RESEARCH ARTICLE Bharath et.

al / IJIPSR / 3 (8), 2015, 1111-1124

Department of Pharmaceutics ISSN (online) 2347-2154

International Journal of Innovative

Pharmaceutical Sciences and Research
www.ijipsr.com

FORMULATION AND EVALUATION ORAL DISINTEGRATING

TABLETS OF CELCOXIB
1
Bandi Bharath*, 1A.Pratyusha, 1V.Uma Maheshwara Rao
Department of Pharmaceutics, C.M.R College of pharmacy, Kandlakoya(V), Medchal Road,
Hyderabad -501 401, Telangana, INDIA

Abstract
In the present work, an attempt has been made to develop oral disintegrating tablets of Celecoxib. The
drug is a poorly water-soluble drug, The purpose of the present investigation was to increase the
solubility and dissolution rate of celecoxib by preparing a solid dispersion with polyvinyl pyrrolidone
K30 (PVP-K30) using a solvent-evaporation method. Drugpolymer interactions were investigated
using Fourier transform infrared spectroscopy (FTIR). For the preparation of celecoxib oral
disintegrating tablets, a 1:2 solid dispersion with PVP-K30 was used with different superdisintegrants.
Croscarmellose Sodium, Crospovidone and sodium starch glycolate were selected as super
disintegrates. All the formulations were prepared by direct compression method The blend of all the
formulations showed good flow properties such as angle of repose, bulk density, tapped density. The
prepared tablets were shown good post compression parameters and they as within I.P limits. Among
all the formulations F4 formulation showed maximum % drug release i.e., 99.4 % in 20 min and also
showed excellent wetting time and water absorption ratio hence it is considered as optimized
formulation. accelerated stability studies were carried out on optimized formulation in accordance with
ICH guidelines. They were no changes observed in the physicochemical properties and drug release
pattern of tablets.

Keywords: Celecoxib, PVP K-30, Croscaremellose Sodium, Crospovidone and sodium starch
Glycolate.

Corresponding Author:
Bandi Bharath
Department of Pharmaceutics,
C.M.R College of pharmacy,
Kandlakoya (V), Telagana, INDIA
Email: bandi.bharath33333@gmail.com
Phone: + 91 9603865544

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INTRODUCTION
The oral route of administration is the most preferred route due to its many advantages like ease
of administration, accurate dosage, self-medication, pain avoidance, versatility and patient
compliance. It is always the aim of a scientist or a dosage form designer to enhance the safety of a
drug molecule while maintaining its therapeutic efficacy. Recent advances in NDDS aim for the
same by formulating a dosage form, convenient to be administered so as to achieve better patient
compliance. Oral Disintegrating Tablet (ODT) is one among such approaches. The different
names of oral dispersible tablets are quick disintegrating tablets, mouth dissolving tablets, fast
disintegrating tablets, rapid dissolving tablets, porous tablets, and rapid melts. The advantages of
this new type of solid dosage form are widely recognized, since the term Oro-dispersible tablet
(ODTs) appears in the European Pharmacopoeia, where it has been defined as uncovered tablet
for buccal cavity, where it disperses before ingestion. United States Food and Drug
Administration (US-FDA) defined orally disintegrating tablet as a solid dosage form containing
medicinal substance or active ingredient which disintegrates rapidly usually within a few seconds
when placed upon the tongue [1].

Fig. 1: Oro dispersable tablet

The disintegration time for orally disintegrating tablets generally ranges from several seconds to
about a minute [2]. Most pharmaceutical forms for oral administration are formulated for direct
ingestion, or for chewing, or for prior dispersion and/or dissolution in water; some of them are
absorbed in the oral cavity (sublingual or buccal tablets).

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Orally disintegrating tablets have been developed, which combine hardness, dosage uniformity,
stability and other parameters, with extremely easy administration, since no water is required for
swallowing the tablets and they are thus suitable for geriatric, pediatric and travelling patients
[3,14]. These tablets display a fast and spontaneous de-aggregation in the mouth, soon after the
contact with saliva, though they can be handled or extracted from the package without alteration.
The active agent can thus rapidly dissolve in the saliva and be absorbed through whatever
membrane it encounters, during deglutition, unless it is protected from pre-gastric absorption. To
fulfill these requirements, tablets must be highly porous and by incorporating hydrophilic
excipients, they are able to quickly absorb water for a rapid disaggregation of the matrix [4].

These tablets disintegrate in the mouth in less than 30 seconds and the resulting suspension is
swallowed without the need for water, making this dosage form a convenient, potentially more
effective alternative to conventional solid dosage forms. Table1.1 depicts the three types of ODTs
available in market currently along with their therapeutic use [5,6].

