Routes Of Administration Oral (Capsules)

Question 1

What is the definition of a capsule?

Answer 1

• Drug enclosed in a small shell
• Solid preparations with hard or soft shells of various shapes and capacities containing a single dose of active substance

Question 2

What are the advantages of capsules?

Answer 2

• Easy to swallow
• Easy to handle and carry
• Mask taste and smells of drugs
• Minimal excipients needed
• Minimal pressure is required to compact

Question 3

What are the disadvantages of capsules?

Answer 3

• Not suitable for highly soluble substances like KCl. Can cause sudden release in the stomach resulting in irrirtation
• Not suitable for highly deliquescent materials (absorb moisture from the air) - may dry the capsule shell causing bitterness
• Product cost is more than tablets

Question 4

What are the types of capsules?

Answer 4

• Hard capsules ( 2 piece)
• Soft capsules ( 1 piece)

Question 5

What are the raw materials?

Answer 5

• Gelatin
• Colourants
• Water
• Plasticisers

Question 6

What is gelatin?

Answer 6

• Major component for making the capsule shells
• Prepared by hydrolysis of collagen from connective tissues
• Commonly made from calf bones and pig skin

Question 7

What is the acidic process of producing gelatin?

Answer 7

• Acidification to pH4
• Heating from 50.c to boiling
• Elimination of fat
• Filtration
• Vacuum evaporation and drying

Question 8

What is the alkali process of producing gelatin?

Answer 8

• Treatment of NaOH and removing
• Treatment of acid to adjust pH
• Heating to boiling
• Demineralisation
• Filtration
• Vacuum evaporation and drying

Question 9

What are the properties of gelatin?

Answer 9

• Non-toxic and non-irritant
• Soluble on biological fluids at body temps
• Good film forming properties
• Solutions of high conc are mobile at 50 degrees
• Changes from solution to gel at room temp

Question 10

What are the problems with gelatin?

Answer 10

• Gelatin allergy
  -Not suitable for vegans or vegetarian
• Not suitable for certain ethnic groups

Question 11

What are hard gelatin capsules?

Answer 11

• More common
• Consist of a cap (the short piece) and body (the longer piece) which lock together
• Filled with drug
• 8 sizes

Question 12

How should hard capsules be stored?

Answer 12

• Capsules are meant to have a moisture content of 13%-16%
• Stored at controlled temp and humidity. (Too humid = too soft, Too dry = brittle)

Question 13

What do the filling materials in hard capsules need to be?

Answer 13

• Be free from large amounts of moisture
• Not react with shell
• Not leak out
• Have good powder flow
• Not be adhesive and be filled uniformly

Question 14

What are the excipients used in powder filled capsules

Answer 14

• Diluents
• Lubricants
• Glidants
• Wetting agents
• Stabilisers
• Disintegrants

Question 15

How should hard capsules be filled?

Answer 15

1. The halves of a capsule are separated
2. The dose is placed on the surface of the body plate and is spread with a spatule to fill the capsule body
3. Cap locked onto body
4. Capsule removed from machine

Question 16

What are soft capsules?

Answer 16

• Consist of liquid or semi solid matrix sealed inside in 1 piece flexible gelatin shell - considered biphasic dosage form
• 1 single step to form

Question 17

What are the advantages of soft capsules?

Answer 17

• Improved drug absorption - drug is already in solution
• Convenience, ease of use
• Dose Uniformity and precision
• Product stability - protected by soft gel shell

Question 18

What are different of softgels?

Answer 18

• Oral softgel (cod liver oil)
• Chewable
• Twist off
• Suckable
• Meltable

Question 19

What is the composition of soft gel?

Answer 19

• Gelatin (40%)
• Plasticizers
• Water
• Flavour/ dye

Question 20

What are the types of soft gel matrices?

Answer 20

• Lipophilic liquids
• Hydrophilic liquids
• Self emulsifying systems (contains oil and surfactant which emulsify into droplets)