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8/6/2019 Packaging and Labeling of Pharmaceutical Products
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PACKAGING AND
LABELING OFPHARMACEUTICAL
PRODUCTS.
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PACKAGING.
� A product is not correctly formulated
unless it is properly packaged.
� In some cases the major part of the
formulation process may beconcerned with selecting the right
package for the product.
� The stability of pharmaceuticals may
be totally dependent on the proper
functioning of the package.
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� For example, there must be rigorous
exclusion of light and oxygen from oily
vitamin preparations, loss of potency due to
oxidation is to be avoided.
Dfn
� Packaging can be dfined as an economicalmeans of providing presentation,protection,
identification, containment, covinience and
compliance for product during storage,
carriage and display until such time as theproduct is used or administered.
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� Packaging of pharmaceuticals is doneby using containers (packs).Normally, there are specifications of acontainer required for packing aparticular product.
A package consist of;
The container in the product is placed.
The closure which seals the container.The carton or outer( it gives secondary
protection)
The box in which multiples of the
product are placed.
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� The following are the comonly usedcontainers;
a) Glass
b) Rubber c) Plastics
d) Metal
An ideal container should have the followingfeatures
i. The container must be rigid enough toprevent damage to the contents e.g.fracture of tablets and crushing of capsules.
ii. The materials of construction must notreact with the contents.
iii. The closure must be easily removed andreplaced.
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iv. It must not be difficulty to abstractthe contents or to empty the container completely.
v. For many products, protection from lightmust be given.
vi. Medicaments or adjuncts must not beabsorbed by the container material nor must diffusion through the walls be
possible.vii. It must be easy to label the container
correctly
viii. It must have a pharmaceutically elegantappearance.
ix. The closure must prevent access of moisture or loss of moisture and entry of dirty or other contaminants.
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Types of containers.
With respect to method of closure, there are
four types of containers;
Well closed containers
This container protects the contents
from contamination with extraneous solids
and under normal condition of handling,storage and transport, prevent
unintentional release of the product.
Air tight container.
This container gives protection fromextraneous solids, liquids and vapors, and
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Securely-closed containers
This is an airtight container with a
means of preventing unintentional
displacement of the closurere.
Hermetically-sealed containers
This container is impervious to air
and other gases under normalconditions of handling, storage and
transport. The common example is a
glass ampoule sealed by fusion.
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The role of the pack.� The role of the pack and packaging
operation needs emphasis as the
shelf-life of all pharmaceutical
products is largely dependant oncertain function of the pack.
� The pack must be economical and it
must provide protection against the
following hazards;
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Physical or mechanical damage may
occur due to the following;
� Mechanical hazards.
a) Shock or impact damage- this refers
to rough handling, where rapid
deceleration occurs. Shock can be
reduced or overcomed by cushioning,restriction of movement or more
carefully handling.
b) Compression- Top pressure or
loading can distort and crush a packand damage the product inside.
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c ra on
Vibration can cause components of the
product to separate, screw caps may
loosen, labels or decorations mayabrade.
d) Puncture or piercing.
Many materials can suffer penetrationfrom sharp objects. Adequate
cushioning and/ or resistance to
penetration helps reduce the risks.
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2) Climatic or environmental hazards.
This includes the following;
a) Moisture.
� Moisture as liquid or water vapor may causephysical changes such as dulling, softening
and hardening or chemical changes such as
hydrolysis and effervescence.
� It may also act as carrier for other contaminants.
� Certain materials are to some extent
permeable to moisture, and the screw
closures are likely to permit some passage
of moisture, depending on sealing medium,
the torque the aperture size and
circumferential area of the container.
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b) Temperature.
Extremes of temp. ( cold or hot) or cycling temperatures can cause
deterioration to the product.c) Light
� Light consist of wavelength from theuv zone through the visible region toIR zone.
� UV light is potential for photochemical changes, oncephotochemical changes haveoccurred, this will imply changes in
the product efficacy or strength .� UV absorbers in plastic may alsorestrict light rays entering the pack.
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d). Atmospheric gases
These includes oxygen, carbon dioxide,
nitrogen and any other airborne gasesOxygen may lead to oxidation.
Carbon dioxide can cause a pH shift in
unbuffered solutions or lead to precipitation
of some products
Odorous gases, or volatile ingredients
associated with perfumes, flavours and
product formulations may also pass into or
out of the pack.
If a volatile ingredient is lost from a flavour,an unpleasant odour or taste may result.
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3). Biological hazards.
There is a general tendency towards
improved microbial control for all products.
The packaging material must be reasonably
clean initially and, when put together to form
a finished pack, restrict any further
contamination as much as possible
In the case of sterile product the pack andits closure must maintain a 100% effective
seal against microbial ingress, e.g. bacteria,
moulds and yeast
Ingress of yeast is critical with sugar basedproducts, e.g. syrups, as fermentation may
occur.
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4). Chemical hazards
� The main risk of chemical interactions is
related to interaction or incompatibility
between btn the product an the pack.� The interaction may be due to absorption,
covering migration, adsorption, extraction,
corrosion, erosion etc , where by igredients
may be lost or gained.
� These changes may be identifiable as
organoleptic changes, increased in
toxicity/irritancy, degradation, loss or gain of
microbial effectiveness, precipitation,
turbidity, color change or pH shift.
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PACKAGING MATERIALS.
1)Glass and Glass containers.� Basically, there are three types of glass,
namely,a) Neutral glass (type i)
b) Surface treated soda glass ( type II)
c) Soda or alkali glass (type III)
The major components of type I and type IIIglass are; silica, lime, soda, alumina and
Boric oxide in type I and is absent from
type III
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� In type I glass the alkaline element is
largely eliminated by the use of boric oxide,
to neutralize the oxides of potassium and
sodium. This glass has a high melting temp� Surface treated glass is made by treating
the hot surfaces of type III (Soda glass) with
sulphur dioxide or ammonium sulphate
This neutralizes some of the surface
alkali radicals producing a more neutralsurface.
� Type III glass is the most commonly used
material, where extraction of alkali metal
ions is not critical to the product
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Advantages of using Glass
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