Effect of Different Viscosity Grade of HPMC on Cefixime Trihydrate Sustained Release Matrix Tablet

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

All Rights Reserved by Journals Club & Co. 115

Effect of Different Viscosity Grade of HPMC on Cefixime Trihydrate Sustained Release Matrix Tablet

Patel BP*1, Patel BK1 1Kalol 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 F10-F12. 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

INTRODUCTION

The oral route is the most acceptable drug

delivery route for patient compliance aspects.

The main goal of pharmaceutical formulation

is to achieve better therapeutic activity by

using smallest quantity of drug administered

by the most suitable route.1In some sustained

release formulations, the drug dissolves into

the matrix, and the matrix physically swells to

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

*Address for Correspondence: Parth.B. Patel, Kalol Institute of Pharmacy,

Gandhinagar, Gujarat, India. Email id: [email protected]


counterpart conventional forms that may have

to take three or four times daily to achieve the

same therapeutic effect.2

One of the most common approaches used

for prolonging and controlling the rate of

drug release is incorporating the drug in a

hydrophilic colloidal matrix such as Hydroxy

propyl methyl cellulose (HPMC), Hydroxy

propyl cellulose (HPC), carbopols, chitosan,

alginates and gelatin etc. The mechanism and

kinetics of release of drugs incorporated in

these polymer matrices is depends the type

and amount of polymer as well as on the

physico-chemical properties of drug

substance. Hydrophilic polymer matrix

systems are widely used in oral controlled

drug delivery because they make it easier to

achieve a desirable drug-release profile, cost

effectiveness and they have broad US Food

and Drug Administration acceptance. The

hydration rate of HPMC depends on the

nature of these substituents, such as the

molecular structure and the degree of

substitution. Specifically, the hydration rate

of HPMC increases with an increase in the

hydroxyl propyl content. The solubility of

HPMC is pH independent. 3

Cefixime Trihydrate is broad spectrum third

generation cephalosporin antibiotic having

bactericidal activity and used in the treatment

of uncomplicated UTI, otitis media,

pharyngitis, and acute exacerbation of chronic

bronchitis, uncomplicated gonorrhea. It has

very good in vitro activity against

Streptococcus pneumonia, Streptococcus

pyogenes, Branhamella catarrhalis,

Haemophilus influenza, Escherichia coli,

Klebsiella pneumoniae, Proteus mirabilis and

Neisseria gonorrhoeae. It also has activity

against Gram-+ve bacteria, especially against

Streptococci.4

After 200 mg of the conventional release

dosage form of Cefixime trihydrate is

administered, the peak plasma concentration

achieved is 1.2 mg/L, and this concentration

slowly decline below minimum effective

concentration (MEC) within 12 hours.

Cefixime trihydrate inhibit mucopeptide

synthesis in the bacterial cell wall, rendering

it defective and osmotically unstable. The

steady-state maintenance of plasma

concentration will increase the rate of

bacterial killing and more quickly relieve the

excruciating symptoms of bacteremia.

The present research work involves the

formulation development of sustained release

matrix tablet of cefixime trihydrate by

applying full factorial design to understand

the effect of formulation variables like

concentration and viscosity of HPMC K-4M,

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

chemical properties of matrix tablet and on in


vitro dissolution rate and stability were also

studied. The drug release data were plotted

using various kinetic models to evaluate the

drug release mechanism and kinetics.6

MATERIALS & METHODS

Cefixime Trihydrate was gifted to us by

Alembic pharmaceuticals; Baroda,

Gujarat.HPMC K-4M, HPMC K-15M,

HPMC K-100M, microcrystalline cellulose

(MCC), Lactose and Polyvinyl pyrrolidone

(PVP K-30) was procured from Merck India

Ltd., Mumbai. Polymers used were of

analytical grade and other chemicals of

Laboratory grade.

