WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

Lavanya et al. World Journal of Pharmacy and Pharmaceutical Sciences

SJIF Impact Factor 2.786

Volume 4, Issue 1, 561-576. Research Article ISSN 2278 4357

FORMULATION AND EVALUATION OF BISOPROLOL FUMARATE

OPTIZORB DISPERSIBLE TABLET TO IMPROVE TABLET
DISINTEGRATION

B. Lavanya*1 and V. Shanmugam2

1
Department of Pharmaceutics, Sri Padmavathi School of Pharmacy, Tiruchanur- 517503,
Tirupati, Andhra Pradesh, India.
2
Faculty in Pharmaceutics, Sri Padmavathi School of Pharmacy, Tiruchanur- 517503,
Tirupati, Andhra Pradesh, India.

ABSTRACT
Article Received on
23 Oct 2014, The present research work was aimed the formulation and evaluation

Revised on 18 Nov 2014,

of OptiZorb dispersible tablets of bisoprolol fumarate, an
Accepted on 14 Dec 2014 antihypertensive agent. The OptiZorb technology is based on the use of
excipients of Alginic acid and calcium carbonate. Alginic acid absorbs
lot of water, swells and leads to decay effect brought about. Calcium
*Correspondence for
Author
carbonate reacts with the stomach acid, within 3 minutes it releases
B. Lavanya 90% of the active ingredient this compared with only 10-15% in
Department of marketed paracetamol. Optizorb technology is five times faster in
Pharmaceutics, Sri tablet disintegration and thus gets to work much more quickly.
Padmavathi School of
Dispersible tablets were prepared by wet granulation method by using
Pharmacy, Tiruchanur-
517503, Tirupati, Andhra
Alginic acid and calcium carbonate as disintegrants in different
Pradesh, India. concentrations. Compatibility studies of drug and excipients were
carried out by using FT- IR spectroscopy and DSC. The formulations
were evaluated for precompressional parameters such as bulk density, tapped density, angle
of repose, Carrs index and Hausners ratio. The tablets were evaluated for weight variation,
thickness, hardness, friability, drug content, dispersion time, disintegration time and invitro
dissolution study. Invitro dissolution studies were performed by using USP dissolution
apparatus type II paddle in 900 ml of 0.1N Hydrochloric acid at 50 rpm. No chemical
interaction between drug and excipients was confirmed by FTIR studies. After study of all
formulations F9 showed short dispersion time with maximum drug release in 15 min and it
contains Alginic acid and calcium carbonate (1:1).

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KEYWORDS: Alginic acid, antihypertensive, Bisoprolol fumarate, calcium carbonate,

dispersible tablet, OptiZorb technology.

INTRODUCTION
A novel tablet concept which offers ease of oral administration and benefits of increased
patient compliance is the fast dissolving/disintegrating tablet (FDDT). Dispersible tablets are
uncoated or film-coated tablets that can be dispersed in liquid before administration giving a
homogenous dispersion. Technology which allows the tablet to start disintegrating in as little
as 5 minutes is called Optizorb. OptiZorb disintegration technology is five times faster and
thus gets to work much more quickly. It is easily dispersed in stomach and work faster, relief
faster. OptiZorb technology is based on the use of super-disintegrants as alginic acid and
calcium carbonate that make it act within five minutes. Alginic acid is a hydrophilic that
draws acidic gastrointestinal fluid into the tablet as calcium carbonate reacts with gastric acid
to liberate carbon dioxide to help it disintegrate to provide faster relief. [1-6]

MATERIALS AND METHODS

Bisoprolol fumarate was obtained as gift sample from A-Z pharmaceuticals, Chennai. Alginic
acid and calcium carbonate were obtained from Himedia Pvt. Ltd, Mumbai. All other
chemicals used were of analytical grade.

