Documentos de Académico
Documentos de Profesional
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Perfiles de Disolucion
Perfiles de Disolucion
COMPARACIÓN DE PERFILES DE
DISOLUCIÓN
100 100
90 90
80 80
70 70
% fármaco disuelto
% fármaco disuelto
60 60
50 50
40 40
30 30
20 20
10 10
0 0
0 10 20 30 40 50 60 70 0 10 20
Tiempo (min)
90
80
70
% de fármaco disuelto
60
50
40
30
20
10
0
0 2 4 6 8 10 20 30 45 60
Tiempo (min)
100
FÁRMACO A FÁRMACO B 90
ED 0.6797525 0.6012491667 80
67.97525 60.12491667
% de fármaco disuelto
% 70
DDSOLVER #ERROR! #ERROR! 60
50
40
30
20
10
0
0 2 4 6 8 10 20
Tiempo (min)
FÁRMACO A FÁRMACO B
ti ∆Q1 ti∆Qi ti ∆Q1
1.0 14.71 14.71 1 16.85
3.0 25.03 75.09 3 8.76
5.0 11.22 56.1 5 6.26
7.0 8.07 56.49 7 11.35
9.0 3.38 30.42 9 5.1
15.0 6.05 90.75 15 13.21
25.0 4.46 111.5 25 7.99
37.5 4.98 186.75 37.5 0.86
52.5 3.51
TMD 184.275 52.5 1.95
TMD
(min) 8.06085 (min)
DDSOLV DDSOLV
ER #ERROR! ER
FÁRMACO A
TIEMPO mg
%DISUELTO
/min) DISUELTO
2 14.71 73.55
4 39.74 198.7
6 50.96 254.8
8 59.03 295.15
10 62.41 312.05
20 68.46 342.3
30 72.92 364.6
45 77.90 389.5
60 81.41 407.05
f1
QRt-QMt QRt
10.70 73.55
70.65 198.7
95.45 254.8
79.05 295.15
70.45 312.05
34.65 342.3
17.00 364.6
37.60 389.5
45.40 407.05
∑ 460.95 2637.7 ∑
n
F1 F2
17.4754521 46.6550494
Factor de diferencia (f1) es aceptable entre 0 y
15, siendo 0 la ideal. Lo cual indica que
prácticamente no hay diferencia entre las
formulaciones. Factor de similitud (f2) es
aceptable entre 50 y 100, siendo 100 el ideal. Lo
cual indica que prácticamente las formulaciones
son iguales, o muy parecidas.
N DE PERFILES DE
N
FÁRMACO B
%
DISUELTO
0
16.85
25.61
31.87
43.22
48.32
61.53
69.52
70.38
72.33
100
90
80
70
% fármaco disuelto
60
50
40
30
20
10
0
0 10 20 30 40 50 60 70
Tiempo (min)
ÁREA
RMACO BBAJO LA
CURVA
0
16.85
42.46
57.48
75.09
91.54
549.25
655.25
1049.25
1070.325
3607.495
#ERROR!
0 45 60
CIÓN (ED)
ÁREA
RMACO BBAJO LA
%
CURVA
DISUELTO
0 100
16.85 100
42.46 100
57.48 100
75.09 100
91.54 100
549.25 100
655.25 100
1049.25 100
1070.325 100
3607.495 6000
Column G
Column C
Column J
4 6 8 10 20 30 45 60
Tiempo (min)
SOLUCIÓN
RMACO B
ti∆Qi
16.85
26.28
31.3
79.45
45.9
198.15
199.75
32.25
102.375
7.32305
#ERROR!
