Vol 1|Issue 1| 2011 |18-32.

Asian Journal of Pharmaceutical Science & Technology

e-ISSN: 2248 9185
Print ISSN: 2248 9177

www.ajpst.com

Formulation and evaluation of sustained release oral matrix tablet by using

rifampicin as a model drug
Samiran Deya*, L. Ajoy Singha, A.Pandiselvia , Nidhi Rania , Rakhal Chandra Dasb ,B. Bharat
Kumarb, P. Malairajanc, K. Jessi Kala Venic, R. Murugand, Shafique Ahmedc
a

Department of Pharmaceutical Analysis, Innovative College of Pharmacy, Greater Noida, Uttar Pradesh, India
Department of Pharmacology, M.R.R. College of Pharmacy, Nadigama, Krishna Dist., A.P.
c
Department of Quality Assurance, Roefl Shri G M Bilakhia College of Pharmacy, Vapi, Gujarat.
d
Department of Pharmacology,C. U. Shah College of Pharmacy & Research, Surendranagar,Gujarat, India.
e
Department of Pharmacology, Jamia Hamdard, New Delhi.
b

ABSTRACT
The present study was aim to formulate and evaluate the sustained release oral matrix tablet by using rifampicin as a
model drug and see the effects of different polymers to prolong the release of drug for extended period of time in order to
formulate the sustained release dosage form of rifampicin, improve patient compliance, ease of administration, reduce dosing
frequency, increase bioavailability of drug. Based on preformulation studies different batches of rifampicin were prepared using
selected excipients. Granules were evaluated for tests Bulk density, tapped density, compressibility index, Hausner ratio before
being punched as tablets. Various formulations of sustained release tablets of rifampicin were developed using various polymers
viz, Guar gum, Tragacanth Gum, PEG-6000 and Carbopol in different proportions and combinations by direct compression
technique. The tablets were evaluated for physical characterization, in vitro swelling behavior, in vitro release study and stability
studies. Results of in vitro release profile indicated that formulation (F2) was the most promising formulation as the extent of drug
release from this formulation was high as compared to other formulations. Results of in vitro swelling study indicate that the
formulation F2 was having
considerable swelling index. It is concluded that formulation of sustained release tablet of
Rifampicin containing Guar gum (1.5%), batch F2 can be taken as an ideal or optimized formulation of sustained release tablets
for 12 hour release as it fulfills all the requirements for sustained release tablet.
Key words: Rifampicin, Preformulation studies, in vitro release study, antitubercular agent.
INTRODUCTION
Rifampicin is an antitubercular agent, with half life
of 1.5-4 hours and requires multiple daily doses to maintain
adequate plasma concentrations. So it is selected to prepare
a sustained release tablet. The objective of this present study
is to develop a sustained release tablet of Rifampicin which
releases the drug in a sustained manner over a period of 12
hours, by using different polymers and study on polymer
concentration effect on release pattern. Reason for selection
of drug Rifampicin: Shorter biological half life and Protein
binding is very low. So attempts have been made to develop
Sustained release dosage forms.

Method of Analysis
Method of quantitation
Spectroscopy.

of

Rifampicin

by

U.

V.

U. V. Method
A solution of Rifampicin was prepared and
scanned for UV absorption. The solution of Rifampicin
showed maximum UV absorption at 263 nm. Preparation of
0.1 N HCl: Dilute 8.5 ml of concentrated HCl in 1000 ml of
distilled water to get 0.1 N HCl.

Corresponding Author: Samiran Dey E-Mail: dey.samiran@gmail.com

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Preparation of phosphate buffer pH 6.8.

