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Formulation and In-Vitro Characterization of Oseltamivir Fast Dissolving Tablets Using Super Disintegrants
Formulation and In-Vitro Characterization of Oseltamivir Fast Dissolving Tablets Using Super Disintegrants
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ͳǣͲǤͷ Ȁǡ αͲȀ
ȋͳǣͳ ȀȌǤ ǡ ǡ Ͳ
͵Ǥ Ǥ
͓ Ǥ
b. Tapped Density (Dt)
2. Step-2 Preparation of Oseltamivir Fast Dissolving
Tablet
Ǥ
Ǥ
Ǥ ͶͲ
Ǥ αȀǤ
Ǥ ǡǡ
ǡ Ǥ
c. Carr’s Index (%)
ͺǦͳʹ ǯ ͳͲͲ
ͳͷͲ Ǥ
ʹǤ Ǥ ǯ
Ǥ
Evaluation of Fast Dissolving Tablets of Oseltamivir
െ
1. Preformulation Studies ǯ ൌ ൈ ͳͲͲ
2. Compatibility Studies [8-10]
a. FTIR
d. Hausner’s Ratio
Ǧ ǯ
ȋ ʹͳ Ǥ ǯ
ǡ Ȍ Ǥ Ǥ
ǣ
b. DSC
ǯ ൌ
ͳȀͲͲȀʹͻͲ Ͳǡ
Ǥ Ǥ ǡ
e. Angle of Repose (Ɵ)
ͶͲρǡͳͲιȀǡ
ʹͷι͵ͲͲιǤ
Ǥ
c. XRD
Ǥ
Ǧ ȋȌǤ
ǣ
Ǧ αǦͳȋȀȌ
ͲǦͲιʹɅΫͳǤ
ǣ ǡαǤ
ȋȌ Ͷͷ Ǣ ͶͲ Ǣ
ͻȀ ͲǤͲͲͺιȋʹɅȌǤ 4. Evaluation of Tablets [16-17]
a. Weight Variation
3. Evaluation of Blends
ȋǡ Ȍ
ǡ ǡ ǯ ǡ ǯ Ǥ
ǤȏͳͳǦͳͷȐ Ǥ ȏͻȐ
ǣ
a. Bulk Density (Db)
Ǥ Ǥ
ȋȌ
Ǥ ͺͲ άͳͲΨ
Ǥ ͺͲʹͷͲ άǤͷΨ
εʹͷͲ άͷΨ
Ǥ
Figure 1:
90
3349.84
3157.40
80
2875.74
2937.79
1444.59
1330.94
70
%Transmittance
1621.19
2965.95
1463.44
1373.67
60
1204.49
786.70
1660.59
1548.74
603.35
50
1721.98
1242.881260.15
552 19
1166.81 1188.74
654.79
851.66
1025.21
40
1124.91
1290.46
677.12
950.64
873.82
1067.50
30
730.09
967.01
20
4000 3500 3000 2500 2000 1500 1000
Wavenumbers (cm-1)
Figure 2:
Figure 3: Ϊ
90
3349.33
