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DESIGNING ROSUVASTATIN ORODISPERSIBLE
TABLET WITH MODIFIED STARCH-5-PHOSPHATE
SOLID DISPERSION TARGETING IMPROVEMENT
OF SOLUBILITY AND BIOEQUIVALENCE
MODULATION
UNDER GUIDANCE OF
PROF. DR. TAPAS KUMAR PAL
DEBADITYA SAHA M.PHARM (PHARMACEUTICS)
ROLL NO: 27720313003; REGD NO: 132772310015 of 2013-2014
NSHM COLLEGE OF PHARMACEUTICAL TECHNOLOGY
Objective of the Study
The work plan has been proposed as per following steps
• Comparison of Rosuvastatin commercial branded and generic
tablets of their bio-equivalence and interchangeability by
comparative dissolution profile.
• Formulation Development of Orodispersible sublingual
immediate release tablet utilizing solid dispersion with modified
starch phosphate.
• Comparison of in vitro cumulative release, dissolution
efficiency of formulated sublingual immediate release tablets of
Rosuvastatin with commercial brands & generics
• Comparative in-vivo evaluation of cholesterol reducing activity
of formulated sublingual immediate release tablets with
reference to marketed tablets.
ROSUVASTATIN CALCIUM
• Anti-hyperlipidemic, HMG-CoA reductase inhibitor.
• belongs to BCS class II.
• reduces low density lipoprotein (LDL) cholesterol and triglycerides.
• increases high density lipoprotein (HDL) in patients with hypercholesterolemia and
dyslipidemia.
• Chemical IUPAC name: bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-
[methyl(methyl sulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydrohexyhept-6-
enoic acid]calcium salt.
• Empirical formula: (C22H27FN3O6S)2Ca
• Molecular weight: 1001.14
• Appearance: White amorphous powder.
• Melting point: 122C.
• Solubility: Sparingly soluble in water and methanol,
and slightly soluble in ethanol.
Pharmacokinetic properties of Rosuvastatin Calcium
• Absorption: In clinical pharmacology studies in man, peak plasma
concentrations of rosuvastatin were reached 3-5 hours following oral dosing.
The absolute bioavailability of rosuvastatin is approximately 20%.
• Distribution: Mean volume of distribution at steady-state of rosuvastatin is
approximately 134 liters.
Rosuvastatin is 88% bound to plasma proteins, mostly albumin.
• Metabolism: Rosuvastatin is not extensively metabolized; approximately 10%
of a radio labeled dose is recovered as metabolite. The major metabolite is N-
desmethyl rosuvastatin.
• Excretion: Following oral administration, rosuvastatin and its metabolites are
primarily excreted in the feces (90%) of which 28% was via the renal route and
72% via the hepatic route.
The elimination half-life (t1/2) of rosuvastatin is approximately 19 hours.
What is Solid Dispersion
Involves a dispersion of one or more active ingredients in an inert carrier
or matrix in solid state prepared by:
 Fusion (melt)
 Solvent evaporation
 Spray drying
 Lyophilization
 Hot melt extrusion
 Electrostatic spinning method
 Supercritical fluid technology
 Coating on sugar beads using fluidized bed-coating system.
Used to improve
o solubility
o dissolution rates
o Bioavailability of poorly water soluble drug.
Starch 5-Phosphate
Starch phosphate is one of the modified starches that have been evaluated
as effective disintegrant as well as solid dispersions to increase solubility
and to optimize bioavailability.
 Preparation: by reacting starch IP (100g) with di-sodium hydrogen
orthophosphate anhydrous (30g) at elevated temperatures (130°C for 3
hrs).
 Appearance: white, crystalline, non-hygroscopic powder.
 Solubility: insoluble in water and aqueous fluids of acidic and alkaline
pHs.
 Swelling property: 400 times more swelling in water.
Property Result
Solubility Insoluble in all aqueous and organic solvents tested
pH (1% w/v aqueous dispersion) 7.27
Melting point Charred at 210C
Viscosity (1% w/v aqueous dispersion) 2.15cps
Swelling index 400
Gelling property No gelling and swollen particles of Starch-5-
phosphate separated from water.
Density 1.567 gm/cc
Bulk density 0.534 gm/cc
Angle of Repose 23.05
Compressibility Index 15%
Physical properties of Starch-5-phosphate prepared
Concentration Absorbance
5 0.097
10 0.174
15 0.266
20 0.354
25 0.436
30 0.513
y = 0.0174x
R² = 0.9981
0
0.2
0.4
0.6
0 5 10 15 20 25 30 35
Absorbance
Absorbance
concentration
Standard Curve of Rosuvastatin Calcium in Methanol
Standard Curve of Rosuvastatin Calcium in pH 6.8 Phosphate Buffer
Concentration Absorbance
5 0.169
10 0.295
15 0.446
20 0.62
25 0.766
30 0.908
y = 0.0305x
R² = 0.9983
0
0.5
1
