Pharmaceutical Development and Technology

ISSN: 1083-7450 (Print) 1097-9867 (Online) Journal homepage: http://www.tandfonline.com/loi/iphd20

Formulation and evaluation of a montelukast

sodium orally disintegrating tablet with a similar
dissolution profile as the marketed product

Yong Chen, Tingting Feng, Yong Li, Bin Du & Weiyu Weng

To cite this article: Yong Chen, Tingting Feng, Yong Li, Bin Du & Weiyu Weng (2015):
Formulation and evaluation of a montelukast sodium orally disintegrating tablet with a similar
dissolution profile as the marketed product, Pharmaceutical Development and Technology,
DOI: 10.3109/10837450.2015.1121498

To link to this article: http://dx.doi.org/10.3109/10837450.2015.1121498

Published online: 10 Dec 2015.

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ISSN: 1083-7450 (print), 1097-9867 (electronic)

Pharm Dev Technol, Early Online: 1–5

! 2015 Taylor & Francis. DOI: 10.3109/10837450.2015.1121498

RESEARCH ARTICLE

Formulation and evaluation of a montelukast sodium

orally disintegrating tablet with a similar dissolution profile as the
marketed product
Yong Chen, Tingting Feng, Yong Li, Bin Du, and Weiyu Weng

School of Pharmacy, East China University of Science and Technology, Shanghai, P.R. China

Abstract Keywords
A major challenge of orally disintegrating tablet (ODT) development is predicting its Dissolution profile comparison, evaluation,
bioequivalence to its corresponding marketed product. Therefore, comparing ODT dissolution formulation, montelukast sodium, orally
profiles to those of the corresponding marketed product is very important. The objective of this disintegrating tablets, wet granulation
study was to develop a 5.2-mg montelukast sodium (MS) ODT with a similar dissolution profile method
Pharmaceutical Development and Technology

to that of the marketed chewable tablet. Dissolution profiles were examined in different media
to screen each formulation. We found that MS dissolution from ODTs in acidic medium heavily History
depended on manufacturing methods. All MS ODTs prepared using direct compression rapidly
disintegrated in acidic medium. However, dispersed MS powders aggregated into sticky Received 29 September 2015
masses, resulting in slow dissolution. In contrast, MS ODTs prepared using wet granulation had Revised 28 October 2015
much faster dissolution rates in acidic medium with no obvious aggregation. Additionally, the Accepted 5 November 2015
optimized formulation, prepared using wet granulation, displayed similar dissolution profiles to Published online 8 December 2015
the marketed reference in all four types of media examined (f2450). The in vitro disintegration
time of the optimized ODT was 9.5 ± 2.4 s, which meets FDA requirements. In conclusion,
the wet granulation preparation method of MS ODTs resulted in a product with equivalent
dissolution profiles as those of the marketed product.

Introduction 900 mL of water containing 0.5% sodium lauryl sulfate (SLS).

However, MS solubility is pH dependent10 and multimedia
Montelukast sodium (MS) is a selective and orally active
dissolution studies in various buffer solutions with different pH
leukotriene receptor antagonist that specifically inhibits the
levels are required to properly assess in vitro MS ODT
cysteinyl leukotriene 1 receptor1. The drug is indicated for the
performance and pharmaceutical equivalence. Unfortunately,
prophylaxis and chronic treatment of asthma, prevention of
previous studies have only examined MS ODT dissolution
exercise-induced bronchoconstriction, and relief of allergic rhin-
properties in water containing 0.5% SLS.
itis symptoms2,3. Currently, marketed dosage forms of MS are
The aim of the current study was to develop an MS ODT with
film-coated tablets, chewable tablets and granules.
equivalent dissolution profiles to marketed chewable tablets
Oral administration of medications is the most common, least
(SingulairÕ ). All evaluated MS ODTs were prepared using the
invasive and easiest drug administration route. However, some
direct compression and wet granulation methods. Dissolution
patients, particularly pediatric and geriatric patients, have diffi-
profiles in different media were the key screening tools for each
culty swallowing and/or chewing solid dosage forms. Orally
formulation. The optimized formulation was then examined using
disintegrating tablets (ODTs) have been developed to overcome
dissolution profile comparison tests. Other parameters evaluated
these issues. Because ODTs are designed to rapidly disintegrate in
included wetting time, friability and disintegrating time.
the mouth without additional liquid, they are ideal for patients
with dysphagia. Other ODT benefits include rapid pharmaco-
Materials and methods
logical action, good product stability and increased bioavailabil-
ity4,5. Over the past three decades, ODTs have received Materials
considerable attention and are the preferred alternative to conven-
MS and ferric oxide red were generously donated for study
tional tablets and capsules.
purposes by Venturepharm Group (Beijing, China). The MS
Several different research groups have prepared MS ODTs over
chewable tablets (5.2 mg MS/tablet, SingulairÕ , batch number
the past few years6–9. These groups prepared MS ODTs using
K003502) were obtained directly from Merck Sharp & Dohme
direct compression and evaluated MS dissolution profiles in
Corp. (Hangzhou, China). Inactive ODT ingredients included
mannitol [PearlitolÕ 160C and PearlitolÕ SD200, kindly donated
Address for correspondence: Weiyu Weng, Department of Pharmaceutics,
by Roquette China (Shanghai, China)], microcrystalline cellulose
School of Pharmacy, East China University of Science and Technology, [MCC, ComprecelÕ M105 and ComprecelÕ M301, Mingtai
130 Meilong Road, Shanghai 200237, P.R. China. Tel: +86 2164250187. Chemical Co., Ltd. (Taiwan, China)], croscarmellose sodium
Fax: +86 2164253250. E-mail: wyweng@ecust.edu.cn [CC-Na, Nichirin Chemical Industries, Ltd. (Tokyo, Japan)],
 2 Y. Chen et al. Pharm Dev Technol, Early Online: 1–5

