WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

Chanda et al. World Journal of Pharmacy and Pharmaceutical Sciences

SJIF Impact Factor 2.786

Volume 4, Issue 04, 1247-1258. Research Article ISSN 2278 – 4357

EVALUATION AND ISOLATION OF NOVEL BINDING AGENT

ALSTONIA SCHOLARIS IN THE FORMULATION OF TABLET

Abhijit Chanda*, Vikash B, Arijit Dey, Pankaj Gupta, Yuvraj P.K, Dr.Grace Rathnam

C. L. Baid Metha College of Pharmacy, Chennai-60097.

Article Received on ABSTRACT

04 Feb 2015,
Plant gums and mucilage’s are being used due to their abundance in
Revised on 25 Feb 2015,
Accepted on 18 March 2015
nature, safety and economy. So in the present study an attempt was
made to know the efficacy of Alstonia scholaris gum as a binder in

*Correspondence for
paracetamol tablets by comparing with starch. In majority of tablets
Author and capsules binders are used as important additives and in the present
Abhijit Chanda study gum isolated from trunk of Alstonia scholaris was studied at
C. L. Baid Metha College different concentrations and conditions. The paracetamol granules
of Pharmacy, Chennai-
were prepared with different concentration of gum as binder by wet
60097
granulation method and evaluated for moisture content, angle of
repose, bulk and tapped densities. The tablets were evaluated for thickness, weight variation,
hardness, friability, and disintegration time and in vitro release profiles. Studies showed that
increase in binding concentration of Alstonia scholaris gum, increases the hardness, as well
as the disintegration time, decreases the percentage friability and decreases percentage
cumulative release. Results obtained indicated that Alstonia scholaris gum performed as good
binder at lower percentage.

KEYWORDS: Alstonia scholaris gum, Paracetamol, Starch binder.

INTRODUCTION
Binder is one of the important excipients to be added in tablet formulation. In simple words,
binders or adhesives are the substances that promote cohesiveness. It is utilized for
converting powder into granules through a process known as granulation. A sticky, colloidal
carbohydrate found in certain trees and plants, which dries into an uncrystallized, brittle mass
that dissolves or swells in water is known as gums. Gum are amorphous, translucent solids,

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insoluble in alcohol and most organic solvent; they are however soluble in water to yield
viscous, adhesive solutions and are swollen by absorption of water to get a jelly like mass.

For this present study the gum was obtained from the tree Alastonia Scholaris, family
Apocynaceae. Alstonia is named after Dr C. Alston (1685-1760), a professor of botany at
Edinburgh University. The specific name scholaris is derived from the use of the wood for
school boards in Myanmar. In India this plant is mainly found in North East zone. It is
commonly known as Chatian. Alstonia scholaris is a medium to large tree, to about 40 meter
high with a somewhat tessellated corky grey to grey-white bark. The boles of larger trees are
strongly fluted to 10 m. The outer blaze is cream to yellowish in colour with abundant, milky
latex that flows rapidly when cut. This plant contains indole alkaloids mainly Picrinie,
Alstonine, Echitamine, Akuamicine.[5] the various gums were used as a tablet binder in
pharmaceutical dosage forms. In this present investigation A. scholaris gum has been
evaluated as a suitable binder for paracetamol tablet preparation.

MATERIALS AND METHODS

Paracetamol was obtained from Fourts Labs, Chennai. Starch, Talc, Magnesium stearate, and
other excipients are obtained from S.D.Fine Chemicals and Loba Chemie Pvt ltd, Mumbai..
The gum resin was collected from the incised trunk of Alstonia scholaris in North East
region. (Panisagar, Tripura (North) India). The gum authentication was done by Dr. P.
Jayaraman, Ph.D Retd. Professor, Presidency College. (Reg. No of the certificate
PARC/2013/1459).

Isolation and purification of gum

The gum was collected from trees (injured site). It was dried, ground, and passed through
sieve no 80. Dried gum (10 g) was stirred in distilled water (250 ml) for 6-8 h at room
temperature. The concentrated solution was precipitated in acetone. The precipitate was
separated and dried at 50ºC. The dried gum was powdered and stored in tightly closed
container.

