Introduction-[Packaging, Labeling, Storage and Stability]

Proverbs 16:3

Packaging

An economical means of providing presentation, protection, preservation, identification, information, containment, convenience, and compliance for a drug product.

Immediate Container

Primary Packaging is also known as ______.

Primary Packaging

Has direct contact with the drug

a. Primary Packaging

b. Secondary Packaging

Primary Packaging

Has a direct effect on the drug.

a. Primary Packaging

b. Secondary Packaging

• Bottle

• Cap

• Cap liner

Examples of Primary Packaging [3]

Secondary Packaging

EXTERNAL to the primary container.

a. Primary Packaging

b. Secondary Packaging

Secondary Packaging

Adds PHYSICAL PROTECTION and MARKETING INFORMATION.

a. Primary Packaging

b. Secondary Packaging

• Cartons

• Boxes

• Shipping containers

• Pallets

Examples of Secondary Packaging [4]

• Well-closed Container

• Tight Container

• Hermetic Container

• Light-resistant Container

Classification of Containers According to Protection Ability [4]

• Single-unit container

• Multiple-unit container

Classification of Containers According to Quantity Held [2]

Well-closed Container

[Classification of Containers by Protection Ability]

Protects against extraneous solids and loss of drug under ordinary conditions of handling, shipment, storage, and distribution.

Tight Container

[Classification of Containers by Protection Ability]

Protects from extraneous solids, liquids, or vapors, from loss of drug, and from efflorescence, deliquescence, or evaporation under ordinary conditions of handling, shipment, storage, and distribution.

Hermetic Container

[Classification of Containers by Protection Ability]

Impervious to air or any other gases under ordinary conditions of handling, shipment, storage, and distribution.

Sterile

Hermetic Container is generally _____.

a. Unsterile

b. Sterile

Light-Resistant Container

[Classification of Containers by Protection Ability]

Protects the contents from photochemical deterioration.

• Amber

• Opaque

• Blue glass / Plastic

Examples of Light-Resistant Container [3]

Single-unit Container

[Classification of Containers by Quantity Held]

Designed to hold a quantity of drug intended for administration as a single dose.

Single-unit Container

[Classification of Containers by Quantity Held]

STERILITY is not assured after opening.

• Ampule

• Prefilled syringe

Example of Single-unit Container [2]

Multiple-unit Container

[Classification of Containers by Quantity Held]

Contains more than a single dose of the medication.

Vial

Example of Multiple-unit container [1]

Glass

[Materials Used for Packaging]

Available in white flint (clear), amber, or colored types.

Type I

[Type of Glass]

Highly resistant borosilicate glass

Type II

[Type of Glass]

Treated soda lime glass

Type III

[Type of Glass]

Soda lime glass

Type NP

[Type of Glass]

General purpose soda lime glass

• Type I (Highly resistant borosilicate glass)

• Type II (Treated soda lime glass)

• Type III (Soda lime glass)

Type of Glass Use for Parenterals [3]

Type NP (General Purpose Soda Lime Glass)

This is the only type of glass use for other products (except parenterals)

Powdered Glass Test

What is the standard test for the following?

• Type I (Highly resistant borosilicate glass)

• Type III (Soda lime glass)

• Type NP (General purpose soda lime glass)

Water Attack Test

What is the standard test for Type II (Treated soda lime glass)?

Polypropylene (PP)

[Type of Plastic]

Autoclavable

Polyvinyl Chloride (PVC)

[Type of Plastic]

____-

• This type of plastic is RIGID and has GOOD CLARITY

• This is used for BLISTER packaging

Polyvinyl Chloride (PVC)

[Type of Plastic]

This type of plastic is RIGID and has GOOD CLARITY.

Polyvinyl Chloride (PVC)

[Type of Plastic]

This is used for BLISTER packaging

Polyethylene Terephthalate (PET)

[Type of Plastic]

This is used for BEVERAGES

• PETG (PET glycol)

• APETG (amorphous PET glycol)

Types of Polyethylene Terephthalate (PET) [2]

PETG (PET glycol)

Type of Polyethylene Terephthalate (PET):

• This has transparency and luster

• This can undergo gamma radiation sterilization

PETG (PET glycol)

Type of Polyethylene Terephthalate (PET):

Has transparency and luster

PETG (PET glycol)

Type of Polyethylene Terephthalate (PET):

Can undergo Gamma Radiation Sterilization

Polyethylene (PE)

[Type of Plastic]

Cannot be autoclaved

Low-density Polyethylene (LDPE)

