Design and Evaluation
of Orodispersible Tablet of Aceclofenac
Using Different Superdisintegrants by 23
Factorial Designs
DG Umalkar1*, GV Shinde1, GS Bangale1,
Rajesh KS2 and RSR Murthy2
1Parul Institute of
Pharmacy, Limda, Vadodara-391760, Gujarat, India
2Indo Soviet Friendship College of Pharmacy, Ghalkalan
Moga Punjab.
ABSTRACT:
In the present work, Orodispersible tablet of Aceclofenac
were designed with a view to Enhance patient compliance. A combination of
super-disintegrants i.e.Ac-di-sol (Croscarmellose sodium), Polyplasdone XL-10, Microcrystalline Cellulose pH 102 was
Used along with directly compressible dextrose to enhance mouth feel. The
prepared Batches of tablet were evaluated for hardness, friability, drug
content uniformity, wetting time, water absorption ratio and in vitro
dispersion time. Based on in vitro dispersion time, two formulation were tested
for in vitro drug release pattern (in pH7.4phosphatebuffer),
short – term stability at 250C 
20C/60% RH,
300C 20C/65% RH,
400C 20C/75% RH
for 3 month and drug –excipient interaction (IR
Spectroscopy) among the two formulation, the formulation prepared by direct
Compression method using Ac-di-sol (croscarmellose sodium) 50mg, Polyplasdone
XL- 10 -25mg, Microcrystalline Cellulose pH 102- 25mg was found tobe better formulation
T80% = 5 min. based on in- vitro drug release
characteristics. Short term stability studies on the formulation indicated that
there is no significant change in drug content and in vitro dispersion time
KEYWORDS: Orodispersible tablet, Aceclofenac, Direct compression, 23 Factorial Design.
INTRODUCTION:
Oral route of drug
administration have wide acceptance up to 50-60% of total dosage forms The most
popular solid dosage forms are being tablets and capsules; one important drawback of
these dosage forms for some patients, is the difficulty to swallow. Drinking
water plays an important role in the swallowing of oral dosage forms. Often
times people experience inconvenience in swallowing conventional dosage forms
such as tablets when water is not available, in the case of motion sickness (kinetosis) and sudden episodes of coughing during the
common cold, allergic conditions and bronchitis. For these reasons, tablets that can rapidly
dissolve or disintegrate in the oral cavity have attracted great deal of
attention.
Orodispersible tablets are not only
indicated for people who have swallowing difficulties, but also are ideal for
active people. Orodispersible
tablets are those when put on tongue, disintegrates instantaneously, releasing
the drug, which dissolves or disperses in the saliva.Aceclofenac
3 an
inflammatory site specific NSAID, The objective of present study is to mask the
bitter taste of Aceclofenac by using Dextrose with
Physical Mixture method. And to develop
mouth dissolving drug delivery system by simple and cost effective technique.
The oro-dispersible tablets can be swallowed without
water in the form of
dispersion. They increase the patient compliance as well as
provide quicker onset of action. This mouth dissolving tablet of Aceclofenac will disintegrate rapidly in the patient mouth without
need of water or chewing and released its drug content instaneously
So this dosage form is more comfortable for pediatric, geriatric patients.
Table
No.1: Composition of different batches
of Orodispersible tablet of Aceclofenac
|
Sr. No.
|
Ingredients
( mg)
|
A1
|
A2
|
A3
|
A4
|
A5
|
A6
|
A7
|
A8
|
|
1
|
Aceclofenac
|
100
|
100
|
100
|
100
|
100
|
100
|
100
|
100
|
|
2
|
Dextrose
|
100
|
100
|
100
|
100
|
100
|
100
|
100
|
100
|
|
3
|
Ac-di-sol
(
Croscarmellose sodium)
|
25
|
50
|
25
|
50
|
25
|
50
|
25
|
50
|
|
4
|
Polyplasdone XL-10
|
25
|
25
|
50
|
50
|
25
|
25
|
50
|
50
|
|
5
|
Microcrystalline
Cellulose
p H 102
|
25
|
25
|
25
|
25
|
50
|
50
|
50
|
50
|
|
6
|
Magnesium
stearate
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
|
7
|
Sodium
saccharine
|
10
|
10
|
10
|
10
|
10
|
10
|
10
|
10
|
|
8
|
Vanillin
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
9
|
Menthol
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
10
|
Talc
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
1.5
|
MATERIALS AND
METHODS:
Aceclofenac, Ac-di-sol(croscarmellose
sodium) Polyplasdone XL-10 Microcrystalline
Cellulose pH 102 obtained as a gift sample
from Kairav chemical Ltd. Mumbai
Dextrose, Magnesium stearate sodium Saccharin, Vanillin, Menthol, Talc from Swstik Chemical, Vadodara. All other materials
used were of pharmaceutical grade.
