Study Set Content:
High temperatures
– Sublimation (solid)
– Solvent loss (liquid)
– Chemical decomposition of dyes (color fading)
– Phase separation (emulsions)
– Increased sedimentation (suspensions)
– Increased disintegration times (tablets)
Sublimation
(solid)
Solvent loss
(liquid)
Chemical decomposition of dyes
(color fading)
Phase separation
(emulsions)
Increased sedimentation
(suspensions)
Increased disintegration times
(tablets)
Low temperatures
– Crystal formation in solutions
– Phase separation (emulsions)
– Increased sedimentation (suspensions)
– Cracking of sugar-coated tablets
Phase separation
(emulsions)
Increased sedimentation
(suspensions)
Temperature Effects
• High temperatures
• Low temperatures
• Humidity
• Gases
• Light
Reasons to Protect from Freezing
• Risk of container breakage • Loss of strength or potency • Destructive alteration of dosage form
When no specific instructions are given, it is understood to include protection from
moisture, freezing, and excess heat.
A dosage formulation contains the drug substance (active pharmaceutical
ingredient) and
excipients
A drug delivery system requires an additional mechanism to control the
physicochemical/biochemical processes that can alter (blank)
the rate or extent of
response
Solid dosage forms
POWDERS
GRANULES
CAPSULES
TABLETS
SUPPOSITORIES,INSERTS, STICKS
Semi-Solid Dosage Forms
OINTMENTS
CREAMS
GELS
PASTES
CERATES
Liquid Dosage Form
SOLUTIONS
SUSPENSIONS
EMULSIONS
LOTIONS
OThers
PARENTERALS
BIOLOGICS
RADIOPHARMACEUTICALS
INHALATIONS
TRANSDERMAL PATCHES
Considerations for selecting the DF and DDS
Physical and chemical properties of the drug substance
● Therapeutic use
● Patient’s characteristics or situation
● Route of administration
