks of manufacturing, packaging &
shipping,
To ensure consumer acceptance.
Hardness can affect the disintegration. So if the tablet is too hard, it
may not disintegrate in the required period of time. And if the tablet is
too soft, it will not withstand the handling during subsequent
processing such as coating or packaging.
In general, if the tablet hardness is too high, we first check its
disintegration before rejecting the patch. And if the disintegration is
within limit, we accept the patch.
Instruments used:
a) Monsanto Hardness Tester
b) Strong Cobb Hardness Tester -Manual mode.
c) Pfizer Hardness Tester.
d) Erweka Hardness tester. – Automatic.
e) Schleuniger Apparatus. – Operates without manual involvement.
Hardness of a tablet:
The hardness at which the tablet crushes is the hardness of the tablet.
• Unit of hardness: Kg/sq.in. or lb/ sq.in
• Limit: Generally maximum 5 kg/sq.in. hardness is required.
Friability Test
Friability
Tablet hardness is not an absolute indicator of strength since some
formulations, when compressed into very hard tablets may produce
chipping, capping and lamination problems. Therefore, another measure
of tablet strength i.e. friability is often measured, i.e. the friability.
Instrument: Roche Friabilator
Objective of friability test:
This apparatus is designed to evaluate the ability of the tablet to
withstand abrasion, in handling, packaging and shipping operation.
Method :
20 tablets, previously weighed are taken in the plastic chamber of the laboratory
friability tester. In the plastic chamber the tablets are subjected to abrasion and
shock by rotating the plastic chamber at 25 rpm for 4 mins (i.e. total 100
revolutions). The tablets are dedusted and reweighed.
Procedure:
1. Weigh 20 tab altogether
2. Put these tablets in the friabilator and adjust the instrument at
100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones)
F = 100 × (1-w/w0)
Where w0 = weight of tablets before friability
w = weight of tablets after friability
4. Friability (% loss) = It must be less than or equal to1% but
Disintegration Test
It is the time required for the tablet to break into particles, the
disintegration test is a measure only of the time required under a given
set of conditions for a group of tablets to disintegrate into particles
which will pass through 10 mesh screen.
• To test the disintegration time one tablet is placed in each tube, and the
basket rack assembly is positioned in a 1-litre beaker of water, simulated
gastric fluid or simulated intestinal fluid, at 370C+20C, such that the
tablet remains 2.5 cm from the bottom of the beaker.
• A standard motor moves the basket up and down through a distance of
5 to 6 cm at a frequency of 28 to 32 cpm (cycles per minute).
Type of Tablets Disintegration Time
During testing, a tablet is placed in each of the six tubes of the basket, and
through the use of a mechanical device, the basket is raised and lowered in
the immersion fluid at 29 to 32 cycles per minute, the wire screen is always
below the level of the fluid.
Assay Test
In a tablet an active ingredient is present which is called Active
pharmaceutical ingredient. So to prepare the tablet assay has to be
done by using suitable analytical method to produce good finished
product.
1. Determines API Potency: Confirms the active ingredient's amount matches the
label.
2. Ensures Quality: Verifies the tablet meets pharmaceutical standards.
3. Safety and Efficacy: Confirms the correct dose for safe and effective treatment.
4. Regulatory Compliance: Required to meet industry regulations and standards.
5. Batch Consistency: Ensures uniformity in production batches.
Dissolution Test
The dissolution rate is defined as the amount of drug substance that goes
into solution per time under standardized conditions of liquid / solid
interface, temperature, and solvent composition .
Dissolution is one of most important quality control tests and consider as
tool for predicating bioavailability , in some cases, replacing clinical studies
to determine bioequivalence.
A variety of designs of apparatus for dissolution testing is varying from
simple beaker to complex system where an attempt is made to mimic the
biological media. The choice of the apparatus to be used depends largely on
the physicochemical properties of the dosage form.
• For a high-solubility and high-permeability Category I drug, an IVIVC
may be expected if the dissolution rate is slower than the rate of gastric
emptying (the rate-limiting factor).
• In addition to formulation and manufacturing controls, the method of
dissolution testing must be controlled to minimize important variables
such as paddle rotational speed, vibration, and disturbances by
sampling probes.
• Dissolution testing for oral dosage forms has been a component of
evaluating product quality in the USP when only 12 monographs
contained such a requirement. Today the requirement is standard for
tablets and capsules.
Moisture Content
The moisture content test for a tablet measures the amount of water within the
tablet, which affects stability, shelf life, and performance. Here’s a basic outline:
1. Sample Preparation: Weigh an accurately measured sample of the tablet(s).
2. Method Selection:Loss on Drying (LOD): Place the sample in a drying oven
(usually at 105°C) for a specified time until constant weight is achieved.
3. Karl Fischer Titration: Dissolve the sample in a suitable solvent and titrate with
Karl Fischer reagent, which specifically measures water content.Infrared Moisture
Balance: Uses IR radiation to dry the sample and measures moisture loss.
4. Calculation: Calculate the moisture content as a percentage of the original
sample weight.
5. Documentation: Record the initial and final weights, conditions used, and the
final moisture content.Moisture content is typically kept within specific limits to
ensure tablet stability and prevent degradation.
Stability Test
Stability testing for pharmaceutical tablets is a critical process to ensure
the safety, efficacy, and quality of the product throughout its shelf life. This
testing helps determine the degradation pathways of the drug and ensures
that it maintains its properties under different environmental conditions.
Purpose of Stability Testing
To understand how environmental factors like temperature, humidity, and
light affect the pharmaceutical tablet.
To determine the product's shelf life and storage conditions.
To ensure the tablet maintains its efficacy, appearance, and safety over
time.
Types of Stability
Testing Long-term Stability Testing: Conducted under normal storage
conditions, such as room temperature. This typically lasts for at least
12months (or longer) to evaluate long-term effects.
Accelerated Stability Testing: Uses elevated conditions (e.g., 40°C and
75% relative humidity) to simulate aging and predict the shelf life in a
shorter time. Usually conducted over 6 months.
Intermediate Stability Testing: Done if the product is sensitive to certain
conditions but not highly sensitive to accelerated conditions. Typically
conducted at intermediate conditions, like 30°C and 65% relative humidity.
Stress Testing: Exposes the product to extreme conditions, such as very
high temperatures, freezing, high humidity, and intense light. Determines
degradation pathways and identifies stable formulations.
Identification Test
To identify a pharmaceutical tablet, you'll need details like the tablet's imprint code,
color, shape, and size. Here’s a guide for conducting a preliminary identification:
Check the Imprint Code Most pharmaceutical tablets have an imprint code, often a
combination of letters, numbers, or symbols. This code is unique to each drug,
dosage, and manufacturer.
Observe Color and Shape Color and shape are secondary identifiers. Common
shapes include round, oval, and rectangular. Common colors include white, blue,
yellow, and red.
Use Online Databases Websites like Drugs Pill Identifier, WebMD Pill Identifier, and
Pillbox (by the National Library of Medicine) allow you to input details such as the
imprint code, shape, and color to find potential matches.
Consult a Professional If you’re unable to identify the tablet or want to confirm its
identification, a pharmacist can be a reliable resource. They can often identify it
quickly or check against their professional databases.
