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KARISHMA AGGARWAL
ASSISTANT PROFESSOR
DEPT. OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY
WEBSITE: - WWW.ISFCP.ORG
EMAIL: KARISHMAAGGARWAL18@YAHOO.COM
ISF College of Pharmacy, Moga
Ghal Kalan,nGT Road, Moga- 142001, Punjab, INDIA
Internal Quality Assurance Cell - (IQAC)
INTRODUCTION 2
After the manufacturing of drugs it is essential that these should be
stored properly.
The stability of the drug depends upon the packing, so proper storing
of drug is required.
PROPERTIES OF PACKING MATERIAL
 It must be neutral.
 It should not interact physically or chemically.
 It should help in maintaining the stability of the
product.
 Withstands wear and tear during normal
handling.
 It should be non toxic.
3
MATERIALS USED FOR PACKING
 Glass
 Plastics
 Metal
 Rubber
 Paper and board
 Blister and strips
4
GLASS
 Glass is composed of sand, soda ash, lime and cullet.
 Silicon, aluminum, boron, sodium, potassium, calcium,
magnesium, zinc, and barium are generally used in the
preparation of glass
5
TYPES OF GLASS 6
Lime soda glass.
Borosilicate glass.
Neutral glass.
LIME SODA GLASS 7
COMPOSITION:
SiO2 - 75%.
Na2O - 15%.
CaO - 10%.
K2O, MgO, Al2O3
Al2O3 - improves the mechanical strength and chemical durability and makes
melting easier.
MgO - reduces the temperature required for the manufacture of glass.
ADVANTAGES:
 This glass can be manufactured at a convenient temperature & is easy to process.
DISADVANTAGES:
 It yields an appreciable quantity of alkali.
 Flakes separate comparatively easily.
 On repeated use its surface losses some of its brilliance.
BORO SILICATE GLASS 8
COMPOSITION:
SiO2 - 80%.
B2O3 -12%.
Al2O3 -2%.
Na2O -6% + CaO + other oxides.
ADVANTAGES:
Defects of lime soda glass can be overcome by decreasing
the proportion of alkali (Ca, NaO).
It is used for chemical glassware, ovenware, & containers for
alkali sensitive preparations.
NEUTRAL GLASS 9
COMPOSITION:
SiO2 - 72-75%.
B2O3 - 7-10%.
Al2O3 - 4-6%.
Na2O -6-8%.
K2O - 0.5-2%
BaO - 2-4%.
ADVANTAGES:
They are softer and more easily manipulated than borosilicate
but have good resistance to autoclaving, weathering &
solutions of pH up to about 8.
10
Glass Composition Properties Application
Type I Borosilicate & neutral Very high hydrolytic
resistance low thermal
expansion
Acidic and neutral parenteral
preparations
alkaline preparations if qualified
Type II Soda-lime
(treated–dealkalized)
Relatively high
hydrolytic resistance
Acidic and neutral parenteral
preparations;
alkaline preparations if qualified
Type III Soda-lime (untreated) Similar to Type II, but
with leachable oxides
Anhydrous liquids and dry
products;
parenteral preparations only if
qualified
Type NP Soda-lime (general
purpose)
Very low hydrolytic
resistance
Non-parenteral use only (oral,
topical, etc.)
MERITS & DEMERITSDEMERITS 11
Merits:
They are transparent.
They are available in various shapes and sizes.
They can withstand the variation in temperature and pressure during
sterilization.
They are economical.
They can protect the photosensitive medicaments from light.
They can be easily labeled.
They have good protection power.
They are neutral.
Demerits:
Glass is fragile.
Glass may leak alkali.
Glass containers are heavy, which increases the cost of its
transportation.
PLASTICS 12
Plastics are synthetic polymers.
They are sensitive to heat and may melt at or soften at below 100o
C.
Light in weight.
Easy to handle.
Mechanically they are as strong as metals.
They are resistance to inorganic chemicals and are attacked by organic chemicals.
CLASSIFICATION 13
Thermoplastic:
On heating these soften to a viscous fluid which hardens again on cooling.
Thermosetting plastic:
On heating these may become flexible but they do not become fluid, usually their
shape is retained.