hydroxypropyl cellulose (HPC)-SL [Nippon Soda Co., Ltd.
(Tokyo, Japan)], magnesium stearate and aspartame [both
kindly donated by Shanghai Yunhong Pharmaceutical
Excipients & Technology Co., Ltd. (Shanghai, China)]. SLS
(pharmacopeial grade) and other analytical grade reagents and
chemicals were purchased from Sinopharm Chemical Reagent
Co., Ltd. (Shanghai, China). Deionized water was prepared using
a Milli-Q water purifying system (Millipore Corp., Bedford, MA).
Preparation of montelukast ODTs
All MS ODTs were prepared using the formulations listed in
Table 1. The F1 ODT design was roughly based on previously-
described formulations created with direct compression6–9.
However, the F2–F6 formulations were designed to be created
with the wet granulation method. All ODTs created for this
study were manufactured in a dark room to minimize MS
exposure to light.
Direct compression method
The MS was sieved through a 120-mesh sieve and other
ingredients were separately passed through an 80-mesh sieve.
All ingredients, except magnesium stearate, were accurately
weighed and thoroughly mixed together for 15 min. Magnesium
Pharmaceutical Development and Technology
Technology Co., Ltd., Tianjin, China) at a stirring rate of 50 rpm.
Dissolution media examined included 0.2% (w/v) SLS in water,
0.2% SLS in phosphate buffer (pH 6.8), 0.2% SLS in phosphate
buffer (pH 4.5) and 0.1% SLS in a 0.1 M HCl solution. Aliquots
of 5 mL were withdrawn at specified intervals (5, 10, 15, 30, 45
and 60 min) and replaced with an equal volume of fresh media at
the same temperature. Withdrawn aliquots were filtered through a
0.45-mm membrane filter. The MS concentration of the aliquot
was measured with a validated ultraviolet spectroscopy method at
a wavelength of 255 nm.
Dissolution profiles of different products were compared using an
independent mathematical model for calculating a similarity factor.
The similarity factor (f2) was defined by the following equation11:
2( 3
 X )0:5
n
1
f2 ¼ 50  log4 1 þ ðRt  Tt Þ2
1005,
n t¼1
where n is the number of withdrawal points, Rt is the percentage
dissolved in the reference at time t, and Tt is the percentage
dissolved in the test aliquot at time t. Values of f2 between 50 and
100 indicated that the two dissolution profiles being compared
were similar.
Wetting time and water absorption ratio

