1
Q
What five items must be included on a label for a compounded mixture?
A
- Name
- Strength
- Dosage Form
- Lot, control or batch number and storage conditions
- BUD vs Expiry Date
- Total Volume (Brackets)
2
Q
Incorporation
A
Blending ointment/cream using a mortar & pestle or ointment pad/slab and spatula
3
Q
Fusion
A
Melting together ingredients with high melting points and temperature stability
4
Q
Trituration
A
Grinding a chemical to fine powder using a mortar & pestle
5
Q
Levigation
A
Reducing particle size using a liquid (levigating agent) that is insoluble
6
Q
Spatulation
A
Mixing powders on a slab/pad using a spatula
7
Q
Geometric Dilution
A
Mix equal size portion of base with powder and keep doubling mixture until all powder is incorporated. Use figure 8 motion to mix.
8
Q
Eutectic mixture
A
Lower melting point together then seperate
9
Q
API (Active Pharmaceutical Ingredient)
A
Chemical, substance or component intended to treat/prevent disease - active ingredient
10
Q
Pharmaceutic Ingredient
A
Added substance, inactive ingredient, excipient - has separate function from the drug effect
11
Q
Excipient Uses
A
- Facilitate the manufacturing process
- Improve therapeutic effect
- Extend/improve shelf life
- Make product more attractive or better tasting
12
Q
Solvent
A
Liquid that holds another substance in solution
13
Q
Vehicle
A
Excipient or substance used as medium to give bulk
14
Q
What are the 4 types of water used in compounding?
A
- Sterile water for inhalation, irrigation, injection (Bacteriostatic)
- Non-sterile and sterile purified water (distilled)
- Water for hemodialysis
- Potable (tap) water
15
Q
Water for compounding - levels of sterilization
A
- Purified water (non-sterile)
- Sterilized purified water
- Water for injection (start only)
- Sterile water for injection (further sterilized and meets certain standards, LVP and injectables)
- SWI - Inhalation only
- SWI - Irrigation only
- SWI - Bacteriostatic (antimicrobial agent added) for parenteral products only
16
Q
Alcohol (properties for compounding)
A
- Solvent
- Preservative (5-10%)
- Antiseptic (60%+)
17
Q
Glycols
A
- Dihydroxy alcohol
- High water solubility
- High boiling point
18
Q
Glycerin (Glycol)
A
- Clear, colorless, viscous and hard to dissolve things in it
- Makes a solution with alcohol and water
- Add body, smoothness, sweetness
- Preservative and humectant properties
19
Q
Propylene Glycol
A
- Colorless, viscous, acrid taste that can be substituted for glycerin
- Makes a solution with alcohol and water
- Preservative and humectant properties
- Do not use as primary vehicle - especially for kids
20
Q
Polyethylene Glycol (PEG)
A
- Labelled with number - molecular weight
- Under 600 - liquid at RT
- Over 600 - waxy solid
- Store in tightly closed containers
21
Q
Ketones
A
- Acetone & Methyl Isobutyl Ketone
- Volatile, flammable, toxic
- Makes a solution with water, alcohol and most oils
- Store in tight container away from heat
22
Q
Oils
A
- Can be a solvent or a vehicle
- Can be used to flavor or scent
23
Q
Cyclodextrins
A
- Nontoxic starch derivative
- Increase solubility of drugs that are poorly water-soluble
- Increases bio-availability of drug and product stability
24
Q
Antimicrobial Preservatives
A
Substance added to non-sterile dosage forms to protect them from microbial growth
25
When and what types of products need a preservative?
When: At the time of preparation, when there is a possibility of contamination, or the product contains water
What types: Emulsions, suspensions, creams, ointments, oral solutions, eye drop/ointments
26
When is a preservative not required?
Immediate use, no water present, PH is very high or very low, ingredients have antimicrobial properties already, neonates, eye surgery procedures
27
What would the ideal preservative look like?
1. Effective at low/non-toxic concentrations against wide range of organisms
2. Stable in a wide PH/Temperature range
3. Compatible with most drugs and excipients
4. Oder, taste, colour free
5. Will not react with container
28
Why would a buffer or agent be added to a mixture?
To adjust or stabilize the PH in order to increase drug absorption, stability and/or solubility in water
29
PH Scale
0 - Acidic
7 - Neutral
14 - Basic
30
When are antioxidants required for a mixture?
To prevent or inhibit the oxidative process, enhancing physical and chemical stability (ascorbic acid)
31
What does a chelating agent do?
They bind metal ions that might cause contamination of drug products (EDTA)
32
What is a surfactant?
Emulsifying agent that lowers surface tension between 2 liquids (SLS or stearic acid)
33
What does an emulsifying agent do?
Integrates two fluids that wouldn't normal mix together - helps oil/fat evenly disperse in a water-based substance (acacia)
34
What is viscosity a measure of?
The resistance to flow of a system under applied stress (Thick liquids are USUALLY more viscous). This is measure in "centipoise" from 1 (acetone) to 300,000 (toothpaste)
35
What do viscosity inducing agents do?
Increase viscosity by interrupting the flow of molecules past each other
36
What are the two types of suspending/Vis. Increasing agents?
Cellulose Derivatives and Natural Polymers (gums, polysaccarides and hydrocolloids)
37
What are two examples of a synthetic polymer?
