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Formulation, in-vitro evaluation and comparative study of diclofenac

potassium loaded fast dissolving tablet using natural and synthetic
superdisintegrants

Article · January 2022

DOI: 10.31838/ijpr/2021.13.03.106

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 ISSN 0975-2366
DOI:https://doi.org/10.31838/ijpr/2021.13.03.106
Research Article

Formulation, in-vitro evaluation and comparative

study of diclofenac potassium loaded fast dissolving
tablet using natural and synthetic superdisintegrants
CHHITIJ THAPA1, NILU KUMARI RAUNIYAR1, ANITA YADAV2*, PRADYUMNA CHAUDHARI2
1,2
Department of Pharmacy, Universal College of Medical Sciences, Tribhuvan University, Siddhartha
Nagar, Rupandehi 32900, Nepal
*Corresponding author:
Email: anita.yadav2047@gmail.com
Received: 15.02.21, Revised: 09.03.21, Accepted: 04.04.21

ABSTRACT
The study aims to extract and characterize starch and mucilage from Jackfruit seeds, Banana powder, Hibiscus
leaves, Fenugreek seed, Mango peel, and Lepidium sativum and using these dry extracts as a natural
superdisintegrant in the formulation of fast dissolving Tablets and comparing disintegration time with a
commercially available synthetic superdisintegrant, Sodium Starch Glycolate. Various phytochemical test
concludes the presence of polysaccharides in the extracts of natural superdisintegrants while no indications of
the presence of alkaloids, glycosides, proteins, saponins, and other phenolic compounds were observed.
Thirteen different formulations of diclofenac potassium loaded FDTs were prepared by the direct compression
method and were subjected for both pre-compression and post-compression studies. Flow properties
depicted the formulations to be within the considerable range indicating a good flow of powders while post-
compression studies including weight variation, thickness, hardness, and friability of different formulations were
within the acceptable limit.
A drug-excipient compatibility study was conducted using the FTIR spectrophotometer indicating no
interaction between the drug and excipient. In vitro drug disintegration studies suggests minimum
disintegration time in F4 with 19 seconds and maximum in F6 with 29 seconds. In vitro drug release also
suggests a similar result with maximum drug release in F4 with 93.42±8.79 % and minimum in F6 with
86.42±8.36 %. Percentage drug release from the fast disintegrating Tablets formulations was observed to be
significant (*P<0.05) when compared with the marketed product of Diclofenac potassium oral Tablets in acidic
medium. The data were analyzed by Tukey’s post hoc multiple compression test.
Keywords: Fast dissolving Tablets, Diclofenac potassium, Disintegration time, Natural and synthetic super
disintegrants, Direct compression method.

INTRODUCTION United States Food and drug administration (FDA)

Fast dissolving Tablets (FDT’s) are the solid unit
dosage forms which when placed in the oral
cavity disintegrates within 15-60 sec or less
without the need for water [1]. FDT’s are thus
helpful in the patient having difficulty in
swallowing and in a condition where there is no
access to water. FDT’s are helpful in geriatric,
pediatric, and other bed-ridden patients who
have difficulty in swallowing the conventional
Tablet or capsule [2]. Sometimes FDT’s are also
called orodispersible Tablets, mouth-dissolving
Tablets, melt-in-mouth Tablets, rapid melts,
porous Tablets, quick-dissolving, and so forth.
The small volume of saliva is usually sufficient to
result in Tablet disintegration in the oral cavity
where the disintegration of Tablets has received
significant attention as a major step for faster
release of drugs [3].
defined FDT as "A solid dosage form containing
the medicinal substance or active ingredient
which disintegrates fast usually within a few
seconds when placed upon the tongue."FDT's
differs from conventional Tablets as they are
intended to be consumed on the tongue instead
of being swallowed in their whole. In cases like
sore throat the patient experiences difficulty in
swallowing a conventional dosage form like
Tablet and capsule, in this case, the FDT seems to
have a promising result on improving the
medication, patient compliance, and convenience
by riding the lag time by providing the faster
onset of action of the drug [4]. Various methods
are currently practiced for formulating the FDT’s
that include freeze-drying (lyophilization), Tablet
molding, spray drying, sublimation, and direct
compression by masking the Tablet [5]. The key
excipient used in the formulation of FDT includes

713| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants
the superdisintegrants which increases the rate of
disintegration of the compacted mass when
placed into a fluid environment [6]. However, it is
important to choose an optimum concentration of
superdisintegrants to ensure rapid disintegration
and high Tablet dissolution levels. If the
superdisintegrants concentration exceeds the
critical concentration, the time of disintegration
may remain steady, or may even rise. The
primary working mechanism of the
superdisintegrants might be due to their capillary
and swelling action, deformation recovery, the
heat of wetting, chemical reaction, enzymatic
reaction, or particle repulsive forces [3].
Diclofenac is a non-steroidal anti-inflammatory
drug (NSAIDs)with several therapeutic usages
considered safe and effective. It belongs to the
class II category as per the Biopharmaceutical
Classification System (BCS) owing to its low
solubility and high permeability. It delivers its
action by inhibiting cyclo-oxygenase enzyme and
modulating the release and uptake of arachidonic
acid and is used for various clinical conditions like
musculoskeletal complaints, especially arthritis
(rheumatoid arthritis, osteoarthritis,
spondylarthritis, ankylosing spondylitis), and in
acute and chronic pain management [7,8,9,10].
It is well absorbed orally and undergoes first-pass
metabolism with 50-60% bioavailability. The
normal adult dose is 50 mg and has a plasma
half-life of 1.2-2 hr. It is free-soluble in methanol,
soluble in ethanol (95%), sparsely soluble in water
and glacial acetic acid, nearly insoluble in ether,
chloroform, and toluene [11].
The study attempts to formulate the FDT of
diclofenac potassium. Various mucilage and
powders extracts were used as a natural
superdisintegrants. FDT formulated by natural
superdisinegrants were undertaken for various
pharmacopeia test and comparative study were
performed for FDT’s using synthetic
syperdisintegrants.
MATERIALS AND METHODS
Diclofenac potassium was kindly gifted by Apple
International Pharmaceuticals Pvt. Ltd. Tilottama-
8, Rupandehi, Lumbini, Nepal. Sodium starch
glycolate (SSG) was purchased from SD fine
chemicals. Other excipients and chemicals were
available at the college laboratory. The study was
conducted after getting ethical approval from
Institutional Review Committee of Universal
College of Medical Sciences.
1.1. Extraction of natural super
disintegrants
1.1.1. Extraction of starch from jackfruit seed
714| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
The extraction of starch from jackfruit seeds was
carried via an aqueous extraction process.
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. Then the
slurry was filtered through eight folded muslin
cloth, and the remaining sediment was washed
with distilled water three times. The filtrates were
collected and precipitated at 4 °C overnight. The
supernatant was removed, and the coarse starch
was washed with distilled water. The process was
repeated for three times, and the starch cake
obtained was dried at 40°C for 24 hours in a hot
air oven. The starch cakes were ground with a
mortar and pestle and were packed in air-tight
containers and stored at room temperature [3].
1.1.2. Preparation of dehydrated Banana
powder
Banana peels were removed and fruits were
sliced. Sliced pulp was washed with distilled water
to remove water-soluble contents and were dried
in an oven at 45°C until a constant weight was
observed. The dried pulps were finely grounded
and sieved [12].
1.1.3. Isolation of pectin from mango peel
Dried mango peel powder was used for extracting
pectin using the Soxhlet apparatus. The round
bottom flask containing acidified water (pH 2)
using 0.5N citric acid was heated continuously at
75°C for 7-8 hrs after the start of the first siphon
cycle. Powder to solvent was maintained at the
ratio of 1:8. After the heating period was over,
the mixture was passed through a two-fold muslin
cloth and cooled to room temperature. The
solution was added twice the amount of ethyl
alcohol with continuous stirring for 15 min, the
resulting mixture was held aside for 2hrs. Pectin
was precipitated through a 4-layered muslin cloth
and filtered. Ethyl alcohol was used to wash the
precipitate 2-3 times, to further eliminate any
residual impurities. Finally, Precipitate was placed
in a hot-air oven for drying at 35-40° C,
powdered, sieved, and placed in a desiccator
until use [13].
1.1.4. Extraction of mucilage from Hibiscus
rosa-Sinensis
For the extraction of mucilage from Hibiscus rosa-
Sinensis, new leaves were amassed, washed with
water to clean dirt and debris, and dried. The
dried leaves were finely grounded to obtain the
powder and were soaked in water for 5-6 hours,
boiled for 30 min, and held aside for 1 hour for
complete release of the mucilage into water.
Leaves were squeezed from a four-fold muslin
cloth bag for complete removal of mucilage into
the solution. To precipitate the mucilage, a
double volume of acetone was introduced to the
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants
filtrate. The precipitate was isolated, dried in an
oven at a temperature of 50 ° C, powdered,
sieved, and placed in desiccators until use [14].
1.1.5. Isolation of Mucilage from Lepidium
Sativum
The Lepidium sativum seeds comprise mucilage
covering the outer layer. Mucilage was extracted
with distilled water by soaking the seeds and
stored for 24 hours. The mucilage solution was
passed through 2-folds of muslin cloth and
precipitated by adding 95 % ethanol in the ratio
1:1 with constant stirring. The coagulated mass
was dried in an oven at 40-45 ° C, ground to a
finely divided powder, sieved and placed in a
desiccator until use [15].
a)Preparation of fenugreek seeds powder[16]
The dried fenugreek seeds were collected and
finely grounded, sieved, and placed in a
desiccator until further use.
2.2. Qualitative phytochemical screening of
extracts[17]
2.2.1. Tests for carbohydrates
To 5 ml of distilled water 100 mg of extracts were
dissolved and filtered.
Molisch’s test
To 2ml of filtrate, two drops of alcoholic solution
of α-naphthol (Molisch's reagent) were added and
the mixture was shaken well. To the mixture, 1 ml
of concentrated sulphuric acid was gradually
introduced along the side of the test tube and
allowed to stand. A violet ring shows the presence
of carbohydrates.
Fehling’s test
To 1 ml of Fehling solution A and 1 ml of Fehling
solution B, 1 ml of filtrate was boiled in a water
bath. Red precipitate suggests the presence of
sugar.
2.2.2. Test for polysaccharide
To dried mucilage powder, 1 ml of 0.2 N Iodine
solution was added. No color development
confirms positive test for polysaccharides.
2.2.3. Test for alkaloids
To 10 ml of dilute hydrochloric acid, an extract of
100 mg was mixed and filtered. To a few ml of
filtrate (2 ml), few drops of Wager’s reagents
were added by the side of the test tube. A
reddish-brown precipitate confirms the test as
positive. Similarly, few drops of Mayer's reagent
were added to a filtrate (2ml). The appearance of
a white or creamy precipitate indicates the
presence of alkaloids in the sample.
2.2.4. Test for glycosides
For the detection of glycosides, the Keller Kellani
test was performed. 50 mg of extracts was stirred
with 5 ml distilled water and was filtered. 2 ml of
glacial acetic acid was added with 2-3 drops of
715| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
ferric chloride solution. To the solution, 1 ml of
conc. H2SO4 was added by the side of the test
tube. A green ring initially appears which first
turns to violet and then to brown at the interphase
which suggests the presence of glycosides.
2.2.5. Test for phenolic compound and
flavonoids
Ferric chloride test
To 5 ml of distilled water 50 mg of extract was
introduced. To this few drops of neutral 5%, a
ferric chloride solution was introduced. A dark
green color infers the presence of phenolic
compounds.
Lead acetate test
To 5 ml of distilled water, 50 mg of extract was
mixed and 3 ml of 10% lead acetate solution was
introduced. Bulky white precipitate infers the
presence of flavonoids compounds.
2.2.6. Test for protein and amino acids
To 10 ml of distilled water, 100 mg of extracts
was dissolved.
Biuret test
2 ml of filtrate was treated with a drop of 2%
copper sulfate solution. To this 1 ml of ethanol
(95%) was introduced, followed by a sufficient
amount of potassium hydroxide pellets. The pink
color of the ethanoic layer depicts the presence of
proteins.
Ninhydrin test
To 2 ml of the filtrate, two drops of ninhydrin
solution (10 mg of ninhydrin in 200 ml of
acetone) was incorporated. A characteristics
purple color suggests the presence of amino
acids.
2.2.7. Foam test for saponins
50 mg of the extract was taken and diluted with
distilled water up to 20 ml. The suspension was
agitated in a graduated cylinder for 15 minutes.
The presence of saponins was indicated by the
presence of the 2 cm layer of foam.
2.3. Physiochemical characterization of extracts
2.3.1. Organoleptic characterization
The purified extract was evaluated for
organoleptic characters such as appearance,
color, odor [18].
2.3.2. Loss on drying
Loss on drying was determined by drying
accurately weighed quantity of extract at
105±5°C in hot air oven until a constant weight
of extract was obtained [18]. Loss on drying was
calculated by using the following formulae:
2.3.3 Ash value determination
Three gm of the sample was taken in finely clean
silica crucible and ignited for 4 hours with
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

