Pharmaceutical Manufacturing Handbook: Production and

170 PACKAGING AND LABELING
TABLE 1 Plastic Additives
Type
Purpose
Examples
Lubricants
Improve processability Stearic acid paraffi n waxes, polyethylene
(PE) waxes
Stabilizers Retard degradation Epoxy compounds, organotins, mixed
metals
Plasticizers Enhance fl exibility,
resiliency, melt fl ow
Phthalates
Antioxidants Prevent oxidative Hindered phenolics (BHT), aromatic
degradation
amines, thioesters, phosphites
Antistatic agents Minimize surface static
charge
Quaternary ammonium compounds
Slip agents Minimize coeffi cient of
friction, especially
polyolefi ns
Dyes, pigments Color additives
Source : From ref. 6 .
TABLE 2 Parenteral Drug Administration Devices
Sterile Device
Plastic Material
Containers for blood products
Polyvinyl chloride
Disposable syringes
Polycarbonate, polyethylene, polypropylene
Irrigating solution containers Polyethylene, polypropylene, polyvinyl chloride
Intravenous infusion fl uid containers Polyethylene, polypropylene, polyvinyl chloride
Administration sets Nylon (spike), polyvinyl chloride (tubing),
polymethylmethacrylate (needle adapter),
polypropylene (clamp)
Catheter
Tefl on, polypropylene, thermoplastic elastomers
Source : From ref. 6 .
Some examples of plastic additives and parenteral drug administration devices used
as packaging materials for sterile products can be seen in Tables 1 and 2 .
Ophthalmic ointments are marketed in a metal tube with an ophthalmic tip.
Ophthalmic ointments that are reactive toward metal may be packaged in a tube
lined with an epoxy or vinyl plastic coating.
Metal containers, pressurized or not, may also be used for topical drug products.
Topical dosage forms include aerosols, emulsions, gels, powders, and solutions
and may be marketed in metallic fl asks, pressurized or not. Topical dosage formulations
are for local (not systemic) effect and are generally applied to the skin or
oral mucosal surfaces. Some vaginal and rectal creams and nasal and otic spray
drug products may be considered for marketing in metallic containers for topical
use.
A number of topical products marketed as a pressurized aerosol may be dispensed
in a metallic bottle with a screw cap. Topical dosage forms in aluminum tubes
usually include a liner. A tube liner is frequently a lacquer or shellac whose composition
should be stated. A metallic pressurized packaging system for a liquid -