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Table: 9 Formulation Of Metoprolol Succinate Sustained Release Granules

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Table: 9 Formulation of Metoprolol Succinate Sustained Release Granules
S. No. Ingredients F-1 mg/tab F-2 mg/tab F-3 mg/tab F-4 mg/tab F-5 mg/tab F-6 mg/tab F-7 mg/tab F-8 mg/tab F-9 mg/tab F-10 mg/tab
1 Metoprolol Succinate 25 25 25 25 25 25 25 25 25 25
2 Microcrystalline cellulose PH 101 144.5 144.5 142.5 132.5 122.5 112.5 102 94 94 94
3 Hydroxypropyl Methyl cellulose (HPMC K100M) 35 30 32 35 37.5 43.8 46 50 50 50
4 Hydroxypropyl Methyl
Cellulose (HPMC K4M) 0 7.5 7 7 7.5 10 10.5 11 11 11
5 Poly vinyl pyrrolidone (K- 30) 15 15 15 15 15 15 15 15 15 15
6 Iso propyl alcohol qs qs qs qs qs qs qs qs qs qs LUBRICATION
7 Hydroxypropyl Methyl cellulose (HPMC K100M) 27.5 25 20.5 27.5 35 35 41.5 44 44 44
8 Hydroxypropyl Methylcellulose (HPMC …show more content…

Hardness (kg/cm2)
NLT 3.0
6.5±0.02
7.0±0.2
6.5±0.3
7.0±0.02
6.5±0.02
5.
Friability (%w/w)
NMT 1%
0.02±0.01
0.18±0.01
0.21±0.01
0.19±0.01
0.21±0.01
6.
Weight variation (n=20)
±5% from the average weight
+2.1to-2.3
+2.3to-2.5
+2.8to-2.7
+3.7to-2.9
+2.1to-2.3
7. Assay

a)Metoprolol succinate

b) Hydrochlorothiazide

90-110%

90-110%
95.2

96.2
95.7

96
96.4

97.1
96.2

98.2
96.4

97.1 * All the values are mean ± SD, n=6
Table: 33 Evaluation of Bilayer Tablets of Metoprolol Succinate SR and Hydrochlorothiazide IR (F-6 to F-10)
S. No. Tests Specification F-6 F-7 F-8 F-9 F-10

1.
Description
Blue/ white colored circular shaped uncoated bilayer tablet
Complies with the internal specification Complies with the internal specification Complies with the internal specification Complies with the internal specification Complies with the internal specification 2.
Average weight (g)
375mg ± 3%
377. 4 mg
374.8mg
376.2mg
375.2
375.2

3.
Thickness (mm)
4.80 ± 0.2
4.78±0.2
4.81
4.78±0.2
4.78±0.2
4.80±0.2

4.
Hardness (kg/cm2)
NLT 3.0
6.9±0.02
6.8
7.0
7.0
6.8

5.
Friability (%w/w)
NMT 1%
0.34±0.01
0.19±0.1
0.22±0.01
0.19±0.01 …show more content…

Weight variation (n=20)
±5% from the average weight
+3.2t0-2.8
+3.5to-3.1
+3.1to-2.1
+3.5to-2.9
+3.1to-2.1

7. Assay
a)Metoprolol succinate

b) Hydrochlorothiazide
90-110%

90-110%
96.6

97.6
97.2

97.4
96.2

97.1
99.4

99.7
99.4

99.7 * All the values are mean ± SD, n=6

Table: 40 Evaluation of Bilayer Tablets of Metoprolol Succinate SR and Hydrochlorothiazide IR after Stability Study at 40°C±2°C/75% ±5%RH

S. No. Tests Specification 1 Month 2 Month
1. Description Blue/ white colored circular shaped uncoated Bilayer tablet F-8(Batch-1)
Complies F-8(Batch-2)
Complies F-8(Batch-1)
Complies F-8(Batch-2)
Complies
2. Average weight (g) 375mg ± 3% 375±3% 375±2% 375±2% 374±2%
3. Thickness (mm) 4.80 ± 0.2 4.80±0.24 4.80±0.26 4.85±2% 4.80±4%
4. Hardness (kg/cm2) NLT 3.0 6.5±0.02 6.5±0.05 6.5±4% 6.5±6%
5. Friability (%w/w) NMT 1% 0.22±0.01 0.25±0.01 0.28±1% 0.31±1%
6. Weight variation (n=20) ±5% from the average weight ±3.8 ±3.1 ±4.1 ±3.9
7. Assay
a)Metoprolol Succinate

b)Hydrochlorothiazide

90-110%

90-110%
93.6

95.6
95.2

94.4
93.2

95.1

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