gradually increasing in temperature up to 450 oC
to make it dull red hot until free from carbon. The
crucible was cooled and weighed. The procedure
was repeated to get constant weight. The
percentage of total ash was calculated [19].
2.3.4. pH value determination of extract
The pH of 1% w/v solution of extract in distilled
water was determined using a digital pH meter at
25°C [18].
2.3.5. Solubility test
One part of dry extract powder was shaken with
different solvents including methanol, ethanol, hot
water, cold water for the determination of
solubility behavior of the extract [20].
2.3.6. Swelling Index
Accurately weighed (1g) powdered mucilage was
taken in 25ml of the graduated cylinder and the
initial volume was noted. The desired volume was
maintained with distilled water and allowed to
stand for 24 hours at room temperature [19]. The
swelling index was calculated using the following
formula:
2.3.7. Flow properties of the extract
The dried extracts were tested for flow property
study. The study on the angle of repose, bulk
density, tapped density, compressibility index, and
Hausner's ratio was carried on. The experiments
were run in triplicate and the results were
expressed as mean±SD.
2.3.8. Drug-excipient interaction studies
FTIR spectrum of the pure drug and mixture of
drug with polymers were recorded. The mixture of
drug and polymer was stored at 40°C and 75%
relative humidity for 30 days. The samples were
run in an IR range of 650-4000 cm-1. The
significant shift in characteristics wave number of
any functional group concerning pure drug in the
drug excipient mixture was evaluated [1].
2.4. Preparation of fast disintegrating Tablet of
Diclofenac potassium
Different formulations were prepared by the direct
compression method using natural
superdisintegrants as depicted in Table 1.
Weighed quantities of excipients were shifted
through stainless steel sieve. Microcrystalline
cellulose (MCC) was used as a diluent and was
initially mixed with diclofenac potassium
homogeneously. Extracts of fenugreek, jackfruit,
banana, Lepidium, hibiscus and mango peel
pectin were used as a natural super disintegrant.
Aspartame was used as a sweetening agent,
while talcum and magnesium stearate was used
as a glidant and lubricating agent respectively. All
the excipients were added and were geometrically
mixed. The resultant powder mixture was
compressed using a rotary multiple compression
machine [8]. Similar formulations were prepared
using SSG as a superdisintegrant in single and in
combination with natural super disintegrants as
depicted in Table. 1.