Preparation of 0.2 M potassium dihydrogen
phosphate solution-Dissolve 27.213 g of potassium
dihydrogen phosphate in 1000 ml of distilled water to get
0.2 M potassium dihydrogen phosphate. Preparation of 0.2
M sodium hydroxide solution- Dissolve 8.0 g of sodium
hydroxide pallets in 1000 ml of distilled water.
Preparation of phosphate buffer pH 6.8.
weigh accurately 2 g of sodium hydroxide in a 250ml of
distilled water and weigh 6.8 g of potassium dihydrogen
phosphate in a 250ml of distilled water from 250ml of
sodium hydroxide solution take 112 ml of solution in a
1000ml beaker and add 250ml of potassium dihydrogen
phosphate to 1000ml beaker and make the final volume to
1000ml with water.
Preparation of Stock solution:
An accurately weighed 100 mg of Rifampicin
was dissolved in 100 ml of phosphate buffer of pH 1.2, Ph
6.8, to get solutions of 1000 g/ml. From this 10ml of
solution was withdrawn and diluted upto 100 ml with
phosphate buffer to get Rifampicin stock solution of
100g/ml.
Preparation of Standard solutions:
From above stock solutions aliquot of 10, 20, 30,
40,upto 100 ml were withdrawn and diluted to 100ml with
phosphate buffer pH 1.2, and pH 6.8 to get concentration
range of 10-100 g/ml, for Rifampicin
Preparation of standard Curve: The absorbance of
standard solutions prepared above was measured at max
263nm for Rifampicin. The data so obtained was plotted for
concentration in X axis and absorbance in Y axis and
regression was carried out.
Table no. (1): FORMULATION OF RIFAMPICIN
MATRIX TABLET
Each quantity mentioned will be taken in mgs
Total weight of the tablet = 350mg
Each tablet contains
= 100mg of the drug
An accurately weighed quantity of the powder (W)
was carefully poured into the graduated cylinder and the
volume (vo) was measured. then the graduated cylinder was
closed with lid, set into the density determination apparatus
(bulk density apparatus, electro lab, Mumbai). The density
apparatus was set for 500 taps and after that, the volume
(Vf) was measured and continued operation till the two
consecutive readings were equal. The bulk density, and
tapped density were calculated using the following formulas
[1,2].
Bulk density = W/Vo, Tapped density = W/Vf
Where, Vo = initial volume, Vf = final volume.

Compressibility index
The Compressibility index and Hausner ratio are
measures of the propensity of a powder to be compressed.
As such, they are measures of the relative importance of
interparticulate interactions. In a free-flowing powder, such
interactions are generally less significant, and the bulk and
tapped densities will be closer in value. For poorer flowing
materials, there are frequently greater interparticle
interactions, and a greater difference between the bulk and
tapped densities will be observed. These differences are
reflected in the Compressibility Index and the Hausner
Ratio.
The compressibility index and Hausner ratio may
be calculated using measured values for bulk density (
bulk)

and tapped density (

tapped)

as follows:
tapped -

Compressibility index =

bulk

X 100
tapped

Loss on drying
Determination of loss on drying of granules is
important drying time during granulation was optimized
depending LOD value. LOD of each batches were tested at
105oc for 2.5 minutes by using Sartorius electronic LOD
apparatus.
Angle of repose
The flow characteristics are measured by angle of
repose. Improper flow of powder is due to frictional forces
between the particles. These frictional forces are quantified
by angle of repose. Angle of repose is defined as the
maximum angle possible between the surface of a pile of
the powder and the horizontal plane.
tan = h/r
= tan-1 h/r
Where
h = height of pile
r = radius of the base of the pile
= angle of repose
EVALUATION OF TABLET
All the prepared Sustained release tablets were
evaluated for following official and unofficial parameters
such as Weight Variation, Thickness, Hardness Test,
Friability Test, Drug content, Dissolution Study [1].
WEIGHT VARIATION:
Twenty tablets were randomly selected from each
batch and individually weighed. The average weight and
standard deviation of 20 tablets was calculated. The batch
passes the test for weight variation test if not more than two
of the individual tablet weight deviate from

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the average weight by more than the percentage shown in

