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PACKAGING OF PHARMACEUTICAL
             PRODUCTS




1                           4/5/2011
CONTENTS:
       PACKAGING
       FUNCTIONS OF PACKAGING
       TYPES OF PACKAGING
       COMPONENTS OF PACKAGING
       AEROSOL PACKAGING
       CONTAINER & CLOSURES
       PACKAGE TESTING
       REFERENCES




2                                 4/5/2011
PACKAGING
    Packaging has been defined as the means economically providing :-

    • Presentation

    • Identification

    • Protection

    • Convenience

    • Containment during storage




3                                                                       4/5/2011
TYPES OF PACKAGING:
    1. SOLID PRODUCTS

    2. SEMI-SOLID PRODUCT

    3. LIQUID PRODUCTS

    4. UNIT PACKS

    5. CHILD RESISTANCE PACKAGING

    6. TEMPER RESISTANCE PACKAGING




4                                    4/5/2011
1. SOLID PRODUCTS:

 Solid dosages form such as tablets and capsules are by far the most commonly used today.
 Traditionally they have been packed in bottles, originally made from glass but latterly from
various plastics.
 The walls of the container are usually amber or completely opaque to minimize the
possibility of photo degradation.
 Powder or granules have a variety of role when used as a final dosage form.
 They usually packed as single dosages in flexible sachets.




5                                                                                  4/5/2011
2. SEMI-SOLID PRODUCT
     The relevant characteristics of these products for packaging purpose are that they are often too viscous to
    flow but contain a sufficient amount of water to be classified as “wet ” products.

    Semi solid product include creams, emulsions, gels or ointments.

    Flexible tubes are frequently used to contain semi solids.

    These can be made from aluminium or plastic such as polyethylene.




6                                                                                                   4/5/2011
3. LIQUID PRODUCTS

Traditionally glass has been the material of choice for the packaging of liquid but a
variety of plastics is now widely used providing they have little or no permeability to
the liquid




7                                                                                   4/5/2011
UNIT PACKS:
    Unit packs in which individual dosage are separated from each other are popular for
    many type of dosage form.




8                                                                           4/5/2011
CHILD RESISTANCE PACKAGING:


    Child resistance container work on one of two principle-
    Certain degree of strength will be needed to open the product.
    High degree of manual coordination is required




9                                                                     4/5/2011
TAMPER RESISTANCE PACKAGING:

     Tamper resistance can be conferred on a pack by using a roll on closure which
     has a perforated collar
     Which grips on to a lip on the bottle neck & these perforation must be broken
     before the cap can be unscrewed.




10                                                                         4/5/2011
COMPONENTS OF PACKAGING:
     I.    GLASS

     II.   METALS

     III. RUBBERS

     IV. PLASTICS

     V.    FIBROUS MATERIALS

     VI. FOIL, FILMS &LAMINATES




11                                4/5/2011
I. GLASS:
     Glass is composed of sand, soda ash, limestone,& cullet.

     Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass

         ADVANTAGE:

      They are transparent.
      They have good protection power.
      They can be easily labelled.


       DISADVANTAGE:


  Glass is fragile so easily broken.
  Release alkali to aqueous prerparation.




12                                                                        4/5/2011
 TYPE OF GLASS:

     I.   COLOURED GLASS OR AMBER GLASS

     II. SULPHURED GLASS

     III. BOROSILICATE GLASS

     IV. TREATED SODALIME GLASS

     V. REGULAR SODALIME GLASS

     VI. GENERAL PURPOSE SODALIME GLASS




13                                        4/5/2011
PLASTICS:

 These are synthetic polymers of high molecular weight.
 These containers are made from following polymers :
 a) POLYETHYLENE
 b) POLYVINYL CHLORIDE
 c) POLYSTYRENE
 d) NYLON
 e) POLYCARBONATE




14                                                         4/5/2011
METALS:

      The thickest aluminium is used for rigid containers. Eg. Aerosol cans

      Intermediate thickness is steel important but the pack should be capable of being
     deformed under a reasonable force. Eg. Collapsible tube for semisolid preparations.

      Thinnest aluminium is used in flexible foils.




15                                                                             4/5/2011
RUBBERS:

      Rubbers are excellent material for forming seals so they are used almost
     exclusively to form closures such as bungs for vials or in similar application
     such as gasket in aerosol can
     These are consist of Two types:
     a) NATURAL

     b) SYNTHETIC




16                                                                             4/5/2011
FIBROUS MATERIALS:
      Paper & board are used in various form for packaging of pharmaceutical
     products.

     They are used for preparing outer container such as cartons, boxes, envelopes.




17                                                                         4/5/2011
FOIL, FILMS & LAMINATES
       FOILS:
 The most important metal for this application is aluminium.

        FILMS

 Cellophane is an attractive transparent film which can be colored and printed
 upon so it useful as outer wrap.

      LAMINATES


     Laminates are used to combine the properties of individual foil and films and
     strictly are made by bonding the layer with adhesive.




