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  1. 1. Packaging<br />GadadeDipakDilip,<br />Dept. of Pharmaceutics, <br />Bhagwan College of Pharmacy,<br />Aurangabad<br />
  2. 2. Introduction<br />Defn :- Art & science of enclosing protecting products for distn, storage, sale & use.<br />Package label- Written, electronic or graphic on packaging or separate but associated label<br />Recognition of product<br />Packaging drug regulations<br />
  3. 3. Objectives<br /><ul><li>Physical protection eg. Shock, vibration
  4. 4. Barrier protection eg. O2, light
  5. 5. Containment eg. 10*10 packs
  6. 6. Information trasmissioneg. Direction
  7. 7. Marketing potential
  8. 8. Security eg. Antithept seal,
  9. 9. Convenience eg. Distribution, handling, sale
  10. 10. Portion control eg. Single dosage pack</li></li></ul><li>Primary Packaging<br /><ul><li>Packaging material that is in intimate contact with product
  11. 11. First envelopes & holds product
  12. 12. Smallest unit of distribution eg. Aerosol can, wrappers, bottle, envelope
  13. 13. It should be inert (no leaching, absorption or adsorption, etc.)
  14. 14. Should withstand mfg. condition eg. Freezing</li></li></ul><li>Secondary Packaging<br /><ul><li>Packaging material outside the primary packaging
  15. 15. Perhaps used to group primary packaging eg. Boxes, cartons, shrink-wrap, etc.
  16. 16. Should protect from excessive moisture, light, reactive gases, microbes, etc.
  17. 17. Protection to flexible container
  18. 18. Ease in handling</li></li></ul><li>Tertiary Packaging<br />Used for bulk handling and shipping eg. Barrel, crate, Slip sheet, etc.<br />
  19. 19. Components of Packaging<br /><ul><li>Container: refers to storage media in which product is placed or enclosed. Glass, Plastic
  20. 20. Closure: tightly packs container to exclude O2, CO2, moisture and micro-organisms & prevent loss of water and volatile substances from product. Rubber, aluminum</li></li></ul><li>Components of Packaging<br />Carton: Outer covering which gives sec. protection against mech. & environmental hazards also display written informationCardboard, molded wood pulp, expanded polystyrene<br />Box: Prim. defence against ext. hazards provide containment, absorbs shocks. Cardboard, wood<br />
  21. 21. Components of Packaging<br />Container Closure<br />Carton<br />
  22. 22. Closures <br /><ul><li>Prevents contents from escaping and allow no substance to enter the container
  23. 23. Resiliency of liner, flatness of sealing surface & tightness of seal
  24. 24. Closure designs:
  25. 25. Threaded screw cap- Engage threads in corresponding threads molded on neck of bottle
  26. 26. Crimp on (crown)- Used for beverage bottles
  27. 27. Press on(snap)- Cap pressed to seal
  28. 28. Roll on- Seals securely, opened easily, specific, available as reselable, nonresealable & pliferproof
  29. 29. Friction design</li></li></ul><li>Closure liner<br /><ul><li>Material inserted in a cap to effect a seal between closure &container usually made of resilient backing & facing material (soft & elastic)
  30. 30. Types
  31. 31. Homogenous
  32. 32. Heterogeneous
  33. 33. Selection factors
  34. 34. Compatibility
  35. 35. Appearance
  36. 36. Gas Transmisson
  37. 37. Heat resistance
  38. 38. Shelf life
  39. 39. Economic</li></li></ul><li>USP Terminology<br /><ul><li>Well closed Container: Protects from extraneous solids & loss of article under ordinary or customary conditions of handling, shipment, storage & distribution
  40. 40. Tight Container: Protects from contamination by extraneous material, prevents loss of by vaporization, efflorescence, deliquescence under ordinary or customary conditions of handling, shipment, storage & distribution and capable of tight re-closure.</li></li></ul><li>USP Terminology<br />Hermetic Container: Impervious to air or any other gas under ordinary…<br />Light Resistant Containers…<br />
  41. 41. Tamper Resistant Packaging<br />Package having indicator or barrier to entry which if breached or missing provides evidence of tampering.<br />It may involve immediate container/closure system or Sec. container/carton system<br />It was introduced to avoid adulteration of product <br />Eg. Film wrappers, Blister packages, Strip Package, Bubble packs, Shrink Seal, Aerosol container<br />