stearate was then added and the mixture was blended for an
additional minute. The final blend was compressed into tablets Wetting time and water absorption ratio (R%) were determined
using a single punch tablet press machine (TDP-5, Shanghai Tianfan using previously established methods12. A piece of tissue paper
Machinery Factory, Shanghai, China) fitted with a 7-mm round was folded twice and was placed in a small Petri dish containing
flat punch. The thickness of tablets was approximately 3.5 mm. 6 mL of water. The tablet being examined was carefully placed on
the surface of the tissue paper. This caused water uptake into the
Wet granulation method tablet to occur from the bottom tablet surface. The time required
All ingredients were sieved in the same manner as was done in the for water to reach the center of the upper tablet surface was noted
direct compression method. The MS and intragranular ingredients as the wetting time. The wetted tablet was then weighed and R%
were accurately weighed and thoroughly mixed for 15 min. Wet was calculated using the following equation:
granules were prepared by wetting the intragranular mixture with Wt  W0
an HPC solution and passing the wet coherent mass through a 40- R% ¼  100%,
W0
mesh sieve. Wet granules were then dried in a hot-air oven at
60  C for 45 min and sieved through a 40-mesh sieve to break where W0 is the initial tablet weight and Wt is the tablet weight
lumps. Dried granules were thoroughly mixed with magnesium after water absorption.
stearate and an intergranular disintegrant, and punched into tablets.
Tablet disintegration
In vitro dissolution studies and comparison of dissolution
Tablet disintegration time was measured in vitro according to the
profiles
USP (30th edition) method using distilled water at 37 ± 2  C. Six
In vitro dissolution studies were performed in 900 mL of different tablets were randomly chosen for disintegration testing using a
media types at 37 ± 0.5  C using a United States Pharmacopeia disintegration tester (LB-2D, Huanghai Medicine & Drug Testing
(USP) dissolution test apparatus II (ZRS-8GD, Tianda Tianfa Instruments Co., Ltd., Shanghai, China). A disintegration time
that was less than 30 s was considered acceptable.
Table 1. Formulations examined of MS ODTs.
Tablet friability
Formulations (mg/tablet)
Tablet friability (F%) was determined using a tablet friability
Ingredient F1 F2 F3 F4 F5 F6 apparatus (FT-2000, Tianda Tianfa Technology Co., Ltd.). Tablets
of known weight (approximately 6.5 g) were placed in the
MS 5.20 5.20 5.20 5.20 5.20 5.20
MCC (M105) NA NA 30.00 30.00 18.00 18.00 friabilator and rotated at 25 rpm for 4 min. The dust was removed
MCC (M301) 30.00 30.00 NA NA NA NA from the tablets and they were reweighed. Friability was
Mannitol (SD200) 74.24 72.14 72.14 69.14 84.14 NA calculated using the following equation:
Mannitol (160C) NA NA NA NA NA 84.14
CC-Na 9.00 9.00 9.00 12.00 9.00 9.00 W0  Wt
F% ¼  100%,
Aspartame 0.36 0.36 0.36 0.36 0.36 0.36 W0
Ferric oxide 0.60 0.60 0.60 0.60 0.60 0.60
HPC NA 2.10 2.10 2.10 2.10 2.10 where W0 is the initial tablet weight and Wt is the tablet weight
Magnesium stearate 0.60 0.60 0.60 0.60 0.60 0.60 after the test. A tablet F% that was51% was considered acceptable.
Total 120 120 120 120 120 120
Tablet hardness
MS, montelukast sodium; MCC, microcrystalline cellulose; CC-Na,
croscarmellose sodium; HPC, hydroxypropyl cellulose; NA, not Three tablets of each formulation were randomly chosen for
applicable. hardness testing using a hardness tester (YPD-200C, Huanghai
 DOI: 10.3109/10837450.2015.1121498 Montelukast sodium orally disintegrating tablets 3

Medicine & Drug Testing Instruments Co., Ltd.). The average

value of three independent tests was used in data analyses.

Content and content uniformity

Ten tablets were individually weighed and directly transferred to a
100-mL volumetric flask. Approximately 70 mL of 90% methanol
(v/v) was added to each flask. The solution was sonicated for
30 min, diluted to the proper volume with 90% methanol, and
filtered through a 0.45-mm membrane filter. After dilution, the
MS concentration was determined using a validated high
performance liquid chromatography (HPLC) method at a wave-
length of 238 nm. A Shimadzu (Kyoto, Japan) HPLC system
equipped with an SCL-10Avp system controller, an SPD-10Avp
detector and an LC-10ADvp pump was used for HPLC. The
chromatographic separation was performed on a Luna Phenyl-
Hexyl New Column (250 mm  4.6 mm, 5 mm). The acceptance
value of content uniformity was calculated by the formula listed in
the USP 30th edition59054. The maximum allowed acceptance
value was 15.
Twenty tablets were weighed and powdered. The amount of
powder containing 5.2 mg of MS was transferred into a 100-mL
volumetric flask. The concentration of MS was then determined
using procedures already described above.
Pharmaceutical Development and Technology

