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ISSN No: 2321 8630, V 1, I 1, 2014

Journal Club for Pharmaceutical Sciences (JCPS)


Manuscript No: JCPS/RES/2014/18, Received on: 04/08/2014, Revised on: 10/08/2014, Accepted on: 14/08/2014

RESEARCH ARTICLE
Effect of Different Viscosity Grade of HPMC on Cefixime Trihydrate Sustained Release
Matrix Tablet
Patel BP*1, Patel BK1
1

Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India.

ABSTRACT
The present work aims to study effect of different viscosity grade of HPMC on cefixime
trihydrate sustained release matrix tablet with a view to prolong drug release in vivo and reduce
frequency of dosing. Cefixime Trihydrate is an orally active third generation cephalosporin. It
has plasma half-life of 3-4 hrs. It is active against Gram+ve as well as Gram-ve bacteria. The
Sustained release matrix tablets were prepared by wet granulation method using various release
retardant polymers like different grade of HPMC, Lactose, MCC, and PVP K-30. The granules
were subjected to pre-compression and post-compression parameters and they were in the
acceptable limits. The in vitro retardation of drug release from HPMC matrices in accordance
with its different proportion and viscosity grade was HPMC K-100M>HPMC K-15M >HPMC
K-4M with ratio of (1, 1.5, 2) individually in formulation F1-F9 and (0.5, 0.75, 1) ratio in F10F12. Among various kinetic models drug release was found to best fit the case II
transport, Zero order release model. A drug-excipient interaction was performed by DSC and
FTIR; results were shown that there was no interaction between drug and excipients used. After
3 months stability study at 400C/75% RH, formulations found to be stable. So as the viscosity
and proportion of HPMC increases release rate from sustained release cefixime trihydrate matrix
tablet decreases.
KEYWORDS
Sustained release matrix tablet, Cefixime Trihydrate, HPMC, Antibiotic
is to achieve better therapeutic activity by
INTRODUCTION
using smallest quantity of drug administered
The oral route is the most acceptable drug
delivery route for patient compliance aspects.

by the most suitable route.1In some sustained

The main goal of pharmaceutical formulation

release formulations, the drug dissolves into


the matrix, and the matrix physically swells to

*Address for Correspondence:


Parth.B. Patel,
Kalol Institute of Pharmacy,
Gandhinagar, Gujarat, India.
Email id: pb91patel@gmail.com

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form a gel, allowing the drug to exit through


the gel's outer surface. Sustained release
tablets and capsules are commonly taken only
once

or

twice

daily,

compared

with

115

counterpart conventional forms that may have

pharyngitis, and acute exacerbation of chronic

to take three or four times daily to achieve the

bronchitis, uncomplicated gonorrhea. It has

same therapeutic effect.2

very

One of the most common approaches used

Streptococcus

for prolonging and controlling the rate of

pyogenes,

drug release is incorporating the drug in a

Haemophilus influenza, Escherichia coli,

hydrophilic colloidal matrix such as Hydroxy

Klebsiella pneumoniae, Proteus mirabilis and

propyl methyl cellulose (HPMC), Hydroxy

Neisseria gonorrhoeae. It also has activity

propyl cellulose (HPC), carbopols, chitosan,

against Gram-+ve bacteria, especially against

alginates and gelatin etc. The mechanism and

Streptococci.4

kinetics of release of drugs incorporated in

After 200 mg of the conventional release

these polymer matrices is depends the type

dosage form of Cefixime trihydrate is

and amount of polymer as well as on the

administered, the peak plasma concentration

physico-chemical

drug

achieved is 1.2 mg/L, and this concentration

matrix

slowly decline below minimum effective

substance.

properties

Hydrophilic

of

polymer

good

in

vitro

activity

against

pneumonia,

Streptococcus

Branhamella

catarrhalis,

systems are widely used in oral controlled

concentration

drug delivery because they make it easier to

Cefixime

achieve a desirable drug-release profile, cost

synthesis in the bacterial cell wall, rendering

effectiveness and they have broad US Food

it defective and osmotically unstable. The

and Drug Administration acceptance. The

steady-state

hydration rate of HPMC depends on the

concentration will increase the rate of

nature of these substituents, such as the

bacterial killing and more quickly relieve the

molecular structure and the degree of

excruciating symptoms of bacteremia.

