Similarity Factor

Dissolution Profile Comparision Using Similarity Factor f2 between
Tribenzor 40mg/10mg/25mg tablets and Marvitense 40mg/10mg/25mg tablets
As per the FDA guidance , the assessment of profile comparability was achieved through estimation of the similarity factor(f2). The f2 metric is a
logarithmic reciprocal square root transformation of the sum of squared error that provides a measure of the similarity in the percent dissolved
between two curves and is calculated as follows.
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
n = number of time points
Rt = dissolution value of the Aerius 5 mg tab at time t.
Tt = dissolution value of Deslorat 5 mg at time t
Tribenzor 40mg/10mg/25mg (Reference batch) Marvitense 40mg/10mg/25mg tablets
Daiichi-Sankyo EVA Pharma
B.NO.080312 , Exp. Date : 03/2014
Media = 0.1 N HCL
Time in Percent dissolved

minutes
(Rt - Tt) (Rt - Tt)2 STDEV Mean % CV
Innovator(Rt) Deslorat (Tt)
5 80.567 82.241 -1.674 2.802276 1.1836968 81.404 1.454101459
10 90.4966 90.496 0.0006 3.6E-07 0.0004243 90.4963 0.0004688192
15 92.029 91.876 0.153 0.023409 0.1081873 91.9525 0.1176556782
20 93.137 92.184 0.953 0.908209 0.6738728 92.6605 0.7272492189
30 93.679 93.483 0.196 0.038416 0.1385929 93.581 0.1480994316
45 94.748 93.0613 1.6867 2.8449569 1.192677 93.90465 1.2700936618
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 6.61726725
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 68.959321
Similarity Factor (f2) = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 } = 91.9296487
Hydrochlorothiazide Dissolution profiles Marvitense versus Tribenzor

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
1
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = 0.1 N HCL

minutes
5 82.672 79.936 2.736 7.485696 1.9346442 81.304 2.3795190314
10 93.015 89.814 3.201 10.246401 2.2634488 91.4145 2.4760282084
15 88.213 88.412 -0.199 0.039601 0.1407142 88.3125 0.1593367297
20 95.342 89.334 6.008 36.096064 4.2482975 92.338 4.6008117366
30 98.211 89.9336 8.2774 68.515351 5.8530057 94.0723 6.2218162739
45 96.6311 88.061 8.5701 73.446614 6.0599758 92.34605 6.5622469239
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 195.8297268
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 17.2418181
Amlodipine Dissolution profiles Marvitense versus Tribenzor

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
2
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = 0.1 N HCL

minutes
5 81.391 81.417 -0.026 0.000676 0.0183848 81.404 0.0225846105
10 92.218 90.1 2.118 4.485924 1.4976522 91.159 1.6429010438
15 93.3298 91.146 2.1838 4.7689824 1.5441798 92.2379 1.6741272175
20 94.434 91.069 3.365 11.323225 2.3794143 92.7515 2.5653647851
30 94.7112 91.693 3.0182 9.1095312 2.1341897 93.2021 2.2898515022
45 94.8206 89.7322 5.0884 25.891815 3.5980421 92.2764 3.8992008199
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 55.58015324
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 31.2144181
Olmesartan Dissolution profiles versus Tribenzor

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
3
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = PH 6.8

minutes
5 67.754 90.492 -22.738 517.01664 16.078194 79.123 20.3205060357
10 86.127 95.535 -9.408 88.510464 6.6524606 90.831 7.3239979714
15 88.607 96.865 -8.258 68.194564 5.8392878 92.736 6.2966785273
20 89.251 97.207 -7.956 63.297936 5.6257416 93.229 6.0343257475
30 90.8332 97.456 -6.6228 43.86148 4.6830268 94.1446 4.9742914521
45 91.1619 98.076 -6.9141 47.804779 4.889007 94.61895 5.1670484568
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 828.6858667
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 8.47840377

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
4
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = PH 6.8

minutes
5 58.512 86.678 -28.166 793.32356 19.91637 72.595 27.4349054327
10 82.865 92.033 -9.168 84.052224 6.482755 87.449 7.4131836498
15 86.116 93.912 -7.796 60.777616 5.5126045 90.014 6.1241634258
20 91.626 92.802 -1.176 1.382976 0.8315576 92.214 0.9017693351
30 91.1244 96.7736 -5.6492 31.913461 3.9945876 93.949 4.2518681713
45 89.18 98.076 -8.896 79.138816 6.2904219 93.628 6.7185264295
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 1050.588649
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 7.53568359

