Capsules

Question 1

Define capsule and what are the two types

Answer 1

• Capsule is an edible package made from gelatin or other suitable material which is filled with medicine to produce dosage form, for oral use
• Two types: hard and soft capsules

Question 2

Name raw materials used to make capsules x5

Answer 2

• Gelatin (or hydroxypropylmethylcellulose HPMC)
• Water
• Colourants
• Optional materials (process aids and preservatives)
• Plasticizers (in soft capsules)

Question 3

Describe how gelatin is produced (hint: theres two ways)

Answer 3

Question 4

Properties of gelatin x4

Answer 4

• Non-toxic
• Soluble at body temperature - Changes from gel to sol at temperature just above room temp
• Has good film forming properties (outter coat)
• Solutions of high concentration, 40% w/v, are mobile at 50 C

Question 5

Certification of gelatin

Answer 5

• Bloom strength (measure of rigidity) - seeing how many grams is required to push a plunger for 4mm into the gel
  Hard capsules – 200-250 g
  Soft capsules - 150 g
• Viscosity

Question 6

What is the role of plasticizer in gelatin

Answer 6

• Empty gelatin capsules contain water which acts as plastizer to the film
• It allows gelatin walls to flex during filling and packaging
• This makes gelatin soft
• Substances like glycerin and sorbitol are added to make the capsule shell more flexible in softgels.

Question 7

What is the main issue with gelatin

Answer 7

• Not suitable for vegetarians
• Made from animal bones, cartilage and pug skin

Question 8

Whats an alternative to gelatin

Answer 8

Question 9

Describe the structure of a hard capsule

Answer 9

Question 10

Name the three types of materials for the filling of a hard capsule

Answer 10

Question 11

How to store empty capsules

Answer 11

Question 12

How are capsules filled

Answer 12

• The two halves of the capsule are separated
• An exact dose is placed into the smaller half (the body)
• The cap is then locked onto the smaller half
• The filled capsule is removed from the machine.

Question 13

Name some types of capsule filling machines

Answer 13

• hand operated
• semi-automatic
• fully automatic

Question 14

Name atleast five excipients in powder filled capsules

Answer 14

• Diluents – used to achieve desired weight and consistency
• Lubricants – reduce powder to metal adhesion, smooth filling
• Glidants – improve powder flow
• Wetting agents – improve water penetration
• Disintegrants – produce disruption of the powder mass
• Stabilisers – improve product stability

Question 15

Name some pharmacopoeial standards for capsules

Answer 15

Similar to those for tablets

Question 16

Name some factors to think of when choosing between capsules or tablets

Answer 16

• Masking Taste and Odor: Capsules can contain and mask unpleasant tastes or odors of certain drugs, improving patient compliance.
• Ease of Swallowing and Administration: Capsules are smooth and easy to swallow, which is beneficial for patients who struggle with tablets.
• Flexible Dosing: Capsules can be filled with a variety of forms, including powders, granules, liquids, and gels, providing versatility for different drugs.
• Enhanced Bioavailability: Softgel capsules can improve the bioavailability of poorly water-soluble drugs, as the active ingredients are often dissolved in oils or other suitable solvents.
• Precision in Dosing: Capsules offer accurate dosing compared to other forms (like suspensions), which is crucial for maintaining efficacy and safety.

Question 17

Overview of differentiation between hard and soft capsules

Answer 17

• Hard Capsules: Also known as hard gelatin capsules, these consist of two rigid pieces (a body and a cap) that fit together. They are typically used for dry, powdered, or pellet-filled formulations.
• Soft Capsules: Soft gelatin capsules (or softgels) have a single, flexible shell often filled with liquid or semi-solid ingredients. They are widely used for oils, vitamins, and medications that require rapid absorption.