27 Capsules

Question 1

What is a hard capsule?

Answer 1

A solid dosage form comprising a physiologically inert, hard exterior shell filled with a therapeutic substance - in powder, granule or pellet form.

Question 2

What are pro’s and cons of hard capsules

Answer 2

Pro’s:
- rapid release can be offered by containing powder form.
- able to mix ingredients that are incompatible in tablets
- advantages of tablet coating
- can be readily retrieved for extempraneous compounding.
Cons:
- expensive and takes longer to manufacture than tablets.

Question 3

What can hard capsules be made of?

Answer 3

Gelatin: most common ingredient but derived from animals so use has decreased.
Hydroxylpropyl methylcellulose: semi-synthetic plant-based, more costly than gelatin.
Starch (potato-based), pullulan (tapioca based), polyvinyl alcohol (for oily ingredients)

Question 4

How are hard capsules made?

Answer 4

Metal moulds dipped into capsule material. Gel film is dried, cut and removed from mould - then joined with another piece.

Question 5

How is the quality of dipping gel tested and what does this tell you?

Answer 5

Tested by bloom strength - tells us the resistance offered by the gel to deformation, and to ensure capsule shels have consistent rigidity.

Question 6

What are the moisture content parameters for hard capsules? Why are these parameters in place?

Answer 6

moisture contetn <12% = too brittle, >18% = too soft.

Ensures that capsules don’t leech out or take in moisture.

Question 7

What quality tests are performed on hard capsules?

Answer 7

• content uniformity
• weight variation
• disintergration
• dissolution

Question 8

What are softgels?

Answer 8

One-piece, hermetically sealed soft shells made of gelatin and water.
These do not let air in or moisture out.

Question 9

Why would softgels be used over hard capsules?

Answer 9

• more size and shape flexibility
• ease of incorporating liquids
• faster action for low solubility drugs
• more accurate dosing of low concentration drugs
• easy to administer low MP drugs
• cleaner process (no particulates)

Question 10

What are some excipients of soft gels?

Answer 10

Shell: contains gelatin, water and plasticiser for elasticity
Other shell: opacifiers, colouring and flavours/sweeteners.
Fill: oil solvent base (with dissolved/suspended active), flavours (if chewable), antioxidants/preservatives, suspending agents

Question 11

How are soft gels made?

Answer 11

Using a rotary die process where two gel ribbons are run into moulds with filling added.

Question 12

What is tested for in softgels?

Answer 12

• ribbon thickness and seal thickness (consistent)
• fill matrix weight and capsule weight
• softgel moisture levels and capsule hardness
• bloom strength

Question 13

What tests are performed on the finished product of soft gels

Answer 13

• disintergration and dissolution
• active ingredient concentration
• content uniformity
• weight variation
• microbial testing

Question 14

What are limitations of soft gels?

Answer 14

• interior is liquid making this less stable than hard capsules or tablets
• difficult to incorporate water into capsule core so hard to administer water soluble drugs
• tough to extract contained drug for extemporaneous compounding

Question 15

what functions are softgels able to perform compared to hard capsules?

Answer 15

• can be chewed to release drug in oral cavity
• swallowed whole
• sucked like lozenges

Question 16

what are non-oral applications for capsules?

Answer 16

administration via rectal and vaginal routes. can also be combined with inhalers.

Question 17

How can capsules be used to administer devices?

Answer 17

Can administer insulin via SOMA devices. Insulin needs to be injected directly into bloodstream, so these devices attach to the stomach wall and directly inject insulin into the stomach wall.

Question 18

Summarize soft gel properties and use

Answer 18

• incorporates oily drugs in liquid form
• size and shape flexibility
• accurate dosing of low concentration drugs
• manufacturing process devoid of particulates.