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Thesis Presentation on:

Formulation, In-vitro Evaluation and Comparative Study
of Diclofenac Potassium Loaded Fast Dissolving Tablet
Using Natural and Synthetic Superdisintegrants

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Thesis presented by:
Nilu Kumari Rauniyar
Roll. No:-1088
5th Batch, B. Pharmacy
UCMS
Thesis supervised By: Thesis co-supervised By:
Mr. Chhitiz Thapa Mr. Pradhumann Chaudhary
Co-ordinator (Lecturer) Lecturer
Department of Pharmacy Department of Pharmacy
UCMS UCMS

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Contents
 Introduction
• Mechanism Of Drug Release
• Drug Profile

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 Literature Review
 Rationale Of Study
 Objective Of The Study
 Methodology
 Drug- excipient compatibility study
 Result and Discussion
 Conclusion
 Acknowledgement
 Refrences

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INTRODUCTION
Oral route, easy to self administered, a convenient, safe, natural and uncomplicated dosage form.

FDTS is a solid dosage form containing medicinal substance or active ingredient which

disintegrate fast usually within a few seconds when placed upon the tongue.

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MDTs tablet needs no water, fast action, easy to administered, accurate dosing being unit dosage

form , helpful for the non-cooperative patient.

Usually, superdisintegrants are added to the drug formulation to facilitate the breakup or

disintegration of tablets or capsule content into smaller particles that can dissolve more rapidly

than drugs in the absence of disintegrants.

Having no GI side effect, as it disintegrate in mouth.

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Mechanism of action of drug release:

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Click to edit Master title style Types of Super disintegrants

 Synthetic superdisintegrants: Example; Croscarmellose sodium (CCS), sodium

starch glycollate (SSG), crosspovidone, and modified cellulose.

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 Co processed superdisintegrants: Example; Ludiflash, pharmaburst, modified
mannitol, polacrilin potassium, and glucidex IT.

 Natural superdisintegrants: Example; Psyllium seed mucilage (Plantago ovate),

garden cress mucilage (Lepidium sativum), fenugreek seed mucilage (Trigonella
foenum-graecum), holy basil mucilage (Ocimum sanctum), mango peel
pectin(Mangifera indica), orange peel pectin(Citrus sinensis), banana powder,
jackfruit seed, locust bean, and Hibiscus rosa-sinensis.

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Drug profile of Diclofenac potassium
Drug properties Explanation
Name Diclofenac potassium
Category Non-steroidal, anti-inflammatory drug (NSAID)

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Molecular formula C14H10Cl2KNO2
Molecular weight 334.24 g/mol
Water solubility 0.00482 mg/ml
Oral bioavailability 50-60%
Half life 1.2-2 hr
Description White to off-white solid
Unit dose 50-100 mg
BCS class II
Mechanism of action COX-1 and COX-2 inhibitor thus inhibiting PG synthesis
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Click to edit Master title style Literature review
 Modi et al. conducted a study to formulate and evaluate a fast-dissolving tablet of
diclofenac sodium (50 mg) using different super disintegrants by direct compression
method. In the study, six different batches were prepared. It was concluded that a
combination of super disintegrants was best among all formulations and also fast-
dissolving formulations of diclofenac sodium to possess ideal and reproducible
characteristics of disintegration time and enhanced dissolution and thus give better

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patient compliance.

 Kumar and Babu., conducted a study to formulate diclofenac sodium as FDTs using
fenugreek gum as a natural super disintegrant. Nine batches of FDTs containing varying
proportions of fenugreek gum along with microcrystalline cellulose as diluents and
mannitol as sweetening agents were prepared by the direct compression method and
evaluated. It was concluded that formulation F3 containing fenugreek gum with a
concentration of 6% produced least disintegrating time 21 seconds resulting in a higher
drug release rate 93.74% at the end of 25 min. The characteristic peaks in the physical
mixture of diclofenac sodium and fenugreek gum indicated that the gum did not
interfere with the peak of the drug confirming its compatibility.