substitution. Specifically, the hydration rate

The present research work involves the

of HPMC increases with an increase in the

formulation development of sustained release

hydroxyl propyl content. The solubility of

matrix tablet of cefixime trihydrate by

HPMC is pH independent. 3

applying full factorial design to understand

Cefixime Trihydrate is broad spectrum third

the effect of formulation variables like

generation cephalosporin antibiotic having

concentration and viscosity of HPMC K-4M,

bactericidal activity and used in the treatment

HPMC K-15M, HPMC K-100M on physico-

of

chemical properties of matrix tablet and on in

uncomplicated

UTI,

otitis

media,

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(MEC)

trihydrate

within
inhibit

maintenance

12

hours.

mucopeptide

of

plasma

116

vitro dissolution rate and stability were also

then passed through sieve 20, loading in

studied. The drug release data were plotted

RMG premixing for 10min.Then binder PVP

using various kinetic models to evaluate the

K-30was added for 5min after that kneading

drug release mechanism and kinetics.6

for 3min then run the chopper (500rpm) for


2min dried in hot air oven then again passed

MATERIALS & METHODS


Cefixime Trihydrate was gifted to us by

through sieve no 20 at finally add lubricant

Alembic

Baroda,

and glidant (mg. stereate, talc) and compress

K-15M,

in rotary press compression machine by using

HPMC K-100M, microcrystalline cellulose

11-mm punches at a compression force

(MCC), Lactose and Polyvinyl pyrrolidone

required to produce tablets of about 812

(PVP K-30) was procured from Merck India

kg/cm2 hardness. All the tablets were stored

Ltd., Mumbai. Polymers used were of

in airtight containers for further study. Prior

analytical grade and other chemicals of

to compression, granules were evaluated for

Laboratory grade.

their flow and compressibility characteristics.

pharmaceuticals;

Gujarat.HPMC

Preparation

K-4M,

of

HPMC

Cefixime

Trihydrate

Evaluation of Cefixime Trihydrate Sustained

Sustained Release Matrix Tablet1, 7

Release Matrix Tablet10-15

Different viscosity grade of HPMC based

Pre-compression Parameters8, 9

sustained release matrix tablets were prepared

BulkDensity:

by

Weight of the PowderVolume of the packing

wet

granulation

technique.

The

compositions of different tablet formulations

Tapped

are shown in the table-1. PVP-K30 is used as

Density:

a binder in 25%, Micro Crystalline Cellulose

Weight of the powderTapped volume of the packing

(7-15%), Lactose (13-23) was widely used as

Hausners

a binder/diluent that makes it useful in

Ratio: Bulk DensityTapped Density

tableting. The formulations F-1 to F-3 are

Carrs Compressibility Index

composed

of

HPMC

K-4M,

whereas

formulations F-4 to F-6 are composed of


HPMC K-15M and Formulations F-7 to F-9
were composed of HPMC K-100M in various
percentages too

(like-100,150,200).

Tapped Density Bulk Density


100
Tapped Density
Angle of Repose
Tan = h/r OR = tan-1 [h/r]

First

Polymers & other materials were weighed and

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Post-Compression Parameters10-15

117

The prepared tablets can be evaluated for

weighed and placed in the Rouche friability

various

test apparatus and operated at rate of 25 RPM

official

and

non

official

specifications.

for 4 minutes (or up to 100 revolutions),

Thickness and Diameter of Tablets

tablets were de-dusted and weighed again.

Three tablets were taken and the thickness

The loss of tablet weight due to abrasion and

and diameter was measured using a dial-

fracture was measured in terms of % friability

caliper. The tablet thickness and diameter

(A value of <1%F) was acceptable.

should be controlled within the 5%

variation of a standard value.

Initial Wt. Final Wt.


