Scribd
Upload
12 views10 pages

Ip Cma

Uploaded by

Dhruva Patel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
12 views10 pages

Ip Cma

Uploaded by

Dhruva Patel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 10

Material Selection for Primary Packaging : Balancing

Protection and Compactibility

Group - M : 22BPH049
22BPH034
22BPH015
22BPH032
What is Packaging ?

The packaging can be defined as the economical


means of providing presentation, protection,
identification, information, containment,
convenience compliance, integrity and Stability for
a product during storage, transportation display
and until it is consumed or throughout its shelf life.
Pharmaceutical packaging is the science, art and
technology of enclosing or protecting products for
distribution, storage, sale, and use. Packaging also
refers to the process of design, evaluation, and
production of packages.
Ideal Packaging Requirements :

1. They must protect the preparation from environmental


conditions.
2. They must not be reactive with the product.
3. They must not impart to the product tastes or odors.
4. They must be nontoxic.
5. They must be FDA approved.
6. They must meet applicable tamper-resistance
requirements.
7. They must not be the cause of product degradation.
Types of Packaging

Primary packaging Secondary packaging Tertiary packaging Special types


Eg : Ampoules , Eg : Paper and It is used for Bulk Unit-dose
Containers , boards , Cartons , handling , packaging
Blisters , Syringe , Corrugated warehouse storage Device
Closures , Vials , Fibres , Box and transport packaging
Strips . Manufacture . shipping
Selection of the Packaging Materials
-On the facilities -On the cost of the -On the physical form -On the route of
available product. of the product. administration.
e.g- pressurized Expensive products E.g : solid, semi-solid, E.g :oral, parenteral,
dispensor requires usually justify expensive liquids or gaseous external, etc.
special filling equipments packaging dosage form.

-On the ultimate use of -On the contents. -On the stability of the material.
product. The product may react E.g :moisture, oxygen, carbon
The product may be with the package such as dioxide, light, trace metals,
used by skilled person in the release of alkali from temperature or pressure or
hospital or may need to the glass or the corrosion fluctuation of these may have a
be suitable for use in of the metals and in turn deleterious effect on the
the home by a patient.
the product is affected. product.
Types of Packaging Materials
1. Glass Advantage
They are hygienic and suitable for sterilization
Glass has been widely used as a It can accept variety of closures
drug packaging material.Glass is They are transparent.
composed of sand, soda ash They can be easily labelled
,limestone. and Si,Al,Na,Mg,Zn ,etc. They can withstand variation in temperature .

Types of glass : Disadvantage


Type 1 [Neutral or Borosilicate It is relatively heavy.
glass] Glass is fragile so easily broken
Type 2 [Treated soda lime glass] Release alkali to aqueous preparation
Type 3 [soda lime glass] Photosensitive drug cannot be protected in
Type NP [ General purpose soda the transparent glass container
lime glass]
2. Plastic

Thermoplastic Type Thermosetting Type


On heating , they are soften to When heated, they may
viscous fluid which hardens again become flexible but they
on cooling and it is resistance to do not become liquid.
breakage.
Plastics appear to have certain
Low in cost P C disadvantages like interaction,
adsorption, absorption lightness and
Light in weight
R O hence poor physical stability.
Durable
Able to return their shape O N All are permeable to some degree to
moisture, oxygen, carbon dioxide etc
odorless and inert. S S and most exhibit electrostatic
Pleasant to touch. attraction, allow penetration of light
rays unless pigmented, black etc.
3.Metals
Metal containers are used for medicinal
products for non-parenteral administration.
Metal is strong, opaque, impermeable to
moisture, gases, odors, light, bacteria, and
shatterproof, it is the ideal packaging material
for pressurized containers.
It is resistant to high and low temperatures

Aluminum Disadvantages and their overcome solution-Major


disadvantage is its reactivity in raw state,
Lead although it rapidly forms a protective film of
aluminium oxide it is still liable to corrosion ,when
Tin exposed to some liquids and semi solid
formulations, particularly at extreme pH or if the

Linings product contains electrolytes.


Stability Aspects : Contaminants:

1. Non-sterile product - Mechanical hazards


pack validation Chemical hazards
Water vapour permeability Climatic hazards
Light transmission Biological hazards
Stability

2. Sterile product-pack validation

Seal Integrity test


Compactibility
Thank you!

You might also like