1. Carbomer MF (Gels with water and water/alcohol liquids)
2. Poloxamer NF (Polyvinyl alcohol)
38
When/why would we use colors in our compounds?
1. Add to oral dosage form to go with flavor (Red for strawberry flavor)
2. Flesh toned for a topical preparation
3. Can be natural or synthetic dye
39
How are flavours and sweeteners used in compounding?
Both are commonly added to oral dosage forms to improve palatability and mask unpleasant taste of active ingredient. Sweeteners should be colourless, odourless and water soluble.
40
What dosage form would a scent be added too?
Topical
41
What does a humectant do?
1. Prevents water loss from compounded product
2. Stabilizes (glycerols)
42
What dosage form would a stiffening agent be used for?
Topical ointment (paraffin wax or cetyl alcohol)
43
What advantage would a coating agent provide?
1. Mask taste/odour
2. Protection from oxidization and humidity
3. Extended release of drug
4. Attractive appearance
44
Why would a disintegrate be added to a tablet?
To promote the breakup of tablet into smaller pieces (starch)
45
Define the following three agents for tablets and capsules:
Anti-adherants, Binders, Diluents
1. Anti-adherants: keeps tablet powder from sticking to punches or dies
2. Binders: help powder particles stick together in the formation of tablets (acacia, gelatin)
3. Diluents:Filler that provides bulk in tablets and capsules (lactose, starch, cellulose)
46
Why wold glidants, lubricants or polishing agents be added to a tablet or capsule?
Glidants improve flow of powder, lubricants reduce friction in tablet compression, polishing agents make tablets shiny
47
What is the difference between BUD and expiry date?
Expiry date refers to date of expiry applied to commercial product - projected length of time they can be expected to retain purity and potency
BUD (beyond use date) is estimate of time interval that a compounded product can be expected to retain purity and potency - determined when made (not dispensed). Date is determined, after which compounded product should not be used
48
BUD guidelines
No water - 6 months or less
Oral formulations - 14 days in fridge
Topical containing water - 30 days or less
49
What are the 5 types of stability?
1. Chemical
2. Physical
3. Microbiological
4. Therapeutic
5. Toxicological
50
What are three physical properties to look out for when assessing the stability of product?
1. Precipitation: when a drug reacts with another drug in solution - it can cause a salt to form that falls out of solution resulting in therapy failure or toxicity
2. Sorption: when a drug reacts with a container (glass/plastic)
3. Eutectic Mixtures: damp powder, pasty mass and liquid that can result when 2 chemicals (RT) are triturated together
51
What are the steps to follow when compounding?
1. Interpret RX, verify it is appropriate and that a valid formula is available
2. Wash hands and don appropriate PPE
3. Assemble ingredients, equipment and container
4. Perform calculations and record all necessary information on master formula sheet
5. Follow recommended technique and procedures
6. Visual inspection/Quality control
7. Package and label (aux)
8. Recheck and get verification
9. Clean all equipment and return ingredients
52
What are some techniques to reduce errors?
1. Use triple-self check and colleague verification when weighing and measuring
2. Use caution with potent drugs (narrow therapeutic limits, antineoplastics, electrolytes, elderly/pediatrics, ISMP high alert)
3. Write down all calculations with units and use independent verification
53
When would we use potable water and when would we use purified water?
Use potable water for washing hands, glassware and compounding equipment.
Use purified water as ingredient in non-sterile compounds and for rinsing compounding equipment.
54
What are some common causes of sub-standard products?
1. Lack knowledge of accepted standards
2. Don't have the proper training
3. Disregard for procedures
4. Calculation/weighing/measuring errors
5. Wrong ingredient selection
6. Procedural errors (steps in wrong order)
55
NAPRA GUIDELINES 5.4
Facilities & Equipment
- large enough to work comfortably and safely, storage room, clean and secure surroundings
- Storage is off of the floor
- Easy cleaning and sanitary waste disposal
- Good lighting and HVAC system that can be controlled
- Clean water supply (hot and cold)
- Equipment is appropriate and won't affect the quality of mixture
- cleaned, maintained, inspected, calibrated and records kept
56
NAPRA Guidelines 6
Product/Prep Requirements
- BUD determined by regulated professional who is trained and knowledgeable
- Master Formulations are developed by regulated professional, have all necessary information, and be readily accessible
- Ingredients are pure and good quality, purified water is used as ingredient, have lot #, expiry and receipt, SDS is accessible, properly stored
- Compounding records must be kept for each RX and batches
- Employees follow PPE requirements, no food/drink in compounding area
- Verification performed at each stage with final verification before dispensed
- Labels and packaging comply with regulatory authorities
- Storage follows recommendations and reduces chance of cross-contamination
- Comply with regulations for transport and delivery
- Follow all recalls
- Record all incidents and accidents
57
NAPRA QA 7
QA program is developed and implemented
- Temperature readings
- Equipment checks
- Personnel training and assessment
- Compliance of procedures
- Proper documentation
58
DPRA requirements
- Two sinks
- Hot and cold water
- Min 12 sq ft
- Dedicated fridge with thermostat that displays temperature
- Torsion or electronic balance that is sensitive enough for compounding needs
59
What are the three characteristics of compounded prescriptions?
1. Practitioner-patient-compounder relationship
2. Quantity prepared in anticipation of receiving rx is consistent with normal dispensing practices
3. Conditions of sale and limited to specific prescription orders
Compounding
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