Overactive bladder (OAB) is a combination of urinary symptoms that includes a sudden, strong need to urinate. The major symptom of OAB is a sudden, strong urge to urinate that you can't ignore. Leak urine or have “urge incontinence.” This means urine leaks when you feel the sudden urge to go.

1. Pre Submission Seminar Presentation
Formulation and Evaluation of Immediate Release Tablet for
Treatment of Overactive Bladder
Presented by: Bhumin Nitin Jain Guided by:
M. Pharmacy 2nd Year Sem IV Dr. Monika Ola
22MPH1007 Associate Professor
Dept. of Pharmaceutics
1
R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur

2.  Contents
• Introduction
• Aim, Need and Objective
• Plan of Work
• Drug Profile
• Excipients Profile
• Materials and Instruments
• Preformulation Studies
• Formulation Studies
• Evaluation Studies
• Stability Studies
• Test Product VS Reference Product
• References
2

3.  Introduction
• Overactive bladder (OAB) is a combination of urinary symptoms that includes a
sudden, strong need to urinate.
Figure 1 Normal and Overactive Bladder
• The major symptom of OAB is a sudden, strong urge to urinate that you can't ignore.
3
Reference:https://www.ever
ydayhealth.com/overactive-
bladder/causes/

4. • Leak urine or have “urge incontinence.” This means urine leaks when you feel the
sudden urge to go.
• Urinate frequently. You may need to go to the bathroom many times during the day.
• Wake up at night to pass urine.
 Risk Factors for OAB:
• Hormone changes
• Pelvic muscle weakness or spasms
• A urinary tract infection
• Side effects from a medication
4
Reference:https://www.myrbetriqhcp.com/combi
nation-treatment/#
Figure 2 MOA of Drug

5.  Aim, Need and Objective
• Aim: To formulate and evaluate immediate release tablet for treatment of Overactive
Bladder
• Need:
1. The cost for (branded) oral tablet 10 mg is around $411 for a supply of 30 tablets. It
indicates that there is strong need of generic version for affordable healthcare.
2. The data shows that number of people affected with overactive bladder is 37
million.
Figure 3 No. of people affected by OAB
5
Reference:https://www.urovantmed
icalaffairs.com/overview-of-
overactive-bladder

6. • Objective:
1. To formulate and evaluate immediate release tablets by Direct compression.
2. To study dissolution profile and to compare their drug-release profiles with
(innovator)
3. To study stability of optimized formulation.
4. To compare test product with reference product.
6

7.  Plan of work
1. Literature review
2. Selection of Drug and Excipients
3. Preformulation Studies
4. Formulation Development
5. Evaluation of Formulation
6. Stability Studies of Formulation
7

8.  Drug Profile
Drug Name Drug X
Category Antimuscarinic Antagonist
Molecular weight 362.465 g/mol
BCS class BCS class I
Half-life 45-68 hrs
Log P 1.69
Solubility It is freely soluble at room temperature in
water, glacial acetic acid, dimethyl sulfoxide,
and methanol.
8
Table 1 Drug Profile

9.  Excipients Profile
9
Parameter Lactose
Monohydrate
Corn Starch Hypromellose
2910
Magnesium
Stearate
Molecular
formula
C12H22O11 H2O C27H48O20 C56H108O30 C36H70MgO4
Molecular
weight g/mol
360.31 692.65 1261.45 591.27
Solubility Freely soluble in
water; practically
insoluble in ethanol,
diethyl ether and
chloroform.
Practically
insoluble in cold
ethanol and in
cold water.
Partially soluble
in DMSO.
Soluble in cold
water,practically
insoluble in hot
water and ether,
but soluble in
mixtures of
ethanol
Practically
insoluble in
ethanol, ether and
water; slightly
soluble in warm
benzene and
warm ethanol.
Melting point 201–2020 C 256-258OC 225–230oC 117–150o C
Function Diluent / filler Disintegrant Binder Lubricant
Table 2 Excipients Profile

