PHARMACEUTICS II NOTE

1. Packing of
pharmaceutical dosage
form
Nirmal Raj Marasine
WHSA

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

3. FUNCTIONS OF PACKAGING
• Product Identification:- Packaging greatly helps in
identification of products.
• Product Protection:- Packaging protects the contents
of a product from spoilage, breakage, leakage, etc.
• Facilitating the use of product:- Packaging should be
convenience to open, handle and use for the
consumers.
• Product Promotion:- Packaging is also used for
promotional and attracting the attention of the people
while purchasing.

4. TYPES OF PACKAGING
• Primary packaging- is the material that first envelops
the product and hold it. This usually is the smallest unit
of distribution or use and is the package which is in
direct contact with the contents
• Examples: Ampoules,Vials ,Containers ,Dosing dropper
,Closures (plastic, metal) ,Syringe ,Strip package,
Blister packaging
•
•

5. • Secondary packaging is outside the primary
packaging perhaps used to group primary packages
together.
• Example: Paper and boards, Cartons ,Corrugated
fibers ,Box
•

6. • Tertiary packaging is used for bulk handling ,
warehouse storage and transport shipping. The most
common form is a palletized unit load that packs tightly
into containers.
• E.g. : Barrel, container, edge protector

7. CHARACTERISTICS OF PACKAGING
MATERIAL
The material selected must have the following
characteristics:
• Must meet tamper-resistance requirements
• Must be FDA approved
• Must be non-toxic
• Must not impart odor/taste to the product
• Must not reactive with the product
• They must protect the preparation from environmental
conditions

8. Container
• A Pharmaceutical container is a device that holds the drug
and may be in direct contact with product.
Closures
• It is a device which protects the drug (or) drug product by
preventing the entry of air, moisture, particulate matter, and
microorganisms etc., thereby keeping the product in a safe
condition and also assists in proper use & of the drug.

9. Desirable Features of Containers and closures/ideal
characteristics of Containers and closures
• It must protect the dosage form from environmental
conditions
• It must be non-reactive with the product
• It should not impart taste and odor to the product
• It must be non-toxic
• It must meet applicable tamper resistant requirement
• It must comply with the legal requirements
• It must preserve the product up to its shelf life
• It must be economical

10. • It must not allow leakage,spoilage or permeation of the
product
• It must not absorb or adsorb the drug conent of the
product
• It must withstand pressure during handling ,storage and
transport
• It must provide an acceptable presentation for the
product and at the same time maintain identification
and information

11. Classification of containers on the basis of method
of closure and use
• Well – closed containers:
A well-closed container protects the contents from loss
during transportation, handling, storage or sale.
• Single dose containers :
 These containers are used to supply only one of
medicament and hold generally parenteral products.
E.g. ampoules and vials
• Multi dose containers:
These containers allow the withdrawal of dose at
various intervals without changing the strength, quality
or purity of remaining portion. these containers hold
more than one dose and are used for injectable. E.g.
vials

12. • Light-resistant containers:
 These containers protect the medicament from
harmful effects of light.
These containers are used to store those medicaments
which are photo-sensitive.
• Air -tight containers:
 These are also called hermetic containers.
These containers have air-tight sealing or closing.
These containers protect the products from dust,
moisture and air.

13. Where as air-tight sealed containers are used for
injectable, air-tight closed containers are meant for the
storage of other products.
• Aerosol containers:
These containers are used to hold aerosol products.
These containers have adequate mechanical strength
in order to bear the pressure of aerosol packing.

14. TYPES OF PACKAGING MATERIALS
USED FOR
PHARMACEUTICAL PACKAGING
• Glass
• Plastics
• Rubbers
• Paper/card boards
• Metals

15. GLASS:
• Glass has been widely used as a drug packaging
material.
• Glass is composed of sand, soda ash, limestone,&
cullet.
• Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into
preparation of glass
Advantages
• They are hygienic and suitable for sterilization
• They are relatively non reactive ( depending on the
grade chosen)

16. • It can accept a variety of closures
• They can be used on high speed packaging lines
• They are transparent.
• They have good protection power.
• They can be easily labeled.
DISADVANTAGES
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation

17. TYPES OF GLASS
• Type I—Highly resistant borosilicate glass
• Type II—Treated soda lime glass
• Type III—soda lime glass
• NP—soda glass (non parenteral usage)