0 5 10 15 20 25 30 35
Absorbance
Absorbance
concentration
Ingredients (mg) F1cc1 F1cc2 F4cc1 F4cc2 F5cc1 F5cc2
Drug 1000 1000 1000 1000 1000 1000
PEG - - 2000 2000 1000 1000
Starch-5-phosphate 5050 5550 5000 5000 9000 9000
Mannitol 11000 11000 9050 9550 6050 6550
Aspartame 500 500 500 500 500 500
Sodium saccharin 300 300 300 300 300 300
Talc 300 300 300 300 300 300
Magnesium stearate 300 300 300 300 300 300
Vanilline 50 50 50 50 50 50
Cross-carmellose 1500 1000 1500 1000 1500 1000
Total weight 20000 20000 20000 20000 20000 20000
Composition of different formulations by Direct Compression
Comparative dissolution study of branded generic Rosuvastatin
Calcium Tablets
TIME
(MIN)
% CDR from different brands
ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
5 20.40 19.20 19.80 18.60 25.20
10 27.00 25.80 30.60 26.40 33.60
15 31.80 31.20 48.60 30.60 42.00
20 45.00 39.00 55.80 37.20 57.00
25 57.60 47.40 63.60 48.60 68.40
30 77.40 68.40 76.80 66.60 79.80
45 92.40 78.00 90.60 80.40 87.00
60 97.80 89.40 96.60 94.80 94.80
No of Time Points where %CDR 70% as per IP
Comparative dissolution study of Formulated Rosuvastatin Calcium
Tablets
TIME
(MIN)
% CDR from different formulations
F1cc F1cc1 F1cc2 F4cc F4cc1 F4cc2 F5cc F5cc1 F5cc2
0 0 0 0 0 0 0 0 0 0
5 94.64 76.11 88.79 96.33 85.80 93.15 106.62 90.67 95.10
10 95.40 96.86 96.83 97.76 99.04 99.19 109.23 99.68 99.26
15 95.40 100.40 98.06 97.76 102.67 102.95 113.41 100.95 101.36
20 100.77 102.03 96.80 99.20 104.52 104.43 113.94 102.24 102.22
25 100.77 102.54 100.69 100.16 105.27 105.48 115.51 103.13 102.98
30 100.38 105.15 102.08 100.16 107.13 106.25 119.69 104.93 103.62
45 101.53 107.08 102.92 101.12 107.52 107.64 119.69 106.10 105.56
60 102.30 109.01 105.45 104.95 108.28 108.01 120.73 107.63 106.82
% Dissolution Efficiency of Marketed brands
DEtmax= AUC/(Ymax*tmax)
%DEmax ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
DE5 23.70 22.50 25.20 22.50 29.40
DE15 30.50 28.70 39.00 28.30 38.90
DE30 77.50 67.80 83.00 67.65 83.95
DE45 83.37 73.10 86.53 74.20 86.27
% Dissolution Efficiency of F1 formulated product
DEtmax= AUC/(Ymax*tmax)
%DEmax F1cc F1cc1 F1cc2
DE5 95.02 86.48 92.81
DE15 111.94 108.13 110.69
% Dissolution Efficiency of F4 formulated product
DEtmax= AUC/(Ymax*tmax)
%DEmax F4cc F4cc1 F4cc2
DE5 97.04 92.42 96.17
DE15 113.82 113.26 115.84
% Dissolution Efficiency of F5 formulated product
DEtmax= AUC/(Ymax*tmax)
%DEmax F5cc F5cc1 F5cc2
DE5 107.93 95.18 97.18
DE15 128.75 114.11 115.61
Comparative % Dissolution Efficiency study of Marketed and
Formulated Rosuvastatin Calcium Tablets
Quality control parameters for tablets
PARAMETERS ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
Weight variation (mg) 76.7 155.46 80.5 76.5 75.3
Thickness (mm) 5.62 7.04 5.50 5.53 5.60
Hardness (kg/cm2) 6.2 5.5 6.0 6.5 5.0
Disintegration time 1hr 10min 1hr 12min 1hr 10min 1hr 10min 1 hr
Price Rs 65 Rs 42.35 Rs 72 Rs 82.40 Rs.66.10
Formulation Average weight
(mg)
Hardness
(kg/cm2)
Disintegration time
(min)
Drug content (mg)
F1cc1 101±0.81 3.0±0.11 2.40 5.97
F1cc2 100±0.75 3.0±0.13 2.51 5.82
F4cc1 101±1.17 3.0±0.11 3.00 5.48
F4cc2 102±1.24 3.0±0.11 3.20 5.66
F5cc1 103±1.17 3.5±0.14 4.30 5.91
F5cc2 102±2.16 4.0±0.17 3.40 6.01
Zero Order Release
y = 0.0783x + 0.7526
R² = 0.9231
y = 0.0682x + 0.7006
R² = 0.9462
y = 0.0702x + 1.1712
R² = 0.9064
y = 0.0728x + 0.606
R² = 0.9655
y = 0.0656x + 1.3257
R² = 0.8875
0.00
1.00
2.00
3.00
4.00
5.00
6.00
0 20 40 60 80
ROZUCOR ROZUMAC ROSUVAS
ZYROVA CRESTOR
Qt
Time
y = 0.0112x + 7.449
R² = 0.6987
y = 0.0153x + 5.2219
R² = 0.3659
y = 0.0095x + 5.1966
R² = 0.4469
y = 0.0656x + 1.3257
R² = 0.8875
y = 0.0702x + 1.1712
R² = 0.9064
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
0 20 40 60 80
F1cc F1cc1 F1cc2 CRESTOR ROSUVAS
Time
Qt
y = 0.0087x + 6.0108
R² = 0.9454
y = 0.0086x + 5.2339
R² = 0.2583
y = 0.0048x + 5.426
R² = 0.22
y = 0.0656x + 1.3257
R² = 0.8875
y = 0.0702x + 1.1712
R² = 0.9064
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
0 10 20 30 40 50 60 70
F4cc F4cc1 F4cc2 CRESTOR ROSUVAS
Time
Qt
y = 0.0103x + 6.2762
R² = 0.5885
y = 0.0062x + 5.2523
R² = 0.1758
y = 0.0028x + 5.4508
R² = 0.0628
y = 0.0656x + 1.3257
R² = 0.8875
y = 0.0702x + 1.1712
R² = 0.9064
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
0 20 40 60 80
F5cc F5cc1 F5cc2 CRESTOR ROSUVAS
Time
Qt
First Order Release
y = -0.0298x + 0.9232
R² = 0.9629
y = -0.0165x + 0.757
R² = 0.9683
y = -0.0254x + 0.8065
R² = 0.9876
y = -0.0207x + 0.8296
R² = 0.9462
y = -0.0215x + 0.7302
