basic

1. PRESENTED BY:
SOURAV KR SHAH
M.PHARM(PHARMACEUTICS) 1ST YEAR
SB & BT, DEPARTMENT OF PHARMACEUTICAL SCIENCES
BABASAHEB BHIMRAO AMBEDKAR UNIVERSITY, LUCKNOW

2.  INTRODUCTION
 NEED OF PACKAGING
 SELECTION CRITERIA & PROPERTIES
 TYPES OF PACKAGING MATERIALS AND THEIR
EVALUATIONS
 GLASS
 PLASTICS
 METALS
 FILM, FOILS , LAMINATES
 ELASTOMERIC CLOSURES
 SECONDARY PACKAGING MATERIALS
 TERTIARY PACKAGING MATERIALS
 REFERENCES

3.  Pharmaceutical packaging is the means of
providing protection, presentation,
identification and information, containment,
and convenience to compliance with a course
of therapy.
 Packaging is as vital as formulation. If
unsatisfactory packaging permits
deterioration to set before patient uses it.

4.  Physical protection- eg: shock, vibration
 Barrier protection- eg: Oxygen, light
 Containment
 Information transmission
 Marketing
 Security
 Convenience- eg: distribution, handling, sale
 Portion Control- eg: single dose pack

5.  Pharmaceutical Properties- dosage form,
route of administration, stability of product
 Mechanical Properties- adequately strong,
heat stable, impermeable
 Physico-chemical properties: non-reactive,
inert, F.D.A Approved
 Biological properties: non-toxic, resistant to
micro-organisms
 Economical aspect- reasonable cost

6.  1. PRIMARY PACKING MATERIALS:
 a. Glass
 b. Plastics
 c. Metals
 d. Films, Foils & Laminates
 e. Elastomeric closures
 2. SECONDARY PACKING MATERIALS: eg- paper
and board packaging materials etc.
 3. TERTIARY PACKING MATERIALS: eg- barrel,
crate container, edge protector etc.

7.  Glass has been the container of choice for
pharmaceutical dosage form because of its
resistance to decomposition by atmospheric
conditions or by solid or liquid contents of
different chemical composition
 Furthermore by varying the chemical
composition of glass, it is possible to adjust
the chemical behavior and radiation
protective properties of glass.

8. ADVANTAGES:
• Chemically inert
• Non-corrosive
• Impermeable to vapours
• Possess FDA approval
• Do not deteriorate with age
DISADVANTAGE:
• Fragile and heavier
• Less pressure safety
• Less impact resistance
• Expensive machinability

9. As per USP mainly four types:
 Type-I: Highly resistant borosilicate glass
 Type-II: Treated Soda-lime glass
 TYPE-III: Soda-lime glass
 Type-NP: General purpose Soda-lime glass
Type I releases the less amount of alkali and
type NP releases the most. TYPE II glass has
been de-alkalized by surface treatment of the
finished container. The bulk composition of
type-II container is equivalent to type-III. Type-
NP are fabricated from general purpose soda-
lime glass and used for non- parenterals.

10.  Composition: sand, soda ash, limestone,
cullet's, lead, alumina
 Color composition: flint, amber
 Manufacturing Techniques:
• Blowing
• Drawing
• Pressing
• Casting

11.  Chemical resistant test:
o Powdered glass test
o Water attack test
 Hydrolytic resistance test
 Arsenic test
 Thermal shock test

12.  Plastics include a group of natural or synthetic
origin consisting mainly polymers of high
melting point, capable of being moulded into
variety of shapes or forms by utilizing heat or
pressure.
 Advantages:
a. Good mechanical strength
b. Non-breakable, light, available
c. Poor conductor of heat
Disadvantages:
a. Permeable
b. Additives can cause interaction
c. Majority of plastics are heat sensitive

13. 1. Thermosetting polymers: a polymerization process
involving a curing or vulcanization stage during which
material becomes set to a permanent state by heat or
pressure produces thermoset polymers. These comprise of
phenolics, melamine, urea, epoxies etc.
2. Thermoplastics polymers: are heat softening materials,
which can be repeatedly heated, made mobile and then
reset to a solid state by cooling. Eg: polyethylene , PVC, PS,
PP, Nylon(PA), polycarbonates etc.

15. Drug plastics considerations have been divided
into five separate categories:
 PERMEATION
 LEACHING
 SORPTION
 CHEMICAL REACTION
 ALTERATION OR MODIFICATION IN THE PHYSICAL
PROPERTIES OF PLASTICS OR PRODUCTS.
 NEGATIVE FEATURES: cavitation panelling,
stress cracking, crazing, poor printability, poor
impact resistance.

17.  LEAKAGE TEST
 CLARITY TEST
 NON-VOLATILE RESIDUE
 WATER VAPOR PERMEABILITY TEST
 Collapsibility test
 MECHANICAL TESTS: impact strength, tensile
strength, stiffness, tear strength, flex
resistance, coefficient of friction of slip,
fatigue resistance.
 Other tests- melting point, heat sealability,
sterilizability etc.

18.  Metal is strong, opaque, and impermeable to
moisture, gases, light, bacteria etc. It is
resistant to high and low temperatures.
 Disadvantage: metal is not inert it can be
attacked by acids and alkalies. It will corrode
unless coated or lacquered.
Different metals used are:
 Aluminum
 Aluminium foil
 Tin
 Lead
 Collapsible metal tubes

19.  If the product is not compatible with bare
metal, the interior can be flushed with wax
type formulation or with resin solutions
 In tins – phenolics, epoxides
 In aluminiums: vinyls

20.  Lead test
 Evaluation for metal containers for eye
ointments
 Various Inhouse tests

21.  Film, foils and laminates perform different
roles, such as supportive, barrier, heat seal
and decorative.
 Films:
 Regenerated cellulose films
 Films and coatings based on plastics
 Special films
 Foils: aluminium foils
 Laminates: eg: papers, pVdc, LDPE etc.

22.  An elastomeric closure forms the most critical
components of a container as far as the
stability and compatibility of a product are
concerned.
 Functions as safety, security, prevent hazards
from pilferage, leakage, contamination
 Types:
 Rubber closures
 Caps and overseals
 Special types: tamper evident, child resistant

25.  For rubber closures:
 Fragmentation test
 Self sealability test
 Sterility test
 Closure efficiency

26.  Paper and board are broadly cellulose
natural fiber materials.

27.  Used for bulk handling and shipping

28.  Visual inspection of surfaces
 Principal instrumental techniques:
 Spectrophotometry
 Chromatographic methods
 Thermal analysis techniques
 Gas transmission analysis
 Physical test methods
 Miscellaneous techniques

29.  Lachman L, Lieberman H.A. & Kanig J.L.
‘The Theory & Practice of Industrial
Pharmacy.’ Varghese Publishing Home.
 Banker GS & Rhodes C.T., Modern
Pharmaceutics, Marcel Dekker, New York.
 Gennaro A.R., ‘Remington, The Science &
Practice of Pharmacy,’ Lippincott. Williams &
Wilkins.
 Jain UK, Goupale DC, Nayak S,
‘Pharmaceutical Packaging Technology’,
PharmaMed press, Hyderabad.

30. THANK YOU.