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Asian Journal of Pharmaceutical Science & Technology
e-ISSN: 2248 – 9185 www.ajpst.com Print ISSN: 2248 – 9177
DEVELOPMENT AND EVALUATION OF FAST DISINTEGRATING
TABLETS OF GRANISETRON HCL WITH NATURAL AND
SYNTHETIC POLYMERS
*B. Sunil Kumar Reddy, Shubhrajit Mantry, S. Anil Kumar, E. Satheesh Kumar
*Department of Pharmaceutics, Kottam Institute of Pharmacy, Erravally-X-roads, Mahaboob Nagar Dist - 509125, A.P, India.
ABSTRACT
Granisetron HCl is a novel serotonin 5-HT3 receptor antagonist used as an antiemetic to treat nausea and vomiting
during cancer chemotherapy but its oral bioavailability is low due to extensive first-pass metabolism in liver which makes it an
ideal candidate for Fast dissolving drug delivery system. The present study aimed to develop fast disintegrating tablets of
Granisetron HCl using natural superdisintegrants like Plantago ovata, Gum Karaya and Agar & synthetic superdisintegrants like
Indion 234, Croscaramellose sodium, Sodium starch glycolate and crospovidone. Precompressional studies revealed good
micromeritic properties of powder blend. Various Formulations of were prepared by direct compression method and were
evaluated for their physico chemical properties, drug release and stability studies. FTIR and DSC show that there is no interaction
with drug and other excipients. The hardness, friability, drug content and disintegration time of fast dissolving tablets were
found uniform and reproducible. Dissolution test shows that 5 % w/w concentration was found optimum. Selected Formulation
F4 were subjected to FTIR and DSC that shows that is compatible and release was found superior to marketed conventional
tablets with respect to disintegration and dissolution and found to be stable. Stability studies shows that there is no much more
differences in their release.
Key words: Fast disintegrating tablets, Granisetron HCl, Superdisintegrants.
INTRODUCTION
Fast dissolving tablets disintegrates instantaneously
when placed on tongue, releasing the drug that dissolves or
disperses in the saliva. Cancer chemotherapy causes lot of
adverse effects, of which nausea and vomiting is prime
once. This can be clearly seen with model anticancer drug
cisplatin, which is first line drug in many types of cancers.
Hence anti-emetic drugs like ondansetron, granisetron are
administered one hour prior to the administration of
anticancer drug. Granisetron HCl is a novel serotonin 5-
HT3 receptor antagonist used as an antiemetic to treat
nausea and vomiting following chemotherapy. Its main
effect is to reduce the activity of the vagus nerve, which is a
nerve that activates the vomiting centre in medulla
oblongata. During chemotherapy - induced vomiting,
mucosal enterochromaffin cells release serotonin, which
stimulates 5-HT3 receptors [1-3]. The present study aimed
to develop fast dissolving tablets by using various of natural
and synthetic super disintegrants to increase the
bioavailability of drug. Identify drug-polymer compatibility
by FTIR and DSC studies. Prepare fast dissolving tablets by
using plain drug with different superdisintegrants by direct
compression method. Evaluate tablets for various physico-
chemical parameters such as hardness, friability, weight
variation, drug content, wetting time, in vitro disintegration
time. Subject the tablets for in vitro dissolution studies and
analyse with different kinetic models. Carryout stability
studies on selected fast dissolving tablets as per ICH
guidelines.
MATERIALS & METHODS
All the materials used in the formulation and
evaluation are listed below. Distilled water was used in the
present study.
The tablets were prepared by taking various
combinations of natural and synthetic polymers of plantago
ovata Gum karya, Agar, Indion 234, Crospovidone,
Croscaramellose sodium, SSG with various proportions
[4,5].