100
Initial Wt.

Weight variation test as per I.P 9610


6 Tablets were randomly selected from each
batch and weighed on an electronic balance
both weight of 6 tablets and individual tablet
was considered mean and standard deviation
(S.D) of weight was calculated from each

determined by placing the tablet in the


dissolution medium of Phosphate buffer pH
7.2 at 37 0.50C. The tablets were removed

draining off the free water from the surfaces,

Hardness10
Hardness indicates the ability of a tablet to
withstand mechanical shocks while handling.
The hardness of the tablets was determined
Monsanto

hardness

tester.

It

they were measured for weight gain. It is


expressed in terms of percentage water uptake
(WU %) and calculated by using the equation,
.

is

expressed in kg/cm2. Three tablets were


randomly selected from each formulation and
the mean and standard deviation values were
calculated.
Friability (%)

The swelling properties of matrix tablets were

after 10 hrs from dissolution medium. After

batch and shown in table -3.

using

Swelling Index (%)11-12

Wt. of swollen tablet Initial wt. of tablet


Initial Wt. of tablet

100
Drug content13
Ten

Tablets

were

selected

accurately,

10

It is the ability of tablets to withstand


mechanical shocks during handling and
transportations. The % of friability of
prepared tablet was shown in table-3. 6 tablets
were randomly picked from each batch and

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weighed and average weight per tablet


calculated. Tablets were ground individually
to fine powder. Accurately weighed tablet
powder, equivalent to 200 mg of Cefixime
Trihydrate

was

transferred

to

100

ml

volumetric flask. Powder was dissolved in 80

118

ml of pH 7.2 Phosphate buffer and dissolved

using buffer. The absorbance was measured at

completely and made upto 100 ml with

288 nm using an UV spectrophotometer. The

buffer. This solution was filtered by whatman

experiments were carried out in triplicate for

filter paper. From this 10 ml of solution was

the tablets of all formulations and average

withdrawn and volume made upto 100 ml

values were recorded as shown in table 3

Composition of Phosphate Buffer pH 7.2


Ingredients

Quantity

Potassium dihydrogen phosphate (KH2PO4)

26.22g

Sodium Carbonate (Na2CO3)

7.78 g

Magnesium Chloride

5 ml

Distilled Water

Up to 1000ml

In-vitroDrug Release Study14

In order to determine the release mechanism

The dissolution test was performed according

that provides the best description pattern of

to USP type-II paddle apparatus (Electolab,

drug release, the in vitro release data were

Mumbai). The dissolution medium consists of

fitted to zero-order, first-order Higuchi matrix

900 ml of Phosphate buffer of pH 1.2 for two

model and KorsmeyerPeppas model. The

hours, followed by Phosphate buffer pH 7.2

release exponent (n) was calculated by

for the next ten hours at 370.5C with a

regression

rotation rate of 100 rpm. 10 ml aliquots of

equation. Mt/ M = Kt, Where Mt/M is the

samples were taken at every 1 hr and replaced

fraction of drug released (using values of

with the same. Cefixime Trihydrate was

Mt/M within the range 0.100.60) at time t

assayed spectrophoto- metrically at 288 nm

and K is a constant incorporating the

(UV-Thermo scientific). The release studies

structural and geometric characteristics of the

for each formulation were conducted in

release device. A value of n=0.5 indicates

Phosphate buffer pH 1.2 and pH 7.2,

case I (Fickian) diffusion, 0.5<n<1 indicates

indicating the reproducibility of the results.

anomalous (non-Fickian) diffusion, and n=1

The results were expressed as each value is

indicates case II transport (Zero order

the mean SD, n = 3 determinations.

release), n>1 indicates Super case IItransport.

Kinetic analysis of in vitro release data

From the mathematical treatment of the in

analysis using

the

following

vitro release data of Cefixime Trihydrate

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119

sustained release matrix tablet, the values of

Cefixime

Trihydrate

R2 (coefficient of determination) has been

Matrix Tablet was designed with the objective

obtained as presented in table -5.[15]

of prolong drug release leading to minimize

Stability studies:[2, 6]

the peak and valley effect in the plasma and

The formulations (F3, F6, F9, F10, F11, F12)

provide

were also subjected to stability studies by kept

Hydrophilic polymer matrix systems are

them for 3 months under environmental

widely used in sustained release matrix tablet

conditions such as room temperature of 27

because they make it easier to achieve a

2C/65% RH, oven temperature of 40

desirable drug-release.