R² = 0.9855
-1.20
-1.00
-0.80
-0.60
-0.40
-0.20
0.00
0.20
0.40
0.60
0.80
1.00
0 20 40 60 80
ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
Time (min)
Logamt.ofdrugremaining
y = -0.0264x - 0.0548
R² = 0.9083
y = -0.0173x - 0.2251
R² = 0.5967
y = -0.0097x - 0.2332
R² = 0.6278
y = -0.0215x + 0.7302
R² = 0.9855
y = -0.0254x + 0.8065
R² = 0.9876
-2.00
-1.50
-1.00
-0.50
0.00
0.50
1.00
0 20 40 60 80
F1cc F1cc1 F1cc2 CRESTOR ROSUVAS
Logamt.ofdrugremaining
Time
y = -0.0219x - 0.0215
R² = 0.7717
y = -0.008x - 0.4944
R² = 0.1459
y = -0.0204x - 0.3808
R² = 0.8321
y = -0.0215x + 0.7302
R² = 0.9855
y = -0.0254x + 0.8065
R² = 0.9876
-2.00
-1.50
-1.00
-0.50
0.00
0.50
1.00
0 10 20 30 40 50 60 70
F4cc F4cc1 F4cc2 CRESTOR ROSUVAS
Logamt.ofdrugremaining
Time
y = -0.0136x - 0.1698
R² = 0.8977
y = -0.0044x - 0.2433
R² = 0.1316
y = -0.0015x - 0.3043
R² = 0.0263
y = -0.0215x + 0.7302
R² = 0.9855
y = -0.0254x + 0.8065
R² = 0.9876
-1.20
-1.00
-0.80
-0.60
-0.40
-0.20
0.00
0.20
0.40
0.60
0.80
0 20 40 60 80
F5cc F5cc1 F5cc2 CRESTOR ROSUVAS
Time
Logamt.ofdrugremaining
Higuchi Model
y = 0.6059x
R² = 0.9174
y = 0.535x
R² = 0.9297
y = 0.6365x
R² = 0.9702
y = 0.5445x
R² = 0.9202
y = 0.6374x
R² = 0.9686
0
1
2
3
4
5
6
0 2 4 6 8 10
ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
√t
Qt
y = 1.437x
R² = 0.1114
y = 1.0506x
R² = 0.2831
y = 1.0211x
R² = 0.1559
y = 0.6374x
R² = 0.9686
y = 0.6365x
R² = 0.9702
0.00
2.00
4.00
6.00
8.00
10.00
12.00
0 2 4 6 8 10
F1cc F1cc1 F1cc2 CRESTOR ROSUVAS
√t
Qt
y = 1.1588x
R² = 0.1472
y = 1.0178x
R² = 0.2024
y = 1.0292x
R² = 0.1191
y = 0.6374x
R² = 0.9686
y = 0.6365x
R² = 0.9702
0
1
2
3
4
5
6
7
8
9
10
0 2 4 6 8 10
F4cc F4cc1 F4cc2 CRESTOR ROSUVAS
√t
Qt
y = 1.2186x
R² = 0.1821
y = 1.0069x
R² = 0.1614
y = 1.0223x
R² = 0.0907
y = 0.6374x
R² = 0.9686
y = 0.6365x
R² = 0.9702
0
1
2
3
4
5
6
7
8
9
10
0 2 4 6 8 10
F5cc F5cc1 F5cc2 CRESTOR ROSUVAS
√t
Qt
Korsmeyer-Peppas Model
y = 0.7123x - 1.2457
R² = 0.9514
y = 0.6706x - 1.2368
R² = 0.96
y = 0.6696x - 1.1465
R² = 0.9744
y = 0.6947x - 1.2682
R² = 0.9625
y = 0.5853x - 1.0218
R² = 0.9655-0.90
-0.80
-0.70
-0.60
-0.50
-0.40
-0.30
-0.20
-0.10
0.00
0.10
0.000 0.500 1.000 1.500 2.000
ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
log t
log(Mt/M∞)
y = 0.0238x - 0.0356
R² = 0.3998
y = 0.0861x - 0.1417
R² = 0.6048
y = 0.0465x - 0.0865
R² = 0.4329
y = 0.5853x - 1.0218
R² = 0.9655
y = 0.6696x - 1.1465
R² = 0.9744
-0.80
-0.70
-0.60
-0.50
-0.40
-0.30
-0.20
-0.10
0.00
0.10
0.000 0.500 1.000 1.500 2.000
F1cc F1cc1 F1cc2 CRESTOR ROSUVAS
log t
log(Mt/M∞)
y = 0.0302x - 0.0411
R² = 0.8576
y = 0.0581x - 0.0783
R² = 0.5996
y = 0.0318x - 0.0503
R² = 0.5462
y = 0.5853x - 1.0218
R² = 0.9655
y = 0.6696x - 1.1465
R² = 0.9744
-0.80
-0.70
-0.60
-0.50
-0.40
-0.30
-0.20
-0.10
0.00
0.10
0.000 0.500 1.000 1.500 2.000
F4cc F4cc1 F4cc2 CRESTOR ROSUVAS
log t
log(Mt/M∞)
y = 0.0436x - 0.0002
R² = 0.8376
y = 0.0462x - 0.0989
R² = 0.5081
y = 0.0268x - 0.0721
R² = 0.329
y = 0.5853x - 1.0218
R² = 0.9655
y = 0.6696x - 1.1465
R² = 0.9744-0.80
-0.70
-0.60
-0.50
-0.40
-0.30
-0.20
-0.10
0.00
0.10
0.20
0.000 0.500 1.000 1.500 2.000
F5cc F5cc1 F5cc2 CRESTOR ROSUVAS
log t
log(Mt/M∞)
Dissolution
Model
Parameters ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR
Zero order
k0 0.078 0.068 0.07 0.072 0.065
R2 0.923 0.946 0.906 0.965 0.887
First order
k1 -0.029 -0.016 -0.025 -0.02 -0.021
R2 0.962 0.968 0.987 0.946 0.985
Higuchi model
k2 0.605 0.535 0.636 0.544 0.637
R2 0.917 0.929 0.97 0.92 0.968
Hixon - Crowel
Model
k3 0.02 0.015 0.02 0.016 0.019
R2 0.974 0.978 0.992 0.976 0.965
Koresmeyer -
Peppas Model
k4 1.245 1.236 1.146 1.268 1.021
R2 0.951 0.96 0.974 0.962 0.965
n 0.712 0.67 0.669 0.694 0.585
Dissolution
Model
Parameters F1cc F1cc1 F1cc2 F4cc F4cc1 F4cc2 F5cc F5cc1 F5cc2
zero order
k0 0.011 0.015 0.009 0.008 0.008 0.004 0.01 0.006 0.002
R2 0.698 0.365 0.446 0.945 0.258 0.22 0.588 0.175 0.062
first order
k1 -0.026 -0.017 -0.009 -0.021 -0.008 -0.020 -0.013 -0.004 -0.001
R2 0.908 0.596 0.627 0.771 0.145 0.832 0.897 0.131 0.026
Higuchi
model
k2 1.437 1.05 1.021 1.158 1.017 1.029 1.218 1.006 1.022
R2 0.111 0.283 0.155 0.147 0.202 0.119 0.182 0.161 0.09
Hixon -
Crowel
Model
k3 0.053 0.031 0.03 0.051 0.055 0.039 0.071 0.025 0.025
R2 0.323 -0.35 -0.85 0.393 -0.16 -0.85 -1.46 -1.1 -1.41
Koresmeyer
-Peppas
Model
k4 0.035 0.141 0.086 0.041 0.078 0.05 0 0.098 0.072
R2 0.399 0.604 0.432 0.857 0.599 0.546 0.837 0.508 0.329
n 0.023 0.086 0.046 0.03 0.058 0.031 0.043 0.046 0.026
FT-IR Study