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Click to edit Master title style Rationale of the study

. Rationale:
 Indicated for mild to moderate pain, osteoarthritis, rheumatoid arthritis, gout attack,
acute migraine, etc.
 Conventional tablets leads toward patient Non compliance due to bitter taste, patient

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having swallowing problem, psychosis patient, slow action, GI , needs water for
administration, etc.
 Fast and rapid onset of action than the conventional formulation with increased
bioavailability and better therapeutic income.
 Improve patient compliance as it has no GI irritation.
 No need of water for the administration so can be take anywhere where
accessibility of water is difficult .
 Helpful in patient having swallowing problem, non-cooperative patient.

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Click to edit Master title style Objective of the study
General objective:
•Formulation, In-vitro Evaluation and Comparative Study of Diclofenac
potassium Loaded Fast Dissolving Tablet Using Natural and Synthetic
Superdisintegrants.

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Specific objective:
•To carry out extraction of superdisintegrants from natural plants.
•To study and evaluate the micromeretic properties of extracts and
powders of various formulations.
•To study the effect of different natural and synthetic superdisintegrants
on the tablet disintegrating property.
•To conduct a drug-excipient interaction study.
•To achieve better dissolution and absorption of the drug which will
produce quick onset of action.

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Click to edit Master title style Method of the study
Extraction of natural superdisintegrants:

1. Extraction of jackfruit seed starch:

 Jackfruit seed powder (5 gm) was added into 100 ml distilled water and set aside for 6–8 hours at
room temperature with constant stirring, filtered, and the sediment was washed with distilled

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water, precipitated overnight at 4°C, supernatant was discarded, and the crude starch was washed
with distilled water.

 The starch cake obtained was dried at 40°C for 24hours in a tray dryer and stored in dessicator .

2. Extraction of lepidium sativum mucilage:

 The seeds were soaked with 10 times its weight with distilled water and kept for 24 hrs and the
viscous solution obtained was passed through muslin cloth(8 folds).

 Then, the mucilage was precipitated well by the addition of 95% ethanol in the ratio 1:1 by
constant stirring.

 The coagulated mass was dried in an oven at 40-45°C, ground and was stored in a desiccator.
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3. Extraction of banana powder:
 Peels were removed and fruits were sliced.
 Sliced pulp was washed with distilled water to remove water-soluble contents and
was dried in oven at 45°C for 24 hours to get constant weight, ground and stored

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in dessicator.

4. Extraction of hibiscus mucilage:

 The powdered leaves of hibiscus were soaked in water for 5-6 hr., boiled for 30
min, and kept aside for 1hr. for complete release of the mucilage into water.
 The material was squeezed from an eight-fold muslin cloth bag to remove the
marc from the solution and acetone was added to the filtrate to precipitate the
mucilage in a quantity of three times the volume of the total filtrate.
 The mucilage was separated, dried, grounded and stored in dessicator.

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5. Extraction of mango peel pectin:
 Round bottom flask of Soxhlet apparatus containing acidified water (pH 2) using 0.5N
citric acid and powder in the ratio 8:1 were heated continuously at 75°C for 7-8 hr. after the
start of the first siphon cycle.

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 After the heating period was over, it was passed through a two-fold muslin cloth and cooled
to room temperature.
 Double amount of ethyl alcohol was added to the solution with continuous stirring for 15
min, kept aside for 2hr.
 Pectin was precipitated and filtered through 4-layered muslin cloth, washed 2-3 times by
ethyl alcohol, dried at 35-40°C in hot air oven, and stored in desiccator until use.

6. Extraction of fenugreek powder:

 The dried fenugreek seeds were collected and size reduction was done in the grinder then
and stored in a desiccator.

