22
Selection and Evaluation of Pharmaceutical Packaging Materials, Containers and Closures Prepared by:- Hemant Rathod Guided by:- Miss Natasha Sharma

Selection and evaluation of pharmaceutical packaging materials, containers and closures

Embed Size (px)

DESCRIPTION

 

Citation preview

Page 1: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Selection and Evaluation of Pharmaceutical

Packaging Materials, Containers and Closures

Prepared by:-Hemant Rathod

Guided by:-Miss Natasha Sharma

Page 2: Selection and evaluation of pharmaceutical packaging materials, containers and closures

ContentsCharacteristics of Packaging materialsRole of PackagingSelection of the Packaging materialsContainerso Ideal requirements of containero Types of containerso Materials for making of containersClosureso Types of closureso Materials for making of closures

Page 3: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Packaging is the process by which the pharmaceuticals are suitably packed so that they should retain their therapeutic effectiveness from the time of their packaging till they are consumed. Packaging may be defined as the art and science which involves preparing the articles for transport, storage, display and use.

Types of Pharmaceutical Packaging Materials:-

GlassPlasticMetalPaper and board

Page 4: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Characteristics of Packaging Materials:-They must protect the preparation from

environmental conditions.They must not be reactive with the product.They must not impart to the product tastes or

odors.They must be nontoxic.They must be FDA approved.They must meet applicable tamper-resistance

requirements.They must be adaptable to commonly

employed high speed packaging equipment.

Page 5: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Role of Packaging:-Protection-against light -against reactive gases -against moisture -against microbes -against physical damage -against pilferage and adulterationPresentationIdentificationInformationCompatibleConvenience 

Page 6: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Selection of the Packaging Materials:-1. On the facilities available, for example, pressurized

dispenser requires special filling equipment.2. On the ultimate use of product. The product may

be used by skilled person in hospital or may need to be suitable for use in the home by a patient.

3. On the physical form of the product. For example, solid, semi-solid, liquids or gaseous dosage form.

4. On the route of administration. For example, oral, parenteral, external, etc.

5. On the stability of the material. For example, moisture, oxygen, carbon dioxide, light, trace metals, temperature or pressure or fluctuation of these may have a deleterious effect on the product.

Page 7: Selection and evaluation of pharmaceutical packaging materials, containers and closures

6. On the contents. The product may react with the package such as the release of alkali from the glass or the corrosion of the metals and inturn the product is affected.

7. On the cost of the product. Expensive products usually justify expensive packaging

Factors affecting selection of Packaging Materials:-

1.Mechanical Factors:-• Shock• Compression• Puncture• Vibration

Page 8: Selection and evaluation of pharmaceutical packaging materials, containers and closures

2. Environmental Factors:-• Temperature• Pressure• Moisture• Gases• Light• Infestation• ContaminationContainers:-Container is one in which the product is placed.A pharmaceutical container is defined as a

device that holds the drugs and is or may be in direct contact with the preparation.

Page 9: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Ideal Requirements of Container:-

Must be neutral towards the material which stored in it.

Must not interact with the substance which it holds.Help in maintaining the stability of the product aWithstand wear and tear during normal handling.Dose can be drawn from it conveniently.Able to withstand changes in pressure and

temperature. Must be non-toxic.Can be labelled easily.Pharmaceutically elegant appearance.

Page 10: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Types of Containers:-

Well-closed containersSingle dose containersMulti dose containersLight-resistant containersAir-tight containersAerosol containers

Materials used for Making of Containers:-1. Glass2. Plastic3. Metal4. Paper and board

Page 11: Selection and evaluation of pharmaceutical packaging materials, containers and closures

GlassAdvantages:-They are transparent.They are available in various shapes and sizes.They can withstand the variation in temperature and

pressure during sterilization.They are economical and easily available.They can protect the photosensitive medicaments from

light during their storage.They are neutral after proper treatment.They are impermeable to atmospheric gases and

moisture.They have good protection power.They do not deteriorate with age.They can be easily labelled.They can be sealed hermetically or by removable

closures.

Page 12: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Composition of Glass:-• Glass is composed of sand, soda ash, lime

stone and cullet.• Silicon, aluminium, boron, sodium,

potassium, calcium, magnesium, zinc and barium are generally used in the preparation of glass.

Types of Glass:-Type 1:-Neutral or Borosilicate glassType 2:-Treated Sodalime glassType 3:-Regular Sodalime glassType 4:-General Purpose Sodalime glass

Page 13: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Evaluation of Glass Containers:-U.S.P. and I.P. provides two testes to determine

the chemical resistance of glass containers:Table: Limits of alkalinity for glass containersTestes Containers Limits, ml of

0.02 N H2SO4

1.Powder glass test Type 1 1 Type 3 8.5 Type NP 15

2.Water attack test Type 2 (100 ml or less) 0.7

Type 2 (over 100 ml) 0.2

Page 14: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Plastic

Advantages:-

They are light in weight and can be handled easily.

They are poor conductor of heat.They have sufficient mechanical strength.They can be transported easily.They are unbreakable.They are available in various shapes and

sizes.They are resistant to inorganic chemicals.They have good protection power.

Page 15: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Disadvantages:-They are permeable to water vapour and atmosphere

gases.They cannot withstand heat without softening or

distorting.They may interact with certain chemical to cause

softening or distortion.They may absorb chemical substances, such as

preservatives for solution.

Composition of Plastic:-• Plastics are synthetic polymers of high molecular

weight. Plastic is made from one or more polymers together with certain additives. The polymers commonly used are polyethylene, polypropylene, polyvinyl chloride, polystyrene, etc.

Page 16: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Classification of Plastics:-1. Thermoplastic type2. Thermosetting type

Evaluation of Plastic:-• Leakage test• Collapsibility test• Clarity of aqueous extract• Water vapour permeability test

Page 17: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Metals• The metals commonly used are aluminium, tin plated

steel, stainless steel, tin and lead.

Advantages:-They are sturdy.They are impermeable to light, moisture and gases.They can be made into rigid unbreakable containers by

impact extrusion.They are light in weight as compared to glass

containers.

Disadvantages:-They are expensive.They may shed metal particles into the pharmaceutical

product.

Page 18: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Closures:-

Closures are the devices by means of which containers can be opened and closed.

It prevents loss of material by spilling or volatilization.

It avoids contamination of the product from dirt, micro-organism or insects.

It prevents deterioration of the product from the effect of the environment such as moisture, oxygen or carbon dioxide.

Page 19: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Types of Closures:-

• Threaded screw capLug capCrown capRoll on closuresPilfer proof closuresMaterials used for making of Closures

Page 20: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Materials used for making of Closures:-1. Cork2. Glass3. Plastic4. Metal5. Rubber

Evaluation of closures:-1. Sterilization test2. Fragmentation test3. Self sealibility test

Page 21: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Reference:-

Pharmaceutics-1 by R.M.Mehta, Page No.:-74-85

The Theory and Practice of Industrial Pharmacy by Leon Lachman, Page No.:-711-724

Pharmaceutical Product Development by N.K.Jain, Page No.:-341-377

Aulton’s Pharmaceutics by Michael E. Aulton, Page No.:-626-638

Page 22: Selection and evaluation of pharmaceutical packaging materials, containers and closures

Thank You