The oral route is the most favorable route for administration of drugs because of accurate dosage, low cost of therapy, self medication, non-invasive method, and ease of administration leading to a high level of patient compliance. Of the oral Dosage forms, solid dosage form is the preferred class of product as tablet represents a unit dosage form in which one dose of drug is placed accurately.

1. 88
1
Comparative Evaluation of Disintegrant
Properties in Nimesulide Tablet
Formulation
Miss. GHARGE VARSHA GAJANAN
FINAL YEAR B. PHARMACY
G.I.P.E.R,LIMB,SATARA.
Under The guidance of
Ms. SAKHARE S.S.
ASSI.PROF.
Department of Pharmaceutics,
G.I.P.E.R. LIMB ,SATARA.

2. INTRODUCTION:
• The oral route is the most favorable route for administration of
drugs because of accurate dosage, low cost of therapy, self
medication, non-invasive method, and ease of administration
leading to a high level of patient compliance. Of the oral dosage
forms, solid dosage form is the preferred class of product as tablet
represents a unit dosage form in which one dose of drug is placed
accurately. [1]
• ‘Fast Dissolve’, ‘Quick Dissolve’, ‘Rapid Melt’, ‘Quick
Disintegrating’, ’Mouth Dissolving’, ‘Orally Disintegrating’, ‘Oro
Dispersible’, ‘Melt-In-Mouth’, etc. are terms that represent the
same drug delivery system.
• Superdisintegrants are more effective at lower concentrations with
greater Disintegrating efficiency and mechanical strength. On
contact with water the superdisintegrants swell, hydrate, change
volume or form and produce a disruptive change in the tablet.
2

3. APPLICATION:
• 1. Ease of administration for patients who are mentally ill,
disabled and uncooperative.
• 2. Requires no water.
• 3. Quick disintegration and dissolution of the dosage form.
• 4. Overcomes unacceptable taste of the drugs.
• 5. Can be designed to leave minimal or no residue in the
mouth after administration and also to provide a pleasant
mouth feel.
• 6. Provides good stability, accurate dosing, easy
manufacturing, and small packaging size and easy to handle by
patients.
• 7. Bioavailability of drugs that are absorbed from mouth,
pharynx, and esophagus is increased.
• 8. Pregastric absorption of drugs avoids hepatic metabolism,
which reduces the dose and increase the bioavailability [4]
3

4. Mechanism Of Oral Dispersible Tablet:
4

5. ADVANTAGES :
 Patient compliance is more.
 Having rapid onset of action which may leads to an
improved bioavailability.
 Patient having difficulty in swallowing tablet can
easily administer this type of dosage form.
 Useful for pediatric, geriatric and psychiatric
patients.
 Suitable during traveling where water is may not be
available.
Gives accurate dosing as compared to liquids.
Good chemical stability.
 Free of need of measuring, an essential drawback in 5

6. 6
1. Lyophilization or Freeze-
Drying
2. Molding
3. Mass Extrusion
4. Melt granulation

7. DISINTEGRANTS AND SUPERDISINTEGRANTS
Disintegrants are the substances or a mixture of substances added to a
tablet to facilitate its breakup or disintegration after administration,
which play major role in the formulation of ODT. Starches, clays,
cellulose and cross linked polymers are most commonly used
disintegrants. Super disintegrants are similar to the above but with more
intense action and more porous in nature.
Basically, the disintegrants major function is to oppose the efficacy of the
tablet binder and the physical forces that act under compression to form
the tablet. The mechanism by which tablet is broken down into smaller
particles and then produces a homogeneous suspension or solution is
based on
 1. By capillary action
 2. High swell ability of disintegrants
 3. Capillary action and high swell ability
 4. Chemical reaction (release of gases).
7

8. OBJECTIVE:
-To study the techniques of tablets formulation
& evaluation.
-To explore the role of superdisintegrants in
oral disintegrants tablet.
-To study the effect of varying concentration of
superdisintegrants on oral disintegrants tablet.
-To compare the performance of natural &
synthetic superdisintegrants.
-To evaluate the tablet formulation for various
parameters.
8

9. Literature Review:
1.*Velmurugan S, et.al in their review commented that Oral drug
delivery remains the most preferred route for administration of
various therapeutic agents. Recent advances in technology prompted
researchers and scientists to develop oral disintegrating tablets
(ODTs) with improved patient convenience and compliance.
2. Chiman Beri*and co-workers, focused on ideal requirements, need
for development of FDTs, challenges in formulations, suitability of
drug candidates superdisintegrants employed, various technologies
developed for FDTs.
3. S. Parthiban and coworkers formulated Novel Drug Delivery System
oriented towards increasing safety and efficacy of existing drug
molecule through novel concepts like oral drug delivery system.
Tablets containing Atenolol with super disintegrants like Starch
citrate, Sodium starch glycolate and cross carmellose sodium were
prepared by direct compression technique
9