Preliminary stability studies

Stress testing was performed to evaluate the stability of developed
MS ODTs. Testing conditions included high temperature (40 and
60  C), high humidity (relative humidity ¼ 75% and 92.5%), and
strong light exposure (4500 Lx). Tablets were removed from their
packaging and placed under each of the above stress conditions.
Samples were collected at baseline (day 0) and day 10 and
evaluated for dissolution rate, in vitro disintegration time, drug
content and impurities. Dissolution tests were carried out in 0.2%
SLS in water and had a fixed sampling time of 15 min. In vitro
disintegration time and drug content were measured using
methods already described above. The amount of impurities was
determined using a validated HPLC method. All results were
compared with those of the marketed chewable tablets.
Statistical analysis
Statistical analysis was performed using Excel 2010 (Microsoft,
Redmond, WA). Results are expressed as means ± standard
deviation (SD). An unpaired Student’s t-test was used to compare
means of two groups. A p50.05 was deemed statistically
significant.
Results
MS oral disintegrating tablet preparation
All MS ODTs were prepared using one of the formulations listed
in Table 1. Tablet weight was fixed at 120 mg and tablet hardness
varied between 30 and 40 N. The developed MS ODTs were pink,
round tablets, with a radius of 7 mm, for all formulations.
In vitro dissolution study for formulation screening
All MS ODT formulations had their in vitro dissolution profiles
evaluated according to the procedure described above. The
marketed chewable tablet served as the reference in all cases.
Dissolution media used in tablet screening stages were 0.1% SLS
in 0.1M HCl (pH 1.2) and 0.2% SLS in phosphate buffer (pH 6.8).
As shown in Figure 1(A), the dissolution of MS from ODTs in
acidic medium heavily depended on the manufacturing method.
The MS ODTs that were prepared using direct compression
(formulation F1), rapidly disintegrated in acidic medium.
Figure 1. In vitro dissolution profiles of ODTs and the reference
marketed chewable tablet (SingulairÕ ) (n ¼ 6). (A) Dissolution profiles in
0.1 M HCl containing 0.1% SLS. (B) Dissolution profiles in phosphate
buffer (pH 6.8) containing 0.2% SLS. Error bars that are not visible lie
within the symbol point.
However, dispersed MS powders aggregated together, which
resulted in slow dissolution of MS during the initial sampling
times. In contrast, the dissolution of MS from ODTs prepared
using wet granulation (formulations F2–F6) was much faster than
that measured for F1. Formulations F2–F6 had no obvious
aggregation during the initial phases of testing.
Excipients used in the wet granulation method also greatly
affected MS dissolution in acidic medium. MCC is one of the
commonly used excipients because of its unique compressibility
and carrying capacity. We found that the type of MCC heavily
influenced MS dissolution and MCC M105 (F3) was more
conducive to dissolution in acidic medium. In addition, the overall
palatability of MS ODTs was better with MCC M105 because of
its small particle size (approximately 20 mm). Formulations with
higher amounts of disintegrant (CC-Na, F4) had a slower rate of
drug dissolution and formulations with lower amounts of MCC
M105 (F5) had a higher rate of drug dissolution. PearlitolÕ 160C
was more suitable than PearlitolÕ 200SD for use in the wet
granulation method. Therefore, we substituted PearlitolÕ 160C for
PearlitolÕ 200SD to create ODT formulation F6. The dissolution
rate of F6 was higher than that of both F5 and the marketed
product.
As illustrated in Figure 1(B), all developed formulations and
the reference product had very rapid dissolution (85% within
15 min) in phosphate buffer (pH 6.8) containing 0.2% SLS, which
indicated that the discriminatory power of neutral aqueous
medium was poorer than that of acidic medium. Therefore, acidic
medium was more suitable for MS ODTs formulation screening.
Our results revealed that, in two of the media tested, the
dissolution properties of F5 were most similar to those of
marketed chewable tablets. Therefore, dissolution profiles of F5
 4 Y. Chen et al. Pharm Dev Technol, Early Online: 1–5