Table No.4 and none deviate by more than twice the
percentage shown.
THICKNESS
Twenty tablets were randomly selected from each
batch and there thickness and diameter was measured by
using digital vernier caliper.
TABLET HARDNESS
The crushing strength Kg/cm2 of prepared tablets
was determined for 10 tablets of each batch by using
Monsanto tablet hardness tester. The average hardness and
standard deviation was determined. The results are shown in
Table No. 4.
FRIABILITY
Method
Twenty tablets were weighed and placed in the
Electro lab friabilator and apparatus was rotated at 25 rpm
for 4 minutes. After revolutions the tablets were dedusted
and weighed again Table No. 8 The percentage friability
was measured using the formula,
% F = {1-(Wt/W)} 100
Where,
%F
= friability in
percentage, W = Initial weight of tablet, Wt = weight of
tablets after revolution.
UNIFORMITY OF CONTENT
Transfer one finely powdered tablet to a 500ml
volumetric flask with the aid of 200ml of water. Shake by
mechanical means for 30min. add water to volume and mix
filter and discard with first 20ml of the filtrate dilute a portion
of the filtrate quantitatively and step wise if necessary with a 3
in 100 mixture 0.1N HCL and water to obtain a solution
containing about 10g/ml. dissolve an accurately weighed
quantity of USPRF in a volume of water corresponding to that
used to dissolve a similar amount of Rifampicin from tablet and
dilute if necessary with a 3 in 100mix of 0.1n HCl and water to
obtain a std solution having known concentration of about
10g/ml concomitantly determine the absorbance of both
solutions in 1 cm cells at wave length max absorbance at
263nm.suitable spectrophotometer using water as a blank
calculate quantity in mg of C6H7N3O in tablet taken [2].
IN VITRO DISSOLUTION STUDIES
In Vitro dissolution study was carried out using
USP I apparatus (basket apparatus) in 900 ml of 0.1 N HCl
(pH 1.2), pH 6.8 for 12 hours. The temperature of the
dissolution medium was kept at 37 0.5oC and the basket
was set at 50 rpm. 10 ml of sample solution was withdrawn
at specified interval of time and filtered through Whatman
filter paper. The absorbance of the withdrawn samples was
measured at max 263 nm using UV visible

Spectrophotometer. The concentration was determined from

the standard curve of Rifampicin prepared in 0.1N HCl (pH
1.2), pH 6.8 at max 263 nm. Cumulative percentage of
drug release was calculated using the equation obtained
from a standard curve. The immediate release part for
sustained release Rifampicin was also calculated [2].
SWELLING INDEX
The swelling index of tablets was determined in 0.1
N HCl (pH 1.2) at room temperature. The swollen weight of
the tablets was determined at predefined time intervals. The
swelling index was calculated by the following equation [3]:
Method
One tablet was weighed and placed in a Petri plate
containing 25ml of 1.2 pH buffer solution. After each
interval the tablet was removed from beaker, removes
excess of buffer by using filter paper and weighed again
upto 12 hours. Swelling index was calculated by using the
following formula [5].
Swelling index WU
= (W1 W0) x 100
W0
Where, Wt
= Weight of tablet at time t, W0 = Initial
weight of tablet.
MODELING OF DISSOLUTION PROFILES
In vitro dissolution has been recognized as an
important element in drug development under certain
assessment of Bioequivalence. Several theories kinetics
models describe drug dissolution from immediate and
modified release dosage forms. There are several models to
represent the drug dissolution profiles where ft is a function
oft (time) related to the amount of drug dissolved form the
pharmaceutical dosage system .Whenever a new solid
dosage form is developed or produced, the drug
release/dissolution from solid pharmaceutical dosage form
is necessary to ensure that the drug dissolution occurs in an
appropriate manner. Several theories/ kinetic models
describe drug dissolution form immediate and modified
release dosage. These represents the drug dissolution
profiles where ft is a function oft (time) related to the
amount of drug dissolved from the pharmaceutical dosage
forms [6]. The quantitative interpretation of the value
obtained from the dissolution assay is facilitated by
mathematical equation which translates the dissolution
curve in function of some parameters related with the
pharmaceutical dosage forms.
In the present study, data of the in vitro release
were fitted to different equations and kinetic models to
explain the release kinetics of Rifampicin from the matrix
tablets. The kinetic models used were a Zero order equation,
First order, Higuchi release and Korsmeyer-Peppas models
[4].