TREATMENT GROUP TOTAL CHOLESTEROL (mg/dl)
24 HRS 48 HRS
NORMAL CONTROL 150.34±0.25 151.43±0.25
POSITIVE CONTROL 198.83±0.65 209.57±1.17
F4 FORMULATION 144.95±0.35 78.14±0.10
CRESTOR 146.05±0.10 111.25±0.92
0.00
50.00
100.00
150.00
200.00
250.00
normal control positive control F4 crestor
24hrs 48hrs
Group
TotalCholesterol
(mg/dl)
Comparative effect of F4 formulation and Crestor in Total Cholesterol levels
Histopathology studies of liver
Normal control
Triton induced positive
control
F4 (5mg/kg) + Triton
(200mg/kg) treated group
Crestor (5mg/kg) + Triton
(200mg/kg) treated group
Normal control liver sections illustrates
portal vein surrounded by cords of
hepatocytes extended radialy from central
portal vein and branches of hepatic artery
around the lobular periphery .Among the
nonparanchymal cells, the following
types have been identified bile duct,
endothelial, kupffer cells, kupffer cells
are located preferentially in the per portal
region figure. There were flat endothelial
cells around the central vein and
sinusoids with normal architecture of
their liver sections.
In treated rats with mild changes these
changes includes, moderate congestion,
necrosis, hepatocytes degeneration with
enlargement of some hepatocytes
(ballooning shape), and some of which
have two nuclei and some of hepatocytes
undergo hepatocytomegally with
pyknotic nuclei.
Histopathology studies of heart
Normal control Triton induced positive
control
F4 (5mg/kg) + Triton
(200mg/kg) treated group
Crestor (5mg/kg) + Triton
(200mg/kg) treated group
Light microscopy of the cardiac tissue
sections of normal control group
showing normal myofibrillar structure
with striations, branched appearance
and continuity with adjacent myofibrils.
Light microscopy of the cardiac tissue
sections of positive control group
showing loss of normal architecture of
cardiac muscle fibers, loss of cross
striations and fragmentation of
sarcoplasm, infiltration of mononuclear
cells in between the muscle fibers and
connective tissue proliferation in the area
of necrosis.
Light microscopy of the cardiac tissue
sections of F4 formulation (5mg/kg)
treated group showing almost normal
appearance of cardiac muscle fibers. It
shows the area of congestion &
hemorrhage with fragmentation and loss
of cross striation of muscle fibers in
occasional areas.
Starch-5-phosphate prepared by reacting starch IP with di-sodium hydrogen
orthophosphate anhydrous at elevated temperatures was insoluble in water and has good
swelling (400%) property without pasting or gelling when heated in water. Rosuvastatin
Calcium tablets formulated employing starch-5-phosphate disintegrated within 3mins.
Dissolution followed first order kinetics and increase in the dissolution rate of
Rosuvastatin calcium was observed with solid dispersions prepared at 1:2:5 and 1:1:9
ratios of drug: PEG 6000: starch-5-phosphate. The dissolution was also increased when
the drug: carrier ratio was increased.
FTIR study showed there was no interaction between Rosuvastatin calcium and
excipients .
Thus starch-5-phosphate, a new modified starch was found to be a promising disintegrant
in tablet formulations and can be used in the concentration of 5-10% as an effective
disintegrant.
Based on the study it may be concluded that rosuvastatin calcium tablets (F1, F4, F5)
prepared with 20% cross-carmellose sodium as superdisintegrant showed rapid drug
release when compared to marketed tablet formulations.
CONCLUSION
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• K.P.R. CHOWDARY AND VEERAIAH ENTURI “Preparation, characterization and
evaluation of starch phosphate: A new modified starch as directly compressible vehicle in
tablet formulations”, Journal of Pharmacy Research; 2011; 4(9); 3241-3243.
• I. JUBRIL, J. MUAZU AND G. T. “Mohammed Effects of Phosphate Modified and
Pregelatinized Sweet Potato Starches on Disintegrant Property of Paracetamol Tablet
Formulations”, Journal of Applied Pharmaceutical Sciences; 2012; 2(2); 32-36.
• SANJOY KUMAR DAS, SUDIPTA ROY, YUVARAJA KALIMUTHU, JASMINA
KHANAM, ARUNABHA NANDA “Solid Dispersions: An Approach to Enhance the
Bioavailability of Poorly Water-Soluble Drugs”, International Journal of Pharmacology
and Pharmaceutical Technology (IJPPT); volume 1; issue 1; 2277-3436.
• MOGAL S. A, GURJAR P. N, YAMGAR D. S AND KAMOD A.C. “Solid dispersion
technique for improving solubility of some poorly soluble drugs”, Scholar Research
Library, Der Pharmacia Lettre; 2012; 4(5); 1574-1586.