Formulation of Orodispersible
Tablet of Aceclofenac:
Orodispersible tablet of Aceclofenac
were prepared by Direct compression according to formula given in (Table.1) A total number of
Eight formulations were prepared. All the ingredients were passed through
60-mesh sieve separately and collected, finally compressed into tablets after
lubrication with talc (2%) and magnesium stearate
(1%) by using 8.5mm flat beveled edged punch set, on 16 station Rotatory Tablet compressing Machine (RIMEK MUMBAI) weight
and at approximately equal hardness. Tablets were compressed at equal
compression force.
Before tablet
preparation, the mixture blend subjected for compatibility studies (IR) by
using Shimadzu FTIR spectrophotometer and pre-compression parameters like angle
of repose4, Compressibility index 4, and bulk density.4, Tapped density4, Hausner ratio5. The prepared Orodispersible Tablet of Aceclofenac
were subjected for post-compression parameters like uniformity of thickness,
hardness, friability, weight variation, drug content uniformity, wetting time,
and in vitro disintegration time.
Evaluation Parameters
1)
Thickness, Hardness 4
The thickness of five tablets was measured
using vernier calipers..
Hardness of the tablets was tested by using 'Monsanto' hardness tester
2)
Content uniformity 6
The Aceclofenac
content in the tablets was estimated as follows.
Method:
Powder the tablet and weight equivalent to
10mg of Aceclofenac and dissolved in 100ml phosphate
buffer pH 7.4. From that 1ml of solution was diluted to 10ml and assayed for
drug content using UV-Visible spectrophotometer at 275nm.
3)
Weight Variation 4
Twenty tablets were randomly
selected form each batch and individually weighed.
The average weight and standard deviation of 20 tablets was calculated. The
batch passes the test for weight variation test if not more then
two of the individual tablet weight deviate from the average Weight.
4)
Friability 5
Friability of the tablets was determined
using Roche Friabilator.
5)
Porosity: 4
Ratio of total volume of void spaces to the
bulk volume of material is often selected to monitor the progress of
compression. This ratio is referred to as porosity. It was calculated by using
the formula.
Porosity E = 
= 1- 
Where, t = true volume of tablets.
Frequently Porosity is expressed as
%E=100
[1- ]
6) Disintegration
time: 7
The Dis-integration
time of the tablets was determined as per Indian Pharmacopoeia monograph.
7) Water
uptake of water absorption Ratio: 8
The water uptake characteristic of the loose disintegrant powder allows and evaluation of both the
intrinsic swelling and the wettability of the superdisintegrants water uptake were performed at room
temperature. A piece of tissue paper folded twice was placed in small Petri
dish containing 6 ml of water. A tablet was put on the paper and the time required
for complete wetting was 0.5-2min. The wetted tablet was then weighed. Water
absorption ratio, R, was determined by using following equation.
Where, Wb
=weight of tablet before water absorption and
= Weight of tablet
after water absorption
8)
In-vitro Release studies: 6, 7
Method:
Dissolution profiles of Aceclofenac
tablets wee determined using the Dissolution Test apparatus USP (Lab India
Disso 2000) set with a paddle speed of 50rpm. Dissolution was tested in 7.4pH
phosphate buffer, Dissolution was performed in 900 ml, at 37+0.50C,
5 ml aliquot was withdrawn, at the 5, 10, 15, 20 up to 60 min with 5minutes
interval, and filtered through whatmann filter paper.
From these samples, 1ml taken into test tube volume made up with the same
buffer up to 10 ml and the drug solution absorbance was analyzed at 275 nm in
1cm cuvettes using UV-Visible spectrophotometer (Systronics UV-VIS spectrophotometer 117).
