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PRACTICAL-3
AIM: To prepare and evaluate IR tablet formulation by wet granulation method using ascorbic acid as model drug and to study the effect aqueous and non-aqueous granulating agents.
A. Tablets using aqueous granulating agent (hydrophilic binder).B. Tablets using non-aqueous granulating agent (hydrophobic binder).
FORMULA:
Each tablet contains 250 mg Ascorbic acid I.P.
Excipients: Quantity sufficient
Batch size: 20 tablets
Packaging: Aluminium strip of 10 tablets
FORMULATION:
A. Tablets using aqueous granulating agent (hydrophilic binder).
INGREDIENTS QUANTITY PER TABLET
QUANTITY PER 20 TABLETS
ROLE OF EACH INGREDIENTS
Ascorbic acid 250 mg 5 g Vitamin C supplement
Starch paste (10%W/V)
q.s. q.s. Binder
Microcrystalline cellulose (Avicel)
30 mg 0.6 g Diluent and disintegrant
Magnesiun stearate 10 mg 0.2 g Lubricant and glidant
Aerosil (Silicic acid)
5 mg 0.1 g Lubricant and antiadherent
Date Page no.
OBSERVATION TABLE:
A. Tablets using aqueous granulating agent (hydrophilic binder).
1. Weight variation:
2. Hardness:
No. of tablet
Hardness (Kg/cm2)
12345MEAN
No. of tablets
Weight (mg)
1234567891011121314151617181920MEAN
Date Page no.
B.Tablets using non-aqueous granulating agent (hydrophobic binder).
INGREDIENTS QUANTITY PER TABLET
QUANTITY PER 20 TABLETS
ROLE OF EACH INGREDIENTS
Ascorbic acid I.P. 250 mg 5 g Vitamin C supplements
Ethyl cellulose 5% solution in ethanol
q.s. q.s. Binder
Microcrystalline cellulose (Avicel)
30 mg 0.6 g Diluent and disintegrant
Magnesiun stearate 10 mg 0.2 g Lubricant and glidant
Aerosil (Silicic acid)
5 mg 0.1 g Lubricant and antiadherent
PROCEDURE:
1. METHOD OF PREPARATION:A. Tablets using aqueous granulating agent (hydrophilic binder).
PREPARATION OF STARCH PASTE (10%W/V):
10 g of starch powder was weighed accurately and dissolved in 100 ml hot boil water (60◦c) with continuous heating until thick paste was obtained.
PREPARATION OF TABLETS:
Weighed accurately API and microcrystalline cellulose and transferred to mortar to mix properly.
Added sufficient quantity of starch paste (10%W/V) slowly and made up a wet dump mass with suitable consistency.
Passed through it 10 # sieve and dried granules in hot air oven. Dried granules were passed through the arrangements of sieve No, 22 # and
44 # sieves. Granules were collected on 44 # sieve and fines were collected below the 44 # sieve.
Suitable proportion of fines and granules were compressed to tablet under rotary tablet machine with proper tooling.
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3. Friability:
No. of tablet % weight loss
4. Disintegration:
No. of tablet
Disintegration time
12345MEAN
5. Dissolution rate profile:
Tim
e
Abs
rban
ce
Con
c(m
cg/m
l)
Con
c. *
dil.
Fa
ctor
conc
(mcg
/5m
l)
Con
c.(m
cg/9
00m
l)
Cum
.con
c(m
cg/5
ml)
Tot
al
mcg
/900
ml
Tot
al
(mg/
900m
l)
%D
R
Date Page no.
B. Tablets using non-aqueous granulating agent (hydrophobic binder).
Preparation of ethyl cellulose (5%w/v) solution:
2.5 g ethyl cellulose was weighed accurately and dissolved in 50 ml ethanol.
Preparation of tablets:
Weighed accurately API and microcrystalline cellulose and transferred to mortar to mix properly.
Added sufficient quantity of ethyl cellulose (5%W/V) solution slowly and made up a wet dump mass with suitable consistency.
Passed through it 10 # sieve and dried granules in hot air oven. Dried granules were passed through the arrangements of sieve No, 22 # and
44 # sieves. Granules were collected on 44 # sieve and fines were collected below the 44 # sieve.
Suitable proportion of fines and granules were compressed to tablet under rotary tablet machine with proper tooling.
2. METHOD OF CHARACTERIZATION:
1. Weight variation: It was performed by using 20 tablets by alternatively weighing of each tablet on weighing machine.
2. Hardness: It was characterized for each tablet by using the Monsanto tester.
3. Friability: It was performed by subjecting a weighed No. of tablets to Roche Friabilator that revolved at 25 rpm and dropping the tablets.
4. Disintegration: It was performed using USP disintegrating test apparatus.
5. Dissolution rate profile: It was performed by using USP type apparatus.
Tablets using non-aqueous granulating agent (hydrophobic binder).
Date Page no.
1. Weight variation:
2. Hardness:
No. of tablet
Hardness (Kg/cm2)
12345MEANComments:
No. of tablets
Weight (mg)
1234567891011121314151617181920MEAN
Date Page no.
1. If the API is moisture sensitive /hygroscopic, then aqueous granulating agent is not advisable because it may degrade API by hydrolysis/oxidation If the given API is heat sensitive then drying is necessary which can be achieved non-aqueous granulation easily.
2. In the formulation where the wet granulation method is only advisable method when choice of granulating agent is critical depending on the sensitivity of API.
3. In present study, the effect of aqueous and non- aqueous binder solution on stability of moisture sensitive API is investigated by key parameters like content and dissolution profile.
NOTE: The formulation characterizes after 6-8 hours of the formulation.
The observations show that the hydrophobic granulating agent for the moisture sensitive API is important as binding agent which increase the stability of formulation.
Date Page no.
3. Friability:
No. of tablet % weight loss
4. Disintegration:
No. of tablet
Disintegration time
12345MEAN
5. Dissolution profile
Tim
e
Abs
rban
ce
Con
c(m
cg/m
l)
Con
c. *
dil.
Fa
ctor
conc
(mcg
/5m
l)
Con
c.(m
cg/9
00m
l)
Cum
.con
c(m
cg/5
ml)
Tot
al
mcg
/900
ml
Tot
al
(mg/
900m
l)
%D
R
Date Page no.
REFERENCE :
Pharmaceutical dosage forms: Tablet volume 1, edited by Herbert A Liebermann and Leon Lachmann.