14
ADVATGES DIS ADVATAGES APPLICATIONS
LDPE
(Low Density
Polyethylene)
Easily stretched; Very good impact strength, Very
light; inexpensive; low H2O permeability; Good
acid, alcohol, and alkali resistance; Odorless,
tasteless
More permeable to H2O than HDPE;
Higher absorption of certain additives; susceptible to
stress cracking :High permeability to halogens and O2;
poor odor barrier; softened/permeable by certain oils
Squeeze bottles;
Soft plastic wrapper
HDPE
(High Density
Polythene)
Harder, more rigid, and less clear than LDPE; Good
heat resistance Very light; inexpensive; Low H2O
permeability; Good acid, alcohol, and alkali
resistance; odorless, Tasteless
Less clarity than LDPE (but usually pigmented) High
permeability to halogens and O2; poor Odor barrier;
softened/ permeable by certain oils
Bottles for solid dosage
forms
PVC
(Polyvinyl
Chloride)
Lightest plastic; very clear in film;
Very inexpensive; High melting point; Good
chemical resistance; excellent gas and Vapor barrier;
few additives
Brittle at low temperatures; significant Shrinkage with
injection molding; resistant to stress cracking; lack of
clarity; difficult to heat seal
Screw caps; films; package
Over wrap ; sterilizable
packages; blister packs; Some
IV bags
PP
Polypropylene
Stable to irradiation; very high strength and impact
resistance; Good CO2 and aroma barrier; easily
recyclable
Better H2O permeability (but still not for highly sensitive
preparations), Poor heat resistance
Plastic bottles for liquid Oral
pharmaceutical dosage
forms
THERMOSETITNG TYPES 15
Phenol-Formaldehyde-
They are dark and discolor easily.
It has good heat and moisture resistance so that it can be autoclaved.
Use: outer caps of injection bottles and caps of eye drops bottles.
Urea-Formaldehyde-
It is much less heat and moisture resistant than phenol-formaldehyde.
Pale or colorless, odorless and tasteless.
Melamine-Formaldehyde-
Highly strength and ease to fabricate and has low-
Thermal resistance
Chemical reactivity
Sorption of substance
MERITS & DEMERITSDEMERITS 16
Merits:
They are light in weight & can be handled easily.
They are poor conductor of heat.
They have sufficient mechanical strength.
They can be transported easily.
They are unbreakable.
Demerits:
They are permeable to water vapour & atmospheric gases.
They cannot withstand heat without softening or distorting.
They are relatively expensive.
RUBBER 17
Rubber components may be made from either natural or synthetic sources .
Rubber is used mainly for the construction of closure meant for vials ,transfusion
fluid bottles and as washers in many other types of products.
TYPES OF RUBBER:-
Natural.
Synthetic.
NATURAL RUBBER 18
Most of the raw rubber make it unsuitable for the production of most rubber
articles.
A large number of substances are added to give better chemical and physical
properties and facilitate manufacture.
SYNTHETIC RUBBERS 19
These are more resistant to high temperatures & resistant to the agents that accelerate
ageing.
Types:-
Butyl rubbers-
These are copolymers of isobutylene with 1-3 percent of isoprene or butadiene.
Permeability to water vapour and air is very low, water absorption is only slight
and their resistance to steam is greater than that of the other rubbers.
Nitrile rubbers-
These are butadiene–acrylonitrile co-polymers .
Their most important property is oil resistance, which is due to the polar nitrile
group
Silicone rubbers-Silicone rubbers-
METALS 20
Tin-
Most chemically inert, of all collapsible tube metals.
Good appearance and compatibility with a wide range of products.
Aluminium-
Savings in product shipping cost because of there light weight.
Lead-
Lowest cost of all tube metals and is widely used for non food product such
as adhesives and lubricants
Never be used alone for anything taken internally because of the lead
poisoning.
BLISTER PACKS 21
Provide barrier protection for shelf life requirements, and a degree of
tamper resistance.
A series of blister cavities is sometimes called a blister card or blister
strip as well as blister pack
The assurance of product/packaging integrity (including shelf life) of
each individual dose.
Blister packs consist of two principal components-
A formed base web creating the cavity inside which the
product fits.
The lidding foil for dispensing the product out of the pack.
STRIP PACKAGE 22
Used for the packaging of tablet and capsules.
Formed by feeding two web of a heat –sealable flexible film through
either a heated crimping roller or heated reciprocating platen.
The product is dropped into the pocket formed prior to forming the
final set of seal.
For high barrier application, a paper /polyethylene/ foil/ polyethylene
lamination is commonly used.
CARTONS 23
These come in two types-
Seal end cartons.
Tuck end cartons.
Seal end cartons differ from tuck end cartons in that rather than using
the mechanical interlocking design of the tuck end to close the
carton, externally applied glue or hot melt is used to provide carton
sealing.
TYPES OF CONTAINERS 24
 Well closed containers.
 Single dose containers.
 Multi dose containers.
 Light resistant containers.
 Air tight containers.
 Aerosol containers.
 Tight container.
 Hermetic container.
 Tamper-evident container.
CLOSURES 25
Closures are available in five basic deigns:-
Screw-on threaded or lug.
