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FORMULATION AND EVALUATION OF MEDICATED JELLY OF
BITTER DRUGS T. Salunke*1, R. Mayee 2
1. Shri Jagdishprasad Jhabarmal Tibrewala University, Dist-Jhunjhunu, Raj, India
2. Dr.Vedprakash Patil College of pharmacy, Aurangabad, MS, India
ABSTRACT
Present study was aimed to formulate and evaluate medicated Jelly of Bitter drugs i.e.
Ofloxacin and Ornidazole. For taste masking of Ofloxacin, ion-exchange resin method was
used. The resins like Indion 204, Indion 214 and Tulsion 335 was tested at various ratios.
Based on the results Tulsion 335 with the ratio 1:1.5 was selected for complexation. For taste
masking of Ornidazole, addition of sweetening agent method was used. The slurry was
prepared using Sorbitol 70%, Polyethylene glycol 400 and Glycerin in the concentration of
10%, 6% and 7% respectively. It was observed that the batch F7 containing 0.4% Xanthan
gum, 0.5% Carrageenan and 0.3% sodium citrate and shows satisfactory results. The
optimized formulation F7 evaluated which shows satisfactory results. pH of the maximum
stability of Ofloxacin and Ornidazole in aqueous phase is in between 5 to 6. The drug content
of jelly of batches F1 to F9 was evaluated by HPLC method. The results are between 97.00%
to 103.00% for Ofloxacin and 95.00 % to 104.00 for Ornidazole. The dissolution studies of
the Medicated jelly for all the formulations show more than 70% drug release at 20 minutes
time point and complete drug release within 45 minutes. The optimized formulation F7 kept
for the three month at storage condition and it was evaluated with similar test as per initial
analysis which shows satisfactory results.
Keywords: - Bitter drugs, Taste masking, Medicated Jelly, Tulsion 335, sweetener addition
method, Xanthum gum, Carrageenan
INTRODUCTION
Many therapeutic agents are absorbed in
the oral cavity. For the drugs having
significant buccal absorption, dosage
forms such as Medicated Jelly and
Chewing Gums permit more rapid
therapeutic action as compared to oral
dosage forms. Medicated Jelly has been
very well received by the parents for their
use in children with full dentition.
Children in particular may consider
chewing gum as a more preferred method
of drug administration compared with oral
liquids and tablets. The use of Medicated
Jelly is feasible in local treatment of
diseases of oral cavity as well as treatment
of systemic conditions. Jellies are
transparent or translucent, non-greasy,
semisolid preparation generally applied
internally as well as externally. They are
used for medication, lubrication and some
miscellaneous applications.1-3
*Corresponding Author
Tushar Salunke
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MATERIALS AND METHODS
Materials: Ofloxacin was gifted by Shree
Venkatesh International ltd., Mumbai also
Ornidazole was gifted by Yeshika
Pharmaceutical Pvt. Ltd., Thane. Tulsion
335 gifted by Thermax India Ltd.,
Mumbai. Sorbitol, Polyethylene Glycol
400, Xanthum Gum, Carrageenan,
Sucrose, Sodium citrate, Citric acid,
Methyl paraben, Propyl paraben, mixed
fruit Flavour and Yellow oxide of iron
were procured from local vendors.
Preparation of taste masked Ofloxacin-
resin (resinate) complex
Batch method had been used to prepare
drug-resin complex. Ofloxacin had mixed
with different ion exchange resins i.e.
Tulsion 335, Indion 204, and Indion 214 in
the ratio of 1:1, 1:1.5, and 1:2. Fixed
amount of resin had been soaked in 500 ml
of distilled water and allowed to swell for
the definite period of time (30 min).
