ISSN: 2321-5674(Print)

ISSN: 2320 3471(Online)

Indian Journal of Research in Pharmacy and Biotechnology

Rajesh et.al.

FORMULATION OF MOUTH DISSOLVING TABLETS OF NAPROXEN

Rajesh Reddy K, Nagamahesh Nandru, Desam Asha Latha, Srinivasa Rao Chekuri
MRR College of Pharmacy, Nandigama, Andhra Pradesh, India
Corresponding author: Email: rajbiz.36@gmail.com
ABSTRACT
The aim of the present work is to investigate the possibility of preparing mouth dissolving tablet
containing naproxen by direct compression method. Basic goals in the development of mouth dissolving tablet
are to increase patient compliance, ease of administration, safety and appropriate dosing. It has perceived
faster onset of action as the dosage form is disintegrated prior to reaching the stomach and is ideal for acute
diseases like allergies, nausea, and vomiting and particularly applicable to manage breakthrough systems.
Direct compression method was used to compress the tablets as it is the easiest way to manufacture tablets and
less time consuming. Conventional equipment, commonly available excipients and limited number of
processing steps are involved in the direct compression and so manufacturing cost is low. Keeping in view the
advantages of this delivery system, in the present study, attempts were made to formulate mouth dissolving
tablet.
Key words: Naproxen, Mouth dissolving, Disintegration.
INTRODUCTION
Mouth Dissolving Tablet is an innovative tablet
technology where the dosage form containing active
pharmaceutical ingredients disintegrates rapidly, usually
in a matter of seconds, without the need for water,
providing optimal convenience to the patient. Innovators
and inventor companies have given these tablets various
names such as orally disintegrating tablets (ODT),
mouth dissolving (MD), fast melting, fast dissolving or
Orodisperse. The European Pharmacopoeia defines
Orodisperse as a tablet that can be placed in the mouth
where it disperses rapidly before swallowing.
Researchers have formulated ODT for various
categories of drugs, which are used for therapy in which
rapid peak plasma concentration is required to achieve
desired pharmacological response. These include
neuroleptics, cardiovascular agents, analgesics, antiallergic and drugs for erectile dysfunction.

Evaluation of Naproxen Mouth Dissolving Tablets:

The formulated tablets has been evaluated for the
following parameters such as Thickness,
Weight
variation test, Hardness test, Friability test, Water
absorption Ratio Content uniformity test, Wetting time,
In-vitro dispersion time and In-vitro dissolution studies
RESULTS AND DISCUSSION
Surface Morphology: Morphological characteristics
such as colour, form, taste etc of naproxen were studied
and the results are tabulated in table. As the API is bitter
in taste, taste masking with sweetener may prove
beneficial for a palatable dosage form.
Physical parameters: The pure drug showed angle of
repose value is 350311indicates the good flow properties.
The compressibility index, Hausners ratio values of the
drug are 28.40% and 1.397 indicates that the drug has
poor compressibility properties.

MATERIALS AND METHODS

Drug Excipient compatibility studies

Naproxen was obtained as an gift sample form

Granules India, Hyderabad, Microcrystalline cellulose,
Mannitol, Crosscarmellose sodium, Sodium starch
glycollate, Crosspovidone, Aerosil, Aspartame and
Magnesium stearate was obtained from Kniss
laboratories Pvt limited, Chennai

Fourier transforms infra-red spectroscopy (FTIR):

The FTIR analysis was conducted for the structure
characterization. FTIR spectra of the pure drug, pure
polymers and mixture of both were recorded.
Formulations were taken in a KBr pellet using BOMEN
MB SERIES FTIR instrument. Approximately 5mg of
samples were mixed with 50mg of spectroscopic grade
Kbr; samples were scanned in the IR range from 500 to
3500 cm-1, with a resolution of 4 cm-1.

Pre-formulation studies
Preparation of mixed blend of drug and excipients:
All the Ingredients were passed through mesh 60.
Required quantity of each ingredient was taken for each
specified formulation and all the ingredients were cog
rind in a mortar and pestle. The powder blend was
evaluated for flow properties such as Bulk density,
Tapped density, Compressibility index, Hausner ratio
and angle of repose.
Volume 1(4)

Compatibility Studies: Drug excipient compatibility

study showed no interactions as principle peaks are
retained. Thus all excipients were compatible with drug.
Optimized formula: The dissolution profile of
formulations (F1-F6) indicates a faster release of drug
i.e. 90% or more of the drug released from all
formulations with in 60 min. however the maximum

July-August 2013

Page 565

ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology

Rajesh et.al.

release of drug (99.4%) was observed in F4.This

formulation also exhibited better performance in the

other evaluation parameters. Hence, formulation (F4) is

selected as optimized formula.

