MDM: Capsules Flashcards
What are hard gelatine capsules made off?
- Colour
- water
- gelatin
What are soft gelatin capulses made off?
- Water
- Gelatine
- colour
- flavours
- glycerol
Why choose capsules?
- Ease of administration
- taste masking
- Easy to formulate
- stability enhancement
Why is gelatine used?
- Non-toxic
- Easy prepared
- soluble in gastric fluids
- good film former
What other materials apart from geltaine can be used for capsules?
- Vcaps Hypromellose: Hydroxypropylmethylcellulose, plant based (vegetarin)
- NCaps Pullulan: Polysaccharide
Benefits of HGCs?
- colour aids identificstion
- easy shape to swallow
- shell masks taste
- What are SGC?
- What are they used for?
- What are their advantages?
- Flexible single piece capsules
- oils, paints, toiletries
- banded HGC have poor yields, difficult to process and aesthetically unapealing. They have short production runs, secure seals, colour coding
What can be filled into a capsule?
What are the requirements?
- 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
- For hard gelatine capsules being filled with powder, what are the requirements of the powder?
- What types of methods are used to fill these?
- Powder must flow well. Powder must have a degree of cohesivness but not so that it sticks to machines
- flooding technique - dose contained within full capacity of capsule. All other techniques - dose contained in less than half full capacity of capsule
- How is maxium capsule fill weight calculated?
- How is capsule volume required calculated?
- Maximum capsule fill weight = Tapped bu;=lk density (g/ml) x capsule volume (ml)
- Capsule volume required = Required fill weight (g) / tapped bulk density (g/ml)
- What can SS and liquids be filled into?
- What are the limitations?
- 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
What can properties of liquid/ SS formulations be?
- Water (im)miscible
- solutions, suspensions
- multiple or single phase
- self emulsifying systems
What are the types of liquid capsules?
- 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
limitations of liquid capsules
- require special equipment for filling SGC
- inelequent and low yields with HGCs
Tablet vs Capsules
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
Describe what type of dilutent would be used depending on the API. What are examples?
- 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
How much glidant/ lubricant should be used. Examples
- 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
When are wetting agents used? example?
when fluid needs to penetrate powder
sodium lauryl sulphate
Example of distigrant
•Ac-Di-Sol or Explotab
Example of granulating agent
PVP
Discuss F of liquid capsules
HOw are capsules filled?
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”
What are capsule filling requirements?
- 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
Explain the 5 basic operations for filling for any capulse filling machine
Which step is the crucial step?
- Supply of tablets
- Rectification - align capulse vertically to allow for filling
- Seperation - seperate body and cap of capsule
- filling - fill capsule with liquid/ powder/ tablet
- Joining - join body and cap together
- Ejection - remove tablet from machinary
Describe filling liquid capsules
- 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
Write a short statement describing both of the processes for powder filling of capsules entitled ‘auger dosing method’ and ‘dosator & piston dosing method (intermittent)’
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
Write a short statement describing both of the processes for pellet filling of capsules entitled ‘slide/piston dosing method’ and ‘dosage tube method’.
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
Write a short statement describing the process for filling solid dosage forms into capsules entitled ‘form slide dosage method’.
Conical drug hopper transfers tablets one at a time via a form slide to capsule body.