18                                                                         4/5/2011
AEROSOL PACKGING

 Aerosol may be defined as disperse phase system in which very fine solid
 particles or liquid droplets get dispersed in the gas which act as continuous
 phase.
      ADVANTAGE:
Absence of air prevents oxidation of the product
The application of medicaments is easier

         DISADVANTAGE:

     Aerosols are costly preparation
     Some of the propellants are very toxic




19                                                                          4/5/2011
PARTS OF AEROSOL CONTAINER
     I.   CONTAINER

     II. VALVE

     III. ACTUATOR

     IV. DIP TUBE




20                                 4/5/2011
21   4/5/2011
 CONTAINER AND CLOSURE

        CONTAINER:
      Pharmaceutical containers has been defined as a device that holds the
     drugs or it may or may not be indirect contact with the pharmaceutical
     preparation.
        TYPES OF CONTAINERS




          I.     WELL CLOSED CONTAINER
          II.    SINGLE DOSE CONTAINER
          III.   MULTI DOSE CONTAINER
          IV.    LIGHT RESISTANCE CONTAINER
          V.     AIR TIGHT CONTAINER
          VI.    AEROSOL CONTAINER



22                                                                        4/5/2011
CLOSURE:

 An effective closure must prevent the contents from escaping & allow no substance
 to the container.
       TYPE OF CLOSURE:



         A.   PLUG TYPE
         B.   CROWN TYPE
         C.   PUSH FIT TYPE
         D.   SCREW TYPE




23                                                                      4/5/2011
24   4/5/2011
COMMON TYPE OF PACKAGING

     1) BLISTER PACKAGING

     2) STRIP PACKAGING

     3) BUBBLE PACKAGING




25                               4/5/2011
26   4/5/2011
 REFERENCES:
I.    Aulton Michael E., “Aulton’s Pharmaceutics The Design and Manufacture of Medicines”, Edited by
      Churchill Livingstone Elsevier limited, 3rd edition,2007,pp 626-639.

II.   Lachman leon, Lieberman Herbert A., Kanig Joseph L., “The theory & practice of industrial pharmacy”
      published by Varghese publishing house, bombay, 3rd edition,1991,pp 711-732.

III. Cooper and Gunn’s, “Tutorial pharmacy”, edited by S.J.Carter,Publishing by CBS publisher &distributors,
     Delhi, 6th edition, 2005,pp 131-141.

IV. Mehta R.M., “Pharmaceutics- 1”Published by vallabh prakashan, delhi, 2nd edition, pp 73-93.

V.    http://www.ipapharma.org/events/Stability/JBhat.pdf (15/11/09)




27                                                                                                4/5/2011
28   4/5/2011
QUERIES?????
     ?????




29                  4/5/2011

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Packaging of pharmaceutical products