18. Type I-borosilicate glass
• Least reactive.
• Alkalinity is removed by using boric oxide to neutralized
the oxide of potassium and sodium
• It is highly resistant glass.
• It has high melting point so can with stand high
temperatures.
• It is more chemically inert than the soda lime glass
• It can resist strong acids, alkalies and all types of
solvents.
• Reduced leaching action
• Mostly ampoules and vials are made up of Type I glass

19. Type II-treated soda lime glass
• Type II containers are made of commercial soda lime
glass that has been dealkalized or treated to remove
surface alkali
• The de-alkalizing process is know as sulphur treatment.
• Sulfur treatment neutralizes the alkaline oxides on the
surface, rendering the glass more chemically resistant.
Uses: Used for alkali sensitive products. Infusion fluids,
blood and plasma. Large volume container.

20. Type III—soda lime glass
• Containers are untreated are made of commercial soda
lime glass of average or better than average chemical
resistance.
• It contains high concentration of alkaline oxides and
imparts alkalinity to aqueous substance
Uses
Used for all solid dosage form
For oily preparation

21. NP—soda glass (non parenteral usage)
• Containers are made up of soda lime
• Glass supplied for non-parenteral product intended for
oral to topical use.

22. PLASTIC
• Plastics may be defined as any group of substances, of
natural or synthetic origins, consisting chiefly of polymers of
high molecular weight that can be moulded into a shape or
form by heat and pressure.
Advantages
• Less weight than glass,
• flexible
• Variety of sizes and shapes
• Essentially chemically inert, strong, rigid Safety use, high
quality, various designs
• Extremely resistant to breakage
Disadvantages
• Absorption permeable to moisture
• Poor printing, thermostatic charge

23. TYPES OF PLASTICS
Thermosetting type –
• When heated they may become flexible but they do not
become liquid
• e.g. Urea formaldehyde (UF),Phenol formaldehyde
,Melamine formaldehyde (MF), Epoxy resins (epoxides),
Polyurethanes (PURs)
Thermoplastics type-
• On heating they are soften to viscous fluid which harden
again on cooling.
• e.g. Polyethylene{HDPE – LDPE},
Polyvinylchloride(PVC),Polystyrene Polypropylene,
Nylon(PA), Polyethylene terepthalate(PET) ,Polyvinylidene
chloride(PVdC), Polycarbonate Acrylonitrile butadiene
styrene(ABS)

24. METALS
Metals are used for construction of containers. The
metals commonly used for this purpose are aluminium
,tin plated steel, stainless steel, tin and lead
Advantages:
• They are impermeable to light, moisture and gases.
• They are made into rigid unbreakable containers by
impact extrusion.
• They are light in weight compared to glass containers.
• Labels can printed directly on to their surface.
Disadvantages:
• They are expensive.
• They react with certain chemicals

25. Paper
• Paper and paper boards as packaging material are
used to prepre containers as envelops for dispensing
powders,few tablets few capsules etc.of as cartoons
boxes drums for storing large quantity of drugs in an
industries .
• They are mostly used for secondary packging and
tertiary packaging

26. Describe the packaging guidelines for
pharmaceuticals implemented in Nepal

29. Strip packaging:
• Strip packaging uses two thin foils of aluminum for
packing the tablets and capsules in a strip.
• Strip packing is done for moisture and light sensitive
drugs. Double layer of aluminium foil one side consists
printed and another side plane foil is used for strip
packing.
• In this, One of the foil is plain whereas other is printed
in which the batch no., mfg date, exp date and price are
printed.
• Thickness of foil is about 0.04mm.The inner side of
aluminum foil is coated with a thin layer of VMCH (Vinyl
Monomer Coating and Heat sealable) which helps in
heat sealing of foils.

30. Blister packaging
• In blister packing, product is enclosed between the
pocket of thermoplastic resin and the backing material
is made up of printed aluminum foil.
• Most commonly used thermoplastic for blister packing
are Polyvinyl Chloride (PVC with thickness of 0.25mm,
and 0.35mm) and Polyvinylidene Chloride (PVDC,
thickness 0.35mm).
• PVDC provides more protection against moisture than
PVC. Aluminum foil (0.025mm) coated with VMCH is
used as backing material in which VMCH serves as
sealing material for blister packing.
• It is done for the products that are not much sensitive
towards light and moisture.