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PRACTICAL-11

AIM: To prepare and evaluate stable oral suspension of given API.

(Taste masking by various approach)
FORMULA:
Each 5 ml contains: 125 mg paracetamol
Packaging: Narrow mouth ambered colour glass bottle with mettle screw cap.
Pack size: 60 ml bottles
FORMULATION:
INGREDIENTS
Paracetamol
Sodium benzoate
Methyl
paraben
sodium
Propyl
paraben
sodium
Sorbitol solution
Sucrose
Glacial acetic acid
Carboxy
methyl
cellulose sodium
Sodium stearate
Stearic acid
Tween 80
Purified water

QUANTITY
TAKEN
2.625 g

QUANTITY
GIVEN
31.5 Kg

0.1 g
0.1 g

1.2 Kg
1.2 Kg

ROLE OF EACH
INGREDIENT
Bitter
drugAnalgesic, Antipyretic
Antimicrobial agent
Preservative

0.05 g

0.6 Kg

Preservative

21.4 ml
45 g
0.125 ml
0.2 g

257 ml
540 Kg
1.5 ml
2.4 Kg

Sweetening agent
Sweetening agent
Buffer
Viscosity enhancer

0.1 g
0.09 g
0.075 ml
QS 100 ml

1.2 Kg
1.08 Kg
0.9 ml
1200 litre

Solubilizing agent
Solubilizing agent
Viscosity enhancer
Vehicle

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Observation:
1. Organoleptic characteristic:
a. Color:
b. Odour:
c. Taste:
2. Redispersibility:
3. pH value:
4. Viscosity:

5. Particle size distribution

Calibration factor:
No. of divisions of stage micrometer: 10(y)
No. of divisions of eye piece micrometer: 7.1(x)
(y/x)*10 =

Range

Mean(d)

Frequency(f)

f*d

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Procedure:
(Taste masking by sweetening agents and viscosity enhancers)

1. Method of preparation:
Dissolved accurately weighed sucrose in part of water with the help of
heat and stirring. Boiled to make the syrup. Filtered it and cooled to RT.
Then mixed glacial acetic acid in few quantity of water and added to the
syrup.
Dissolved sodium benzoate, methyl paraben sodium and propyl paraben
sodium in few quantity of hot water separately in a beaker & added sorbitol
solution with filter cloth.
Added API slowly to the above mixture with continuous stirring.
Dissolved carboxy methyl cellulose sodium in 10 ml of hot water (80c).
Filtered it and cooled to RT.
Suspended sodium stearate in few quantity of water and heated to dissolve.
Added stearic acid and mix it with tween 80: water solution. Cooled to RT.
Mixed all solutions (syrup, carboxy methyl cellulose slurry and above
solutions) in a beaker and stirred well for 30 min.
Made up the volume up to 100 ml and stirred for 30 min.

2. Method of characterization:
1. Viscosity: It was characterized by using a Brook- Field Viscometer.
2. Particle size distribution: It was performed using the microscopic
method.
3. Taste evaluation: Taste evaluation of oral suspension was performed
using human volunteers.

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Mean particle size = f*d / f

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COMMENTS:
1. There are various approach to mask the taste of bitter drugs in suspension
or oral liquid form. This includes the use of combination of excipients
like sweeteners, flavours, taste enhancers / taste potentiating agents / taste
masking agents.
Sophisticated techniques for taste masking like microencapsulation
pelletization, complexation with resins etc. are also employed.
In present study, the attempt is made to mask the taste by various
approaches and is evaluated by volunteers.
2. Observations show that complete taste masking of bitter drug is achieved
by using the sweetening agents and viscosity enhancers.

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TASTE PANEL EVALUATION FORM

Type of Product Being Evaluated:
Samples Being Evaluated:
Sample A: ____________________________________________
NAME

Total Points: _________

Is the product acceptable? _________
Comments/Explanations:______________________________________
__________________________________________________________
__________________________________________________________
Name:

Date: