1. PREPARATION

2. METHODS OF PREPARATION
Four methods
Molding by hand
Compression
Pour molding
Compression in a tabletting machine

3. MOLDING BY HAND
Hand molding is useful when we are preparing a small number of suppositories

4. MOLDING BY HAND
STEP 1
drug
fine powder

5. MOLDING BY HAND
STEP 2
Drug (fine powder)
Base

6. MOLDING BY HAND
STEP 3
Trituration
in pestle and mortar

7. MOLDING BY HAND
STEP 4
Mass
Rolled
Long rods

8. MOLDING BY HAND
STEP 5
Rods
cut into pieces

9. COMPRESSION MOLDING
The cold mass of the base containing the drug is compressed into suppositories using a hand operated machine.

10. COMPRESSION MOLDING
STEP 1
drug
fine powder

11. COMPRESSION MOLDING
STEP 2
Drug (fine powder)
Base

12. COMPRESSION MOLDING
STEP 3
Trituration
in pestle and mortar

13. Compress the mixture in the compression mold
COMPRESSION MOLDING
STEP 4
Compress the mixture in the compression mold

14. ADVANTAGES It is a simple method
More elegant than hand molded suppositories.
Sedimentation of solids in the base is prevented.

15. DISADVANTAGES Air entrapment may take place.
This air may cause weight variation.
The drug and/or the base may be oxidized by this air.

16. POUR MOLDING
The melted mass of the base containing the drug is poured into suppository moulds

17. POUR MOLDING
STEP 1
drug
fine powder

18. POUR MOLDING
STEP 2
Melt the base

19. Drug incorporation into melted base
POUR MOLDING
STEP 3
Drug incorporation into melted base

20. POUR MOLDING
STEP 4
Cooling down process

21. (lubricate if necessary)
POUR MOLDING
STEP 5
Molds are chilled
(lubricate if necessary)

22. POUR MOLDING
STEP 6
Molten liquid mass
chilled molds

23. POUR MOLDING
STEP 7
Warm spatula

24. Removed excessive part via warm spatula
POUR MOLDING
STEP 8
Removed excessive part via warm spatula

25. After solidification the cone shaped suppositories are removed.
POUR MOLDING
STEP 9
After solidification the cone shaped suppositories are removed.

26. AUTOMATIC MOLDING MACHINE
In industry all the operations in pour molding are done by automatic machines.
Using this machine, up to about 10,000 suppositories per hour can be produced.

27. PRACTICAL PROCEDURE

28. STEP 1 Given by physician Drug quantity e.g., 400 mg zinc oxide
Total weight of suppository e.g., 2g
No of suppositories e.g., 10
Purpose e.g., For rectal use

29. Specific shape and volume
STEP 2
Select mold
Specific shape and volume

30. Pour only melted base into mold
STEP 3
Pour only melted base into mold
Solidification
excessive removed

31. STEP 4 melt Check volume of remelted base
Confirm average weight of suppository

32. STEP 5 Check the weight by using formula Mass= density × volume
Calculate total weight of 10 suppositories
= 20g

33. STEP 6
Displacement value of drug to the base e.g., 4.7g of ZnO= 1g of cocoa butter
Means 400mg × 10 = 0.85 g of base
Volume of base needed = 20g-0.85
=19.15g

34. STEP 7 Drug Solution into mold Fill mold with base
Upon solidification Excess removed

35. STEP 8
Melt the suppository
Homogeneous mixture

36. STEP 9
pour into the mould
Solidification
Excessive removed

37. RESULT Desired suppository Note
it is normal practice to prepare for an excess quantity of suppositories

38. SUPPOSITORY PACKAGING
RULES AND PREVENTIONS
SUPPOSITORY PACKAGING

39. PACKAGING Types of molds of different shapes and volumes Reusable
Stainless steel mold
Aluminium mold
Brass mold
Plastic
Disposable
Soft Plastic molds

40. PACKAGING
Suppositories manufactured in metal moulds Separated from moulds carefully Wrapped individually by aluminium foil Placed in container

42. PACKAGING Suppositories manufactured in disposable moulds
Dispensed to the patient as it is
Note = It should be easy to release each suppository from mould

44. Best to keep all suppositories refrigerated
PACKAGING
In General:
Best to keep all suppositories refrigerated
Base of Cocoa Butter:
Store < 30oC
Base of glycerinated gelatin:
Store <35oC
Base of PEG:
High m.p. so usually OK slightly warm

45. PACKAGING About Containers: Tightly closed glass
(i.e. glycerin is very hygroscopic)
Individually wrapped foil
(Use: Unwrap & insert)

46. PACKAGING Environmental Factors: Important due to base
High humidity—absorbs water from atmosphere
Low humidity—loose water to atmosphere--brittle

47. SUPPOSITORY DISCARD DATES

48. DISCARD DATES Discard dates are w.r.t. official data
If official data is not available
Discard date = 3 months
after manufacturing

49. SUPPOSITORY LABELLING

50. LABELLING In addition to standard rules for labelling
Followings are important to mention
For _____ use only
Rectal
Vaginal
Store below 150C

51. Thanks
Questions?