2C/75% RH and in the refrigerator at 48C.

Pre-Compression Parameters

At the end of the period, Hardness, drug

Angle of Repose

content, and release profiles were determined.

Formulation F3-F12 having angle of repose

Drug Excipient Interaction Studies

between 23-30 which shows excellent flow

The Cefixime Trihydrate drug &F10tablet

property. Formulation F1-F2 having angle of

were subjected to thermal analysis by

repose between 31-35 which showed good

Differential Scanning Calorimetry (DSC) to

flow property.

confirm the absence of any interactions.

Carrs Compressibility Index

Instrument Model no- DSC-60, Temp range-

All the formulation F1-F12 shows Carrs

500C-3000C, Rate-200Cper min., Atmosphere

Compressibility index between ranges 5-

Air and Made by- shimadzu corporation,

15which indicate excellent flow property.

patient

Sustained

convenience.

Release

Therefore,

Japan.[12-15]
Fourier Transforms Infrared Spectroscopy

Post-Compression Parameters

Studies (FTIR)

It was observed that Thickness, Diameter,

Fourier

transform

infrared

spectrum of

Weight Variation, Swelling Indexwere found

Cefixime Trihydrate pure drug, physical

to be satisfactory.

mixture of pure drug and polymers were taken

Hardness

respectively. Potassium bromide disc (pellets)

All the formulation F1-F12 shows hardness

method. All the spectra were scanned from

between 8-11 kg/cm2 which was effective for

4000 cm-1 to 500 cm-1.10, 15

sustained drug release. It was found that as

RESULT AND DISCUSSION

the concentration and grade of HPMC


increases hardness increases.

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120

Friability

slower. This may be due to HPMC K-100M,

The percent friability for all the formulations

K-15M and K-4M in ratio of (1-0.75-0.5) that

was below 1%, indicating that the friability is

result in decrease wettability and penetration

within the prescribed limits. The results of

of water into the film matrices and hence

friability indicate that the tablets possessed

decrease diffusion of the drug. Whereas

good mechanical strength.

release rates of other formulation were

Drug Content

comparatively higher than F10.

The percentage drug content of both the drugs

Drug

release

from

HPMC

matrices

in all the formulated tablets was found to be

showed that viscosity and proportion of

within limit. Percentage drug content values

polymer

of Cefixime Trihydrate are within 93.17 to

retardation of drug

98.67 % for all the formulations. The results

following order specifically for F1-F9

plays

important

role

release was

in
in

within range indicate uniformity of mixing.


In vitro Dissolution Studies

HPMC K-100M > HPMC K-15M > HPMC

In vitro drug release study was carried out

K-4M

using USP dissolution apparatus, type-II.


Comparative dissolution profile of all batches

The retardation of drug release from

is given in Figure 1. Being the sustained

HPMC matrices in accordance with its

release formulations the release rates of all the

different proportion was in the following

formulations were controlled. Formulation

order specifically for F10-F12.

F10 released Cefixime Trihydrate completely


HPMC K-4M HPMC K-15M HPMC K-100M INFERENCE
0.5

0.75

SLOWEST

0.75

0.5

SLOWER

0. 5

0.75

SLOW

Kinetic Analysis of in vitro Release Data

fitted to zero-order, first-order, and Higuchi

In order to determine the release mechanism

matrix model and KorsmeyerPeppas model.

that provides the best description pattern of

The release data were matched kinetically

drug release, the in vitro release data were

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121

with case II transports (Zero order release

There was no significant change observed in

model).

the physical appearance, hardness and drug


content uniformity tests as conducted at the

Drug Excipient Interaction Studies

end of 3 months. The in-vitro dissolution

As per DSC study of drug shows the

profile for formulation F10 stored at 25

characteristic peak at 220.60C as its melting

point is 220-222 C reported. The figure 3

Cefixime Trihydrate, while for formulation

showed the characteristic peak of Cefixime

stored at 400C/75%RH, Cefixime Trihydrate

Trihydrate alone. The figure showed the

accounted for 74.00% release. Therefore the

combined peaks of Cefixime Trihydrate

stability studies revealed no change in

HPMC grades, PVP K30.DSC study of drug

physical appearance, Hardness, Drug content

and F10 matrix tablet showed sharp peak at

and not much change in In-vitro dissolution

221.16C,

109.24C,

respectively.