Preparation of Cefixime Trihydrate

Sustained Release Matrix Tablet1, 7

Different viscosity grade of HPMC based

sustained release matrix tablets were prepared

by wet granulation technique. The

compositions of different tablet formulations

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

a binder in 25%, Micro Crystalline Cellulose

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

a binder/diluent that makes it useful in

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

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). First

Polymers & other materials were weighed and

then passed through sieve 20, loading in

RMG premixing for 10min.Then binder PVP

K-30was added for 5min after that kneading

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

2min dried in hot air oven then again passed

through sieve no 20 at finally add lubricant

and glidant (mg. stereate, talc) and compress

in rotary press compression machine by using

11-mm punches at a compression force

required to produce tablets of about 812

kg/cm2 hardness. All the tablets were stored

in airtight containers for further study. Prior

to compression, granules were evaluated for

their flow and compressibility characteristics.

Evaluation of Cefixime Trihydrate Sustained

Release Matrix Tablet10-15

Pre-compression Parameters8, 9 BulkDensity:

Weight of the Powder Volume of the packing

Tapped

Density:Weight of the powder Tapped volume of the packing Hausners

Ratio: Bulk Density Tapped Density Carrs Compressibility Index Tapped Density Bulk DensityTapped Density 100 Angle of Repose Tan = h/r OR = tan-1 [h/r]

Post-Compression Parameters10-15


The prepared tablets can be evaluated for

various official and non official

specifications.

Thickness and Diameter of Tablets

Three tablets were taken and the thickness

and diameter was measured using a dial-

caliper. The tablet thickness and diameter

should be controlled within the 5%

variation of a standard value.

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

batch and shown in table -3.

Hardness10 Hardness indicates the ability of a tablet to

withstand mechanical shocks while handling.

The hardness of the tablets was determined

using Monsanto hardness tester. It is

expressed in kg/cm2. Three tablets were

randomly selected from each formulation and

the mean and standard deviation values were

calculated.

Friability (%)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

weighed and placed in the Rouche friability

test apparatus and operated at rate of 25 RPM

for 4 minutes (or up to 100 revolutions),

tablets were de-dusted and weighed again.

The loss of tablet weight due to abrasion and

fracture was measured in terms of % friability

(A value of


ml of pH 7.2 Phosphate buffer and dissolved

completely and made upto 100 ml with

buffer. This solution was filtered by whatman

filter paper. From this 10 ml of solution was

withdrawn and volume made upto 100 ml

using buffer. The absorbance was measured at

288 nm using an UV spectrophotometer. The

experiments were carried out in triplicate for

the tablets of all formulations and average

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 The dissolution test was performed according

to USP type-II paddle apparatus (Electolab,

Mumbai). The dissolution medium consists of

900 ml of Phosphate buffer of pH 1.2 for two

hours, followed by Phosphate buffer pH 7.2

for the next ten hours at 370.5C with a

rotation rate of 100 rpm. 10 ml aliquots of

samples were taken at every 1 hr and replaced

with the same. Cefixime Trihydrate was

assayed spectrophoto- metrically at 288 nm

(UV-Thermo scientific). The release studies

for each formulation were conducted in

Phosphate buffer pH 1.2 and pH 7.2,

indicating the reproducibility of the results.

The results were expressed as each value is

the mean SD, n = 3 determinations.

Kinetic analysis of in vitro release data

In order to determine the release mechanism

that provides the best description pattern of

drug release, the in vitro release data were

fitted to zero-order, first-order Higuchi matrix

model and KorsmeyerPeppas model. The

release exponent (n) was calculated by

regression analysis using the following

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

fraction of drug released (using values of

Mt/M within the range 0.100.60) at time t

and K is a constant incorporating the

structural and geometric characteristics of the

release device. A value of n=0.5 indicates

case I (Fickian) diffusion, 0.5


sustained release matrix tablet, the values of

R2 (coefficient of determination) has been

obtained as presented in table -5.[15]

Stability studies:[2, 6] The formulations (F3, F6, F9, F10, F11, F12)

were also subjected to stability studies by kept

them for 3 months under environmental

conditions such as room temperature of 27

2C/65% RH, oven temperature of 40

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

At the end of the period, Hardness, drug

content, and release profiles were determined.

Drug Excipient Interaction Studies

The Cefixime Trihydrate drug &F10tablet

were subjected to thermal analysis by

Differential Scanning Calorimetry (DSC) to

confirm the absence of any interactions.