Table
no.2
|
Batch code
|
Angle of repose
|
Bulk Density (gm/cm3)
|
Tapped Density (gm/cm3)
|
Compressibility Index (%)
|
Hausner ratio
|
|
A1
|
30.14
|
0.47
|
0.59
|
20.30
|
1.25
|
|
A2
|
32.00
|
0.49
|
0.75
|
15.80
|
1.53
|
|
A3
|
32.47
|
0.59
|
0.68
|
13.04
|
1.15
|
|
A4
|
35.47
|
0.56
|
0.75
|
25.33
|
1.33
|
|
A5
|
32.86
|
0.53
|
0.63
|
34.60
|
1.18
|
|
A6
|
30.69
|
0.38
|
0.48
|
20.00
|
1.26
|
|
A7
|
34.41
|
0.35
|
0.50
|
30.00
|
1.42
|
|
A8
|
31.00
|
0.46
|
0.55
|
16.36
|
1.19
|
Table
no. 3
|
Batch
code
|
Weight
Variation
(5%)
|
Thickness
(mm)
|
Hardness
(
kg/cm2 )
|
Friability
(%)
|
Tensile
Strength
(kg/cm2)
|
Content
uniformity
(%)
|
Porosity
(%)
|
|
A1
|
Pass
|
4 ±0.06
|
3.2±0.31
|
0.58
|
12.57
|
99.35±1.26
|
20
|
|
A2
|
Pass
|
4 ± 0.04
|
3.4±0.45
|
0.19
|
13.92
|
99.08±1.43
|
35
|
|
A3
|
Pass
|
5 ± 0.06
|
3.3±0.34
|
0.83
|
10.37
|
98.86±1.19
|
25
|
|
A4
|
Pass
|
5 ± 0.03
|
3.3±0.64
|
0.54
|
9.82
|
98.14±0.69
|
14
|
|
A5
|
Pass
|
5 ± 0.05
|
3.5±0.54
|
0.70
|
13.10
|
99.42±1.56
|
16
|
|
A6
|
Pass
|
6 ± 0.04
|
3.4±0.15
|
0.43
|
12.74
|
99.88±1.35
|
30
|
|
A7
|
Pass
|
5 ± 0.04
|
3.3±0.71
|
0.66
|
12.63
|
98.10±1.24
|
22
|
|
A8
|
Pass
|
6 ± 0.04
|
3.5±0.45
|
0.46
|
13.10
|
99.23±1.46
|
16
|
An equal volume of fresh medium, which was prewarmed at 370C replaced into the dissolution
medium after each sampling to maintain the constant volume throughout the test.
9)
Stability studies of the tablets 9
Stability studies for the present work
carried out at 250C 20C/60% RH,
300C 20C/65% RH,
400C 20C/75% RH
for the selected formulation
for 3 month.
RESULTS AND
DISCUSSION:
Pre-compression
studies:
The present work was aimed to find out the
effect of various super-disintegrants on the
dissolution profile and various properties of Orodispersible
Aceclofenac tablet.
Eight formulation of Aceclofenac
were prepared with different level addition of superdisintegrants,
Ac-di-sol( croscarmellose sodium), Polyplasdone
XL-10, and Microcrystalline cellulose p H 102 .For each designed formulation
powder mixed blend of drug and excipient was prepared
and Evaluated for various pre-compression parameters.
Compatibility studies (IR) – There was no
appearance or disappearance of peaks in the polymer-drug mixture, which
confirmed the absence of any chemical interaction between the drug and
polymers.
Pre-compression parameters result indicated a
good flowability.
The results are as follows.
Table
no. 4
|
Batch
code
|
Disintegration
time ( seconds)
|
|
A1
|
42±0.12
|
|
A2
|
24±0.25
|
|
A3
|
25±0.15
|
|
A4
|
38±0.36
|
|
A5
|
47±0.45
|
|
A6
|
43±0.13
|
|
A7
|
49±0.32
|
|
A8
|
39±0.15
|
Disintegration
Time:. The disintegration
time was found in the range 24-50 seconds for all batches. The batch A2 showed
fastest disintegration. The result are given in Table no. 4
Water uptake test: Water uptake test which is important criteria for understanding the capacity
of disintegrants to swell in presence of little
amount of water was calculated and found in the range of 159.40-203.01. The
result are given in table no. 5
Table no.5
|
Batch code
|
Maximal water uptake ( mg/tablet)
|
|
A1
|
183 ±0.32
|
|
A2
|
190.96±061
|
|
A3
|
190.32 ±0.54
|
|
A4
|
203.01 ±0.38
|
|
A5
|
159.40 ±031
|
|
A6
|
184.20 ±0.19
|
|
A7
|
162.20 ±0.12
|
|
A8
|
196.90 ±0.20
|
|
Time (Min.)