10.  Materials and Instruments
10
Sr no. Material Grade Function Supplier
1. Drug X - API
Enaltec Labs
Pvt. Ltd.
2.
Lactose
Monohydrate
Super Tab 14,
spray- Dried
Diluent DFE Pharma
3. Corn Starch
Maize Starch B
Pharma Grade
Disintegrant
Roquette
Freres
4.
Hypromellose
2910
Methocel E5
Premium LV
Binder
Dow
chemical
company
5.
Magnesium
Stearate
Hyqual,
Vegetable
Source
Lubricant
Avantor
Performance
materials Inc.
6. Opadry yellow
Opadry yellow
(03F520313)
Coating
Ingredient
Colorcon Asia
Pvt. Ltd.
7. Opadry pink
Opadry pink
(03F540267)
Coating
Ingredient
Colorcon Asia
Pvt. Ltd.
Sr No. Equipments Name
Name of Manufacturer with
model
1. Weighing Balance Sartorius CP224S
2. Weighing Balance Mettler Toledo BBA422
3. Double Cone Blender Gansons
4. Compression Machine Cadmach CMB4-MT
5. Sieve Shaker
Electromagnetic Sieve Shaker
EMS-8
6. Vernier Caliper
Mitutoyo Absolute AOS
Digimatic
7. Moisture Analyzer Mettler Toledo HB43-S
8. Hardness Tester
Dr. Schleuniger Pharmatron
8M
9. Friability Tester Electrolab EF-2
10. Disintegration Test Apparatus Electrolab ED-2SAPO
11. Tapped Density Apparatus Electrolab ETD-1020
12. Tablet Coating Machine Neocota
13. Differential Scanning Calorimeter
Mettler DSC 1 star system,
Mettler-Toledo, Switzerland
14. Dissolution Apparatus Electrolab ED-2SAPO
15. FTIR Thermo Scientific iD3
Table 3 List of Materials
Table no 4 List of Instruments

11.  Preformulation studies
• Organoleptic properties:
Table 5 Organoleptic Properties
• UV Analysis:
Test Results
Description White Powder
Taste and Odour Bitter and Odourless
Loss on Drying 1.50 %
Figure 4 UV Spectrum of Drug
11

12. Concentration
(µg/mL)
Absorbance
5 0.265
10 0.437
15 0.627
20 0.824
25 0.981
30 1.134
Concentration
(µg/mL)
Absorbance
5 0.265
10 0.437
15 0.627
20 0.824
25 0.981
30 1.134
Table 6 Absorbance of Drug
Figure 5 Calibration curve of drug in water
• XRD :
Figure 6 XRD Pattern of API
2θ values
3.75
7.45
11.16
14.19
18.61
19.30
20.99
23.21
25.13
Table 7 2θ Values of X-Ray
12

13. • FTIR:
13
Figure 7 FTIR of Drug
Type of Vibrations
Standard
Peakcm-1
Observed
Peakcm-1
C=O 1730-1715 1716.95
C-H 3000-2500 2876.85
C≡N 2500-2000 2298.10
C=C 2000-1500 1578.61
C-N 1500-1000 1352.98
S-O 700-500 548.29
Table 8 Reported IR Frequency of Drug

14. • Melting Point:
1) Capillary Rise Method:
2) Differential scanning calorimetry: The melting point of Drug X was confirmed by
differential scanning calorimetry which was performed at the scanning rate of
10°C/min with 80 mL/min of nitrogen purging. It was confirmed with the reported
melting point of i.e., Drug X ranges between 144-149°C.
14
Standard Observed
144 – 149 °C 145 – 151 °C
Table no 9 Melting Point
Figure no 8 DSC Curve of drug

15. • Particle Size Determination:
Conclusion: From above study, it was found that Drug used for observation was
relatively fine.
• Sieve Analysis:
15
Specification Particle Size
d (10) 11 um
d (50) 36 um
d (90) 73 um
Sieve
Sizes
Initial
weight of
sieves
Final
weight of
sieves
Difference
in weights
%
retained
Cumulative
% retained
20# 366.6 366.6 0 0 0
40# 328.8 328.8 0 0 0
60# 334.2 338.0 3.8 19 19
80# 336.8 344.8 8.0 40 59
100# 328.0 331.6 3.6 18 77
Pan 531.6 536.2 4.6 23 100
Total 20.0
Conclusion: Drug was passed from
respective sieves using sieve
shaker and cumulative % retained
was calculated .
Table no 10 Particle Size Determination
Table no 11 Sieve Analysis of drug

16. • Flow Property:
Conclusion: Based on the findings, Flow character of Lubricated blend is Passable.
16
Properties Characters
Bulk Density 0.571 gm/ml
Tap Density 0.762 gm/ml
Compressibility Index 25.065 %
Hausner’s Ratio 1.335
Table no 12 Flow Property