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Fig 1: Parts of Alstonia scholaris tree

Phytochemical screening of the gum

The various phytochemical screening of the Alstonia scholaris gum was done.2 (Result
mentioned in Table No. 2)
 Molisch’s Test for carbohydrates.
 Ferric chloride test for tannins.
 Ninhydrin test for proteins.
 Wagner test for alkaloids.
 Keller-Killani test for glycosides.
 Ruthenium test for mucilage.
 Fehling’s test for reducing sugar

Physicochemical characterization of the gum

Physiochemical property such as solubility, Loss on drying, total ash and acid insoluble ash
determination, pH, angle of repose, bulk and tap densities, Hausner’s ratio, and
Compressibility index (C %) . (Result mentioned in Table No. 3)

Solubility test
The separated gum was evaluated for solubility in water, acetone, chloroform and ethanol in
accordance with the Indian Pharmacopoeia specifications.

Loss on drying
1.0 g of the sample was transferred into each of several Petri dishes and then dried in an oven
at 105°C until a constant weight was obtained. The moisture content was then determined as
the ratio of weight of moisture loss to weight of sample expressed as a percentage.

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Total ash and acid insoluble ash determination

Ash content was estimated by the measurement of the residue left after combustion in a
furnace at 450°C. The ash obtained from the determination of the ash was boiled with 25 ml
of 2M hydrochloric acid solution for 5 minutes and the insoluble matter was filtered and
washed with hot water and ignited and the subsequent weight was determined. The
percentage of acid insoluble ash was calculated.

pH determination
pH was determined by shaking a 1%w/v dispersion of the sample in water for 5 min and the
reading were noted by digital pH meter.

Angle of repose
The static angle of repose “θ” was measured according to the fixed funnel and free standing
cone method. A funnel was clamped with its tip 2 cm above a graph paper placed on a flat
horizontal surface. The powders were carefully poured through the funnel until the apex of
the cone thus formed just reached the tip of the funnel. The mean diameters of the base of the
powder cones were determined and the tangent of the angle of repose calculated using the
following equation;

Where θ = Angle of repose

h= High of granules
r = Radius of granules

Bulk and tap densities

2.0 g quantity each of the powder samples was placed in a 10ml measuring cylinder and the
volume (Vb) occupied by each of the samples without tapping was noted. After 100 taps on
the table, the occupied volume (Vt) was noted. The bulk and tap densities were calculated as
the ratio of weight to volume (Vb, and Vt respectively) by the following equations;
Loose bulk density ( ρu ) =

Tapped bulk density ( ρt ) =

ρu = Loose bulk density

ρt = Tapped bulk density

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M = Weight of powder
Vb = Volume occupied by powder without tapping
Vt = Volume occupied by powder after tapping

Hausners index
This was calculated as the ratio of tapped density to bulk density of the samples
Hausner’s ratio = ρt / ρu

Compressibility index (C %)
The Carr’s compressibility index (C %) was calculated using by the following equation.

Carr’s compressibility index (C %) =

Compatibility study by Fourier Transform Infra Red (FTIR) spectroscopy

Excipient compatibility studies are an important part of any preformulation screening for
dosage form development. 200 mg each of the drug and the gum extract were blended and
kept in closed vials at 50o C for 7 days. The samples were taken for FTIR studies. Samples
(about 1% w/w) were mixed with potassium bromide powder and compressed to a 12 mm
disc by a hydraulic press at 10 tons compression force for 30 s. Samples were analyzed in a
FTIR Spectrophotometer (Nicolet Magna 4R 560, MN, USA) in the region 4600 to 400 cm-
1
. Triplicate measurements were made, and the spectrum with the clearest identifiable peaks
was chosen. (Result Mentioned in Table No. 4 9.3 & Figure No. 2,3,&49.1, 9.2, & 9.3)

Fig 2: IR Spectrum of Paracetamol

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Fig 3: IR Spectrum of ASG

Fig 4: IR Spectrum of Combination of ASG and PCM

Preformulation studies of paracetamol

Preformulation studies were performed on the drug, which included melting point
determination, solubility and compatibility studies. The λ max of the paracetamol was found
to be 257 nm, specific absorbance also found. All studies shows the above specified
parameters are within the limit.

Preparation of granules
Wet granulation method was used to prepare granules of drug. Weighed quantity of
Paracetamol IP was taken in mortar. Lactose, starch and were sifted through #16 mesh sieve,
triturated and mixed well. The binder solution containing starch mucilage (7%) & ASG

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solution (2.5%, 5%, and 7.5%) in water was added to above mixture. The wet mass was
passed through sieve # 16 mesh. The granules were dried at 45ºC for 30 to 45 minutes in hot
air oven. The dried granules were again reseived, lubricated with lubricants and were
compressed by using hydraulic press with flat faced punches.

