manu1 : 3 !

1. wet granulation
-
- binder solution = , . .
moist .
- .+. ex.paracetamol
2. granulation by compression, dry granulation, slugging
-
- ./. ex.aspirin, penicillinG ( direct dose)
-
3. direct compression
-
- . wet granulation + slugging
- dose excipient
- lake = .
- diluent direct compression aids .
1. .. (compressibility)
2. . (flowability)
3. (dilution potential) :
4. . (good blending, content uniformity)
5. . (inert substance, physical property)
. direct compression aids
1. spray dried lactose ex. Ludipress
- lactose monohydrate, polyvinylpyrrolidone(binder),
crosspovidone(disintegrant)
2. modified starch ex. Era-tab **(. spray dried )
3. modified cellulose ex. AVICEL102 lab
4. .
5. dicalcuim phosphate
- lubricant (die)

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3
wet granulation granule by compression, slugging direct compression
1. + 1. + 1. +
2. . 2. . 2. .
3. API+diluent 3. API+diluent 3.
4. binder solution 4. compression hard+large tablet 4.
5. wet granulation slug
6. dry moist 5. dry granulation
7. dry granulation slug
8. lubricant, disinegrant, glidant 6. lubricant, disinegrant, glidant
9. 9.

* wet granulation = . * dry granulation wet *

 Dry moist = . binder solution 1.
Dry granulation . 2.
* slug
3. .


!
. granulation
? binder solution ~~~
- wet granulation =
- dry granulation =

Lab3:direct compression
Chlorpheniramine maleate tablets .500
. ./ ./500
1. Chlorpheniramine maleate API 4
2. starch-lactose granule Direct compression aid 165
3. dried corn starch Disintegrant 8
4. Aerosil 200 glidant 1
5. Magnesium stearate Lubricant 1
6. lake pigment Colorant 1

.
1. everything lubricant 5
2. lubricant 1
3. -.-

Lab4:dry granulation (slugging)

Aspirin
aspirin 325 mg .500
. ./ ./500
1. Aspirin API 325
2. Avicel pH102 Diluent, filler 181.2
3. stearic acid (1) lubricant 5.3
4. crosspovidone Glidant 13.2
5. stearic acid (2) lubricant 5.3

.
1. API + diluent 1.30
2. lubricant(1) 30
3. slug . 5-6 kp, punch 15mm ( slug ;

:P)
4. slug
hi-speed rotary granulator #12
5. dranule ( ) glidant
6. lubricant(2) 30
7. . 8-10 kp, punch 11mm
8.
note :
1. stearic acid magnesium stearate (magnesium stearate =!
!)
2. Avicel pH102 diluent

 - inert +

-
- ..
- .

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Lab5+6:wet granulation
paracetamol
paracetamol 600 mg .666
. ./ ./666
1. paracetamol API 500.00
2. tapioca starch Intragranular disintegrant 70.20
3. tapioca starch (binder) binder 10.20
starch gel (binder)
4. PVP K30 (binder) binder 4.60
5. primogel extragranular 12.00
disintegrant
6. Magnesium stearate lubrincant 3.00
total 600.00

.
1. API + intragranular disintegrant + binder (1-4) granule
2. granule sieve granule
3. t < 60 oc 6 .
4. granule .granule (. )
. 666
note : . granule 1. . 5 g, 2. tap density 25 g,
3. sieve analysis #20,40,60 100 g.
- . granule
5. (lubricant, extragranular disintegrant)
- granule . % granule
% , x666(
)
-
%batch size
()
- . . + .
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