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