Table 1: Reasons and conditions for using ODTs

Medication type Indication

Fast-acting Pain, fever, heartburn, diarrhoea, migraine, anxiety, insomnia etc.
Parkinsons disease, Alzheimers disease, psychosis,
Compliance-critical
schizophrenia, hypertension etc.
Pediatric Cough & allergy, pain, fever, ADHD etc.

MATERIALS:
Celecoxib, PVP K-30, Sodium Starch Glycolate Cross Povidine, Cross Carmellose Sodium,
Mannitol, Magnesium stearate, Talc and MCC pH 102 were obtained as gift samples from
Startech labs, Hyderabad.
METHODOLOGY:
Preparation of Solid Dispersions of Celecoxib with PVPK-30: Accurately weighed quantities
of physical mixtures of celecoxib and PVP-K30 in proportions of 1:1, 1:2, 1:3, and 1:4 were
dissolved in petri dishes containing methanol. Methanol was evaporated at room temperature for
2 h. The solidified mass obtained in each case was scraped, crushed, pulverized, and passed
through an 80-mesh sieve [6].

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Department of Pharmaceutics ISSN (online) 2347-2154

Evaluation of Solid Dispersions; All four batches of solid dispersion were evaluated for their
drug content and dissolution profile to select the optimized batch.

Drug content analysis

Drug content was determined by dissolving the 100 mg powdered samples of solid dispersion
equivalent to 100 mg of celecoxib into 100 ml distilled water containing 1% SLS solution and
samples were assayed for celecoxib content by measuring the absorbance on UV-
spectrophotometer at 254 nm [7]. The experiment was conducted in triplicate. The method obeyed
Beers law in the concentration range of 0-10 g/ml. Allow to stand the samples overnight.

In-vitro dissolution study

Dissolution study of celecoxib as such and its solid dispersions were performed using USP
Apparatus 2 with a paddle stirrer in a 900 ml distilled water containing 1% SLS at 37 C with a
rotation speed of 50 rpm to maintain sink condition. Powdered samples of each preparation
equivalent to 100 mg of celecoxib were added to the dissolution medium. At appropriate time
intervals, 5 mL of the mixture was withdrawn through a filter (0.45). The initial volume was
maintained by adding 5 mL of fresh dissolution medium. The samples were assayed for celecoxib
content by UV spectrophotometry at 254 nm [8,12].

Drug-Excipient Compatibility Studies:

FTIR spectra of moisture-free samples were obtained using a spectrophotometer by the potassium
bromide (KBr) pellet method (2 mg sample in 200 mg KBr).

Formulation of Celecoxib Dispersible Tablet by Direct- Compression:

A powdered 1:2 dispersion containing an amount of celecoxib equivalent to 100 mg was mixed
with other excepients. Required quantity of drug and excipient mixed thoroughly. The blend is
compressed using rotary tablet machine-8 station with 12 mm flat punch, B tooling. Each tablet
contains 100 mg Celecoxib and other pharmaceutical ingredients. A minimum of 20 tablets was
prepared for each trail batch.

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Department of Pharmaceutics ISSN (online) 2347-2154

Table 2: Formulation chart

Ingredient F1 F2 F3 F4 F5 F6 F7 F8 F9
F10 F11 F12
Celecoxib+PVK-
300 300 300 300 300 300 300 300 300 300 300 300
K30 (1:2)
Crospovidone 5 10 15 20 - - - - - - - -
CCS - - - - 5 10 15 20 - - - -
SSG - - - - - - - - 5 10 15 20
Mannitol 30 35 40 45 30 35 40 45 30 35 40 45
Talc 10 10 10 10 10 10 10 10 10 10 10 10
Mg. Stearate 5 5 5 5 5 5 5 5 5 5 5 5
MCC pH 102 150 140 130 120 150 140 130 120 150 140 130 120
TOTAL 500 500 500 500 500 500 500 500 500 500 500 500
Croscarmellose Sodium = CCS; Sodium Starch Glycolate = SSG

Evaluation of Tablets of Standard Formulation: For evaluation of compressed tablets

following parameters was considered- General Appearance, Weight variation, Hardness,
Thickness and Diameter, Friability, Drug content, Disintegration time, Wetting time, Water
absorption ratio, In vitro dissolution study, Kinetic model of drug release and Stability studies
[9,10,11].
RESULTS AND DISCUSSION
Evaluation of Solid Dispersions:
Drug content analysis: All the solid dispersions (SDS) were found to be low values of content
variation (<1.0%) in percent drug content indicated uniformity of drug content in each batch of
solid dispersions.
Standard calibration curve