Corresponding Author: B. Sunil Kumar Reddy E-mail: [email protected]
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S.No Material Supplier/ Manufacturer
1 Granisetron HCL Natco Pharma Ltd. Hyderabad
2 Plantago ovata Gift sample, Crystal colloid, Mumbai
3 Gum Karaya Krystal Colloid Ltd. Mumbai
4 Agar Hiedialabtrs Pvt Ltd, Mumbai
5 Crospovidone, Croscaramellose sodium, Sodium starch glycolate Maruti Chemicals, Ahmadabad
6 Iodine 234 Ion exchange ltd, Mumbai
7 Direct Compression mannitol Torrent Pharma Ltd, Ahmadabad
8 Microcrystalline Cellulose, Magnesium Stearate S.D.Fine Chemicals Pvt Ltd, Mumbai
9 Aerosil, Sodium Hydroxide, Potassium Di hydrogen Phosphate S.D.Fine Chemicals Pvt Ltd, Mumbai
Table 1. Composition of Granisetron HCl fast dissolving tablets containing Natural superdisintegrants
Ingredients(mg) Formulation code
F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12
Granisetron HCl 2 2 2 2 2 2 2 2 2 2 2 2
plantago ovata 4 6 8 10 … … … … … … … …
Gum karya … … … … 4 6 8 10 … … … …
Agar … … … … … … … … 4 6 8 10
MCC 136 134 132 130 136 134 132 130 136 134 132 130
SD Mannitol 50 50 50 50 50 50 50 50 50 50 50 50
Talc 2 2 2 2 2 2 2 2 2 2 2 2
Mg Stearate 2 2 2 2 2 2 2 2 2 2 2 2
Aerosil 2 2 2 2 2 2 2 2 2 2 2 2
Na. saccharin 2 2 2 2 2 2 2 2 2 2 2 2
TOTAL 200 200 200 200 200 200 200 200 200 200 200 200
Table 2. Composition of Granisetron HCl fast dissolving tablets containing synthetic superdisintegrants
Fig 1. UV absorbance spectra of Granisetron HCl in phosphate buffer of pH 6.8
Ingredients(mg) Formulation code
F13 F14 F15 F16 F17 F18 F19 F20
Granisetron HCl 2 2 2 2 2 2 2 2
Indion 234 4 6 8 10 … … … …
Crospovidone … … … … 4 6 8 10
Croscaramellose
sodium … … … … … … … …
SSG … … … … … … … …
MCC 136 134 132 130 136 134 132 130
SD Mannitol 50 50 50 50 50 50 50 50
Talc 2 2 2 2 2 2 2 2
Mg Stearate 2 2 2 2 2 2 2 2
Aerosil 2 2 2 2 2 2 2 2
Na. saccharin 2 2 2 2 2 2 2 2
TOTAL 200 200 200 200 200 200 200 200
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Table 3. Composition of Granisetron HCl fast dissolving tablets containing synthetic superdisintegrants
Ingredients(mg) Formulation code
F21 F22 F23 F24 F25 F26 F27 F28
Granisetron HCl 2 2 2 2 2 2 2 2
Crospovidone … … … … … … … …
Indion 234 … … … … … … … …
Croscaramellose Na 4 6 8 10 … … … …
SSG … … … … 4 6 8 10
MCC 136 134 132 130 136 132 128 124
SD Mannitol 50 50 50 50 50 50 50 50
Talc 2 2 2 2 2 2 2 2
Mg Stearate 2 2 2 2 2 2 2 2
Aerosil 2 2 2 2 2 2 2 2
Na. saccharin 2 2 2 2 2 2 2 2
TOTAL 200 200 200 200 200 200 200 200