FÁRMACO B
TIEMPO % mg
/min) DISUELTO DISUELTO
2 16.85 84.25
4 25.61 128.05
6 31.87 159.35
8 43.22 216.1
10 48.32 241.6
20 61.53 307.65
30 69.52 347.6
45 70.38 351.9
60 72.33 361.65
f2
∑QRt-
QMt)^2
4.5796
199.6569
364.4281
249.9561
198.5281
48.0249
11.56
56.5504
82.4464
1215.7305
9
AUC TMD ED %
fármaco A 4078.515 8.06085 67.97525
fármaco B 3607.495 7.32305 60.124917
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-25
Method Difference factor, f1 Time 22:37:44
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
2 14.71 14.71
4 39.74 39.74
6 50.96 50.96
8 59.03 59.03
10 62.41 62.41
20 68.46 68.46
30 72.92 72.92
45 77.90 77.90
60 81.41 81.41
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
2 16.85 16.85
4 25.61 25.61
6 31.87 31.87
8 43.22 43.22
10 48.32 48.32
20 61.53 61.53
30 69.52 69.52
45 70.38 70.38
60 72.33 72.33
Difference factor: f1
f1 Ref.1
Test.1 17.48
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f1 17.48 17.48
Is f1 ∈[ 0,15 ] between Mean_R and Mean_T No
Similarity of R and T Reject
90
80 Column C
Column C
70
Fraction dissolved (%)
60
50
40
30
20
10
0
0 10 20 30 40 50 60 70
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-25
Method Similarity factor, f2 Time 22:38:56
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
2 14.71 14.71
4 39.74 39.74
6 50.96 50.96
8 59.03 59.03
10 62.41 62.41
20 68.46 68.46
30 72.92 72.92
45 77.90 77.90
60 81.41 81.41
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
2 16.85 16.85
4 25.61 25.61
6 31.87 31.87
8 43.22 43.22
10 48.32 48.32
20 61.53 61.53
30 69.52 69.52
45 70.38 70.38
60 72.33 72.33
Similarity factor: f2
f2 Ref.1
Test.1 47.79
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f2 47.79 47.79
Is f2 ∈[50,100] between Mean_R and Mean_T No
Similarity of R and T Reject
90
80 Column C
Column C
70
Fraction dissolved (%)
60
50
40
30
20
10
0
0 10 20 30 40 50 60 70
Time (min)
EJERCICIO 2.COMPARACIÓN DE PERFILES DE
DISOLUCIÓN
ADIRO PROMEDIO
DE LAS
Tiempo C1(%) C2% C3% C4% C5% C6%
CONCENT
0 0 0 0 0 0 0 0
RACIONES
10 44.77 -6.84 -4.10 26.66 -4.24 20.51 12.79
20 93.74 71.03 74.79 89.90 82.950 86.47 83.15
30 104.9 95.73 87.98 97.01 95.8 94.93 96.06
40 105.24 101.79 89.33 101.72 100.85 99.98 99.82
50 97.53 96.77 89.33 101.72 100.85 99.98 97.70
60 97.2 98.43 89.33 101.72 100.85 99.98 97.92
75 95.88 100.75 89.33 101.72 100.85 99.98 98.09
90 97.19 97.13 89.33 101.72 100.85 99.98 97.70
APOTEX CONCENT
Tiempo
C1% C2% C3% C4% C5% C6% RACIÓN
(min)
0 0 0 0 0 0 0 MEDIA
0
10 70.4 84.07 55.02 53.31 59.12 57.42 63.22
20 101.01 85.29 90.04 86.67 87.68 90.14
30 106.42 102.43 96.11 93.08 97.16 94.11 98.22
40 102.73 104.79 98.81 93.42 98.16 94.44 98.73
50 100.71 101.44 98.81 93.42 98.16 94.44 97.83
60 100.04 102.1 98.81 93.42 98.16 94.44 97.83
75 100.7 102.77 98.81 93.42 98.16 94.44 98.05
90 100.04 107.71 98.81 93.42 98.16 94.44 98.76
CINFA CONCNET
Tiempo C1% C2% C3% C4% C5% C6% RACIÓN
0 0 0 0 0 0 0 PROMEDIO
0
10 22.9 -7.86 -7.18 -12.64 -5.81 -5.13 -2.62
20 90.23 77.15 82.25 85.29 75.12 88.38 83.07
30 115.26 88.99 89.7 92.39 94.74 101.92 97.17
40 108.19 93.37 93.74 93.74 98.78 103.94 98.63
50 99.49 94.04 93.74 93.74 98.78 103.94 97.29
60 97.82 92.37 93.74 93.74 98.78 103.94 96.73
75 97.16 92.37 93.74 93.74 98.78 103.94 96.62
90 106.39 92.7 93.74 93.74 98.78 103.94 98.22
120
100
cONCENTRACIÓN %
80 Column N
Column I
60 Column D
40
20
100
cONCENTRACIÓN %
80 Column N
Column I
60 Column D
40
20
0
0 10 20 30 40 50 60 75 90
Tiempo (min)
100
90
80
70
ración %
60
50 Column K
100
90
80
70
Concentración %
60
50 Column K
Column G
40
Column C
30 Column N
20
10
0
0 10 20 30 40 50 60 75 90
Tiempo (min)
ADIRO APOTEX
ti ∆Q1 ti∆Qi ti ∆Q1 ti∆Qi
5 12.79 63.97 5 63.22 316.12
15 70.35 1055.30 15 26.91 403.72
25 12.91 322.79 25 8.08 202.01
35 3.76 131.60 35 0.51 17.73
45 -2.12 -95.48 45 -0.90 -40.28
55 0.22 12.19 55 0.00 -0.09
67.5 0.17 11.25 67.5 0.22 14.96
82.5 -0.38 -31.76 82.5 0.71 58.85
TMD 14.70 TMD
DDSOLVE 9.73
DDSOLVER #ERROR! R #ERROR!