were further studied using 0.2% SLS in water and 0.2% SLS in
phosphate buffer (pH 4.5). Table 2 shows dissolution profiles of
F5 ODTs and marketed chewable tablets measured under identical
conditions. The two MS preparations had similar profiles in all
dissolution media.
Evaluation of MS oral disintegrating tablets
The MS ODTs that were prepared with the F5 formulation were
evaluated for wetting time, water absorption ratio, disintegrating
time, friability, hardness, content uniformity and drug content.
These results are summarized in Table 3. The F5 MS ODTs
fulfilled relevant requirements regarding tablet friability, hard-
ness, content uniformity and drug content. The in vitro disinte-
gration time was 9.5 ± 2.4 s, which meets the FDA requirement
for ODTs13.
Stress testing
The MS ODTs prepared with formulation F5 underwent stress
testing (Tables 4 and 5). Dissolution characteristics of these ODTs
under each stress condition were similar to that of the marketed
product. High humidity (relative humidity ¼ 92.5%) had the
greatest influence on dissolution rate, followed by strong light
exposure and, finally, high temperature (60  C). The F5 ODT
Pharmaceutical Development and Technology
F1 was a typical sample. Unfortunately, none of these formula-
tions showed equivalent dissolution profiles to the marketed
product in acidic medium. We know that MS powders can rapidly
aggregate into sticky masses after dispersion in acidic medium.
Therefore, when direct compression ODTs disintegrated in acidic
medium, undissolved MS powders may have rapidly aggregated
and slowed MS dissolution. In contrast, when wet granulation
ODTs disintegrated in acidic medium, no obvious aggregation
was observed. A reasonable explanation was that the hydrophilic
HPC film formed during granulation may cover granule surfaces
and block hydrophobic MS powder aggregation. Therefore, the
wet granulation was a more suitable method for the preparation of
MS ODTs. Although the exact manufacturing method of the
reference tablets was unknown, based on its listed ingredients16,
we speculate that it might have been created using wet
granulation.
In the preliminary study, we found that the concentration of
SLS in dissolution media heavily influenced dissolution rate of
MS. When the SLS concentration was set at 0.5%, as recom-
mended by the FDA, the dissolution of MS from developed ODTs
and the reference tablet was very rapid (90% within 10 min, data
not shown) in four types of media. The discriminatory nature of
Table 3. QC parameters of the optimized formulation (F5).

disintegration time was also greatly affected by humidity, but all

other stress conditions had negligible effects. Light exposure and
high temperature were the major factors influencing drug content Parameters
and impurities. Additionally, F5 ODTs had a higher stability than Wetting time (s) (n ¼ 6) 17.4 ± 4.5
the marketed product in drug content and impurities. Water absorption ratio (%) (n ¼ 6) 206.9 ± 8.8
In vitro disintegrating time (s) (n ¼ 6) 9.5 ± 2.4
Discussion Friability (%) 0.5 ± 0.1
Hardness (N) (n ¼ 3) 36.0 ± 2.4
Bioequivalence between an ODT and its corresponding reference Content uniformity 8.2
is a challenge in ODT development14. Comparing dissolution Drug content (%) 100.2 ± 0.9
profiles of ODT and reference tablets is very important in
predicting the bioequivalence of ODTs during formulation
Table 4. In vitro dissolution, measured at 15 min, of the optimized ODT
development. Comparisons of dissolution profiles in three differ- Õ
formulation (F5) and the reference marketed chewable tablet (Singulair )
ent buffers (normally pH 1.2, 4.5, and 6.8) and quality control after 10 days of exposure to stress conditions (n ¼ 6).
(QC) media should be reported4,15. However, all previous studies
on MS ODTs only examined dissolution profiles in QC medium, % dissolution at 15 min
as recommended by the FDA for MS marketed products. This
Conditions F5 Singulair
limited study of dissolution characteristics of new MS ODTs does
not ensure bioequivalence with a marketed product. Baseline (day 0) 97.3 ± 1.0 93.8 ± 3.2
The bioequivalence of the newly developed MS ODTs was the 40  C 95.2 ± 2.4 91.1 ± 6.9
main focus of our study. Formulations were optimized using 60  C 86.5 ± 2.4* 80.0 ± 4.1*
RH 75% 90.6 ± 2.3* 88.9 ± 2.2*
dissolution testing results, which showed that dissolution profiles RH 92.5% 51.3 ± 3.2* 45.1 ± 6.9*
in acidic medium could provide important information for 4500 Lx 85.3 ± 2.2* 80.5 ± 3.4*
formulation screening. Because all previous studies prepared
MS ODTs using direct compression, various formulations were RH, relative humidity.
created with direct compression in our preliminary study and the *p50.05, compared with the baseline data.

Table 2. In vitro dissolution profiles of the optimized ODT formulation

(F5) and the reference marketed chewable tablet (SingulairÕ ) in four different media (n ¼ 12).