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Mathematical models
Zero Order Kinetics
Drug dissolution from pharmaceutical dosage
forms that do not disaggregate and release the drug slowly
(assuming that area does not change and no equilibrium
conditions are obtained) can be represented by the following
equation [7];
Qt = Qo + ko t
Where, Qt = amount of drug released in timet, Qo
= initial amount of drug in the solution, kt = zero order
release constant. The pharmaceutical dosage forms
following this profile, release the same amount of drug by
unit of time and it is the ideal method of drug release in
order to achieve a pharmacological prolonged action. This
relation can be used to describe the drug dissolution of
several types of modified release pharmaceutical dosage
form, as in the case of some transdermal system, as well as
matrix tablets with low soluble drugs (Varelas et al., 1995),
coated form, osmotic systems, etc.

ft = atn
Where, a = constant incorporating structural and
geometric characteristics of the drug dosage form, n =
release exponent, ft = Mt/M = fraction release of drug.

First Order Kinetics

The application of this model to drug dissolution
studies was first proposed by Gibaldi and Feldman (1967).
The following relation can express this model [8]:
Log Qt = Log Qo + ktt/2.303
Where, Qt = amount of drug released in timet, Qo = initial
amount of drug in the solution, kt = first order release
constant.
The pharmaceutical dosage forms following this dissolution
profile, such as those containing water soluble drugs in
porous matrices, release the drug in a way that is
proportional to the amount of drug remaining in its interior,
in such way, that the amount of drug released by unit of
time diminish [9].

Procedure
In the present study stability studies were carried
out for a specified time period up to the 30 days for selected
formulations. The selected formulations were analyzed for
following parameters:

Higuchi Model
Higuchi (1961, 1963) developed several theoretical
models to study the release of water soluble drugs
incorporated in semisolid and/or solid matrixes. Simplified
Higuchi model can be expressed by following equation:
ft = kH t1/2
Where, kH = Higuchi diffusion constant, ft = fraction of drug
dissolved in timet.
Higuchi describes drug release as a diffusion
process based in the Ficks law, square root time dependent.
This relation can be used to describe the drug dissolution
from several types modified release pharmaceutical dosage
forms, as in the case of some transdermal systems (Costa et
al., 1996) and matrix tablets with water soluble drugs [10].
Korsmeyer-Peppas Model
Korsmeyer et al., (1983) developed a simple,
semiempirical model, relating exponentially the drug release
to the elapsed time (t);

STABILITY STUDIES
Stability of a drug has been defined as the ability of
a particular formulation, in a specific container, to remain
within its physical, chemical, therapeutic and toxicological
specifications.
The purpose of stability testing is to provide
evidence on how quality of a drug substance or drug product
varies with time under the influence of a variety of
environmental factors such as temperature, humidity and
light, and enables recommended storage conditions ,re-test
periods and shelf-lives to be established.
ICH specifies the length of study and storage conditions.
Long term testing - 25 c 2c / 60%RH5% for 12 months.
Accelerated testing - 42c 2c / 75% RH5% for 6 months.

Physical evaluation
Appearance: The selected samples were checked for any
change in colour every week.
Hardness: The selected samples were tested for hardness
every week.
Chemical evaluation
Drug content: The selected formulations were checked for
drug content. The selected formulations were subjected to
drug release studies.
PHYSICOCHEMICAL EVALUATION OF MATRIX
TABLET
The results of the thickness, Hardness, weight
variation, drug content, friability, disintegration time of
tablet are shown in Table 6.
Drug content uniformity
The results of drug content of tablets are shown in
Table No.10. The drug content of tablets were found to vary
between 98.60%. To 102.06%
*Values are Mean SD (n=4)
In vitro Release Study
Table No.11 to 14 shows the data for in vitro
release of Rifampicin from matrix tablet of batches F1, F2,
F3, F4, F5, F6, F7, F8, F9, F10, F11, & F12 respectively.
As follows the dissolution profile shows the comparative
release profile of Rifampicin with different concentration of
different polymer from batches.