17. • Drug-Excipient Compatibility Study
17
API Excipients Ratio used
Drug X - -
Drug X Lactose monohydrate (SuperTab 14SD) 1:21.4
Drug X Corn starch (Maize Starch B Pharma Grade) 1:6.3
Drug X Hypromellose 2910 (Methocel E5 Premium LV) 1:1.2
Drug X Magnesium stearate (Hyqual, Vegetable Source) 1:0.1
Drug X Opadry pink (03F540267) 1:0.45
Drug X Opadry yellow (03F520313) 1:0.90
Drug X All excipients (for 5 mg strength) 1:21.4:6.3:1.2:0.1:0.90
Drug X All excipients (for 10 mg strength) 1:21.4:6.3:1.2:0.1:0.45
Figure 9 Normal overlay diffractogram scan of
API, Drug X tablets , 5 mg and Drug X tablets ,
5 mg Placebo
Figure 10 Normal overlay diffractogram scan of
API, Drug X tablets, 10 mg and Drug X tablets,
10 mg Placebo
The X-ray diffractogram DrugX API,
Drug X tablets 5 and 10 mg, and Drug X
tablets 5 and 10 mg placebo has shown
sharp peaks at different angles (2ϴ)
13.5°, 15.5°, 17.6°, 18.1° and
21.8°.
Table 13 Ratio of API & Excipients used

18. 18
Stability condition – Initial
Binary mixture Ratio
Assay
(%w/w)
Related Substances (%w/w)
Method I
Method
II Total
Impu
rities
(Met
hod I
and
II)
Impuri
ty-I
N-
Oxide
impuri
ty
Any
other
individ
ual
impurit
y
R-(-)-3-
Quinucli
dinol
impurity
(Imp.-E)
90.0 –
110.0
NMT
0.5
NMT
0.5
NMT
0.2
NMT
0.5
NMT
2.0
Drug XAPI - 99.90 0.002 0.015 0.030 ND 0.096
Drug X+ SuperTab 14SD
1:21.
4
99.94 0.006 0.014 0.018 ND 0.059
Drug X+ Maize Starch B
Pharma Grade
1:6.3 99.94 0.004 0.019 0.013 ND 0.064
Drug X+ Methocel E5
Premium LV
1:1.2 99.91 0.006 0.017 0.027 ND 0.089
Drug X+ Hyqual,
Vegetable Source
1:0.1 99.94 0.004 0.017 0.017 ND 0.065
Drug X+ Opadry Yellow
0.3F520313
1:0.9
0
99.94 0.005 0.019 0.019 ND 0.058
Drug X+ Opadry Pink
03F540267
1:0.4
5
99.93 0.002 0.018 0.020 ND 0.069
Drug X+ all excipient for
5 mg strength
- 99.93 0.004 0.026 0.021 ND 0.069
Drug X+ all excipients
for 10 mg strength
- 99.93 0.003 0.009 0.033 ND 0.071
Stability condition – 60°C/80% RH; 1M (Open)
Binary mixture Ratio
Assay
(%
w/w)
Related Substances (% w/w)
Method I
Method
II
Total
Impur
ities
(Method
I
and
II)
Impur
ity-I
N-Oxide
impur
ity
Any
other
individual
impur
ity
R-(-)-3-
Quinuclidinol
impur
ity
(Imp.-E)
90.0 –
110.0
NMT
0.5
NMT
0.5
NMT
0.2
NMT 0.5
NMT
2.0
Drug X API - 99.91 0.002 0.022 0.029 ND 0.091
Drug X + SuperTab 14SD 1:21.4 99.93 0.004 0.023 0.021 ND 0.067
Drug X + Maize Starch B
Pharma Grade
1:6.3 99.94 0.004 0.025 0.015 ND 0.066
Drug X + Methocel E5
Premium LV
1:1.2 99.91 0.004 0.021 0.032 ND 0.091
Drug X + Hyqual,
Vegetable Source
1:0.1 99.93 0.003 0.021 0.015 ND 0.071
Drug X + Opadry Yellow
0.3F520313
1:0.90 99.91 0.004 0.027 0.017 ND 0.091
Drug X + Opadry Pink
03F540267
1:0.45 99.92 0.002 0.024 0.027 ND 0.078
Drug X + all excipient for
5 mg strength
- 99.92 0.004 0.027 0.021 ND 0.075
Drug X + all excipients for
10 mg strength
- 99.91 0.003 0.021 0.043 ND 0.090
Table no 14 Initial data of drug-excipient
compatibility study
Table no 15 Stability data of drug-excipient
compatibility study

