Evaluation of Seed Mucilage of Hibiscus Sabdariffa Linn as
Tablet Binder
Ch. Anupama1*,
P. Padmakumari1, K. Abbulu1, Arti
Mohan1 and A. Ppratyusha2
1Malla Reddy Institute of
Pharmaceutical Sciences, Andhra Pradesh, India
2CMR College of Pharmacy,
Andhra Pradesh, India
ABSTRACT:
The
aim of present study is to evaluate the mucilage of Hibiscus sabdariffa seeds as tablet binder using Diclofenac sodium
as standard drug .To the best of our knowledge no significant work has been
reported on seed mucilage as tablet binder. Physicochemical characteristics of
mucilage were studied which confirmed the mucilage nature. The tablets were
prepared by wet granulation technique using mucilage as tablet binder. The
prepared tablets were evaluated for their granulating and binding properties. The
tablets exhibited good uniformity and drug release was more than 85% in 90 min.
Tablet’s hardness and disintegration time was increased with increasing binder
concentration and friability values were decreased with increase in binder concentration.
All these confirm the use of Hibiscus sabdariffa as binder in tablet formulation.
KEYWORDS: Hibiscus sabdariffa, mucilage, binder.
INTRODUCTION:
Binders
are the agents used to impart cohesive qualities to the powdered material
during the production of tablets. They impart cohesiveness to the tablet
formulation, which ensures that the tablet remains intact after compression as
well as improving the flowing quality1. Mucilage are
most commonly used adjuvant in pharmaceutical preparations. They possess a
variety of pharmaceutical properties, which include binding, disintegrating,
suspending, emulsifying and sustaining properties2. Natural mucilage
are preferred over semi-synthetic and synthetic materials due to their
non-toxic, low cost, free availability, emollient and non-irritating nature3.
The present study deals with the isolation of the gum
from the seeds of Hibiscus sabdariffa and its application as binding agent in
tablet formulation. Hibiscus sabdariffa, a shrub belonging to the family Malvaceae. Commonly referred as yerra gogu (telugu), species is found amply in all areas of
India. The binding properties of this gum were compared with starch which was
used as a standard binder at 10% concentration.
MATERIALS AND
METHODS:
The
seeds of Hibiscus sabdariffa
Linn were obtained from Krishna District;
A.P. Diclofenac sodium was obtained from Reddy Laboratories as a gifted sample,
lactose obtained from Shreeji Chem,
Mumbai. All other materials used in this study were of analytical grade.
ISOLATION OF MUCILAGE4,5,6:
The
seeds of Hibiscus sabdariffa
were soaked in distilled water for 12 hours, boiled for half an hour and kept
aside for one hour to release mucilage into water.
The
material was squeezed in a muslin bag to remove the marc from the filtrate.
Then, equal volume of acetone was added to filtrate to precipitate the
mucilage. The mucilage was separated, dried in an oven at temperature less than
500c, powdered and passed through sieve no.80. The powder was stored
in desiccator until further use.
PHYSICOCHEMICAL PROPERTIES OF GUM:
The
physic-chemical properties such as solubility, swelling index, loss on drying,
viscosity and PH were determined according to Indian pharmacopoeial procedure7, using air dried
powder of gum. The PH of mucilage was determined using a digital pH meter. The
viscosity of gum solution was determined at 250c using Ostwald’s
viscometer after 24 hours of hydration. Results shown in Table:1
TABLE:1 PHYSICO CHEMICAL PROPERTIES OF Hibiscus
sabdariffa SEED MUCILAGE
|
Parameter |
Hibiscus sabdariffa |
|
Test
for mucilage: Ruthenium Red |
positive |
|
solubility |
Soluble
in cold water and hot water forming colloidal solution |
|
Swelling
Index |
33 |
|
PH |
5.8 |
|
Loss
on drying % w/w |
8.2 |
|
Viscosity |
20
– 100 cps |
PREPARATION AND EVALUATION OF GRANULES:
All
the materials were passed through a mesh sieve with aperture of 250 µm before
use. The tablets were prepared by wet granulation method. The compositions of
tablets is given in Table: 2
Diclofenac
sodium and lactose were thoroughly mixed and the solution of the mucilage of
specified concentration was prepared by dispersing the mucilage in water. The
mucilage solutions were used for moistening the powder mixture, for preparing
tablets to evaluate the binding potential. The wet mass was then passed through
sieve no.16 and dried at temperature not exceeding 500c in a hot air
oven for 30 minutes. The dried granules were again passed through a sieve
no.20. The same method was followed in the preparation of standard formulation
(STD) using starch mucilage 10%w/w.