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
5
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = PH 6.8

minutes
5 45.638 70.957 -25.319 641.05176 17.903237 58.2975 30.7101275232
10 66.159 80.2755 -14.1165 199.27557 9.9818729 73.21725 13.6332256082
15 72.7816 82.842 -10.0604 101.21165 7.1137771 77.8118 9.1422856963
20 76.113 83.462 -7.349 54.007801 5.1965277 79.7875 6.5129597179
30 79.035 83.196 -4.161 17.313921 2.9422713 81.1155 3.6272615179
45 79.961 82.76 -2.799 7.834401 1.9791919 81.3605 2.432620105
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 1020.695104
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 7.644602
Olmesartan Dissolution profiles Marvitense versus Tribenzor

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
6
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = PH 4.5

minutes
5 88.137 86.197 1.94 3.7636 1.3717872 87.167 1.5737459767
10 96.452 93.296 3.156 9.960336 2.231629 94.874 2.3522029233
15 97.048 94.549 2.499 6.245001 1.7670598 95.7985 1.8445589922
20 98.058 95.61 2.448 5.992704 1.7309974 96.834 1.7875925815
30 98.261 95.9588 2.3022 5.3001248 1.6279012 97.1099 1.6763494058
45 99.186 96.618 2.568 6.594624 1.8158502 97.902 1.8547631449
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 37.85638984
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 36.9878584

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
7
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = PH 4.5

minutes
5 83.883 79.35 4.533 20.548089 3.205315 81.6165 3.927288035
10 92.791 91.515 1.276 1.628176 0.9022683 92.153 0.9790980791
15 93.322 92.337 0.985 0.970225 0.6965002 92.8295 0.750300475
20 82.571 93.672 -11.101 123.2322 7.8495924 88.1215 8.9076926493
30 89.0899 92.549 -3.4591 11.965373 2.4459531 90.81945 2.6932040073
45 95.432 94.0533 1.3787 1.9008137 0.9748881 94.74265 1.0289854878
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 160.2448775
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 18.9977203

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
8
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
B.NO.080312 , Exp. Date : 03/2014
Media = PH 4.5

minutes
5 10.071 13.149 -3.078 9.474084 2.1764747 11.61 18.7465518733
10 12.0413 12.253 -0.2117 0.0448169 0.1496945 12.14715 1.2323426119
15 12.714 13.124 -0.41 0.1681 0.2899138 12.919 2.2440883992
20 13.666 13.413 0.253 0.064009 0.178898 13.5395 1.3213044473
30 13.096 13.786 -0.69 0.4761 0.4879037 13.441 3.6299656203
45 13.633 13.979 -0.346 0.119716 0.2446589 13.806 1.772120428
n = 6
1/n = 0.16667
∑n t=1 (Rt - Tt)2 = 10.34682589
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 60.5841343
Olmesartan Dissolution profiles Marvitense versus Tribenzor

% Dissolved
100
80
60
40
20
0
0 5 10 15 20 25 30 35 40 45 50
Time in minutes
9
For Pharmaceuticals & Medical
Appliances S.A.E
Page 1 of 3
NEURONTIN 300 mg capsules and CONVENTIN 300 mg capsules
As per the FDA guidance , the assessment of profile comparability was achieved through estimation of the
similarity factor(f2). The f2 metric is a logarithmic reciprocal square root transformation of the sum of squared
error that provides a measure of the
f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

where
Rt = dissolution value of the Neurontin capsules at time t.
Tt = dissolution value of Conventin capsules at time t
Neurontin 300 mg capsules (Refrence batch) Conventin 300 mg capsules ( Test batch)
Pfizer , EVA Pharma
B.NO. 6004 , Exp.date : 07/2009 B.NO. 27606 , Exp. Date : 06/2009
(1) Media = Acetate buffer pH 4.5
Percent dissolved
Times in minutes Neurontin(R ) Conventin (T ) (Rt - Tt) (Rt - Tt)2 STDEV Mean % CV
t t
10 99.29 98.203 1.087 1.181569 0.7686251 98.7465 0.778382

