CApsules Flashcards
- Discuss the raw materials used in the manufacture of hard and soft gelatine capsules
- Calculate the size of capsule required from knowledge of fill- weight and the tapped bulk density of the material.
- Discuss the excipients added to the powdered drug substance prior to filling into heard gelatine capsules.
- Provide a full discussion of the following formulation factors affecting drug release from a hard gelatine capsule:
* Physicochemical properties of the active ingredient.
* Nature and effect of the diluent, using a suitable example.
* Effects of glidants and lubricants.
* Addition of a surfactant to the powder mix.
- Discuss the advantages of soft gelatine capsules over other solid dosage forms.
Describe the range of substances that may be enclosed in a softgel and the factors affecting the bioavailability of a drug from a softgel.
- Describe concisely the modern methods of manufacture and filling of hard gelatine capsules (This is covered by the PCCAL package ‘Filling’ on the network. See below).
- State the main components of both hard and soft capsules and their proportions.
- Briefly describe the types of materials which cannot be filled into gelatine capsules and why this is the case.
- Explain the various types of formulation which can be filled into gelatine capsules.
- State four reasons why gelatine is the material of choice when preparing capsules.
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- 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
- Briefly describe the advantages of capsules over conventional immediate release tablets.
- State why liquid filled capsules are still not widely used.
- State three reasons why a tablet could be filled into a hard gelatine capsule.
Maximum capsule = tapped bulk density of formulation (g /mL) x capsule volume (mL)
fill weight (g)
Capsule volume = required fill weight (g) / tapped bulk density of formulation (g / mL) required (ml)
- Using the above two calculations determine the following:
Example a: The maximum fill weight of a capsule if the bulk density of the formulation is 0.78 g / mL and the capsule volume is 0.68 mL.
0.78 g / mL x 0.68 mL = 0.5304 g (530.4 mg)
Maximum capsule = tapped bulk density of formulation (g /mL) x capsule volume (mL)
fill weight (g)
Capsule volume = required fill weight (g) / tapped bulk density of formulation (g / mL) required (ml)
Example b: The capsule volume required for a 330 mg powder blend of density 0.49 g / mL.
0.33 g / 0.49 g / mL = 0.6735 mL
- Write a short statement describing both of the processes for pellet filling of capsules entitled ‘slide/piston dosing method’ and ‘dosage tube method’.
- Write a short statement describing both of the processes for powder filling of capsules entitled ‘auger dosing method’ and ‘dosator & piston dosing method (intermittent)’.
- Briefly describe the process for liquid filling of hard gelatine capsules.
- Explain the five basic operations of any capsule filling machine.
- Write a short statement describing the process for filling solid dosage forms into capsules entitled ‘form slide dosage method’.
- 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.
- 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.
- Based on the PCCAL package, explain the limits which apply to the uniformity of weight test.
- For those products which have a BP monograph which additional test is required?
- For those products which have a BP monograph which additional test is required?
- Identify and explain three types of capsule defect from each of the defect categories found within the PCCAL package.
- Name and explain one defect which could occur at each of the five basic machine operation stages identified in question eleven above.