Evaluation of granules
The prepared gum granules were evaluated for moisture content and flow properties in
comparison with starch granules.4 Results mentioned in the Table No. 5

Preparation and Evaluation of tablets

The compatible excipients were used for formulation and development using suitable process.
Development trials of about 400 tablets were made and evaluated the physical parameters of
the blend and the compressed tablets. Such development trial taken until tentative formula is
prepared. The quantity of granules selected was compressed using a 27 stationary double
rotary compression machine (Cadmach, India) using 19.2×8.9 mm round flat surface and
compressed to obtain hardness in the range 6-7 kg/cm2 to form a uniform tablet. The
compressed tablets were further evaluated for quality control test. Results are mentioned in
Table No. 6.

Table no.1: 8.2 Formulation profile

INGREDIENTS F1 F2 F3 F4
Paracetamol (mg) 500 500 500 500
Lactose (mg) 31 31 31 31
Starch (mg) 60 60 60 60
ASG % 2.5 5 7.5 _
Starch mucilage % _ _ _ 7
Magnesium stearate (mg) 6 6 6 6
Talc (mg) 3 3 3 3

Percentage purity
20 tablets were weighed and powdered. To an accurately weighed quantity of the powder
containing about 0.15 of Paracetamol 50 ml of 0.1M NaOH was added and diluted with 100
ml of water, shaken for 15 minutes and sufficient water was added to produce 200 ml.
Filtered and diluted 10 ml of the filtrate with 100 ml water. To 10 ml of the resulting
solution 10 ml of 0.1 M NaOH was added and diluted to 100 ml with water. Absorbance
was measured at 257 nm using Schimadzu UV-1601 Spectrophotometer. . The content of

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paracetamol (C8H9NO2) was found out by taking 715 as the specific absorbance at 257 nm.
(Result mentioned in Table no: 6)

In-vitro Dissolution Studies

Medium : pH 5.8 Phosphate Buffer
Apparatus : Dissolution Apparatus IP Type – I
RPM : 50
Temperature : 37°C ± 0.5°C
Time : 60 minutes
Cumulative percentage of drug release was calculated using the equation obtained from a
standard curve. (Result Mentioned in Table no: 6)

RESULTS

Fig 5: In-vitro release profile of PCM in different formulation

The lower bulk and tapped densities exhibited by ASG and starch granules show that both
granules have good flow properties. The Hausner’s ratio, which almost equals 1.15, indicates
free flowing granules. In the case of Carr’s compressibility index, all granules possess better
flow properties. The angle of repose for granules was between 24 ºto 28º which indicates free
flowing properties of the granules. The moisture content of all formulations was observed to
be within limits.

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Table No. 2: Phytochemical properties of Alstonia scholaris gum

Sl. No Tests Observation
1. Test for Carbohydrates
( Molisch’s test) +
2. Test for Tannins _
(Ferric chloride test)
3. Test for proteins _
( Ninhydrin test)
4. Test for alkaloids _
(Wagner’s test)
5. Test for glycosides _
(Keller – Killaini test)
6. Test for mucilage
( Ruthenium red test) +
7. Test for reducing sugar _
(Felhing’s test)

Table no. 3: Physicochemical properties of Alstonia scholaris gum

Sl.No Parameter Result
1. Percentage yield 69.24%
2. Solubility Soluble Methylene chloride, Chloroform,
slightly soluble in ethanol, methanol, partially
soluble in water.
3. Loss on drying 10.12%
4. Swelling index 4%
5. Total ash and acid 5.52 & 0.63
insoluble ash (%)
6. pH 5.9 – 6.7
7. Angle of repose 46.84º
8. Bulk and tap 0.692 & 0.872
densities
9. Hausners index 1.38
10. Compressibility 23.24
index

Table no. 4: Interpretation of FTIR spectrum of PCM, ASG, and Combination

Stretching/
Sl.No. IR Spectrum Peaks (cm-1) Groups
Deformation
3326.35 N-H Amide Stretching
3162.30 O-H Phenol Stretching
1. PCM
2880.63 C-H (Alkane) Stretching
1654.89 C=O Amide Stretching
2945.50 C-H (Alkane) Stretching
C=C
1736.40 Stretching
2. ASG (Aromatic)
1245.00 C-O (Ph OH) Stretching
1097.11 C-N (3º amine) Stretching

