The document discusses various aspects of pharmaceutical packaging, including its types: primary, secondary, and tertiary. It highlights essential criteria for selecting packaging materials, such as protection, stability, convenience, and cost-efficiency, along with compliance to legal and safety standards. The functions of packaging also include product identification, promotion, and protection against external influences, ensuring safe administration to patients.

1. Pharmaceutical Product Development
Pharmaceutical Packaging Material
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Objective Selection Criteria Function

3. Packaging is the art of science & technology of enclosing or
protecting products for distribution , storage, sale & use.
Pharmaceutical packaging can be defined as the
economical means of providing presentation, protection,
identification, information, convenience compliance, integrity
& stability of the product.
INTRODUCTION

4. Primary Packaging
In primary packaging material are directly covered the products & come close to the products &
hold it.The main function of this package is to protect the pharmaceutical formulation from any
chemical, climatic, mechanical damage. It is also called consumer unit packaging.
Ex – Strip, Blister, Bottle, Spray cane
Secondary Packaging
This packaging external to the primary package is called as secondary package. Secondary
package also includes the information about the drugs which is present in primary package.
Ex- Boxes
Tertiary Packaging
Tertiary packaging is used for the transportation of pharmaceutical product is bulk form.
It facilitates the handling, storage & transport of goods.
It provides the protection to secondary as well as primary packaging of drugs.
Ex- Container, edge protector, Large box
Type Of Packaging

5. Product Identification
Packaging greatly helps identification of products.
Product Protection
Packaging protect the contents of a product from spoilage, breakage, leakage, etc.
Facilitating the use of Product
Packaging should be convenience to open, handle & use for the customers.
Product Promotion
Packaging is also used for promotional & attracting the attention of the people while
purchasing.
Objectives

6.  Container should not absorb or adsorb any material containing.
 Containers should afford protection from moulds, bacteria etc.
 Material must not interact with the contents.
 Sufficient strength to withstand shocks of handling, transportation etc.
 Facilitate efficient safe and convenient use of contents.
 Cost of material should be as low as possible without compromising the
quality.
 Closer should be compatible with the preparation.
 Closure should provide air tight closing to the container.
 They should afford protect against environmental conditions like light, air
and moisture during storage.
Ideal Requirements

7. Physical Characteristics
Selection decision depending upon certain physical characteristics of product like physical state,
weight, stability, fragility, rigidity, surface finish etc. to be packed.
Facilitates Available
It depends facilities required to convert these material into packaging components.
Ex – Pressurized dispenser requires special filling, scaling & labeling equipment’s.
Formulation Components
Product may react with package as release of alkali from glass or corrosion of metals & in turn
product is destabilized.
Selection Criteria For Packaging Material

8. Stability
Environmental factor like moisture, oxygen, light, flame, bacteria, fungi, chemical action etc.
affect stability of formulation.
Economy
In pharmaceutical packaging, quality of packaging is very important in view of product stability &
marketing.
Convenience
Packaging must necessarily possess the quality of convenience from point of view of
consumers, distributors, producers.
Environmental Criteria
Packaging material selection influenced by environmental factor like weather & climate.
Selection Criteria For Packaging Material

9. Containment Protection
Presentation & information Labels
Repacking, relabeling, & dispensing Patient information leaflet
Compliance Protection of Patients
Detection of Packaging Materials
Functions Of Packaging

10. Containment – The containment of the product is the most fundamental function of packaging
for medical products.
» Not to leak & allow diffusion & permeation of the product.
» Strong enough to hold the content
» Not to be alter by ingredients
Protection – The packaging must protect the product against all adverse external influences
that may affect its quality.
Light Moisture Oxygen
Biological Contaminant Mechanical Damage
Presentation & Information – Such information is provided by labels & package inserts for
patients. Identification number for dispensing record.
Identification of the medicinal products (Name, strength , quantity, physical description)
Direction for use Date of dispensing
Storage instruction Name & address of dispenser
Functions Of Packaging

11. Labels – Throughout manufacturing, a succession of specific outer labels is applied to the
container of the medicinal products. All information concerning the medicinal products.
→ Quarantine
→ Storage
→ Distribution
Repacking, Relabeling & Dispensing – It is common practice not to dispense drugs in the
original packaging, but rather than in a personalized manner to each patient.
Patient Information Leaflets – Product information must help patients & other users to
understand the medication.
Labels ADR & Interaction Storage Condition Expiry Date
Functions Of Packaging

12. Compliance – The design of pharmaceutical packaging should be such that the product can
easily be administrated in a safe manner to the patients. If the patient feel ease with the
packaging & route of administration.
Protection of Patients– Packaging equipped with a temper-evident device protects against
incidental & accidental poisoning. To protect children, several child-resistant closures have been
developed.
Detection of Packaging Materials – “ Governments & pharmaceutical manufactures to
cooperate in the detection & prevention of increasing incidence of the export or smuggling of
falsely labeled, spurious, counterfeited or standard pharmaceutical preparations”.
Functions Of Packaging

13. THANKS!
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