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Click to edit Master title style Evaluation parameter of
natural extracts:
a. Qualitative phytochemical screening:
The different qualitative chemical tests were performed for establishing
profile of given extracts for their chemical composition. Different
chemical tests were performed to detect proteins, carbohydrates

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alkaloids, polysaccharides, amino acids, flavonoids, glycosides, phenolic
compounds and saponins The different qualitative chemical tests were
performed for establishing profile of given extract for its chemical
composition.
b. Physiochemical characterization:
The obtained extracts were evaluated for their physiochemical properties
like pH, solubility, viscosity swelling index, loss on drying, ash value, etc.
c. Micromeretic properties:
Micromeretic properties of extracts powder were evaluated which include
angle of repose, bulk density, tapped density, carr's index and hausner's
ratio.
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Click to edit Master title style Preparation of fast dissolving tablets
 Weighed quantities of API and excipients were shifted through stainless
steel sieve (#80).
 Initially the MCC and the API i.e., diclofenac potassium was mixed
homogeneously, then supaerdisintegrants and aspartame was mixed in
geometric order.

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 Lubrication was done with magnesium stearate and talcum powder in
polybag and was compressed using 8 station compression machine.
 Fenugreek powder, Jackfruit extract, banana powder, Lepidium sativum
powder, hibiscus leaf mucilage, mango peel pectin were used as a natural
super disintegrants, sodium starch glycolate (SSG) and SSG was used in
combination with natural super disintegrants.

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 Formulation design
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Chemicals F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12 F13

Diclofenac potassium 50 50 50 50 50 50 50 50 50 50 50 50 50

MCC 187 187 187 187 187 187 187 187 187 187 187 187 187

SSG - - - - - - 30 15 15 15 15 15 15

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Fenugreek powder 30 - - - - - - 15 - - - - -

Jackfruit starch - 30 - - - - - - 15 - - - -

Banana powder - - 30 - - - - - - 15 - - -

Lepidium sativum - - - 30 - - - - - - 15 - -

Hibiscus leaf mucilage - - - - 30 - - - - - - 15 -

Mango peel pectin - - - - - 30 - - - - - - 15

Aspartame 24 24 24 24 24 24 24 24 24 24 24 24 24

Magnesium stearate 3 3 3 3 3 3 3 3 3 3 3 3 3

Talcum powder 6 6 6 6 6 6 6 6 6 6 6 6 6

Total wt. (in mg) 300 300 300 300 300 300 300 300 300 300 300 300 300
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Click to edit Master title style Evaluation parameter
Evaluation parameter

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-Tapped density
-Hausner’s ratio
-Carr’s index
-Angle of repose

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Click to edit Master title style Preparation of calibration curve of
Diclofenac potassium
In phosphate buffer (pH 6.8, λmax=276nm)

Calibration data Calibration curve

Absorbance
0.35
Concentration( µg/ml ) Absorbance

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0.3
f(x) = 0.03 x + 0.01
1 0.048 R² = 0.98
0.25
Absorbance
2 0.0765 0.2 Linear (Absorbance)

0.15
4 0.1055
0.1

6 0.177
0.05

8 0.2565 0
0 2 4 6 8 10 12

Concentration
10 0.2905

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Click to edit Master title style Results and Discussion
Isolation of natural extracts:

Mucilage extracted from chamsur Dried mucilage

extract
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Fenugreek powder Jackfruit powder Banana powder Chamsur

Hibiscus extract Mango peel pectin

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Phytochemical tests results for natural extracts
Chemical tests for Tests Fenugreek Jackfruit Banana Lepidium Hibiscus Mango

Carbohydrates Molisch’s + + + + + +
Fehling’s _ _ + _ _ _

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Polysaccharides Iodine + + + + + +

Alkaloids Mayer’s _ _ _ _ _ _
Wagner’s + _ _ _ _ _
Glycosides Kellar Kelani _ _ _ _ _ _

Protein Biuret _ _ _ _ _ _

Amino acids Ninhydrins _ _ _ _ _ _

Phenolic Ferric _ _ _ _ _ _
compounds chloride

Flavonoids Lead acetate + + + + + +

saponins Foam _ _ _ _ _ _

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Fig: Phytochemical tests of Fenugreek powder Fig: Phytochemical tests of Jackfruit extract

Fig: Phytochemical tests of Banana powder Fig: Phytochemical tests of Chamsur mucilage
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UCMS Fig: Phytochemical tests of Mango peel pectin

