COMPARISION AND IN VITRO EVALUATION OF

VARIOUS COMMERCIALLY AVAILABLE BRANDS OF

PANTOPRAZOLE SODIUM ENTERIC COATED
TABLETS

IN PARTIAL FULFILLMENT OF REQUIREMENT FOR DEGREE OF BACHELOR

OF PHARMACY
BY
BIBEK SHRESTHA
A DISSERTATION SUBMITTED TO THE
TRIBHUVAN UNIVERSITY
 1. INTRODUCTION

• Pantoprazole Sodium is a drug used in treatment of stomach ulcers, erosive

esophagitis due to GERD, Zolllinger – Ellision Syndrome.it may also be used in
combination with other drugs for elimination of H. Pylori infection. It is a
substituted Benz imidazole derivative an irreversible proton pump inhibitor. The
formulation was approved by Food and Drug Administration on Feb 02, 2000. [1]

Figure 1 a Structure of Pantoprazole

1.1 Drug profile

• Empirical Formula : C16H17F2N3NaO5S

• Molecular mass: 424.375 g/mol
• IUPAC name: 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)
• methyl] sulfinyl]-1H-benzimidazole sesquihydrate
• Description: white to off-white crystalline powder, racemic and has weakly basic and acidic
properties
• Category: Proton pump inhibitor
• Solubility: soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically
insoluble in n-hexane.
• Pharmacodynamics:
This drug acts to decrease gastric acid secretion, which reduces stomach acidity. Pantoprazole
administration leads to long-lasting inhibition of gastric acid secretion.Pantoprazole has been shown to
reduce acid reflux-related symptoms, heal inflammation of the esophagus, and improve patient quality of
life more effectively than H2 blockers. This drug has an excellent safety profile and a low incidence of
drug interactions. It can be used safely in various high-risk patient populations, including the elderly and
those with renal failure or moderate hepatic dysfunction [2].
• Mechanism of action:
Hydrochloric acid (HCl) secretion into the gastric lumen is a process regulated mainly by the H(+)/K(+)-
ATPase of the proton pump, expressed in high quantities by the parietal cells of the stomach. ATPase is an
enzyme on the parietal cell membrane that facilitates hydrogen and potassium exchange through the cell,
which normally results in the extrusion of potassium and formation of HCl (gastric acid).
Pantoprazole is a substituted benzimidazole derivatives, weak bases, which accumulate in the acidic
space of the parietal cell before being converted in the canaliculi (small canal) of the gastric parietal cell,
an acidic environment, to active sulfenamide derivatives. This active form then makes disulfide bonds
with important cysteines on the gastric acid pump, inhibiting its function. Specifically, pantoprazole binds
to the sulfhydryl group of h+, k±atpase, which is an enzyme implicated in accelerating the final step in
the acid secretion pathway. The enzyme is inactivated, inhibiting gastric acid secretion. The inhibition of
gastric acid secretion is stronger with proton pump inhibitors such as pantoprazole and lasts longer than
with the H2 antagonists. [2]
• Absorption:
Pantoprazole is absorbed after oral administration as an enteric-coated tablet with maximum
plasma concentrations attained within 2 – 3 hours and a bioavailability of 77% that does not
change with multiple dosing. Delayed-release tablets are prepared as enteric-coated tablets
so that absorption of pantoprazole begins only after the tablet leaves the stomach. [2]
• Volume of distribution:
The apparent volume of distribution of pantoprazole is approximately 11.0-23.6 L,
distributing mainly in the extracellular fluid.
• Protein binding: Approximately 98%
• Metabolism:
Pantoprazole is heavily metabolized in the liver by the cytochrome P450 (CYP) system. Pantoprazole metabolism
is independent of the route of administration (intravenous or oral). The main metabolic pathway is demethylation,
by CYP2C19 hepatic cytochrome enzyme, followed by sulfation; other metabolic pathways include oxidation by
CYP3A4. There is no evidence that any of the pantoprazole metabolites are pharmacologically active. [2]
After hepatic metabolism, almost 80% of an oral or intravenous dose is excreted as metabolites in urine; the
remainder is found in feces and originates from biliary secretion.
• Route of elimination:
After a single oral or IV dose of 14C-labeled pantoprazole to healthy, normal metabolizing subjects, about 71% of
the dose was excreted in the urine, with 18% excreted in the feces by biliary excretion. There was no kidney
excretion of unchanged pantoprazole.
• Half life
About 1 hr
 1.2 Enteric coated Delivery System

• A tablet is a pharmaceutical dosage form comprising a mixture of active

substances and excipients, usually in powder form, pressed or compacted from a
powder into a solid dose. Coating is a process by which an essentially dry, outer
layer of coating material is applied to the surface of a dosage form in order to
confer specific benefits that broadly ranges from facilitating product identification
to modifying drug release from the dosage form. An enteric coating is a barrier
that controls the location of oral medication in the digestive system where it is
absorbed. The word “enteric” indicates small intestine; therefore enteric coatings
prevent release of medication before it reaches the small intestine. The enteric
coated polymers remain unionized at low pH, and therefore remain insoluble. But
as the pH increases in the GIT, the acidic functional groups are capable of
ionization, and the polymer swells or becomes soluble in the intestinal fluid.
Materials used for enteric coatings include CAP, CAT, PVAP and HPMCP, fatty
 1.3 Advantages of Enteric Coating Delivery System

• Protection of active pharmaceutical ingredients, from the acidic environment of

the stomach (e.g. enzymes and certain antibiotics).
• To prevent gastric distress or nausea from a drug due to irritation (e.g. sodium
salicylate).
• For the delivery of drugs that are optimally absorbed in the small intestine to their
primary absorption site in their most concentrated form.
• To provide a delayed-release component for repeat action.
• Required for minimizing first pass metabolism of drugs.[5]
 1.4 Limitation

• The reliability and delivery efficiency is doubtful due to presence of

wide range of pH values and different enzymes present in the GI tract
which is encountered by the drugs before reaching the target site. [6]
 1.5 Mechanism of enteric coated time-release press coated tablets

• ETP tablets are composed of three layers, a drug containing core tablet (rapid
release function), the press coated swellable hydrophobic polymer layer
(Hydroxy propyl cellulose layer (HPC), time release function) and an enteric
coating layer (acid resistance function). The tablet does not release the drug in
the stomach due to the acid resistance of the outer enteric coating layer. The
enteric coating layer rapidly dissolves after gastric emptying and the intestinal
fluid begins to slowly erode the press coated polymer (HPC) layer. Rapid drug
release occurs when the erosion front reaches the core tablet since the erosion
process takes a long time as there is no drug release period (lag phase) after
gastric emptying. The duration of lag phase (drug release period) is controlled
either by the weight or composition of the polymer (HPC) layer. [1]
Figure 1 b Mechanism of release of enteric coated timed-release
press coated tablet
 2. RATIONALITY OF STUDY

• Ulcers, crater-like sores, formed in the stomach and duodenum are

called gastric and duodenal ulcers, respectively. Stomach and
duodenum ulcer are generally referred to as Peptic ulcers. Helicobacter
pylori infection is the major cause of peptic ulcer, since 85 to 95% of
patients with peptic ulcer have this organism [7]. Non-steroidal anti-
inflammatory Drugs such as aspirin can also cause or worsen ulcer [8].
Pantoprazole, a proton pump Inhibitor, which belongs to the
benzimidazole groups, is used for the treatment of peptic ulcer. There
are various brands of pantoprazole currently marketed in the country
with varying formulations used which includes both national and
international brands.
 3. LITERATURE REVIEW

• Bashar et.al performed evaluation of different marketed brands of Pantoprazole

Sodium. This study concluded that all the brands passed all official tests prescribed by
Indian Pharmacopoeia (IP). The study also concluded that due to variation in
formulation additives, physical form of drug used in tablet and manufacturing
processes, variation in observed dissolution profiles was detected.
• Mostafa et.al performed assessment of pharmaceutical quality of marketed enteric
coated pantoprazole sodium sesquihydrate products in comparison with innovator
product pantozol® (20.0 mg pantoprazole). This showed a significant variation in the
in vitro release pattern compared with the innovator product except generic product I.
These generic products were found to fail USP requirements due to inappropriate
coating which resulted in the release of the drug in acid medium indicating non-
effective product.
• Dharmaraj.et.al performed comparative evaluation of commercially available
pantoprazole delayed release tablets with standard Pantoprazole sodium sesquihydrate.
This study concluded that all the products gave complied satisfactorily with IP.
• Mansoor et.al performed Comparative study on in vitro evaluations (hardness,
friability, weight variation, assay, disintegration and dissolution tests) of marketed
pantoprazole tablets (2 batches of each) from WHO GMP certified Nepalese companies
(encoded with BP-02-A1, BP-02-A2), non-GMP certified Nepalese companies
(encoded with BP-02-B1, BP-02-B2) and multinational Companies. This study
concluded that BP-02-A2 (90 % drug release) complied best with standard RDRL
protocol while BP-02-B2 (78% drug release) does not comply with above specification.
 4. OBJECTIVES:

• General Objectives:
• To compare in- vitro evaluation result of selected brands of commercially available
pantoprazole sodium tablets.
• To help pharmacists and practicing physicians to choose the best drug among a very large
number of formulations.
• Specific objectives:
• To calculate weight variation and friability of different brands of pantoprazole sodium
enteric coated tablets.
• To perform perform comparative analysis of disintegration time and drug release profile of
the tablets.
• To determine assay of these tablets.
 5. MATERIALS AND METHODS

5.1 Materials
a. Materials required:
• Sample
• Marketed Pantoprazole Sodium Tablets (3 batches of each)
• Chemicals
• Standard Pantoprazole sodium
• Phosphate buffer 6.8 pH
• 0.1 N HCl
b. Equipments and Instruments Required

• Electronic Balance, d=0.0001 g, Max=110g, model: Adventurer Pro AU114 (Ohaus

Corporation Pine Brook, NJUSA)
• UV/Visible spectrophotometer, Model: UV-1800 240V (Shimadzu, UV-1800)
• pH meter, model: CL180 (Labline Technology)
• Sonicator, model: 1.5L50H (PCI Analytics)
• Disintegration apparatus
• Filter paper (Whatman)
• Dissolution apparatus
• Friability Tester
 5.2 Methodology

•• Friability: 20 tablets were selected randomly and weighed individually, then placed in the
friability test apparatus. It was then operated for 100 revolutions at 25 rpm. The tablets
were then dusted, reweighed and percent loss was calculated.
Formula used: % friability= X 100
Where, w0 =Initial weight wf = final weight
• Weight Variation: 20 tablets were selected randomly and weighed individually. The
average weight was calculated and individual weight was compared to the average weight.
The tablet passes the test if not more than two of the individual weights deviate from the
average weight by more than ± 7.5% and none deviated by twice ± 7.5% [9].
Formula used:
Where, W1=Individual weight Wavg= Average weight
 Disintegration Test:
• The disintegration test was performed by taking 1 tablet in each of the
six tubes of the basket. The apparatus was operated using 0.1N HCl as
immersion fluid at 37± 2 °C for 2 hours. Then after, tablets were
observed for any sign of disintegration, cracking or softening. Then,
immediately tablets were taken outside and the immersion fluid was
replaced with phosphate buffer, pH 6.8 and apparatus was operated on
same condition for 1 hour.
 Dissolution Test:
• The dissolution test was conducted using simulated gastric fluid (0.1N HCl) and intestinal fluid (phosphate
•buffer, pH-6.8) as dissolution medium. Using simulated gastric fluid, 900 ml of 0.1N HCl was placed in the
vessel and allowed to come to 37 ± 0.5°C. Then, pantoprazole tablets were placed in six baskets, one in each
basket and stirrer was rotated at 100 rpm for 2 hrs. After 2 hrs, the medium was thrown to observe the integrity of
coating layer of tablets. The coating layer was found to remain intact. Immediately, same tablets were placed in
900 ml of phosphate buffer (pH-6.8) at same rotation speed and temperature as mentioned above for 1 hr. After
15, 30 and 45 min, sample of 5 ml was pipetted out and same volume of fresh phosphate buffer was added to
keep volume of the dissolution medium constant. The sample was diluted to 15 ml and the absorbance was
measured at 289 nm and calculation was done using Lambert beer’s law. Similarly, the absorbance of known
concentration of standard solution of pantoprazole was measured and percent drug release was calculated.
Formula used:
Concentration of drug:
Amount of drug released:
% Drug release:
 Assay:

•• Standard Preparation: 50 mg of Pantoprazole Sodium reference standard was weighed and

transferred into 50 ml volumetric flask. 40 ml of methanol was added and dissolved using sonicator.
The volume was made up using same solvent and mixed. 1 ml of this solution was diluted to 100 ml
with methanol and mixed.
• Sample Preparation: Powdered tablet equivalent to 100 mg of Pantoprazole was weighed
accurately and placed into 100 ml volumetric flask.60 ml of methanol was added, mixed and
sonicated for 30 minutes. The volume was then made upto 100ml with methanol. This solution was
then filtered through Whatmann No. 1 filter paper. 1ml of this solution was diluted to 100 ml with
methanol. (10 ppm)
The absorbance of both sample and standard solution was measured at 289 nm and content per tablet
was calculated as follows:
Quantity found per tablet: X X X X X Avg. tablet weight
Assay: X 100
 Analytical method validation

• Determination of λmax:
1.
A 50 mg of propranolol hydrochloride was weighed accurately and dissolved in phosp hate
buffer solution pH 6.8 and 0.1 N HCl separately to obtain 500 mcg per ml each. These solutions
were subjected to scanning between 200-400 nm and absorption maxima was determined. The
above solution was diluted to 20 mcg/ml and scanned from 200-400 nm.
2. Accuracy:
The accuracy of an analytical procedure expresses the closeness of agreement between the
value which is accepted either as a conventional true value or an accepted reference value and
the value found. Accuracy is performed in three different concentrations of sample. Three
replicates of each concentration are taken and expressed as % recovery. The percent recovery is
determined by the equation:
%Recovery =........................................................................
3. Precision:
The precision of an analytical procedure expresses the closeness of agreement (degree of
scattering) between a series of measurements obtained from multiple sampling of the
same homogeneous sample under the prescribed conditions. Precision may be considered
at three levels: repeatability, intermediate precision and reproducibility.
4. Linearity Curve (Calibration Curve):
The linearity of an analytical procedure is its ability (within a given range) to obtain test
results which are directly proportional to the concentration (amount) of analyte in the
sample. Five serial concentration of standard drug is prepared. The absorbance of the
resultant solutions is taken at absorption maxima. Calibration curve is prepared by
plotting concentration versus absorbance for the various concentrations of drug medium.
•
5. Limit of detection:
The limit of detection (LOD) is the point at which a measured value is larger than the uncertainty associated with it. It is
the lowest concentration of analyte in a sample that can be detected but not necessarily be quantified. Various
concentrations of reference standard are prepared as mentioned in calibration curve. Limit of detection is calculated by
using equation
Limit of detection = 3.3
Where, σ is standard error of predicted y-value for each x in the regression and s is the value of slope of calibration curve.
6. Limit of quantitation:
The limit of quantitation (LOQ) of an individual analytical procedure can be defined as the lowest amount of analyte in a
sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter
of quantitative assays for low level of compounds in sample matrices and is used particularly for the determination of
impurities or degradation of products.
Various concentration of reference standard are prepared as mentioned in calibration curve. Limit of quantitation was
calculated by using equation
Limit of quantitation = 10
Where σ is standard error of predicted y-value for each x in the regression and S is the slope of the standard calibration
curve.
 Specificity:

• Specificity can be defined as the ability to assess unequivocally the

analyte in presence of components which may be expected to be
present. Typically this might include impurities .degradants, matrix,
etc. Solution of reference standard is prepared. The specificity test is
carried out by measuring the spectrum of these solutions at the
spectrum range of 200-400 nm in UV-visible spectrophotometer.
 
 6. RESULTS AND DISCUSSION

6.1 Analytical method validation:

• Determination of λmax:
The spectrum of 20 mcg/ml of standard pantoprazole sodium solution
was observed. The solution gave the absorbance maxima at 289 nm.
• Accuracy:
The parameter is performed to determine the closeness of test result with that of the true value which
is expressed as % recovery. These studies were performed at three different concentrations 8, 10 and
12 mcg/ml. The % recovery was found to be 98.4% , 99.65% and 98.85% respectively which were
within the range (98%-102%). The method was considered to be accurate.
Concentration(mcg/ml) TableObtained
1: Average absorbance values for accuracy dataRecovery
value(mg)

8 39.36 98.40%

10 39.86 99.65%

12 39.54 98.85%
• Precision:
Precision was calculated statistically and was considered at three levels.
The value of mean RSD calculated was 0.506 % which was less than
2%. So, the method was found to be précised.
Table 2: RSD Values for repeatability data
Concentration (mcg/ml) Mean Assay Value (mg) S.D RSD=
(SD/Mean × 100)

8 39.36 0.160 0.406504

10 39.86 0.138 0.346021

12 39.54 0.302 0.764668

• Linearity Curve (Calibration Curve)

Calibration curve was prepared by plotting graph of concentration versus absorbance for the concentration of 5, 10,
15, 20 and 25 mcg/ml of pantoprazole sodium reference standard in phosphate buffer pH 6.8 and 0.1 N HCl solution
at 289 nm. The plot of concentration vs absorbance of pantoprazole sodium in phosphate buffer is shown in
figure‑below:
0.9
0.8
0.7 f(x) = 0.03x + 0
0.6 R² = 1
absorbance

0.5
0.4
0.3
0.2
0.1
0
0 5 10 15 20 25 30
concentration

Linear ()
Figure 3 a Calibration curve of pantoprazole sodium in phosphate buffer pH 6.8
 1

0.8 f(x) = 0.03x + 0.04

R² = 0.99
absorbance

0.6

0.4

0.2

0
0 5 10 15 20 25 30
concentration

Linear ()

Figure 3 b Calibration curve of pantoprazole sodium in 0.1 N HCl

• The regression analysis for linearity showed good correlation,
R2=0.9961 and 0.9923, absorbance taken at the wavelength 289 nm in
phosphate buffer 6.8 and 0.1 N HCl respectively .This showed that the
method of analysis of pantoprazole sodium by UV spectrophotometer
was suitable.
• Limit of detection:
Various concentration of pantoprazole sodium reference standard (5 to
25 mcg/ml) were prepared in phosphate buffer pH 6.8 and 0.1 N HCl as
mentioned in calibration curve.The standard error of predicted y-value
for each x in the regression is 0.017278 for phosphate buffer 6.8 pH and
0.026053 for 0.1 N HCl solution, the value of slope of calibration curve
is 0.03044 For phosphate buffer 6.8 pH and 0.03246 for 0.1 N HCl.
Therefore, the limit of detection of pantoprazole sodium is 1.87312 in
phosphate buffer 6.8 pH and 2.648657 in 0.1 N HCl solution.
• Limit of quantification:
The limit of quantification of standard pantoprazole sodium is 5.6761 mcg/ml.
and 8.02623 mcg/ml in in phosphate buffer 6.8 pH and 0.1 N HCl solution
respectively.
• Specificity:
The specificity test was carried out by measuring the spectrum at 200-400 nm
in UV visible spectrophotometer. The spectrum of pantoprazole sodium
showed maximum peak at absorbance at 289 nm for reference standard.
Therefore, the method was specific for analysis of pantoprazole sodium. The
spectrum for specificity is shown in Annex I.
Table 3.1 Comparative results of different parameters of enteric coated tablet of pantoprazole sodium of selected brands

Brand code Weight variation Friability Disintegration in phosphate buffer Assay

6.8pH(min)

P1B01 0.381±1.129 0.276 8.71 96.292

P1B02 0.105±1.070 0.244 9.54 97.763

P2B01 0.343±1.015 0.114 12.69 101.309

P2B02 0.150±1.088 0.210 11.27 100.279

P3B01 0.100±0.726 0.099 6.48 97.779

P3B02 0.153±0.745 0.152 5.98 99.789

P4B01 0.081±0.677 0.108 11.52 95.842

P4B02 0.026±1.234 0.210 13.42 95.269

• Friability:
The weight loss of tablets varied from 0.108% to 0.276%. P1B01 showed the
highest loss while P4B01 showed the lowest loss. However the value were with
pharmacopoeial limit. The variation may be as a result of variation in binder
quantity or variation in moisture content.
• Weight Variation:
The weight variation of tablets differ depending on average tablet weight. The
result of weight variation showed that all the brands P1B01, P1B02, P2B01, P2B02,
P3B01, P3B02, P4B01 and P4B02 fall within 7.5% tolerance i.e. all brands satisfy
pharmacopoeial specifications. The weight variation varied from 0.026% to
0.381%, of which larger variation was observed for P1B01 and lowest for P4B02.
• Disintegration:
Disintegration was carried out in both 0.1 N HCl and phosphate buffer of 6.8 pH. None of the tablets
disintegrated in 0.1 N HCl nor there was any sign of cracking or softening. P3B02 showed the fastest
disintegration at about 5.98 minutes while P4B02 showed the slowest disintegration time of about
13.42 minutes in phosphate buffer of 6.8 pH. All the brands of tablets disintegrated before 15
minutes conforming to the I.P. specifications.
 Figure 3 c Comparison of DT of different brands

