Stability and QC Flashcards
The act of preparing, mixing, assembling, packaging and/ or labeling of a drug or a device as a result of a practitioner’s prescription or drug order
Pharmaceutical compounding
What are the 3 steps involved in quality control?
- Raw materials controls
- In process controls
- Product specifications/Finished product controls
T or F: Enantiomers have identical physical and chemical properties
T
What kind of dosage form is greatly influenced by pH?
Liquid dosage forms
2 ways of minimizing oxidation of ingredients?
- replace O2 w/ a diff gas (CO2, N2)
2. Use air-tight container
Name the five types of stability.
- Chemical
- Physical
- Microbiological
- Therapeutic
- Toxicological
Name the 6 factors affecting a drug product’s stability.
- temp
- moisture
- excipients
- pH
- oxygen
- light
Does the following occur when the temp is too low or too high?
- Reduced chemical stability
- Evaporation
- Ointments become liquified
- Suppositories soften
High temperature
Term for the extent to which a product retains its original properties and characteristics since its manufacture
Stability
API strength must be b/w what percentage range?
+/-10% (90-110%)
What temp is considered excessive heat?
> 40ºC
T or F: The BUD of a compounded drug can be later than the expiration date of the manufacturer’s original drug??
F
Name the dosage form for which finished product tests include clarity, pH, sterility, pyrogen test, and volume
Injectables
BUD of non-aqueous liqs or solids?
No longer than 6 months.
Is freezing a drug product ever okay?
NO!
- container breakage
- loss of drug potency
- dosage form changes
Beyond-use date (BUD)
Date after which a compounded prep shouldn’t be used
The ICH topics are divided into four categories, which are…
- Quality guidelines
- Safety guidelines
- Efficacy guidelines
- Multidisciplinary guidelines
Main requirements of drug packaging?
- Protect contents
2. That it doesn’t physically or chemically interact w/ the drug
Poor quality drug products fail to meet official standards for what? (5)
- Strength
- Quality
- Purity
- Packaging
- Labelling
Ampoules and vials are examples of what type of container?
Single-dose container
What’s an active ingredient?
Chemical/substance that endows preparation w/ pharmacological activity
T or F: The active ingredient comprises the major portion of a dosage form
F
The excipients do
5 jobs of active ingredients/drugs?
- diagnosis
- cure
- mitigation
- treatment
- prevention
What can poor quality drug products lead to? (7)
- treatment failure
- adverse effects
- prolonged illness
- drug resistance
- distrust in healthcare sys
- waste of financial resources
- death
What additive must be added to multiple dose IV injection meds?
Antimicrobials
When would child resistant packing NOT be used? (3)
- Drugs for emergencies
- Unnecessary (i.e. no children present)
- Too hard to open for certain pts (e.g. elderly, Parkinson’s)
Why are stability tests not done at room temp?
It would take too long.
Total quality management includes…
Detection (QC) + Prevention (QA)
What temp is considered cool?
8-15ºC
identifies the time during which the product may be expected to meet the requirements of the Pharmacopeial monograph, provided it is kept under the prescribed storage conditions
Expiration date
Period during which a product remains suitable for the INTENDED USE
Shelf life
Give an example of a drug whose enantiomer had devastating consequences on fetal development.
Thalidomide
_____ describes all those planned and systematic actions needed to provide confidence that the product or a service will satisfy given requirements for quality.
Quality Assurance (QA)
Name the dosage form for which finished product tests include pH, sterility, and weight variation
Ophthalmic products
T or F: Manufacturing involves the preparation of Rxs for specific pts
F
This describes COMPOUNDING
A book that details the strength and purity of therapeutic drugs, and how to use them.
Pharmacopeia
Different types of containers? (4)
- Well-closed
- tight
- hermetic
- light resistant
What kind of container can protect drugs from sunlight?
Amber glass/amber containers
Term for when a product has gone through irreversible chemical rxns, resulting in diff chemical entities that can either be inactive or toxic
Instability
What temp is considered cold?
<8ºC
What does ICH stand for?
International Conference of Harmonisation
A type of study that determines how stable a drug is under varying conditions. Also used to recommend good storage conditions and shelf life.
Stability Study
Are blister packs single dose or multiple dose?
Single dose
Name the dosage form for which finished product tests include dissolution/disintegration, weight variation and brittleness
Capsules
What is “Finished Product Controls”?
Ensuring that each batch of product is tested for identity, quality, potency, and purity
Does the following occur when the temp is too low or too high?
- Reduced solubility of solutions > Crystallization occurs
- Emulsions “crack” (separate)
- Suspensions are disrupted
Low temperature
What is the primary requirement of excipients?
Chemically inert > do not chemically interact w/ API or other excipients
What temp is considered warm?
30-40ºC
What is considered to be “raw materials”?
active ingredients and excipients
Time at which product retains 90% of its original POTENCY
Shelf life
T or F: Enantiomers display identical biological activities.
F
Another term for “in process controls”.
Good Manufacturing Practice Regulations
A type of study that determines how stable a drug is under stress or accelerated conditions.
Forced Degradation Study
Why is quality management important? (3)
- Ensure safety of product
- Ensure product contains correct amt of drug
- Consumer can’t judge quality of Rx products
Primary fn of a pharmacopeia?
Describe the formulations of drugs.
What does a desiccant do?
It absorbs moisture in order to keep drug dry (usually tablets)
The ____ of a product is the totality of features and characteristics of a product that bear on its ability to satisfy stated or implied needs
quality
What new packaging requirement was introduced following the Tylenol murders?
Tamper resistant > barriers to entry into drug packaging
Inactive/inert materials of a dosage form.
Excipients
BUD of fmlations that aren’t water-containing fmlations, non-aqueous liqs, or solids?
Either 30 days or intended duration of therapy
What is the goal of “finished product controls”? (4)
To ensure…
- Amt of drug claimed is amt of drug present
- All of the drug is available for absorption
- Drug is stable in final fmlation and final container
- Dosage form doesn’t contain toxic/foreign substances
3 types of materials used in packaging
- glass
- plastic
- metal
Most common packaging material?
Glass
Name the dosage form for which finished product tests include dissolution/disintegration, weight variation, uniformity of content, friability, and hardness
Tablets
____ describes all activities such as measuring, examining, testing or gauging one or more characteristics of a product (including raw materials) and comparing the findings with specified requirements to determine conformity
Quality Control (QC)
What are enantiomers?
Molecules that’re non-superimposable mirror images of each other.
It provides the health professional w/ the essential info on a prescription-only medication. It must also present both +ve and -ve aspects of the drug product.
Package insert
The large-scale production, preparation, propagation, conversion, and/or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis
Pharmaceutical manufacturing
What temp is considered room temp?
15-30ºC
BUD of water-containing fmlations?
No later than 14 days (when stored in cold temps, 2-8ºC)
How are in-process controls regulated?
Quality assurance (basically, making sure everything is running as they should)
Are Rx bottles single dose or multiple dose?
Multiple dose
