Packaging Materials Science

Packaging any material used to preserve the integrity of the product based on the products physical
and chemical characteristics
Economical provision of preservation

Classification of Packs
1. Primary direct contact to the drug product
Maintain quality
Imp: amber, bottles, film
2. Secondary protection for both the drug product and primary container
Indirect contact
May also provide information
Eg. Box, plastic wrappers

Types of Protective Functions
1. Environmental protection
a. Temperature
b. Moisture and humidity
c. Light
d. Gases and volatile materials
2. Mechanical protection
a. Compression improper stocking, folds
b. Impact
c. Vibration
3. Biological hazards
a. Microbiological
b. Other infestations insects, rodents
c. Human easier handling, protection from tampering pilferage, child-resistant

Characteristics of an Ideal Package
1. Able to protect the preparation form environmental condition
2. Not reactive with product itself
3. Does not impart to the products, taste or odor
4. Non-toxic
5. FDA approved
6. Meet tamper-resistant requirements
7. Adaptable to commonly employed high speed packaging equipment

Types of Package Materials
A. Glass
Superior protective qualities
Chemicaaly inert, impermeable
Strong and rigid doesnt deteriorate with age
Susceptible to impaction
Heavy expensive shipping

Composition
1. Sand pure silica, most abundant element in earths crust
2. Soda ash Na
2
CO
3

3. Limestone - CaCO
3

4. cullets broken glass pieces; binding agent
5. cations and anions
eg. Al - durability, MP, resist chemical reactions
Na - resistance to heat; chemical reactivity
Pb clarity and brilliance

Types of Glass
1. Type I used for ampules and vials
in the presence of water, Na comines with Si and is leached from the surface of the glass -
quality
6% Boron is added to reduce leaching
2. Type II
De-alkalized to remove surface alkali by a process called Sulfur treatment
Sulfur treatment glass is exposed to atmosphere with vapor and acidic gasesat elevated
temperature
3. Type III
Untreated and made od commercial sodalime glass
Reactivity ishiger (Type Ii)
Average quality
4. Supplies to contain oral/topical liquid products

B. Plastic Containers
Ease of manufacture and design
Resistant to breakage, lightweight
General addictves include aantioxidants, antistastic agents, colorants, impact modifiers, libricants,
plasticizers, and stabilizers

Materials:
1. Polyethylene
Most widely used and is good barrier against moisture, poor against gases/oxygen
Not affected by strong acids or bases
Susceptible to oxidation during processing and subsequent exposures
2. Polypropylene
Doesnt stress crack in any condition
Resistant to chemicals except to hot aromatic or halogenated solvents that soften it
Suitable for boilable/sterilizable products and with excellent gas/vapor barriers

3. PVC
Crystal clear, good barrier and with greater sriffness
Cheap, easily processed
Can e used as skin coating to glass bottles to make them shatter resistant
Accumulate colon prevents sorption + lipophilix substances (oil, petroleum products)
4. Polystyrene
Rigid, crystal clear, furable
water vapor transmission and oxygen permeability
Has a lower MP not hot material
For solid DFs
5. Nylon
6.