19.  Formulation studies
Trial no. Trial name Observations
1. To take trial batch by DC
and to study
physicochemical
parameters
All parameters were
found satisfactory and
meet the specification.
Dissolution of generic
Drug X tablets, 10 mg
was observed more than
85% in 15 minutes.
2. To take trial batch using
reduced particle size to
study impact on
dissolution of drug
It was concluded that
reduced API PSD has no
impact on dissolution of
drug product.
3. To take trial batch 5mg
using reduced particle size
of API to study impact on
dissolution of drug
It was concluded that
reduced API PSD has no
impact on dissolution of
drug product.
19
Sr.
No.
Name of
Ingredient
Qty (mg) / tablet
T1 (10
mg)
T2 (10
mg)
T3 (5
mg)
Optimized
Batch
5 mg 10
mg
1. Drug X 10.00 10.00 5.00 5.00 10.00
2. Lactose
Monohydrate
102.00 125.00 130.00 130.
00
125.0
0
3. Corn Starch 31.50 7.50 7.50 7.50 7.50
4. Hypromellose
2910
6.00 6.00 6.00 6.00 6.00
5. Magnesium
Stearate
0.50 1.50 1.50 1.50 1.50
6. Opadry Pink 3.75 3.75 - - 3.75
7. Opadry
Yellow
- - 3.75 3.75 -
8. Purified Water q.s q.s q.s q.s q.s

20. 20
Trial no Dose
Tablet
wt.
(mg)
Thickness
(mm)
Diameter
(mm)
Hardness
(N)
Friability
(% w/w)
Assay
(%
w/w)
D.T
Time
T1 10 mg
146.0 -
153.0
3.35 -3.40 7.51 - 7.52 39 -55 0.22 99.0 3-4 min
T2 10 mg
149.1 –
152.3
3.46 – 3.49 7.52 – 7.54 45 -50 0.09 98.2 4-5 min
T3 5 mg
148.3 –
154.9
3.39 – 3.46 7.50 – 7.53 37 -47 0.11 96.9 4-5 min
Optimi-
zed
Batch
5 mg
149.00 –
156.00
3.44 - 3.52 7.49 -7.52 41 – 49 0.13 97.90
4 min 13
sec
10 mg
146.00 –
154.00
3.40 – 3.47 7.53 -7.55 43-51 0.10 98.0
3 min 50
sec
Trial no
Tablet wt.
(mg)
Thickness
(mm)
Diameter
(mm)
D.T Time
T1 149.0 – 163.0 3.39 – 3.51 7.54 – 7.57 4-5 min
T2 148.8 – 154.3 3.43 – 3.47 7.52 – 7.55 5-6 min
T3 148.9 – 155.2 3.42 – 3.49 7.52 – 7.55 5-6 min
Optimized
Batch
5 mg 151 – 156 3.51 – 3.56 7.53 -7.56
4 min 43
sec
10 mg 151 – 156 3.49 – 3.56 7.51 -7.54
4 min 14
sec
Table no 16 Physical In process Parameters of
Core Tablets
Table no 17 Physical In process Parameters of
Coated Tablets

21. • In Vitro Dissolution Release
1) Trial Batch 1
21
Batch No. (RLD) Trial batch 1
Dissolution
conditions
USP II/900 mL Water/50 rpm
Time (Minutes) % Drug release % RSD % Drug release % RSD
10 67 7.05 64 14.8
15 88 5.23 91 7.91
30 101 1.84 97 4.9
45 101 1.49 97 5.08
0
20
40
60
80
100
120
0 10 20 30 40 50
%
Drug
release
Time (min.)
Comparative dissolution profiles of Drug X tablets, 10 mg in water
RLD
Trial batch 1
Table no 18 Dissolution profiles of Drug X
tablets, 10 mg in water
Figure no 11 Dissolution profiles of Drug X
tablets, 10 mg

22. 2) Trial Batch 2
22
Impact of particle size on % drug release of drug product
Batch No.
(API with d90: 110.38 µm) (API with d90: 45.2 µm)
Dissolution condition USP II/900 mL Water/50 rpm
Time (Minutes) % Drug release % RSD % Drug release % RSD
10 64 14.8 60 29.9
15 91 7.91 82 15.72
30 97 4.9 94 2.81
45 97 5.08 96 2.7
0
50
100
150
0 10 20 30 40 50
%
Dr
ug
r
elease
Time (min.)
Dissolution profiles of Drug X tablets, 10 mg with different API
PSD
d90:110.38µm
d90: 45.2µm
Table no 19 Dissolution profile of Drug X
tablets, 10 mg with different API PSD
Figure no 12 Dissolution profile of Drug X
tablets, 10 mg with different API PSD

23. 3) Trial Batch 3
23
Batch No. (RLD) Trial batch 3
Dissolution
condition
USP II/900 mL Water/50 rpm
Time (Minutes) % Drug release % RSD % Drug release % RSD
10 37 15.89 55 16.79
15 72 12.33 73 14.0
30 97 2.48 90 2.02
45 97 1.01 96 2.77
F2 value 50.59
0
20
40
60
80
100
120
0 10 20 30 40 50
%
Drug
release
Time (min.)
Comparative dissolution profiles of Drug X tablets, 5 mg in water
RLD
Trial batch 3
Table no 20 Dissolution profiles of RLD and
Drug X tablets, 5 mg
Figure no 13 Dissolution profiles of RLD and
Drug X tablets, 5 mg

