This document discusses pharmaceutical packaging materials and their evaluation. It introduces the need for packaging in protecting pharmaceutical products and providing information. The main types of primary packaging materials discussed are glass, plastics, metals, films and foils, elastomeric closures. Secondary and tertiary packaging materials are also mentioned. Various tests for evaluating the different materials are summarized such as permeability and mechanical tests.

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.