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(Standard curve)

Dilution (g/ml)
1
2
3
4
5
6
7
8
9
10

S.No.
1
2
3
4
5
6
7
8
9
10

DISSOLUTION STUDIES (Conventional)


Absorbance
0.048
0.107
0.167
0.205
0.243
0.281
0.311
0.364
0.413
0.464

Sample absorbance
0.171
0.246
0.275
0.444
0.533
0.597
0.666

Conc. (g/ml)
34.61
51.74
58.36
96.94
117.26
131.87
147.63

Standard curve
0.5

100.00
y = 0.0438x + 0.0194
R = 0.9942

0.3
0.2

Absorbance

0.1

80.00

% Release

Absorbance

0.4

60.00
40.00
20.00

0.00

6
Dilution (g/ml)

10

12

Conc.+C.F
34.61
51.93
58.64
97.26
117.80
132.52
148.36

(Release profile)
Time (in min.) % Release
10
20.77
20
31.16
30
35.19
40
58.36
50
70.68
60
79.51
70
89.01

Drug content (mg)


31.15
46.73
52.78
87.54
106.02
119.27
133.52

Release Profile

% Release

10

20

30

40

50

Time (in min.)

60

70

Correction factor
%
%
%
%
%
%
%

173.0594
258.6758
291.7808
484.7032
586.3014
659.3607
738.1279

Correction factor
0.192288
0.287418
0.324201
0.538559
0.651446
0.732623
0.820142

DISSOLUTION STUDIES (Fast release)

(Standard curve)
Dilution (g/ml)
1
2
3
4
5
6
7
8
9
10

S.No.
1
2
3
4
5
6
7
8
9
10

Absorbance
0.048
0.107
0.167
0.205
0.243
0.281
0.311
0.364
0.413
0.464

Sample absorbance
0.369
0.667
0.682
0.755
0.799
0.816
0.829

Conc. (g/ml)
79.82
147.85
151.28
167.95
177.99
181.87
184.84

Standard curve
0.5

120.00
y = 0.0438x + 0.0194
R = 0.9942

0.3
0.2

Absorbance

0.1

100.00
% Release

Absorbance

0.4

80.00
60.00
40.00
20.00

0.00
0

6
Dilution (g/ml)

10

12

Conc.+C.F
79.82
148.30
152.10
168.79
178.92
182.86
185.85

(Release profile)
Time (in min.) % Release
10
47.89
20
88.98
30
91.26
40
101.27
50
107.35
60
109.72
70
111.51

Drug content (mg)


71.84
133.47
136.89
151.91
161.03
164.57
167.27

Release profile

% Release

10

20

30

40

50

Time (in min.)

60

70

Correction factor
%
%
%
%
%
%
%

399.0868
739.2694
756.3927
839.726
889.9543
909.3607
924.2009

0.44343
0.82141
0.840436
0.933029
0.988838
1.010401
1.02689

S.No.
1
2
3
4
5
6
7
8
9
10

(Standard curve)
Dilution (g/ml)
1
2
3
4
5
6
7
8
9
10

DISSOLUTION STUDIES (Marketed formulation)


Absorbance
0.048
0.107
0.167
0.205
0.243
0.281
0.311
0.364
0.413
0.464

Sample absorbance
0.507
0.828
0.879
0.901
0.915
0.916
0.922

Standard curve
0.5
0.45
0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0

y = 0.0438x + 0.0194
R = 0.9942

Absorbance

10

12

STUDIES (Marketed formulation)


Conc. (g/ml)
111.32
184.61
196.26
201.28
204.47
204.70
206.07

Conc.+C.F
111.32
185.23
197.28
202.37
205.59
205.84
207.21

(Release profile)
Time (in min.)
% Release
10
66.79
20
111.14
30
118.37
40
121.42
50
123.36
60
123.50
70
124.33

Drug content (mg)


100.19
166.71
177.55
182.13
185.03
185.26
186.49

% Release
140.00

.0438x + 0.0194
R = 0.9942

120.00
100.00
80.00

Absorbance

% Release

60.00
40.00
20.00
0.00
10

20

30

40

50

60

70

Correction factor
%
%
%
%
%
%
%

556.621
923.0594
981.2785
1006.393
1022.374
1023.516
1030.365

0.618468
1.025622
1.090309
1.118214
1.135972
1.13724
1.14485

Release Profile Comparison


Time (in min.)
10
20
30
40
50
60
70

% Release
Conventional
20.77
31.16
35.19
58.36
70.68
79.51
89.01

Fast dissolving
47.89
88.98
91.26
101.27
107.35
109.72
111.51

Marketed formulation
66.79
111.14
118.37
121.42
123.36
123.5
124.33

RELEASE PROFILE
140
120
Fast dissolving

100
% Release

S.No.
1
2
3
4
5
6
7

Conventional

80

Marketed formulation

60
40
20
0
10

20

30

40

50

TIME (in min.)

60

70

ase Profile Comparison

RELEASE PROFILE
140

Fast dissolving
Conventional
Marketed formulation

% RELEASE

120
100
80
60
40
20
0
0

10

20

30

40

50

60

70

TIME (in min.)


Fast dissolving

Conventional

Marketed formulation

80

80

Weight variation
(Fast dissolving) (Conventional)
Tablet code
Weight (mg)
Weight (mg)
A
403
401
B
417
410
C
405
412
D
408
406
E
399
419
F
402
409
G
420
411
H
411
408
I
401
405
J
413
410
AVERAGE =
407.90
409.10
S.D =
7.14
4.77
% DEVIATION =
1.75
1.17 %

Hardness
Tablet code
A
B
C
D
E
F
G
H
I
J
AVERAGE =
S.D =
% DEVIATION =

(Fast dissolving)
Hardness (kg/cm2)
3.5
3
3.5
3
3.5
3
3
3.5
3
3
3.2
0.26
8.07

(Conventional
Hardness (kg/cm2)
3
3.5
3
3.5
3
2.5
3.5
3
3
3.5
3.15
0.34
10.71

SIZE ANALYSIS
(Fast dissolving)
TABLET CODE
DIAMETER (mm) THICKNESS (mm)
A
12.1
3.1
B
12.2
3.2
C
12.1
3.2
D
12.1
3.2
E
12.2
3.2
F
12.1
3.1
G
12.2
3.2
H
12.1
3.1
I
12.1
3
J
12.2
3.1
AVERAGE =
12.14
3.14
S.D =
0.052
0.070
% DEVIATION=
0.425
2.227

(Conventional)
DIAMETER (mm) THICKNESS (mm)
12.1
3.1
12.2
3
12.1
3.2
12.1
3.1
12
3.1
12.2
3.2
12.1
3
12.2
3.2
12.1
3.1
12.1
3.1
12.12
3.11
0.063
0.074
0.522
2.373

FRAIABILITY TEST
Initial weight =
Final weight =
Weight loss =
% Friability =

(Fast Dissolving)
6.532 g
6.507 g
0.025 g
0.38 %

(Conventional)
6.588 g
6.554 g
0.034 g
0.52 %

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