f1 ADIRO VS f1 ADIRO VS
APOTEX CINFA
QRt-QMt QRt QRt-QMt QRt
50.43 12.79 10.17 12.79
6.99 83.15 0.08 83.15
2.16 96.06 1.11 96.06
1.09 99.82 1.19 99.82
0.13 97.70 0.41 97.70
0.09 97.92 1.19 97.92
0.03 98.09 1.46 98.09
1.06 97.7 0.51 97.7
∑ 62.00 683.22 ∑ 16.12 683.22
F1 9.074183397 F1 2.359915107
Factor de diferencia (f1) es aceptable entre 0 y
15, siendo 0 la ideal. Lo cual indica que
prácticamente no hay diferencia entre las
formulaciones. Factor de similitud (f2) es
aceptable entre 50 y 100, siendo 100 el ideal. Lo
cual indica que prácticamente las formulaciones
son iguales, o muy parecidas.
Se compararon 2 marcas de AAS frente a
uno de referencia cuya marca era ADIRO, la
concentración del comprimido era de 100
mg
PROMEDIO
DE LAS CONCENTR
CINFA CONCENTR ACIÓN
Tiempo (min) ACIONES PROMEDIO AUC
0 0 0
ABS 0.00
10 -2.62 2.62 13.1
20 83.07 83.07 428.45
30 97.17 97.17 901.1833333
40 98.63 98.63 978.9666667
50 97.29 97.29 979.575
60 96.73 96.73 970.1
75 96.62 96.62 1450.15
90 98.22 98.22 1461.275
AUC
DDSOLVE 7182.80
R #ERROR!
Column N
Column I
Column D
Column N
Column I
Column D
CONCENTR
ACIÓN
AUC
%
PROMEDIO FÁRMACO
ABS 0 0.00 100
2.62 13.10 100
83.07 428.45 100
97.17 901.18 100
98.63 978.97 100
97.29 979.58 100
96.73 970.10 100
96.62 1450.15 100
98.22 1461.28 100
AUC 7182.80 9000
CINFA
ti ∆Q1 ti∆Qi
5 2.62 13.1
15 80.45 1206.75
25 14.10 352.4166667
35 1.46 51.1
45 -1.34 -60.225
55 -0.56 -30.61666667
67.5 -0.11 -7.425
82.5 1.59 131.45
TMD 16.5655
DDSOLVER #ERROR!
OLUCIÓN (F2)
CINFA CONCNETR mg de
Tiempo ACIÓN fármaco
PROMEDIO disuelto
10 2.62 2.62
20 83.07 83.07
30 97.17 97.17
40 98.63 98.63
50 97.29 97.29
60 96.73 96.73
75 96.62 96.62
90 98.22 98.22
f2 ADIRO
VS
f2 ADIRO VS APOTEX
CINFA
∑QRt-QMt)^2 ∑QRt-QMt)^2
103.50 2543.18
0.01 48.88
1.23 4.67
1.42 1.20
0.17 0.02
1.41 0.01
2.14 0.00
0.27 1.13
∑ 110.13 ∑ 2599.08
n 8 n8
F2 70.76801072 F2 37.17338073
aceptable entre 0 y
o cual indica que
ferencia entre las
e similitud (f2) es
endo 100 el ideal. Lo
nte las formulaciones
y parecidas.
