MDM: Capsules

Question 1

What are hard gelatine capsules made off?

Answer 1

• Colour
• water
• gelatin

Question 2

What are soft gelatin capulses made off?

Answer 2

• Water
• Gelatine
• colour
• flavours
• glycerol

Question 3

Why choose capsules?

Answer 3

• Ease of administration
• taste masking
• Easy to formulate
• stability enhancement

Question 4

Why is gelatine used?

Answer 4

• Non-toxic
• Easy prepared
• soluble in gastric fluids
• good film former

Question 5

What other materials apart from geltaine can be used for capsules?

Answer 5

• Vcaps Hypromellose: Hydroxypropylmethylcellulose, plant based (vegetarin)
• NCaps Pullulan: Polysaccharide

Question 6

Benefits of HGCs?

Answer 6

• colour aids identificstion
• easy shape to swallow
• shell masks taste

Question 7

1. What are SGC?
2. What are they used for?
3. What are their advantages?

Answer 7

1. Flexible single piece capsules
2. oils, paints, toiletries
3. banded HGC have poor yields, difficult to process and aesthetically unapealing. They have short production runs, secure seals, colour coding

Question 8

What can be filled into a capsule?

What are the requirements?

Answer 8

• Solids (powder, pellets), liquids or semi solids that don’t react with geltaine
• Water and aldehydes can’t be used - soften and distort capsule
• Must relase AI in bioavailable form
• Must be able to acurately dose in capsule shell

Question 9

1. For hard gelatine capsules being filled with powder, what are the requirements of the powder?
2. What types of methods are used to fill these?

Answer 9

1. Powder must flow well. Powder must have a degree of cohesivness but not so that it sticks to machines
2. flooding technique - dose contained within full capacity of capsule. All other techniques - dose contained in less than half full capacity of capsule

Question 10

1. How is maxium capsule fill weight calculated?
2. How is capsule volume required calculated?

Answer 10

1. Maximum capsule fill weight = Tapped bu;=lk density (g/ml) x capsule volume (ml)
2. Capsule volume required = Required fill weight (g) / tapped bulk density (g/ml)

Question 11

1. What can SS and liquids be filled into?
2. What are the limitations?

Answer 11

1. SGC or HGC

• Emulsions not used
• aldehydes not used
• Surfactants used with care
• water or other gelatine solventa not used
• extremes of pH not used
• SS must become liquid to allow filling

Question 12

What can properties of liquid/ SS formulations be?

Answer 12

• Water (im)miscible
• solutions, suspensions
• multiple or single phase
• self emulsifying systems

Question 13

What are the types of liquid capsules?

Answer 13

• simple - liquid at RT. Hydrophillic vehicles (PEG), lipophillic (simple plant based oils)
• Intermeidate - more complex materials, (SCT, MCT, LCT), refined plant oils, chemically altered plant oils
• Complex

Question 14

limitations of liquid capsules

Answer 14

• require special equipment for filling SGC
• inelequent and low yields with HGCs

Question 15

Tablet vs Capsules

Answer 15

Tablet: compression problems

• Capping/ lamination
• picking/ sticking
• dose uniformity/ flow problems

Capsules: No Compression

• No sticking, picking, lamination, capping
• API in solution or fine suspension so dose uniformity not a problem

Tablet - API problems

• Stability
• solubility
• physical form
• hygroscopicty

Capsule - API problems overcome

• Limited contact with air, moisture, heat
• liquid active can be filled directly
• lipids used for formulation

Question 16

Describe what type of dilutent would be used depending on the API. What are examples?

Answer 16

• if poorly soluble drug use soluble dilutent. This makes more hydrophobic so distigration is greater. This increases dissolution rate. E.g mannitol, lactose
• if readily soluble API use insoluble dilutent. This avoids competition for GI fluid e.g. dicalcium phosphate

Question 17

How much glidant/ lubricant should be used. Examples

Answer 17

• makes more hydrophibic so should only be used in small quantities
• small amounts
• L - magnesium sterate. reduces cohesiveness of small particles so spread more rapidly through dissolution medium
• G - colloidal silicon dioxide

Question 18

When are wetting agents used? example?

Answer 18

when fluid needs to penetrate powder

sodium lauryl sulphate

Question 19

Example of distigrant

Answer 19

•Ac-Di-Sol or Explotab

Question 20

Example of granulating agent

Answer 20

PVP

Question 21

Discuss F of liquid capsules

Answer 21

Question 22

HOw are capsules filled?

Answer 22

ØFor powders - dosator type, auger type, tamping finger / dosing disc, flooding.

ØFor pellets/granulations – slide / piston method

ØFor liquids and semi-solids – fluid dosing method

ØPCCAL package “Methods of Filling of hard gelitin capsules”

Question 23

What are capsule filling requirements?

Answer 23

• Ability to maintain product at constant temperature
• Ability to maintain a homogenous suspension in the product hopper
• Ability to accurately dose volumes between 0.1 - 1ml
• ability to inteupt filling if capulse body missing
• ability to eject capule if cap missing

Question 24

Explain the 5 basic operations for filling for any capulse filling machine

Which step is the crucial step?

Answer 24

1. Supply of tablets
2. Rectification - align capulse vertically to allow for filling
3. Seperation - seperate body and cap of capsule
4. filling - fill capsule with liquid/ powder/ tablet
5. Joining - join body and cap together
6. Ejection - remove tablet from machinary

Question 25

Describe filling liquid capsules

Answer 25

* When capsule is in filling station liquid is drawn into dosing cyclinder * downward motion of control valve closes outlet valve and prevents flow to fill. * Simultaneously dosage piston forces measured dose into dosing needle into capsule * banded to prevent leakage

Question 26

Write a short statement describing both of the processes for powder filling of capsules entitled ‘auger dosing method’ and ‘dosator & piston dosing method (intermittent)’

Answer 26

Dosator and piston mehtod involeves using specially shaped tubes which dip into powder/ granulation fill and compress it into slugs which are depositied into capsule bodies Augar dosing method - uses a hopper with a fitted agitator and an augar. Agigtator used to feed material into augar which in turn feeds it into capsule

Question 27

Write a short statement describing both of the processes for pellet filling of capsules entitled ‘slide/piston dosing method’ and ‘dosage tube method’.

Answer 27

Dosage tube method (volumetric filling) – vacuum applied to dosage tubes which dip into rotating dosage trough. Dosage piston transfers the slug to the capsule body Slide/piston - Pellets picked up by dosage hopper and transferred into capsule body

Question 28

Write a short statement describing the process for filling solid dosage forms into capsules entitled ‘form slide dosage method’.

Answer 28

Conical drug hopper transfers tablets one at a time via a form slide to capsule body.