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ยาเม็ด (Tablets)
ยาเม็ด (Tablets)
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: /
/ /
1. 2. 3.
Die filling
Die filling
???
Tablet formation
???
Tablet ejection
punch
punch 1 die
lower punch
200
1.
Hopper
4. die
mass
+ Granulating fluid --> Wet --> Damp mass --> --> --> --> --> -->
Granulating fluid
Binding solution
Organic solvent :
Shear granulator HighHigh-speed granulator FluidizedFluidized-bed granulator SpraySpray-driers Slugger Roller compactor
Shear granulator
Planetary mixer
Planetary mixer
Shear granulator
Wet mass
Oscillating granulator
Oscillating granulator
Shear granulator
Tray drier
Shear granulator
Tray drier
fluid
Shear granulator
Solute migration
Shear granulator
Impeller : Chopper :
mass
granulating fluid
granulating fluid
SpraySpray-driers
SpraySpray-driers
SpraySpray-driers
Slugger
Slug 25 mm 10 - 15 mm Slug
Hammer mill
Roller compactor
Roller compactor
1. 2. 3. 4. 5. 6. 7. 8.
1. 2. 3. 4. 5. Slug
1. 2. -
magnesium stearate
1.
1.
1. 2.
1. 2.
Compressibility
(binder)
Flow ability
.....
--> -->
granule (glidant)
Wet ability
granule
Lubricity
pH
wet
or
dry
50 mg --> -->
Local effect
Systemic effect
:
: : :
(Filler, Diluent)
--> -->
Lactose
Lactose ***
crystalline Crystalline form < 93. 5 rC 93 . monohydrate > 93.5rC 93. Amorphous form
amorphous
EF-anhydrous / sprayspray-dryer
Amorphous form
Crystalline lactose
Sucrose
+ sugar
3 % --> -->
Icing
Mannitol
Sorbitol
Mannitol
Mannitol
Starch
hydrolysis
Cellulose
: Cellulose cellulose
Microcrystalline
Microcrystalline cellulose
Cellulose crystalline amorphous Cellulose Spray drying Crystalline cellulose
Avicel PH101 PH101 PH102 Avicel PH102 Direct compression & Wet granulation
Wet mass
Inorganic substance
(Binder)
Slug
Starch
Starch paste
2 -4 ...
water bath
glucose
dye migration
calcium
phosphate,
Sucrose
5050-85 %
Gelatin
sucrose
: : PVP
PVP
3-15% 15%
citric
Methylcellulose
) (Methocel
1 -5 %
Lactose,
Mannitol
Ethylcellulose
) (Ethocel
0.5-2%
Enteric polymer
(Disintegrant)
--> -->
--> -->
......
.....
Extragranular addition
--> -->
Intragranular addition
--> -->
10
Pregelatinized starch : Starch1500, Starch1500 Amijel Sodium starch glycolate : Explotab, Primogel Microcrystalline cellulose : Avicel PH101, PH102 PH101, PH102
CO2 generator
Effervescent tablets
(Lubricant)
Fluid lubrication
Liquid paraffin
Boundary lubrication
***
2-5
(Glidant)
--> -->
Hopper
Talcum : 1-2% Colloidal silicon dioxide (Aerosil) : 0.2-1 % Magnesium stearate < 1%
(antiadherant)
--> -->
Food, drug and cosmetic (FD&C) Drug and cosmetic (D&C) External drug and cosmetic (Ext. D&C)
2
Direct compression
500
Sucrose NaCl 1
Aspartame
Sucrose Ascorbic
(Absorbent)
Colloidal silicon dioxide, Microcrystalline cellulose
50% 50%
(Fluid extract)
Binding Sticking, Picking, Filming Capping, Laminating Chipping, Cracking Double impression Drug migration, Dye migration Weight variation Hardness variation
Binding
-->
***
***
Binding
-->
Binding
Binding
(Tapered die)
Binding
Sticking
Sticking
Sticking
2 Picking Filming
Sticking
Picking
Filming
***
Sticking
Sticking
Sticking
Sticking
--> -->
Sticking
Sticking
Isopropanol polysiloxane
Sticking
A, B, O
Chromium
Capping, Laminating
Capping
Laminating
Capping, Laminating
Capping, Laminating
Capping, Laminating
elastic deform
Capping, Laminating
capping
prepre-compression
Capping, Laminating
elastic deform
Capping, Laminating
Capping, Laminating
1) Flat faced (r = g )
Capping, Laminating
Capping, Laminating
Capping, Laminating
Capping, Laminating
--> -->
Capping, Laminating
Capping, Laminating
/ > Capping
--
starch,
Acacia,
Capping, Laminating
stearate
--> --> Capping
--> -->
Capping, Laminating
100100 -200
Capping, Laminating
Hopper
capping
Chipping, Cracking
Chipping
Chipping, Cracking
--> -->
Hopper
Chipping, Cracking
Cracking
capping
Double impression
Intragranular migration
Intergranular migration
Drug migration : Content uniformity Content potent drug Dye migration : (Mottling)
Tray dryer
Intragranular
4040-80rC
intragranular migration
lake
dye
lake
Weight variation
Weight variation
Weight variation
--> -->
(Glidant)
Weight variation
Weight variation
binding
sticking
--> -->
Hardness variation
.....
The