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Difference factor, f1 Time 18:58:59
Time Ref.1
(min) F(%) Mean SD RSD(%)
10 12.79 12.79
20 83.15 83.15
30 96.06 96.06
40 99.82 99.82
50 97.70 97.70
60 97.92 97.92
75 98.09 98.09
90 97.70 97.70
Time Test.1
(min) F(%) Mean SD RSD(%)
10 63.22 63.22
20 90.14 90.14
30 98.22 98.22
40 98.73 98.73
50 97.83 97.83
60 97.83 97.83
75 98.05 98.05
90 98.76 98.76
Difference factor: f1
f1 Ref.1
Test.1 9.07
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f1 9.07 9.07
Is f1 ∈[ 0,15 ] between Mean_R and Mean_T Yes
Similarity of R and T Accept
120
Column C
100 Column C
120
Column C
100 Column C
Fraction dissolved (%)
80
60
40
20
0
0 10 20 30 40 50 60 70 80 90 100
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Similarity factor, f2 Time 19:00:10
Time Ref.1
(min) F(%) Mean SD RSD(%)
10 12.79 12.79
20 83.15 83.15
30 96.06 96.06
40 99.82 99.82
50 97.70 97.70
60 97.92 97.92
75 98.09 98.09
90 97.70 97.70
Time Test.1
(min) F(%) Mean SD RSD(%)
10 63.22 63.22
20 90.14 90.14
30 98.22 98.22
40 98.73 98.73
50 97.83 97.83
60 97.83 97.83
75 98.05 98.05
90 98.76 98.76
Similarity factor: f2
f2 Ref.1
Test.1 37.17
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f2 37.17 37.17
Is f2 ∈[50,100] between Mean_R and Mean_T No
Similarity of R and T Reject
120
Column C
100 Column C
120
Column C
100 Column C
Fraction dissolved (%)
80
60
40
20
0
0 10 20 30 40 50 60 70 80 90 100
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Difference factor, f1 Time 19:02:23
Time Ref.1
(min) F(%) Mean SD RSD(%)
10 12.79 12.79
20 83.15 83.15
30 96.06 96.06
40 99.82 99.82
50 97.70 97.70
60 97.92 97.92
75 98.09 98.09
90 97.70 97.70
Time Test.1
(min) F(%) Mean SD RSD(%)
10 2.62 2.62
20 83.07 83.07
30 97.17 97.17
40 98.63 98.63
50 97.29 97.29
60 96.73 96.73
75 96.62 96.62
90 98.22 98.22
Difference factor: f1
f1 Ref.1
Test.1 2.36
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f1 2.36 2.36
Is f1 ∈[ 0,15 ] between Mean_R and Mean_T Yes
Similarity of R and T Accept
120
Column C
100 Column C
120
Column C
100 Column C
Fraction dissolved (%)
80
60
40
20
0
0 10 20 30 40 50 60 70 80 90 100
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Similarity factor, f2 Time 19:03:27
Time Ref.1
(min) F(%) Mean SD RSD(%)
10 12.79 12.79
20 83.15 83.15
30 96.06 96.06
40 99.82 99.82
50 97.70 97.70
60 97.92 97.92
75 98.09 98.09
90 97.70 97.70
Time Test.1
(min) F(%) Mean SD RSD(%)
10 2.62 2.62
20 83.07 83.07
30 97.17 97.17
40 98.63 98.63
50 97.29 97.29
60 96.73 96.73
75 96.62 96.62
90 98.22 98.22
Similarity factor: f2
f2 Ref.1
Test.1 70.77
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f2 70.77 70.77
Is f2 ∈[50,100] between Mean_R and Mean_T Yes
Similarity of R and T Accept
120
Column C
100 Column C
120
Column C
100 Column C
Fraction dissolved (%)
80
60
40
20
0
0 10 20 30 40 50 60 70 80 90 100
Time (min)
EJERCICIO 3.COMPARACIÓN DE PERFI
DISOLUCIÓN
140
120
100
Concentración %
80
60
40
20
0
0 15
Tiem
MEDICAMENTO ORIGINAL
PROMEDIO MEDICAMENTO GENÉRICO A
PROMEDIO
DE LAS DE LAS
Tiempo (min) AUC Tiempo (min)
CONCENTR CONCENTR
0 ACIONES
0.00 0 0 ACIONES
0.00
15 91.87 689 15 111.39
30 106.16 1485.175 30 112.53
45 107.96 1605.9 45 112.98
60 109.39 1630.15 60 117.37
AUC
DDSOLVE 5410.225 AUC
DDSOLVE
R #ERROR! R
ORIGINAL GENÉRICO A
ti ∆Q1 ti∆Qi ti ∆Q1
7.5 91.87 689.00 7.5 111.39
22.5 14.29 321.53 22.5 1.14
37.5 1.81 67.75 37.5 0.45
52.5 1.43 74.90 52.5 4.39
TMD
DDSOLVE 11.53 TMD
DDSOLVE
R #ERROR!
