Date

Practical 20
Aim: To study the effect of formulation factors on oral antacid
suspension formulation (Aluminum hydroxide gel).
Parameter: (a) Effect of different polyols
(b) Effect of different pattern of addition of colors
[A]
Formula:
Each 5 ml contains Aluminum hydroxide.. 1.05 gm
Magnesium hydroxide .. 0.65 gm

Batch size: 60ml, 120ml.

Packaging: Narrow mouth glass bottle with metal screw cap.
Ingredients

Quantit Different Pattern of Role

y (gm) polyols
addition of ingredient
(%w/w)

colors

Aluminum hydroxide gel

Magnesium hydroxide

21
12.9

Polyol
Simethicone
Hydroxypropyl cellulose
Methyl parabens
Flavors
Avicel RC-591
Citric acid, anhydrous

6 ml
0.37
0.33
0.16
0.12
0.11
0.06

Methyl cellulose
Propyl parabens
Sodium saccharin
Amaranth red

0.03
0.03
0.02

--

of

Date
Purified water
58.87 ml
I. Evaluation for polyols

Observation:
1.) Organoleptic properties
Excipient

Color

Odor

2.) Viscosity study

Excipient

Rpm

Cp

3.) Particle size distribution

Factor calculation

Average particle size:

Excipients

Size Range Mean size (d) No.

of Fxd
(mcm)
(mcm)
particles (f)

Date

Procedure:
A. Method of preparation (For polyols):
1. 40% of the total amount of water was taken in 250 ml beaker.
2. In a small beaker methyl cellulose and simethicone were dispersed in about
15% water.
3. Slurry of parabens were prepared in about 2% water and added to 250 ml
beaker.
4. Avicel and Hydroxypropyl cellulose were vigorously agitated in 13% of
water.
5. Magnesium hydroxide paste and dispersion of gums were added into the 250
ml beaker and mixed with the help of propeller stirrer.
6. Then Aluminum hydroxide gel was added and mixed thoroughly.
7. Citric acid, sodium saccharin and sorbitol solution were added and mixed.
8. Flavor solution was added and the volume was made up to 100 ml with
purified water.
Different types of polyols taken: Sorbitol, Glycerol, Propylene glycol
B. Method of preparation (For addition pattern of color):
Preparation procedure of antacid was same as describes above
difference was addition pattern of colour:
i)
Added as triturated powder (dry form) during step 6.
ii)
Added in solution form during step 8.
B.) Method for evaluation:
Evaluation was done as described in earlier practicals
Evaluation parameters:
1.
2.
3.
4.

Organoleptic properties
Rheological study
Particle size distribution
Sedimentation parameters
a. Sedimentation volume ratio
4.) Sedimentation parameters

only

Date
a.) Sedimentation volume ratio
Excipient

Time interval Initial volume Final volume Ratio (H/H)

(min)
(H) cm
(H) cm

b.) Sedimentation rate:

Excipient

Sedimentation rate

c.) Redispersibility
Excipient

b. Sedimentation rate
c. Redispersibility

No. of strokes

Date
Comment:

Reference:
Pharmaceutical Dosage Forms: Disperse system vol-2; second edition; H. A.
Lieberman, Leon Lachman and Joseph B. Schwartz; Pg. no. 129

II. Evaluation for addition pattern of colors:

Date
Addition pattern
Added in dry form
Added in solution form

Observation