Preformulation
Identification of the drug was carried out by FTIR (Analytical Technologies, Mumbai,
Standardization of the drug was carried out using UV/Vis spectrophotometer (Shimadzu,
Japan). FTIR and DSC spectral analysis of the formulations was performed to assess drug
excipients compatibility. Preliminary studies were carried out on the tablets using different
concentrations of superdisintegrants. Thus, after evaluation of the quality parameters and
subjecting to in vitro disintegration and in vitro dissolution studies the final concentrations of
the superdisintegrants were optimized. Based on this Preformulation data the optimized
formulations for further investigations were decided.

Preparation of OptiZorb Dispersible Tablets

Dispersible tablets of Bisoprolol fumarate were prepared by wet granulation method. The
drug and excipients were passed through sieve (#22) to ensure better mixing. Super
disintegrant like Alginic acid and calcium carbonate were used in different concentrations.
All the ingredients were mixed in mortar and pestle starch paste is added then magnesium

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stearate and talc were added. The formulations were compressed with a sixteen station rotary
tablet punching machine.

Table No 1: Composition of different formulations of Bisoprolol fumarate.

Formulation code
S.NO Ingredients (mg)
F1 F2 F3 F4 F5 F6 F7 F8 F9
Bisoprolol
1 10 10 10 10 10 10 10 10 10
fumarate
2 Alginic acid 3 6 9 - - - 3 6 9
3 Calcium carbonate - - - 10 20 30 3 6 9
4 Lactose 159 156 153 152 142 132 156 150 144
5 Starch paste (Q.S) 20 20 20 20 20 20 20 20 20
Magnesium
6 4 4 4 4 4 4 4 4 4
stearate
7 Talc 4 4 4 4 4 4 4 4 4

Precompression Technological Parameters

Density Measurement
1. Bulk Density
10 g of Bisoprolol fumarate granules were weighed separately and transferred into a
graduated measuring cylinder via a large funnel and measure the volume of the powder. The
bulk densities of the granules were calculated by given formula. [7]
Bulk density = Weight of powder / Bulk volume.

2. Tapped Density
The tapped density is calculated by the following formula. [8]
Tapped density = Weight of powder / Tapped volume.

Flow properties
1. Carrs Index [Compressibility Index]
It is one of the most important parameter to characterize the nature of powders and granules.
It can be calculated from the following equation. [9]
Carrs index = (Tapped density - Bulk density) X 100
Tapped density
2. Hausners Ratio
Hausners ratio is an important character to determine the flow property of powder and
granules. This can be calculated by the following formula. [10]
Hausners ratio = Tapped density / Bulk density

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3. Angle of Repose
The angle of repose is defined as the maximum angle possible between the surfaces of pile of
powder and the horizontal plane. Angle of repose of granules is done by fixed funnel method
and is calculated by using following formula. [11]
= tan-1 h/r
Where, h = height of the pile; r = radius of the pile
The tangent of the angle is equal to the coefficient of friction (M) between the particles.

Post Compression Technological Parameters

1. Weight Variation Test
From each batch twenty tablets were selected at a random and average weight was
determined. Then individual tablets were weighed and the individual weight was compared
with an average weight, the variation in the weight was expressed in terms of % deviation [12].

2. Hardness
Ten tablets from each formulation were selected for the hardness and it was determined by
using Monsanto hardness tester. [13]

3. Thickness
Ten tablets form each formulation was taken for thickness and it was measured using Vernier
callipers. [14]

4. Friability Test
The friability of the tablet was determined by Friabilator. Initially weighed 10 tablets after
dusting and placing them in a friability tester, which was rotated for 5 min at 25 rpm. After
dusting, the total remaining mass of tablets was recorded and the percent friability was
calculated by using the formula. [15]

Intial weight final Weight

Friability = 100
Intial weight

5. Content Uniformity
Ten tablets were weighed individually and powdered. The powder equivalent to 20 mg of
Bisoprolol fumarate was weighed and extracted in water (100 ml) and the concentration of
drug was determined by measuring absorbance at 222 nm by spectrophotometer. [16]

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6. Disintegration Time
The test was carried out on 5 tablets using the Disintegration Test Apparatus. Distilled water
at 37oC was used as a disintegration media and the time in second taken for complete
disintegration of the tablet by no palatable mass remaining in the apparatus was measured. [17]

7. Wetting Time
A piece of tissue paper folded twice was placed in a small Petri dish containing 6 ml of water.
A tablet was put on the paper and time required for complete wetting was measured. [18]

8. Invitro Drug Release

Dissolution rate of fast disintegrating tablet of Bisoprolol fumarate was studied by using USP
Type-II apparatus at 50rpm using 900 ml of 0.1N HCl as dissolution medium. Temperature of
the dissolution medium was maintained at 370C an aliquot of dissolution medium was
withdrawn at every specific time interval and filtered. The absorbance of filtered solution was
checked by UV spectrophotometer at 222 nm and concentration of the drug was determined
from standard calibration curve. [19]

Drug Release Kinetics

As a model-independent approach, comparison of the time taken for the given proportion of
the active drug to be dissolved in the dissolution medium and figures such as T50 and T90
calculated by taking the time points of 50% and 90% of the drug dissolved and another
parameter Dissolution Efficiency (DE) suggested by Khan were employed. DE is defined as
the area under the dissolution curve up to the time t expressed as a percentage of the area of
the rectangle described by 100% dissolution in the same time. [20]
t
y.dt
Dissolution Efficiency (DE) = 0
y .t 100
100

The dissolution efficiency can have a range of values depending on the time interval chosen.
In any case constant time intervals should be chosen for comparison. For example, the index
DE30 would relate to the dissolution of the drug from a particular formulation after 30
minutes could only be compared with DE30 of other formulations. Summation of the drug
dissolution data into a single figure DE enables ready comparison to be made between a large
numbers of formulations.

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Characterization of Dispersible Tablets

FTIR Studies for drug
FTIR spectra are recorded from KBr disks. This ground KBr powder was use because the
background in the measurements beneath identical conditions. The measured wave number
range was from 4000 to 400cm-1.

DSC Thermal Analysis

Thermal analysis of Bisoprolol fumarate and their drug and excipients were recorded with
Netzsch DSC 200PC (Netzsche, Selb, German). The temperature axis and cell constant of
DSC were previously calibrated with Indium. A heating rate of 5/min was employed over a
temperature range of 0- 3500C with nitrogen purging. The sample was weighed into an
aluminium pan was used as reference.

Bioequivalence Studies
Bioequivalence study was performed between the marketed products Carvedilol-3.125mg
(coreg) tablets and prepared OptiZorb dispersible tablets of bisoprolol fumarate.

The Bioequivalence study was done by performing disintegration, invitro studies between
marketed products and prepared OptiZorb dispersible tablets.

Stability Studies
The purpose of stability testing is to provide evidence on how the 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, enabling recommended storage conditions, re-test
periods and shelf-lives. Generally, the observation of the rate at which the product degrades
under normal room temperature requires a long time. To avoid this undesirable delay, the
principles of accelerated stability studies are adopted. [21]

ICH specifies the length of study and storage conditions.

Long-Term Testing: 250 C 20 C / 60% RH 5% for 12 Months
Accelerated Testing: 400 C 20 C /75% RH 5% for 6 Months
Stability studies were carried out at 400C 20C /75% RH 5% for all the formulations for a
period of 3 months.

The selected formulations were closely packed in amber colour bottles and then stored at 400
C 20 C /75% RH 5% in stability chamber for 3 months and evaluated for their physical

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appearance, drug content and in-vitro drug release studies at intervals of 1month. The shelf
life period of the prepared dispersible tablets is determined by using similarity factor.