2850.35
3281.46
1722.08
2916.56
80
1375.17
3391.07
1463.03
%Transmittance
1652.02
1125.82
1421.61
1544.54
70
1261.06 1277.53
784.17
952.82
1208.28
730.20
863.76
60
1070.16
970.36
878.12
579.92 629.53
1017.83
50
552 91
664.70
567.36
40
Figure 6:
Figure 8:Ϊ
Figure 10:
Figure 11: Ϊ
Figure 12: Ϊ
Figure 13: ΪΪ
XRD ȋΪȌ
Ǧ ͳǤͲͶ
ǡ ͳǤͻͺͲ ͵Ǥ͵ͺʹ ͵ǤͲʹͳ ͳʹǤ
ʹ ͷǤͳͺͲ
ͳͲǤ ȋ Ϊ Ȍ ʹͻǤͷͶͲǤ ȋ Ϊ
Ͷ Ϊ Ȍ
ͳǤͲͶʹǤͲͷͲ ͳʹǤͲ
ͳͳǤ ʹǤͶͺͳ ͳ͵Ǥ
ʹ ͷǤͳͺͲ ͶͶǤͳͷͲǤ ʹ ͳ͵ǤͳͻͲ
͵ǤͳͺͲǤ Ǧ Ǥ ʹͳΨ
Ͷǡ ͳʹ Ǥ
ͻǤͲͻ ͳͷǤͺǤ
Ǥǡ
ʹ Ǥǡ Ǥ
͵Ǥ
Ǥ
5. Hausner’s Ratio
Precompression Evaluations for the Powder Blend ǯ
ǤͳǤʹͷ
Ǥ Ǥ ǯ ͳʹ
ͳǤͳͲ ͳǤͳͺǤ
Ǥ
Ǥ Ǥ
ǣ ͵Ǥ
1. Angle of Repose ǡ
ǡ
Ǥ ʹͷͲ
Ǥ Ǥ
ʹͳǏǤͺͲǯ ʹͷǏǤͶǯǤ
ǡ ǯ Post Compression Evaluations
Ǥ
͵Ǥ
2. Bulk Density ǯǤ
Ǥ 1. Weight Variation Test
ͲǤʹͻȀ ͵ ͲǤ͵͵ Ȁ ͵Ǥ ͳ ͳʹ
ͳͶǤͷͳͷͲǤͷǤ
Ǥ ά Ǥͷ Ψ
͵Ǥ Ǥ
ͶǤ
3. Tapped Density
2. Hardness
Ǥ ͳ ͳʹ
ͲǤ͵ʹȀ ͵ ͲǤ͵ͺȀ ͵Ǥ ͵ǤͲ͵Ǥ͵Ȁ ʹǤ
ǡ Ǥ
Ǥ ͶǤ
͵Ǥ
3. Friability Test
4. Compressibility Index ͳΨ
ȋȌǤ
ʹͲ
Time ( Sec )
ͳͷ
ͳͲ
Ͳ
ͳ ʹ ͵ Ͷ ͷ ͺ ͻ ͳͲ ͳͳ ͳʹ
Formulation Code
Figure 14:
ͳΨ Ǥ Ǥ
ͶǤ ͶǤ
4. Thickness 7. Disintegration Time
ͳ
ͳʹ ͵Ǥ ǡ
Ǥ Ǥ
ͶǤ Ǥ
ͳǡ ʹǡ ͵ǡ Ͷǡ ͷǡ
5. Drug Content ǡ ǡ ͺǡ ͻǡ ͳͲǡ ͳͳ ͳʹ͵ͺǡʹͻǡʹʹǡ
ͳʹǡ Ͷͷǡ ͵ͳǡ ʹ͵ǡ ͳͶǡ ͵ǡ ʹͳǡ ͳǡ ͳʹ Ǥ
Ǥ ͻǤͲͲΨ
ͻͻǤͺΨͷǤ
ǡ
Ǥ
ǤͶǤ ͶǤ
6. Wetting Time 8. Dissolution Study
in-vitro
Ǥͺ ͵Ͳ Ǧͳͳ
ǡ Ǥ In-vitro
Ǥ ǡ ͳǡ ʹǡ ͵ Ͷ
ͺͶǤ͵ͺΨǡ ͻ͵ǤͻʹΨǡ ͻͺǤͷΨ ͻͻǤͺʹΨ
ǡ ͵Ͳ Ǥ Ͷ
Ǥ ͳͷΨ
ͳǡ ʹǡ ͵ǡ Ͷǡ ͷǡ ǡ ǡ ͺǡ ͻǡ ͳͲǡ ͳͳ Ǥ ͻͻǤͺʹ
ͳʹͳͺǡͳͻǡͳͶǡͳͲǡͳͷǡͳͶǡͳͲǡͺǡʹͲǡͳͷǡ Ǥ
ͳͳǡͳͲ Ǥ ͳͷǤ
