PHARMACEUTICAL PACKGING

Adequate selection of the package preserves the integrity of the product. Package selection criteria:
Physical and chemical characteristics of the product. The protection needed Marketing requirements

 They must protect the product from environmental conditions They must not be reactive with the product. They must not impart to the product taste or odor. They must be nontoxic They must be FDA approved They must meet applicable tamper resistance requirements. They must be adaptable to high speed packaging equipments

 Glass Plastics

Metals

 commonly used in packaging because

it has superior protective properties. Economical Readily available in a variety of sizes and shapes. Chemically inert. Impermeable Rigid. Strong FDA approved. Does not deteriorate with age. Excellent barrier from all environmental conditions except light. Colored glass, amber, gives protection from light.

 Disadvantages of glass:
fragility. Weight.

Sand: pure silica, silicon dioxide . Soda ash: sodium carbonate. Limestone: calcium carbonate. Cullet: broken glass that is mixed with the batch and acts as a fusion agent for the entire mixture. It helps in the melting process.

Composition of glass varies and is adjusted according to its purpose. Presence of sodium or other alkalies makes the melting and processing of glass easier. Reduction of sodium content increases the chemical resistance of glass.
Boron oxide is incorporated to aid in the melting process. Lead in small amounts gives clarity and brilliance, but also introduces softness in the glass. Alumina (Aluminum oxide) used to increase hardness, durability and chemical resistance of glass.

Blowing Drawing

Pressing
Casting

Clear Amber Blue Emerald Green

Only Amber and green glass can protect products from sunlight by screening out UV light

 Amber can be introduced into glass by the addition of iron oxide, but iron oxide could leach out and contaminate the product. Therefore if the product is prone to iron catalyzed chemical reactions, amber glass should not be used.

 Glass should be evaluated for its chemical resistance (according to USP, NF) by doing these two tests:
Powdered glass test: Performed on crushed glass. Water attack test: Performed on whole containers. Used only for type II glass.

In these tests the amount of alkalinity leached from the glass by pure water is measured.

Type I, Borosilicate glass Type II, Treated soda-lime glass Type III, Regular soda lime glass Type NP, General purpose soda-lime glass

 Highly resistant glass. Substantial replacement of alkali and earth cations by boron, aluminum and zinc. Leaching of sodium is reduced significantly.

 Treated to remove alkalis from its surface. The dealkalization process is known as sulfur treatment. The treatment exposes glass to sulfur dioxide and water vapor at elevated temperature. This treatment makes glass more chemically resistant.

 Untreated glass. With average or better than average chemical resistance. When distilled water is stored in this type of glass containers for one year it picks up 10-15 ppm of sodium hydroxide as a result of leaching.

 supplied for non-parenteral products.

Can be used for topical or oral products.

 Usefulness:
Ease of formation. High quality. Freedom of design. Extremely resistant to breakage.

 Polymers usually used in the making of plastic containers:

Polyethylene. Polypropylene PVC Polystyrene.

 Additives used in plastic containers:

Antioxidants. Antistatic agents. Colors. Impact modifiers. Lubricants. Plasticizers. Stabilizers, keep the plastic from burning at high temperatures.

 These additives must be chosen such that they can not be extracted into the product in significant amounts.

 Most widely used for containers by the pharmaceutical industry. Good barrier against moisture. Unaffected by strong acids and alkalies. Low cost Permeable to oxygen, odors, and flavors. Limits its use for some pharmaceutical preparations.

 The density of polyethylene ranges from 0.910.96. Increase in density is due to presence of fewer side branches in the polymer structure. This density difference affects the following properties:
Stiffness. Moisture vapor transmission. Stress cracking. Clarity.

The denser the polymer is the stiffer, less permeable to gases and vapors, and less resistant to stress cracking.

 Additives to polyethylene:
Antioxidants: reduces the susceptibility of the polymer to oxidative degradation. Usually very small amounts are used (0.01 ppm) examples, butylated hydroxyl toluene and dilauryl thiodopropionate. Antistatic: used in bottle grade polyethylene. Used to minimize air borne dust accumulation on the surface of the bottle during handling. Examples polyethylene glycols 0.1-0.2%.

 Has similar properties to polyethylene but it does not stress crack under any condition. Good resistance to almost all types of chemicals such as strong acids alkalies, etc. Has high boiling point, good for sterilizable products. Excellent gas and vapor barrier. Slightly better than high density polyethylene. Its draw back is its lack of clarity. And it is fragility at low temperatures addition of polyethylene to it can reduce this.

Clear and rigid. Good oxygen, and volatile oils barrier. Good stiffness. Not affected by acids or alkalies. Can be affected by some oxidizing agents. Vinyl chloride (monomer) is associated with lever cancer. Major reduction in the monomer content in PVC has been achieved. Expensive Poor impact resistance, can be softened by addition of plasticizers

 other additives include:

Antioxidants. Stabilizers: used to prevent yellow discoloration of PVC when exposed to heat or UV light. Example Dioctyl-tin mercaptoacetate, sulfur, calcium and zinc salts). Lubricant. Colors.

 Rigid, crystal clear. Low cost. High water vapor transmission as well as high oxygen permeability. Not usefull for packaging liquid products. Low crack resistance (brittle). This can be improved by mixing it with ruberand acrylic compounds. Resistant to strong acids but not to strong alkalies or oxidizing agents.

 Dibasic acid combined with a diamine. This leads to great variety in nylons. Nylon 6/10 has 6 carbon atoms in the diamine and 10 in the acid. Extremely strong. Resistant to wide range of chemicals. Highly impermeable to oxygen. Not a good barrier to water vapor. Can be laminated with polyethylene to improve this. Possibility of drug-plastic interaction.

 Clear and transparent. Ability to be sterilized. Resistant to heat and flame. Rigid as glass. High impact strength. Drug-plastic interactions not fully investigated. Relatively expensive. Fair moisture barrier. Attacked by alkalies, amines, some alcohols and others.

Excellent strength. High gas barrier. Good chemical resistance. Medium cost. Fairly clear. Regulated for monomer content not to exceed certain limits.

 Excellent impact resistance. Excellent gas barrier. Used for packaging carbonated beverages.

 Coextruded resins: such as polypropylene/ethylene-vinylalcohol. The first polymer provides the moisture barrier while the second enhances the gas barrier properties of the mix.

 The packaging system must protect the drug without in any way altering the composition of the product until the last dose is removed. The selection of a suitable package for the drug is not an easy task, any error can lead to serious consequences.