(2) Labelling, Storage Condition, & Dosage Form Design

Labelling

• __ on immediate container

• package inserts

• company literature

• advertising and promotional materials

Rx symbol / Legend

act prohibits dispensing without prescription

controlled substances

the statement: “Warning - May be habit forming”

OTC label

• statement of pharmacologic category

• no Rx symbol

prescription drug label

• Nonproprietary and Proprietary name of the drug

• Name and address of manufacturer

• Dosage strength or potency

• Type of dosage form

• Net content

• Prescription logo and Legend statement

• Label reference to see the accompanying package insert

• Special storage instructions

• Bar code and Registration number

• Lot or control number

• Expiration date

• *For controlled substances, the symbol “C” and the

  statement “Warning: Maybe habit-forming”

OTC drug label

• Product name (generic and brand)

• Name and address of manufacturer

• Net content

• Formulation

• Name of any habit-forming substances

• Pharmacologic category (principal intended action)

• Cautions and warnings

• Na+ content for oral preparations

• Storage conditions

• Description of tamper-evident feature

• Lot number and expiration date

dietary supplement

The label should contain “This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure or prevent any disease”

herbal products

should state specific parts of the plant used (supplement facts)

USP verified program
NSF certification program
Consumer Laboratories

product standardization

consumer laboratories

SEAL (assurance of product safety but not guarantee effectiveness)

Cold temperature

any temperature not exceeding 8°C

Refrigerator

2°C to 8°C

freezer

-25°C to -10°C

cool temperature

any temperature between 8°C to 15°C

controlled room temperature

20°C - 25°C or 15°C - 30°C

warm temperature

any temperature between 30°C to 40°C

excessive heat

temperature above 40°C

risks of freezing

• breakage of container

• loss of potency / strength

• destructive alteration of the dosage form

dosage form design

• the general area of study concerned with the following areas of pharmaceutical __:

  • formulation

  • manufacture

  • stability

  • effectiveness
    

coated tablets
sealed ampules

To protect drug substance from the destructive influences of atmospheric oxygen or humidity

enteric coated tablet

to protect drug substance from the destructive influence of gastric acid after oral administration

capsule
coated tablets
syrups

to conceal bitter, offensive or salty taste or odor of a drug substance

suspension
clear preparation solution

to provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle

controlled release tablet
capsule
suspension

to provide rate-controlled drug action

ointment
creams
transdermal patch
ophthalmic preparation
ear preparation
nasal preparation

To provide optimal drug action from topical administration sites

injection

To provide placement of drug directly in the bloodstream or body tissues

inhalants
inhalation aerosols

to provide optimal drug action through inhalation therapy