part 2: PACKAGING

Packaging

Packaging

An economical means of providing presentation, protection, identification/information, containment, convenience, and compliance, for a product during storage, carriage, display and use until such time as the product has used or administered

1. Primary

2. Secondary

3. Tertiary

Types of Packaging

Immediate Packaging

Primary Packaging is also known as?

Primary or Immediate Packaging

Type of packaging that has DIRECT interaction with the product

Secondary Packaging

Type of packaging that has NO DIRECT interaction with the product

Tertiary Packaging

Exclusively used for BULK packaging purposes and must withstand transportation hurdles

Primary or Immediate Packaging

Liners; Containers: Ampules, Bottles, Vials

Secondary Packaging

Boxes, Cartons, Injection trays

Tertiary Packaging

Container barrels, edge protector

1. Well closed container

2. Tight container

3. Hermetic container

4. Light resistant container

5. Child resistant container

6. Tamper resistant container

Classification of container according to PROTECTING ABILITY FROM EXTERNAL CONDITIONS

Well closed container

Protects from extraneous solids and loss of article

Tight container

• Protects from extraneous solids, liquids, or vapors; from loss of article; and from efflorescence, deliquescence, or evaporation

• Capable of tight reclosure

Hermetic container

• Container that is impervious to air

• Important in vacuum and pressure packaging

Light resistant container

Protects the contents from the effect of radiation at a wavelength between 290nm and 450nm

Nifedipine

If exposed to light, it contains Nitrosophenylpyridine analog

Dacarbazine

Chemotherapeutic; if exposed to light, its color changes from Pale Yellow to Pink

Adriamycin, Daunorubicin

If exposed to light, formation of Aglycones and Polymeric substances

Metronidazole

If exposed to light, darkening of tablets occur

Child resistant container

Container significantly difficult for children under 5 years of age to open

1. Press-turn

2. Squeeze-turn

3. Combination lock

Commonly known Child resistant container

Tamper resistant container

Container having an indicator or barrier to entry which, if breached can reasonable expected to provide visible evidence to consumers that tampering has occurred

1. Breakable caps

2. Tape seal

3. Bottle seal

Examples of Tamper resistant container

Aerosol container

Tamper resistant container by design

1. Single dose container

2. Multiple dose container

Classification of container according to QUANTITY HELD

Unit dose container

Single dose container is also known as?

Single dose or Unit dose container

• For products intended for single use

• Cannot be resealed or reused

• Examples: Ampules, prefilled syringes

1000mL or 1L

Volume USP limit of Single dose container

Multiple dose container

• Possess more than a single dose of drug product

• Uses BWFI

• Example: Vials

1. Benzyl alcohol

2. Mixture of Propyl and Methyl parabens

Antimicrobials used in Multiple dose container

30mL

Volume USP limit of Multiple dose container

1. Glass

2. Plastics

3. Foils, Films, Laminates

4. Rubber

5. Metal

Classification of container according to MATERIAL

Glass

Most commonly used container

Silicon dioxide

Main component of Glass

1. Gas and moisture barrier properties

2. Allows easy inspection of the container contents

3. Strength, Inertness and Rigidity

Advantages of Glass

1. Fragility

2. Expensive and heavy compared to plastic

3. Certain type of glass release alkali into contents

Disadvantages of Glass

1. Carbon dioxide & Sulfur

2. Iron & Manganese oxide

Added to make the glass AMBER

Compounds of Cadmium and Sulfur

Added to make the glass YELLOW

Cobalt oxide & Cupric oxide

Added to make the glass BLUE

1. Iron oxide

2. Manganese dioxide

3. Chromium dioxide

Added to make the glass GREEN

Fluorides and Phosphates

Added to make the glass OPAL

1. Type I

2. Type II

3. Type III

4. Type IV or NP

Type of Glass

Highly Resistant Borosilicate Glass

Type I glass is also known as?