Accurately weighed amount of Ofloxacin
as per the ratio had been added and stirred
for 7 hours. Prepared complex had been
kept overnight for the proper
complexation. On the next day drug-resin
complex had been allowed to dry for the
definite period of time in the tray dryer at a
temperature of 600C. The dried complex
had been sifted through sieve no. 30 and
LOD had been determined at a temperature
of 1050C
4, 5. Formulation trials of different
ion exchange resins were carried out as
shown in table no. 1
Table No.1: Trials with ion exchange resin
S. N. Resins Batch Drug: Resin Ratio Swelling time (min) Stirring time (hr)
1 Indion
204
C1 1:1 30 7
2 C2 1:1.5 30 7
3 C3 1:2 30 7
4 Indion
214
C4 1:1 30 7
5 C5 1:1.5 30 7
6 C6 1:2 30 7
7 Tulsion
335
C7 1:1 30 7
8 C8 1:1.5 30 7
9 C9 1:2 30 7
Table No.2: formulation for Ornidazole slurry
Ingredients F1 (%) F2 (%) F3 (%) F4 (%) F5 (%)
Ornidazole 2.50 2.50 2.50 2.50 2.50
Sucrose syrup 5.00 10.00 --- --- ---
Sorbitol 70% --- --- 5.00 10.00 10.00
Polyethylene Glycol 400 5.00 5.00 4.00 5.00 6.00
Glycerin 6.00 6.00 5.00 6.00 7.00
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Preparation of Ornidazole slurry:
Glycerin, Sorbitol 70 % or Sucrose syrup
and Polyethylene Glycol 400 had been
transferred in clean stainless steel vessel
and stirred for 15 min. Ornidazole bad
been added in it and stirred for 30 minutes.
For the formula referred table no. 2
Preparation of Medicated Jelly:
Xanthum gum and Carrageenan had been
dispersed in 50 ml of distilled water
maintained at 95ºC. The dispersion had
been stirred at 95ºC for 30 min using a
magnetic stirrer. The Sucrose and
Sucralose had been added to the gum
solution with continuous stirring and the
temperature had maintained above 80ºC.
Then, the thus-obtained dispersion is
cooled to 65ºC to 50ºC and the medically
effective components such as Ofloxacin-
resin complex and Ornidazole slurry had
been added thereto followed by stirring.
Citric acid, Methyl paraben, Propyle
paraben, Mixed Fruit flavour and Yellow
oxide of Iron had been added under
stirring. Finally, required amount of
Sodium citrate had been dissolved in 10 ml
of distilled water and added to the mixture.
The weight of the jelly had been monitored
continuously during manufacturing and
finally it was adjusted to the 100 g with
distilled water. The mixture had been
allowed to cool to room temperature (25±5
oC) for 2 hours to form jelly. The mixture
had been packed in polyethylene bag with
airtight seal. The Medicated Jelly had
been prepared using three different
combinational concentrations of Xanthum
gum (0.1, 0.2, 0.3, 0.4 and 0.5%) with
Carrageenan (0.2, 0.3, 0.4 and 0.5%) each
with two different sodium citrate
concentrations (0.3 and 0.5%) 6,7
.
Table No.3: formulation for Medicated Jelly
Ingredients Quantity (%)
F1 F2 F3 F4 F5 F6 F7 F8 F9
Ofloxacin 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
Tulsion 335 1.15 1.15 1.15 1.15 1.15 1.15 1.15 1.15 1.15
Ornidazole 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50
Sorbitol 70% 10.00 10.00 10.00 10.00 10.00 10.00 10.00 10.00 10.00
PEG 400 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00
Glycerin 6.00 6.00 6.00 6.00 6.00 6.00 6.00 6.00 6.00
Xanthum Gum 0.10 0.15 0.20 0.20 0.30 0.40 0.40 0.50 0.50
Carrageenan 0.20 0.30 0.30 0.40 0.40 0.50 0.50 0.50 0.50
Sucrose 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00
Sucralose 0.30 0.30 0.30 0.30 0.30 0.30 0.30 0.30 0.30
Sodium citrate 0.30 0.30 0.30 0.50 0.30 0.50 0.30 0.30 0.50
Citric acid 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05
Methyl paraben 0.18 0.18 0.18 0.18 0.18 0.18 0.18 0.18 0.18
Propyl paraben 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02
Mixed fruit Flavor 0.50 0.50 0.50 0.50 1.00 1.00 1.00 1.00 1.00
Yellow Oxide of Iron 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10
Purified water (QS) 100 100 100 100 100 100 100 100 100
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EVALUATION OF MEDICATED
JELLY
Physical appearance:
The medicated jelly was examined for
physical appearance in terms of clarity,
texture and consistency.
