RESEARCH ARTICLE

1. Sivakumar R et al. / IJPPDR / 7(1), 2017, 19-22. Page | 19
e-ISSN: 2249-7625
Print ISSN: 2249-7633
International Journal of
Pharmacy Practice & Drug Research
www.ijppdr.com
DESIGN AND EVALUATION OF ORODISPERSIBLE TABLETS OF
PANTOPRAZOLE SODIUM
Preethi TJ, Rahul Krishnan, Sivakumar R*, Reshma Fathima K, Kavitha. K,
B.Vijayakumar
Grace College of Pharmacy, Kodunthirapully, Palakkad – 678004, Kerala, India.
ABSTRACT
The main aim of the tablet is formulate and evaluate orodispersble tablets containing pantoprazole tablets by sublimation
method. Totally four different formulations were developed using various concentration of sublimation agent and
superdisintegrants. The developed formulations were analyzed for FTIR, hardness, friability, weight variation test wetting
time, and dissolution study. The results of the indicate F4 formulation was found to be best among the other formulations.
Keywords: Orodispersible Tablets, Sublimation method, Pantprazole sodium.
INTRODUCTION
Orodispersible tablet is the solid unit dosage
form containing super disintegrates which impart the
quality of quick disintegration in the presence of saliva
and without producing any difficulty in swallowing of
tablets. As soon as the tablet gets disintegrated into the
mouth, the drug is released, then it is dissolved or
dispersed in saliva and is absorbed sublingually. Due to
effectiveness of this kind of dosage form, the United
States Pharmacopoeia has also approved these dosage
forms as Orodispersible tablets [1-4].
In this dosage form, drug is released quickly
from this dosage from and gets dissolved in GIT tract
without getting in to the stomach, thus increased bio
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Received:25.02.17 Revised:12.03.17 Accepted:15.03.17
Corresponding Author
R. Sivakumar
Department of Pharmaceutics, Grace College of Pharmacy, Palakkad
– 678004, Kerala.
Email : rrsk1879@gmail.com
availability can be achieved. It also produces good mouth
feel property, which helps to change perception of the
medication. This factor useful while preparing dose for
pediatric patients.
Sublimation is the process in which excipients
used have high volatility and are chemically inert such as
urea, urethane, naphthalene, camphor, menthol and
ammonium bicarbonate. These are adding with
compression of blend into tablet. When these volatile
substances get removed by sublimation process, pores in
the tablet structure are left. Mouth dissolving tablets with
highly pores structure and good by mechanical strength
can be developed by this method. In this method, tablets
dissolve in 10-20 sec. and exhibit sufficient mechanical
strength.
Pantoprazole is a proton pump inhibitor and used
for the treatment of peptic ulcer. It comes under BCS 111(
High solubility and Poor permeability) Classified drug.
The pKa of the drug is 8.35. The drug showed less
stability below the pH of 6. The average pH of saliva is
7.4 [5]. Considering the all above factor decided to design
orodispersble pantoprazole tablets using sublimation
method to release the drug in oral cavity for improved
patient compliance.
Research Article

