Put (√ ) for the right statements and (X) for the wrong ones:
•Heat conduction microcalorimetry gives direct information
about the chemical nature of the reaction.
•In vitro dissolution is an appropriate test to predict possible
clinically relevant modification of bioavailability.
•A number of regulatory agencies (eg. FDA) are showing
now much more reluctance to approve overages for new
drug products than previously.
Put (√ ) for the right statements and (X) for the wrong ones:
•A pilot scale batch of tablets should be ≥ 1/10 that of a full production scale. •Changing the immediate packaging of a pharmaceutical product after completing its registration necessitates additional stability studies. •Published literature about degradation products of APIs without official pharmacopoeial monographs could be provided for CAPA instead of performing stress testing. •Matrixing is a reduced stability design in which only samples on the extremes of package size are tested at all time points as in a full design.
Write the scientific term corresponding to the following definitions:
•Any aspect of the pharmaceutical product that might suggest that the
product is somehow substandard or variable.
•Type of testing that aims to make up a reasonably ratioed mixtures of
drugs and excepients.
•A suitable compatibility test for both solid and liquid states.
•An advantage of film coat over sugar coat.
Fresh Stored
Appearance White free flowing
powder
White free flowing
powder
Taste score 2 2
Moisture content (%) 3.5 3.4
Reconstitution time
(min)
0.6 1.1
The following table shows the results of testing the fresh
and stored samples of an antibiotic powder for
reconstitution as an oral suspension.
•What could be the cause of the reported difficulty in
reconstitution?
•What are the factors affecting disintegration
time (tN) of tablets on storage, taking in
consideration the following equations?
Loss of pharmaceutical elegance of a product may not
necessarily affect its inherent safety or efficacy but it may
impair patient acceptability or appropriate use of this
product. Explain with examples.
The next figure shows the DSC thermograms of theophylline, as well as, its physical mixtures with two excepients. Interpret the provided data.
Time (months)
6 12 18 24
90
100
110
% o
f la
be
led
cla
im
30 36
Time (months)
6 12 18 24
90
100
110
% o
f la
be
led
cla
im
The following figures show a trial to improve the shelf life of an
oral suspension preparation.
The used strategy is:
Sampling
strategy
Statistical
strategy
A √ √
B √ x
C x √
D x x
The next scanning electron microscope picture was taken for a
parentral solution after storage for 18 months.
1. The primary packaging of this solution could be:
2. This problem can be resolved by: ……………………………………………………………………………………………………………
a b c
The above figure shows the results of measuring
sedimentation volume of certain suspension during
storage at room temperature up to 10 months. Describe
the provided results and comment on them explaining
the possible causes for this behavior.
Time (months)
2 4 6 8
0.4
0.8
1
Sed
ime
nta
tio
n v
olu
me
0.6
10
0.2
Consider the next in vitro dissolution
profiles of tablets during a long term
stability study and answer the following
questions:
0
20
40
60
80
100
120
0 50 100 150
% d
rug
rel
ease
d
Time (min)
Fresh
Three month storage
six month storage
pH 1.2 pH 7
•The tablets could be
•immediate release b. delayed release c. sustained release
•Similarity factor between the fresh and the 3 month stored tablets could be
•25 b. 50 c. 75
•The required tests during stability program are:
• b. c.
Type of sustained release dosage
form
Kinetics release
model Release data kinetics
…………………………. Hixon-crowel
equation
Osmotic pump tablets Zero order model
Insoluble matrix tablets ……………………..
time
3√
re
leas
ed
√ time %
re
leas
ed
Fill in the spaces to match each dosage form to its corresponding release data kinetics
0 10 20 30 40 50 60 70 80 90
100
0 20 40 60
% d
rug
rele
ase
d
Time (min)
Fresh Stored
Fresh Stored
Appearance yellow yellow
Hardness (Kg) 6 6
Disintegration time (min) 52 53
Dissolution efficiency (%) 70 47
Thickness (mm) 0.20 0.27
How to interpret this slowing down in drug release from the
provided tablets after storage for 2 years, taking in
consideration the data provided in the adjacent table?
Fill in the spaces to match each dosage form to its corresponding
release data kinetics.
Type of sustained
release dosage form
Kinetics release
model Release data kinetics
………………
………….
Hixon-crowel
equation
Osmotic pump
tablets Zero order model
Insoluble
matrix tablets
……………………..
time
3√
re
leas
ed
√ time
% r
ele
ase
d
The next figure shows the DSC thermograms of a drug powder,
as well as, its physical mixtures with a series of tablet excepients
(a-h).Interpret the provided data.
Drug