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PRACTICAL-2

AIM: To prepare and evaluate immediate release tablet containing high dose and
low dose of API and to study effect on dissolution rate and content uniformity.
a. Tablet of Aspirin of high dose
b. Tablet of Aspirin of low dose

FORMULA:
( a) Each tablet contains Aspirin = 300mg
Excipients

= q.s.

(b) Each tablet contains Aspirin = 25mg

Excipients

= q.s.

Batch size = 50 tablets

Packaging = Aluminium strip or Polypropylene strip of 10 tablets
FORMULATION:

( a) For high dose drug:

INGREDIENTS
Aspirin
Starch
Starch paste
Lactose
DCP
Talc
Mg stearate
Aerosil

QUANTITY
GIVEN
300mg
15.8mg
q.s
15.8mg
13.8mg
8mg
4mg
0.148mg

QUANTITY
TAKEN
15g
0.79g
q.s
0.79g
0.69g
0.4g
0.2g
.074g

ROLE
OF
INGREDIENTS
Analgesic
Diluent
Binder
Diluent
Disintegrant
Lubricant
Glidant
Glidant

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OBSEVATION TABLE:
WEIGHT VARIATION:
Sr No.

Weight of tablets

Assay
BURETTE
READING
BLANK
BACK
DIFFERENCE

Calculation:

FOR
DOSE

HIGH FOR LOW DOSE

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(b) For low dose drug

INGREDIENTS
Aspirin
Starch
Starch paste
Lactose
DCP
Talc
Mg stearate
Aerosil

QUANTITY
GIVEN
25mg
290.8mg
q.s
15.8mg
13.8mg
8mg
4mg
0.148mg

QUANTITY
TAKEN
1.2g
14.5g
q.s
0.79g
0.69g
0.40g
0.2g
0.074g

ROLE
OF
INGREDIENTS
Analgesic
Diluent
Binder
Diluent
Disintegrant
Lubricant
Glidant
Glidant

PROCEDURE:
METHOD OF PREPARATION:
All the ingredients were weighed accurately.
Aspirin, starch powder, lactose, DCP, were taken in mortar nd pestle and
grinded together to have uniform mixing nd obtain fine powder.
10% of starch paste was prepared and q.s was added to the fine powder to
obtain the lump mass.
This lump mass was then passed through 10# sieve to obtain granules and
were allowed to dry in oven at 60C.
Granules were then passed through 20# sieve and retained on 40# sieve.
Fines obtained were weighed.
15% of fines were added to the dried granules and pack edt in zip lock bag
and punched into tablets using tablet punching machine.

Tablets were then evaluated.

METHOD OF CHARACTERIZTION:
Micromeritical Properties of granules:
i. Carrs Index
ii. Hausners ratio
iii. Angle of repose
Hardness

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1) Dissolution study:
For high dose:
SR TIME ABSORBANC CONC.
CONC.
CONC.
%CPR
NO
(Gm/100ml) (mg/100ml) (mg/900ml)

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Friability
Dissolution study:
Weight Variation
Assay procedure:
20 tablets were weighed and powdered.
A quantity of powder was weighed accurately containing about 0.5g of
Aspirin and 30 ml of 0.5M NaOH was added.
It was boiled gently for 10 mins.
The excess of alkali was cooled and titrated with 0.5M HCl using phenol red
as an indicator.
The operation was repeated without the substance under examination.
The difference between the titrations represents the amount of NaOH
required.

FACTOR:
1ml of 0.5M NaOH is equivalent to 0.04504g of Aspirin

LIMITS:
NLT 95% and NMT 105% of stated amount of Aspirin should be present.

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For low dose:

SR TIME ABSORBANC CONC.
CONC.
CONC.
%CPR
NO
(Gm/100ml) (mg/100ml) (mg/900ml)

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COMMENT:
1. In case of high dose formulation the physicochemical characteristics of
API determines the formulation characteristics. If API is poorly flowable
and poorly wettable it should be made hydrophilic by wet granulation
method. If API is having good flow and hydrophilicity it can be
formulated by direct compression.
2. The formulation containing low dose/ potent API the excipient
determines the formulation characteristics so excipient which provides
good flow and compressibility should be used for preparation. Incase of
low dose formulation the blend uniformity is very important to ensure
content uniformity so geometric mixing is advisable.
3. In present study the effect of dose of API on the key parameters like
content uniformity and dissolution rate is investigated.
4. The observation shows that

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