1. Silicon dioxide

2. Boron trioxide

Components of Type I (Highly Resistant Borosilicate Glass) glass

Type I (Highly Resistant Borosilicate Glass)

• MOST inert

• Low leachability, low thermal coefficient

• MOST resistant to heat

• With HIGHEST resistance

• MOST unreactive

• MOST expensive

1. Buffered and Non-buffered Aqueous Solution

2. Glass of choice for Parenterals

Type I (Highly Resistant Borosilicate Glass) is used for?

Powdered Glass Test

QC test for Type I (Highly Resistant Borosilicate Glass)

Treated Soda Lime Glass

Type II glass is also known as?

1. Buffered aqueous solutions

2. Large volume parenterals

3. Eye preparations and dropper bottles

Type II (Treated Soda Lime Glass) is used for?

Water Attack Test

QC test for Type II (Treated Soda Lime Glass)

Soda Lime Glass

Type III glass is also known as?

TRUE

TRUE OR FALSE:

Type III (Soda Lime Glass) is less resistant to high temperature?

1. Dry powders

2. Oily solutions

3. Intended for Oral and Topical use

4. NOT USED for Parenterals

Type III (Soda Lime Glass) is used for?

Powdered Glass Test

QC test for Type III (Soda Lime Glass)

General Purpose Soda Lime Glass

Type IV glass is also known as?

1. Topical and Oral use

2. NOT USED for Parenterals

Type IV (General Purpose Soda Lime Glass) is used for?

Powdered Glass Test

QC test for Type IV (General Purpose Soda Lime Glass)

1. Lightweight

2. Resistance to breakage

3. Disposable after single use

Advantages of Plastics

1. Permeation of molecules in either direction through the wall of container

2. Leaching

3. Sorption

Disadvantages of Plastics

1. Thermoplastics

2. Thermosetting plastics

Classification of Plastics

Thermoplastics

Rigid at operating temperature, but can be re-melted and re-processed without decomposition

Thermosets

Thermosetting plastics are also known as?

Thermosetting plastics

• Plastic with good dimensional and temperature stability

• Cannot be re-melted

• Softens during production and inversibly hardens by the action of heat

1. Polypropylene (PP)

2. Polyvinyl chloride (PVC)

3. Polystyrene (PS)

4. Polyethyelene (PE)

   1. Low Density Polyethyelene (LDPE)

   2. High Density Polyethyelene (HDPE)

Types of Plastics

Polypropylene (PP)

Type of plastic that is heat resistant and can be autoclaved

Vinyl

Polyvinyl chloride (PVC) is also known as?

Polyvinyl chloride (PVC)

Type of plastic that has the least resistance to moisture vapor permeation

1. Blister packs

2. IV bags

Polyvinyl chloride (PVC) is used for?

Polystyrene (PS)

• OLDEST and MOST WIDELY USED plastic (in general)

• Has poor gas barrier and solvent resistance

Large production of cans and bottles

Polystyrene (PS) is used for?

Branched polyethylene

Low Density Polyethyelene (LDPE) is also known as?

Low Density Polyethyelene (LDPE)

• Polyethyelene (PE) that is softer, more flexible, easily stretched

• Permeable to Essential oils and Chloroform

1. Squeezed bottles

2. Soft bags

3. Infusion bottles

Low Density Polyethyelene (LDPE) is used for?

Linear polyethylene

High Density Polyethyelene (HDPE) is also known as?

High Density Polyethyelene (HDPE)

• Polyethyelene (PE) that is stronger and stiffer

• MOST WIDELY USED material for pharmaceutical containers

Bottles for Solid Dosage Forms

High Density Polyethyelene (HDPE) is used for?

Foils, films and laminates

Container materials that are low cost, have heat sealibility, and used for decoration

1. Strip packs

2. Blister packs

3. Sachets

4. Liners

Foils, films, and laminates, are used for?

Rubber

Container material that is used as accessory to containers

1. Stoppers (Vials)

2. Bulb (Ophthalmic pipets)

3. Plugs (Syringes)

Rubbers are used for?

Metal

Container material that is made of Aluminum or Tin

1. Aerosol cans

2. Collapsible tubes

3. Crimps in vials

Metal is used for?