MDM: Capsules Flashcards

1
Q

What are hard gelatine capsules made off?

A
  • Colour
  • water
  • gelatin
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2
Q

What are soft gelatin capulses made off?

A
  • Water
  • Gelatine
  • colour
  • flavours
  • glycerol
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3
Q

Why choose capsules?

A
  • Ease of administration
  • taste masking
  • Easy to formulate
  • stability enhancement
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4
Q

Why is gelatine used?

A
  • Non-toxic
  • Easy prepared
  • soluble in gastric fluids
  • good film former
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5
Q

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

A
  • Vcaps Hypromellose: Hydroxypropylmethylcellulose, plant based (vegetarin)
  • NCaps Pullulan: Polysaccharide
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6
Q

Benefits of HGCs?

A
  • colour aids identificstion
  • easy shape to swallow
  • shell masks taste
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7
Q
  1. What are SGC?
  2. What are they used for?
  3. What are their advantages?
A
  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
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8
Q

What can be filled into a capsule?

What are the requirements?

A
  • 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
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9
Q
  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?
A
  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
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10
Q
  1. How is maxium capsule fill weight calculated?
  2. How is capsule volume required calculated?
A
  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)
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11
Q
  1. What can SS and liquids be filled into?
  2. What are the limitations?
A
  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
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12
Q

What can properties of liquid/ SS formulations be?

A
  • Water (im)miscible
  • solutions, suspensions
  • multiple or single phase
  • self emulsifying systems
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13
Q

What are the types of liquid capsules?

A
  • 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
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14
Q

limitations of liquid capsules

A
  • require special equipment for filling SGC
  • inelequent and low yields with HGCs
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15
Q

Tablet vs Capsules

A

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
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16
Q

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

A
  • 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
17
Q

How much glidant/ lubricant should be used. Examples

A
  • 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
18
Q

When are wetting agents used? example?

A

when fluid needs to penetrate powder

sodium lauryl sulphate

19
Q

Example of distigrant

A

•Ac-Di-Sol or Explotab

20
Q

Example of granulating agent

A

PVP

21
Q

Discuss F of liquid capsules

A
22
Q

HOw are capsules filled?

A

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”

23
Q

What are capsule filling requirements?

A
  • 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
24
Q

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

Which step is the crucial step?

A
  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
25
Q

Describe filling liquid capsules

A
  • 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
26
Q

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

A

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

27
Q

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

A

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

28
Q

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

A

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

29
Q
A