formulation and evaluation of medicated jelly of …€¦ · optimized formulation f7 evaluated...

INTERNATIONAL JOURNAL OF RESEARCH ARTICLE PHARMACEUTICAL INNOVATIONS ISSN 2249-1031

1 | P a g e Volume 3, Issue 5, September ₋ October 2013 http://www.ijpi.org

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



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



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



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.



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



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.



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


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



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


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.



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



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



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.



% 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)


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 (at 1 Month 25⁰C/60%RH)




% 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 (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 (at 1 Month 30⁰/65 %RH)

Ornidazole Formulation F7 (at 3 Month 30⁰/65%RH)



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.

REFERENCES

1. Hiroshi Ninomiya, Toshio Shimizu,

Masatake Dairaku, Takeshi

Komagata, Masayo Misawa. Jellied

medicinal composition for oral

administration. Unites States Patent,

Patent number US 5932235

2. Lachman L, Lieberman H. A, Kanig J.

L. (1991), Theory and Practice of

Industrial Pharmacy. 4th Indian

Edition. Verghese Publishing House.

534-563.

3. Chater S.J. (2001), Cooper and Gunn

Dispensing For Pharmaceutical

Students. 12th Edition. CBS

Publication. 192-231.

4. Rashmi Dahima, Rajesh Sharma.

(2010). Comparative study of ion-

exchange resin Indion 204 and Indion

214 for the taste masking of

metoclopramide hydrochloride and

http://www.asiapharmaceutics.info/searchresult.asp?search=&author=Rashmi+Dahima&journal=Y&but_search=Search&entries=10&pg=1&s=0

http://www.asiapharmaceutics.info/searchresult.asp?search=&author=Rajesh+Sharma&journal=Y&but_search=Search&entries=10&pg=1&s=0



formulation of rapid-disintegrating

tablets. Acian Journal of

Pharmaceutics. 4(2): 110-115.

5. Sharma S, Lewis S (2010). Taste

masking technologies: a review. Int J

Pharmacy Pharm Sci; 2(2): 6-13.

6. Gohel, M.C. et.al. (2009). Preparation

and evaluation of soft jelly and gum

containing paracetamol. IJPS, 71(2),

120-124.

7. Mohapatra, A. et.al. (2008).

Formulation, development and

evaluation of patient friendly dosage

form of metformin, Part-II: Oral Soft

jelly. AJP, 172-176.

8. Covington, A. K.; Bates, R. G.; Durst,

R. A. (1985). Definitions of pH

scales, standard reference values,

measurement of pH, and related

terminology. Pure Appl. Chem. 57; 3:

531–542.

9. Vishnu Vardhan Reddy Beeram

(2010). Formulation, development

and evaluation of cefixime oral

medicated jelly. Indian Journal of

Pharmaceutical Sciences. 78(2): 68-

73.

10. Ashutosh Mohapatra, Rajesh K

Parikh, Mukesh C Gohel, (2008).

Formulation, development and

evaluation of patient friendly dosage

forms of metformin, Part-II: Oral soft

gel. Asian Journal of Pharmaceutics.

2(3):172-176

http://www.asiapharmaceutics.info/searchresult.asp?search=&author=Ashutosh+Mohapatra&journal=Y&but_search=Search&entries=10&pg=1&s=0

http://www.asiapharmaceutics.info/searchresult.asp?search=&author=Rajesh+K+Parikh&journal=Y&but_search=Search&entries=10&pg=1&s=0



http://www.asiapharmaceutics.info/searchresult.asp?search=&author=Mukesh+C+Gohel&journal=Y&but_search=Search&entries=10&pg=1&s=0

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