Rosuvastatin orodispersible tablet

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Rosuvastatin orodispersible tablet

  • 1. DESIGNING ROSUVASTATIN ORODISPERSIBLE TABLET WITH MODIFIED STARCH-5-PHOSPHATE SOLID DISPERSION TARGETING IMPROVEMENT OF SOLUBILITY AND BIOEQUIVALENCE MODULATION UNDER GUIDANCE OF PROF. DR. TAPAS KUMAR PAL DEBADITYA SAHA M.PHARM (PHARMACEUTICS) ROLL NO: 27720313003; REGD NO: 132772310015 of 2013-2014 NSHM COLLEGE OF PHARMACEUTICAL TECHNOLOGY
  • 2. Objective of the Study The work plan has been proposed as per following steps • Comparison of Rosuvastatin commercial branded and generic tablets of their bio-equivalence and interchangeability by comparative dissolution profile. • Formulation Development of Orodispersible sublingual immediate release tablet utilizing solid dispersion with modified starch phosphate. • Comparison of in vitro cumulative release, dissolution efficiency of formulated sublingual immediate release tablets of Rosuvastatin with commercial brands & generics • Comparative in-vivo evaluation of cholesterol reducing activity of formulated sublingual immediate release tablets with reference to marketed tablets.
  • 3. ROSUVASTATIN CALCIUM • Anti-hyperlipidemic, HMG-CoA reductase inhibitor. • belongs to BCS class II. • reduces low density lipoprotein (LDL) cholesterol and triglycerides. • increases high density lipoprotein (HDL) in patients with hypercholesterolemia and dyslipidemia. • Chemical IUPAC name: bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methyl sulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydrohexyhept-6- enoic acid]calcium salt. • Empirical formula: (C22H27FN3O6S)2Ca • Molecular weight: 1001.14 • Appearance: White amorphous powder. • Melting point: 122C. • Solubility: Sparingly soluble in water and methanol, and slightly soluble in ethanol.
  • 4. Pharmacokinetic properties of Rosuvastatin Calcium • Absorption: In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3-5 hours following oral dosing. The absolute bioavailability of rosuvastatin is approximately 20%. • Distribution: Mean volume of distribution at steady-state of rosuvastatin is approximately 134 liters. Rosuvastatin is 88% bound to plasma proteins, mostly albumin. • Metabolism: Rosuvastatin is not extensively metabolized; approximately 10% of a radio labeled dose is recovered as metabolite. The major metabolite is N- desmethyl rosuvastatin. • Excretion: Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%) of which 28% was via the renal route and 72% via the hepatic route. The elimination half-life (t1/2) of rosuvastatin is approximately 19 hours.
  • 5. What is Solid Dispersion Involves a dispersion of one or more active ingredients in an inert carrier or matrix in solid state prepared by:  Fusion (melt)  Solvent evaporation  Spray drying  Lyophilization  Hot melt extrusion  Electrostatic spinning method  Supercritical fluid technology  Coating on sugar beads using fluidized bed-coating system. Used to improve o solubility o dissolution rates o Bioavailability of poorly water soluble drug.
  • 6. Starch 5-Phosphate Starch phosphate is one of the modified starches that have been evaluated as effective disintegrant as well as solid dispersions to increase solubility and to optimize bioavailability.  Preparation: by reacting starch IP (100g) with di-sodium hydrogen orthophosphate anhydrous (30g) at elevated temperatures (130°C for 3 hrs).  Appearance: white, crystalline, non-hygroscopic powder.  Solubility: insoluble in water and aqueous fluids of acidic and alkaline pHs.  Swelling property: 400 times more swelling in water.
  • 7. Property Result Solubility Insoluble in all aqueous and organic solvents tested pH (1% w/v aqueous dispersion) 7.27 Melting point Charred at 210C Viscosity (1% w/v aqueous dispersion) 2.15cps Swelling index 400 Gelling property No gelling and swollen particles of Starch-5- phosphate separated from water. Density 1.567 gm/cc Bulk density 0.534 gm/cc Angle of Repose 23.05 Compressibility Index 15% Physical properties of Starch-5-phosphate prepared
  • 8. Concentration Absorbance 5 0.097 10 0.174 15 0.266 20 0.354 25 0.436 30 0.513 y = 0.0174x R² = 0.9981 0 0.2 0.4 0.6 0 5 10 15 20 25 30 35 Absorbance Absorbance concentration Standard Curve of Rosuvastatin Calcium in Methanol Standard Curve of Rosuvastatin Calcium in pH 6.8 Phosphate Buffer Concentration Absorbance 5 0.169 10 0.295 15 0.446 20 0.62 25 0.766 30 0.908 y = 0.0305x R² = 0.9983 0 0.5 1 0 5 10 15 20 25 30 35 Absorbance Absorbance concentration
  • 9. Ingredients (mg) F1cc1 F1cc2 F4cc1 F4cc2 F5cc1 F5cc2 Drug 1000 1000 1000 1000 1000 1000 PEG - - 2000 2000 1000 1000 Starch-5-phosphate 5050 5550 5000 5000 9000 9000 Mannitol 11000 11000 9050 9550 6050 6550 Aspartame 500 500 500 500 500 500 Sodium saccharin 300 300 300 300 300 300 Talc 300 300 300 300 300 300 Magnesium stearate 300 300 300 300 300 300 Vanilline 50 50 50 50 50 50 Cross-carmellose 1500 1000 1500 1000 1500 1000 Total weight 20000 20000 20000 20000 20000 20000 Composition of different formulations by Direct Compression
