Capsules final

Question 1

What is a capsule dosage form?

Answer 1

A solid dosage form in which an active drug is enclosed within a shell, usually for oral administration but also usable via inhalation, rectal, or vaginal routes.

Question 2

What are the two main types of capsules?

Answer 2

Hard capsules (two-piece) and soft capsules/softgels (one-piece).

Question 3

Give examples of drugs commonly supplied as capsules.

Answer 3

Antibiotics such as amoxicillin and cefalexin.

Question 4

Describe the structure of a hard capsule.

Answer 4

Two-piece shell consisting of a longer narrow body inserted into a wider cap.

Question 5

What is the main material of hard capsule shells and its origin?

Answer 5

Gelatin — hydrolysed collagen from connective tissues (skin, bones, ligaments).

Question 6

What are the types of gelatin?

Answer 6

Type A (acid-hydrolysed) and Type B (alkali-hydrolysed).

Question 7

What non-gelatin capsule shell polymers exist?

Answer 7

HPMC (vegetarian) and PVA.

Question 8

Typical composition of a hard capsule shell?

Answer 8

Gelatin/polymer, 13–16% water, plasticiser (e.g., glycerol), surfactant (SLS), colourant/opacifier (e.g., TiO2).

Question 9

Functions of excipients in capsule shells?

Answer 9

Plasticiser gives flexibility; surfactant improves wetting during manufacture; opacifier/dye provides colour and light protection.

Question 10

Why do capsule shells dissolve in the body?

Answer 10

Polymers are soluble in biological fluids at body temperature.

Question 11

Typical capsule shell wall thickness?

Answer 11

~100 µm.

Question 12

Relationship between capsule size number and volume?

Answer 12

Smaller number equals larger capsule.

Question 13

What features prevent hard capsules opening during handling?

Answer 13

Notches/dimples and locking grooves.

Question 14

Function of tapered rim and air vent?

Answer 14

Rim prevents splitting; air vent allows air escape during filling.

Question 15

How are hard capsules manufactured?

Answer 15

Metal pins dipped into gelatin solution, dried, removed, trimmed, and assembled (pin-dipping method).

Question 16

Why is the manufacturing principle notable?

Answer 16

It has remained essentially unchanged for about 180 years.

Question 17

What materials can be filled into hard capsules?

Answer 17

Powders, granules, pellets, tablets, semi-solids, and non-aqueous liquids.

Question 18

What cannot be filled into hard gelatin capsules and why?

Answer 18

Aqueous solutions because water dissolves the gelatin shell.

Question 19

What formulation properties must hard capsule fill materials have?

Answer 19

Homogeneity, appropriate particle size and density, compatibility, and good flow.

Question 20

Why are good flow properties important?

Answer 20

To ensure accurate filling and dose uniformity.

Question 21

Difference between dependent and independent dosing?

Answer 21

Dependent: fill volume determined by capsule body; Independent: fill weighed separately.

Question 22

Describe dosator and tamping-finger systems.

Answer 22

Dosator measures a powder mass; tamping fingers compress plugs into capsules.

Question 23

Structure of soft capsules?

Answer 23

One-piece continuous gelatin shell, usually ovoid or oblong.

Question 24

Softgel shell composition?

Answer 24

Gelatin plus plasticiser (20–30%), water (30–40% wet then 5–8% dry), colourants and sometimes preservatives.

Question 25

Examples of softgel plasticisers?

Answer 25

Glycerol, sorbitol, PEG.

Question 26

What do softgels usually contain?

Answer 26

Drug in solution or suspension (lipophilic oils or hydrophilic PEG).

Question 27

Why are softgels ideal for poorly water-soluble drugs?

Answer 27

Drug is pre-dissolved, improving absorption.

Question 28

Examples of drugs suitable for softgels?

Answer 28

Ibuprofen, cod liver oil, vitamins A, D, E, and K.

Question 29

What are self-emulsifying drug delivery systems?

Answer 29

Drug-oil-surfactant mixtures forming micro or nano droplets in GI fluid.

Question 30

What are lipolysis systems?

Answer 30

Lipid matrices digested in the GI tract to enhance drug dissolution and absorption.

Question 31

What must the softgel fill matrix achieve?

Answer 31

Dissolve or suspend drug, release in GI tract, maintain solution, be shell-compatible, and enhance absorption.

Question 32

Why must hydrophilic solvents be limited (<10%) in softgels?

Answer 32

They migrate into and weaken the gelatin shell, causing leakage.

Question 33

In-process QC parameters for softgels?

Answer 33

Gel impurities, ribbon thickness, seal thickness, fill weight, shell weight, moisture content, and hardness.

Question 34

What do these QC parameters affect?

Answer 34

Dose uniformity, stability, and drug release.

Question 35

General advantages of capsules over tablets?

Answer 35

Fewer excipients, easier manufacture, taste masking, and easier swallowing.

Question 36

Stability advantages of capsules?

Answer 36

Protect from oxidation, moisture, and photodegradation and separate incompatible drugs.

Question 37

Clinical and practical advantages?

Answer 37

Allow clinical trial blinding and tamper-resistant designs.

Question 38

Why do patients prefer capsules?

Answer 38

Convenience and ease of swallowing.

Question 39

Why do softgels improve bioavailability?

Answer 39

Drug is already in solution and rapidly released.

Question 40

Why are softgels safer for manufacturing potent drugs?

Answer 40

No airborne powder exposure (e.g., cytotoxic drugs).

Question 41

Why do softgels give good dose uniformity?

Answer 41

Homogeneous drug solution.

Question 42

Why may gelatin capsules be unsuitable for some patients?

Answer 42

Animal origin conflicts with religious or dietary beliefs.

Question 43

What alternative should be offered?

Answer 43

HPMC vegetarian capsules or alternative dosage form.

Question 44

Why are capsules useful in modified-release formulations?

Answer 44

They can contain pellets or multiple components in one shell.

Question 45

Main difference between hard and soft capsules?

Answer 45

Hard are two-piece and usually solid fills; soft are one-piece and usually liquid fills.

Question 46

Which capsule type most improves drug absorption?

Answer 46

Softgels.

Question 47

Which capsule type is more formulation-flexible?

Answer 47

Hard capsules.

Question 48

Which fill is unsuitable for hard gelatin capsules?

Answer 48

Aqueous drug solution.

Question 49

Why does shell moisture matter?

Answer 49

It affects hardness and drug release rate.

Question 50

What topics must you know about capsules for exams?

Answer 50

Structure, shell composition, fill materials, manufacture, QC parameters, and advantages.