10. PLAN OF WORK
10

11. EXPERIMENTAL WORK
LIST OF MATERIALS LIST OF EQUIPMENTS
11
Sr.
NO.
Name of Ingredient Name Of Supplier
1 Nimesulide Alembic Pvt.
Ltd;Vadodara
2 Sodium Starch Glycolate Loba Chemic mumbai
3 Potato starch Loba Chemic mumbai
4 Maize starch Loba Chemic mumbai
5 Microcrystalline
cellulose
Loba Chemic mumbai
6 Avicel PH 102 Loba Chemic mumbai
7 Talc Loba Chemic mumbai
8 Magnesium Stearate Loba Chemic mumbai
Sr.
no.
Name Of Equipment
1 Electronic balance
2 USP Dissolution apparatus-II
3 pH Meter
4 KBR Punch Machine
5 Hardness Tester
6 Friability Tester
7 Venire caliper

12. 12
Ingredients (mg)
SSG1 SSG2 SSG3 MCC1 MCC2 MCC3 PS1 PS2 PS3 MS1 MS2 MS3
Nimesulide 100 100 100 100 100 100 100 100 100 100 100 100
Sodium Starch Glycolate 5 10 15 - - - - - - - - -
Microcrystalline cellulose - - - 5 10 15 - - - - - -
Potato starch - - - - - - 5 10 15 - - -
Maize starch - - - - - - - - - 5 10 15
Avicel PH 102 140 135 130 125 140 135 130 125 140 135 130 125
Talc 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Magnesium Stearate 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Total 250 250 250 250 250 250 250 250 250 250 250 250

13. Evaluation of flow properties of starches-
Properties Sodium Starch
Glycolate
Micro Crystalline
Cellulose
Potato Starch Maize Starch
Bulk Density 0.4761 0.4347 0.6666 0.4761
Tapped Density 0.6250 0.5555 0.8333 0.6250
Hausner’s Ratio 1.3127 1.2718 1.2500 1.3127
% Carr’s Index 23.8240 21.7461 20.0048 23.8240
Angle Of Repose 27.680
25.590
28.300
28.750
13

14. Result and discussion
1) Appearance -Nimesulide was found to be Yellow, Amorphous powder
having bitter test.
2) Melting Point- The melting point of Nimesulide was found to be 1430
C.
3) Calibration curve: Drug Nimesulide
14

15. Parameter from Calibration Curve
Concentration Absorbance
0.2 0.091
0.4 0.131
0.6 0.214
0.8 0.266
1.0 0.327
15
Calibration Curve of Nimesulide

16. Evaluation of Nimesulide Tablet-
CODE Thickness
(mm)
Diameter
(mm)
Weight
Variation
Hardness
(kg/cm)
Friability
(%)
Tensile
Strength
Water
Abs.
Ratio
DT*
(sec)
SSG1
0.540 0.816 Complies 2.10 0.8974 3.0656 65.92 42
SSG2
0.520 0.813 Complies 2.23 0.8438 3.3787 65.89 49
SSG3
0.520 0.820 Complies 2.26 0.7083 3.4242 66.82 55
MCC1 0.540 0.816 Complies 2.11 0.8974 3.0656 65.92 44
MCC2 0.520 0.813 Complies 2.22 0.8438 3.3787 65.89 51
MCC3
0.520 0.820 Complies 2.30 0.7083 3.4242 66.82 56
PS1
0.540 0.816 Complies 2.13 0.8974 3.0656 65.92 50
PS2
0.520 0.813 Complies 2.21 0.8438 3.3787 65.89 56
PS3
0.520 0.820 Complies 2.25 0.7083 3.4242 66.82 60
MS1
0.540 0.816 Complies 2.12 0.8974 3.0656 65.92 59
MS2
0.520 0.813 Complies 2.22 0.8438 3.3787 65.89 61
MS3
0.520 0.820 Complies 2.26 0.7083 3.4242 66.82 66
16

17. 17

18. Nimesulide is poorly water soluble drug hence by oral dispersion of
Nimesulide by direct compression method the dissolution of
Nimesulide can be enhanced. Direct compression method can be
used, because it is an easier, simplified and economical method of
manufacturing of tablets. Thus successful development of a novel
Nimesulide tablets fulfils the objective of work. The result showed that
the disintegration rate of drug in oral dispersed tablet was higher in
tablets prepared by using synthetic disintegrants as compared to
natural ones.
18

19. FUTURE PROSPECT:
According to the present scenario of pharmaceutical
industry, we can conclude that much effort must be
taken for enhancing solubility of class IIdrug to give
life to drug. Oral disintegrating tablet is one of the
most promising techniques giving so many attractions
from scientist due to its effect on improving solubility
& dissolution rate of poorly water soluble drug. Thus
efforts must be taken to develop innovative
formulation for enhancement of solubility of class2
drug.
19

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THANKS