The
flow properties of the granules were evaluated by angle of repose,
Compressibility Index and Hausner’s Ratio. Results
were shown in Table: 3
The
bulk density8 was calculated by weighing 20gm of granules were
introduced into a 100ml measuring graduated cylinder. The cylinder was fixed on
the bulk density apparatus and the timer knob was set for 100 tapings. Then
noted the volume continued another 50 tapings and noted the final volume. This
volume was noted as bulk volume. Based on the bulk and tap densities both the
Carr’s Index (%) [(Tapped density-bulk density) X 100/tapped density] and Hausner Ratio (tapped density/bulk density) were
calculated.
Angle
of repose was determined by fixed funnel method. Funnel with the end of the
stem cut perpendicular to the axis of symmetry was secured with its tip at a
given height (H) above a graph paper placed on a flat horizontal surface. The
material was carefully poured through the funnel until at apex of the conical
pile so formed just touches the tip of the funnel. The mean diameter (2R) of
the base of the powder cone was determined and the tangent of the angle of
repose is given by tan α = H/R, where α is the angle of repose. All
the results were compared with the standard formulation (STD).
PREPARATION AND EVALUTION OF TABLETS:
The
granules were lubricated with 1% w/w magnesium stearate
and talc. The tablets were compressed by using Cadmach
single punch machine using 6mm round flat faced punches. The tablets of average
weights 250mg were prepared. Four batches of tablets were prepared by using
isolated mucilage of four different concentrations (2%, 4%, 6% and 8%) were
used, starch mucilage (10% concentration) was used as a standard binder for comparison.
The
prepared tablets were evaluated for weight variation, hardness, friability, disintegration
time and dissolution. Disintegration time was determined using USP tablet
disintegration apparatus (model ED-2 Electrolab,
Mumbai) using water (900 ml) as medium at 37±0.5˚C. Weight variation test
was carried out as per IP. Monsanto hardness tester and the Roche friabilator were used to test hardness and friability
respectively as per IP. In vitro
dissolution studies were carried out using PH 7.2 phosphate buffer as a
dissolution medium. Results were shown in Table: 4 and 5.
