Study Set Content:
REQUIREMENT:
NMT 1% LOSS FOR
OLD FORMULATION
NMT 0.8% LOSS FOR
NEW FORMULATION
USP PHYSICAL TEST FOR TABLET FORMULATION
1. Content of Active Ingredient/ Absolute Drug Content Test
2. Uniformity of Weight/Content
3. Disintegration Test
4. Dissolution Test
tablets are weighed
individually, then
10, average is calculated
The tablets then are
assayed and the content of active
ingredient in each of the 10 tablets
is calculated assuming
_____ drug distribution.
homogeneous
By_____, 10 dosage units
are individually assayed for their
content according to the method
described in the individual
monograph.
USP Method
Unless otherwise
stated in the monograph, content
uniformity are met if the active
ingredient in each dosage is within
_____ of the label claim
and standard deviation is less
than _____
85% to 115%, 6%.
If (blank) or more dosage
units do not meet these criteria,
additional tests are required as
per USP
One
This is used to determine whether the tablet
meets the specifications of being fully available
for absorption.
DISINTEGRATION TIME TEST
Tablet disintegration provides
drug particles with an increased surface area for
activity in the
GI tract.
All USP tablets must pass
a test for disintegration using a
testing
apparatus.
the state in which any
residue of the unit, except fragment of insoluble
coating or capsule shell, remaining on the
screen of the test apparatus is a soft mass
having no palpably firm core.
Complete disintegration
is the process in which a substance
forms a solution.
Dissolution
measures the extent and rate of solution formation from a
dosage form, such as tablet, capsule, ointment,
etc.
Dissolution testing
The dissolution of a drug is important for its
bioavailability and therapeutic effectiveness
are terms used
interchangeably.
Dissolution and drug release
To properly evaluate the dissolution of drug
products, it is critical for procedures to be
standardized
This standardization helps to
show consistent quality in production and may
serve as a predictive measure of
efficacy.
A dissolution test uses an apparatus with
specific test conditions in combination with
_____ a to evaluate the performance
of the product
acceptance criteria
Dissolution includes 4 standardized apparatus
basket, paddle, reciprocating cylinder, and
flow-through cell