RESULTS AND DISCUSSION

Table No.2: Precompression studies of granules of bisoprolol fumarate.
Angle of Bulk density Tapped Carrs Hausner
Formulations
repose(0) (g/ml) density (g/ml) index (%) s, ratio
F1 32.15 0.40 0.45 11.11 1.12
F2 30.44 0.40 0.44 09.09 1.10
F3 28.85 0.43 0.50 14.00 1.16
F4 32.35 0.43 0.49 12.24 1.13
F5 29.45 0.41 0.47 12.76 1.14
F6 29.30 0.38 0.43 11.62 1.13
F7 33.60 0.40 0.45 11.11 1.12
F8 32.22 0.41 0.46 10.86 1.12
F9 28.65 0.41 0.47 12.76 1.13
The bulk density of all formulations powder containing drug and excipients was found to be
in the range of 0.40 to 0.43gm/ml, whereas the tapped density was observed between 0.43 to
0.50gm/ml. From the values of bulk density and tapped density the values for Carrs index
and Hausners ratio were calculated. The values for Carrs index were found between 09.09
and 14.00 %. The values for Hausners ratio were found to be between 1.10 and 1.16. All
these values are within the specified limits which indicate good flow properties. Angle of
repose was found to be less than 32 which indicate good flow of powder. Overall these values
indicate good flow properties of powder blend, uniform die fill and better compression
ability. Therefore, from this data so obtained, it was decided to go for compression of tablets
from the powder blends.

Table No.3: Evaluation of bisoprolol fumarate tablets.

Formulation code
Parameters
F1 F2 F3 F4 F5 F6 F7 F8 F9
%Wt. Variation PASS PASS PASS PASS PASS PASS PASS PASS PASS
Hardness (kg/cm2) 3.6 3.5 3.6 3.5 3.8 3.8 3.7 3.8 3.8
Thickness (mm) 3.3 3.4 3.3 3.5 3.2 3.5 3.3 3.2 3.3
Friability (%w/w) 0.24 0.21 0.24 0.35 0.27 0.27 0.25 0.24 0.25
Disintegration (mins) 6 7 7 6 5 4 4 3 2
Dispersion Time (mins) 7 8 8 7 6 3 4 2 2
Wetting Time min) 6 7 7 6 5 4 4 3 2
Drug content (%) 84.86 86.12 88.20 86.40 86.30 98.30 98.23 98.32 98.50

The weight variation of all formulations was found to be passes as per I.P guidelines. None of
the tablet was found to deviate from the average weight of tablets (variation with deviation

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less than 7.5, which complies with I.P specification) signifies that there is uniformity in
flow of powder blend which leads to uniform die fill. Hardness test for all formulations was
carried out and observations obtained were in the range of 3.5 to 3.8 kg/cm2. Hardness for all
formulations was observed to be proper, which signify that tensile strength of all formulations
was maintained after compression. Test for friability was conducted for all formulations, %
friability was found to be in the range of 0.21 to 0.35. Friability test for all formulations
indicated that % friability was less than 1%, which compiles the I.P specification and reveals
that all formulations have possessed good physical strength and can withstand the mechanical
shocks that can be observed during handling, shipping and transportation. The thickness of all
formulations was found to be uniform as it was obtained in the range of 3.2 to 3.7 mm. The
values for thickness and diameter signify uniformity and it was due to uniformity in die fill,
good flow properties, uniform pressure and appropriate punch movement.

Table No.4: Dissolution profile of F1-F9

Time (min) F1 F2 F3 F4 F5 F6 F7 F8 F9
5 13.92 22.41 28.07 32.32 35.15 37.98 42.22 46.47 50.71
10 26.80 38.19 41.03 45.30 48.15 50.99 63.80 69.49 76.61
15 46.87 56.90 61.18 65.47 69.76 72.62 78.38 85.53 92.68
20 52.82 65.75 67.21 70.10 75.83 78.71 85.93 90.27 94.61
25 58.80 70.38 71.85 73.33 79.09 81.99 92.09 95.03 97.98
30 67.66 73.61 76.51 78.00 82.37 85.28 94.01 96.97 98.51

Fig. 1: Dissolution profile of F1-F9.

Bisoprolol fumarate dispersible tablets were prepared by wet granulation method. All the
formulations viz. F1-F9 has shown increased cumulative dissolution profiles as shown in
Table No.4 and Fig. 1.

