packaging and labeling of pharmaceutical products

8/6/2019 Packaging and Labeling of Pharmaceutical Products

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PACKAGING AND

LABELING OFPHARMACEUTICAL

PRODUCTS.



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.



� 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.



� 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.



� 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.



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.



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



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.



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;



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.



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.



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.



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.



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.



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.



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.



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



� 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



Advantages of using Glass

packaging and labeling of pharmaceutical products

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