R
F1 9.36 F1 1.09
RACIÓN DE PERFILES DE
OLUCIÓN
NTO GENÉRICO A PROMEDIO
MEDICAMENTO GENÉRICO B MEDICAMENTO GENÉRICO C
DE LAS
AUC Tiempo (min) AUC Tiempo (min)
CONCENTR
0 0 ACIONES
0.00 0 0
835.425 15 92.34 692.55 15
1679.375 30 104.67 1477.6 30
1691.3 45 106.79 1585.975 45
1727.6 60 107.98 1610.8 60
5933.7 AUC
DDSOLVE 5366.925
#ERROR! R #ERROR!
Column O
Column K
Column G
Column C
15 30 45 60
Tiempo (min)
LUCIÓN (ED)
100
90
80
70
ntración %
60
Column O
50
Column K
100
90
80
70
Concentración %
60
Column O
50
Column K
40 Column G
30 Column C
Column R
20
10
0
0 15 30 45 60
Tiempo (min)
GENÉRICO B GENÉRICO C
ti∆Qi ti ∆Q1 ti∆Qi ti
835.43 7.5 92.34 692.55 7.5
25.58 22.5 12.33 277.5 22.5
17.00 37.5 2.12 79.375 37.5
230.30 52.5 1.19 62.65 52.5
11.08 TMD 11.1208
DDSOLVE
#ERROR! #ERROR!
R
Y FACTOR DE DISOLUCIÓN
NTO GENÉRICO
mg deA MEDICAMENTO GENÉRICO
PROMEDIO
mg deB MEDICAMENTO GENÉRICO C
DE LAS
fármaco Tiempo (min) fármaco Tiempo (min)
CONCENTR
disuelto disuelto
0 0 ACIONES
0.00 0 0
111.39 15 92.34 92.34 15
112.53 30 104.67 104.6733333 30
112.98 45 106.79 106.79 45
117.37 60 107.98 107.9833333 60
f1 ORIGINAL VS
GENÉRICO C
QRt-QMt QRt
22.77 91.87
5.22 106.16
2.61 107.96
2.45 109.39
∑ 33.05 415.38 ∑
F1 7.96 n
F2
PROMEDIO
MEDICAMENTO GENÉRICO C
DE LAS
AUC
CONCENTR
ACIONES 0 0
69.1 518.25
100.94 1275.275
105.35 1547.175
106.94 1592.2
AUC
DDSOLVE 4932.9
R #ERROR!
MEDICAMENTO GENÉRICO C
PROMEDIO
DE LAS
AUC % FÁRMACO
CONCENTR
ACIONES 0 0 100
69.1 518.25 100
100.94 1275.275 100
105.35 1547.175 100
106.94 1592.2 100
AUC
DDSOLVE 4932.9 6000
R #ERROR!
GENÉRICO C
∆Q1 ti∆Qi
69.10 518.25
31.84 716.325
4.42 165.625
1.59 83.3
TMD 14.8350
DDSOLVE
#ERROR!
