CApsules

Question 1

1. Discuss the raw materials used in the manufacture of hard and soft gelatine capsules

Question 2

2. Calculate the size of capsule required from knowledge of fill- weight and the tapped bulk density of the material.

Question 3

3. Discuss the excipients added to the powdered drug substance prior to filling into heard gelatine capsules.

Question 4

4. 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.

Question 5

5. Discuss the advantages of soft gelatine capsules over other solid dosage forms.

Question 6

Describe the range of substances that may be enclosed in a softgel and the factors affecting the bioavailability of a drug from a softgel.

Question 7

7. 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).

Question 8

1. State the main components of both hard and soft capsules and their proportions.

Question 9

2. Briefly describe the types of materials which cannot be filled into gelatine capsules and why this is the case.

Question 10

3. Explain the various types of formulation which can be filled into gelatine capsules.

Question 11

4. State four reasons why gelatine is the material of choice when preparing capsules.

Answer 11

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Question 12

5. 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

Question 13

6. Briefly describe the advantages of capsules over conventional immediate release tablets.

Question 14

7. State why liquid filled capsules are still not widely used.

Question 15

8. State three reasons why a tablet could be filled into a hard gelatine capsule.

Question 16

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)

9. 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.

Answer 16

0.78 g / mL x 0.68 mL = 0.5304 g (530.4 mg)

Question 17

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.

Answer 17

0.33 g / 0.49 g / mL = 0.6735 mL

Question 18

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

Question 19

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

Question 20

11. Briefly describe the process for liquid filling of hard gelatine capsules.

Question 21

10. Explain the five basic operations of any capsule filling machine.

Question 22

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

Question 23

15. 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.

Question 24

15. 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.

Question 25

16. Based on the PCCAL package, explain the limits which apply to the uniformity of weight test.

Question 26

17. For those products which have a BP monograph which additional test is required?

Question 26

17. For those products which have a BP monograph which additional test is required?

Question 27

18. Identify and explain three types of capsule defect from each of the defect categories found within the PCCAL package.

Question 28

19. Name and explain one defect which could occur at each of the five basic machine operation stages identified in question eleven above.