Stickiness and grittiness:
Texture of the medicated jelly in terms of
stickiness and grittiness had been
evaluated by visual inspection of the
product after mildly rubbing the jelly
sample between two fingers.
Viscosity:
Viscosity of batches F1 to F9 had been
measured using Brookfield DV-II+Pro
viscometer. The medicated jelly was
squeezed out from the polyethylene plastic
bag by making a cut of uniform size on the
bag and viscosity had been measured using
spindle number LV4 at the rotation of 50
RPM at 25±1°C. The viscosity
measurements were made in triplicate
using fresh samples each time.
pH:
The pH of medicated jelly had been
measured using Electroquip Digital pH
meter at 25±1°C. 8, 9
Drug content (By HPLC):
Five Medicated Jelly had been dissolved in
Buffer: Acetonitrile (80:20). An accurately
weighed sample equivalent to 50 mg of
Ofloxacin and 125 mg of Ornidazole had
been taken in a stoppered volumetric flask
(100 ml). The content had dissolved in
Buffer: Acetonitrile (80:20) and the
volume made up to 100 ml. This solution
had been filtered through Whatman filter
paper no.41. The solution had been diluted
and the absorbance had measured at 315
nm. The drug content was calculated.
In vitro Dissolution Studies :
Medicated jelly of each batch was
subjected to dissolution rate studies. In-
vitro dissolution study was carried out to
determine the drug release from various
formulations. The release characteristic
was determined by withdrawing aliquots
of sample at the interval of 10, 20, 30 and
45minutes using HPLC.
Content uniformity:
The content uniformity test is to ensure
that every dosage form contains equal
amount of drug substance i.e. active
pharmaceutical ingredient within a batch.
Medicated jelly of formulation F7 was
subjected to content uniformity test.
Stability studies:
Medicated jelly of formulation F7 was
subjected to stability studies. The stability
study was evaluated as per ICH guidelines,
in the below conditions.10
1. 25°C / 60 % RH (±20C/±5%RH)
2. 30°C / 65 % RH (±20C/±5%RH)
RESULT AND DISCUSSION
Evaluation results of taste masked
Ofloxacin-resin (resinate) complex
Complex was prepared by using different
drug: resin ratio. Trials were carried out to
obtained taste masked complex of drug
with optimum drug loading efficiency.
Depending upon the taste masking and %
drug loading efficiency batch C8 i.e. with
Tulsion 335 in the ratio 1:1.5 was selected.
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Table No.4: Evaluation results of taste masked Ofloxacin-resin (resinate) complex
S. N. Resins Batch Drug: Resin Ratio Taste % Amount of non
complex drug
1 Indion
204
C1 1:1 + 21.22
2 C2 1:1.5 ++ 19.55
3 C3 1:2 ++ 7.65
4 Indion
214
C4 1:1 + 32.73
5 C5 1:1.5 ++ 20.44
6 C6 1:2 +++ 8.35
7 Tulsion
335
C7 1:1 + 14.80
8 C8 1:1.5 +++ 1.75
9 C9 1:2 +++ 1.68
The batch C8 has complete taste masking
with 98.25% drug loading. Batch C9 also
showed good taste masking with % drug
loading but there is no significant
difference when compared with batch C8.
Hence batch C8 drug-resinate complex
was used for the further study.