Fig: Phytochemical tests of Hibiscus mucilage

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Physiochemical tests results of naural extracts:
Characters Fenugreek Jackfruit Banana Lepidium Hibiscus Mango

Colour Yellowish- Brownish Brown Light brown Green Dark brown

brown white

Odor Pungent Odorless Sweet Odorless Characteristic Aromatic

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Taste Pungent Tasteless Sweet Tasteless Bitter Sour

pH (1%w/v) 7.16 6.78 7.02 6.42 6.37 5.05

Swelling index % 135 87 78 153 148 63.5

%LOD 6.32 5.89 5.63 6.54 7.01 5.48

Total Ash value 4.42 3.31 3.79 2.18 2.87 3.63
% yield 97% 19% 67% 9.7% 11.32% 7.8%

Solubility in cold Swells Insoluble Insoluble Swells Swells Swells

water

Solubility in hot Insoluble Slightly Insoluble Soluble Soluble Soluble

water soluble

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Micromeretic properties of extracts:

Properties Fenugreek Jackfruit Banana Lepidium Hibiscus Mango

Bulk density 0.51±0.03 0.48±0.01 0.42±0.02 0.50±0.03 0.55±0.05 0.53±0.02

(gm/cm )

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Tapped density 0.60±0.02 0.61±0.01 0.54±0.01 0.62±0.03 0.64±0.01 0.67±0.02

(gm/cm3)

Hausner’s ratio 1.17±0.06 1.27±0.03 1.28±0.08 1.24±0.10 1.16±0.01 1.26±0.03

Carr’s index(%) 15.00±0.02 21.31±0.10 22.23±0.2 19.35±0.06 14.06±0.03 20.89±0.05

Angle of 27.25±0.03 37.0 ±0.02 22.36±0.04 19.45±0.03 20.17±0.01 19.09±0.03

repose(Ɵ)

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Drug-excipient compatibility study

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Fig: FTIR spectrum of pure drug
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Fig: FTIR spectrum of mixture of drug and sodium starch glycolate

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Fig: FTIR spectrum of mixture of drug and fenugreek powder

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Fig: FTIR spectrum of mixture of rug and jackfruit powder
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Fig: FTIR spectrum of mixture of drug and banana powder
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Fig: FTIR spectrum of mixture of drug and Lepidium sativum mucilage
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Fig: FTIR spectrum of mixture of drug and hibiscus leaf mucilage

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Fig: FTIR spectrum of mixture of drug and mango peel pectin

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• IR spectra of pure drug of Diclofenac displayed a characteristic peak at

3384.80 cm-1 because of N-H extending of the secondary amine, 1575.75
cm-1 attributable to –C=O extending of the carboxyl particle, at 747.66 cm -1
given C-Cl extending and an intense, well-defined peak, infrared band at
around 1502.85 cm-1 (C=C).

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• Similar peaks are observed from the obtained spectrum of mixture of drug
and other excipients. Since there is no any significance difference in the
observed peak of functional group it is concluded that there is no
interaction between the drug and excipients.

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Click to edit Master title style Pre-compression evaluation
Formulation Bulk Tapped Carr’s index Hausner’s Angle of
code density(gm/cm³) density(gm/cm³) (%) ratio repose(ѳ)

F1 0.43±0.03 0.53±0.06 18.86±0.4 1.23±0.05 29.36±0.3

F2 0.45±0.02 0.56±0.04 19.64±0.2 1.24±0.2 28.45±0.2

F3 0.42±0.10 0.54±0.30 22.32±0.06 1.28±0.07 30.15±0.04

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F4 0.46±0.20 0.55±0.03 16.36±0.5 1.19±0.06 29.58±0.06

