Part 1 Flashcards
if a drug bottle has the expiration:
3/1/24
when can you use it until
the last day of march (3/31)
name 3 drug stability issues and 3 mechanisms of degradation
stability issues:
-loss of Active ingredient from dosage form
-a toxic product can be produced with undesirable effects
-decreased bioavailability
3 mechanisms of degradation:
oxidation, hydrolysis, photolysis
the mechanisms of degradation in regards to drug stability are _____ factors
environmental –
oxidation (atmospheric oxygen)
photolysis (by sunlight OR room light)
hydrolysis
what is the most frequent type/mechanism of degradation of drugs?
hydrolysis
name a drug that has a big issue with hydrolysis and what this means for the dosage forms which it is available
aspirin is very prone to hydrolysis
therefore, when it’s formulated as a suppository, water is not included
name 3 medicinal compounds that are very susceptible to hydrolysis
esters
lactams
amides
the OXIDATION mechanism of degradation is usually mediated through reaction with ____ under _____ conditions
reaction with molecular oxygen under ambient conditions (AUTO-OXIDATION)
what is added to drugs to prevent oxidation
antioxidants
true or false
photolysis is the degradation of drug molecules by normal sunlight
FALSE
normal sunlight OR room light
give a method of shelf life estimation
Q10 method
give the definition of stability
the extent to which a product retains, within specified limits and throughout its period of storage and use, the SAME PROPERTIES AND CHARACTERISTICS THAT IT POSSESSED AT THE TIME OF ITS MANUFACTURE
name the 5 types of stability
chemical
physical
microbiological
therapeutic
toxicologic
odor is an example of what kind of stability?
physical
name 3 factors that must be considered because they can affect the chemical stability of the product
storage conditions
the dispensing container
anticipating interactions that may occur
explain how storage conditions can affect chemical stability
temperature
light
humidity
(environmental factors)
explain how different containers can affect chemical stability
glass vs plastic: plastic is preferred because it wont break but sometimes it has chemical stability issues with the product
clear vs amber – amber protects against photolysis if sensitive to light
explain why it is important to anticipate interactions when trying to preserve chemical stability
anticipate the interactions that can occur when mixing drugs or when selecting certain DOSAGE FORMS
IE: ASPIRIN SUPPOSITORY DOES NOT HAVE WATER
give an example of therapeutic instability
the insulin is there but has no therapeutic effect when injected
define kinetics
motion or movement
rate of change over time
give the rate equation and explain the variables
dC/dt -(C) ^n
dC = change in concentration
dt= change in time
dC/dt = change of concentration with change in time (rate of reaction)
C = concentration
n= the ORDER of the reaction
it’s a minus sign because the concentration is decreasing over time when considering stability
what is zero order kinetics
the rate of the reaction is INDEPENDENT of the concentration of the reactants
give the formula for the rate constant and the slope in a graph of a zero order reaction
ko = -dC/dt
slope = -ko