Nasiruddin Ahmad Farooqui et al / Journal of Pharmaceutical Science and Technology Vol.

3 (2), 2011,555-558

Formulation and Evaluation of Secnidazole Film Coated Tablets

Nasiruddin Ahmad Farooqui1, A.Anton Smith*1, H.K.Sharma2 and R.Manavalan1
1

Department of Pharmacy, Annamalai University, Annamalainagar 608002, Tamilnadu. 2Unichem Laboratories

Ltd., Ghaziabad 201001, Uttar Pradesh.
Abstract:
Film coated tablets are designed to rupture and expose core tablet at the desired location in the gastro intestinal
track the coating is done by using film coating solutions which are polymers in nature, forming smooth coat over
core tablet. The present study it was aimed to formulate film coated tablets of secnidazole by wet granulation and
the granules are compressed for tablets and they are coated with polymers for getting film coated tablets at specified
conditions and the evaluation of film coated tablets for the following parameters as description, average weight,
weight variation, hardness test, thickness, dissolution, related substances, disintegration time and assay of tablet for
compliance with acceptance criteria, for formulation of secnidazole film coated tablets.
Key words: Film coated tablets, Secnidazole, Formulation.

INTRODUCTION
Secnidazole is 1-[2-Hdroxy]-2-methyl-5nitroimidazole, used as antiprotozoal and
antiamoebic [1]. It is a derivative of 5Nitroimidazoles
closely
related
to
metronidazole [2]. Film coated tablets are
compressed tablets coated with a thin layer
of a polymer capable of forming a skin like
film [3-5]. The film is usually colored and
has the advantage over sugar coating in that
it is more durable, less bulky and less time
consuming to apply. Film coating solutions
may be non aqueous or aqueous. The non
aqueous solutions Contains the following
types of material to provide the desired
coating to the tablets a film former capable
of producing smooth [6-8], thin films
reproducible under Conventional coating
conditions and applicable to a variety of
tablets shapes Example is as cellulose
acetate phthalate. Allowing substance
provides water solubility or permeability to
the film to ensure penetration by body fluids
and therapeutic availability of the drug.
Example is polyethylene glycol. A
plasticizer to produce flexibility and
elasticity of the coating and durability is
provided by castor oil. A surfactant is used
to enhance spread ability for the film during
application
[9-11],
example
is
polyoxyethylene
sorbitan
derivatives.
Present study shows the formulation of film
coated tablets and their evaluation for
compliance to acceptance criteria.

MATERIALS AND METHODS

The drug secnidazole was supplied by
Unichem Laboratories Ltd., other chemicals
like Magnesium Stearate, Mciro cystalline
cellulose, Gelatin, Starch, Sodium Starch
Glucollate, Collodial Anhydrous Silica,
Titanium dioxide, Hydroxy Propyl methyl
Cellulose, Macro Gel, Industrial Methylated
Spirit and Dichloro Methane used were AR
grade.
The formulation was prepared so as to each
film coated tablet should contain 1 g of
secnidazole. Area was rapt clean and dry
and free from microbial contamination. All
the ingredients such as secnidazole, Lactose
and HPMC k 100 were sifted through 40#.
The Sifted mixture was mixed thoroughly
for 15 minutes. Polyvinyl pyrrolidine
binding solution (PVP) was soaked in
isopropyl Alcohol and methylene chloride in
a stainless steel vessel. It was dissolved
under Constant stirring. Binder solution was
poured slowly to the above mixture and
mixed for two to three minutes at high speed
until coherent mass was achieved. The Wet
Coherent mass was passed through 30# and
collected in a clean labeled container. The
Wet Granules wear loaded into tray drier
and dried at 50oC till it was dried. Size
Reduction for dried granules is by sifting
through 16# sieve. The sifted granules were
collected in a clean labeled container.The
dried granules were loaded into a blender.
Magnesium stearate was added into it mix

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Nasiruddin Ahmad Farooqui et al / Journal of Pharmaceutical Science and Technology Vol. 3 (2), 2011,555-558

for 15 minutes and stored in a double

polybag. The above granules were
compressed with the help of compression
machine (Cod press part-45)12/32 punch
size at 30 RPM. After compression, weight
variation, Thinness, hardness, friability,
disintegration time and dissolution test were
measured.
Preparation of coating solution:
HPMC K 100, Isopropyl alcohol, methylene
chloride, and titanium dioxide were mixed
together to get a coating solution. The
uncoated, de-dusted tablets were loaded into
the coating pan and the tablets were warmed
up to 50oC. The Coating solution was
sprayed over the warmed tablets using
1.5mm air nozzle spray gun for efficient
coating. Hot air was passed between each
application of coats. Tablets bed temperature
during coating procedure should not exceed
35oC, coating parameters specification is
shown in Table 1.
Table 1: Coating parameter Specification
Specification
Coating pan
Pan speed
Atomizing air prenure
Intent air temperature
Outlet air temperature
Bed temperature
Predrying in pan
Final drying in pan
Post draying in pan
Relative humidity

