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PHS 934 Assignment 3
Show sufficient detail and calculations. There are no one line or “it looks good” answers in this exam.
Question 1. (Score 10 Points)
The Generics products are compared to their branded counterparts during the
dissolution tests. The dissolution tests for the following immediate release products
were performed at 5, 15, 30, 60, 90 and 120 min in compendia media for each drug.
The test was carried out on four replicates for each batch using the paddle method and
mean data is shown below.
Case 1:
Case 2
Case 3
Case 4:
Question:
Explain which of formula(s) should be used for clinical bio-equivalence study for each of
the product.
Use the following table to answer and provide explanation and use more space as you
need it.
Clinical
(Y/N)
CASE 1
A
A1
B
CASE 2
A
B
Detail your analysis and explanation (one sentence is not the
answer) Use more space and attach analysis of the data.
CASE 3
A
CASE 4
A
A1
B
Question 2: (score 5 points (2+1+1+1)
Here are the formulation compositions:
Batch No →
Ingredients ↓
Zolpidem Tartrate
Microcrystalline cellulose
Croscarmellose sodium (Ac-Di-Sol)
Crospovidone
Sodium starch glycolate
Ludiflash
HPMC K4M
Talc
F1
F2
F3
10
62.5
25
10
62.5
18.75
–
143.25
12.5
1
137
12.5
1
F7
F8
F9
10
62.5
12.5
F4
F5
F6
Unit formula (mg per tablet)
10
10
10
62.5
62.5
62.5
–
10
62.5
–
10
62.5
–
10
62.5
–
149.5
12.5
1
25
137
12.5
1
25
137
12.5
1
18.75
143.25
12.5
1
12.5
149.5
12.5
1
18.75
143.25
12.5
1
12.5
149.5
12.5
1
Ludiflash is a co-processed excipient containing 84.0-92.0% D-Mannitol, 4.0-6.0% Kollidon® CL-SF, 3.5-6.0%
Polyvinyl acetate, 0.5-2.0% water and 0.25-0.60% Povidone.
Que 2.1
Explain the experimental design and expected outcome from this series of
experiments.
Que 2.2
Comment on the micrometric properties of the final blend.
Code
F1
F2
F3
F4
F5
F6
F7
F8
F9
Bulk Density
0.41
0.42
0.41
0.44
0.44
0.45
0.43
0.43
0.43
Tapped density
0.47
0.49
0.50
0.51
0.50
0.50
0.51
0.52
0.51
Angle of Repose (θ)
25.78
25.45
27.17
29.37
31.10
28.32
28.18
26.19
27.38
% compressibility
Flowability
Que 2.3:
Explain the Physical properties of different formulations in view of the
experimental design.
Code
F1
F2
F3
F4
F5
F6
F7
F8
F9
Weight
Variation
249.12±0.64
251.21±0.63
250.32±0.57
249.34±0.58
250.14±0.61
250.31±0.67
249.98±0.68
248.98±0.67
250.13±0.58
Hardness
(kg/cm2)
3±0.0122
3.5±0.021
3±0.022
3.5±0.24
3±0.013
3±0.014
3.5±0.042
3±0.021
3.5±0.042
Friability
(%)
0.72
0.82
0.75
0.82
0.68
0.70
0.58
0.67
0.58
Disintegration Time
(sec)
35±0.011
40±0.034
46±0.024
42±0.054
48±0.023
50±0.045
47±0.065
48±0.072
49±0.032
Que 2.4: Describe manufacturing process for a 10 kg batch., (use one of the formulations).
Que 3 Score 5 (1+1+1+1+1)
Here is information on optimized formulations.
Ingredients
I
II
Paracetamol
(77 %)
500
500
Lactose (5 %)
32.5
32.5
MS (5 %)
32.5
32.5
MS paste with water
(3 % dry weight)
19.5
19.5
MS (5, and 7.8 %)
32.5
50.7
TLC (4.9, and 2 %)
31.85
13
MST (0.1, and 0.2 %)
0.65
1.3
Total (mg)
650
650
Extragranular
excipients
MS – Maize starch, TLC – Talc, MST – Magnesium stearate,
Que 3.1
Explain the study design and expected outcome from this series of experiments.
Que 3.2
Describe manufacturing process for a 10 kg batch, (use one of the Formulations).
Que 3.3
Describe interpretation of micrometric properties on the final blend. And Which
formulation will have the disintegration time (2.7 min and 4.5 mins)
Parameters
I
II
Mean granule
size (μm)
462.98
478.71
28.8 ± 0.40
33.7 ± 0.20
0.56 ± 0.02
0.57 ± 0.03
0.63 ± 0.04
0.69 ± 0.01
Angle of repose
Bulk density
Tapped density
Carr’s Index (%)
Flow property
Disintegration
© Mahendra Dedhiya
Que 3.4:
Label the dissolution profiles for formulation I and II in the following figure.
Que 3.5:
Analyze profiles to answer the question: Discuss if the experimental design worked? Provide
calculation is any.
,
© Mahendra Dedhiya
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