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3328.11 N-H (Amide) Stretching

PCM & ASG 2794.60 C-H (Alkane) Stretching
3.
COMBINATION 1665.10 C=O Amide Stretching
1106.5 C-N (3º amine) Stretching

Table no. 5: Physical evaluation of PCM granules

SL. Bulk density Tapped Angle of Carr’s Hausners
Formulation
NO (gm/ml) density repose index (%) ratio
F1
1. 0.62 0.58 24.670 12.50 1.14
(2.5% ASG)
F2
2. 0.66 0.61 28.500 13.33 1.15
(5% ASG)
F2
3. 0.55 0.52 25.620 13.88 1.16
(5% ASG)
F4
4. 0.45 0.52 23.570 11.78 1.12
(7% STR)

Table no.6: Physical Evaluation of PCM tablets

Drug Disintegration
Thickness Weight Hardness Friability
Sl. No Formulation content time (mins)
(mm) variation kg/cm2 (%)
(%)
1. F1 (2.5% ASG) 3.1 ±4.01 5.36 0.82 99.23 4.52
2. F2 (5% ASG) 3.3 ±2.96 6.26 0.70 98.47 7.82
3. F2 (5% ASG) 3.2 ±2.56 6.33 0.65 100.56 12.56
4. F4 (7% STR) 3.4 ±2.87 6.29 0.71 99.76 8.32

Table no.7: Dissolution profile of various formulations

Time Cumulative percentage drug release
Sl.No
(minutes) F1 F2 F3 F4
1. 0 0 0 0 0
2. 15 24.11 18.90 18.39 20.10
3. 30 52.48 44.66 41.71 46.84
4. 45 74.29 66.41 63.21 68.23
5. 60 82.80 76.61 72.50 79.11

DISCUSSION
Results obtained from the IR spectra of the pure drug and mixed drug samples with
excipients are showed that under stressed conditions the gum does not influence any
interaction with the drug. All the functional groups assigned in the wave numbers in the
mixture exhibited maxima which are around the same wavelength and had similar intensities
to that of the reference spectrum.

The present study was carried out to prepare and to evaluate the binding properties of ASG
with PCM as model drug. Different batches were prepared with different concentrations of

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the gum (2.5%, 5%, 7.5%) w/v and compared with 7% w/v starch which is used as a model
binder.

Isolation of gum from crude and pH were found 5.9 – 6.7. Gum was soluble in methylene
chloride, chloroform, slightly soluble in ethanol, methanol, partially soluble in water. Loss on
drying was 10.12 %. Total ash value was found to be 5.52 % and acid insoluble ash was
0.63%. Bulk density and tapped density were found to be 0.872 &, 0.692 respectively.
Compressibility index and Hausner’s index was found to be 23.24 & 1.38 respectively. Angle
of repose was found to be 46.84 and the percentage yield was found to be 69.24%.

Granules were prepared by the wet granulation method using different concentrations of gum.
Granules were studied for drug and excipient interaction studies by FTIR and it was found to
be compatible with drug. There was no interaction between functional group of both drug and
excipients. Moisture content was sufficient and angle of repose, bulk, tapped, & true density
was found to be excellent.

Thickness was sufficient and weight variation, hardness, friability, drug content, &
disintegration time was found between the ranges specified in IP. So it passes the quality
control test. In vitro dissolution studies result shown increase in conc. of gum retard the
percentage of drug release. And in-vitro release profile of PCM in different formulation
shows F2 (5% ASG) has good release characteristic.

CONCLUSION
Alstonia scholaris gum can be an alternative binder for the pharmaceutical formulations. The
gum was found to be affective at low concentrations Abundant availability, economical
feasibility, commercial suitability and reliability make the gum as an alternative for the
existing toxic, synthetic and ineffective excipients.

ACKNOWLEDGEMENTS
It is my great privilege pride and honour in expressing my most cordial and humble thanks to
my eminent esteemed teacher and guide, my project supervisor Dr. Grace Rathnam
(Principal, C.L.Baid Metha College Of Pharmacy, Chennai) who gave permission and
accompanied to carry out my work.

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It is of great pleasure as I take this opportunity to acknowledge the whole hearted support of
my loving parents who has always energized and motivated me in every steps and success of
this project from miles apart.

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