  • 10. Comparative dissolution study of branded generic Rosuvastatin Calcium Tablets TIME (MIN) % CDR from different brands ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR 5 20.40 19.20 19.80 18.60 25.20 10 27.00 25.80 30.60 26.40 33.60 15 31.80 31.20 48.60 30.60 42.00 20 45.00 39.00 55.80 37.20 57.00 25 57.60 47.40 63.60 48.60 68.40 30 77.40 68.40 76.80 66.60 79.80 45 92.40 78.00 90.60 80.40 87.00 60 97.80 89.40 96.60 94.80 94.80 No of Time Points where %CDR 70% as per IP
  • 11. Comparative dissolution study of Formulated Rosuvastatin Calcium Tablets TIME (MIN) % CDR from different formulations F1cc F1cc1 F1cc2 F4cc F4cc1 F4cc2 F5cc F5cc1 F5cc2 0 0 0 0 0 0 0 0 0 0 5 94.64 76.11 88.79 96.33 85.80 93.15 106.62 90.67 95.10 10 95.40 96.86 96.83 97.76 99.04 99.19 109.23 99.68 99.26 15 95.40 100.40 98.06 97.76 102.67 102.95 113.41 100.95 101.36 20 100.77 102.03 96.80 99.20 104.52 104.43 113.94 102.24 102.22 25 100.77 102.54 100.69 100.16 105.27 105.48 115.51 103.13 102.98 30 100.38 105.15 102.08 100.16 107.13 106.25 119.69 104.93 103.62 45 101.53 107.08 102.92 101.12 107.52 107.64 119.69 106.10 105.56 60 102.30 109.01 105.45 104.95 108.28 108.01 120.73 107.63 106.82
  • 12. % Dissolution Efficiency of Marketed brands DEtmax= AUC/(Ymax*tmax) %DEmax ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR DE5 23.70 22.50 25.20 22.50 29.40 DE15 30.50 28.70 39.00 28.30 38.90 DE30 77.50 67.80 83.00 67.65 83.95 DE45 83.37 73.10 86.53 74.20 86.27 % Dissolution Efficiency of F1 formulated product DEtmax= AUC/(Ymax*tmax) %DEmax F1cc F1cc1 F1cc2 DE5 95.02 86.48 92.81 DE15 111.94 108.13 110.69 % Dissolution Efficiency of F4 formulated product DEtmax= AUC/(Ymax*tmax) %DEmax F4cc F4cc1 F4cc2 DE5 97.04 92.42 96.17 DE15 113.82 113.26 115.84 % Dissolution Efficiency of F5 formulated product DEtmax= AUC/(Ymax*tmax) %DEmax F5cc F5cc1 F5cc2 DE5 107.93 95.18 97.18 DE15 128.75 114.11 115.61 Comparative % Dissolution Efficiency study of Marketed and Formulated Rosuvastatin Calcium Tablets
  • 13. Quality control parameters for tablets PARAMETERS ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR Weight variation (mg) 76.7 155.46 80.5 76.5 75.3 Thickness (mm) 5.62 7.04 5.50 5.53 5.60 Hardness (kg/cm2) 6.2 5.5 6.0 6.5 5.0 Disintegration time 1hr 10min 1hr 12min 1hr 10min 1hr 10min 1 hr Price Rs 65 Rs 42.35 Rs 72 Rs 82.40 Rs.66.10 Formulation Average weight (mg) Hardness (kg/cm2) Disintegration time (min) Drug content (mg) F1cc1 101±0.81 3.0±0.11 2.40 5.97 F1cc2 100±0.75 3.0±0.13 2.51 5.82 F4cc1 101±1.17 3.0±0.11 3.00 5.48 F4cc2 102±1.24 3.0±0.11 3.20 5.66 F5cc1 103±1.17 3.5±0.14 4.30 5.91 F5cc2 102±2.16 4.0±0.17 3.40 6.01
  • 14. Zero Order Release y = 0.0783x + 0.7526 R² = 0.9231 y = 0.0682x + 0.7006 R² = 0.9462 y = 0.0702x + 1.1712 R² = 0.9064 y = 0.0728x + 0.606 R² = 0.9655 y = 0.0656x + 1.3257 R² = 0.8875 0.00 1.00 2.00 3.00 4.00 5.00 6.00 0 20 40 60 80 ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR Qt Time y = 0.0112x + 7.449 R² = 0.6987 y = 0.0153x + 5.2219 R² = 0.3659 y = 0.0095x + 5.1966 R² = 0.4469 y = 0.0656x + 1.3257 R² = 0.8875 y = 0.0702x + 1.1712 R² = 0.9064 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 9.00 0 20 40 60 80 F1cc F1cc1 F1cc2 CRESTOR ROSUVAS Time Qt y = 0.0087x + 6.0108 R² = 0.9454 y = 0.0086x + 5.2339 R² = 0.2583 y = 0.0048x + 5.426 R² = 0.22 y = 0.0656x + 1.3257 R² = 0.8875 y = 0.0702x + 1.1712 R² = 0.9064 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 0 10 20 30 40 50 60 70 F4cc F4cc1 F4cc2 CRESTOR ROSUVAS Time Qt y = 0.0103x + 6.2762 R² = 0.5885 y = 0.0062x + 5.2523 R² = 0.1758 y = 0.0028x + 5.4508 R² = 0.0628 y = 0.0656x + 1.3257 R² = 0.8875 y = 0.0702x + 1.1712 R² = 0.9064 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 0 20 40 60 80 F5cc F5cc1 F5cc2 CRESTOR ROSUVAS Time Qt
  • 15. First Order Release y = -0.0298x + 0.9232 R² = 0.9629 y = -0.0165x + 0.757 R² = 0.9683 y = -0.0254x + 0.8065 R² = 0.9876 y = -0.0207x + 0.8296 R² = 0.9462 y = -0.0215x + 0.7302 R² = 0.9855 -1.20 -1.00 -0.80 -0.60 -0.40 -0.20 0.00 0.20 0.40 0.60 0.80 1.00 0 20 40 60 80 ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR Time (min) Logamt.ofdrugremaining y = -0.0264x - 0.0548 R² = 0.9083 y = -0.0173x - 0.2251 R² = 0.5967 y = -0.0097x - 0.2332 R² = 0.6278 y = -0.0215x + 0.7302 R² = 0.9855 y = -0.0254x + 0.8065 R² = 0.9876 -2.00 -1.50 -1.00 -0.50 0.00 0.50 1.00 0 20 40 60 80 F1cc F1cc1 F1cc2 CRESTOR ROSUVAS Logamt.ofdrugremaining Time y = -0.0219x - 0.0215 R² = 0.7717 y = -0.008x - 0.4944 R² = 0.1459 y = -0.0204x - 0.3808 R² = 0.8321 y = -0.0215x + 0.7302 R² = 0.9855 y = -0.0254x + 0.8065 R² = 0.9876 -2.00 -1.50 -1.00 -0.50 0.00 0.50 1.00 0 10 20 30 40 50 60 70 F4cc F4cc1 F4cc2 CRESTOR ROSUVAS Logamt.ofdrugremaining Time y = -0.0136x - 0.1698 R² = 0.8977 y = -0.0044x - 0.2433 R² = 0.1316 y = -0.0015x - 0.3043 R² = 0.0263 y = -0.0215x + 0.7302 R² = 0.9855 y = -0.0254x + 0.8065 R² = 0.9876 -1.20 -1.00 -0.80 -0.60 -0.40 -0.20 0.00 0.20 0.40 0.60 0.80 0 20 40 60 80 F5cc F5cc1 F5cc2 CRESTOR ROSUVAS Time Logamt.ofdrugremaining
