Oral Capsules

Question 1

What are capsules?

Answer 1

Solid preparations with hard or soft shells of various shapes + capacities, containing single dose of active substances

Question 2

What are advantages of capsules?

Answer 2

Easier to swallow than tablets
Easier to handle + carry
Easy to identify wide range of colours
Tasteless
Required minimal excipients
Minimal pressure to compact
High drug loading possible (up to 90%)

Question 3

What are disadvantages of capsules?

Answer 3

Not suitable for highly soluble substances
Not suitable for highly deliquescent materials
High product cost

Question 4

Why are capsules not suitable for highly soluble substances?

Answer 4

Can cause sudden release in stomach = irritation

Question 5

Why are capsules not suitable for highly deliquescent materials?

Answer 5

May dry shell = brittleness

Question 6

What are the different types of capsules?

Answer 6

Cachets
Hard capsules
Soft capsules
Gastro-resistant capsules
Modified-release capsules

Question 7

What are hard + soft capsules made form?

Answer 7

Gelatin

Question 8

How many pieces are hard capsules?

Answer 8

2

Question 9

How many pieces are soft capsules?

Answer 9

1

Question 10

How is gelatin made?

Answer 10

Hydrolysis of collagen from connective tissues

Made form calf bones + pig skin

Question 11

What is the acid process for producing gelatin?

Answer 11

Animal collagen
Acidification pH 4
Heating from 50 degrees to boiling
Elimination of fate
Filtration
Vacuum evaporation
Drying

Question 12

How long does acid process take?

Answer 12

7-10 days

Question 13

What does the acid process produce?

Answer 13

Type A gelatin

Question 14

What is the alkali process for producing gelatin?

Answer 14

Animal collagen 
Treatment with NaOH
Remove NaOH
Treatment with acid to adjust pH
Heating from 50 degrees to boiling 
Demineralisation 
Filtration
Vacuum evaporation
Drying

Question 15

How long does alkali process take?

Answer 15

70-100 days

Question 16

What does the alkali process produce?

Answer 16

Type B gelatin

Question 17

What are the properties of gelatin?

Answer 17

Non-toxic + non-irritant
Soluble in biological fluids at body temp
Good film forming properties
Solutions of high conc mobile at 50 degrees
Change to a gel above RT

Question 18

What are the problems with gelatin?

Answer 18

Gelatin allergy

Vegans + vegetarians

Question 19

Why are colourants added?

Answer 19

Improve patient compliance
Medication identification
Phycological effect
Potential for light protection

Question 20

What are the two types of colourants?

Answer 20

Water soluble dyes

Insoluble pigments

Question 21

Why are optional materials added?

Answer 21

Process aids - eg. surfactants
Preservatives
Performance aids - eg. flavouring agent

Question 22

Describe hard capsule

Answer 22

Most common
Consist of cap + body
Filled with drug

Question 23

How many sizes of hard capsules are available?

Answer 23

8

Question 24

What must hard capsule filling be?

Answer 24

Free form large amount of moisture
Not react with shell
Not leak out
Have good powder flow
Not be adhesive
Be capable of being filled uniformly

Question 25

Why are diluents added in hard capsules?

Answer 25

Bulk forming properties

Question 26

Why are lubricants added in hard capsules?

Answer 26

Reduce powder to metal adhesion

Question 27

Why are glidants added in hard capsules?

Answer 27

Reduce powder cohesion

Question 28

Why are wetting agents added in hard capsules?

Answer 28

Improve H2O penetration

Question 29

Why are stabilisers added in hard capsules?

Answer 29

Improve product stability

Question 30

Why are disintegrates added in hard capsules?

Answer 30

Produce disruption of powder mass

Question 31

How are hard capsules filled?

Answer 31

Empty capsules orientated in correct position 2 halves separated Exact dose places onto surface of body plate + spread with spatula to fill capsule Cap locked on body Filled capsule removed from machine

Question 32

What does soft capsules consist of?

Answer 32

Liquid or semisolid matrix sealed inside one-piece flexible solid-phase gelatin shell

Question 33

What are the advantages of soft capsules?

Answer 33

``` Increase rate of absorption Tasteless Easy to swallow Enhanced safety Dose uniformity Product stability ```

Question 34

Why are soft capsules increased rate of absorption?

Answer 34

Already solution

Question 35

Why do soft capsules have enhanced safety?

Answer 35

No airborne powder during manufacturing

Question 36

Why is it good that soft capsules have dose uniformity?

Answer 36

Better homogeneity + flow than powder

Question 37

Why are soft capsules more stable?

Answer 37

Drug protected by shell + lipid vehicles | Against oxidation, moisture, ect

Question 38

What are the types of soft capsules?

Answer 38

``` Oral soft capsules Chewable Twist-off Suckable Meltable ```

Question 39

What are the composition of soft capsules?

Answer 39

Gelatin (40%) Plasticizers (20-30%) H2O

Question 40

Why are plasticizers used?

Answer 40

Make shell soft + pliable

Question 41

Why is H2O used?

Answer 41

Allow proper processing during gel preparation + soft gel encapsulation

Question 42

What are the different types of softgel fill matrices?

Answer 42

Lipophilic liquid Hydrophilic liquid Self-emulsifying liquid

Question 43

Why are lipophilic liquid used?

Answer 43

For lipophilic drugs | eg. vitamin D + steroids

Question 44

Why are self-emulsifying liquid used?

Answer 44

Auto emulsifies to form droplets when in contact with GI fluid Allow greater capacity to solubilise drug High SA of droplet facilitate rapid diffusion of drug

Question 45

What do self-emulsifying liquid contain?

Answer 45

oil + surfactant

Question 46

What is an example of lipophilic liquid?

Answer 46

Triglyceride oils

Question 47

What is an example of hydrophilic liquid?

Answer 47

Polyethene glycol

Question 48

How are softgels manufactured?

Answer 48

Fully automated machine