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CAPSULES
• solid dosage form
• the drug is enclosed within either a hard or soft shell
 shell is typically made of gelatin
• primarily intended for oral delivery
• provide a rapid release of contents
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Gelatin
protein, prepared from hydrolysis of collagen (animal
bones and skin)
 type A : pI = 7-9, pig skin
 type B : pI = 5, animal bones
possesses 4 essential properties
• stable when dry
• subject to microbial degradation when moist
• digested and absorbed
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Hard Gelatin Capsules
contain 12 - 16 % moisture
typically filled with dry solids
 powders
 granules
 pellets
 tablets
also contain
 colorant
 preservatives
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SIZE
000
00
0
1
2
3
4
5
CHEE 440
VOLUME (cm3)
1.37
0.95
0.68
0.50
0.37
0.30
0.21
0.13
3
Manufacture
http://www.rjengineering.com/process.htm
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Filling
operations involved
 rectification of empty capsules
 separation of caps from bodies
 filling capsule bodies
 replacing caps and ejecting filled capsules
3 basic methods for powder filling
 auger or screw
 dosator
 dosing disc
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Capsule Filling
 auger
• semi-automatic operation
• filling based on volume
• need good powder flow properties
 dosator
• fill based on weight
• continuous operation
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Capsule Filling
 dosing disc
• filled based on weight
• continuous operation
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Bioavailability
factors which influence bioavailability
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Hard Gelatin Capsules
Advantages
 tasteless and odorless
 swallowing is easy
 flexibility in formulating
 uniquely suitable for blinded clinical trials
 useful for extemporaneous compounding by pharmacist
Disadvantages
 tend to be more expensive to produce than tablets
 not suitable for highly soluble salts
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Soft Gelatin Capsules (Softgels)
• consist of a continuous gelatin shell surrounding a
liquid core
• formed, filled, and sealed in one operation
• shells are softened by addition of glycerin or
polyhydric alcohol (ex. sorbitol)
• oblong, spherical, elliptical in shape
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Manufacture
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Bioavailability
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Soft Capsules
ADVANTAGES
 may contain liquids, suspensions, pastes
 rapid release of contents
 useful for drugs prone to oxidation
DISADVANTAGES
 have a greater tendency to adhere to each other
 more expensive
 increased possibility of interactions between drug and shell
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