Fig 2.UV absorbance spectra of Granisetron HCl in buffer of pH 1.2
Fig 3.Calibration curve for the estimation of Granisetron HCl in phosphate buffer of pH 6.8
Fig 4. FTIR spectrum of Granisetron HCl pure drug
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Fig 5. FTIR spectrum of formulation (F4)
Fig 6. DSC thermo gram of Granisetron HCl Pure drug
Fig 7. DSC thermo gram of formulation (F4) containing plantago ovata and Granisetron HCl
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Table 4. Micromeritic properties of Precompressional powder blend
Code Bulk density*
(gm/cm3)
Tapped density*
(gm/cm3)
Angle of repose*(θ) Carr’s Index*
(%)
Hausner’s
Ratio*
F1 0.44±0.15 0.51±0.63 15.08±0.23 13.72±0.18 1.15±0.01
F2 0.47±0.18 0.53± 0.42 14.31±0.17 11.32±0.12 1.12±0.03
F3 0.52±0.15 0.59±0.52 18.04±0.12 11.86±0.16 1.13±0.02
F4 0.55±0.17 0.49±0.35 16.13±0.19 14.28±0.28 1.16±0.01
F5 0.53±0.12 0.59±0.43 13.64±0.15 10.16± 0.31 1.11±0.02
F6 0.41 ± 0.11 0.47± 0.33 19.43±0.17 12.76± 0.25 1.14±0.03
F7 0.47 ± 0.13 0.55 ± 0.36 15.93±0.15 14.54± 0.13 1.17±0.01
F8 0.54 ± 0.12 0.63 ± 0.42 23.12±0.15 14.28± 0.11 1.16±0.03
F9 0.55 ± 0.10 0.62 ± 0.28 17.93±0.15 11.29 ± 0.28 1.12± 0.01
F10 0.53 ± 0.11 0.59±0.55 14.43±0.17 10.16±0.03 1.11 ± 0.02
F11 0.45 ± 0.13 0.52±0.35 24.54±0.18 13.46±0.01 1.15 ± 0.01
F12 0.46 ± 0.12 0.53±0.43 16.13±0.17 13.20±0.04 1.15 ± 0.03
F13 0.53 ± 0.15 0.60±0.28 20.59±0.21 11.66±0.01 1.13 ± 0.04
F14 0.46 ± 0.17 0.53±0.34 22.32±0.15 13.20±0.02 1.15 ± 0.01
F15 0.44±0.15 0.51±0.63 19.08±0.23 13.72±0.18 1.15±0.01
F16 0.47±0.18 0.53± 0.42 17.31±0.17 11.32±0.12 1.12±0.03
F17 0.52±0.15 0.59±0.52 16.04±0.12 11.86±0.16 1.13±0.02
F18 0.55±0.17 0.49±0.35 18.13±0.19 14.28±0.28 1.16±0.01
F19 0.53±0.12 0.59±0.43 23.64±0.15 10.16± 0.31 1.11±0.02
F20 0.41 ± 0.11 0.47± 0.33 14.43±0.17 12.76± 0.25 1.14±0.03
F21 0.47 ± 0.13 0.55 ± 0.36 19.93±0.15 14.54± 0.13 1.17±0.01
F22 0.54 ± 0.12 0.63 ± 0.42 21.12±0.15 14.28± 0.11 1.16±0.03
F23 0.55 ± 0.10 0.62 ± 0.28 15.93±0.15 11.29 ± 0.28 1.12± 0.01
F24 0.53 ± 0.11 0.59±0.55 21.43±0.17 10.16±0.03 1.11 ± 0.02
F25 0.45 ± 0.13 0.52±0.35 18.54±0.18 13.46±0.01 1.15 ± 0.01
F26 0.46 ± 0.12 0.53±0.43 17.13±0.17 13.20±0.04 1.15 ± 0.03
F27 0.53 ± 0.15 0.60±0.28 16.59±0.21 11.66±0.01 1.13 ± 0.04
F28 0.46 ± 0.17 0.53±0.34 22.32±0.15 13.20±0.02 1.15 ± 0.01
Table 5. Physico-chemical Evaluation fast dissolving tablets
Code Thickness (mm) Hardness
test(kg/cm2)
Weight variation
(%) Friability Drug content (%)
F1 4.28 ± 0.03 4.0±0.55 195.58±1.32 0.34±0.03 99.41 ± 0.39