Instrument Model no- DSC-60, Temp range-

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

Air and Made by- shimadzu corporation,

Japan.[12-15]

Fourier Transforms Infrared Spectroscopy

Studies (FTIR)

Fourier transform infrared spectrum of

Cefixime Trihydrate pure drug, physical

mixture of pure drug and polymers were taken

respectively. Potassium bromide disc (pellets)

method. All the spectra were scanned from

4000 cm-1 to 500 cm-1.10, 15

RESULT AND DISCUSSION

Cefixime Trihydrate Sustained Release

Matrix Tablet was designed with the objective

of prolong drug release leading to minimize

the peak and valley effect in the plasma and

provide patient convenience. Therefore,

Hydrophilic polymer matrix systems are

widely used in sustained release matrix tablet

because they make it easier to achieve a

desirable drug-release.

Pre-Compression Parameters

Angle of Repose

Formulation F3-F12 having angle of repose

between 23-30 which shows excellent flow

property. Formulation F1-F2 having angle of

repose between 31-35 which showed good

flow property.

Carrs Compressibility Index

All the formulation F1-F12 shows Carrs

Compressibility index between ranges 5-

15which indicate excellent flow property.

Post-Compression Parameters

It was observed that Thickness, Diameter,

Weight Variation, Swelling Indexwere found

to be satisfactory.

Hardness

All the formulation F1-F12 shows hardness

between 8-11 kg/cm2 which was effective for

sustained drug release. It was found that as

the concentration and grade of HPMC

increases hardness increases.


Friability

The percent friability for all the formulations

was below 1%, indicating that the friability is

within the prescribed limits. The results of

friability indicate that the tablets possessed

good mechanical strength.

Drug Content

The percentage drug content of both the drugs

in all the formulated tablets was found to be

within limit. Percentage drug content values

of Cefixime Trihydrate are within 93.17 to

98.67 % for all the formulations. The results

within range indicate uniformity of mixing.

In vitro Dissolution Studies In vitro drug release study was carried out

using USP dissolution apparatus, type-II.

Comparative dissolution profile of all batches

is given in Figure 1. Being the sustained

release formulations the release rates of all the

formulations were controlled. Formulation

F10 released Cefixime Trihydrate completely

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

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

result in decrease wettability and penetration

of water into the film matrices and hence

decrease diffusion of the drug. Whereas

release rates of other formulation were

comparatively higher than F10.

Drug release from HPMC matrices

showed that viscosity and proportion of

polymer plays important role in

retardation of drug release was in

following order specifically for F1-F9

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

K-4M

The retardation of drug release from

HPMC matrices in accordance with its

different proportion was in the following

order specifically for F10-F12.

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

0.5 0.75 1 SLOWEST

0.75 1 0.5 SLOWER

1 0. 5 0.75 SLOW

Kinetic Analysis of in vitro Release Data

In order to determine the release mechanism

that provides the best description pattern of

drug release, the in vitro release data were

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

matrix model and KorsmeyerPeppas model.

The release data were matched kinetically


with case II transports (Zero order release

model).

Drug Excipient Interaction Studies

As per DSC study of drug shows the

characteristic peak at 220.60C as its melting

point is 220-222 C reported. The figure 3

showed the characteristic peak of Cefixime

Trihydrate alone. The figure showed the

combined peaks of Cefixime Trihydrate

HPMC grades, PVP K30.DSC study of drug

and F10 matrix tablet showed sharp peak at

221.16C, 109.24C, 97.70C, 89.66C

respectively. Theses confirmed drug

compatibility with polymer. All the peaks

were present in graph and hence the Cefixime

Trihydrate was not being interfered due to

presence of other Excipients.

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

There was no significant change observed in

the physical appearance, hardness and drug

content uniformity tests as conducted at the

end of 3 months. The in-vitro dissolution

profile for formulation F10 stored at 25 0C/40% RH exhibited 74.78% release of

Cefixime Trihydrate, while for formulation

stored at 400C/75%RH, Cefixime Trihydrate

accounted for 74.00% release. Therefore the

stability studies revealed no change in

physical appearance, Hardness, Drug content

and not much change in In-vitro dissolution

profiles. Hence these formulations were found

to be stable at the above temperatures.