  • 16. Higuchi Model y = 0.6059x R² = 0.9174 y = 0.535x R² = 0.9297 y = 0.6365x R² = 0.9702 y = 0.5445x R² = 0.9202 y = 0.6374x R² = 0.9686 0 1 2 3 4 5 6 0 2 4 6 8 10 ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR √t Qt y = 1.437x R² = 0.1114 y = 1.0506x R² = 0.2831 y = 1.0211x R² = 0.1559 y = 0.6374x R² = 0.9686 y = 0.6365x R² = 0.9702 0.00 2.00 4.00 6.00 8.00 10.00 12.00 0 2 4 6 8 10 F1cc F1cc1 F1cc2 CRESTOR ROSUVAS √t Qt y = 1.1588x R² = 0.1472 y = 1.0178x R² = 0.2024 y = 1.0292x R² = 0.1191 y = 0.6374x R² = 0.9686 y = 0.6365x R² = 0.9702 0 1 2 3 4 5 6 7 8 9 10 0 2 4 6 8 10 F4cc F4cc1 F4cc2 CRESTOR ROSUVAS √t Qt y = 1.2186x R² = 0.1821 y = 1.0069x R² = 0.1614 y = 1.0223x R² = 0.0907 y = 0.6374x R² = 0.9686 y = 0.6365x R² = 0.9702 0 1 2 3 4 5 6 7 8 9 10 0 2 4 6 8 10 F5cc F5cc1 F5cc2 CRESTOR ROSUVAS √t Qt
  • 17. Korsmeyer-Peppas Model y = 0.7123x - 1.2457 R² = 0.9514 y = 0.6706x - 1.2368 R² = 0.96 y = 0.6696x - 1.1465 R² = 0.9744 y = 0.6947x - 1.2682 R² = 0.9625 y = 0.5853x - 1.0218 R² = 0.9655-0.90 -0.80 -0.70 -0.60 -0.50 -0.40 -0.30 -0.20 -0.10 0.00 0.10 0.000 0.500 1.000 1.500 2.000 ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR log t log(Mt/M∞) y = 0.0238x - 0.0356 R² = 0.3998 y = 0.0861x - 0.1417 R² = 0.6048 y = 0.0465x - 0.0865 R² = 0.4329 y = 0.5853x - 1.0218 R² = 0.9655 y = 0.6696x - 1.1465 R² = 0.9744 -0.80 -0.70 -0.60 -0.50 -0.40 -0.30 -0.20 -0.10 0.00 0.10 0.000 0.500 1.000 1.500 2.000 F1cc F1cc1 F1cc2 CRESTOR ROSUVAS log t log(Mt/M∞) y = 0.0302x - 0.0411 R² = 0.8576 y = 0.0581x - 0.0783 R² = 0.5996 y = 0.0318x - 0.0503 R² = 0.5462 y = 0.5853x - 1.0218 R² = 0.9655 y = 0.6696x - 1.1465 R² = 0.9744 -0.80 -0.70 -0.60 -0.50 -0.40 -0.30 -0.20 -0.10 0.00 0.10 0.000 0.500 1.000 1.500 2.000 F4cc F4cc1 F4cc2 CRESTOR ROSUVAS log t log(Mt/M∞) y = 0.0436x - 0.0002 R² = 0.8376 y = 0.0462x - 0.0989 R² = 0.5081 y = 0.0268x - 0.0721 R² = 0.329 y = 0.5853x - 1.0218 R² = 0.9655 y = 0.6696x - 1.1465 R² = 0.9744-0.80 -0.70 -0.60 -0.50 -0.40 -0.30 -0.20 -0.10 0.00 0.10 0.20 0.000 0.500 1.000 1.500 2.000 F5cc F5cc1 F5cc2 CRESTOR ROSUVAS log t log(Mt/M∞)
  • 18. Dissolution Model Parameters ROZUCOR ROZUMAC ROSUVAS ZYROVA CRESTOR Zero order k0 0.078 0.068 0.07 0.072 0.065 R2 0.923 0.946 0.906 0.965 0.887 First order k1 -0.029 -0.016 -0.025 -0.02 -0.021 R2 0.962 0.968 0.987 0.946 0.985 Higuchi model k2 0.605 0.535 0.636 0.544 0.637 R2 0.917 0.929 0.97 0.92 0.968 Hixon - Crowel Model k3 0.02 0.015 0.02 0.016 0.019 R2 0.974 0.978 0.992 0.976 0.965 Koresmeyer - Peppas Model k4 1.245 1.236 1.146 1.268 1.021 R2 0.951 0.96 0.974 0.962 0.965 n 0.712 0.67 0.669 0.694 0.585
  • 19. Dissolution Model Parameters F1cc F1cc1 F1cc2 F4cc F4cc1 F4cc2 F5cc F5cc1 F5cc2 zero order k0 0.011 0.015 0.009 0.008 0.008 0.004 0.01 0.006 0.002 R2 0.698 0.365 0.446 0.945 0.258 0.22 0.588 0.175 0.062 first order k1 -0.026 -0.017 -0.009 -0.021 -0.008 -0.020 -0.013 -0.004 -0.001 R2 0.908 0.596 0.627 0.771 0.145 0.832 0.897 0.131 0.026 Higuchi model k2 1.437 1.05 1.021 1.158 1.017 1.029 1.218 1.006 1.022 R2 0.111 0.283 0.155 0.147 0.202 0.119 0.182 0.161 0.09 Hixon - Crowel Model k3 0.053 0.031 0.03 0.051 0.055 0.039 0.071 0.025 0.025 R2 0.323 -0.35 -0.85 0.393 -0.16 -0.85 -1.46 -1.1 -1.41 Koresmeyer -Peppas Model k4 0.035 0.141 0.086 0.041 0.078 0.05 0 0.098 0.072 R2 0.399 0.604 0.432 0.857 0.599 0.546 0.837 0.508 0.329 n 0.023 0.086 0.046 0.03 0.058 0.031 0.043 0.046 0.026
  • 21. TREATMENT GROUP TOTAL CHOLESTEROL (mg/dl) 24 HRS 48 HRS NORMAL CONTROL 150.34±0.25 151.43±0.25 POSITIVE CONTROL 198.83±0.65 209.57±1.17 F4 FORMULATION 144.95±0.35 78.14±0.10 CRESTOR 146.05±0.10 111.25±0.92 0.00 50.00 100.00 150.00 200.00 250.00 normal control positive control F4 crestor 24hrs 48hrs Group TotalCholesterol (mg/dl) Comparative effect of F4 formulation and Crestor in Total Cholesterol levels
  • 22. Histopathology studies of liver Normal control Triton induced positive control F4 (5mg/kg) + Triton (200mg/kg) treated group Crestor (5mg/kg) + Triton (200mg/kg) treated group Normal control liver sections illustrates portal vein surrounded by cords of hepatocytes extended radialy from central portal vein and branches of hepatic artery around the lobular periphery .Among the nonparanchymal cells, the following types have been identified bile duct, endothelial, kupffer cells, kupffer cells are located preferentially in the per portal region figure. There were flat endothelial cells around the central vein and sinusoids with normal architecture of their liver sections. In treated rats with mild changes these changes includes, moderate congestion, necrosis, hepatocytes degeneration with enlargement of some hepatocytes (ballooning shape), and some of which have two nuclei and some of hepatocytes undergo hepatocytomegally with pyknotic nuclei.