24. • Optimized Batch
Table 21 Multimedia dissolution profiles of
Drug X tablets, 5 mg
Figure 14 Multimedia dissolution profiles of Drug
X tablets, 5 mg
Table 22 Multimedia dissolution profiles of
Drug X tablets, 10 mg
0
20
40
60
80
100
120
0 10 20 30 40 50
%
Drug
release
TIme (min.)
Multimedia dissolution profile of solifenacin succinate tablets, 10 mg
Water
0.1N HCl
pH 4.5 acetate buffer
pH 6.8 phosphate buffer
Figure 15 Multimedia dissolution profiles of Drug
X tablets, 10 mg
24
0
20
40
60
80
100
120
0 10 20 30 40 50
%
Drug
release
TIme (min.)
Water
0.1N HCl
pH 4.5 acetate buffer
pH 6.8 phosphate buffer
Product Drug XTablets, 5 mg
Dissoluti
on
conditio
n
USP II / 900 mL
water / 50 rpm
USP II / 900 mL
0.1 N HCl / 50
rpm
USP II / 900 mL
pH 4.5 acetate
buffer / 50 rpm
USP II / 900 mL
pH 6.8
phosphate buffer
/ 50 rpm
Time
(minutes
)
%
Release
% RSD
%
Release
% RSD
%
Release
% RSD
%
Release
%
RSD
10 49 28.55 44 26.01 47 18.32 49 23.15
15 75 18.98 72 24.37 79 13.64 76 16.93
30 96 4.03 101 1.48 101 0.51 92 2.94
45 97 3.5 102 1.66 101 0.93 93 2.13
Product Drug X tablets, 10 mg
Dissoluti
on
condition
USP II / 900 mL
water / 50 rpm
USP II / 900 mL
0.1 N HCl / 50
rpm
USP II / 900 mL
pH 4.5 acetate
buffer / 50 rpm
USP II / 900 mL
pH 6.8
phosphate buffer
/ 50 rpm
Time
(minutes)
%
Release
% RSD
%
Release
% RSD
%
Release
% RSD
%
Release
%
RSD
10 59 29.5 65 9.98 67 15.23 61 22.82
15 78 22.62 84 8.22 90 11.19 82 17.86
30 97 1.42 98 1.8 100 1.27 93 1.65
45 97 1.55 98 1.41 100 1.59 93 1.24

25. • RLD Dissolution
25
Product Innovator drug , 5 mg
Dissolution
condition
USP II / 900 mL
water / 50 rpm
USP II / 900 mL 0.1
N HCl / 50 rpm
USP II / 900 mL pH
4.5 acetate buffer /
50 rpm
USP II / 900 mL pH
6.8 phosphate buffer
/ 50 rpm
Time
(minutes)
%
Release
% RSD
%
Release
% RSD
%
Release
% RSD
%
Release
% RSD
10 37 15.89 53 7.68 62 5.83 37 23.69
15 72 12.33 72 6.54 86 4.69 56 20.78
30 97 2.48 94 4.3 101 2.58 81 8.47
45 97 1.01 99 2.45 102 1.69 85 3.6
Table 23 Multimedia dissolution profile of Innovator
drug , 5 mg
0
20
40
60
80
100
120
0 10 20 30 40 50
%
Drug
Release
Time (min.)
Water
0.1N HCl
pH 4.5 acetate buffer
pH 6.8 phosphate buffer
Figure 16 Multimedia dissolution profile of
Innovator drug , 5 mg
Product Innovator drug , 10 mg
Dissolution
condition
USP II / 900 mL
water / 50 rpm
USP II / 900 mL 0.1
N HCl / 50 rpm
USP II / 900 mL pH
4.5 acetate buffer /
50 rpm
USP II / 900 mL pH
6.8 phosphate buffer
/ 50 rpm
Time
(minutes)
%
Release % RSD
%
Release % RSD
%
Release % RSD
%
Release % RSD
10 67 7.05 60 5.54 48 28.37 48 30.06
15 88 5.23 79 5.64 70 23.68 69 23.91
30 101 1.84 99 1.65 97 6.55 92 9.39
45 101 1.49 102 1.35 100 2.04 95 2.27
Table 24 Multimedia dissolution profile of Innovator
drug , 10 mg
0
20
40
60
80
100
120
0 10 20 30 40 50
%
Drug
Release
Time (min.)
Water
0.1N HCl
pH 4.5 acetate buffer
pH 6.8 phosphate buffer
Figure 17 Multimedia dissolution profile of
Innovator drug , 10 mg