Table 3: Concentration and absorbance obtained for calibration curve of Celecoxib

S. No. Concentration Absorbance*

(g/ml) (at 254 nm)
1 2 0.113
2 4 0.220
3 6 0.337
4 8 0.445
5 10 0.566
Correlation Coefficient = 0.999
Absorbance y = 0.056x -0.001

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Fig. 2 Standard graph of Celecoxib

Dissolution Studies:

Table 4: Dissolution studies of Pure Celecoxib and Solid Dispersions

Drug Release at Time 10 min 30 min

Celecoxib 5.64 0.5 21.20
Drug/PVP-K30 (1:1) 26.64 0.5 64.337
Drug/PVP-K30 (1:2) 39.64 0.5 94.445
Drug/PVP-K30 (1:3) 35.64 0.5 82.566
Drug/PVP-K30 (1:4) 21.64 0.5 74.42

FT-IR Analysis:

Fig. 3: FT-IR Spectrum of Celecoxib pure drug

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Department of Pharmaceutics ISSN (online) 2347-2154

Fig. 4: FT-IR Spectrum of Celecoxib with PVP-K30

The IR spectrum of celecoxib shows medium absorption bands at 3160 and 3260 cm1, which
were assigned to the drug NH symmetric and asymmetric stretching vibrations, respectively. The
other characteristic bands may be attributed to the following group vibrations: 1150 and 1340
cm1 (S=O symmetric and asymmetric stretching, respectively), 1560 cm1 (NH bends), and 780
cm1 (aromatic CH bend).

The solid dispersion prepared at a 1:2 ratio using the solvent evaporation method showed a
decrease in band intensity and a shift to higher wave numbers. This finding suggests that there
might be molecular interaction between the drug and PVP-K30 in a solid dispersion.

The presence of PVP-K30 increases the dissolution rate of celecoxib up to 94.44% in 30 min in
drug-to-polymer ratio of 1:2

Fig. 5: FT-IR Spectrum of Celecoxib solid dispersion with excepients

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Evaluation Parameters for oral disintegrating Tablets:

Table 5: Pre-Compression Parameters

Carrs Angle Of
Bulk Density Tap Density Hausner
Formulations Index
(gm/cm2) (gm/cm2) ratio Repose ()
(%)
F1 0.410.04 0.540.06 11.78 1.200.10 26.910.02
F2 0.500.06 0.560.05 11.39 1.180.07 28.230.11
F3 0.450.03 0.510.06 11.86 1.130.02 28.340.21
F4 0.460.09 0.560.03 16.36 1.190.13 26.710.13
F5 0.440.05 0.580.09 14.79 1.160.06 29.340.08
F6 0.480.03 0.560.04 12.54 1.170.17 28.230.09
F7 0.500.10 0.580.03 13.79 1.160.11 29.340.11
F8 0.420.04 0.500.06 15.12 1.200.14 26.780.13
F9 0.490.06 0.500.08 13.12 1.200.07 26.780.22
F10 0.470.07 0.490.09 14.43 1.170.11 28.450.11
F11 0.460.05 0.530.06 12.23 1.150.13 26.590.12
F12 0.430.06 0.490.07 11.43 1.190.12 28.870.17

Table no:6 Post-compression parameters

Weight Thickness Hardness
Sl. Form. Friability Drug content
Variation Avg.(mm) Avg.(kg/
No. Code (%) SD (%) SD
Avg.(mg) SD SD cm2) SD
1. F1 501.191.31 3.210.06 3.870.90 0.360.12 98.170.98
2. F2 500.351.55 3.510.08 3.760.53 0.150.31 99.200.37
3. F3 501.051.63 3.411.01 3.270.06 0.480.08 98.270.8
4. F4 500.171.25 3.640.05 3.700.05 0.240.06 99.970.31
5. F5 499.721.57 3.360.21 3.840.21 0.250.09 99.170.67
6. F6 500.161.69 3.310.76 3.960.36 0.460.12 98.171.11
7. F7 500.201.63 3.840.26 3.771.1 0.190.02 99.20.87
8. F8 499.541.15 3.280.45 3.341.2 0.590.10 99.171.07
9. F9 500.151.35 3.410.19 3.560.71 0.210.14 99.190.17
10. F10 500.311.11 3.340.76 3.440.94 0.450.21 98.970.37
11. F11 500.471.35 3.310.06 3.720.63 0.350.11 100.100.27
12. F12 500.711.25 3.460.06 3.320.73 0.450.09 98.770.35

DISSOLUTION STUDIES

In vitro dissolution studies were carried out by using 900ml of water 1% SLS in USP dissolution
apparatus by using paddle method. The dissolution studies were carried out for about 30 min.

