Selection and evaluation of pharmaceutical packaging materials, containers and closures


Published on

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Selection and evaluation of pharmaceutical packaging materials, containers and closures

  1. 1. Prepared by:- Hemant Rathod Guided by:-Miss Natasha Sharma
  2. 2. Contents Characteristics of Packaging materials Role of Packaging Selection of the Packaging materials Containerso Ideal requirements of containero Types of containerso Materials for making of containers Closureso Types of closureso Materials for making of closures
  3. 3.  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:- Glass Plastic Metal Paper and board
  4. 4.  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.
  5. 5.  Role of Packaging:- Protection-against light -against reactive gases -against moisture -against microbes -against physical damage -against pilferage and adulteration Presentation Identification Information Compatible Convenience
  6. 6.  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.
  7. 7. 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
  8. 8. 2. Environmental Factors:-• Temperature• Pressure• Moisture• Gases• Light• Infestation• Contamination Containers:- 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.
  9. 9. 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 a Withstand 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.
  10. 10.  Types of Containers:- Well-closed containers Single dose containers Multi dose containers Light-resistant containers Air-tight containers Aerosol containers Materials used for Making of Containers:-1. Glass2. Plastic3. Metal4. Paper and board
  11. 11.  Glass Advantages:- 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.
  12. 12. 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
  13. 13. 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 containers Testes 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
  14. 14.  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.
  15. 15.  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.
  16. 16. Classification of Plastics:-1. Thermoplastic type2. Thermosetting type Evaluation of Plastic:-• Leakage test• Collapsibility test• Clarity of aqueous extract• Water vapour permeability test
  17. 17.  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.
  18. 18. 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.
  19. 19. Types of Closures:-• Threaded screw cap Lug cap Crown cap Roll on closures Pilfer proof closures Materials used for making of Closures
  20. 20. Materials used for making of Closures:-1. Cork2. Glass3. Plastic4. Metal5. Rubber Evaluation of closures:-1. Sterilization test2. Fragmentation test3. Self sealibility test
  21. 21.  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
  22. 22. Thank You