26.  Evaluation Studies
26
Trial no Dose
Tablet wt.
(mg)
Thickness(
mm)
Diameter(
mm)
Hardness(
N)
Friability(
% w/w)
Assay(%
w/w)
T1 10 mg
146.0 -
153.0
3.35 -3.40 7.51 - 7.52 39 -55 0.22 99.0
T2 10 mg
149.1 –
152.3
3.46 – 3.49 7.52 – 7.54 45 -50 0.09 98.2
T3 5 mg
148.3 –
154.9
3.39 – 3.46 7.50 – 7.53 37 -47 0.11 96.9
Optimi-
zed
Batch
5 mg
149.00 –
156.00
3.44 - 3.52 7.49 -7.52 41 – 49 0.13 97.90
10 mg
146.00 –
154.00
3.40 – 3.47 7.53 -7.55 43- 51 0.10 98.0
RLD
5 mg
146.00-
157.00
3.44- 3.51 7.48- 7.53 40- 49 0.13 100.4
10 mg
145.00-
154.00
3.39-3.47 7.52-7.58 40- 50 0.10 100.4

27.  Stability Studies
27
Stability data of Drug X tablets, 5 mg
Packing
configuration
30 tablets in 23cc HDPE bottle with PPCR closure
Time points
Shelf-life
specification
Initia
l
1M 2M 3M 6M
Stability
conditions
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
1. Assay (% w/w) 90.0 – 110.0 97.7 98.0 97.4 98.6 98.3 98.1
97.
4
2. Related Substances
Procedure I
a) Impurity I
Not more than
0.5
ND BDL ND ND ND ND ND
b) N-Oxide
impurity
Not more than
0.5
0.03 0.09 0.14 0.06 0.13 0.09
0.1
3
c) Any other
individual impurity
Not more than
0.2
0.01 0.02
0.09
(RRT
-0.63)
0.09
(RRT
-0.63)
0.14
(RRT-
0.63)
0.09
(RRT
-0.64)
0.1
6
(RR
T-
0.6
4)
Procedure II
d) R-(-)-3-
Quinuclidinol
impurity
Not more than
0.5
ND ND ND ND ND ND ND
e) Total impurities
(I and II)
Not more than
2.0
0.05 0.16 0.30 0.25 0.40 0.20
0.4
0
3. Water by KF
(%)
Not more than
8.0
4.9 5.5 5.0 4.8 4.9 4.1 5.2
4. Dissolution
NLT 80% (Q)
in 30 min.
% Drug release
30 min. 98 97 93 99 99 92 90
Stability data of Drug X Tablets, 5 mg
Packing
configuration
90 tablets in 30cc HDPE bottle with PPCR closure
Time points
Shelf-life
specification
Initial
1M 2M 3M 6M
Stability
conditions
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
1. Assay (% w/w) 90.0 – 110.0 97.9 97.7 97.2 98.3 97.9 97.5
96.
4
2. Related Substances
Procedure I
a) Impurity I
Not more
than 0.5
ND ND ND ND ND ND ND
b) N-Oxide
impurity
Not more
than 0.5
0.03 0.09 0.13 0.08 0.14 0.11
0.1
6
c) Any other
individual
impurity
Not more
than 0.2
0.01
0.01
(RRT-
0.48)
0.09
(RRT-
0.64)
0.07
(RRT-
0.64)
0.13
(RRT-
0.63)
0.06
(RRT-
0.64)
0.1
5
(RR
T-
0.6
4)
Procedure II
d) R-(-)-3-
Quinuclidinol
impurity
Not more
than 0.5
ND ND ND ND ND ND ND
e) Total impurities
(I and II)
Not more
than 2.0
0.05 0.13 0.31 0.20 0.39 0.23
0.4
3
3. Water by KF
(%)
Not more
than 8.0
4.9 4.8 4.7 5.2 5.1 3.6 4.0
4. Dissolution
NLT 80%
(Q) in 30
min.
% Drug release
30 min. 98 98 96 98 97 95 93
Stability data of Dr ug X Tablets, 5 mg
Packing
configuration
PVC/Aclar unit dose blister pack of 10 tablets
Time points
Shelf-life
specification
Initia
l
1M 2M 3M 6M
Stability
conditions
40°C/75%RH
25°C/60%RH
40°C/75%RH
25°C/60%RH
40°C/75%RH
1. Assay (% w/w) 90.0 – 110.0 97.9 97.7 97.3 98.0 97.3 97.3 96.5
2. Related Substances
Pr ocedur e I
a) Impurity I
Not more
than 0.5
ND BDL ND ND ND ND ND
b) N-Oxide
impurity
Not more
than 0.5
0.03 0.07 0.12 0.08 0.11 0.10 0.11
c) Any other
individual impurity
Not more
than 0.2
0.01
0.02
(RRT
-0.23)
0.11
(RRT
-0.64)
0.06
(RRT
-0.63)
0.16
(RRT-
0.63)
0.06
(RRT
-
0.64)
0.19
(RR
T-
0.6
4)
Pr ocedur e II
d) R-(-)-3-
Quinuclidinol
impurity
Not more
than 0.5
ND ND ND ND ND ND ND
e) Total impurities
(I and II)
Not more
than 2.0
0.05 0.15 0.35 0.20 0.42 0.22 0.41
3. Water by KF
(%)
Not more
than 8.0
4.9 5.0 5.0 4.9 5.5 3.4 5.5
4. Dissolution
NLT 80%
(Q) in 30
min.
% Dr ug r elease
30 min. 98 99 96 97 94 94 93