|
Percent Drug Release
|
|
Batch code
|
A1
|
A2
|
A3
|
A4
|
A5
|
A6
|
A7
|
A8
|
|
5
|
64.8
|
80.1
|
77.4
|
74.1
|
53.1
|
54.9
|
64.8
|
61.2
|
|
10
|
68.3
|
85.5
|
83.4
|
85.5
|
54.3
|
63.0
|
71.2
|
69.4
|
|
15
|
70.6
|
90.0
|
87.7
|
90.0
|
59.4
|
67.6
|
72.6
|
74.9
|
|
20
|
72.6
|
98.9
|
90.0
|
99.1
|
60.9
|
69.9
|
74.8
|
80.1
|
|
25
|
78.3
|
100.0
|
99.3
|
100.0
|
66.7
|
73.0
|
76.3
|
81.9
|
|
30
|
81.1
|
-
|
100.0
|
-
|
69.4
|
80.2
|
76.7
|
85.6
|
|
35
|
85.5
|
-
|
-
|
-
|
74.8
|
84.2
|
83.9
|
90.0
|
|
40
|
90.0
|
-
|
-
|
-
|
78.8
|
90.0
|
87.3
|
96.5
|
|
45
|
97.7
|
-
|
-
|
-
|
84.5
|
95.4
|
90.0
|
99.7
|
|
50
|
99.2
|
-
|
-
|
-
|
90.0
|
99.3
|
94.3
|
100.0
|
|
55
|
100.0
|
-
|
-
|
-
|
99.5
|
100.0
|
99.6
|
-
|
|
60
|
-
|
-
|
-
|
-
|
100.0
|
-
|
100.0
|
-
|
In-vitro Release studies: The comparative analysis of each formulation was based on in-vitro kinetic
parameters which elucidated the release profile. The time taken for 80% drug
release was taken as a response for comparative interpretation of superdisintegrants. Table
no.-6
Fig-1 – Release profile of formulated
batches.
Table-6: T80% VALUES
FOR ORODISPERSIBLE TABLET OF ACECLOFENAC
|
Batch Code
|
T80% Values(In
minutes)
|
|
A-1
A-2
A-3
A-4
A-5
A-6
A-7
A-8
|
29
5.0
7.5
7.5
42
33
29.5
20
|
Stability studies: The selected formulations ( Batch A2,A3 ) were stored at 25° C ± 2°C/60% RH, 30°C ± 2°C/65% RH, 40°C ± 2°C/75% RH for 3 month in Humidity chamber(Thermo lab Mumbai) and evaluated
for their physical appearance and drug content at specified intervals of time.
Tablet were evaluated for Weight Variation, Hardness,
Friability, Drug content, T80%, There is no change in these parameters as given in Table no. 7 .
Based on the results it can be concluded that the formulated Orodispersible tablet of Aceclofenac
were stable at given conditions.
FACTORIAL DESIGN CALCULATION 10: For analyzing 2 factor interaction and 3 factor interaction with basic
polynomial equation aided by Yates algorithm, the magnitude and nature of
influence of variables when either alone or in combination is listed in the
table and various effect of them were given in table 8.1, 8.2.
Calculation for Main Effect
1) Effect of Ac-di-sol= [Y2-Y1]+[Y4-Y3]+[Y6-Y5]+[Y8-Y7]
4
= [5-29]+[7.5-7.5]+[33-42]+[20-29.5]
4
= -10.62
2) Effect of Polyplasdone
XL-10
= [Y3-Y1] + [Y4-Y2] +Y7-Y5] + [Y8-Y6]
4
= -11.12
3) Effect of MCC p H 102
= [Y5-Y1]+[Y6-Y2]+[Y7-Y3]+[Y8-Y4]
4
= +18.87
Calculation for Two factor interaction
1)
Calculation for Ac-di-sol
Vs Polyplasdone XL-10 interaction
High [+] = [Y4-Y3]+[Y8-Y7]
2
=[7.5-7.5]+[20-29.5]
2
= -4.75
Low [-] = [Y2-Y1]+[Y6-Y5]
2
= [5-29]+[33-42]
2
= -16.5
Ac-di-sol Vs Polyplasdone XL-10 interaction = ˝ difference
= -4.75-[-16.5]
2
= 5.87
Table no. 7.1: Aging studies of formulated Orodispersible
tablet of Aceclofenac at 25° C ± 2°C/60% RH for 3 month.
|
Sr. No.