F5 0.49±0.06 0.59±0.20 16.95±0.3 1.20±0.4 31.43±0.10

F6 0.43±0.05 0.55±0.05 21.81±0.01 1.27±0.03 28.46±0.04

F7 0.41±0.03 0.53±0.04 22.64±0.06 1.29±0.10 29.28±0.05

F8 0.47±0.04 0.60±0.08 21.31±0.1 1.27±0.30 31.76±0.02

F9 0.42±0.04 0.52±0.06 19.23±0.3 1.24±0.06 26.43±0.3

F10 0.47±0.06 0.61±0.20 22.95±0.4 1.30±0.3 31.93±0.20

F11 0.45±0.08 0.58±0.16 22.41±0.03 1.28±0.2 30.65±0.05

F12 0.45±0.04 0.57±0.10 21.05±0.21 1.26±0.3 27.84±0.30

F13 0.44±0.03 0.56±0.05 21.42±0.3 1.27±0.1 28.31±0.3

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 Post-compression evaluation
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of tablets
Formulation Weight Thickness( Hardness Friability D.T Wetting Disper- Assay
No. variation mm)±SD, (kg/cm2) (%) (sec) time (sec) sion %
(mg)±SD, n=10 ±SD, n=10 time
n=20 (sec)
F1 301±0.91 5.50±0.10 2.44±0.01 0.32 22 73 69 99.32

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F2 301±0.35 5.38±0.02 2.58±0.12 0.21 24 70 65 99.04
F3 304±0.45 5.35±0.05 2.94±0.62 0.22 28 87 85 101.48
F4 298±0.90 5.40±0.10 2.45±0.40 0.34 19 69 58 97.31
F5 297±2.06 5.32±0.08 2.83±0.27 0.29 21 81 72 94.90
F6 300±0.51 5.31±0.01 2.90±0.48 0.33 29 94 78 99.60
F7 296±1.01 5.48±0.02 2.88±0.12 0.47 27 72 64 95.62
F8 301±2.13 5.40±0.04 2.54±0.16 0.45 22 76 68 98.47
F9 303±0.53 5.35±0.02 2.46±0.27 0.31 23 74 62 102.08
F10 300±0.63 5.29±0.06 2.48±0.16 0.25 26 78 72 99.37
F11 302±1.32 5.30±0.05 2.42±0.56 0.53 21 72 60 101.22
F12 301±1.69 5.49±0.04 2.86±0.13 0.25 22 76 67 99.64
F13 299±0.76 5.25±0.05 2.76±0.46 0.46 27 82 75 98.56
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• The maximum wetting time (94sec) was found in F6 comprising mango

pectin peel. This might be due to the fact of lower swelling property of
mango peel pectin.
• The minimum wetting time was found in F4 formulation (69 sec)
comprising the extracts of Lepidium sativum, which might be due to the

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greater swelling property of the extract.
• The maximum dispersion time (85 sec) was found in F3 whereas minimum
dispersion time (58 sec) was found in F4 formulation.
• Dispersion time correlates with the wetting time and disintegration
property of super disintegrants. F4 formulation shows better dispersion
time than other formulation as it swells absorbing water quickly.

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• Formulation of Lepidium seed extracts was found to possess good

disintegrating property (19 sec) than others. This might be because the
mucilage at higher concentration swells and tablet disintegrate rapidly
enhancing increase in drug release.
• The disintegration time was higher in F6 comprising mango peel pectin. This

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might be due to poor swelling property compared to other extracts.
• The disintegration time of sodium starch glycolate formulation is slightly
higher (27 sec) as compared to the majority of natural super disintegrants due
to its gelling and its subsequent viscosity producing effect.
• While, SSG in combination with natural super disintegrants in the ratio 1:1
unveiled similar disintegration time as compared to natural super
disintegrants within the range of 21 to 27 sec in F11 and F13 respectively.
This might be due to the combined effect of natural and synthetic super
disintegrant.

