PACKAGING MATERIALS PLASTICS

DODDA DINESH KUMARIST YEAR M.PHARMACY

GITAM INSITUTE OF PHARMACY

CONTENTS:- Classification Advantages Disadvantages Drug plastics consideration Moulding processes Testing of plastics Application

Packaging:-

Packaging is best described as a coordinated system of preparing goods for transport, distribution, storage, retailing, and use of the goods.

PLASTICS

Plastics are group of substances either natural or synthetic origins, consisting chiefly of polymers of high molecular weight, that can be moulded into a shape or form by heat and pressure

Different Types of Plastics:LDPE HDPE Polystyrene Polycarbonate Poly propylene PVC PET

Advantages of Plastics

Light weight.

Reduced volume, (these two result in significant savings in warehousing and distribution costs plus advantages to the consumer).

No corrosion problems.

Good resistance to mould and bacteria.

Generally inert chemically, but be wary of ‘solvents’.

Usually have good impact strength; difficult to break, if breakage occurs fragments tend to be less hazardous than glass.

Wide design and decorative possibilities.

Offer a wide range of moulding processes.

Disadvantages of Plastics

No plastic is totally impermeable to moisture, gases, etc.

May be permeable to, or subject to attack by, organic substances, particularly solvents.

Subject to adsorption and absorption according to formulation ingredients.

Fully effective closing systems are sometimes difficult to achieve.

Guides offered by the FDA have identified the need for the following information when a plastic is used for parenterals (now similarly covered by EN 9090/III).

1. Name of manufacturer.

2. Type of plastic.

3. Composition, method of manufacture of the resin and the finished container, plus a full description of the analytical controls.

4. Physical characteristics (size, dimensions, whether flame treated, etc.).

5. Defect classifications (weight, seams, seals, wall thickness, pin holes, etc.).

6 .Light transmission test, USP (particularly if product is photosensitive).

7. Tests (USP):

• biological

• physico-chemical

• permeation.

8. Vapour transmission test (if appropriate).

9 .Toxicity studies not included in USP:

• sub-acute on extracts

• cell culture.

10 .Tests for leaching and migration.

11. Compatibility.

12. Sampling plan.

13. Acceptance specifications.

DRUG PLASTIC CONSIDERATIONS

Permeation Leaching Sorption Chemical Reaction

PERMEATION

Transmission of gases, vapours or liquids through packing material.Permeation of oxygen and water vapour may cause oxidation or hydrolysis of sensitive drugs.Increase in temperature and humidity will make the condition still worst.

LEACHING

Migration of contents of the container to the drug product.Problems will be with colouring agents used in plastics.

SORPTION

Removal of constituents of the drug product by packing material.

This may cause serious problem like loss of potency of drug.

A common problem is loss of preservatives.

Factors influencing: Chemical structure, pH. Solvent system, temperature, length and area of contact

CHEMICAL REACTION

Some ingredients of plastic containers may chemically react with drug product or vise versa.

MOULDING PROCESS:-• EXTRUSION MOULDING

COMPRESSION MOULDING/COMPRESSION TRANSFER MOULDING

•

• THERMOFORMING BY PRESSURE, VACUUM, MECHANICAL FORMING OR COMBINATIONS

ROTATIONAL MOULDING

REACTION INJECTION MOULDING (RIM)

SOFT MOULDING

DIP MOULDING

TESTING OF PLASTICS

General tests on plastics for pharmaceutical purposes include

Extractive and biological tests, Chemical tests, Physical tests and Toxicity tests.

STANDARD TEST PROCEDURES APPLIED TO PLASTICS.

Density Melt flow index (MFI)Appearance—optical properties Gloss, Haze and transmittance (Clarity), Refractive index, Fastness to lightGeneral physical properties Tensile properties Resistance to stress and flexing Compression, Torsion, Shear, Stress Impact strength Tear properties (tear propagation resistance) Hardness Abrasion resistance (wear resistance)Temperature and heat sensitive evaluations (thermal properties) Heat distortion temperature (or heat deflection temperature) Melting point (Tm or crystalline melting point) Vicat softening point Brittleness temperature Thermal conductivity FlammabilityElectrical properties

APPLICATIONS

Based on the utility of plastics they can be categorized as

1. Rigid material plastics

2. Flexible material plastics

3. Metallic surface plastics

4. Plastic cements

Rigid material plastics These are the phenolic resines with

various inert filters these are used in the fabrication of a number of items and it is light in weight such as gears, pipes, valves, filter press, pumps, etc…

Flexible material plastics These are thermo plastic materials

these materials can be rigid or flexible depending upon the amount of plasticizer added these are used in the fabrication of tanks,funnels,buckets,etc…

Metallic surface plastics Plastics of polyethylene or poly vinyl

chloride types are used along with plasticizer for the coating of metallic surface these are used to protect the metals from corrosion. These linings are applied on tanks, vessels, bottle caps etc..

Plastic cements These are used for spaces between

acid resistance tiles and bricks.

References…

1. Packaging of pharmaceutical dosage forms

by. Thomas J Ambrosio

2. Pharmaceutical engineer

by. C.V.S. Subrahmanyam

3. www.google.com

THANK YOU