DISCUSSION

This investigation showed effect of HPMC on

release rate of drug with the intention of

obtaining better therapeutic efficiency by

controlling drug release thereby improving

patient compliance and 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 containing HPMCK-100M


showed delayed release of drug as compared

to those containing HPMC K-15M and

HPMC K- 4M. These revealed that as the

viscosity of HPMC increased, the rate of drug

release was decreased. Formulation of

sustained release matrix tablets of Cefixime

Trihydrate thus helped to decrease dosing

frequency , reduces local adverse effects, and

extends release of drug from the matrix to a

prolong period of time, thus improves patient

compliance. This may also extends biological

half-life of existing drug.

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

FORMULATION CODE

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

CEFIXIME TRIHYDRATE

200 200 200 200 200 200 200 200 200 200 200 200

HPMC K 4 M (4,000 mPa s)

100 150 200 - - - - - - 50 75 100

HPMC K 15 M (15,000 mPa s)

- - - 100 150 200 - - - 75 100 50

HPMC K 100 M

(100,000 mPa s) - - - - - - 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 4 4 4 4 4 4 4 4 4 4 4 4

TALC 6 6 6 6 6 6 6 6 6 6 6 6


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

Code (F)

Bulk Density (g/cc)

Tapped Density (g/cc) Hausner Ratio

Carrs Compressibility

index (%)

Angle of Repose (o)

F1 0.405 0.0035 0.454 0.0000 1.121 0.0098 10.79 0.7627 32.55 0.4792 F2 0.417 0.0000 0.459 0.0046 1.102 0.0110 9.21 0.9180 31.48 0.4503 F3 0.426 0.0040 0.475 0.0046 1.113 0.0185 10.17 1.4905 29.98 0.4215 F4 0.438 0.0000 0.487 0.0058 1.111 0.0133 9.99 1.0750 30.23 0.4215 F5 0.459 0.0046 0.517 0.0064 1.126 0.0029 11.21 0.1986 29.28 0.3984 F6 0.478 0.0052 0.536 0.0064 1.121 0.0254 10.75 2.0150 27.97 0.3637 F7 0.503 0.0058 0.564 0.0075 1.120 0.0277 10.68 2.2309 28.61 0.3811 F8 0.521 0.0000 0.590 0.0081 1.133 0.0156 11.73 1.2182 27.15 0.0000 F9 0.536 0.0064 0.604 0.0081 1.128 0.0146 11.36 1.1221 26.38 0.3291

F10 0.610 0.0150 0.707 0.0115 1.160 0.0159 13.81 1.1872 23.34 0.2540 F11 0.590 0.0162 0.676 0.0000 1.146 0.0312 12.67 2.3914 24.61 0.2887 F12 0.564 0.0075 0.652 0.0095 1.158 0.0285 13.57 2.1344 25.47 0.5300

Each value is the mean, n = 3 determinations

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 11.02 0.0000 550.67 1.1547

8.57 0.0577 0.41 61.81 93.17

F2 3.53 0.0115 11.08 0.0058 550.00 1.0000

8.73 0.0577 0.36 63.81 93.83

F3 3.55 0.0115 11.13 0.0173 550.67 1.1547

8.83 0.0577 0.29 66 94.67

F4 3.57 0.0115 11.17 0.0058 551.33 1.5275

8.97 0.0577 0.30 62.91 95

F5 3.60 0.0000 11.21 0.0115 549.33 1.1547

9.03 0.0577 0.27 65.64 96.17

F6 3.64 0.0000 11.30 0.0000 549.33 0.5774

9.20 0.0000 0.25 66.90 96.5

F7 3.63 0.0115 11.35 0.0058 549.33 2.0817

9.33 0.0577 0.22 66.36 96.83

F8 3.65 0.0115 11.37 0.0115 551.67 1.5275

9.47 0.0577 0.21 68.91 97

F9 3.68 0.0000 11.43 0.0306 550.33 0.5774

9.70 0.1000 0.23 70.18 97.67

F10 3.71 0.0115 11.63 0.0115 548.67 1.1547

10.43 0.0577 0.11 75.45 98.67

F11 3.70 0.0000 11.56 0.0153 550.67 1.1547

10.23 0.0577 0.16 73.27 97.67

F12 3.69 0.0115 11.51 0.0058 550.00 1.0000

9.97 0.0577 0.18 72.18 97.17


Each value is the mean SD, n = 3 determinations

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

Time (Hrs.)