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Table 7: In vitro Dissolution studies

Time (Min) F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12

2 18.4 19.5 24.3 26.9 31.7 28.3 18.4 35.2 22.4 18.6 16.4 19.5
4 35.2 26.3 31.6 49.4 34.5 42.9 25.2 48.9 39.1 25.4 23.2 27.4
6 48.9 44.2 49.3 79.2 41.9 58.7 38.7 66.8 49.5 34 41.5 49.6
8 66.8 57.7 58.3 87.8 62.4 65.8 48.3 79.3 62.5 57.4 51.2 63.7
10 78.1 64.6 74.3 92.8 79.1 75.2 54.3 88.9 71.8 68.9 66.4 78.5
15 86.4 81.6 88.1 96.8 89.5 80.6 77.4 93.5 89.6 76.3 78.9 89.1
20 91.3 92.6 94.6 99.4 91.6 91.8 88.77 97.7 84.5 85.8 94.5 96.5
30 95.7 98.2 98.1 97.6 98.2 98.2 101.8 91.06 93.2 96.7 99.8

From the tabular column it was evident that the formulations prepared with super disintegrant
crospovidone at 4% and Mannitol at 9% showed maximum % drug release in 20 min i.e. 99.4 %
(F4 formulation). The formulations prepared with croscarmellose sodium showed maximum
percentage drug release in 30 min i.e., 101.8 % (F8 formulation) .The formulations prepared with
Sodium starch glycolate showed maximum percentage drug release in 30 min i.e., 99.8% (F12
formulation). Irrespective of super disintegrate type and increase in Concentration of pore forming
agent the disintegration time decreases and Dissolution time also decreases. The dissolution profile
was represented in below graphs.

Fig. 6: Dissolution profile of formulations F1-F12

Disintegration Time, Wetting Time and Water Absorption

Tablets of each batch were evaluated for in vitro disintegration time and the time was found to be
in the range of 38 to 78 seconds. Which is maximum for F5 and varying the proportion of
superdisintegrant disintegration time decreased for F4, F8 and F12. Among there
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superdisintegrant Cross povidone was found to have good disintegrating property. The wetting
time of tablets was 38 sec to 29 sec seconds. The water absorption ratio of was 105.1 to 154.54
seconds. F4 formulation showed good water absorption ratio. From results it was concluded that
the amount of Super disintegrates and Mannitol was increased, the wetting period of the tablets
decreased.

Table 6: Disintegration time, wetting time and Water absorption ratio values

Sl. Form. Disintegration Time (Sec.) Wetting Time (Sec.) Water Absorption
No. Code SD SD ratio

1. F1 650.45 380.12 1042.34

2. F2 540.97 360.07 1241.32
3. F3 430.55 330.04 1341.54
4. F4 381.22 290.05 1541.01
5. F5 780.97 340.06 1330.85
6. F6 650.81 320.1 1141.21
7. F7 600.93 310.09 1470.28
8. F8 460.88 300.14 1261.32
9. F9 660.7 380.07 1481.54
10. F10 560.47 360.06 1371.28
11. F11 470.86 340.12 1061.38
12. F12 400.94 320.08 1341.68
Kinetics of Drug Release from Optimized Formulation:
Release data were analysed as per zero order and first order. The release mechanisms were
analysed as per Higuchi and korsmeyer and peppas model.
Table 7: In vitro cumulative percent drug release, Log percent drug released and Log
percent drug unreleased from the Optimized Formulation.
Sl. Sq.rt. of Log %Cumulative Log % drug Log % drug
Time(h)
No. Time Time drug released released unreleased
1. 0 0 0 0 0 0
2. 2 1.414 0.301 26.9 1.429 1.863
3. 4 2 0.602 49.4 1.693 1.704
4. 6 2.449 0.778 79.2 1.898 1.318
5. 8 2.828 0.903 87.8 1.943 1.086
6. 10 3.162 1 92.8 1.967 0.859
7. 15 3.87 1.17 96.8 1.985 0.505
8. 20 4.47 1.30 99.4 1.997 -0.22

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Table 8: Comparison of orders of in vitro release of the drug formulation

Release kinetics R2 value Regression equation

Zero-order kinetics 0.808 y = 3.643x + 39.29
First-order kinetics 0.985 y = -0.112x + 2.2061

Table indicate that all the formulations follow the first order kinetics as the co-efficient of
regression (R2) was more near to unity as compared to the regression value of zero order

Comparison of mechanism of in vitro release of the drug from the formulation

Table 9: Comparison of mechanism of in vitro release of the drug from the formulation

Release mechanism R2 value Regression equation

Higuchi diffusion model 0.943 y = 38.29x - 18.66

korsmeyer and peppas model 0.949 y = 0.629x + 1.297

A perusal to the Table indicated that the release mechanism of the drug followed korsmeyer and
peppas model from optimized coated formulation (F4).