Selection of Ornidazole slurry complex
The selection of Ornidazole slurry
complex was based on organoleptic
property. The in-vivo taste evaluation
consists of a double blind crossover study,
carried out on a trained taste panel of
healthy volunteers with sound organoleptic
senses.
Table No.5: Taste evaluation of Ornidazole slurry
Batch Taste
F1 Slight taste masking
F2 Slight taste masking
F3 Slight taste masking
F4 moderate taste masking
F5 moderate taste masking
Based on the above results the F4 and F5
formulation shows the moderate taste
masking. Therefore on the basis of
quantitative value the F4 was selected for
Ornidazole slurry.
Evaluation result of Medicated jelly:
Physical appearance
The final formulation was evaluated for
the physical appearance. The results are
shown in the table no. 6.
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Table No.6: Physical appearance of Formulations of Medicated Jelly
Test F1 F2 F3 F4 F5 F6 F7 F8 F9
Clarity Turbid
form
Turbid
form
Turbid
form
Turbid
form
Turbid
form
Turbid
form
Turbid
form
Turbid
form
Turbid
form
Texture Smooth Smooth Smooth Smooth Smooth Smooth Smooth Smooth Smooth
Consistency Fluid
like
Very
thin
Thin Thin Thin Thick Thick Very
thick
Very
thick
All the batches of medicated jelly were
turbid in nature. The texture of medicated
jelly was found smooth in all batches. The
medicated jelly of batch F1 exhibited fluid
like consistency, medicated jelly of
batches F2, F3, F4 and F5 were very thin
to thin, while the medicated jelly of
batches F8 and F9 were very thick in
consistency. The medicated jelly of
batches F6 and F7 shows the good
Consistency. It indicates that Medicated
jelly contains Xanthum gum 0.4% and
Carrageenan 0.5% concentration suitable
for getting good consistency.
Stickiness and grittiness
Table No.7: Stickiness and grittiness of Formulations of Medicated Jelly
Test F1 F2 F3 F4 F5 F6 F7 F8 F9
Stickiness Sticky Sticky Slightly
Sticky
Slightly
Sticky
Slightly
Sticky
Non-
sticky
Non-
sticky
Non-
sticky
Non-
sticky
Grittiness More
Gritty Gritty
Slightly
Gritty
Slightly
Gritty
Slightly
Gritty
Less
Gritty
Less
Gritty
Less
Gritty
Less
Gritty
The medicated jelly of batches F1 and F2
exhibited stickiness, medicated jelly of
batches F3, F4 and F5 were shows slightly
sticky, while the medicated jelly of batches
F6, F7, F8 and F9 were shows non-sticky.
The medicated jelly of batches F1
exhibited more grittiness, F2 exhibited
grittiness, medicated jelly of batches F3,
F4 and F5 were slightly gritty, while the
medicated jelly of batches F6, F7, F8 and
F9 were less-gritty.
Table No.8: Folding endurance of Formulations of Medicated Jelly
F1 F2 F3 F4 F5 F6 F7 F8 F9
Folding
endurance
---
Eas
ily
Fold
able
Eas
ily
Fold
able
Eas
ily
Fold
able
Eas
ily
Fold
able
Fold
able
Fold
able
Sli
ght
Cra
ck
Sli
ght
Cra
ck
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The medicated jelly of batches F2, F3, F4
and F5 exhibited easily foldable,
medicated jelly of batches F6 and F7 were
foldable, while the medicated jelly of
batches F8 and F9 were shows slightly
cracks on the surface of medicated jelly.
Table No.9: Viscosity of Formulations of Medicated Jelly
F1 F2 F3 F4 F5 F6 F7 F8 F9
Viscocity
(cPs)
626
± 80
1745
± 130
2598
± 50
2789
± 93
5324
± 115
5899
± 112
6326
± 58
10056
± 123
13001
± 67
Batch F7 consisting of 0.4% Xanthan gum,
0.5% Carrageenan and 0.3% sodium
citrate was considered as an optimum
batch considering viscosity and
appearance.