Table 1: Formulation design involving different diclofenac loaded FDT’s formulations

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
Fenugreek powder 30 - - - - - - 15 - - - - -
Jackfruit starch - 30 - - - - - - 15 - - - -
Banana powder - - 30 - - - - - - 15 - - -
Lepidium sativum - - - 30 - - - - - - 15 - -
Hibiscus leaf - - - - 30 - - - - - - 15 -
mucilage
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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 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants
3. Evaluation of Tablets
3.1. Pre-compression parameters
3.1.1. Bulk Density
The apparent bulk density of the powder was
estimated by pouring the powder mixture into a
graduated cylinder. The bulk volume (Vb) and
weight of powder (M) were determined. The bulk
density was calculated [34].
3.1.2. Tapped Density
The measuring cylinder comprising the known
blend mass was tapped for a fixed period. The
minimum volume (Vt) in the cylinder and the
weight (M) of the blend were assessed. The
tapped density (ρt) was calculated [22].
3.1.3. Hausner’s Ratio
Hausner's ratio (HR) is an indirect index of ease of
flow of powder. It is defined as the ratio of tapped
density to the bulk density of the powder [21].
3.1.4. Carr’s index
The easiest way of measuring the flow of the
powder is its compressibility, an indication of the
ease with which the material can be caused to
flow is offered by the carr’s index (I) [23]. Carr’s
index was calculated as:
3.1.5. Angle of repose
The angle of repose of the powder blend was
estimated with the help of the fixed funnel
method. The height of the funnel was customized
in a way that the tip of the funnel just touches the
peak of the powder blend. The powder blend was
allowed to flow freely via the funnel to a surface
till the cone was formed, with its peak just
touching the tip of the funnel. The angle of repose
was calculated [20, 37].
Tan Ɵ = h/r
Where, Ɵ = Tan-1(h/r),
h = height of pile and r = radius of the base of
the pile
3.2. Post compression parameters
3.2.1. Weight variation
Twenty Tablets were chosen and the individual
and average weight were calculated on a digital
weighing scale. Weight variation was calculated
[21].
717| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
3.2.2. Tablet hardness
Ten Tablets were taken from each formulation
and Tablet hardness tests were performed by
using Pfizer hardness tester [22, 36]. The results
were expressed as mean ± SD and the
experiments were run in triplicate.
3.2.3. Friability
A sample of whole Tablets equivalent to
approximately 6.5 gm was weighed and placed
in the Roche friabiliator. Tablets were rotated at
25 rpm for 100 revolutions and were taken out
and dedusted. The final weight was recorded and
the percentage friability was calculated [24].
3.2.4. Thickness
Ten Tablets from each batch were considered for
measuring the thickness using Vernier’s caliper.
The extent of deviation from standard value was
determined [35].
3.2.5. Wetting time
Tissue paper was folded twice and placed in a
Petri plate (6.5 cm inner diameter) comprising 6
ml of water. The Tablet was placed on the paper
and the time for the Tablet to be fully wet was
measured in seconds [25].
3.2.6. In-vitro dispersion time
Ten Tablets from each batch were chosen and put
on a beaker comprising 10 ml of pH 6.8
phosphate buffer and the time required for total
dispersion of theTablet was recorded in seconds
[26].
3.2.7. In-vitro disintegration test
The disintegration time was assessed using the
disintegration test apparatus. One Tablet was
inserted in each tube of a basket. The
temperature was maintained at 37±2°C and the
frequency of disintegration was adjusted to 28 to
32 cycles/min. The time required for the total
disintegration of the Tablet into each tube was
noted [27].
3.2.8. In-vitro dissolution studies
In-vitro dissolution of both fast disintegrating
Tablet formulation and marketed (Mktd)
formulation were studied in USP type-II dissolution
apparatus in phosphate buffer of pH 6.8 at 37±
0.5ºC as a dissolution medium. The medium was
agitated using a paddle rotated at 75 r.p.m.
Aliquots of dissolution medium (5 ml) were
withdrawn at a specified interval of time (5
minutes) and analyzed for drug content by
measuring the absorbance at 276 nm. The
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