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Table 1. Determination of bulk density and tapped density
Batch > ingredients

F1

F2

F3

F4

F5

F6

F7

F8

F9

F10

F11

F 12

Drug
Guar gum
Tragacanth- gum
PEG-6000
Carbopol-934p
Magnesium- Stearate
Talc
Starch
Compressible Lactose

100
100
7
7
21
115

100
150
7
7
21
65

100
200
7
7
21
15

100
100
7
7
21
115

100
150
7
7
21
65

100
200
7
7
21
15

100
100
7
7
21
115

100
150
7
7
21
65

100
200
7
7
21
15

100
100
7
7
21
115

100
150
7
7
21
65

100
200
7
7
21
15

Table 2. Preformulation studies

Parameters>Batch

Bulk Density

Tapped Density

Carrs Index

Hausners Ratio

Angle Of Repose(degree)

F1

0.442

0.638

7.22

1.08

18.100.03

F2

0.522

0.513

7.29

1.10

18.190.06

F3

0.510

0.601

7.31

1.04

19.510.057

F4

0.521

0.711

7.63

1.06

20.330.042

F5

0.560

0.730

7.59

1.14

21.4940.02

F6

0.493

0.513

7.86

1.09

21.110.026

F7

0.591

0.509

8.30

1.12

23.9620.01

F8

0.601

0.600

8.14

1.15

18.210.02

F9

0.630

0.609

9.11

1.11

24.140.042

F 10

0.616

0.510

11.62

1.00

24.180.41

F 11

0.592

0.611

13.60

1.18

20.640.026

F 12

0.660

0.731

13.11

1.13

24.130.042

Table 3. Results of Thickness and Disintegration time

Parameter Batch
F1
F2
F3
F4
F5
F6
F7
F8
F9
F 10
F 11
F 12

Thickness (mm)*
4.4
4.0
4.3
4.1
4.5
4.2
4.6
4.3
4.1
4.2
4.6
4.1

Disintegration Time(sec)*
196
240
210
243
191
200
317
250
213
300
144
231

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Table 4. Result of weight variation, Hardness and Friability

Parameter Batch
F1
F2
F3
F4
F5
F6
F7
F8
F9
F 10
F 11
F 12

Weight Variation (mg)

350.1
348.9
325.2
351.4
349.3
348.4
350.7
351.5
349.3
350.1
353.1
349.2

Hardness (Kg/cm2)*
5.51
5.80
5.93
6.20
6.11
6.35
6.41
6.44
6.68
6.71
6.89
6.91

Friability(%)
0.55
0.59
0.61
0.58
0.63
0.76
0.70
0.66
0.53
0.71
0.69
0.68

Table 5. Result of Drug content uniformity

Parameter Batch
F1
F2
F3
F4
F5
F6
F7
F8
F9
F 10
F 11
F 12

Drug Content (%)

99.50
98.60
100.02
99.59
99.38
99.05
99.60
102.06
100.62
99.50
100.02
101.01

Table 6. Physicochemical evaluation of matrix

Serial no.

Time (hrs)

%release F 1

%release F 2

%release F3

2.37

2.61

2.45

2
3
4
5
6
7
8
9
10
11
12

2
3
4
5
6
7
8
9
10
11
12

5.58
14.78
20.53
21.13
32.14
39.89
52.23
56.81
59.66
74.81
75.95

7.63
21.41
34.67
40.17
48.85
55.88
64.72
88.32
94.05
97.19
98.87

5.78
16.03
29.45
31.98
45.76
49.25
68.66
72.32
75.57
80.35
84.81

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Table 7. Comparison of all kinetic models

Batch code
F1
F2
F3
F4
F5
F6
F7
F8
F9
F10
F11
F12

Polymer concentration (%)