  • 1. PACKAGING OF PHARMACEUTICAL PRODUCTS 1 4/5/2011
  • 2. CONTENTS:  PACKAGING  FUNCTIONS OF PACKAGING  TYPES OF PACKAGING  COMPONENTS OF PACKAGING  AEROSOL PACKAGING  CONTAINER & CLOSURES  PACKAGE TESTING  REFERENCES 2 4/5/2011
  • 3. PACKAGING Packaging has been defined as the means economically providing :- • Presentation • Identification • Protection • Convenience • Containment during storage 3 4/5/2011
  • 4. TYPES OF PACKAGING: 1. SOLID PRODUCTS 2. SEMI-SOLID PRODUCT 3. LIQUID PRODUCTS 4. UNIT PACKS 5. CHILD RESISTANCE PACKAGING 6. TEMPER RESISTANCE PACKAGING 4 4/5/2011
  • 5. 1. SOLID PRODUCTS:  Solid dosages form such as tablets and capsules are by far the most commonly used today.  Traditionally they have been packed in bottles, originally made from glass but latterly from various plastics.  The walls of the container are usually amber or completely opaque to minimize the possibility of photo degradation.  Powder or granules have a variety of role when used as a final dosage form.  They usually packed as single dosages in flexible sachets. 5 4/5/2011
  • 6. 2. SEMI-SOLID PRODUCT  The relevant characteristics of these products for packaging purpose are that they are often too viscous to flow but contain a sufficient amount of water to be classified as “wet ” products. Semi solid product include creams, emulsions, gels or ointments. Flexible tubes are frequently used to contain semi solids. These can be made from aluminium or plastic such as polyethylene. 6 4/5/2011
  • 7. 3. LIQUID PRODUCTS Traditionally glass has been the material of choice for the packaging of liquid but a variety of plastics is now widely used providing they have little or no permeability to the liquid 7 4/5/2011
  • 8. UNIT PACKS: Unit packs in which individual dosage are separated from each other are popular for many type of dosage form. 8 4/5/2011
  • 9. CHILD RESISTANCE PACKAGING: Child resistance container work on one of two principle- Certain degree of strength will be needed to open the product. High degree of manual coordination is required 9 4/5/2011
  • 10. TAMPER RESISTANCE PACKAGING: Tamper resistance can be conferred on a pack by using a roll on closure which has a perforated collar Which grips on to a lip on the bottle neck & these perforation must be broken before the cap can be unscrewed. 10 4/5/2011
  • 11. COMPONENTS OF PACKAGING: I. GLASS II. METALS III. RUBBERS IV. PLASTICS V. FIBROUS MATERIALS VI. FOIL, FILMS &LAMINATES 11 4/5/2011
  • 12. I. GLASS: Glass is composed of sand, soda ash, limestone,& cullet. Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass  ADVANTAGE:  They are transparent.  They have good protection power.  They can be easily labelled. DISADVANTAGE:  Glass is fragile so easily broken.  Release alkali to aqueous prerparation. 12 4/5/2011
  • 13.  TYPE OF GLASS: I. COLOURED GLASS OR AMBER GLASS II. SULPHURED GLASS III. BOROSILICATE GLASS IV. TREATED SODALIME GLASS V. REGULAR SODALIME GLASS VI. GENERAL PURPOSE SODALIME GLASS 13 4/5/2011
  • 14. PLASTICS: These are synthetic polymers of high molecular weight. These containers are made from following polymers : a) POLYETHYLENE b) POLYVINYL CHLORIDE c) POLYSTYRENE d) NYLON e) POLYCARBONATE 14 4/5/2011
  • 15. METALS:  The thickest aluminium is used for rigid containers. Eg. Aerosol cans  Intermediate thickness is steel important but the pack should be capable of being deformed under a reasonable force. Eg. Collapsible tube for semisolid preparations.  Thinnest aluminium is used in flexible foils. 15 4/5/2011
  • 16. RUBBERS:  Rubbers are excellent material for forming seals so they are used almost exclusively to form closures such as bungs for vials or in similar application such as gasket in aerosol can These are consist of Two types: a) NATURAL b) SYNTHETIC 16 4/5/2011
  • 17. FIBROUS MATERIALS:  Paper & board are used in various form for packaging of pharmaceutical products. They are used for preparing outer container such as cartons, boxes, envelopes. 17 4/5/2011
  • 18. FOIL, FILMS & LAMINATES FOILS: The most important metal for this application is aluminium. FILMS Cellophane is an attractive transparent film which can be colored and printed upon so it useful as outer wrap. LAMINATES Laminates are used to combine the properties of individual foil and films and strictly are made by bonding the layer with adhesive. 18 4/5/2011
  • 19. AEROSOL PACKGING Aerosol may be defined as disperse phase system in which very fine solid particles or liquid droplets get dispersed in the gas which act as continuous phase. ADVANTAGE: Absence of air prevents oxidation of the product The application of medicaments is easier DISADVANTAGE: Aerosols are costly preparation Some of the propellants are very toxic 19 4/5/2011
  • 20. PARTS OF AEROSOL CONTAINER I. CONTAINER II. VALVE III. ACTUATOR IV. DIP TUBE 20 4/5/2011
  • 21. 21 4/5/2011
  • 22.  CONTAINER AND CLOSURE CONTAINER:  Pharmaceutical containers has been defined as a device that holds the drugs or it may or may not be indirect contact with the pharmaceutical preparation. TYPES OF CONTAINERS I. WELL CLOSED CONTAINER II. SINGLE DOSE CONTAINER III. MULTI DOSE CONTAINER IV. LIGHT RESISTANCE CONTAINER V. AIR TIGHT CONTAINER VI. AEROSOL CONTAINER 22 4/5/2011
  • 23. CLOSURE: An effective closure must prevent the contents from escaping & allow no substance to the container.  TYPE OF CLOSURE: A. PLUG TYPE B. CROWN TYPE C. PUSH FIT TYPE D. SCREW TYPE 23 4/5/2011
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  • 25. COMMON TYPE OF PACKAGING 1) BLISTER PACKAGING 2) STRIP PACKAGING 3) BUBBLE PACKAGING 25 4/5/2011
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  • 27.  REFERENCES: I. Aulton Michael E., “Aulton’s Pharmaceutics The Design and Manufacture of Medicines”, Edited by Churchill Livingstone Elsevier limited, 3rd edition,2007,pp 626-639. II. Lachman leon, Lieberman Herbert A., Kanig Joseph L., “The theory & practice of industrial pharmacy” published by Varghese publishing house, bombay, 3rd edition,1991,pp 711-732. III. Cooper and Gunn’s, “Tutorial pharmacy”, edited by S.J.Carter,Publishing by CBS publisher &distributors, Delhi, 6th edition, 2005,pp 131-141. IV. Mehta R.M., “Pharmaceutics- 1”Published by vallabh prakashan, delhi, 2nd edition, pp 73-93. V. http://www.ipapharma.org/events/Stability/JBhat.pdf (15/11/09) 27 4/5/2011
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  • 29. QUERIES????? ????? 29 4/5/2011