Crimp-on (crown).
Press-on (snap).
Roll-on.
Friction.
Thank you
26

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PACKING OF PHARMACEUTICALS

  • 1. KARISHMA AGGARWAL ASSISTANT PROFESSOR DEPT. OF PHARMACEUTICS ISF COLLEGE OF PHARMACY WEBSITE: - WWW.ISFCP.ORG EMAIL: KARISHMAAGGARWAL18@YAHOO.COM ISF College of Pharmacy, Moga Ghal Kalan,nGT Road, Moga- 142001, Punjab, INDIA Internal Quality Assurance Cell - (IQAC)
  • 2. INTRODUCTION 2 After the manufacturing of drugs it is essential that these should be stored properly. The stability of the drug depends upon the packing, so proper storing of drug is required.
  • 3. PROPERTIES OF PACKING MATERIAL  It must be neutral.  It should not interact physically or chemically.  It should help in maintaining the stability of the product.  Withstands wear and tear during normal handling.  It should be non toxic. 3
  • 4. MATERIALS USED FOR PACKING  Glass  Plastics  Metal  Rubber  Paper and board  Blister and strips 4
  • 5. GLASS  Glass is composed of sand, soda ash, lime and cullet.  Silicon, aluminum, boron, sodium, potassium, calcium, magnesium, zinc, and barium are generally used in the preparation of glass 5
  • 6. TYPES OF GLASS 6 Lime soda glass. Borosilicate glass. Neutral glass.
  • 7. LIME SODA GLASS 7 COMPOSITION: SiO2 - 75%. Na2O - 15%. CaO - 10%. K2O, MgO, Al2O3 Al2O3 - improves the mechanical strength and chemical durability and makes melting easier. MgO - reduces the temperature required for the manufacture of glass. ADVANTAGES:  This glass can be manufactured at a convenient temperature & is easy to process. DISADVANTAGES:  It yields an appreciable quantity of alkali.  Flakes separate comparatively easily.  On repeated use its surface losses some of its brilliance.
  • 8. BORO SILICATE GLASS 8 COMPOSITION: SiO2 - 80%. B2O3 -12%. Al2O3 -2%. Na2O -6% + CaO + other oxides. ADVANTAGES: Defects of lime soda glass can be overcome by decreasing the proportion of alkali (Ca, NaO). It is used for chemical glassware, ovenware, & containers for alkali sensitive preparations.
  • 9. NEUTRAL GLASS 9 COMPOSITION: SiO2 - 72-75%. B2O3 - 7-10%. Al2O3 - 4-6%. Na2O -6-8%. K2O - 0.5-2% BaO - 2-4%. ADVANTAGES: They are softer and more easily manipulated than borosilicate but have good resistance to autoclaving, weathering & solutions of pH up to about 8.
  • 10. 10 Glass Composition Properties Application Type I Borosilicate & neutral Very high hydrolytic resistance low thermal expansion Acidic and neutral parenteral preparations alkaline preparations if qualified Type II Soda-lime (treated–dealkalized) Relatively high hydrolytic resistance Acidic and neutral parenteral preparations; alkaline preparations if qualified Type III Soda-lime (untreated) Similar to Type II, but with leachable oxides Anhydrous liquids and dry products; parenteral preparations only if qualified Type NP Soda-lime (general purpose) Very low hydrolytic resistance Non-parenteral use only (oral, topical, etc.)
  • 11. MERITS & DEMERITSDEMERITS 11 Merits: They are transparent. They are available in various shapes and sizes. They can withstand the variation in temperature and pressure during sterilization. They are economical. They can protect the photosensitive medicaments from light. They can be easily labeled. They have good protection power. They are neutral. Demerits: Glass is fragile. Glass may leak alkali. Glass containers are heavy, which increases the cost of its transportation.
  • 12. PLASTICS 12 Plastics are synthetic polymers. They are sensitive to heat and may melt at or soften at below 100o C. Light in weight. Easy to handle. Mechanically they are as strong as metals. They are resistance to inorganic chemicals and are attacked by organic chemicals.
  • 13. CLASSIFICATION 13 Thermoplastic: On heating these soften to a viscous fluid which hardens again on cooling. Thermosetting plastic: On heating these may become flexible but they do not become fluid, usually their shape is retained.