cumulative percent of Tablet release was
calculated [26, 38].
3.2.9. Assay of the sample of the Tablet
Ten Tablets of each formulation were weighed,
powdered, and passed through a sieve. Powder
equivalent to 50 mg of diclofenac potassium was
accurately weighed and transferred into a 100 ml
volumetric flask and dissolved in a suitable
quantity of buffer. The prepared solution was
diluted up to 100 ml with buffer. 1.0 ml of the
resulting solution was diluted to 10 ml with a
buffer to get a concentration in the range of 10
μg/ml. A portion of the sample was filtered and
analyzed by UV/Visible spectrophotometer at 276
nm and the percentage of diclofenac potassium
in the sample was determined [14].
Statistical Analysis
Graph pad prism version 7 software (Graph pad
software Inc., La Jolla, CA) was used for the
statistical analysis. All the experiments were
conducted in triplicate and results were expressed
as mean ±SD. The data were analyzed by Tukey's
post hoc multiple comparison test. Statistical
significance was predefined at P*<0.05.
RESULTS AND DISCUSSION
5.1. Isolation and characterization of natural
extracts
Natural superdisintegrants were extracted in the
form of powders as depicted in Figure 1. The
powder extracts were evaluated for various
phytochemical screening tests for alkaloids,
carbohydrates, flavonoids, protein, phenolic
compounds, polysaccharides and saponins and
physicochemical properties including pH, swelling
index, loss on drying, solubility in a different
medium, and total ash value as depicted in Table
no. 3.

Fig.1:Powder extracts of natural super disintegrants depicting Jackfruit Powder (A), Banana
Powder (B), Mango peel pectin (C), Hibiscus Powder (D), Lepidium Powder (E), and Fenugreek
Powder (F).

5.1.1. Phytochemical tests for natural extracts carbohydrates, polysaccharides, and flavonoids in
The preliminary confirmatory tests and purity tests all the extracts. The observed results are depicted
of natural extracts confirm the presence of in Table 2.

Table 2: Result of phytochemical tests of natural extracts

Chemical tests for Tests Fenugreek Jackfruit Banana Lepidium Hibiscus Mango

Carbohydrates Molisch’s + + + + + +
Fehling’s _ _ + _ _ _
Polysaccharides Iodine + + + + + +
Alkaloids Mayer’s _ _ _ _ _ _

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 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

Wagner’s + _ _ _ _ _
Glycosides Kellar _ _ _ _ _ _
Kelani
Protein Biuret _ _ _ _ _ _
Amino acids Ninhydrins _ _ _ _ _ _
Phenolic Ferric _ _ _ _ _ _
compounds chloride
Flavonoids Lead + + + + + +
acetate
saponins Foam _ _ _ _ _ _

5.1.2. Organoleptic and Physiochemical
properties of extracts
The organoleptic characteristics of natural extracts
such as odor, color, the taste resemble the
organoleptic behavior of the pure extracts as
depicted in Figure 1. Similarly, another
physiochemical study suggests the maximum %-
yield of fenugreek powder (97%) and minimum
%-yield of mango peel pectin (7.8%). The %-yield
of jackfruit seed starch, banana powder,
Lepidium seed mucilage, and hibiscus leaf
mucilage was found to be 19%, 67%, 9.7%, and
11.32% respectively. The results are depicted in
Table 3.