F2 4.35 ± 0.01 3.8±0.35 200.64±1.46 0.36±0.01 99.18 ± 0.55
F3 4.25 ± 0.04 4.1±0.43 196.45±1.28 0.42±0.04 98.85 ± 0.63
F4 4.33 ± 0.06 4.2±0.28 201.68±1.53 0.33±0.01 99.28 ± 0.65
F5 4.32 ± 0.03 4.0±0.34 198.48±1.74 0.41±0.02 98.14 ± 0.73
F6 4.30 ± 0.05 3.9±0.30 200.64±1.43 0.44±0.01 99.24 ± 0.45
F7 4.31 ± 0.01 4.1±0.24 201.55±1.50 0.32±0.03 99.44 ± 0.65
F8 4.28 ± 0.02 4.2±0.28 198.48±1.56 0.49±0.01 99.81 ± 0.53
F9 4.35± 0.01 4.0±0.38 195.51±1.48 0.46±0.02 99.10± 0.46
F10 4.33± 0.03 3.8±0.41 200.66±1.52 0.45±0.04 98.46± 0.78
F11 4.30± 0.01 4.2±0.53 196.45±1.62 0.51±0.01 99.29± 0.83
F12 4.32± 0.03 4.1±0.23 198.68±1.32 0.49±0.02 98.17± 0.54
F13 4.31± 0.01 3.9±0.45 200.51±1.48 0.53±0.03 99.39± 0.68
F14 4.26 ± 0.03 4.0±0.53 201.66±1.53 0.42±0.01 98.58 ± 0.45
F15 4.28± 0.01 4.1±0.63 198.40±1.46 0.53±0.02 99.65± 0.72
F16 4.33± 0.03 4.2±0.42 196.64±1.53 0.38±0.03 99.45± 0.63
F17 4.31± 0.02 4.0±0.52 197.47±1.71 0.35±0.05 99.81± 0.38
F18 4.32± 0.01 3.8±0.35 195.60±1.54 0.49±0.01 99.32± 0.42
F19 4.28 ± 0.03 4.1±0.43 200.41±1.43 0.32±0.03 99.61± 0.53
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Code Thickness (mm) Hardness
test(kg/cm2)
Weight variation
(%) Friability Drug content (%)
F20 4.30 ± 0.01 4.2±0.33 196.56±1.52 0.52±0.05 99.17± 0.45
F21 4.31± 0.02 4.0±0.36 201.42±1.63 0.38±0.01 99.24± 0.43
F22 4.30± 0.03 3.8±0.42 197.70±1.35 0.52±0.03 98.39± 0.54
F23 4.28± 0.01 4.0±0.28 200.61±1.71 0.35±0.01 98.42± 0.63
F24 4.31 ± 0.01 3.8 ± 0.35 200.47±1.53 0.31 ± 0.01 97.75 ± 0.34
F25 4.28 ± 0.03 4.0 ± 0.43 197.64±1.34 0.45 ± 0.03 99.26 ± 0.54
F26 4.26 ± 0.01 4.1 ± 0.56 201.55±1.72 0.51 ± 0.03 97.09 ± 0.72
F27 4.28 ± 0.02 4.2 ± 0.63 199.60±1.65 0.34 ± 0.02 98.23 ± 0.36
F28 4.33 ± 0.03 3.9 ± 0.52 200.58±1.42 0.33 ± 0.05 99.03 ± 0.73
Table 6. Comparison of wetting time, water absorption ratio and disintegration time of tablets
Code Wetting time
(sec) Water absorption ratio
Disintegration time
(sec)
F1 24.23 ± 1.1 68.23.± 1.3 27.58 ± 1.5
F2 20.11 ± 1.2 71.50 ± 1.8 24.18 ± 1.3
F3 17.05 ± 1.6 78.51.± 1.2 22.12 ± 1.1
F4 13.18 ± 1.8 80.48 ± 1.6 17.10 ± 1.2
F5 29.16 ± 1.3 65.00 ± 1.1 32.05 ± 1.4
F6 25.08 ± 1.4 67.33 ± 1.3 29.14 ± 1.1
F7 22.28 ± 1.3 71.45 ± 1.1 27.14 ± 1.2
F8 18.10 ± 1.1 76.56 ± 1.0 22.35 ± 1.8
F9 40.31 ± 1.8 68.32 ± 1.3 43.08 ± 1.2
F10 33.17 ± 1.3 72.16 ± 1.4 37.11 ± 1.1
F11 28.25 ± 1.5 70.36 ± 1.3 33.18 ± 1.8
F12 23.21 ± 1.4 67.23 ± 1.1 27.18 ± 0.9
F13 41.18 ± 1.2 58.28 ± 1.5 45.18 ± 1.3
F14 37.12 ± 1.7 54.52 ± 1.3 41.12 ± 1.4
F15 32.15 ± 1.3 53.28± 1.5 35.15 ± 1.2
F16 27.32± 1.1 56.34± 1.0 31.32± 1.5