28. 28
Stability data of Drug X Tablets, 10 mg
Packing
configuration
30 tablets in 23cc HDPE bottle with PPCR closure
Time points
Shelf-life
specification
Initia
l
1M 2M 3M 6M
Stability
conditions
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
1. Assay (% w/w) 90.0 – 110.0 98.0 97.5 99.4 97.9 97.7 98.4 97.9
2. Related Substances
Procedure I
a) Impurity I
Not more
than 0.5
ND ND ND ND ND ND ND
b) N-Oxide
impurity
Not more
than 0.5
0.02 0.09 0.15 0.06 0.16 0.08 0.17
c) Any other
individual impurity
Not more
than 0.2
0.01
0.01
(RRT
-0.30)
0.07
(RRT
-0.64)
0.05
(RRT
-0.64)
0.12
(RRT
-0.64)
0.04
(RRT-
0.64)
0.13
(RR
T-
0.64
)
Procedure II
d) R-(-)-3-
Quinuclidinol
impurity
Not more
than 0.5
ND ND ND ND ND ND ND
e) Total impurities
(I and II)
Not more
than 2.0
0.05 0.15 0.29 0.17 0.39 0.16 0.37
3. Water by KF
(%)
Not more
than 8.0
5.2 4.3 5.2 4.3 4.2 5.5 4.7
4. Dissolution
NLT 80%
(Q) in 30
min.
% Drug release
30 min. 95 99 89 95 91 96 94
Stability data of Drug X Tablets, 10 mg
Packing
configuration
90 tablets in 30cc HDPE bottle with PPCR closure
Time points
Shelf-life
specification
Initia
l
1M 2M 3M 6M
Stability
conditions
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
1. Assay (% w/w) 90.0 – 110.0 98.0 97.4 98.7 98.4 97.1 97.7 97.5
2. Related Substances
Procedure I
a) Impurity I
Not more
than 0.5
ND 0.01 ND ND ND ND ND
b) N-Oxide
impurity
Not more
than 0.5
0.02 0.10 0.16 0.05 0.16 0.08 0.20
c) Any other
individual
impurity
Not more
than 0.2
0.01
0.01
(RRT
-0.30)
0.01
(RRT
-0.63)
0.04
(RRT
-0.64)
0.10
(RRT
-0.63)
0.04
(RRT
-0.64)
0.12
(RR
T-
0.64)
Procedure II
d) R-(-)-3-
Quinuclidinol
impurity
Not more
than 0.5
ND ND ND ND ND ND ND
e) Total impurities
(I and II)
Not more
than 2.0
0.05 0.15 0.30 0.14 0.36 0.17 0.39
3. Water by KF
(%)
Not more
than 8.0
5.2 3.9 5.1 4.6 3.5 3.6 5.7
4. Dissolution
NLT 80%
(Q) in 30
min.
% Drug release
30 min. 95 98 92 97 97 99 97
Stability data of Drug X Tablets, 10 mg
Packing
configuration
PVC/Aclar unit dose blister pack of 10 tablets
Time points
Shelf-life
specification
Initia
l
1M 2M 3M 6M
Stability
conditions
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
25°C/60%
RH
40°C/75%
RH
1. Assay (% w/w) 90.0 – 110.0 98.0 97.6 98.4 98.1 97.1 97.7 97.9
2. Related Substances
Procedure I
a) Impurity I
Not more than
0.5
ND BDL ND ND ND ND ND
b) N-Oxide
impurity
Not more than
0.5
0.02 0.10 0.17 0.07 0.16 0.10 0.15
c) Any other
individual impurity
Not more than
0.2
0.01 0.01
0.09
(RRT
-0.63)
0.05
(RRT
-0.63)
0.13
(RRT-
0.64)
0.05
(RRT
-0.63)
0.15
(RR
T-
0.63
)
Procedure II
d) R-(-)-3-
Quinuclidinol
impurity
Not more than
0.5
ND ND ND ND ND ND ND
e) Total impurities
(I and II)
Not more than
2.0
0.05 0.13 0.33 0.20 0.43 0.20 0.38
3. Water by KF
(%)
Not more than
8.0
5.2 4.6 4.7 5.6 5.2 5.2 5.5
4. Dissolution
NLT 80% (Q)
in 30 min.
% Drug release
30 min. 95 97 91 93 93 97 98