Type of Polyethylene (PE):

For droppers and spray

a. Low-density Polyethylene (LDPE)

b. High-density Polyethylene (HDPE)

High-density Polyethylene (HDPE)

Type of Polyethylene (PE):

For SOLID oral preparations

a. Low-density Polyethylene (LDPE)

b. High-density Polyethylene (HDPE)

• Lightweight

• Flexibility

• Resistance to impact

🧠Mnemonic: “LFR”

Advantages of Plastic Packaging [3]

• Permeability (environment → container)

• Leaching (container → content)

• Sorption (content → container)

• Transmission of light (Permeation of light)

• Alteration of container upon storage

Disadvantages of Plastic Packaging [5]

Permeability

[Disadvantages of Plastic Packaging]

Environment to container

a. Leaching

b. Sorption

c. Permeability

Leaching

[Disadvantages of Plastic Packaging]
Container to content

a. Leaching

b. Sorption

c. Permeability

Sorption

[Disadvantages of Plastic Packaging]
Content to container

a. Leaching

b. Sorption

c. Permeability

Transmission of light

[Disadvantages of Plastic Packaging]
The PERMEATION of light

• Tin

• Aluminum

• Aluminum alloy

Example of Metal Materials used for Packaging [3]

• Layer boards

• Labels

• Cartons

📌Mnemonic: “LLC”

Example of Paper and Board Materials used for Packaging [3]

• Blisters

• Sachets

• Seals

• Strips

'📌Mnemonic: “BS³

Example of Films, Foils and Laminations Materials used for Packaging [4]

Rubber

This is used as a CLOSURE (e.g., a stopper) for sterile products

Cold

[Recommended Storage Conditions for Labeling]

Not exceeding 8°C

Freezer

[Recommended Storage Conditions for Labeling]

A cold place thermostatically controlled between -25°C to -10°C

Refrigerator

[Recommended Storage Conditions for Labeling]

A cold place thermostatically controlled between 2°C to 8°C

Cool

[Recommended Storage Conditions for Labeling]

Any temperature between 8°C to 15°C

Room Temperature

[Recommended Storage Conditions for Labeling]

The temperature prevailing in a working area (usually 20°C to 25°C)

Controlled Room Temperature

[Recommended Storage Conditions for Labeling]

20°C to 25°C, or alternatively 15°C to 30°C (subject to specific product requirements)

Warm

[Recommended Storage Conditions for Labeling]

30°C to 40°C

Excessive Heat

[Recommended Storage Conditions for Labeling]

Above 40°C

TRUE

[Additional Guidelines for Storage Labeling]

TRUE OR FALSE:

The use of terms such as “ambient conditions” or “room temperature” is UNACCEPTABLE

TRUE

[Additional Guidelines for Storage Labeling]

TRUE OR FALSE:

General precautionary statements, such as “Protect from light” and/or “Store in a dry place”, may be included, but should not be used to CONCEAL STABILITY PROBLEMS.

TRUE

[Additional Guidelines for Storage Labeling]

TRUE OR FALSE:

If applicable, recommendations should also be made as to the utilization period and storage conditions after opening and dilution or reconstitution of a solution, e.g., an antibiotic injection or suspension supplied as a powder for reconstitution

TRUE

[Additional Guidelines for Storage Labeling]

TRUE OR FALSE:

Specific requirements should be stated, particularly for drug products that cannot tolerate FREEZING.

Stability

This is the capacity of a drug to remain within its specifications over time.

90%

MINIMUM ACCEPTABLE POTENCY LEVEL of a drug is ______ % of the labeled potency.

Overage

The EXCESS MEDICAMENTS added during the manufacturing of UNSTABLE DRUGS to ensure the potency remains above the minimum level throughout the product's shelf life.

15%

A _____ % decrease in potency of ANTIBIOTICS is considered ADMISSIBLE (acceptable).

15%

The following Overages normally should not exceed:

_____% for DRY DOSAGE FORM

a. 15%

b. 20%

20%

The following Overages normally should not exceed:

_____% for FLUIDS

a. 15%

b. 20%

25%

The following Overages normally should not exceed:

_____%

For:

• Ointments

• Suppositories

• Creams

• Aerosols

• Foams

📌 Mnemonic: “OSCAF”

• Ointments

• Suppositories

• Creams

• Aerosols

• Foams

📌 Mnemonic: “OSCAF”

The following Overages normally should not exceed 25% for ____ [5]

Real-Time Stability Studies

[Stability Testing Methods]

Purpose is to evaluate the product under RECOMMENDED STORAGE CONDITIONS for its intended shelf life.

Real-Time Stability Studies

[Stability Testing Methods]

Products are stored under SPECIFIED CONDITIONS (e.g., 25°C and 60% relative humidity for pharmaceuticals)

Real-Time Stability Studies

[Stability Testing Methods]

Tested at PREDETERMINED INTERVALS.

Real-Time Stability Studies

[Stability Testing Methods]

Provides the MOST ACCURATE PREDICTION of a product’s shelf life and stability.

Real-Time Stability Studies

[Stability Testing Methods]

TIME- CONSUMING , as it requires the FULL DURATION of the product’s intended shelf life to complete.

Accelerated Stability Studies

[Stability Testing Methods]

Purpose is to assess the product's stability under ELEVATED STRESS CONDITIONS to predict its shelf life MORE QUICKLY.

Accelerated Stability Studies

[Stability Testing Methods]

Products are STORED at HIGHER TEMPERATURES and HUMIDITY LEVELS (e.g., 40°C and 75% relative humidity for pharmaceuticals).

Accelerated Stability Studies

[Stability Testing Methods]

Tested at SHORTER INTERVALS.

Accelerated Stability Studies

[Stability Testing Methods]

Provides FASTER RESULTS, helping to identify potential stability issues and reduce time to market.

Accelerated Stability Studies

[Stability Testing Methods]

May NOT ALWAYS accurately predict real-time stability, especially for products SENSITIVE to STRESS conditions.

Accelerated Stability Studies

[Stability Testing Methods]

LESS ACCURATE than real-time studies.

Forced Degradation Studies

[Stability Testing Methods]

Identify potential DEGRADATION PATHWAYS

Forced Degradation Studies

[Stability Testing Methods]

Identify the INTRINSIC STABILITY of a product by exposing it to EXTREME CONDITIONS

Forced Degradation Studies

[Stability Testing Methods]

Products are subjected to SEVERE STRESS CONDITIONS such as:

• High temperatures

• Strong acids or bases

• Oxidation

• UV light

Forced Degradation Studies

[Stability Testing Methods]

Helps to understand DEGRADATION mechanisms

Forced Degradation Studies

[Stability Testing Methods]

Develop STABILITY indicating analytical methods.

Forced Degradation Studies

[Stability Testing Methods]

Conditions may bet TOO HARSH and NOT REFLECTIVE of normal storage conditions, potentially OVERESTIMATING degradation rates.

Shelf-Life Extension Studies

[Stability Testing Methods]

Purpose is to evaluate whether the SHELF LIFE of an existing product can be EXTENDED beyond its current expiry date.

Shelf-Life Extension Studies

[Stability Testing Methods]

Products nearing the end of their shelf life are SUBJECTED to REAL TIME or ACCELERATED STABILITY STUDIES to determine if they remain within acceptable quality limits.

Shelf-Life Extension Studies

[Stability Testing Methods]

Helps to EXTEND product shelf life, reducing WASTE and COSTS.

Shelf-Life Extension Studies

[Stability Testing Methods]

Limited to products already CLOSE TO THEIR EXPIRY DATE and may NOT BE APPLICABLE for ALL PRODUCTS.

In-Use Stability Studies

[Stability Testing Methods]

Purpose is to assess the stability of a product AFTER IT HAS BEEN OPENED or PREPARED FOR USE ensuring it remains effective and safe during its intended USAGE PERIOD.

In-Use Stability Studies

[Stability Testing Methods]

Products are tested under conditions that STIMULATE ACTUAL USE , such as repeated opening/closing, exposure to air, or reconstitution in a solvent.

In-Use Stability Studies

[Stability Testing Methods]

Ensures PRODUCT STABILITY and SAFETY throughout its USAGE PERIOD providing crucial information for end users.

In-Use Stability Studies

[Stability Testing Methods]

Specific to the intended USE CONDITIONS.

In-Use Stability Studies

[Stability Testing Methods]

May NOT APPLY to UNOPENED PRODUCTS.

Temperature

[Key Factors Affecting Stability]

Accelerates chemical reactions (degradation) and causes physical changes (crystallization, separation).

High temperatures

[Key Factors Affecting Stability]

_____ temperatures can cause hydrolysis, oxidation, and degradation of proteins, which can result in LOSS OF POTENCY and formation of TOXIC IMPURITIES.

a. High temperatures

b. Low temperatures