15 100.78 96.859 3.921 15.37424 2.7725657 98.8195 2.805687
20 100.73 96.67 4.06 16.4836 2.8708535 98.7 2.908666
30 101.75 93.658 8.092 65.48046 5.7219081 97.704 5.85637
45 102.11 93.789 8.321 69.23904 5.8838355 97.9495 6.007009
60 102.45 93.485 8.965 80.37123 6.3392123 97.9675 6.47073
n = 12
1/n = 0.0833333333
∑n t=1 (Rt - Tt)2 = 248.13014
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 21.4780716
Dissolution profiles of NEURONTIN 300 mg capsules & CONVENTIN 300 mg capsules in acetate buffer pH 4.5
120
% Dissolved
100
80
60
40
20
0 10 20 30 40 50 60
Neurontin Conventin Time in minutes
Appliances S.A.E
(2) Media = Phosphate buffer pH 6.8 Page 2 of 3
Percent dissolved
t t
10 97.61 105.74 -8.13 66.0969 5.7487781 101.675 5.654072

15 98.4 106.66 -8.26 68.2276 5.840702 102.53 5.696579
20 98.01 106.85 -8.84 78.1456 6.2508239 102.43 6.102532
30 99.61 107.41 -7.8 60.84 5.5154329 103.51 5.328406
45 99.85 108.28 -8.43 71.0649 5.9609102 104.065 5.728064
60 100.34 109.15 -8.81 77.6161 6.2296107 104.745 5.947406
n = 12
1/n = 0.0833333333
∑n t=1 (Rt - Tt)2 = 421.9911
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 16.6283904
Similarity Factor (f2) = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }= 61.0425106
Dissolution profiles of NEURONTIN 300 mg capsules & CONVENTIN 300 mg capsules in Phosphate buffer pH 6.4
120
% Dissolved
100
80
60
40
20
0
0 10 20 30 40 50 60
Neurontin Conventin Time in minutes
Appliances S.A.E
(3) Media = 0.1 N HCl Page 3 of 3
Percent dissolved
t t
10 95.34 92.16 3.18 10.1124 2.2485996 93.75 2.398506

15 96.11 92 4.11 16.8921 2.9062089 94.055 3.089904
20 96.31 91.75 4.56 20.7936 3.2244069 94.03 3.429126
30 96.41 91.93 4.48 20.0704 3.1678384 94.17 3.363957
45 96.75 92.21 4.54 20.6116 3.2102648 94.48 3.397825
60 97.13 91.36 5.77 33.2929 4.0800061 94.245 4.329149
n = 12
1/n = 0.0833333333
∑n t=1 (Rt - Tt)2 = 121.773
[1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 *100 = 29.9506595
Similarity Factor (f2) 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 } 73.8203195
Dissolution profiles of NEURONTIN 300 mg capsuls&CONVENTIN 300 mg capsules in 0.1 N HCl
120
% Dissolved
100
80
60
40
20
0 10 20 30 40 50 60
Neurontin Conventin
Time in minutes
Similarity Summary sheet
Dissolution Media Hydrochlorothiazide Amlodipine Olmesartan
0.1 N HCL
Buffer PH 4.5 78.4 63.93 89.11
Buffer PH 6.8
Olmesartan
89.11

Similarity Factor

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Dissolution Profile Comparision Using Similarity Factor f2 between

Tribenzor 40mg/10mg/25mg tablets and Marvitense 40mg/10mg/25mg tablets

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Media = 0.1 N HCL

Time in Percent dissolved

Hydrochlorothiazide Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Media = 0.1 N HCL

Time in Percent dissolved

Amlodipine Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Media = 0.1 N HCL

Time in Percent dissolved

Olmesartan Dissolution profiles versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Time in Percent dissolved

Hydrochlorothiazide Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Time in Percent dissolved

Amlodipine Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Time in Percent dissolved

Olmesartan Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Time in Percent dissolved

Hydrochlorothiazide Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Time in Percent dissolved

Amlodipine Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

Time in Percent dissolved

Olmesartan Dissolution profiles Marvitense versus Tribenzor

f2 = 50 * log {[ 1 + (1/n)∑ n t=1 (Rt - Tt)2 ]-0.5 * 100 }

(1) Media = Acetate buffer pH 4.5

10 99.29 98.203 1.087 1.181569 0.7686251 98.7465 0.778382

(2) Media = Phosphate buffer pH 6.8 Page 2 of 3

10 97.61 105.74 -8.13 66.0969 5.7487781 101.675 5.654072

(3) Media = 0.1 N HCl Page 3 of 3

10 95.34 92.16 3.18 10.1124 2.2485996 93.75 2.398506

Dissolution profiles of NEURONTIN 300 mg capsuls&CONVENTIN 300 mg capsules in 0.1 N HCl

Buffer PH 4.5 78.4 63.93 89.11

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