TABLE:2 COMPOSITION OF
TABLETS CONTAINING Hibiscus sabdariffa SEED MUCILAGE AS BINDER
|
S. No |
Ingredients |
F1 |
F2 |
F3 |
F4 |
STD |
|
1 |
Diclofenac sodium |
50mg |
50mg |
50mg |
50mg |
50mg |
|
2 |
H.sabdariffa mucilage |
2 % |
4% |
6% |
8% |
|
|
3 |
Starch mucilage |
- |
- |
- |
- |
10% |
|
4 |
Talc |
1% |
1% |
1% |
1% |
1% |
|
5 |
Mg stearate |
1% |
1% |
1% |
1% |
1% |
|
6 |
Lactose |
q.s |
q.s |
q.s |
q.s |
q.s |
|
7 |
Total weight |
250 mg |
250 mg |
250 mg |
250 mg |
250 mg |
TABLE:3 EVALUATION OF
GRANULES
|
Properties |
F1 |
F2 |
F3 |
F4 |
STD |
|
Tapped
bulk density |
0.635 |
0.632 |
0.636 |
0.655 |
0.634 |
|
Loose
bulk density |
0.572 |
0.575 |
0.571 |
0.550 |
0.570 |
|
Carr’s
Index |
9.206 |
9.018 |
10.22 |
10.56 |
10.14 |
|
Hausner’s ratio |
1.10 |
1.09 |
1.11 |
1.10 |
1.11 |
|
Angle
of repose |
23093' |
24025' |
24073' |
24035' |
22095' |
TABLE:4 EVALUATION OF TABLETS
|
Formulation |
Hardness |
Friability% |
Wt variation% |
Disintigration time |
|
F1 |
2.5±0.16 |
0.5168±0.01 |
249.25±2.01 |
2 min 20 sec |
|
F2 |
3.0±0.13 |
0.4532±0.03 |
248.75±2.39 |
3 min 13sec |
|
F3 |
4.0±0.17 |
0.3125±0.02 |
247.35±2.35 |
3 min 65sec |
|
F4 |
5.2±0.13 |
0.2456±0.03 |
250.45±2.75 |
4 min 50sec |
|
STD |
5.6±0.14 |
0.2105±0.02 |
248.65±2.16 |
4 min 14sec |
TABLE:5 IN VITRO DISSOLUTION PROFILE :
|
Time(min) |
PERCENTAGE OF DRUG RELEASE |
||||
|
F1(2%) |
F2(4%) |
F3(6%) |
F4(8%) |
STD |
|
|
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
36.23 |
34.21 |
29.21 |
26.34 |
40.23 |
|
20 |
46.37 |
43.58 |
36.21 |
35.24 |
56.34 |
|
30 |
60.21 |
59.21 |
48.84 |
44.34 |
68.39 |
|
40 |
74.29 |
63.35 |
60.21 |
58.21 |
79.21 |
|
50 |
80.21 |
79.21 |
78.24 |
74.31 |
83.34 |
|
60 |
93.21 |
90.32 |
89.45 |
88.23 |
96.36 |
|
90 |
93.56 |
92.32 |
90.32 |
89.24 |
97.89 |
|
120 |
94.13 |
93.21 |
92.21 |
90.32 |
98.34 |
RESULTS AND
DISCUSSION:
Mucilage
obtained from Hibiscus sabdariffa
seeds was in an amorphous free flowing powder with brown colour. Mucilage nature was confirmed by various
physicochemical properties. The granules were prepared and evaluated for tapped
bulk density, loose bulk density, Carrs
index, Hausner’s ratio and angle of repose. Flow
property of granules was determined by angle of repose and it was found that
the values are in the range of 22˚ 95' - 24˚ 25'. All the
formulations tested for a Carr’s index ranging from 9-10%, Hausner’s
ratio was below 1.12. Hence all granules exhibited good flow property.
Four
batches of tablets were prepared using four different concentrations of
mucilage and starch mucilage as standard (10% concentration). The prepared
tablets were evaluated for weight variation, hardness, friability, disintegration
time and in vitro dissolution
profile.
All
batches exhibited good uniformity, tablet hardness and disintegration time was
increased with increasing binder concentration, the friability values were
decreased with increase in binder concentration. In vitro dissolution study showed that drug release from the
tablets prepared by mucilage at four different concentrations was more than 85%
in 90 minutes.
CONCLUSION:
The
evaluation of tablets reveals that the binding efficacy of tablets prepared
using Hibiscus sabdariffa
seed mucilage is comparable with the tablets prepared using 10%w/w starch as a
standard binder. Therefore, it is concluded that Hibiscus sabdariffa seed mucilage could
be used well as a binding agent in the formulation of tablet dosage forms.
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Received on 16.09.2010
Accepted on 12.10.2010
© A&V Publication all right reserved
Research Journal of Pharmaceutical
Dosage Forms and Technology.
2(6): Nov.-Dec. 2010, 370-373