Table 1: Formula for Naproxen Mouth Dissolving Tablets

Ingredients (Mg)
F1
F2
F3
F4
F5
Naproxen
150
150
150
150
150
Microcrystalline Cellulose
18
10
18
10
18
Mannitol
26
14
26
14
26
Croscarmellose sodium
40
60
-

Test
Description:
Colour
Odour
Form
Taste
Solubility

Table: 2 Identity Parameters of API

Specifications
white
None
Crystalline
Bitter
Soluble in ethanol and methanol

F6
150
10
14
-

Results
Complies

Complies

Identification:
IR-Spectrum of the test sample should match
Complies
IR-Spectrum
with the IR-Spectrum of the working standard.
Assay
99% w/w
99.0% to 101.0% w/w
All the Identity parameters of the API are found to be within the limits
Table: 3 Physical parameters of API in Preformulation studies
parameters
Tapped density
Bulk density
Compressibility Index
Hausner Ratio
Angle of repose

Result
0.728 gm/ml
0.521 gm/ml
28.40 %
1.397
350311

Table: 4 Ftir Spectrum of the Naproxen

Type of Vibrations
C=O
C-H
C-C
C-O

Range
1788
3192
1631
1028

Table No: 5 Pre-compression properties of the naproxen mouth dissolving tablets.

Formulation Bulk density Tapped density
Hausners Ratio
Carrs
Angle of repose
(g/ml)
(g/ml)
index
(0o)
F1
0.530.005
0.620.02
1.160.02
13.651.06
31'
F2
0.520.01
0.610.014
1.180.03
14.271.06
30.
F3
0.5260.005
0.610.014
1.160.01
14.780.18
279'
F4
0.520
0.60
1.150
14.580
32.05'
F5
0.5260.01
0.6050.01
1.1630.02
12.510.02
29.82'
F6
0.5260.005
0.630.08
1.1630.005
14.890
27.21'
The data are expressed as meanS.D. (n=3)
Table: 6 Post compression properties of the naproxen mouth dissolving tablets.
Formulation
Weight
Thickness
Hardness
Friability
Disintegration
variation (mg)
(mm)
(kg/cm2)
(%)
Time (sec)
F1
Passes
3.740.02
3.630.15
0.50
28 0.54
F2
Passes
3.760.02
3.80.1
0.450.12
26 0.02
F3
Passes
3.260.02
4.030.05
0.410.22
25 0.14
F4
Passes
3.140.02
3.330.11
0.220.08
26 0.25
F5
Passes
3.210.03
3.80.1
0.80.08
27 0.14
F6
Passes
3.66 0.05
4.030.15
0.620.16
24 0.01
The data are expressed as meanS.D. (n=3)
Volume 1(4)

July-August 2013

Page 566

ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology

Rajesh et.al.

Table: 7 Post compression properties of the naproxen mouth dissolving tablets

Formulation
Water absorption
Content
Wetting time
In-vitro dispersion
Ratio
uniformity
(sec)
time(Sec)
F1
78.92 0.14
98.19 0.51
50.663.05
114.664.16
F2
72.35 0.41
98.42 1.01
43.333.05
93.34.16
F3
69.32 0.58
97.77 1.26
262
74.34.04
F4
75.63 0.47
99.82 0.33
182
551.0
F5
74.21 0.25
99.740.44
72.663.05
93.62.51
F6
74.23 0.14
98.500.55
67.333.05
842
The data are expressed as meanS.D. (n=3)
Table: 8 Cumulative Percentage drug Release of F1 F6in pH 6.8 Phosphate Buffer
Time
Cumulative Percentage Of Drug Release in pH 6.8 Phosphate Buffer
(min)
F1
F2
F3
F4
F5
F6
10
42.8
56.6
68.6
78.6
68.4
76.8
20
70.6
64.8
74.8
79.8
74.8
83.6
30
78.4
80.6
86.4
84.8
76.6
91.8
40
84.6
84.8
90.6
91.4
88.4
95.8
50
88.8
92.8
94.8
97.8
89.6
97.4
60
92.6
94.7
96
99.4
96.6
98.7
Table: 9. Optimized formulas of Naproxen Mouth dissolving tablet
Ingredients
Quantity (mg)
Naproxen
150
Microcrystalline cellulose
10
Mannitol
14
Crospovidine
60
Aerosil
2
Aspartame
10
Magnesium stearate
4
Total
250

Fig 1: FTIR of naproxen

Volume 1(4)

Fig 2: FTIR of naproxen with croscarmellose

sodium

July-August 2013

Page 567

ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology

Rajesh et.al.

