Pharmaceutical packaging of plastics || plastics definition and types

 

PACKAGING OF PHARMACEUTICALS

     Plastics

Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality, and the freedom of design to which they lend themselves.

Plastic containers are extremely resistant to breakage and thus offer safety to consumers along with reduction of breakage losses at all levels of distribution and use.

Plastic containers for pharmaceutical products are primarily made from the following polymers: polyethylene, polypropylene, polyvinyl chloride, polystyrene, and to a lesser extent, polymethyl methacrylate, polyethylene terephthalate, polytrifluoroethylene, the amino formaldehydes, and polyamides.

Plastic containers consist of one or more polymers together with certain additives.

Those manufactured for pharmaceutical purposes must be free of substances that can be extracted in significant quantities by the product contained therein.

Thus, the hazards of Toxicity or physical and chemical instability are avoided.

The amount and nature of the additives are determined by the nature of the polymer, the process used to convert the plastic into the containers, and the service expected from the container.

For plastic containers in general, additives may consist of antioxidants, antistatic agents, colors, impact modifiers, lubricants, plasticizers, and stabilizers Mold release agents are not usually used unless they are required for a specific purpose.

1.    Polyethylene: density of polyethylene ranges 0.91 to 0.96 susceptible to oxygen, and    oxide.

Antioxidant added: Butylated hydroxyl toluene (BHT) and Dilauryl thiodipropionate

Antistatic additives: Minimize air born dust accumulation at surface of glass.

 Example: Polyethylene Glycol and long chain fatty acid amide, Concentration-0.1-0.2% in high density polyethylene

2.  Poly propylene- Does not stress, crack under any condition except not aromatic and halogenated solvents.  

Suitable for "boilable package" and for "sterilization product".

-Brittleness at low temp. Blended with another polymer

3.    PVC:  Does not over heat degrade at 280 F, Degradation product are corrosive.

Added Stabilizers: Dioctyl tin mercapto acetate and Malleate compound. Others are Sulphur, calcium and zinc salts.

4.    Poly styrene: Not useful for liquid product because of high water vapour transmission and high oxygen permeability. Used for dry products only.

5.    Nylon: Dibasic acid diamine.

Example: Nylon 6/10: six c-atom in diamine and 10 in acid. Nylon 6, 6/6, 6/10

6.    Polycarbonate: Rigid as glass, can be replaced in place of glass vials and syringes, can be subjected to repeated sterilization.

7.    Acrylic polymers: (for food packaging)

Acrylonitrile, Methacrylonitrile-monomer Safety standard: <11 ppm and 0.3 ppm for all other products.

8. Other plastics: Co-extrusion technique permits the use of high barrier resin. A coextrusion such as polypropylene/ethylene-vinyl- alcohol/polypropylene provides the moisture barrier of polypropylene coupled with the enhanced gas barrier of ethylene vinyl alcohol. Coextruded resins are providing packaging alternatives for products that previously were packaged only in glass.

Drug plastic consideration:

Permeation-transmission of Gases, vapors liquid through plastic packaging materials.

Leaching-migration of constituent from container to the drug.

Sorption-Removal of constituents from drug product by packaging materials. Commonly encountered loss of preservative.

Chemical reaction-Plastic formulation reacts chemically with one or more compound of drug product After appearance of plastic and drugs.

Modification- Physical and chemical alteration of packaging materials by the drug products.

Collapsible tubes

1. Metals used: Aluminum, tin (most chemically inert), lead Not for food product (Pb. Poisoning)

Tin is alloyed with 0.5% copper for stiffening when lead is used 3% antimony is added to

(1)  Tin: preferred food packaging increases hardness

(2)   Linings: Epoxy lining, vinyl, with Aluminum tubes

Phenolics: Effective with acid product.

Epoxides for alkaline materials

Wax is also used for tin

It does not have Suck back property.

2. Plastics tube: has advantage of having Suck back property which prevent the product to Ooze out.

The disadvantage being the contamination.

Most commonly used plastic tubes are high- and low-density polyethylene.

3. Lamination tube: Machine used "side seamer"



Head made of-Low density poly ethylene    -   Some permeation possible

                                                                                        |

Head insert made of "urea formaldehyde" reduce product permeation.

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