Table 1: Result of physiochemical evaluation of natural extracts

Characters Fenugreek Jackfruit Banana Lepidium Hibiscus Mango

Color Yellowish- Brownish Brown Light brown Green Dark brown

brown white

Odor Pungent Odorless Sweet Odorless Characteristic Aromatic

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 4.42 3.31 3.79 2.18 2.87 3.63

value
% yield 97% 19% 67% 9.7% 11.32% 7.8%

Solubility in Swells to Insoluble Insoluble Swells to Swells to forms Swells to form

cold water form gel forms gel gel gel

Solubility in Insoluble Slightly Insoluble Soluble Soluble Soluble

hot water soluble

The pH of almost all the extracts was found to be
neutral. The maximum pH (7.16) was observed in
fenugreek powder. While mango peel pectin
exhibited an acidic pH (5.05). pH study suggests
that the extracts are less irritant to the buccal
cavity and can be utilized for the formulation of
fast-disintegrating Tablets [28]. The maximum
swelling index was observed in Lepidium sativum
mucilage with 153%while mango peel pectin
exhibited a minimum swelling index with 63.5%.
The study suggests the considerable water-
absorbing capacity of all the extracts. However,
mucilage of Lepidium sativum displayed greater
water-absorbing capacity and swelling property

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 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

as compared to other extracts as illustrated in
Table no.3. The water-absorbing and swelling
property of the extracts further support their role
as super disintegrant during the formulation of
FDT’s[15].
Similarly, the maximum loss on drying was
observed in banana powder with 7.63% and
minimum in mango peel pectin with 5.48%. The
ash value was observed to be maximum in
fenugreek powder with 4.42% and minimum in
Lepidium seed mucilage with 2.81%. solubility
study suggests that the natural extracts were
insoluble in an organic solvent like acetone,
methanol, ethanol, and chloroform and exhibit
greater solubility behavior in cold water and hot
water. The results on the physicochemical
property of the extracts are depicted in Table 3.
The study suggests that the flow property of all the
extracts was within an acceptable range. The
result of the Hausner's ratio and carr’s index value
of all the extracts is depicted in Table4.The angle
of repose value was found to be lowest in mango
peel pectin with 19.09±0.03º and highest in
jackfruit extract with 37.0±0.02º. Considering the
results it is suggestable to use the natural
excipient in the formulation of an FDT[15].

Table 4: Result depicting flow property of natural extracts, (n=3)

Properties Fenugreek Jackfruit Banana Lepidium Hibiscus Mango

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

(gm/cm3)

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

density
(gm/cm3)
Hausner’s 1.17±0.06 1.27±0.03 1.28±0.08 1.24±0.10 1.16±0.01 1.26±0.03
ratio
Carr’s 15.00±0.02 21.31±0.10 22.23±0.2 19.35±0.06 14.06±0.03 20.89±0.05
index(%)
The 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)

5.2. Drug-excipient Interaction studies

As per the previous studies, IR spectra of
Diclofenac sodium 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 attributable to C=C
bonding [29, 30]. IR spectrum of a mixture of
diclofenac and the different extracts were
compared with the spectrum of pure diclofenac
powder and no significant changes in the peaks
of the functional groups in the spectrums were
observed assuring no significant interaction
between the drug andextracts.The IR spectrum of
the mixture of drugs with different natural and
synthetic superdisintegrants is depicted in Figure 2
and Figure 3.

Fig.2:FTIR spectrum of the pure drug (A), drug and SSG (B), drug and fenugreek powder (C), and
drug and jackfruit seed extract (D).

720| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

Fig.3: FTIR spectrum of a mixture of drug and banana powder (A), drug and Lepidium sativum
mucilage (B), drug and hibiscus leaf mucilage (C), and drug and mango peel pectin (D).

5.4. Pre-compression evaluation of powder: with 22.95±0.4% and minimum in F4 with

The result of the pre-compression evaluation is
depicted in Table 5. The pre-compression study of
powder suggests maximum and minimum bulk
density in F11 and F7 with a value of 0.49±0.08
g/cm2 and 0.41±0.03g/cm3 respectively.
Similarly, the maximum tapped density was found
in F11 with 0.62±0.16 g/cm2 while F9 exhibited
minimum tapped density in 0.52±0.06 g/cm3.
Carr’s index was found to be maximum in F10
16.36±0.5%. Hausner's ratio of all the
formulations was within the acceptable limit with
the maximum value of 1.30±0.3 in F10 and the
minimum value of 1.19±0.06 in F4. The
maximum angle of repose was found in F10 with
31.93±0.20° and minimum in F9 with
26.43±0.30°. The angles of repose of almost all
the formulations were good indicating the good
flow property of the powder.