Percentage cumulative drug released F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12

1 20.01 17.18 13.06 16.41 12.03 11.26 10.75 9.21 7.92 5.61 8.43 13.83 2 26.14 26.88 21.95 25.07 22.97 16.79 17.30 17.54 12.89 13.64 15.73 19.39 3 30.84 33.16 27.71 33.91 30.29 25.08 26.11 23.54 21.69 20.16 21.47 26.39 4 37.32 39.14 34.97 38.89 36.54 35.97 32.89 30.29 28.99 27.69 30.01 31.87 5 44.59 45.12 40.96 46.15 43.81 40.20 42.48 38.85 34.98 33.68 36.28 40.41 6 56.24 53.93 50.29 54.97 52.37 48.73 49.79 46.92 46.11 41.21 42.52 46.94 7 62.54 60.20 53.99 59.18 58.13 54.49 57.33 53.44 51.11 44.63 49.79 48.81 8 74.95 69.01 59.94 62.06 66.16 59.95 65.12 60.71 58.63 52.90 56.30 51.66 9 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

Model (R2) Zero order First order Higuchi Korsemeyer-peppas

F1 0.9903 0.7973 0.9581 0.9609 F2 0.9974 0.9248 0.9811 0.9926 F3 0.9981 0.9404 0.9807 0.9967 F4 0.9932 0.8472 0.9721 0.9918 F5 0.9956 0.9455 0.9871 0.9980 F6 0.9934 0.9625 0.9877 0.9939 F7 0.9976 0.9035 0.9829 0.9972 F8 0.9981 0.9532 0.9825 0.9987 F9 0.9952 0.9659 0.9797 0.9952 F10 0.9968 0.9812 0.9869 0.9949 F11 0.9982 0.9717 0.9836 0.9992 F12 0.9916 0.9341 0.9664 0.9869


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

0102030405060708090

100

0 1 2 3 4 5 6 7 8 9 10 11 12

Perc

enta

ge cu

mul

ativ

e dru

g re

leas

ed

Time (Hrs.)

In-vitro Drug Release Study

F1

F2

F3

F4

F5

F6

F7 -0.500

0.000

0.500

1.000

1.500

2.000

2.500

0 1 2 3 4 5 6 7 8 9 10 11 12

Log

% C

D R

emai

ning

Time (Hrs.)

FIRST ORDER RELEASE

F1

F2

F3

F4

F5

F6

F7

0102030405060708090

100

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50Perc

enta

ge c

umul

ativ

e dr

ug r

elea

se

T

HIGUCHI MODEL

F1

F2

F3

F4

F5

F6 0.0000.2500.5000.7501.0001.2501.5001.7502.000

0.000 0.500 1.000 1.500

Log

% C

DR

Log Time (Hrs.)

KORSEMEYER-PEPPAS MODEL

F1

F2

F3

F4

F5

F6


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

code

STABILITY STUDY DATA (mean S.D , n = 3)

Hardness (kg/cm2) Drug Content In vitro Drug Release

Initial After 3 months

(400C 75%RH)


(400C 75%RH)


(400C 75%RH)

F3 8.83

0.0577 8.78 0.0153 94.67 92.02 86.73 85.22

F6 9.20

0.0000 9.14 0.0000 96.5 95.75 84.64 83.20

F9 9.70

0.1000 9.64 0.0153 97.67 95.00 81.86 79.82

F10 10.43

0.0577 10.36 0.0577 98.67 97.14 74.78 74.00

F11 10.23

0.0577 10.19 0.0000 97.67 96.45 79.21 78.14

F12 9.97

0.0577 9.91 0.0577 97.17 95.68 82.05 81.11


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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

Effect of Different Viscosity Grade of HPMC on Cefixime Trihydrate Sustained Release Matrix Tablet

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