1% guar gum
1.5% guar gum
2% guar gum
1% TragacanthGum
1.5% TragacanthGum
2% TragacanthGum
1% peg-6000
1.5% peg-6000
2% peg-6000
1% Carbopol
1.5% Carbopol
2% Carbopol

Zero order
0.9849
0.9801
0.9761
0.9758
0.9489
0.9574
0.974
0.957
0.9825
0.9716
0.9666
0.9765

First order
0.9342
0.8458
0.9619
0.9415
0.9615
0.9864
0.9618
0.9652
0.017
0.871
0.963
0.9364

Higuchi
0.8991
0.9506
0.9011
0.8932
0.8665
0.9366
0.9399
0.9183
0.9502
0.9081
0.9111
0.8866

Korsmeyer-Peppas
0.818
0.7933
0.8033
0.7962
0.7946
0.7978
0.7855
0.7803
0.7824
0.759
0.0243
0.7864

Table 8. Swelling Index of Tablets of Batch F1 toF12

TIME (HRS)

Batch

0
0
0
0
0
0
0
0
0
0
0
0
0

F1
F2
F3
F4
F5
F6
F7
F8
F9
F10
F11
F12

1
32.23
49.25
39.21
29.09
56.73
45.65
26.76
35.45
39.06
25.87
24.87
22.46

2
41.38
61.54
51.92
39.45
66.76
53.35
40.98
45.78
47.96
36.54
36.39
34.97

3
54.32
72.90
63.76
51.32
77.72
64.32
49.54
59.87
55.32
47.86
45.48
42.56

4
63.78
82.37
72.52
61.12
82.26
75.45
59.06
69.58
65.34
57.98
56.46
54.23

5
74.12
92.54
842
71.97
94.60
80.09
69.78
81.02
76.09
69.96
65.32
60.85

Table 9. Stability studies of optimized formulation (F2)

Tested after time (hrs.)
1
2
3
4
5
6
7
8
9
10
11
12

Cumulative% release(initial)
2.16
7.63
21.41
34.67
40.17
48.85
55.85
64.72
88.32
94.05
97.19
98.87

Cumulative% release(After 30 days)

2.19
7.88
21.39
35.48
41.11
48.01
56.35
64.23
86.11
93.32
97.45
98.16

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Fig 1. Calibration curve of Rifampicin in phosphate buffer pH 1.2

Calibration curve

y = 0.0083x + 0.0064
R 2 = 0.9997

0.8

0.6
0.5
0.4
0.3

(nm)

Absorbance (nm)

0.7

0.2
0.1
0
0

20

40

60

80

100

Concentration (mcg/ml)

The equation of line for calibration curve of Rifampicin in phosphate buffer was found to be y = 0.0083x+ 0.0064 (R 2 = 0.9997).
Fig 2. Calibration curve of Rifampicin in phosphate buffer pH 6.8

The equation of line for calibration curve of Rifampicin in phosphate buffer was found to be y = 0.0054x+ 0.0049 (R 2 = 0.9996)
Fig 3. IR Curve of Pure Drug (Rifampicin)

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Fig 4. IR Curve of Rifampicin + Guar gum

Fig 5. IR Curve of Rifampicin + Tragacanth

Gaur gum

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Fig 6. IR Curve of Rifampicin + PEG-6000

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Fig 7. IR Curve of Rifampicin + Carbopol

Fig 8. Zero order release of optimized formulation (F2)

PLOT OF CUM% DRUG RELEASE Vs TIME

y = 9.5356x - 7.4891
R2 = 0.9801

Cum%drug release

120
100
80
Series1

60

Linear (Series1)

40
20
0
0

10

15

Tim e in (hrs )

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Fig 9. First order release of optimized formulation (F2)
y = -0.1654x + 2.4651
R2 = 0.8458

PLOTOF LOGCUM%RETAINVsTIME

Log cum % drug retain

2.5
2
1.5

Series1
Linear (Series1)

1
0.5
0
0

10

15

Tim e in (hrs)