Theses

97.70C,
confirmed

89.66C
drug

C/40% RH exhibited 74.78% release of

profiles. Hence these formulations were found


to be stable at the above temperatures.

compatibility with polymer. All the peaks


were present in graph and hence the Cefixime

DISCUSSION

Trihydrate was not being interfered due to


presence of other Excipients.

This investigation showed effect of HPMC on


release rate of drug with the intention of

Infrared Spectroscopy Studies (I.R.)


The figure 2b shown characteristics peaks of
Cefixime Trihydrate are obtained at 3567.18
cm-1, 3296.24 cm-1, 1774.13 cm-1, 1667.30
cm-1, 1583.11 cm-1, 1531.88 cm-1, 1225.19
cm-1, 1185.98 cm-1, 803.17 cm-1, 864.64 cm-1
and 741.90 cm-1. FTIR spectrum of Cefixime
Trihydrate pure drug, physical mixtures of
drug and the polymers were taken. The FTIR
spectra obtained indicates good compatibility
between drug and polymers.
Stability Studies

obtaining better therapeutic efficiency by


controlling drug release thereby improving
patient

compliance

increasing

bioavailability with decreased dosing and


fewer side effects. Prepared tablets did not
disintegrate, however a gel layer was formed
on surface of the tablet due to swelling of
HPMC in presence of water. Here the
polymer ratios of each type of HPMC K- 4M,
K-15M and K-100M were kept individually
in (1, 1.5, 2) for F1-F9. For F10-F12 these
ratio was kept (0.5, 0.75, 1) respectively. The
formulations

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and

containing

HPMCK-100M

122

showed delayed release of drug as compared

Trihydrate thus helped to decrease dosing

to those containing HPMC K-15M and

frequency , reduces local adverse effects, and

HPMC K- 4M. These revealed that as the

extends release of drug from the matrix to a

viscosity of HPMC increased, the rate of drug

prolong period of time, thus improves patient

release

compliance. This may also extends biological

was

decreased.

Formulation

of

sustained release matrix tablets of Cefixime

half-life of existing drug.

Table : 1 Formulation of Cefixime Trihydrate Sustained Release Matrix Tablet (Wt. in mg)

FORMULATION

F1

F2

F3

F4

F5

F6

F7

F8

F9

F10

F11

F12

200

200

200

200

200

200

200

200

200

200

200

200

100

150

200

50

75

100

100

150

200

75

100

50

100

150

200

100

50

75

LACTOSE

125

100

75

125

100

75

125

100

75

45

45

45

MCC

90

65

40

90

65

40

90

65

40

45

45

45

PVP K 30

25

25

25

25

25

25

25

25

25

25

25

25

Mg. STEARATE

TALC

CODE

CEFIXIME
TRIHYDRATE
HPMC K 4 M
(4,000 mPa s)
HPMC K 15 M
(15,000 mPa s)
HPMC K 100 M
(100,000 mPa s)

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123

Table : 2 Pre-Compression parameters of Sustained Release Matrix Tablet


Code
(F)

Bulk Density
(g/cc)

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

0.405 0.0035
0.417 0.0000
0.426 0.0040
0.438 0.0000
0.459 0.0046
0.478 0.0052
0.503 0.0058
0.521 0.0000
0.536 0.0064
0.610 0.0150
0.590 0.0162
0.564 0.0075