F17 49.15 ± 1.4 53.28.± 1.2 53.14 ± 1.6
F18 43.23± 1.5 51.63± 1.2 47.12 ± 1.3
F19 37.18± 1.2 71.48 ± 1.1 42.16 ± 1.2
F20 33.02± 1.1 70.24± 1.6 37.08 ± 1.0
F21 50.17± 1.3 68.56± 1.2 53.17 ± 1.4
F22 46.21± 1.6 70.21± 1.3 50.21 ± 1.5
F23 41.16 ± 1.2 69.44 ± 1.1 44.05 ± 1.1
F24 37.08 ± 1.0 67.33 ±1.5 41.12 ± 1.3
F25 58.17 ± 1.4 68.38 ±1.3 61.16 ± 1.4
F26 51.21 ± 1.5 66.21 ±1.1 55.36 ± 1.2
F27 46.16 ± 1.2 64.09 ±1.9 50.18 ± 1.3
F28 42.03 ± 1.7 80.76 ±1.7 46.08 ± 1.7
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Fig 8. Effect of concentration of superdisintegrants on disintegration time and wetting time of fast disintegrating tablet
Table 7. In vitro release data of Granisetron HCl from the tablets Containing Natural Superdisintegrants
Time
(min) F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12
0 0 0 0 0 0 0 0 0 0 0 0 0
0.5 4.01 9.37 13.39 20.08 2.67 5.35 10.71 14.73 1.33 4.01 6.696 12.05
1 15.34 20.70 26.06 34.09 12.67 16.68 22.04 30.08 9.99 14.01 19.36 24.72
1.5 27.48 32.87 39.59 50.35 22.11 27.49 34.21 43.63 18.08 23.45 31.52 38.25
2 39.68 47.78 57.22 66.70 31.60 39.69 49.13 61.28 27.55 34.30 41.07 51.85
2.5 50.61 60.09 69.59 83.13 39.81 50.62 60.11 76.35 34.39 42.52 49.33 62.84
3 61.60 73.81 87.38 99.66 52.08 61.61 72.49 88.82 42.61 50.78 58.97 71.22
3.5 72.65 86.27 99.91 --- 64.41 74.00 83.60 98.68 49.54 60.43 68.66 79.65
4 83.76 98.79 --- --- 76.82 85.11 97.45 --- 57.84 70.14 79.75 88.11
4.5 98.95 --- --- --- 87.95 96.29 --- --- 66.19 78.55 88.22 97.96
5 --- --- --- --- 97.80 --- --- --- 75.93 87.01 96.73 ---
5.5 --- --- --- --- --- --- --- --- 83.03 98.19 --- ---
6 --- --- --- --- --- --- --- --- 91.51 --- --- ---
6.5 --- --- --- --- --- --- --- --- 98.70 --- --- ---
Table 8. In vitro release data of Granisetron HCl from the tablets containing Synthetic Superdisintegrants
Cumulative release data (%)
Time(Min) F13 F14 F15 F16 F17 F18 F19 F20
0 0 0 0 0 0 0 0 0
0.5 9.37 10.71 12.05 13.39 6.69 8.03 9.37 10.71
1 16.68 20.70 23.38 26.06 12.67 15.34 18.02 20.70
1.5 24.81 27.51 30.20 34.24 19.43 23.46 27.49 31.53
2 31.64 35.69 38.40 42.46 24.89 30.29 34.34 37.06
2.5 37.17 42.58 45.31 48.05 31.72 35.81 41.22 43.95
3 44.06 48.17 52.25 53.66 35.91 41.36 46.80 49.55
3.5 48.32 52.45 56.55 60.65 40.12 45.60 52.41 55.17
4 52.60 56.75 60.87 64.99 45.69 49.86 56.71 59.49
4.5 56.90 61.07 65.22 69.36 49.96 55.49 61.04 63.83
5 61.22 65.42 70.93 75.09 55.58 59.80 65.38 69.53
5.5 65.57 71.13 76.66 80.85 59.90 64.14 71.09 75.26
6 71.27 76.86 82.43 86.64 65.58 71.18 76.83 81.01
