MDM: Capulses DS Flashcards
1
Q
- State the main components of both hard and soft capsules and their proportions.
A
- Hard: Colours, water, gelatine
- Soft: Colours, flavouring, gelatine, glycerol, water
2
Q
- Briefly describe the types of materials which cannot be filled into gelatine capsules and why this is the case.
A
- Emulsions
- Water/ aldehyde/ gelatine solvents – soften/ distort capsule
- Surfactants used with care
- Not extremes of pH
3
Q
- Explain the various types of formulation which can be filled into gelatine capsules.
A
- Solid: powder, tablets, pellets, granulation
- Liquids – non aqueous
- Semi solids
- These can be filled in due to the nature of the filling process
4
Q
- State four reasons why gelatine is the material of choice when preparing capsules.
A
- Non toxic
- Prepared easily
- Good film former
- soluble in gastric fluid
5
Q
- Identify and state the purpose of the main excipients which would be used in the preparation of a granulation for filling into a hard gelatine capsule.
A
- Dilutent
- Lubricant
- Distigrant
- Flavouring
- Colouring
- Vehicle
6
Q
- Briefly describe the advantages of capsules over conventional immediate release tablets.
A
Tablets: Compression problems/ API
- Laminating/ sticking / picking/ capping/ fracturing
- Uniformity of dose/ flow problems
- API problems: Stability, solubility, physical form, hygroscopic
Capsules: no compression problems/ API
- No laminating/ sticking/ picking / capping/ fracturing problems
- Drug in solution or fine suspension so no uniformity problems
- Drug can be directly filled into capsule
- Limited contact with air, heat, moisture
Unlike tablets, capsules don’t need to be compressed so there is no lamination, picking, sticking or capping. There is also uniformity of dose unlike tablets as the API is in a fine suspension or solution
7
Q
- State why liquid filled capsules are still not widely used.
A
- SGC – specialist equipment required to fill
- HGC - In HGC they produce low yields and unappealing
8
Q
- Explain the five basic operations of any capsule filling machine.
A
- Supply of tablets
- Rectification – position tablet vertically ready to be filled
- Separation – separate cap from body
- Filling- fill capsule with liquid/ powder
- Joining – join/ bind cap and body
- Ejection – remove tablet from capsule filling machine
9
Q
- Briefly describe the process for liquid filling of hard gelatine capsules.
A
When capsule is in filling station the liquid fill is drawn into the dosage cyclinder. Downward motion of control valve closes outlet valve to shut off flow to fill when right amount of liquid. Simultaneously dosage piston forces measured dose through dosage needle into capsule. Capsules banded to prevent leakage
10
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
- 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
- Dosator and piston: This filling method makes use of specially shaped tubes (Dosator and pistons). These dip into powder or granule fill and compress it into slugs which are deposited into capsule bodies
11
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
- Slide/piston - Pellets picked up by dosage hopper and transferred into capsule body
- 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
12
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.
13
Q
- Based on the PCCAL package, explain the limits of the EP uniformity of content test and the number of capsules on which the test must be performed.
A
- Done if capsule contains less than 2mg or 2%w/V API
- Determine concentration of AI in 10 capsules. Only 1 capsule is allowed to deviate from the mean between 85 – 115%. None are allowed to deviate outside 75- 125%.
- If 2/3 do fall outside 85-115% (not extra limits!) retest 20. 27/30 must be in the 85 – 115% limits.
14
Q
Based on the PCCAL package, explain the limits which apply to the uniformity of weight test.
A
- Weigh capsule then empty contents an weigh just shell. Capsule weigh – shell is the value for contents.
- Do this for 20 capsules
- No more than 2 should deviate from % stated
- None deviate by twice more than %stated
15
Q
- Identify and explain three types of capsule defect from each of the defect categories found within the PCCAL package.
A
-
Critical – defects that would interfere dramatically with filling process:
- Cracked – cause leakage of powder
- Short body – low dosage of fill
-
Major – Defects which would cause a problem in the use and effectiveness of the capsule
- Bad join – improperly joined risk non-seperation problems prior to filling
- Thin spots – capsules with thin spots in gelatine capsule can give rise to powder leakage if gelatine splits
-
Minor – Don’t affect performance of capsule/ only appearance
- Splits – cause leakage from gelatine capsule
- Bubbles – can occur during manufacture
-
Printing
- Unprinted – (Major) capsule with no logo
- Multiple print – multiple prints of logo making it iledgible