Table 6: In-Vitro Dissolution Data of Formulations F5, F6, F7 and F8 (Xanthan Gum)
ͺͲ
Ͳ
ͶͲ
ʹͲ
Ͳ
Ͳ ͷ ͳͲ ͳͷ ʹͲ ʹͷ ͵Ͳ ͵ͷ
Time (min)
ͳ ʹ ͵ Ͷ
Figure 15: In-vitro ͳǡ ʹǡ ͵ Ͷȋ Ȍ
ͺͲ
Ͳ
ͶͲ
ʹͲ
Ͳ
Ͳ ͷ ͳͲ ͳͷ ʹͲ ʹͷ ͵Ͳ ͵ͷ
Time (min)
ͷ ͺ
in-vitro ͵Ͳ Ǥ
Ǥͺ ͵Ͳ Ǧͳͳ ͳʹΨ
Ǥ In-vitro Ǥ ͻͺǤʹ
ǡ ͷǡ ǡ ͺ Ǥ
ͺ͵ǤͻͺΨǡ ͺͺǤͳΨǡ ͻͺǤͳΨ ͻǤͶΨ ͳǤ
Table 7: In-Vitro Dissolution Data of Formulations F9, F10, F11 and F12 (Crospvidone + Xanthan Gum)
ͳͲͲ
% Drug Release
ͺͲ
Ͳ
ͶͲ
ʹͲ
Ͳ
Ͳ ͷ ͳͲ ͳͷ ʹͲ ʹͷ ͵Ͳ ͵ͷ
Time (min)
ͻ ͳͲ ͳͳ ͳʹ
Figure 17:In-vitro ͻǡ ͳͲǡ ͳͳ ͳʹ
Figure 18: In-vitro ͳ ͳʹ
in-vitro ͵Ͳ Ǥ ͳʹ
Ǥͺ ͵Ͳ Ǧͳͳ ͳͷΨ Ϊ
Ǥ In-vitro Ǥ ͻͻǤͺͶ
ǡ ͻǡ ͳͲǡ ͳͳ ͳʹ ʹͷ
ͺͺǤͳΨǡ ͺͻǤ͵ͲΨǡ ͻͷǤ͵ͺΨ ͻͻǤͺͶΨ Ǥ ͳǤ
Ǥ ǡ Ǥ
ǡ ǣǤ ǡͳȋͳȌǣͳͳǦ
Ǥ ͳ͵ͻǡʹͲͳͳǤ
Ǥ ǡ Ǥ
ǣ Ǥ
ǡͷȋʹȌǣͺǦʹǡʹͲͳͷǤ
ͺǤ ǡǤ Ǧ
Ǥ Ǥ
ǡͶͻȋͶȌǣͺͶǦͻͳǡʹͲͳ͵Ǥ
Ǥ ͻǤ ǡ ǡ ǡ ǡ
͵ͲǤ ǡǤ
Ǥ
ͺͶǤ͵ͺͻͻǤͺͶ ǡ͵ȋ͵Ȍǣͳ͵ͳͶȂͳ͵ʹͳǡʹͲͳͳǤ
ͳͲǤ ǡǡǡǡǤ
ͺͲ Ψ ͵Ͳ
Ǥ
Ǥ ǡ
ǡ ͵ȋͳȌǣʹͺͳȂʹͺͷǡʹͲͳͳǤ
ΪǤǤ ͳͳǤ ǡ ǡ ǡ Ǥ
ͳʹ ǡ Ǥ ǡ
ͳʹ ͳͷΨ Ϊ ʹȋʹȌǣͳͷͶȂͳͷǡʹͲͳͲǤ
ͳʹǤ ǡ ǡ Ǥ
ͳʹ ǡ ͳͲ Ǥ
ͻͻǤͺͶʹͷ ǡ ͳȋ͵ȌǣͶͺ͵ȂͶͺǡ
ʹͲͲͻǤ
ǤͺǤ ͳ͵Ǥ ǡ Ǥ
CONCLUSION Ǥ
ǡ ǡʹȋͶȌǣͻͳ͵ȂͻʹͳǡʹͲͳͳǤ
ͳͶǤ Ǥ Ǧ Ǥ
ǤǤ ǡ ǡͳȋͳȌǣͳǦǡʹͲͳʹǤ
Ϊ ȋǡ ͳͷǤ Ǥ
ͻǡ ͳʹ ͳͷΨȌ Ǥ Ǥ ǡ
ͳȋͳͲȌǣ͵ͳͳǦ͵ͳǡʹͲͳʹǤ
ͳͷΨ Ϊ
ͳǤ ǡ Ǥ
ȋȌ Ǥ ǡ
ȋȌǣͳͲͶǦͳͳʹǡʹͲͳǤ
Ǥ ͳǤ ǡǡǢ
ͻͻǤͺͶʹͷ
Ǥ ǡ Ͷʹȋ͵ȌǣͶͻǦͷͶǡ
ʹͲͳ͵Ǥ
REFERENCES
ͳǤ ǡ ǡǤ ǣ Acknowledgment
Ǥ Ǥ
ǡ͵ȋ͵Ȍǣ͵Ǧ͵ͺͲǡʹͲͳʹǤ
ʹǤ ǡ ǡ Ǥ ǣ Ǥ Ǥ
Ǥ ǡ ǡ
ǡͻȋʹȌǣͺǦͳͺǡʹͲͳǤ ǡǤ
͵Ǥ ǡ ǡ Ǥ ǣ
ǡ ǣǤ
ǡͶȋʹȌǣͺǦͻǡʹͲͳͲǤ Cite this article as:ǡǡ
et alǤ In-Vitro
ͶǤ Ǥ ǣ
Ǥ ǡ ʹȋͳȌǣͷǦ Ǥ ǣ ǡ
ͳͲǡʹͲͳͲǤ ʹͲʹͲȋ͵ȌǣͳǦͳͳǡʹͲʹͲǤ
ͷǤ ǡ ǡ ǡ Ǥ
Ǥ
ǡȋͳȌǣʹ͵Ǧ͵ͲǡʹͲͳǤ