Fig 3: Ftir Of Naproxen With Crospovidone

Fig 4: FTIR of naproxen with sodium starch

glycolate

Fig 5: Formulated mouth dissolution for naproxen mouth dissolving tablets

15 Sec

30Sec

45 Sec
55 Sec
Fig 6: Disintegration time at the end of Various time interval

Fig :7 In-vitro drug release of mouth dissolving tablets of Naproxen (F1-F6)

Volume 1(4)

July-August 2013

Page 568

Rajesh et.al.

ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology

CONCLUSION
The demand for orally disintegrating tablets
has enormously increased during the last decade,
particularly for geriatric and pediatric patients who feel
difficulty in swallowing conventional tablets and
capsules. Fast dissolving or fast disintegrating dosage
form is advantageous for such patients. Fast dissolvable
or fast disintegrating dosage forms are meant to
disintegrate immediately upon contact with the saliva
leading to faster release of drug in the oral cavity. By
administrating the fast disintegrating dosage forms,
absorption of the drugs occurs through buccal mucosa
and it may reduce the first pass metabolism leading to
better efficacy of the drug. In my present work an
attempt was made to develop mouth dissolving tablets of
naproxen by direct compression method and by using
cross povidone, cross carmellose sodium and sodium
starch glycolate as superdisintegrants. In the
preformulation studies it has been proved that there is no
interaction between the drug and the excipients. The
blends of varying super disintegrants were formulated
into 6 formulations ranging from F1 to F6, and the blends
were evaluated for the pre and post comparison
parameters and In vitro drug release is also studied. All
the pre compression parameters angle of repose, Cars
index, Hausners ratio, tapped and bulk density and is
within the limits. The results shown that the
formulations containing the Cross povidone have the
good flow properties and the good compactability when
compared with the other formulations. The post
compression parameters include the Weight variation,
Hardness, friability, Thickness, wetting time, In vitro
disintegration and In vitro dispersion time and the water
absorption ratio. The results shown maximum for the
formulation (F4) that containing the cross povidone as
superdisintegrant. The In vitro drug release of
formulation F4 had shown that maximum drug release
99.4 0.54 when compared with the other formulations.
So F4 was choosen as the best formulation which

Volume 1(4)

contains crosspovidone as a super disintegrant. The

naproxen 250 mg mouth dissolving tablet was prepared
by using the finalized formula and optimized
manufacturing process showed good results in
formulation of stable tablet dosage form.
BIBLIOGRAPHY
Allen LV and Wang B, Process for making a particulate
support matrix for making rapidly dissolving tablets, US
Patent No. 5, 1996, 587,180,
Bhaskaran S and Narmada G V, Orally disintegrating
tablets, Indian Pharmacist, 1(2), 2002, 9-12.
Brahmankar DM, Jaiswal SB, Biopharmaceutics &
Pharmaceutics, First Edition, 1995, 335.
Howard C. Ansel, Nicholas G. Popvich, Loyd V, Allen,
Pharmaceutical Dosage Forms and Drug Delivery
System, First Edition, 1995, 78.
Kaushik D, Dureja H, Saini TR, Mouth Dissolving
Tablets: A review, Indian Drugs, 2004, 41(4), 187-193.
Kuccherkar BS, Badhan AC, Mahajan HS, Mouth
dissolving tablets: A novel drug delivery system, Phrma
Times, 2003, 35, 3-10.
Lachmann L., Liebermann H. A. and Kiang J.L., The
theory and practice of Industrial Pharmacy, Third
Edition, Varghese Publishing House, Bombay, 1998,
430-440.
Lailla J K, Sharma A. H., Freeze-drying and its
applications, Indian Drugs, 1993, 31, 503-513.
Mishra B., Panigrahi D and Baghel S., Mouth dissolving
tablets: an overview of preparation techniques,
evaluation and patented technologies, J. Pharm. Res,
4(3), 2005, 33-38.
Seager H, Drug delivery products and zydis fast
dissolving dosage form, J. Pharm. Phamacol., 50, 1998,
375-382.

July-August 2013

Page 569