6.5 77.01 82.63 88.22 92.46 71.28 75.58 81.25 88.14
7 82.78 88.43 92.71 99.65 75.68 81.33 87.04 93.97
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Time(Min) F13 F14 F15 F16 F17 F18 F19 F20
7.5 87.23 92.91 98.56 --- 81.44 87.12 92.86 98.48
8 91.71 97.42 --- --- 87.23 92.94 98.71 ---
8.5 97.55 --- --- --- 93.05 97.45 --- ---
9 --- --- --- --- 97.55 --- --- ---
9.5 --- --- --- --- --- --- --- ---
10 --- --- --- --- --- --- --- ---
Table 9. In vitro release data of Granisetron HCl from the tablets containing synthetic superdisintegrants
Cumulative release data (%)
Time(Min) F21 F22 F23 F24 F25 F26 F27 F28
0 0 0 0 0 0 0 0 0
0.5 4.017 5.35 6.69 8.03 1.33 2.67 4.017 5.35
1 8.65 11.33 14.01 18.02 7.31 8.65 9.99 12.67
1.5 12.71 16.74 19.44 24.82 12.70 14.05 16.74 19.43
2 19.47 23.53 27.58 32.99 18.13 20.82 24.86 26.23
2.5 26.27 30.35 34.42 38.52 20.90 26.29 30.35 33.07
3 31.77 35.87 39.97 44.09 26.37 30.45 34.53 37.26
3.5 37.30 41.42 45.54 49.68 29.19 34.63 40.08 42.82
4 42.86 47.00 51.14 55.31 33.37 38.83 45.65 48.41
4.5 47.11 52.61 56.77 60.96 38.90 45.74 49.91 54.03
5 52.72 58.25 61.10 65.31 44.47 50.00 55.54 59.68
5.5 58.36 62.58 65.44 69.68 48.72 54.29 59.85 64.01
6 62.69 66.94 69.81 75.40 55.68 59.94 65.53 68.37
6.5 67.04 71.31 75.54 81.16 61.33 66.95 72.58 75.43
7 71.42 75.71 81.30 86.95 67.02 72.67 76.98 79.85
7.5 77.15 81.47 88.43 92.77 72.73 78.41 82.75 86.97
8 82.92 87.26 94.25 99.96 78.48 84.18 89.88 92.79
8.5 88.72 93.08 98.77 --- 82.91 88.65 94.38 97.30
9 93.20 97.58 --- --- 87.37 94.47 98.89 ---
9.5 97.71 --- --- --- 91.85 98.99 --- ---
10 --- --- --- --- 97.69 --- --- ---
Fig 9. In-vitro release profile of fast disintegrating tablet of Granisetron HCl in phosphate buffer6.8pH
Effects of 2 %super disintegrants
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Fig 10. In-vitro release profile of fast disintegrating tablet of Granisetron HCl in phosphate buffer 6.8 pH (Effects of 3
%super disintegrants)
Fig 11. In-vitro release profile of fast disintegrating tablet of Granisetron HCl in phosphate buffer 6.8 pH (Effects of 4
%super disintegrants)
0
20
40
60
80
100
0 1 2 3 4 5 6 7 8 9 10
cum
mu
lati
ve
%re
lease
time(min)
plantago
ovata
gum
karaya
Fig 12. In-vitro release profile of fast disintegrating tablet of Granisetron HCl in phosphate buffer 6.8 pH (Effects of 5
%super disintegrants)
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Table 10. In vitro release of selected fast disintegrating tablets of Granisetron HCl (F4) and marketed product