|
Evaluation Parameter
|
Observation
|
|
Batch A2
|
Batch A3
|
|
Before
|
After
|
Before
|
After
|
|
1
|
Physical Appearance
|
* *
|
* *
|
* *
|
* *
|
|
2
|
Weight Variation (mg)
|
* *
|
* *
|
* *
|
* *
|
|
3
|
Hardness(kg/cm2)
|
3.4 ±0.4
|
3.4 ±0.3
|
3.3 ±0.3
|
3.4 ±0.4
|
|
4
|
Friability ( % )
|
0.19
|
0.18
|
0.83
|
0.83
|
|
5
|
Drug content ( mg/tablet)
|
99.08 ±1.43
|
99.52 ±1.19
|
99.86 ±1.56
|
99.59 ±1.35
|
|
6
|
T80% (Dissolution in min.)
|
5.0 ±0.03
|
5.0 ±0.05
|
7.5 ±0.04
|
7.3 ±0.06
|
* * = No change
Table No.7.2:Aging studies of formulated Orodispersible tablet of
Aceclofenac at 30°C ± 2°C/65% RH for 3 month.
|
Sr. No.
|
Evaluation Parameter
|
Observation
|
|
Batch A2
|
Batch A3
|
|
Before
|
After
|
Before
|
After
|
|
1
|
Physical Appearance
|
* *
|
* *
|
* *
|
* *
|
|
2
|
Weight Variation (mg)
|
* *
|
* *
|
* *
|
* *
|
|
3
|
Hardness(kg/cm2)
|
3.4 ±0.2
|
3.5 ±0.3
|
3.3 ±0.4
|
3.4 ±0.4
|
|
4
|
Friability ( % )
|
0.19
|
0.18
|
0.83
|
0.81
|
|
5
|
Drug content ( mg/tablet)
|
99.18 ±1.24
|
99.53 ±1.33
|
99.86 ±1.12
|
99.92 ±1.46
|
|
6
|
T80% (Dissolution in min.)
|
5.0 ±0.05
|
5.2 ±0.06
|
7.4 ±0.07
|
7.5 ±0.08
|
* * = No change
Table No.7.3 :Aging studies of formulated Orodispersible tablet of
Aceclofenac at 40°C ± 2°C/75% RH for 3 month.
|
Sr. No.
|
Evaluation Parameter
|
Observation
|
|
Batch A2
|
Batch A3
|
|
Before
|
After
|
Before
|
After
|
|
1
|
Physical Appearance
|
* *
|
* *
|
* *
|
* *
|
|
2
|
Weight Variation (mg)
|
* *
|
* *
|
* *
|
* *
|
|
3
|
Hardness(kg/cm2)
|
3.4 ±0.5
|
3.3 ±0.4
|
3.3 ±0.6
|
3.4 ±0.4
|
|
4
|
Friability ( % )
|
0.19
|
0.17
|
0.83
|
0.85
|
|
5
|
Drug content ( mg/tablet)
|
99.28 ±1.25
|
99.64 ±1.21
|
99.86 ±1.31
|
99.60 ±1.19
|
|
6
|
T80% (Dissolution in min.)
|
5.0 ±0.06
|
5.4 ±0.04
|
7.5 ±0.06
|
7.5 ±0.04
|
* * = No change
Table no.8.1: YATES ALGORITHM
|
Batch
code
|
X1
|
X2
|
X3
|
X1X2
|
X1X3
|
X2X3
|
X1X2X3
|
Total
|
T80%
|
|
A1
|
-1
|
-1
|
-1
|
+1
|
+1
|
+1
|
-1
|
+1
|
29.0[Y1]
|
|
A2
|
+1
|
-1
|
-1
|
-1
|
-1
|
+1
|
+1
|
+1
|
5.0[Y2]
|
|
A3
|
-1
|
+1
|
-1
|
-1
|
+1
|
-1
|
+1
|
+1
|
7.5[Y3]
|
|
A4
|
+1
|
+1
|
-1
|
+1
|
-1
|
-1
|
-1
|
+1
|
7.5[Y4]
|
|
A5
|
-1
|
-1
|
+1
|
+1
|
-1
|
-1
|
+1
|
+1
|
42.0[Y5]
|
|
A6
|
+1
|
-1
|
+1
|
-1
|
+1
|
-1
|
-1
|
+1
|
33.0[Y6]
|
|
A7
|
-1
|
+1
|
+1
|
-1
|
-1
|
+1
|
-1
|
+1
|
29.5[Y7]
|
|
A8
|
+1
|
+1
|
+1
|
+1
|
+1
|
+1
|
+1
|
+1
|
20.0[Y8]
|
Table no.8.2
|
Batch code
|
Ac-di-sol
|
Polyplasdone XL-10
|
MCC p H 102
|
T80%
|
|
A1
|
25
|
25
|
25
|
29.0[Y1]
|
|
A2
|
50
|
25
|
25
|
5.0[Y2]
|
|
A3
|
25
|
50
|
25
|
7.5[Y3]
|
|
A4
|
50
|
50
|
25
|
7.5[Y4]
|
|
A5
|
25
|
25
|
50
|
42.0[Y5]
|
|
A6
|
50
|
25
|
50
|
33.0[Y6]
|
|
A7
|
25
|
50
|
50
|
29.5[Y7]
|
|
A8
|
50
|
50
|
50
|
20.0[Y8]
|
2)
Calculation for Polyplasdone
XL-10 Vs MCC p H 102 interaction
High [+] = [Y8-Y4]+[Y7-Y3]
2
= 17.25
Low [-] = [Y6-Y2]+[Y5-Y1]