Table No.10: pH of Formulations of Medicated Jelly
F1 F2 F3 F4 F5 F6 F7 F8 F9
pH 5.01 ±
0.05
5.12 ±
0.05
5.09 ±
0.05
5.26 ±
0.05
5.33 ±
0.05
5.40±
0.05
5.45 ±
0.05
5.80 ±
0.05
6.01 ±
0.05
The pH of the maximum stability of
Ofloxacin and Ornidazole in aqueous
phase is in between 5 to 6. Therefore, the
pH of the formulated medicated jelly was
adjusted and maintained in between 5 to 6
with help of buffering agents such as citric
acid and sodium citrate.
Drug content
The drug content of medicated jelly of
batches F1 to F9 was evaluated by HPLC
method. The results are shown in the table.
Table No.11: Drug content of Formulations of Medicated Jelly
Test F1 F2 F3 F4 F5 F6 F7 F8 F9
Drug content
for Ofloxacin 98.46 99.36 101.13 100.35` 103.32 96.65 100.30 97.15 102.56
Drug content
for Ornidazole 104.54 97.44 102.90 96.21 101.48 102.78 101.29 95.39 98.33
The drug content of both drugs i.e.
Ofloxacin and Ornidazole found up to 100
% of formulation F7.
In-vitro Dissolution Study
The formulation F1 to F9 was evaluated
for the drug release within the 45 min.
with the specified condition and method.
In the formulations F7 show more than
70% drug release of both drugs i.e.
Ofloxacin and Ornidazole at 20 minutes
time point and complete drug release
within 45 minutes. It indicates that both
drugs are rapidly dissolved and available at
the site of action immediately.
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Figure No.1: Dissolution profile of Formulation F7
Selection of optimised batch
From the all formulated batches F1- F9 it
was observed that the batch F7 which
containing 0.4% Xanthan gum, 0.5%
Carrageenan and 0.3% sodium citrate; all
evaluation tests satisfactory. Medicated
jelly of this batch showed in-vitro release
profile more than 95% release and uniform
dispersion for both drugs. So the
formulation batch F7 was selected as an
optimised batch and the stability study was
carried out for this batch.
Table No.12: Content uniformity of optimised Formulation F7
Units Content uniformity for Ofloxacin Content uniformity for
Ornidazole
Unit-1 99.34 102.99
Unit-2 103.45 101.29
Unit-3 100.87 100.78
Unit-4 102.59 97.62
Unit-5 102.11 100.47
Unit-6 100.12 101.48
Unit-7 98.55 100.22
Unit-8 99.22 98.72
Unit-9 102.24 98.35
Unit-10 101.11 99.92
Average 100.94 100.18
Relative Standard Deviation 1.63 1.61
Acceptance Value 3.92 3.86
The RSD and acceptance value shows that the formulation F7 drugs uniformly distributed
throughout the formulation.
0
10
20
30
40
50
60
70
80
90
100
0 5 10 15 20 25 30 35 40 45
% C
um
ula
tive
Dru
g
Rel
ease
Time (min.)
Ofloxacin formulation F7
Ornidazole formulation F7
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Content Uniformity
The optimised formulation F7 evaluated
for the content uniformity test is to ensure
that every dosage form contains equal
amount of drug substance i.e. active
pharmaceutical ingredient within a batch
(Table-12)
Taste evaluation of medicated jelly
The optimised formulation F7 was
evaluated for taste using ten healthy, adult
human volunteers. The grading system for
the bitterness, aftertaste, sweetness,
flavour, mouthfeel given below the table:
Table No.13: Taste evaluation of optimised Formulation F7
Parameters Volunteers
1 2 3 4 5 6 7 8 9 10
Bitterness NB NB NB NB NB NB NB NB NB NB
Aftertaste NB NB BT NB NB NB NB NB NB NB
Sweetness VS SW SW VS VS SW VS VS VS VS
Flavour GD MD GD GD MD GD GD GD GD GD
Mouth feel TS TT TT TS TS TS TS TT TS TS
Where,
For Bitterness: non-bitter (NB), less bitter (LB), bitter (BT), Very bitter (VB).
For Sweetness: less sweet (LS), sweet (SW), very sweet (VS).
For Flavour: less (LS), moderate (MD), good (GD).
For Mouth feel: less (TL), moderate (TT), good (TS).
From the table-13 it indicates that overall taste response of ten volunteer it indicated that
optimised formulation F7 having good taste.
STABILITY STUDIES
Physical appearance
The medicated jelly was examined for physical appearance in terms of clarity, texture and
consistency, stickiness and grittiness. The stability sample of 25°C/60 % RH & 30°C/65 %
RH was evaluated. The following table shows the results.
Table No.14: Physical appearance of medicated jelly of stability sample
Test 1 Month 3 Month
25°C / 60 % RH 30°C / 65 % RH 25°C / 60 % RH 30°C / 65 % RH
Clarity Turbid form Turbid form Turbid form Turbid form
Texture Smooth Smooth Smooth Smooth
Consistency Thick Thick Thick Thick
Stickiness Non-sticky Non-sticky Non-sticky Non-sticky
Grittiness Less gritty Less gritty Less gritty Less gritty
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From the above results it shows there is no
significant change in the formulation. The
medicated jelly is stable at25°C / 60 % RH
& 30°C / 65 % RH for 1 month and 3
month.
The medicated jelly was examined for
Viscosity and pH. The stability sample of
25°C / 60 % RH & 30°C / 65 % RH was
evaluated. The following table shows the
results
.
Table No.15: Viscosity and pH of medicated jelly of stability sample
Test 1 Month 3 Month
25°C / 60 % RH 30°C / 65 % RH 25°C / 60 % RH 30°C / 65 % RH
Viscosity 6278± 118 6241 ± 45 6006±32 5.999±84
pH 5.29 5.38 5.41 5.55
From the above results it shows that pH
found between 5 to 6. All the results found
as per initial results. This result shows the
no significant change in the formulation
F7.
The viscosity of the batch F7 was
acceptable. Result shows the no significant
change in the viscosity of formulation F7.
Drug content
The Drug content of Ofloxacin and
Ornidazole was determined by the given
method. The stability sample of 25°C / 60
% RH & 30°C / 65 % RH was evaluated.
The following table and graph shows the
results.
Table No.16: Drug content of medicated jelly of stability sample
Drug
content
1 Month 3 Month
25°C / 60 % RH 30°C / 65 % RH 25°C / 60 % RH 30°C / 65 % RH
Ofloxacin 99.46 98.10 97.90 98.57
Ornidazole 98.67 99.22 99.24 97.01
% Drug release:
The % Drug release of Ofloxacin and
Ornidazole was determined by the given
method. The stability sample of
formulation F7 of 25°C / 60 % RH & 30°C
/ 65 % RH was evaluated. The following
table and graph shows the results.
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% Drug release of Ofloxacin at 25oC/60 %RH:
Figure No.2: % Drug release of Ofloxacin at 25oC/60 %RH
% Drug release of Ornidazole at 25oC/60 %RH:
Figure No.2: % Drug release of Ornidazole at 25oC/60 %RH
0102030405060708090
100
0 5 10 15 20 25 30 35 40 45 50
% D
rug r
elea
se
Time (min)
Stability data for Ofloxacin of Formulation F7 at 25⁰C/60% RH
Formulation F7 (Initial)
Formulation F7 (at 1 Month 25⁰C/60 %RH)
Formulation F7 (at 3 Month 25⁰C/60 %RH)
0102030405060708090
100
0 5 10 15 20 25 30 35 40 45 50
% D
rug r
elea
se
Time (min)
Stability data for Ornidazoleof Formulation F7 at 25⁰C/60% RH
Formulation F7 (Initial)
Formulation F7 (at 1 Month 25⁰C/60%RH)
Formulation F7 (at 3 Month 25⁰C/60 %RH)
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% Drug release of Ofloxacin at 30oC/65 %RH:
Figure No.4: % Drug release of Ofloxacin at 30oC/65 %RH
% Drug release of Ornidazole at 30oC/65 %RH:
Figure No.5: % Drug release of Ornidazole at 30oC/65 %RH
The stability results of Formulation F7 show good % Drug release at 25oC/60% RH and
30oC/65 % RH. It indicates that the formulation is stable at standard stability conditions.