16

14 13.42
12.69
12 11.27 11.52

10 9.54
8.71
Time(Sec)

8
6.48
5.98
6

0
P1B01 P1B02 P2B01 P2B02 P3B01 P3B02 P4B01 P4B02
•  Dissolution:
Dissolution was carried out in six tablets of each batch. The percentage drug release was analyzed in both 0.1 N
HCl and phosphate buffer of 6.8 pH. Percentage drug release was observed to be less than 10 % and were in
range from 0.789% to 2.964% which is less than 10%.
Table 3.2 Release of pantoprazole sodium in 0.1 N HCl medium
Brand code % Drug Release
B1P01 0.711±0.026
B1P02 0.897±0.064
B2P01 2.202±0.231
B2P02 2.261±0.306
B3P01 2.603±0.211
B3P02 2.964±0.252
B4P01 0.786±0.119

B4P02 0.906±0.084
While in phosphate buffer, the % drug release was significantly higher. The
values obtained is shown in the table below. Some of the reasons for such
variation in dissolution rate may be due to:
• Difference in particle or surface area of the drug particles.[10]
• Inclusion of such disintegrant by manufacturer which does not swell but exert
its disintegrating action by capillary action because capillaries are likely to be
formed and liquid is drawn up through these capillaries at very rapid rate. It
ruptures the intergranular bond and the granules are thrown apart with
resultant breaking of tablets [10].
• Slight variation in pH or temperature variation of dissolution medium at
different position.[11]
 Figure 3 d Release of pantoprazole sodium in phosphate buffer 6.8 pH

    % Drug Release  
Brand Code

  In 15 minutes In 30 minutes In 45 minutes

P1B01 61.347±1.936 72.388±1.994 85.862±0.870

P1B02 56.217±1.502 70.763±1.023 81.853±1.603

P2B01 48.135±1.905 60.733±1.439 82.822±1.984

P2B02 53.778±1.453 62.443±1.968 81.468±1.243

P3B01 38.148±0.858 68.053±0.762 77.858±0.953

P3B02 41.187±0.970 73.860±1.220 78.173±1.278

P4B01 63.248±0.952 72.653±1.977 82.792±1.152

P4B02 60.292±1.300 69.606±1.857 85.332±1.718

Figure 3 e Comparison of % drug release of various brands of enteric coated tablets of pantoprazole
sodium in phosphate buffer 6.8 pH

P1B01 P1B02 P2B01 P2B02 P3B01 P3B02 P4B01 P4B02

100
90
80
70
% drug release

60
50
40
30
20
10
0
15 30 45
Time(MIN)
• Assay:
The content of tablet was found to be ranging from 37.937 to 40.404 mg. of stated (40 mg per
tablet). While assay was found to range from 94.842 to 101.009 % which is within the limit of (100 ±
10%).
Table 3.3 Assay of different brands of enteric coated pantoprazole sodium tablets
Brand Code Quantity found(mg) Assay (%)
P1B01 38.517 96.292
P1B02 38.305 95.763
P2B01 40.404 101.009
P2B02 40.112 100.279
P3B01 39.112 97.779
P3B02 38.716 96.789
P4B01 37.937 94.842
P4B02 38.108 95.269
 7. CONCLUSION

Comparative study of various commercially available brands of enteric coated tablets of

Pantoprazole sodium was carried out. Pantoprazole sodium sesquihydrate is highly
unstable at low pH values, so, it is formulated as enteric coated tablets or capsules. Any
defect in the enteric coat will result in the release of the drug in acidic medium, which
leads to degradation of the liberated amount of drug. The defect may be due to choosing
the coating material, concentration of the coating material and type of solvent.
Pantoprazole sodium enteric coated tablets are marketed in various brand names as generic
drugs. Thus, the efficacy of generic drugs should be assessed compared in order to know
the difference in effect between them. All the brands of enteric coated tables of
pantoprazole sodium complied with the pharmacopoeial specifications. All the products
gave satisfactory results, with respect to friability, weight variation, disintegration time,
dissolution and assay. Comparison of dissolution profile of these tablets shows that P1B01
showed highest (85.862%) drug release profile.
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