2
= 20.5
Polyplasdone XL-10 Vs MCC
p H 102 interaction = ˝ difference
= 17.25-20.5
2
= -1.62
3)
Calculation for Ac-di-sol
Vs MCC p H 102 interaction
High [+] = [Y6-Y2]+[Y8-Y4]
2
= 20.25
Low [-] = [Y5-Y1]+[Y7-Y3]
2
= 17.5
Ac-di-sol Vs MCC p H 102
interaction = ˝ difference
= 20.25-17.5
2
= 1.37
Calculation for Extra
Design check point:
Basic Polynomial Equation-
Y = B0 + B1(X1) + B2 (X2) + B3 (X3) + B12 (X1X2) +
B13 (X1X2) + B23 (X2X3) + B123
(X1X2X3)
The value of B1,B2,B3,B12,B13,B23,B123 was
calculated by using the value of X1,X2,X3 from table no.8.1 and which was found
to be as follows.
B1=9.43, B2= -5.31, B3= -5.56, B12= 0.68, B13=
-0.81, B23= 2.93, B123= -3.06,
B0= 21.68
Let us consider transformed value = 0.5
Now, Actual polynomial Equation
Y = B0 + B1(X1) + B2 (X2) + B3 (X3) + B12 (X1X2) +
B13 (X1X2) + B23 (X2X3) + B123
(X1X2X3)
= 21.68+9.43(0.5)+(-5.31)
(0.5) + (-5.56) (0.5) + 0.68 (0.5 x 0.5) + (-0.81) (0.5) (0.5) + 2.93 (0.5) (0.5) + ( -3.06) (0.5) (0.5)
(0.5)
= 27.29-6.01
= 21.28
Predicted T80% value = 21.28
Variables at extra
Design check point
|
Variables
|
Low
level in mg
|
High level in mg
|
|
Ac-di-sol
|
25
|
50
|
|
Polyplasdone XL 10
|
25
|
50
|
|
MCC p H 102
|
25
|
50
|
Calculation for Ac-di-sol
Average of two level = 25+50
2
= 37.5
˝ of the difference between variables = 50-25
2
=12.5
Transformed value to actual properties
X1- Average of two level = 0.5
˝ of the difference between Variables
X1 – 37.5 =
0.5
12.5
X1= 43.75
Like Ac-di-sol, for Polyplasdone XL-10 andMCC p H 102
Variables are calculated, which was tobe same i.e 43.75 mg. and obtained T80% value = 23.10
Having designed using appropriate statistical used
to predict the response, that would fulfill the aim of study, by calculating
the actual polymer concentration from transformed proportion of each variables,
the extra design check point formulation was designed and predicted T80% values
was found tobe 21.28 min. Then the response for extra
design check point was observed to have T80% value of 23.10 min.
The statistical magnificence of difference between
the predicted and observed responses not only validated the design for
optimization but also confirms the usefulness of the polynomial equation in
predicting in-vitro kinetic parameters.
CONCLUSION:
From all the above observations, it was concluded
that Batch A2 which containing (Ac-di-sol 50mg, Polyplasdone XL-10 25mg, Micro crystalline cellulose pH 102
25mg) gave the promising enhancement in the onset action of Aceclofenac.
The superdisintegrants Ac-di-sol (cross carmellose sodium)
was found to have maximum impact on the enhancement of dissolution, which was
followed by Polyplasdone XL10 while Micro crystalline
cellulose pH102 had a negative impact on the enhancement of dissolution of Aceclofenac.
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