0102030405060708090
100
0 5 10 15 20 25 30 35 40 45 50
% D
rug r
elea
se
Time (min)
Stability data for Ofloxacin of Formulation F7 at 30⁰C/65% RH
Formulation F7 (Initial)
Formulation F7 (at 1 Month 30⁰/65%RH)
Formulation F7 (at 3 Month 30⁰/65 %RH)
0102030405060708090
100
0 5 10 15 20 25 30 35 40 45 50
% D
rug r
elea
se
Time (min)
Stability data for Ornidazole of Formulation F7 at 30⁰C/65% RH
Formulation F7 (Initial)
Formulation F7 (at 1 Month 30⁰/65 %RH)
Ornidazole Formulation F7 (at 3 Month 30⁰/65%RH)
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13 | P a g e Volume 3, Issue 5, September ₋ October 2013 http://www.ijpi.org
SUMMARY AND CONCLUSION
The aim of the present study to
formulation and evaluation of Medicated
Jelly of Bitter drugs i.e. Ofloxacin and
Ornidazole. The Excipients used in the
formulation was tested by drug-excipients
compatibility study. All the excipients were
compatible with both drugs i.e. Ofloxacin
and Ornidazole. For taste masking of
Ofloxacin, ion-exchange resin method was
used. The resins like Indion 204, Indion
214 and Tulsion 335 was tested at various
ratios. Based on the results Tulsion 335
with the ratio 1:1.5 was selected for
complexation. For taste masking of
Ornidazole, addition of sweetening agent
method was used. The slurry was prepared
using Sorbitol 70%, Polyethylene glycol
400 and Glycerin in the concentration of
10%, 6% and 7% respectively. All the
batches of Medicated jelly were turbid
form in appearance. The jelly of batch F7
exhibited the good consistency, non-
sticky, less-gritty. The viscosity of the
batch F7 was acceptable. The consistency
and viscosity of the medicated jelly are
related to each other because both are
dependent on concentration of Xanthan
gum, Carrageenan, sodium citrate and co-
solute. The pH of the maximum stability
of Ofloxacin and Ornidazole in aqueous
phase is in between 5 to 6. Sucrose may
crystallize in presence of citric acid on
standing therefore the amount of citric acid
was kept minimum i.e. just to adjust to the
required pH. Sodium citrate was selected
as a salt to contribute cation because it also
act as sequestrant, buffering agent and
helps in maintaining mechanical property
of the jelly. The drug content of jelly of
batches F1 to F9 was evaluated by HPLC
method. The results are between 97.00% to
103.00% for Ofloxacin and 95.00 % to
104.00 for Ornidazole. The dissolution
studies of the Medicated jelly for all the
formulations show more than 70% drug
release at 20 minutes time point and
complete drug release within 45 minutes.
It indicates that both drugs are rapidly
dissolved and available at the site of action
immediately. The batch F7 evaluated for
uniformity of dosage form and taste
evaluation. It shows satisfactory results.
The optimized formulation F7 kept for the
three month at accelerated storage
condition and it was evaluated with similar
test as per initial analysis. It shows
satisfactory results. It indicates that
formulation F7 stable for at least 12
months at room temperature.
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INTERNATIONAL JOURNAL OF RESEARCH ARTICLE PHARMACEUTICAL INNOVATIONS ISSN 2249-1031
14 | P a g e Volume 3, Issue 5, September ₋ October 2013 http://www.ijpi.org
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