PREPARED BY
MATHOLIYA CHETAN
1ST SEM. M.PHARM
FOR SOLID
TABLETS
CAPSULES
TABLET
3
INTRODUCTION
DEFINITION:These are solid dosage forms each containing a
unit dose of one or more medicaments.
May
DISADVANTAGES:
Drug having amorphous nature & low density
drug can not compressed into tablets.
Drugs with poor wetting properties cant be
formulated to make as tablet.
Bitter tasting drugs, drugs with an objectionable
odor, drug sensitive to oxygen coating may be
required.
CIRCULAR LAYOUT
Materials
ENVIRONMENTAL REQUIREMENT:
NAME OF AREA
PRESSURE
MAINTAINED
WARE HOUSE
10 PASCAL
WEIGHING AREA
20 PASCAL
TABLETTING AREA
15 PASCALS
CENTRAL CORRIDOR
30 PASCALS
Temperature 2550C
Humidity 55 10 % RH
10
Humidity
11
EXAMPLE: Suppose
Equipments
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GRANULATION:
Wet
Granulation
Direct Compression
Dry Granulation
OR Slugging
OR Roll Compaction
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14
Direct Compression:
Dry
ROLLER COMPACTOR
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WET GRANULATION: In
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B)
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19
Principle
COMPRESSION MACHINE:
Tablet
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HAND OPERATED
TABLET MACHINE
ROTATORY TABLET
MACHINE
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24
This
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CAPSUL
E
26
INTRODUCTION
Capsules
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2. Soft Gelatin
Capsule
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PAPER
910201/HIMANSHU/M.PHARM/2
009-10
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29
31
GELATIN SOLUTION
DIPPING
SETTING
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DRYING
TO AUTOMATICS
STRIPPING
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CUTTING
JOINING
FINISHED CAPSULE
34
GELATIN PROPERTIES
PIG SKIN
FISH
240-255,
220-260
13.0
13.0
1.
1.0
PH ,1% SOLUTION
5.2-5.8
5.5-6.0
7.0-9.4
7.0-9.4
BLOOM(G)0
+MOISTURE (%MAX)
ASH (%MAX)
35
GELATIN PROPERTIES
PIG SKIN
FISH
100
100
40
40
Absent
Absent
500
500
E.COLI IN 10 GM
Absent
Absent
P. AERUGINOSA IN 10
Absent
Absent
PARTICLE SIZE %
PASSING 4 US #
SO2 (PPM MAX)
H2O2
MICROBIAL STANDARDS
TOTAL COUNT
GM
36
FILLING OF CAPSULE
A. DIRECT FILLING METHOD
37
3. VACUUM-FILLING METHOD
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GENERAL REQUIREMENT
The
40
EXAMPLE
Gelatine
Plasticizer
Glycerine
Sorbitol
Water
Preservative
Methyl paraben
Propyl paraben
Colorants
Certified lakes
Opacifier
Titanium dioxide
Flavouring agent
Ethyl vanillin
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BLOOM(G)0
FISH
180-210
160-210
13.0
13.0
1.
1.0
PH ,1% SOLUTION
5.0-6.0
5.0-6.0
6.0-8.0
7.0-9.4
MOISTURE (%MAX)
ASH (%MAX)
43
GELATIN PROPERTIES
ACID OSSEIN
FISH
100
100
60
60
H2O2 (MAX)
60
60
Clear
no precipitate
500
500
E.COLI IN 10 GM
Absent
Absent
P. AERUGINOSA IN 10 GM
Absent
Absent
4 US #
44
ENCAPSULATION PROCESS:
GLOBEX METHOD
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Advantages:
Capacity:
10,000-40,000 capsules per hour.
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THANK U
50