IPS1 - Introduction - Packaging, Labeling, and Storage of Pharmaceuticals

Proverbs 16:3

Containers

According to USP, it holds the article and is or maybe in direct contact with the article immediate container (the one that is in direct contact with the article at all times) closure

Immediate container

Container that is in DIRECT contact with the article at all times.

● According to their ability to protect the content from external conditions

● According to content

Packaging/Containers of pharmaceuticals can be classified according to ____

● Well-Closed Container

● Tight-Closed Container

● Hermetic Container

● Light-Resistant Container

● Child-Resistant Container

● Tamper-Resistant Container

Containers according to ability to protect the content from external environment

Well-Closed Container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

This container protects content from extraneous SOLIDS and from loss of the drug under ORDINARY conditions of handling, shipment, storage, and distribution.

Tight-Closed Container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

This protects the contents from contamination by extraneous SOLIDS, LIQUIDS, OR VAPORS, from the loss of the drug and from EFFLORESCENCE, DELIQUESCENCE, or EVAPORATION under the usual conditions of handling, shipment, storage and distribution.

Hygroscopic

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tight-Closed Container

Substance that absorbs moisture from air but do not change its form.

Deliquescent

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tight-Closed Container

Substance that absorbs moisture from air and LIQUEFIES.

Efflorescent

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tight-Closed Container

Substances that LOSE MOISTURE in air and change into AMORPHOUS powder.

● Silica gel

● Glycerin

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tight-Closed Container

Examples of HYGROSCOPIC substances [2]

● Sodium hydroxide pellets

● Calcium chloride

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tight-Closed Container

Examples of DELIQUESCENT substances [2]

Washing soda

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tight-Closed Container

Example of EFFLORESCENT substances

Hermetic Container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Container that is IMPERVIOUS to air or any other gas under the ordinary condition of handling, shipment, storage and distribution.

Light-resistant container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Container that protects the contents against PHOTOCHEMICAL degradation.

Amber-colored bottle

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Example of Light-resistant container

Child-resistant container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Container designed to prevent the child accessing the potentially hazardous product.

Tamper-resistant container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Closed container fitted with a device that IRREVERSIBLY indicates if the container has been opened.

● Strip packs

● Blister packs

● Tape seals

● Bubble packs

● Shrink seal or band

● Foil, paper, or plastic pouch

● Bottle seal (inner cap)

● Tape seal

● Breakable cap

● Sealed tube

● Sealed carton

● Aerosol container

[CONTAINERS ACCORDING TO ABILITY TO PROTECT THE CONTENT]

Tamper-resistant containers

● Single-dose container

● Multiple-dose container

Containers according to content [2]

Single-dose container

[CONTAINERS ACCORDING TO CONTENT]

This holds the product which is intended for single use.

Ex. Glass ampule, prefilled syringes and cartridges

● Glass ampule

● Prefilled syringes

● Cartridges

[CONTAINERS ACCORDING TO CONTENT]

Examples of SINGLE-DOSE container [3]

Multiple-dose container

[CONTAINERS ACCORDING TO CONTENT]

This permits withdrawal of successive portions of the contents without changing the strength or endangering the quality of the remaining portions.

Ex. Vials and plastic tablet bottles

● Vials

● Plastic tablet bottles

[CONTAINERS ACCORDING TO CONTENT]

Examples of MULTIPLE-DOSE container [2]

● Polyvinyl chloride (PVC)

● Polyethylene terephthalate (PET)

● Amorphous polyethylene terephthalate glycol (APET)

● Polyethylene terephthalate glycol (PETG)

Materials used in PLASTIC containers [4]

Polyvinyl Chloride (PVC)

[PLASTIC MATERIALS]

● Rigid and has good clarity

● Useful in blister packaging of tablets and capsules

● Not suitable when gamma sterilization is required

Polyvinyl Chloride (PVC)

[PLASTIC MATERIALS]

● Rigid and has good clarity

Polyvinyl Chloride (PVC)

[PLASTIC MATERIALS]

● Useful in BLISTER packaging of tablets and capsules

Polyvinyl Chloride (PVC)

[PLASTIC MATERIALS]

● Not suitable when gamma sterilization is required

gamma sterilization

[PLASTIC MATERIALS]

Polyvinyl Chloride (PVC) is NOT SUITABLE when ___ sterilization is required

Polyethylene Terephthalate (PET)

[PLASTIC MATERIALS]

This is common and used in CLEAR PLASTIC

● Amorphous polyethylene terephthalate glycol (APET)

● Polyethylene terephthalate glycol (PETG)

[PLASTIC MATERIALS]

These have excellent transparency and luster can be sterilized with gamma radiation

gamma radiation

[PLASTIC MATERIALS]

Amorphous polyethylene terephthalate glycol (APET) and polyethylene terephthalate glycol (PETG) have excellent transparency and luster can be sterilized with ____

● Permeability of the containers to atmospheric oxygen and to moisture vapor

● Leaching of the constituents of the container to the internal contents

● Sorption of drugs from the contents to the container

● Transmission of light through the container

● Alteration of the container upon storage

Problems encountered in the use of plastics in packaging are:

Permeability

[PROBLEMS ENCOUNTERED IN THE USE OF PLASTICS]

The ability of a container to allow oxygen or water vapor to pass through, which can affect the chemical stability of the drug.

Leaching

[PROBLEMS ENCOUNTERED IN THE USE OF PLASTICS]

The process in which constituents of the container migrate to the internal contents.

Sorption

[PROBLEMS ENCOUNTERED IN THE USE OF PLASTICS]

The adhesion or absorption of drug molecules onto the surface of the container.

Transmission

[PROBLEMS ENCOUNTERED IN THE USE OF PLASTICS]

The passage of light through the container, which can cause photodegradation

Alteration

[PROBLEMS ENCOUNTERED IN THE USE OF PLASTICS]

The physical or chemical changes in the container over time due to storage conditions.

I. Highly-resistant borosilicate glass

II. Treated soda-lime glass

III. Soda lime glass

IV/NP. General purpose soda-lime glass

Categories of glass containers

Highly resistant borosilicate glass

[CATEGORIES OF GLASS CONTAINERS]

Type I

Treated soda-lime glass

[CATEGORIES OF GLASS CONTAINERS]

Type II

Soda-lime glass

[CATEGORIES OF GLASS CONTAINERS]

Type III

General purpose soda-lime glass

[CATEGORIES OF GLASS CONTAINERS]

Type NP/IV

I. Highly-resistant borosilicate glass

II. Treated soda-lime glass

III. Soda lime glass

[CATEGORIES OF GLASS CONTAINERS]

These glass containers are used in PARENTERAL products.

I. Highly-resistant borosilicate glass

[CATEGORIES OF GLASS CONTAINERS]

This glass container is the MOST RESISTANT.

IV/NP. General purpose soda-lime glass

[CATEGORIES OF GLASS CONTAINERS]

This glass container is used in other preparations and NON-PARENTERALS.

● Label on immediate container

● Package inserts

● Company literature

● Advertising and promotional materials

Labeling is applied to:

● Must include the Rx symbol or legend:

● "Caution: Federal law prohibits dispensing without prescription."

Label required for PRESCRIPTION drugs

The statement: "Warning - May be habit forming"

Label required for CONTROLLED SUBSTANCES

● Statement of pharmacologic category

● No Rx symbol

Label required for OTC drugs

Cold

[STORAGE CONDITION]

≤ 8°C (46°F)

≤ 8°C (46°F)

[STORAGE CONDITION]

Cold

● Refrigerator

● Freezer

[STORAGE CONDITION]

COLD places [2]

Refrigerator

[STORAGE CONDITION]

2-8°C (36-46°F)

2-8°C (36-46°F)

[STORAGE CONDITION]

Refrigerator

Freezer

[STORAGE CONDITION]

-20 to -10°C (-4 to 14°F)

-20 to -10°C (-4 to 14°F)

[STORAGE CONDITION]

Freezer

Cool

[STORAGE CONDITION]

8-15°C (46-59°F)

8-15°C (46-59°F)

[STORAGE CONDITION]

Cool

Room Temperature

[STORAGE CONDITION]

The temperature prevailing in the working area.

Controlled Room Temperature

[STORAGE CONDITION]

20-25°C (68-77°F), allows 15-30°C (59-86°F) variation

20-25°C (68-77°F), allows 15-30°C (59-86°F) variation

[STORAGE CONDITION]

Controlled Room Temperature

Warm

[STORAGE CONDITION]

30-40°C (86-104°F)

30-40°C (86-104°F)

[STORAGE CONDITION]

Warm

Excessive Heat

[STORAGE CONDITION]

>40°C (104°F)

>40°C (104°F)

[STORAGE CONDITION]

Excessive Heat

● Breakage of container

● Loss of potency/strength

● Destructive alteration of the dosage form

Risks of freezing includes [3]