Carrs
Hausner Ratio Compressibility
index (%)
0.454 0.0000 1.121 0.0098
10.79 0.7627
0.459 0.0046 1.102 0.0110
9.21 0.9180
0.475 0.0046 1.113 0.0185
10.17 1.4905
0.487 0.0058 1.111 0.0133
9.99 1.0750
0.517 0.0064 1.126 0.0029
11.21 0.1986
0.536 0.0064 1.121 0.0254
10.75 2.0150
0.564 0.0075 1.120 0.0277
10.68 2.2309
0.590 0.0081 1.133 0.0156
11.73 1.2182
0.604 0.0081 1.128 0.0146
11.36 1.1221
0.707 0.0115 1.160 0.0159
13.81 1.1872
0.676 0.0000 1.146 0.0312
12.67 2.3914
0.652 0.0095 1.158 0.0285
13.57 2.1344
Each value is the mean, n = 3 determinations
Tapped
Density (g/cc)

Angle of
Repose (o)
32.55 0.4792
31.48 0.4503
29.98 0.4215
30.23 0.4215
29.28 0.3984
27.97 0.3637
28.61 0.3811
27.15 0.0000
26.38 0.3291
23.34 0.2540
24.61 0.2887
25.47 0.5300

Table : 3 Post-Compression parameters of Sustained Release Matrix Tablet


Code
(F)

Thickness
(mm)

Diameter
(mm)

Weight
Variation
(mg)

Hardness
(kg/cm2)

Friability
(%)

Swelling
Index
(%)

% Drug
Content

F1

3.50 0.0000

93.17

0.36

63.81

93.83

F3

3.55 0.0115

0.29

66

94.67

F4

3.57 0.0115

0.30

62.91

95

F5

3.60 0.0000

0.27

65.64

96.17

F6

3.64 0.0000

0.25

66.90

96.5

F7

3.63 0.0115

0.22

66.36

96.83

F8

3.65 0.0115

0.21

68.91

97

F9

3.68 0.0000

0.23

70.18

97.67

F10

3.71 0.0115

0.11

75.45

98.67

F11

3.70 0.0000

0.16

73.27

97.67

F12

3.69 0.0115

8.57
0.0577
8.73
0.0577
8.83
0.0577
8.97
0.0577
9.03
0.0577
9.20
0.0000
9.33
0.0577
9.47
0.0577
9.70
0.1000
10.43
0.0577
10.23
0.0577
9.97
0.0577

61.81

3.53 0.0115

550.67
1.1547
550.00
1.0000
550.67
1.1547
551.33
1.5275
549.33
1.1547
549.33
0.5774
549.33
2.0817
551.67
1.5275
550.33
0.5774
548.67
1.1547
550.67
1.1547
550.00
1.0000

0.41

F2

11.02
0.0000
11.08
0.0058
11.13
0.0173
11.17
0.0058
11.21
0.0115
11.30
0.0000
11.35
0.0058
11.37
0.0115
11.43
0.0306
11.63
0.0115
11.56
0.0153
11.51
0.0058

0.18

72.18

97.17

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124

Each value is the mean SD, n = 3 determinations


Table : 4 In-vitro drug release data of Cefixime Trihydrate Sustained Release Matrix
Tablet
Percentage cumulative drug released

Time
(Hrs.)