R
MEDICAMENTO GENÉRICO C
PROMEDIO
DE LAS
mg de fármaco disuelto
CONCENTR
ACIONES 0 0
69.10 69.1
100.94 100.94
105.35 105.35
106.94 106.94
f2 f2 f2
ORIGINA ORIGINA ORIGINA
L∑QRt-
VS A L∑QRt-
VS B L∑QRt-
VS C
QMt)^2 QMt)^2 QMt)^2
381.16 0.22 518.32
40.58 2.20 27.25
25.17 1.38 6.81
63.63 1.98 6.00
510.53 ∑ 5.78 ∑ 558.38
Analyst Samy
Time Unit min Date yyyy-9-28
Method Difference factor, f1 Time 22:17:46
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 91.87 91.87
30 106.16 106.16
45 107.96 107.96
60 109.39 109.39
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 111.39 111.39
30 112.53 112.53
45 112.98 112.98
60 117.37 117.37
Difference factor: f1
f1 Ref.1
Test.1 9.36
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f1 9.36 9.36
Is f1 ∈[ 0,15 ] between Mean_R and Mean_T Yes
Similarity of R and T Accept
140
Column C
120 Column C
100
issolved (%)
80
140
Column C
120 Column C
80
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Difference factor, f1 Time 22:18:24
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 91.87 91.87
30 106.16 106.16
45 107.96 107.96
60 109.39 109.39
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 92.34 92.34
30 104.67 104.67
45 106.79 106.79
60 107.98 107.98
Difference factor: f1
f1 Ref.1
Test.1 1.09
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f1 1.09 1.09
Is f1 ∈[ 0,15 ] between Mean_R and Mean_T Yes
Similarity of R and T Accept
120
Column C
100 Column C
issolved (%)
80
60
120
Column C
100 Column C
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Difference factor, f1 Time 22:18:54
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 91.87 91.87
30 106.16 106.16
45 107.96 107.96
60 109.39 109.39
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 69.10 69.10
30 100.94 100.94
45 105.35 105.35
60 106.94 106.94
Difference factor: f1
f1 Ref.1
Test.1 7.96
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f1 7.96 7.96
Is f1 ∈[ 0,15 ] between Mean_R and Mean_T Yes
Similarity of R and T Accept
120
Column C
100 Column C
issolved (%)
80
60
120
Column C
100 Column C
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Similarity factor, f2 Time 22:19:25
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 91.87 91.87
30 106.16 106.16
45 107.96 107.96
60 109.39 109.39
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 111.39 111.39
30 112.53 112.53
45 112.98 112.98
60 117.37 117.37
Similarity factor: f2
f2 Ref.1
Test.1 49.67
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f2 49.67 49.67
Is f2 ∈[50,100] between Mean_R and Mean_T No
Similarity of R and T Reject
140
Column C
120 Column C
100
issolved (%)
80
140
Column C
120 Column C
80
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Similarity factor, f2 Time 22:20:06
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 91.87 91.87
30 106.16 106.16
45 107.96 107.96
60 109.39 109.39
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 92.34 92.34
30 104.67 104.67
45 106.79 106.79
60 107.98 107.98
Similarity factor: f2
f2 Ref.1
Test.1 91.66
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f2 91.66 91.66
Is f2 ∈[50,100] between Mean_R and Mean_T Yes
Similarity of R and T Accept
120
Column C
100 Column C
issolved (%)
80
60
120
Column C
100 Column C
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)
DDSolver 1.0 In-vitro Dissolution Profile Comparison
Analyst Samy
Time Unit min Date yyyy-9-28
Method Similarity factor, f2 Time 22:20:42
Time Ref.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 91.87 91.87
30 106.16 106.16
45 107.96 107.96
60 109.39 109.39
Time Test.1
(min) F(%) Mean SD RSD(%)
0 0.00 0.00
15 69.10 69.10
30 100.94 100.94
45 105.35 105.35
60 106.94 106.94
Similarity factor: f2
f2 Ref.1
Test.1 48.70
Overall Statistics
Mean_R vs Individual_T Mean_R vs Mean_T
Mean SE
f2 48.70 48.70
Is f2 ∈[50,100] between Mean_R and Mean_T No
Similarity of R and T Reject
120
Column C
100 Column C
issolved (%)
80
60
120
Column C
100 Column C
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)