Dissolution (%)
Media Tablet 5 min 10 min 15 min 30 min 45 min f2
0.1 M HCl + 0.1% SLS F5 55.2 ± 5.9 67.5 ± 5.0 83.0 ± 3.2 97.7 ± 2.1 99.2 ± 2.7 65
Singulair 54.3 ± 5.7 67.1 ± 2.8 76.5 ± 4.6 88.1 ± 3.2 96.5 ± 3.3
pH 4.5 buffer + 0.2% SLS F5 53.5 ± 5.1 62.0 ± 3.8 70.3 ± 4.8 84.9 ± 3.7 93.4 ± 4.4 68
Singulair 59.1 ± 3.2 68.0 ± 4.4 75.3 ± 3.4 88.8 ± 2.9 94.6 ± 3.0
pH 6.8 buffer + 0.2% SLS F5 91.2 ± 2.3 97.0 ± 2.1 99.2 ± 0.8 NA NA #
Singulair 83.3 ± 2.9 91.7 ± 2.7 94.6 ± 1.7 NA NA
Water + 0.2% SLS F5 85.3 ± 4.5 94.0 ± 4.8 97.3 ± 1.0 NA NA #
Singulair 72.0 ± 4.9 90.5 ± 6.4 93.8 ± 3.2 NA NA

Data are presented as mean ± standard deviation (n ¼ 12 tablets) where applicable. It should be noted that only one measurement was made following
85% dissolution.
#Both test and reference products had485% dissolution in 15 min and profiles were considered similar without an f2 calculation.
 DOI: 10.3109/10837450.2015.1121498 Montelukast sodium orally disintegrating tablets 5
Table 5. In vitro disintegration, content and impurities testing results of the optimized ODT formulation (F5) and the reference marketed chewable
tablet (SingulairÕ ) after 10 days of exposure to stress conditions.

Impurities (%)
Conditions Samples In vitro disintegration (s) Content (%) Sulfoxide cis-Isomer Methylketone Total
Baseline (day 0) F5 9.5 ± 2.4 100.2 0.20 0.05 0.00 0.32
Singulair 32.5 ± 3.3 102.6 0.51 0.05 0.08 0.99
60  C F5 11.4 ± 1.2 100.5 0.60 0.09 0.00 0.89
Singulair 30.0 ± 5.1 102.0 1.26 0.15 0.05 3.40
40  C F5 10.5 ± 2.7 100.4 0.38 0.09 0.00 0.87
Singulair 28.7 ± 4.2 98.4 0.63 0.11 0.06 1.69
RH 75% F5 13.3 ± 2.9* 101.8 0.23 0.05 0.00 0.39
Singulair 17.8 ± 5.6* 100.8 0.53 0.07 0.06 0.77
RH 92.5% F5 78.3 ± 9.9* 102.5 0.23 0.06 0.00 0.41
Singulair 117.3 ± 15.6* 100.3 0.62 0.11 0.05 0.87
4500 Lx F5 10.0 ± 2.2 96.7 0.90 0.39 0.00 3.09
Singulair 35.3 ± 4.7 97.1 1.35 0.33 0.06 4.85

*p50.05, compared with the baseline data.

dissolution medium was not satisfied. Therefore, we lowered SLS
concentration during formulation screening, but it can still simul-
taneously meet the sink condition and discrimination requirements.
Conclusion
Pharmaceutical Development and Technology
5. Pahwa R, Piplani M, Sharma PC, et al. Orally disintegrating tablets
– friendly to pediatrics and geriatrics. Arch Appl Sci Res 2010;2:
35–48.
6. Devi NK, Rani AP, Mrudula BS. Formulation and evaluation of oral
disintegrating tablets of montelukast sodium: effect of functionality
of superdisintegrants. J Pharm Res 2010;3:803–808.

7. Mahesh E, Kumar KGB, Mohammed GA, et al. Formulation and

Acidic dissolution medium is more suitable for MS ODTs
formulation screening than neutral medium due to its better
discriminatory power. Wet granulation method, rather than direct
compression method, is the preferred method for the preparation
of MS ODTs with equivalent dissolution profiles to the marketed
product. The optimum ODT prepared using wet granulation
displayed similar dissolution profiles to the reference tablet in
four different media. The in vitro disintegration time met FDA
requirements and other QC parameters, including friabil-
ity, hardness and content uniformity, were within
acceptable ranges.
Declaration of interest
The authors report no declarations of interest.
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