  42. 42. TamperResistant Packaging<br />Wrapper Strip<br />Aerosol <br /> Blister<br />
  43. 43. TamperResistant Packaging<br />Film Wrapper <br />End folded wrapper-Cellophane,PVDC, nitrocellulose<br />Fin seal- Crimping<br />Shrink Seal- PE, PP, PVC<br />Blister Package<br />Heat softened sheet of thermoplastic resin & vacuum drawing of sheet in contoured moulds- PVC, PVC/PE, PP, polystyrene, <br /> Push through backing- Heat seal coated Al-foil<br />Peelable backing-polyester or paper<br />
  44. 44. TamperResistant Packaging<br />Strip Package<br />Formed by feeding 2 webs of heat sealable flexible film thr’ heated crimping roller & product is dropped into pocket formed prior to forming final seal.<br />Cellophane, PE, PVC, etc.<br />Shrink Banding<br />Heat shrinkable polymer slightly larger in diameter than cap and neck ring of bottle <br />Bottle is moved thr’ a heat tunnel which shrinks tubing material tightly to engage cap & neck<br />
  45. 45. TamperResistant Packaging<br />Aerosol<br />HC propellant in its cooled liquid phase added to drawn Al-container along with product and spray nozzle contained in gasketted metal ferrule crimmped over opening of container<br />Other Temper Resistant Packagings<br />Bubble pack<br />Breakable caps<br />Sealed Tubes<br />Sealed Cartons<br />
  46. 46. Pilferproof Packaging<br />Pilferproof packaging has a closure with greater skirt length which extends below threaded portion to form a bank. <br />It has several narrow metal “bridges”<br />When pilferproof closure is removed bridges break and bank remains in place on the neck of container<br />User can reseal closure but detached band indicates package has been opened<br />Torque required to break bridge is nominal <br />
  47. 47. Pilferproof Packaging<br />
  48. 48. Child Resistant Package<br />To avoid cases of poisoning<br />Reduce risk of accidental <br /> ingestion medication<br />Safety cap provided for <br /> prescription drug, OTC <br /> medicine, pesticide, etc.<br />
  49. 49. Selection of Packaging Material<br />
  50. 50. Glass Material<br />Supercooled liquid of viscosity greater than 1013 poise which is composed of SiO2 (65-75%) tetrahedron modified with oxides of metal cations<br />Monovalent cations- M.P. of glass but also reduce strength eg. Na, K, B<br />Divalent Cations- gives mech. strength and chem. resistance eg. CaO, MgO<br />Trivalent Cations- chem. durability & mech. Strength eg. B2O3, Al2O3<br />
  51. 51. Selection of Glass Material<br />Advantages<br />Impermeable<br />Inert<br />Transparent<br />Inexpensive<br />Withstand high temp-pressure<br />Easy to clean<br />No absorption of active<br />Disadvantages<br />Leaching<br />Fragility<br />Flaking<br />Heavy wt.<br />Light trasmission<br />
  52. 52. Selection of Glass Material<br /><ul><li>Glass
  53. 53. Flint glass- Colorless glass
  54. 54. Amber colored glass/Nonactinic- Iron & MnO2
  55. 55. Siliconized glass- avoids sticking of oily formulation</li></li></ul><li>Evaluation of Glass<br /><ul><li>Powdered Glass Test (Crushed Glass Test)</li></ul>Digest borosilicate flask 121ْC for 60 min<br />Crush 6 Containers 10gm powder + 50ml high <br /> Decant & titrate purity water<br /> solution with 0.02N H2SO4<br />Indicator Methyl red <br /> Similarly blank<br />Limits:<br />Type I = 1.0ml, Type III = 8.5ml, NP= 15.0ml<br />Sieving<br />40/50#<br />121ْ C<br />30 min<br />
  56. 56. Evaluation of Glass<br />Water Attack Test for Type II glass<br />3 containers filled 90% of overflow capacity<br />Autoclaving at 121ْC for 30 min<br />100 ml of combined extract titrated with 0.02N H2SO4<br />Capacity 100ml or less = 0.7 ml H2SO4<br />Capacity over 100ml = 0.2 ml H2SO4<br />High Purity Water<br />
  57. 57. Plastic Material<br />Plastics are made of polymer and additives like plasticizer, antioxidant, antistat agent, fillers, lubricant, etc.<br />Additives are not chemically bound hence can migrate into product<br />
  58. 58. Selection of Plastic Material<br />Advantages<br />Light Weight, Inexpensive, Nonbreakable<br />Disadvantages<br />Leaching of plastic additives<br />Sorption of API<br />Permeation of water vapours or gas<br />Loss of volatile components<br />Softening of plastic material during autoclaving<br />Chemical reactivity<br />