Fig 10. Higuchi release of optimized formulation (F2)

PLO T O F C UM % DRUG RELEASE V/s TIME IN RO O T

4

y = 0.0217x + 1.2109
R2 = 0.9506

Cum % drug release

3.5
3
2.5

Series1

Linear (Series1)

1.5
1
0.5
0
0

50

100

150

ROOT TIME

Fig 11. Korsmeyer-peppas release of optimized formulation (F2)

PLO T O F C UM % DRUG RELEASED V/s LO G TIME

y = 0.5729x - 0.2146
R2 = 0.7933

Log cum % drug release

1.2
1
0.8
0.6

Series1

0.4

Linear (Series1)

0.2
0
-0.2

LOG TIME

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Fig 12. Swelling studies of optimized formulation F2

Initial Time

After 6 hours

After 2 Hours

After 12 hours

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Fig 13. Dissolution profile of Matrix Tablets of Rifampicin after one month Accelerated Stability studies.

100
90
Cum % Release

80
70
60
50
40
30
20
10
0
0

10

15

Time (hours)

Cumulative% release(initial)
Cumulative% release(After 30 days)

SUMMARY AND CONCLUSION

Oral route of drug administration is oldest
and safest mode of drug administration. It posses several
advantage. It provides accurate dosing without assistantship
of administration. In conventional oral drug delivery system,
there is little or no control over release of drug, and
effective concentration at the target site can be achieved by
administration of grossly excessive dosage form. Sustained
release technology is relatively new field and as a
consequence, research in the field has been extremely fertile
and has produced many discoveries. With many drugs, the
basic goal is to achieve a steady state blood level that is
therapeutically effective and non-toxic for an extended
period of time. The design of proper dosage form is an
important element to accomplish this goal. Rifampicin is an

antitubercular agent, with half life of 1.5-4 hours and

requires multiple daily doses to maintain adequate plasma
concentrations. So it is selected to prepare a sustained
release tablet. The objective of this present study is to
develop a sustained release tablet of Rifampicin which
releases the drug in a sustained manner over a period of 12
hours, by using different polymers and study on polymer
concentration effect on release pattern. The present study
was undertaken with an aim to formulate develop and
evaluate Rifampicin sustained release tablets using different
polymers as release retarding agent.
Preformulation study was done initially and results
directed for the further course of formulation. Based on
Preformulation studies different batches of Rifampicin were
prepared using selected excipients. Granules were evaluated

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for tests Bulk density, tapped density, compressibility index,
Hausner ratio before being punched as tablets. IR spectra
studies revealed that the drug and polymers used were
compatible. Various formulations of sustained release
tablets of Rifampicin were developed using various
polymers viz, Guar gum, Tragacanth Gum, PEG-6000 and
Carbopol in different proportions and combinations by
direct compression technique. The tablets were evaluated
for physical characterization, in vitro swelling behavior, in
vitro release study and stability studies. Observations of all
formulations for physical characterization had shown that,
all of them comply with the specifications of official
pharmacopoeias and/or standard references. Results of
in vitro release profile indicated that formulation (F2) was
the most promising formulation as the extent of drug release
from this formulation was high as compared to other
formulations. Results of in vitro swelling study indicate that

the formulation F2 was having

considerable swelling
index.
Stability study was conducted on tablets of Batch
F2 stored at room temperature, 370 C for one month. Tablets
were evaluated for hardness, friability, in-vitro release
profile and drug content. After one month no significant
changes were observed in any of the studied parameters
during the study period, thus it could be concluded that
formulation was stable. It was concluded that the tablets of
batch F2 had considerable swelling behaviors and in vitro
drug release. It was observed that tablets of batch F2
followed the Zero order release profiles. From the above
results and discussion it is concluded that formulation of
sustained release tablet of Rifampicin containing Guar gum
(1.5%),batch F2 can be taken as an ideal or optimized
formulation of sustained release tablets for 12 hour release
as it fulfills all the requirements for sustained release tablet.

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