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In-vitro drug release studies were performed in 0.1N HCl for all the prepared formulations by
using USP dissolution test apparatus-Type II, Rotating Paddle method. The data for in-vitro
release profile of the entire prepared tablet formulations were shown in table No4, and the
graphs showing drug release profile for formulations were shown in the fig. 1. In-vitro
dissolution studies were conducted over a period of 30 mins. In formulations F1 to F3
containing Alginic acid, an increase in concentration was observed. In formulations F4 to F6
containing calcium carbonate an increase in concentration was observed. Formulations F7 to
F9 showed quick release as the concentration of disintegrants increased tablets alginic acid
and calcium carbonate.

Drug Release Kinetics

Table No 5: Correlation coefficient (r) & rate constant (k) values of dispersible tablet.
Kinetic
F1 F2 F3 F4 F5 F6 F7 F8 F9
model
First r 0.9939 0.9872 0.9842 0.9702 0.9745 0.9771 0.9971 0.9978 0.9900
order k 0.0369 0.0483 0.0518 0.0553 0.0639 0.0699 0.0969 0.1170 0.1453
Zero r 0.9777 0.9355 0.9100 0.8706 0.8651 0.8518 0.8299 0.7835 0.7160
order k 2.4506 2.9042 3.0255 3.1438 3.3616 3.4947 3.8869 4.0778 4.2566
Hixson- r 0.9923 0.9758 0.9674 0.9463 0.9498 0.9498 0.9713 0.9651 0.9431
Crowell k 0.0106 0.0134 0.0142 0.0150 0.0168 0.0180 0.0226 0.0255 0.0290
r 0.9650 0.9855 0.9915 0.9906 0.9895 0.9892 0.9901 0.9810 0.9643
Higuchi
k 11.3686 13.6717 14.3233 14.9744 16.0227 16.6863 18.6138 19.6182 20.5928
r 0.9875 0.9850 0.9852 0.9809 0.9792 0.9795 0.9845 0.9735 0.9499
Peppas
k 3.5092 7.8546 11.2679 14.6060 15.9892 17.9278 21.5435 25.5588 30.4857
n 0.8915 0.6867 0.5812 0.5094 0.5017 0.4768 0.4525 0.4128 0.3698
DE 30 37.55 40.67 45.17 39.84 43.96 46.9 56.96 51.04 67.72
DE 60 50.43 51.48 57.75 53.32 56.35 58.95 70.19 71.82 76.88
T 50 13.13 11.52 10.24 12.33 10.26 9.50 7.14 6.73 5.53

Fig. 2: Correlation coefficient (r) & rate constant (k) values of dispersible tablet.

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The drug release profiles from the bisoprolol fumarate dispersible tablets were fitted to
various kinetic models. The values of correlation coefficient (r) and release rate constants (K)
from different models for bisoprolol fumarate dispersible tablets are given in Table 1. From
the data of correlation coefficient and rate constant values, it was found that bisoprolol
fumarate release from their tablets has obeyed the first order release followed by the Peppas
model.

FT-IR spectroscopy

Fig. 3: FT-IR spectrum of bisoprolol fumarate.

Fig. 4: FT-IR spectrum of bisoprolol fumarate with Alginic acid.

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Fig. 5: FT-IR spectrum of bisoprolol fumarate with Calcium carbonate.

Fig. 6: FT-IR spectrum of bisoprolol fumarate with Alginic acid and Calcium
carbonate.

From the FT-IR results, Pure bisoprolol fumarate showed principal absorption peaks at
3348.61cm-1, NH (stretching), 3402.62cm-1OH (stretching), 1091.77cm-1 (stretching) and
1145.78 cm-1C-O (stretching). Same peaks of NH, O-H, C-O-C, and C-0 bonds were present
as that of pure drug without much shifting in the spectra of bisoprolol fumarate suggested no
chemical interaction between the drug and disintegrants.