SUMMARY AND CONCLUSION

In the present work, an attempt has been made to develop oral disintegrating tablets of Celecoxib
with improved solubility by solid dispersion technique and to evaluate the effect of different
superdisintegrants and pore forming agent in the formulation.
Solid Dispersion of Celecoxib in PVP K-30
The present study concluded that PVPK-30 is a suitable carrier for the preparation of celecoxib
solid dispersions. In the FTIR spectra, most of the characteristic polymer peaks were present, but
the characteristic peaks of celecoxib were absent. This indicates that celecoxib was trapped inside
the polymer matrix. Invitro dissolution studies concluded that solid dispersion of celecoxib has
improved solubility then pure form. The presence of PVP-K30 increases the dissolution rate of
celecoxib up to a drug-to-polymer ratio of 1:2
Preformulation parameters
Powder blend prepared were investigated for diverse rheological properties like bulk density,
tapped density, Hausners ratio, angle of repose by using standard procedures. The result of bulk
density of Celecoxib range from 0.41 to 0.50 (gm/cc) and tapped density from 0.49 to

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0.58(gm/cc). Hausners ratio was found to be in between 1.13 to 1.20; and Compressibility Index
from 13.06 to 18.18 and the values of Angle of repose found in range of 26 to 39. These values
indicated that the powder blends had good flow properties. Different tablet formulations of
Celecoxib were prepared by direct compression technique.
Post formulation parameters
The thickness of all formulations of Celecoxib was noted to be between 4.21 to 4.84. The tablet
weights of all bathes of were found within recommended USP limits, between 500 1 mg. The
tablets are studied for hardness, disintegration and friability. The hardness was found to be with in
the range of 4.32 to 4.96 kg/cm2. The percentage of friability ranged from 0.15 to 0.59 which was
with in official limits (< 1%).
Disintegration time was found to be 38 to 78 sec. This is maximum for F5 and minimum for F4
and varying the proportion of superdisintegrant disintegration and pore forming agent time
decreased linearly for F4, F8 and F12. Among three superdisintegrants Cross povidone was found
to have good disintegrating property.
The uniformity content of active ingredients in tablets was under USP limit. F11 formulation
showing maximum drug content of 100.2%.
The wetting time of Celecoxib tablets was 38 sec to 29 sec seconds. The water absorption ratio of
was 105.1 to 154.54 seconds. F4 formulation showed good water absorption ratio. From results.
As the amount of superdisintegrant and mannitol was increased, the wetting period of the tablets
decreased. That means that increasing the concentration of superdisintegrant agent or pore-
forming agent decreases the wetting time. F4 formulation exhibited excellent wetting time, water
absorption ration and disintegration time as compared to other formulations. F3 formulation
containing cross povidone 4% (wt/wt) and pearlitol 9% (wt/wt) were selected as the optimum
concentrations. Wicking and capillary action are major factors in the ability of cross povidone for
its action.
Results of in vitro drug release of all formulations revealed that 95 % to 101.8% of drug release
from various formulations. The formulation F4 exhibited 99.4% of Celecoxib released in 20
minutes from tablets. Hence F4 was selected for further studies.
Release Kinetics
Results exhibited that all the formulations follow the first order kinetics as the co-efficient of
regression (R2) was more near to unity as compared to the regression value of zero order and
Higuchi model. Among all the formulations it was observed that R2 value of formulation F3 was
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more near to one than formulations. On the basis of this parameter, F3 was selected for further
study. The values of n in Korsmeyer- peppas model suggested that all formulations of Celecoxib
oral disintegrating tablets follow Non Fickian Anamolous.
STABILITY STUDIES
Stability studies were carried out on most satisfactory formulation(F3) for 3 months at ambient
temperature and accelerated stability conditions to assess their long term stability as per ICH
guidelines Q1C. at the end of 90 days samples were evaluated. There were no major changes in
the various physicochemical parameters evaluated like hardness, drug content and Invitro
dissolution pattern.
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