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PRACTICAL-8

AIM:
A. To prepare and evaluate hard gelatin capsule of given API and
compare with commercial product.
B. To evaluate commercial soft gelatin capsules.
Formula:
Each capsule contain

Paracetamol = 500mg
Excipients = q.s.

Batch size: 30 capsules

Packaging: Aluminium or Polypropylene strip of 10 capsules.
Pack size: 10 capsules.
Marketed Product:
a. VITAMIN B COMPLEX CAPSULES
Brand: OMEGA B-COMPLEX CAPS.
Packaging: Blister package of 10 capsules.
b. PUDIN HARA PEARLS

Strength: Pudina Ka Satva 180 mg

Packaging: Blister pack of 10 capsules.

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OBSERVATION:
1. Micromeritical properties
Parameters

Result

Bulk density
Tapped density
Carrs index
Hausners ratio
Angle of repose
2. Lag time of capsule shell:
3. Moisture content determination

4. Dissolution study :
Apparatus- USP type I (basket)
Dissolution medium- phosphate buffer pH 5.8
A. Paracetamol cpasules
Sr. no Time (min)
1
2
3
4
5
6
7
8
9
10

0
5
10
15
20
25
30
35
40
45

Absorbance mg/100
ml

gm/900ml

% drug
release

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FORMULATION:
INGREDIENTS
Paracetamol
Sodium
glycolate
Aerosil 200
Mg stearate
Starch
Total

QUANTITY PER QUANTITY PER

CAPSULE
20 CAPSULE
500 mg
15 g
starch 30 mg
0.9 g
1 mg
2 mg
17 mg
550 mg

0.03 g
0.06 g
0.51 g
16.5 g

ROLE
OF
INGREDIENT
Antipyretic
Disintigranting
agent
Glidant
lubricant
Binder

PROCEDURE:
1) Method of preparation:

All ingredients were weighed accurately and passed through 80 mesh sieve.
Paracetamol and SSG were mixed in mortar.
In this mixture starch paste was added until damp mass was formed.
Damp mass was passed through 20# sieve and granules were collected on
40# sieve.
Granules were dried in an oven.
These dried granules were filled in to capsule shell of size 0 by capsule
filling machine.
Capsules were evaluated by different parameters.

2) Method of characterization:
a. Hard gelatin capsules
Micromeritical property of granules
Weight variation test
Lag time of capsule

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B. Multivitamin Capsules
Sr. no Time (min)
1
2
3
4
5
6
7
8
9
10

Absorbance mg/100
ml

gm/900ml

0
5
10
15
20
25
30
35
40
45

5. Weight variation test:

Sr no
1
2
3
4
5
6
7
8
9
10

Weight of filled Weight

capsule(A)
shell(B)

of

empty Difference
(A-B)

% drug
release

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Dissolution study
a. Paracetamol hard gelatin capsules
Dissolution media = phosphate buffer pH 5.8
b. Multivitamin hard gelatin capsules
Dissolution media = 0.1N HCL

b. Soft gelatin capsules

I. Weight variation test
II. Moisture content determination
1. Aliquot of sample sufficient to yield 2-4 mL of water (about
40g) was weighed.
2. Sample was transferred quantitatively to distillation flask and
sufficient toluene was added to cover the sample completely and to
middle of distillation flask. A stir bar or boiling chips was added.
3. Apparatus was assembled, and trap was filled with toluene by
pouring through the condenser until it just fills the trap and begins
to flow into the flask. A loose non-absorbing cotton plug was
inserted into the top of the condenser to prevent condensation of
atmospheric moisture into the condenser.
4. Mixture was brought to boil and refluxed at about 2 drops per
second until most of the water had been collected in the trap, then
the reflux rate was increased to about 4 drops per second.
5. Refluxing was continued until two consecutive readings 15 min.
apart showed no change. Heat was turned off and allowed to cool
to ambient temperature. Any water held up in the condenser was
dislodged with a brush or wire loop. Condenser was rinsed
carefully with about 5 mL toluene.
6. Volume of water in the trap was read.

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Weight variation test:

a. Multivitamin hard gelatin capsules.
Sr.
Weight of tablets(x)
no.
1
2
3
4
5
6
7
8
9
10
Avg.

x-x avg

x-x avg /x avg *100

b. Pudin hara Soft gelatin capsules.

Sr.
Weight of tablets(x)
no.
1
2
3
4
5
6
7
8
9
10
Avg.

x-x avg

x-x avg /x avg *100

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COMMENTS:

REFERENCES:
1) Handbook of pharmaceutical manufacturing formulations,
Uncompressed solid products, vol-2
Sarfaraz K Niazi. Page no-52.
2) Indian pharmacopoeia 2007,vol-2
Page no-633.

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