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Click to edit Master title style In-vitro drug dissolution study
Time 0 5 10 15 20 25 30
(min)
F1 0 36.23±3.21a 46.20±3.90a 63.62±5.99a 72.46±6.98a 83.43±7.20a 90.62±7.90a
F2 0 35.54±3.60a 47.59±4.50a 62.15±5.90a 74.29±7.12a 87.63±8.52a 90.15±9.10a
F3 0 32.93±2.89a 41.02±3.82a 56.42±5.43a 66.89±6.66a 79.33±7.89a 88.42±8.63a
F4 0 38.57±3.42a 47.24±4.56a 63.29±6.11a 71.62±6.98a 81.22±7.67a 93.02±8.79a

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F5 0 36.48±3.54a 47.37±4.53a 62.32±5.78a 73.61±7.10a 84.32±8.32a 91.42±8.76a
F6 0 31.53±3.22a 42.32±4.21a 59.67±5.87a 68.66±6.50a 77.89±7.52a 86.42±8.39a
F7 0 35.27±3.39a 48.62±4.62a 62.39±5.79a 77.43±7.62a 84.39±8.07a 90.07±8.91a
F8 0 31.62±2.97a 43.88±4.07a 59.62±5.32a 69.42±6.52a 78.82±7.67a 90.66±8.60a
F9 0 34.62±3.27a 45.40±4.13a 57.42±5.39a 67.48±6.55a 76.65±7.63a 90.78±8.75a
F10 0 29.43±2.23a 37.26±3.62a 53.49±5.21a 61.66±5.64a 76.62±6.53a 89.43±8.59a
F11 0 33.39±3.10a 46.62±4.50a 64.19±5.45a 76.68±6.31a 86.48±7.45a 91.02±8.37a
F12 0 36.27±3.21a 46.22±3.60a 62.31±4.58a 75.42±6.15a 85.41±7.42a 90.66±8.32a

F13 0 32.62±2.16a 44.62±3.22a 61.63±2.34a 69.42±4.35a 78.03±5.78a 89.40±6.81a

Marketed 0 3.56±0.28b 5.80±1.22b 11.20±1.67b 16.38±1.81b 23.54±1.90b 29.60±2.20b

The values are expressed as mean ± SD. The different letter superscript within the cumulative % are significantly
different (p>0.05) 37
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• F2 formulation (Lepidium) exhibit a higher cumulative percentage drug

release with 93.42±8.79% compared with a tablet containing sodium starch
glycolate with 90.07±8.91% in 30 minutes. This might be due to the reason
that tablets prepared with SSG disintegrate because of the rapid uptake of
water followed by rapid swelling but more slowly due to the formation of a

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viscous gel layer at higher concentration.
• The percent cumulative drug release of combined SSG and natural super
disintegrants (1:1) also exhibited similar results like natural super
disintegrants, unlike mango peel pectin.
• All the formulations exhibited significant drug release compared to
marketed formulations (p<0.05). The cumulative in vitro drug release of
the marketed formulations was significantly lower with 29.60±2.20% in 30
min.

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% cumulative release

% cumulative release of F1, F2, F3, F4

100

90

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80

70

60
F1
50 F2
F3
F4
40

30

20

10

0
0 5 10 15 20 25 30 35

Time (min)

Comparison of drug release profile of F1, F2, F3, and F4

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% cumulative release of F5, F6, F7

% cumulative release

100

90

80

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70

60
F5
50 F6
F7
40

30

20

10

0
0 5 10 15 20 25 30 35

Time (min)

Comparision of drug release profile of F5, F6, and F7

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% cumulative release of F8, F9, F10

100

90

80

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% cumulative release

70

60
F8
50 F9
F10
40

30

20

10

0
0 5 10 15 20 25 30 35

Time (min)

Comparison of drug release profile of F8, F9 and F10

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% cumulative release of F11, F12, F13 and marketed tablet

100

90

80
% cumulative release

70

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60
F11
50 F12
F13
40 M

30

20

10

0
0 5 10 15 20 25 30 35

Time (min)

Comparision of drug release profile of F11, F12, F13, and marketed product

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Conclusion
 The formulation prepared from the natural super disintegrant shows
comparable dissolution rate, disintegration time and wetting time with the
formulations prepared from most widely used synthetic superdisintegrants
(SSG).

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 Since the natural extract shows comparable effect with the synthetic
superdisntegrants, it can be concluded that by the use of locally available
natural superdisintegrants, fast dissolving tablets can be prepared.

Future Prospects:
 Stability study of the formulation could be carried out.
 In-vivo study of the formulation can be performed.
 Clinical trial could be carried out.

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Click to edit Master title style Acknowledgement
It is a genuine pleasure to express my deep sense of thanks and gratitude
to all who have encouraged me to complete this task. I am highly
indebted to ;
 Supervisor (Co-ordinator): Mr. Chhitij Thapa

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 Co-supervisor: Mr. Praddhuman Chaudhari
 Principal
 Mr. Bhojraj Bhasyal (QA manager, Siddhartha Pharmaceuticals Pvt.Ltd).
 My parents
 Seniors
 Classmates and
 Juniors

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Click to edit Master title style References

1. Sona P, Muthulingam C. Formulation and evaluation of taste masked orally

disintegrating tablets of diclofenac sodium. Int J PharmTech Res. 2011;3(2):819-
826.
2. Beri C, Sacher I. Development of fast disintegration tablets as oral drug delivery
system-A review. Indian J Pharm. 2013;(1):324-329.

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3. Deshmkh H, Chandrashekhara S, Nagesh C, Murade A, Usgaunkar S.
Superdisintegrants: A recent investigation and current approach. Asian Journal of
Pharmacy and Technology. 2012;2(1):19-25.
4. Suryadevara V, Lankapalli SR, Danda LH, Pendyala V, Katta V. Studies on
jackfruit seed starch as a novel natural superdisintegrant for the design and
evaluation of irbesartan fast dissolving tablets. Integrative Medicine Research.
2017;6(3):280-291.
5. URL-1 (https://pubchem.ncbi.nlm.nih.gov/compound/Diclofenac)
6. Modi A, Pandey A, Singh V, Bonde C, Jain D and Shinde S (2012) Formulation
and Evaluation of Fast Dissolving Tablets of Diclofenac Sodium Using Different
Superdisintegrants by Direct Compression Method. International Journal of
Pharmaceutical & Biological Archives 2012; 3(4):1003-1007.

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7. Kumar MU, Babu MK. Design and evaluation of fast dissolving tablets
containing diclofenac sodium using fenugreek gum as a natural
superdisintegrant. Asian Pacific Journal of Tropical Biomedicine. 2014;
(4):329-334.
8. Sharma V, Arora V. Comparison of various natural superdisintegrants in

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the formulation of fast dissolving carvedilol tablet. International Journal
of Pharmaceutical Sciences and Research. 2012;3(10):39-47.
9. Bharathi A, Basha SK, Deepthi K, Phanindra MC. Formulation and
evaluation of Telmisartan orodispersible tablets by using banana powder.
Indian Journal of Research in Pharmacy and Biotechnology.
2014;2(1):982-987.
10. Bala R, Madaan R, Vibhu A, Arora S. Isolation and Evaluation of Hibiscus
rosa-sinensis leaf mucilage as superdisintegrant. Eur J Pharm Med Res.
2016;(3):434-440.
11. Malviya R, Srivastava P, Bansal M, Sharma PK. Mango peel pectin as a
superdisintegrating agent. Polim. Med. 2010;(42):185-190.

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46
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12. Swain, RP, Nagamani R, Panda S. Formulation, in vitro characterization

and stability studies of fast dispersing tablets of diclofenac sodium. Journal
of Applied Pharmaceutical Science. 2015;(5):094-102.
13. Kantharao CH, Swarna K, Leelakrishna J, Anusha B, Bhavani B.

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Diclofenac Orodispersible Tablets: Formulation and In Vitro Evaluation.
Ann Clin Lab Res. 2019;(7):180-187.
14. Bala R, Madaan R, Vibhu A, Arora S. Isolation and Evaluation of Hibiscus
rosa-sinensis leaf mucilage as superdisintegrant. Eur J Pharm Med Res.
2016;(3):434-440.
15. Mohanachandran P, Sindhumol P, Kiran T. Superdisintegrants: an
overview. International Journal of Pharmaceutical Sciences Review and
Research. 2011;6(1):105-109.

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