  59. 59. Evaluation of Plastic (USP)<br />Physicochemical Tests<br />Aq. Extract tested for nonvoalatile residue, residue on ignition, heavy metals, buffering capacity<br />Biological Reactivity Tests<br />In vitro Test- Extract placed in contact with mammalian cells to check to toxicity<br />In Vivo Test- <br />Systemic Injection Test- Mice<br />Intracutaneous Inj. Test- Rabbit<br />Implantation Test & Eye Irritaion Test- Rabbit<br />
  60. 60. Rubber Material<br />Rubber is generally used as elastomeric closure for vial infusion bottles & cartridges<br />Soft & elastic nature permits needle insertion<br />Resilient- Seal integrity maintained<br />Autoclavable<br />
  61. 61. Rubber Material<br />Composed of <br />Polymer (elastomer)-<br />Vulcanising Agent- cross linking eg.sulphur<br />Accelerator- reduce sulphur requirement & time for vulcanization eg. MBT<br />Activator- Activity of accelerator<br /><ul><li>Filler- carbon black, talc
  62. 62. Antioxidant- Prevents oxidatn of elastomer
  63. 63. Lubricant- Mould release eg.Talc
  64. 64. Softner- Plasticity eg. Mineral oil</li></li></ul><li>Selection of Rubber Material<br /><ul><li>Types of Rubber
  65. 65. Natural- Haeveabrazilensis high preservative uptake
  66. 66. Grey butyl-Polyisobutyl-Low permeability & low preservative uptake
  67. 67. Nitrile- Butadiene acrylonitrile Oil resistant
  68. 68. Silicone Rubber- Heat resistant & high uptake</li></li></ul><li>Selection of Rubber Material<br />Advantages<br />Softness allows needle insertion<br />Resilence maintains sterility<br />Elasticity allows perfect fit<br />Disadvantages<br />Permeation<br />Leaching<br />Sorption<br />Loss of volatile component<br />
  69. 69. Evaluation of Rubber <br />Physico Chemical Testing<br />Extract of Rubber is prepared and tested for total extractable, heavy metals, pH change, turbidity, reducing agents<br />Biological Testing<br />In Vitro Test: on mammalian cells direect contact test<br />In Vivo Test: <br /> Systemic Injection Test- Mice<br /> Intracutaneous Inj. Test- Rabbits<br />
  70. 70. Evaluation of Rubber <br />Apperance <br />Closures must be free from dust, fibres, pigments, oily pathces, etc.<br />Tackiness<br />Closures washed several times with detergent and autoclaved at 121ْC in dist. Water for 30 min. It should not become tacky<br />
  71. 71. Evaluation of Rubber <br />Penetrability<br />Closure fixed to vial and force required to penetrate it measured. It should not exceed in house limits.<br />Self Sealability<br />Half filled vial with methylene blue, then 25 needle punctures made in 5mm circle diameter<br />Vials then inverted in water there should not be leakage of coloured solution<br />
  72. 72. Evaluation of Rubber <br />Fragmentation<br />20 closures selected randomly, 5 times needle penetrated in specific area<br />Needle washed with water to collect fragments<br />Fragments NMT 3 per closure<br />Permeability to water vapours<br />Anhydrous CaCl2 placed in vial, kept it in high humidity conditions, measure wt. gain<br />
  73. 73. Metals <br />Metals used as packaging material for creams, aerosols, beverages, etc.<br />Metals can be moulded as collapsible tubes, beverage cans, aerosol containers, etc.<br />The mechanical strength provided by metal containers is advantageous.<br />Leaching of metals into products may cause catalytic oxidation of product<br />Its chemical reactivity may form pharmacologically inert, less active or toxic cpmpounds<br />
  74. 74. Metals<br />
  75. 75. Metals <br />Gen. Properties<br />Strong(Nonbrekabl)<br />Opaque<br />Mouldable to any shape <br />Withstand high temp-pressure<br />Impermeable to moisture, microbes, gases, light, etc.<br />Disadvantages<br />Leaching (Attcked by acids & alkalis)<br />Sorption<br />Corrosion<br />
  76. 76. Applications of Metal<br />Cans, pails, boxes.<br />Closures<br />Aluminium foil, laminate, labels<br />Barrels, kegs, drums<br />Crates<br />Metal bandings<br />
  77. 77. Paper and Board<br />Cellulose from gettable fibres (Pulp)<br />Lignin, cerin removed by chemical process<br />Fillers, coloring agents, etc. added<br />Properties<br />Low cost, nontoxic, renewable<br />Strength depends on moisture content<br />Readily printable<br />Poor transperancy & gloss comparative to plastic<br />Can’t be sealed unless coated<br />
  78. 78. Thank You…<br />