29.  Test Product VS Reference Product
29
Product Test product Reference product
Strength 5 mg 10 mg 5 mg 10 mg
Brand name -
VESIcare®
Tablets, 5 mg
VESIcare®
Tablets, 10 mg
Generic Name Solifenacin succinate tablets
Appear ance
Light yellow
colored, round
tablets
debossed with
a Logo and
150
Light pink
colored, round
coated tablets
debossed with
a Logo and
151
Light yellow
colored, round
tablets
debossed with
a Logo and
150
Light pink
colored, round
coated tablets
debossed with
a Logo and
151
Tablet weight (mg)
151.00-
156.00
151.00-
155.00
155.18 154.89
Diameter (mm) 7.53-7.56 7.51-7.54 7.63 – 7.66 7.63 – 7.65
Thickness (mm) 3.51-3.56 3.49-3.56 3.51 – 3.54 3.50 – 3.54
Disintegration Time 4 min 43 sec 4 min 14 sec 5 min 23 sec 5 min 19 sec
% Assay 97.90 98.0 100.4 100.4

30.  References
• Chapple, C.R., Cardozo, L., Steers, W.D. and Govier, F.E., 2006. Drug significantly improves all
symptoms of overactive bladder syndrome. International Journal of Clinical Practice, 60(8), pp.959-
966.
• Maniscalco, M., Singh-Franco, D., Wolowich, W.R. and Torres-Colón, R., 2006. Drug for the
treatment of symptoms of overactive bladder. Clinical therapeutics, 28(9), pp.1247-1272.
• Keane, D.P. and O'Sullivan, S., 2000. Urinary incontinence: anatomy, physiology and
pathophysiology. Best Practice & Research Clinical Obstetrics & Gynaecology, 14(2), pp.207-226.
• Sudha, R.K.V., Kishore, V.S., Babu, C.H. and Jitendranath, E., 2015. Design, Development and
Evaluation of Drug Tablets. Research Journal of Pharmaceutical Dosage Forms and Technology, 7(2),
pp.111-117.
• Handoo, S., Arora, V., Khera, D., Nandi, P.K. and Sahu, S.K., 2012. A comprehensive study on
regulatory requirements for development and filing of generic drugs globally. International journal of
pharmaceutical investigation, 2(3), p.99.
• Kushwaha, N., Jain, A., Jain, P.K., Khare, B. and Jat, Y.S., 2022. An Overview on Formulation and
Evaluation Aspects of Tablets. Asian Journal of Dental and Health Sciences, 2(4), pp.35-39.
30

31. • Lusina, M., Cindrić, T., Tomaić, J., Peko, M., Pozaić, L. and Musulin, N., 2005. Stability study of
losartan/hydrochlorothiazide tablets. International journal of pharmaceutics, 291(1-2), pp.127-137.
• Abdelbary, G., Eouani, C., Prinderre, P., Joachim, J., Reynier, J.P. and Piccerelle, P.H., 2005.
Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation
with oral disintegration. International journal of pharmaceutics, 292(1-2), pp.29-41.
• Patel, S., Kaushal, A.M. and Bansal, A.K., 2006. Compression physics in the formulation development
of tablets. Critical Reviews™ in therapeutic drug carrier systems, 23(1).
• Van Snick, B., Holman, J., Cunningham, C., Kumar, A., Vercruysse, J., De Beer, T., Remon, J.P. and
Vervaet, C., 2017. Continuous direct compression as manufacturing platform for sustained release
tablets. International journal of pharmaceutics, 519(1-2), pp.390-407.
• Rowe, R.C. and Sheskey, P.J., 2009. dan Quinn, ME Handbook of PharmaceuticalExipients. Edisi
keenam.
• Morales-Olivas, F.J. and Estañ, L., 2010. Solifenacin pharmacology. Arch Esp Urol, 63(1), pp.43-52.
• Chu, F.M. and Dmochowski, R., 2006. Pathophysiology of overactive bladder. The American journal
of medicine, 119(3), pp.3-8.
31

32. 32