selection and evaluation of pharmaceutical packaging materials, containers and closures
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Selection and Evaluation of Pharmaceutical
Packaging Materials, Containers and Closures
Prepared by:-Hemant Rathod
Guided by:-Miss Natasha Sharma
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
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
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.
Role of Packaging:-Protection-against light -against reactive gases -against moisture -against microbes -against physical damage -against pilferage and adulterationPresentationIdentificationInformationCompatibleConvenience
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.
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
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.
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.
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
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.
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
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
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.
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.
Classification of Plastics:-1. Thermoplastic type2. Thermosetting type
Evaluation of Plastic:-• Leakage test• Collapsibility test• Clarity of aqueous extract• Water vapour permeability test
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.
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.
Types of Closures:-
• Threaded screw capLug capCrown capRoll on closuresPilfer proof closuresMaterials used for making of Closures
Materials used for making of Closures:-1. Cork2. Glass3. Plastic4. Metal5. Rubber
Evaluation of closures:-1. Sterilization test2. Fragmentation test3. Self sealibility test
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
Thank You
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