Table 5: Results of the pre-formulation evaluation of different formulations

Formulat Bulk Tapped Carr’s index Hausner’s The angle
ion code density(gm/cm³) density(gm/cm³) (%) ratio of repose(ѳ)
F1 0.43±0.03 0.53±0.06 18.86±0.4 1.23±0.0 29.36±0.3
5
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±0.0 30.15±0.0
7 4
F4 0.46±0.20 0.55±0.03 16.36±0.5 1.19±0.0 29.58±0.0
6 6
F5 0.49±0.06 0.59±0.20 16.95±0.3 1.20±0.4 31.43±0.1
0
F6 0.43±0.05 0.55±0.05 21.81±0.01 1.27±0.0 28.46±0.0
3 4
F7 0.41±0.03 0.53±0.04 22.64±0.06 1.29±0.1 29.28±0.0
0 5
F8 0.47±0.04 0.60±0.08 21.31±0.1 1.27±0.3 31.76±0.0
0 2
F9 0.42±0.04 0.52±0.06 19.23±0.3 1.24±0.0 26.43±0.3
6
F10 0.47±0.06 0.61±0.20 22.95±0.4 1.30±0.3 31.93±0.2
0

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 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants
F11 0.45±0.08 0.58±0.16
F12 0.45±0.04 0.57±0.10
F13 0.44±0.03 0.56±0.05
5.3. Post compression evaluation of Tablets
The post-compression parameters were evaluated
and results are depicted in Table.6.
5.3.1. Thickness
Maximum thickness with 5.50±0.10 mm was
observed in F1 whereas minimum thickness with
5.25±0.05 mm was observed in F13
formulation.
5.3.2. Weight variation
Weight variation test was carried out for all
formulations. While F3 exhibited maximum
average weight with 304±2.06 mg, the minimum
average weight was observed in F7 with
296±0.76 mg. The weight variations to a
considerable degree were observed due to
differences in the density of the powder material
and partly due to incomplete filling of the
dies[31].
5.3.3. Hardness
Tablet hardness study suggests maximum
hardness with 2.94±0.62 kg/cm2 in F3 and
minimum hardness with 2.42±0.56 kg/cm2 in
F11. A previous study suggests increment in
disintegration time and decrement of drug
dissolution rate with the formulation of higher
hardness value [15].
5.3.4. Friability
The percentage friability of all the formulations
was observed to be less than 1 % indicating a
good mechanical resistance. The maximum
friability with 0.53% was observed in F11 while
formulation F2 exhibited minimum friability with
0.21%. This implies the ability of the Tablet to
resist abrasion in packaging, handling, and
shipping.
5.3.5. Wetting time
Wetting is closely related to the inner structure of
Tablets, which can be correlated with the swelling
ability of disintegrants and their intrinsic capacity
of absorbing the water [12]. The study suggests
the maximum wetting time with 94 secs in F6
722| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
22.41±0.03 1.28±0.2 30.65±0.0
5
21.05±0.21 1.26±0.3 27.84±0.3
0
21.42±0.3 1.27±0.1 28.31±0.3
comprising mango pectin peel. This could be
attributable to the lower swelling property of
mango peel pectin. Similarly, minimum wetting
time was observed with 69 secs in F4 comprising
the extracts of Lepidium sativum which might be
due to its greater swelling property.
5.3.6. In-vitro dispersion time
The maximum dispersion time with 85 secs was
observed in F3 and dispersion time was minimum
in F4 formulation with 58 secs which might be
due to differences in the wetting time, swelling
ability, and disintegrating property of super
disintegrants.
5.3.7. Disintegration time
The maximum disintegration time with 29 secs
was observed in F6 comprising mango pectin
peel which might be because of their poor
swelling property compared to other extracts.
Whereas, minimum disintegration time with 19
secs was observed in F4 formulation comprising
the extracts of Lepidium seeds owing to their
greater swelling ability. The result of the
disintegration time is depicted in Table 6. The
rapid disintegration of the FDTs is attributable to
the penetration of saliva into the pores of the
Tablet, resulting in the swelling of
superdisintegrants to develop sufficient
hydrodynamic pressure to disintegrate the Tablet
rapidly [32]. These natural super disintegrants
when it comes in contact with water may quickly
wick the water into the Tablet through capillary
action to create internal pressure that
disintegrates the Tablet [15].
The disintegration time with 27 secs is observed in
formulation F7 comprising SSG as
superdisintegrants which is comparatively higher
with the majority of a formulation comprising
natural super disintegrants (except F3 and F6)
due to its gelling and subsequent viscosity
producing effect [6].
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

