Polymers: Soft Capsules

Question 1

What is a soft capsule/softgel?

Answer 1

A liquid or semi-solid matrix hermetically sealed inside a 1-piece flexible gelatin shell

Question 2

What makes gelatin soft?

Answer 2

Capsule shell also contains a plasticiser, usually glycerol or propylene glycol

Question 3

Describe the structure of a soft capsule

Answer 3

Shell = gelatin, plasticiser, water
Optional enteric or delayed release coating
Fill = solution or suspension of drug, vehicle = water or oil miscible

Question 4

What goes into a soft capsule?

Answer 4

• Gelatin
• Plasticiser (glycerin, sorbitol, PEG)
• Water
• Dye/pigment
• Opacifier
• Other = flavour, sugar as needed
• Preservatives not normally required

Question 5

List 4 pharmaceutical applications of softgels

Answer 5

1. Oral dosage forms
2. Chewable soft gels
3. Suppositories
4. Topical products

Question 6

How do softgels provide better bioavailability?

Answer 6

Drug is typically in solution form in a soft capsule

This means quicker absorption = better bioavailability

Question 7

List 3 advantages of soft capsules

Answer 7

1. Improved drug bioavailability
2. Formed, filled and sealed in 1 step in an automatic manner
3. Improved patient compliance - easy to swallow

Question 8

List 3 disadvantages of soft capsules

Answer 8

1. Manufacturing requires high quality gelatin
2. Specialised and costly equipment is required
3. Manufacture of softgels = very complex, labour-intensive and time-consuming

Question 9

List 3 requirements for the formulation of soft capsules

Answer 9

1. A stable physical form of the drug
2. Excipients free from interactions with the drug substance
3. Inert environment during manufacture e.g. yellow light for photosensitive compounds

Question 10

List 4 ways that the standard of soft capsules is checked

Answer 10

1. Uniformity of weight
2. Content of API
3. Disintegration test
4. Dissolution test

Question 11

List 3 ways it is decided whether to formulate capsules or tablets for a dru

Answer 11

1. Drug stability
2. Equipment available
3. Competitor products