2. Sivakumar R et al. / IJPPDR / 7(1), 2017, 19-22. Page | 20
MATERIALS AND METHOD
Pantoprazole Sodium received from
Yarrowchem Products, Mumbai. Sodium Starch
Glycolate, lactose, cross povidone were purchased from
SD fine chemicals, Mumbai. All other chemicals and
reagents are analytical grade.
Formulation of Tablets
All the ingredients were mixed together in pestle
motor (in decreasing order of their quantity used). Then
this mixture was triturated and the mixture was passed
through sieve no.10. After passing through sieve, the
powder was compre
EVALUATION OF ORODISPERSED TABLETS
The prepared all the four formulations were
evaluated for the official and unofficial test [6]. Before
formulation of tablets compatibly study were performed
using FTIR.
FTIR Spectroscopy
Compatibility study of drug with polymer was
determined by FT-IR spectroscopy using Shimadzu
spectrophotometer. The pellets were prepared by gently
mixing 200mg of Potassium bromide with 1mg of
Sample. The prepared pellets were analyzed for individual
drug, for individual polymers and for drug polymer
mixture. The drug and polymer interaction were analyzed
by comparing IR spectra of Drug Sample mixture
Weight Variation
20 tablets were selected randomly from the batch
and weighed individually to check for weight variation.
Friability
Pre weighed tablets are placed in friability test
apparatus. The tablets were rotated in the friability test
apparatus for atleast 4 minutes. At the end of the test,
tablets were dusted and reweighed; the loss in the weight
of tablet was measured of friability and is expressed in
percentage as:
Friability (%) = [(W0 – W f) / W0] X 100
Where, W0 = initial weight of tablets, wf = Final
weight of tablets
Hardness (Crushing strength)
A tablet was kept in between the jaws of
Monsanto hardness tester and load required to crush the
tablet was measured.
Drug content uniformity
Twenty tablets were powdered, and 100 mg
equivalent weight of Pantoprazole was weighed and
transferred into a 100 ml volumetric flask. Initially, 10 ml
of phosphate buffer (ph. 6.8) was added and shaken for 10
min. Then the volume was made up to 100 ml with same
phosphate buffer. The solution in the volumetric flask was
filtered, diluted suitably and analyzed by uv visible
spectrophotometer at 277 nm.
Wetting time
A piece of tissue paper folded double was placed
in a Petriplate (internal diameter 7 cm) containing 7ml of
water. The tablet was placed on the paper and the time for
complete wetting was measured in minutes.
Invitro dissolution test
The in vitro dissolution test for oral
disintegrating tablet was conducted in USP Type II
dissolution apparatus which was slightly modified. The
slight modifications were done by taking 250ml beaker
was used and the basket was replaced by paddle because
of the narrow opening of the beaker. Outside this beaker,
water was filled at a level to maintain the constant
temperature. 100 ml media was filled in the beaker and
the temperature was maintained at 37.5 ± 50
C and the
speed of basket was 50 rpm. 1 ml of aliquot was collected
at the time interval of 3 minutes for 9 minutes. The
aliquots collected were diluted suitably with pH 6.8
phosphate buffer and analyzed at 243 nm in UV Visible
spectrophotometer.
RESULTS AND DISCUSSION
The aim of the present work was to prepare and
evaluate orodispersble tablet containing pantoprazole
sodium tablet by sublimation method for rapid onset of
action. FTIR study suggest than there is no interaction
between drug and excipients. Weight variation was
determined for F1, F2, F3, and F4 formulations, all the
formulation and it was within the range of ± 5%.
Friability of the F1, F2, F3, and F4 formulations were
performed. All the formulations passes the friability test
specifications. Content uniformity of the formulations
was ranged from 98 to 101% for all batches. Wetting time
were between 28 to 36 sec. Higher the concentration of
camphor improve the wetting time. Dissolution test for
all the formulation were studied and the percentage of
drug release were from 68% to 87 %. The results of the
study indicate that the amount of camphor and super
disintegrants increases the percentage of drug release. F1,
F2, F3, F4 was used to calculate a practical drug release
for 9 minutes. The highest percentage drug release was
87%.

3. Sivakumar R et al. / IJPPDR / 7(1), 2017, 19-22. Page | 21
Table 1. Composition of Pantoprazole Sodium Orodispersble tablets.
Table 2. Results of the evaluation of Orodispersible Tablets
Code Weight variation Hardness (kg/cm2
) Friability (%) Wetting time(sec) Dissolution(%)
F1 Passed 2.5 0.9 28 68
F2 Passed 3.0 0.7 32 70
F3 Passed 3.5 0.8 33 85
F4 Passed 3.0 0.8 36 87
Fig 1. FTIR spectroscopy for pure pantoprazole sodium.
Fig 2. FTIR spectroscopy of drug and excipients
INGREDIENTS F1 F2 F3 F4
Pantoprazole sodium 80 80 80 80
Camphor 20 30 20 30
Lactose 40 40 40 40
Sodium starch Glycolate 10 - 10 10
Crosspovidone 10 10 10 10
Citric acid 10 10 10 10
Magnesium stearate 2 2 2 2
Mannitol 78 78 78 68

4. Sivakumar R et al. / IJPPDR / 7(1), 2017, 19-22. Page | 22
CONCLUSION
Orodispersible tablets containing pantoprazole
tablets were successfully designed. The F4 formulation
was found to be best among the formulations.
ACKNOWLEDGMENTS
The authors would like to acknowledge their
dear colleagues for their support rendered. The authors
extend their heartfelt regards to the management Grace
College of Pharmacy for their constant support
throughout the research work.
CONFLICT OF INTEREST
No interest.
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Cite this article:
Preethi TJ, Rahul Krishnan, Sivakumar R, Reshma Fathima K, Kavitha K, B.Vijayakumar. Design and Evaluation of
Orodispersible Tablets of Pantoprazole Sodium. International Journal of Pharmacy Practice and Drug Research, 2017;
7(1): 19-22. DOI: http://dx.doi.org/10.21276/ijppdr.2017.7.1.5
Attribution-Non Commercial-No Derivatives 4.0 International