Table 6: Results of the post-compression evaluation of different formulations

Formulati Weight Thickness( Hardness Friability D.T Wetting Dispersi Assay
on variation mm)±SD, (kg/cm2) (%) (sec) time (sec) on time %
(mg)±SD, n=10 ±SD, n=10 (sec)
n=20
F1 301±0.91 5.50±0.10 2.44±0.01 0.32 22 73 69 99.32
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

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 secs in F11 to
27 secs in F13. The improvement in the
disintegration rate of F13 comprising a
combination of SSG and mango pectin peel as
superdisintegrants compared to F6 comprising
mango peel pectin only might be due to the effect
of SSG which enhances the rapid uptake of water
and subsequently enhancing the bursting of
Tablets in lesser time [15].
5.3.8 Drug contents (assay)
Percent assay was found in a range of 94.90 %
w/w to 102.08 % w/w. Maximum drug content of
102.08 %w/w was found in F9 and minimum
drug content of 94.90% w/w was found in F5
formulation. The drug content was found to be
within a considerable limit. The drug content of
the pure drug in the formulations is depicted in
Table no. 6.
5.3.8. In-vitro drug dissolution study
In vitro drug dissolution study suggests maximum
cumulative drug release in F2 with 93.42±8.79%
in 30 minutes. The higher cumulative drug
release might be due to the lower wetting time
and higher swelling index of Lepidium mucilage.
On the contrary, F6 exhibited a minimum
cumulative drug release with 86.42±8.39 %
because of the higher wetting time and lower
swelling index of the mango peel pectin.
Formulation F7 comprising SSG as a
superdisintegrant exhibited the cumulative drug
release of 90.07±8.91 % in 30 minutes. The
mechanism of the drug release might be because
of the rapid absorption of water accompanied by
rapid swelling of SSG but gradual drug release
due to the development of a viscous gel layer at
elevated concentrations [33].
The formulations with natural super disintegrants
comprising hibiscus, fenugreek, jackfruit, and
banana pulp powder revealed comparable
cumulative drug release with 91.42±8.76%,
90.62±7.90%, 90.15±9.10%, and 86.42±8.39
% respectively in 30 minutes.
It was observed that the percent cumulative drug
release of combined SSG and natural super
disintegrants (1:1) also exhibited similar results
like natural super disintegrants. The study of
cumulative percentage drug release of different
formulation at different intervals of time is
depicted in Figure 4.

723| International Journal of Pharmaceutical Research | July - Sep 2021 | Vol 13 | Issue 3
 Chhitij Thapa et al/ Formulation, in-vitro evaluation and comparative study of diclofenac potassium
loaded fast dissolving tablet using natural and synthetic superdisintegrants

Fig.4:Comparative in vitro drug release profile of F1, F2, F3, and F4 (A), F5, F6, and F7 (B), F8, F9,
and F10 (C), F11, F12, F13 and Mktd

All the formulations exhibited significant drug None

release compared to Mktd 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. The study suggests
the possibility of the usage of the natural extracts
as superdisintegrants in the formulation of FDT.
CONCLUSION
Fast disintegrating Tablet of diclofenac potassium
was successfully prepared by direct compression
method using synthetic (sodium starch glycolate)
and natural (extracts of fenugreek, banana,
Lepidium, jackfruit, mango, and hibiscus
mucilage) super disintegrants. The formulation
prepared by the use of natural super disintegrants
shows comparable dissolution, disintegration,
and wetting property with the formulations
prepared by synthetic superdisintegrants
(SSG)and, their combination with the natural
superdisintegrants in the ratio (1:1). The
minimum wetting and disintegration time and
maximum drug release rate were observed in F4.
While F6 exhibited maximum wetting and
disintegration time and minimum drug release
rate. A micrometric study suggests that powders
of all formulations exhibited excellent flow
properties and post-compression parameters
study suggests weight variation, hardness,
thickness, and %-friability of all the formulations
were within the acceptable limit.
DECLARATION OF INTEREST
SOURCE OF FUNDING
None
CONFLICTS OF INTEREST
None
ACKNOWLEDGMENT
Sincere acknowledgment goes to Apple
International Pharmaceuticals Pvt. Ltd.
(Tilotamma, Rupandehi, Nepal) for their
generosity in providing the diclofenac potassium
powder. We are indebted to Universal College of
Medical Sciences (Siddhartha Nagar, Nepal) for
providing Laboratory facilities to successfully carry
out this work. Special thanks to Siddhartha
Pharmaceuticals Pvt. Ltd. (Tilotamma, Rupandehi,
Nepal) for their cooperation during the
conduction of several pre-formulation studies
within their industrial premises.
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