Fig 13. In vitro release profile of selected fast dissolving tablet (F4) and marketed tablet
Table 11. Stability data of selected tablets (F4) after one month study
Tablet Drug content* (%) Disintegration time* (sec) T50% (min) * T90% (min)*
Before(F4) 99.28± 0.63 17.10 ± 1.2 1.5±0.1 2.7 ± 0.5
After (F4) 99.12± 0.16 16.10 ± 1.4 1.4± 1.4 2.6± 0.4
Fig 14. In vitro release profile of selected tablets after stability study
Formulation F4 Marketed tablet
Time
(min)
Conc. of drug
(mg) Cumulative Data
Conc. of drug
(mg) Cumulative Data
5ml 900 ml
Loss of
drug
(mg)
Release of
drug (mg)
% drug
released
*
5ml 900 ml Loss of
drug (mg)
Release of
drug (mg)
% drug
released*
0 0 0 0 0 0 0 0 0 0 0
0.5 0.0022 0.4017 0 0.4017 20.08 0.002 0.402 0 0.402 20.090
1 0.0037 0.6696 0.0123 0.6819 34.09 0.004 0.696 0.012 0.709 35.439
1.5 0.0055 0.9910 0.0160 1.0071 50.35 0.005 0.937 0.016 0.954 47.686
2 0.0072 1.3125 0.0215 1.3340 66.70 0.006 1.152 0.021 1.173 58.660
2.5 0.0090 1.6339 0.0288 1.6627 83.13 0.008 1.366 0.028 1.394 69.695
3 0.0108 1.9553 0.0379 1.9933 99.66 0.009 1.553 0.035 1.589 79.450
3.5 ------ ------ ------ ------ ------ 0.010 1.767 0.044 1.812 90.595
4 ------ ------ ------ ------ ------ 0.011 1.928 0.054 1.982 99.122
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RESULTS AND DISCUSSION
Weight variation test: It was determined as per B.P.
procedure & Complies with specification.
Friability test: Results complies with B.P. as the % losses
NMT 1.0% at both 100 revolutions.
Thickness: was found to be 4.33mm for F4, indicating that
tablets are suitable packing.
Hardness: it is in the range of 4.2 Kg/cm2 indicating that
the tablets are mechanically strong.
Disintegration test: the disintegration time of F4
formulation was found to be 17.10 sec.
Dissolution Studies: indicates that F4 was superior to other
formulations and shows drug relese of 99.66% in 3 min
time.
Drug- excipient compatibility studies: FTIR studies
indicated that there was no interaction with the excipients.
Stability studies: it was conducted for the F4 formulation at
specified temp for 60 days and found that all the parameters
were within the specification limit.
CONCLUSION From the results obtained, it can be concluded that
formulation F-4 has achieved the objective of drug release
when compared with marketed formulation containing
synthetic superdisintegrants. This shows that natural
superdisintegrants is more suitable than synthetic and
recommended for long term stability testing.
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