F1

F2

F3

F4

F5

F6

F7

F8

F9

F10

F11

F12

20.01

17.18

13.06

16.41

12.03

11.26

10.75

9.21

7.92

5.61

8.43

13.83

26.14

26.88

21.95

25.07

22.97

16.79

17.30

17.54

12.89

13.64

15.73

19.39

30.84

33.16

27.71

33.91

30.29

25.08

26.11

23.54

21.69

20.16

21.47

26.39

37.32

39.14

34.97

38.89

36.54

35.97

32.89

30.29

28.99

27.69

30.01

31.87

44.59

45.12

40.96

46.15

43.81

40.20

42.48

38.85

34.98

33.68

36.28

40.41

56.24

53.93

50.29

54.97

52.37

48.73

49.79

46.92

46.11

41.21

42.52

46.94

62.54

60.20

53.99

59.18

58.13

54.49

57.33

53.44

51.11

44.63

49.79

48.81

74.95

69.01

59.94

62.06

66.16

59.95

65.12

60.71

58.63

52.90

56.30

51.66

83.32

72.71

67.21

77.00

74.48

67.98

71.64

67.22

64.62

58.90

61.77

63.52

10

90.09

80.72

73.97

79.23

80.48

70.90

77.37

73.97

73.17

64.63

68.26

67.25

11

96.08

87.49

80.99

88.51

84.92

78.13

83.34

78.93

79.70

70.35

75.27

76.29

12

99.23

91.94

86.73

95.55

90.63

84.64

92.67

86.19

81.83

74.78

79.21

82.05

Each value is the mean, n = 3 determinations


Table : 5 Kinetic analysis parameters for Cefixime Trihydrate Sustained Release Matrix
Tablet
Formulation
code
F1
F2
F3
F4
F5
F6
F7
F8
F9
F10
F11
F12

Zero order
0.9903
0.9974
0.9981
0.9932
0.9956
0.9934
0.9976
0.9981
0.9952
0.9968
0.9982
0.9916

Model (R2)
First order
Higuchi
0.7973
0.9581
0.9248
0.9811
0.9404
0.9807
0.8472
0.9721
0.9455
0.9871
0.9625
0.9877
0.9035
0.9829
0.9532
0.9825
0.9659
0.9797
0.9812
0.9869
0.9717
0.9836
0.9341
0.9664

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Korsemeyer-peppas
0.9609
0.9926
0.9967
0.9918
0.9980
0.9939
0.9972
0.9987
0.9952
0.9949
0.9992
0.9869

125

FIRST ORDER RELEASE

In-vitro Drug Release Study

2.500

F1
F2
F3
F4
F5

10

11

12

F1

2.000
Log % CD Remaining

Percentage cumulative drug released

100
90
80
70
60
50
40
30
20
10
0

F2

1.500

F3

1.000

F4

0.500

F5

F6

0.000

F7

-0.500

F6

10 11 12

F7

Time (Hrs.)

Time (Hrs.)

100
90
80
70
60
50
40
30
20
10
0

KORSEMEYER-PEPPAS MODEL

F1
F2
F3
F4
F5
0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

F6

Log % CDR

Percentage cumulative drug release

HIGUCHI MODEL

2.000
1.750
1.500
1.250
1.000
0.750
0.500
0.250
0.000

F1
F2
F3
F4
F5
0.000

0.500

1.000

F6

1.500

Log Time (Hrs.)

Fig : 1 In vitro drug release and Kinetic analysis parameters for Cefixime Trihydrate
Sustained Release Matrix Tablet

Fig : 2a FTIR peaks of various functional groups of Cefixime Trihydrate + Polymers

Fig: 2b FTIR peaks of various functional groups of Cefixime Trihydrate


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126

Cefixime Trihydrate

Cefixime Trihydrate + Polymers (F10)

Fig : 3 DSC curves of Cefixime Trihydrate Sustained Release Matrix Tablet

Table : 6 Stability Study Data of Cefixime Trihydrate Sustained Release Matrix Tablet
STABILITY STUDY DATA (mean S.D , n = 3)
Hardness (kg/cm2)
code

Drug Content

After 3 months
Initial

(400C

After 3 months
Initial

75%RH)
F3

F6

F9

F10

F11

F12

8.83
0.0577
9.20
0.0000
9.70
0.1000
10.43
0.0577
10.23
0.0577
9.97
0.0577

In vitro Drug Release

(400C

After 3 months
Initial

75%RH)

(400C
75%RH)

8.78 0.0153

94.67

92.02

86.73

85.22

9.14 0.0000

96.5

95.75

84.64

83.20

9.64 0.0153

97.67

95.00

81.86

79.82

10.36 0.0577

98.67

97.14

74.78

74.00

10.19 0.0000

97.67

96.45

79.21

78.14

9.91 0.0577

97.17

95.68

82.05

81.11

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127

Evaluation of Cefixime Trihydrate

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HOW TO CITE THIS ARTICLE


Patel, B, P., Patel, B, K. (2014). Effect of Different Viscosity Grade of HPMC on Cefixime
Trihydrate Sustained Release Matrix Tablet. Journal Club for Pharmaceutical Sciences (JCPS), 1(I),
115-129

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129