1- It is known to you that when volume increases the dissolution rate increases. However, in the
equation shown (below) that volume is in the denominator which apparently indicate that more
volume leads to lower dissolution. Explain how V in the denominator is correct and how increase
in the dissolution media volume practically enhances the dissolution rate, provide a numerical
example?
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=
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2- Define and correlate IQ, OQ, PQ, to the dissolution instrument?
3- Which drug is usually used a calibration standard for dissolution and which parameters are we
expecting to get from the calibration?
4- What is Sink condition and why it is important in dissolution?
Calibration Curve
Sample Absorbance
1
y = 0.02x
R= 1
0.8
0.6
0.4
0.2
0
0
10
20
30
40
50
Sample Conc (ïmL)
The Dose used in Dissolution (50 mg)
Solubility of Drug (z)= 300 mg/mL
Table-1
Dissolution Run-1 (Apparatus II) 900 mL
Without replacement of the medium volume
Vpull=3mL
Sample time
(min)
Sample
Absorbance
5
0.17
10
0.4
15
0.55
20
0.65
25
0.85
30
0.95
45
0.99
60
1.05
Sample Con.
(ïmL)
%LC
a) Is the drug in sink Condition? Show your calculation?
b) Complete the above table (table-1)
c) Plot the Dissolution graph (table-1)

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