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PREPARATION

PREPARATION . METHODS OF PREPARATION. Four methods Molding by hand Compression Pour molding Compression in a tabletting machine. MOLDING BY HAND. Hand molding is useful when we are preparing a small number of suppositories. MOLDING BY HAND. STEP 1. drug fine powder. MOLDING BY HAND.

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PREPARATION

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  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 arepreparing 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 containingthe 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. 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 beoxidized by this air.

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

  17. POUR MOLDING STEP 1 drug fine powder

  18. POUR MOLDING STEP 2 Melt the base

  19. POUR MOLDING STEP 3 Drug incorporation into melted base

  20. POUR MOLDING STEP 4 Cooling down process

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

  25. POUR MOLDING STEP 9 After solidification the cone shapedsuppositories 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. STEP 2 Select mold Specific shape and volume

  30. 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. 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

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

  42. 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

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

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

  45. SUPPOSITORYDISCARD DATES

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

  47. SUPPOSITORY LABELLING

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

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