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Differential Scanning Calorimetry

0.000
10.5mJ/mg 50.9mJ/mg

350.0
-1.000

80.1Cel
-2.000
-1.718mW 300.0

-3.000

DDSC mW/min
250.0
DSC mW

-4.000

-5.000
200.0

-6.000

150.0
-7.000

-8.000
100.0
102.4Cel
-8.163mW
0.0 50.0 100.0 150.0 200.0 250.0
Temp Cel

Fig. 7: DSC of bisoprolol fumarate.

2.000
300.0

1.000 280.0

0.000 28.8mJ/mg 260.0

10.9mJ/mg

240.0
-1.000

220.0
-2.000 80.3Cel
-1.601mW

DDSC mW/min
200.0
DSC mW

-3.000
180.0

-4.000
160.0

-5.000 140.0

101.5Cel
-6.000 120.0
-5.651mW

100.0
-7.000

80.0
-8.000

-100.0 -50.0 0.0 50.0 100.0 150.0 200.0 250.0 300.0 350.0
Temp Cel

Fig. 8: DSC of optimized formulation.

From DSC thermograms the melting point of pure drug bisoprolol fumarate was found to be
102.4C which the value reported in literature hence the procured drugs are pure forms and
were shown in Fig No.7. The dispersible tablets DSC thermograms of bisoprolol fumarate
indicate that there are no interaction between the drugs and excipients which can be accessed
from the peaks in the DSC thermograms (Fig. No. 8).

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Bioequivalence Studies
Disintegration Time
Table No.6: Bioequivalence studies of Disintegration time.
Time Marketed products Prepared dispersible
S. NO
(min) Carvedilol tablets (B.F)
1 5 4 3
2 10 5 2
3 15 4 2
4 20 4 3
5 25 5 2
6 30 4 2

The prepared dispersible tablets are having disintegration time between 2-3 min and the
marketed tablet of Carvedilol-1.325 mg (coreg) dispersible tablet having disintegration time
between 4-5min. Hence the prepared dispersible tablets are having less disintegration time
than that of marketed formulation.

Table No.7: Bioequivalence studies invitro drug release studies.

Time Marketed products Prepared dispersible
S.NO
(min) Carvedilol tablets (B.F)
1 5 45.39 50.71
2 10 65.62 76.61
3 15 75.36 92.68
4 20 85.25 94.61
5 25 91.25 97.98
6 30 95.52 98.51

Fig. 9: Bioequivalence studies invitro drug release studies.

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Stability Studies
The optimized F9 formulation was kept for stability studies. Accelerated stability studies
were carried out at 400/75%RH for 3 months. The tablets were then evaluated for weight
variation for the period of initial, disintegration, hardness and drug content for initial, 1
month, 2 month and 3 month. The results indicated that there was no significant change in
physical evaluation. Evaluations of formulations by parameters including Weight Variation,
hardness, friability, disintegration were within the limits as per prescribed specifications. The
optimized F9 formulation is evaluated for In-vitro drug release studies; the results indicated
that there was no significant change in In-vitro drug release studies which is similar to the
formulations under optimum conditions.

CONCLUSION
OptiZorb dispersible tablets of bisoprolol fumarate were prepared by wet granulation method.
From the present work it concludes that the OptiZorb technology is based on the use of
excipients of Alginic acid and calcium carbonate as disintegrants in different concentrations.
Alginic acid absorbs lot of water, swells and leads to decay effect brought about. Calcium
carbonate reacts with the stomach acid, within 3 minutes it releases 90% of the active
ingredient. OptiZorb technology is five times faster and thus gets to work much more
quickly. After study of all formulations F9 showed short dispersion time with maximum drug
release in 15 min and it contains alginic acid and calcium carbonate (1:1). FT-IR study
reveals that there is no interaction between drug and excipients and can be used for
preparation of OptiZorb dispersible tablets of bisoprolol fumarate.

ACKNOWLEDGEMENT
The authors extend their deep sense of thanks to the Principal, Dr. D. Ranganayakulu and
the Management, Sri Padmavathi School of Pharmacy for their extended support during this
project work.

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