  • 23. Histopathology studies of heart Normal control Triton induced positive control F4 (5mg/kg) + Triton (200mg/kg) treated group Crestor (5mg/kg) + Triton (200mg/kg) treated group Light microscopy of the cardiac tissue sections of normal control group showing normal myofibrillar structure with striations, branched appearance and continuity with adjacent myofibrils. Light microscopy of the cardiac tissue sections of positive control group showing loss of normal architecture of cardiac muscle fibers, loss of cross striations and fragmentation of sarcoplasm, infiltration of mononuclear cells in between the muscle fibers and connective tissue proliferation in the area of necrosis. Light microscopy of the cardiac tissue sections of F4 formulation (5mg/kg) treated group showing almost normal appearance of cardiac muscle fibers. It shows the area of congestion & hemorrhage with fragmentation and loss of cross striation of muscle fibers in occasional areas.
  • 24. Starch-5-phosphate prepared by reacting starch IP with di-sodium hydrogen orthophosphate anhydrous at elevated temperatures was insoluble in water and has good swelling (400%) property without pasting or gelling when heated in water. Rosuvastatin Calcium tablets formulated employing starch-5-phosphate disintegrated within 3mins. Dissolution followed first order kinetics and increase in the dissolution rate of Rosuvastatin calcium was observed with solid dispersions prepared at 1:2:5 and 1:1:9 ratios of drug: PEG 6000: starch-5-phosphate. The dissolution was also increased when the drug: carrier ratio was increased. FTIR study showed there was no interaction between Rosuvastatin calcium and excipients . Thus starch-5-phosphate, a new modified starch was found to be a promising disintegrant in tablet formulations and can be used in the concentration of 5-10% as an effective disintegrant. Based on the study it may be concluded that rosuvastatin calcium tablets (F1, F4, F5) prepared with 20% cross-carmellose sodium as superdisintegrant showed rapid drug release when compared to marketed tablet formulations. CONCLUSION
  • 25. REFERENCES • A.RAMU, S. VIDYADHARA, N. DEVANNA, CH. ANUSHA and J. KEERTHI “Formulation and Evaluation of Rosuvastatin Fast Dissolving Tablets”, Asian journal of chemistry; vol. 25; No. 10(2013); 5340-5346. • BHEEMESWARA RAO K, PRASANNA KUMAR DESU, SUDHAKAR BABU AMS, VENKATESWAR RAO P “Formulation and evaluation of rosuvastatin immediate release tablets 20mg”, Singapore journal of pharmaceutical research; 2014; 1(1); 12-18. • K.P.R. CHOWDARY, VEERAIAH ENTURI AND A. SANDHYA RANI “Formulation Development of Aceclofenac Tablets Employing Starch Phosphate -A New Modified Starch”, International Journal of Pharma Sciences and Research (IJPSR); vol. 2(3); 2011; 124-129. • M.KIRAN BABU, N.TARUN, MD. REHANA SULTHANA, SRINIVAS.M, CH.VIJAY “Formulation and evaluation of rosuvastatin immediate release tablets”, An International Journal of Advances in Pharmaceutical Sciences; vol. 5; issue 2; march- April 2014; 1924-1928. • K. VEERREDDY, TEJA KUMAR. P, BOLLI SANDEEP AND SUNIL KUMAR DANGETI “Comparative evaluation of modified starches in different tablet formulations as disintegrants”; Scholar Research Library, Der Pharmacia Lettre; 2012; 4(6); 1680- 1684.
  • 26. • K.P.R. CHOWDARY AND VEERAIAH ENTURI “Preparation, characterization and evaluation of starch phosphate: A new modified starch as directly compressible vehicle in tablet formulations”, Journal of Pharmacy Research; 2011; 4(9); 3241-3243. • I. JUBRIL, J. MUAZU AND G. T. “Mohammed Effects of Phosphate Modified and Pregelatinized Sweet Potato Starches on Disintegrant Property of Paracetamol Tablet Formulations”, Journal of Applied Pharmaceutical Sciences; 2012; 2(2); 32-36. • SANJOY KUMAR DAS, SUDIPTA ROY, YUVARAJA KALIMUTHU, JASMINA KHANAM, ARUNABHA NANDA “Solid Dispersions: An Approach to Enhance the Bioavailability of Poorly Water-Soluble Drugs”, International Journal of Pharmacology and Pharmaceutical Technology (IJPPT); volume 1; issue 1; 2277-3436. • MOGAL S. A, GURJAR P. N, YAMGAR D. S AND KAMOD A.C. “Solid dispersion technique for improving solubility of some poorly soluble drugs”, Scholar Research Library, Der Pharmacia Lettre; 2012; 4(5); 1574-1586.