Film Coated
12
6 RPM
3 to 4kg/cm2
45 to 500C
40 to 450C
30 to 350C
15 min at 450C
1-2Hrs at 450C
1Hr air drying
40 5%

Evaluation of Film coat tablets:

White, capsule shaped, film coated with
score mark on one side. 20 tablets were
selected at random and average weight was
calculated, which should not more than two
of the individual weights deviated from the
overage weight by 5% and none deviated
by more than 10% of average weight.
The retention time of major peak due to
secnidazole in chromatogram of the sample

preparation correspond to that of the

standard preparation as obtained in assay.
Disintegration test on six tablets was
performed by suspending the assembly in
the beaker containing water where the
temperature was maintained between 36oC
and 38oC for NMT 30 min. Dissolution test
was performed by using USP, Type 11
(Paddle).
Standard preparation:
50 mg of secnidazole working standard was
weighed accurately in a 50 ml volumetric
flask, dissolved and diluted to 50ml with
dissolution medium. 2 ml of the above
solution was taken in a 100ml volumetric
flask and diluted up to the mark with
dissolution medium.
Sample preparation:
One tablet in each of the dissolution jars
containing 900ml of dissolution medium and
dissolution is performed at the end of 30
minutes, supplicant amount of medium
withdrawn and filtered through 0.454 m
membrane filter. In 100ml volumetric flask
2ml of filtrate is diluted up to the mark with
dissolution medium.
System suitability:
Six readings of standard preparation were
taken the relative standard deviation of 6
replicate reading is calculated which is NMT
2.0%.
Absorbance was measured for the standard
and the sample preparation at 294mm on a
spectrophotometer
using
dissolution
medium as blank. The percentage of
secnidazole release was calculated by using
%
of
secnidazole
release
=
(ATxWSx18xP)/(AS x LC)
Where,
AT = Absorbance of sample preparation
AS = Absorbance of standard preparation
WS = Weight of working standard in mg.
P = Potency of secnidazole working
standard in % on as in basis.
LC = Label Claim in mg/tablet.

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Preparation of reference Solution:

50mg of secnidazole working standard was
weighed accurately in a 100ml volumetric
flask. 80ml mobile phase was added and
sonicated. The volume was diluted up to
mark with mobile phase; 5ml of the above
solution was transferred in 100 ml
volumetric flask, diluted with mobile phase.
Further 1 ml of dissolution was diluted to 10
ml with mobile phase.
Sample preparation:
10 tablets were weighed and powdered.
From the powder equivalent to 50 mg of
secnidazole was weighed and transferred in
a 100 ml volumetric flask. About 80ml of
mobile phase was added and sonicated for 5
minutes. The volume was made up to the
mark with mobile phase. The above solution
was filtered through 0.45 m membrane
filter.
System suitability:
Six replicate injections was made of
reference solution into the chromatograph as

per the conditions prescribed and recorded

the responses for the same. The relative
standard deviation for replicate injections is
NMT 5.0%. Separately 20ul of the mobile
phase reference solution (six) and sample
solution injected into the chromatograph and
recorded the response for the same.
RESULTS AND DISCUSSION
Film coated tablet are punched by using
PVP as binding agent, and the tablets are
evaluated for average weight as 1279 mg,
weight variation as 1250.10 to 1290.60mg,
Hardness Test as 5kg/cm2, Thickness as 7.11
mm, dissolution as 97.87%, Related
substances as individual impurities, a)
0.082%, b) 0.052% and the total impurities
0.137%, disintegration time as 18 min, assay
as 98.34% of label claim and % relative
standard deviation is 0.2%. All the above
evaluation values comply with acceptance
criteria shown at table 2.

Table 2: Evaluation of Film coated tablet

Specification

Observation

Acceptance Criteria

Inference

Description

White capsule shaped,

Tablets with Score mark on
one side

White capsule shaped tablets with

score mark on one side.

Complies

Average Weight

1279 mg

1275 + 4.0%(1273 to 1279)

Complies

Weight variation

1250.10 to 1290.60mg

5% of Avg wt. (1275 to 1284 mg)

Complies

Hardness Test

5kg/cm2

NLT 3 kg/cm2

Complies

Thickness

7.11 mm

7.25 7mm

Complies

Dissolution

97.87%

NLT 80% of label claim

Complies

Related substances

1. Individual impurities
a.)0.082%
b.)0.052%
2. Total Impurities -0.137%

1. Individual impurities NMT 1.0%

2. Total impurities NMT 2.0%

Complies

Disintegration
time

18 min

NMT 30 min

Complies

Assay

98.34% of label claim

% RSD = 0.2 %

95.00 to 110.00%of label claim

% RSD should be less than 2%

Complies
Complies

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Nasiruddin Ahmad Farooqui et al / Journal of Pharmaceutical Science and Technology Vol. 3 (2), 2011,555-558

CONCLUSION
A relatively simple secnidazole film coated
tablets formulated and evaluation parameters
such as average weight, weight variation,
hardness test, thickness, dissolution,
disintegration time and assay complies
within the limit. It shows high mechanical
strength and low friability. The film coating
showed a little effect of disintegration and
dissolution of the cores.
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