  • 14. 14 ADVATGES DIS ADVATAGES APPLICATIONS LDPE (Low Density Polyethylene) Easily stretched; Very good impact strength, Very light; inexpensive; low H2O permeability; Good acid, alcohol, and alkali resistance; Odorless, tasteless More permeable to H2O than HDPE; Higher absorption of certain additives; susceptible to stress cracking :High permeability to halogens and O2; poor odor barrier; softened/permeable by certain oils Squeeze bottles; Soft plastic wrapper HDPE (High Density Polythene) Harder, more rigid, and less clear than LDPE; Good heat resistance Very light; inexpensive; Low H2O permeability; Good acid, alcohol, and alkali resistance; odorless, Tasteless Less clarity than LDPE (but usually pigmented) High permeability to halogens and O2; poor Odor barrier; softened/ permeable by certain oils Bottles for solid dosage forms PVC (Polyvinyl Chloride) Lightest plastic; very clear in film; Very inexpensive; High melting point; Good chemical resistance; excellent gas and Vapor barrier; few additives Brittle at low temperatures; significant Shrinkage with injection molding; resistant to stress cracking; lack of clarity; difficult to heat seal Screw caps; films; package Over wrap ; sterilizable packages; blister packs; Some IV bags PP Polypropylene Stable to irradiation; very high strength and impact resistance; Good CO2 and aroma barrier; easily recyclable Better H2O permeability (but still not for highly sensitive preparations), Poor heat resistance Plastic bottles for liquid Oral pharmaceutical dosage forms
  • 15. THERMOSETITNG TYPES 15 Phenol-Formaldehyde- They are dark and discolor easily. It has good heat and moisture resistance so that it can be autoclaved. Use: outer caps of injection bottles and caps of eye drops bottles. Urea-Formaldehyde- It is much less heat and moisture resistant than phenol-formaldehyde. Pale or colorless, odorless and tasteless. Melamine-Formaldehyde- Highly strength and ease to fabricate and has low- Thermal resistance Chemical reactivity Sorption of substance
  • 16. MERITS & DEMERITSDEMERITS 16 Merits: They are light in weight & can be handled easily. They are poor conductor of heat. They have sufficient mechanical strength. They can be transported easily. They are unbreakable. Demerits: They are permeable to water vapour & atmospheric gases. They cannot withstand heat without softening or distorting. They are relatively expensive.
  • 17. RUBBER 17 Rubber components may be made from either natural or synthetic sources . Rubber is used mainly for the construction of closure meant for vials ,transfusion fluid bottles and as washers in many other types of products. TYPES OF RUBBER:- Natural. Synthetic.
  • 18. NATURAL RUBBER 18 Most of the raw rubber make it unsuitable for the production of most rubber articles. A large number of substances are added to give better chemical and physical properties and facilitate manufacture.
  • 19. SYNTHETIC RUBBERS 19 These are more resistant to high temperatures & resistant to the agents that accelerate ageing. Types:- Butyl rubbers- These are copolymers of isobutylene with 1-3 percent of isoprene or butadiene. Permeability to water vapour and air is very low, water absorption is only slight and their resistance to steam is greater than that of the other rubbers. Nitrile rubbers- These are butadiene–acrylonitrile co-polymers . Their most important property is oil resistance, which is due to the polar nitrile group Silicone rubbers-Silicone rubbers-
  • 20. METALS 20 Tin- Most chemically inert, of all collapsible tube metals. Good appearance and compatibility with a wide range of products. Aluminium- Savings in product shipping cost because of there light weight. Lead- Lowest cost of all tube metals and is widely used for non food product such as adhesives and lubricants Never be used alone for anything taken internally because of the lead poisoning.
  • 21. BLISTER PACKS 21 Provide barrier protection for shelf life requirements, and a degree of tamper resistance. A series of blister cavities is sometimes called a blister card or blister strip as well as blister pack The assurance of product/packaging integrity (including shelf life) of each individual dose. Blister packs consist of two principal components- A formed base web creating the cavity inside which the product fits. The lidding foil for dispensing the product out of the pack.
  • 22. STRIP PACKAGE 22 Used for the packaging of tablet and capsules. Formed by feeding two web of a heat –sealable flexible film through either a heated crimping roller or heated reciprocating platen. The product is dropped into the pocket formed prior to forming the final set of seal. For high barrier application, a paper /polyethylene/ foil/ polyethylene lamination is commonly used.
  • 23. CARTONS 23 These come in two types- Seal end cartons. Tuck end cartons. Seal end cartons differ from tuck end cartons in that rather than using the mechanical interlocking design of the tuck end to close the carton, externally applied glue or hot melt is used to provide carton sealing.
  • 24. TYPES OF CONTAINERS 24  Well closed containers.  Single dose containers.  Multi dose containers.  Light resistant containers.  Air tight containers.  Aerosol containers.  Tight container.  Hermetic container.  Tamper-evident container.
  • 25. CLOSURES 25 Closures are available in five basic deigns:- Screw-on threaded or lug. Crimp-on (crown). Press-on (snap). Roll-on. Friction.