Compounding Flashcards
Sterile vs. non-sterile compounds
-Give examples
Sterile: injections, eye drops, irrigations that go into body cavity, pulmonary inhalations, baths and soaks for live tissues/organs, implants
Compounded nonsterile preparations (CNSPs): PO, via tube (gastric tube), PR, PV, topically, nasally, or in the ear (unless the eardrum is perforated)
What is USP? What are the different USP chapters?
USP: standards for compounding that are consistered to be minimum acceptable standards by FDA, state boards of pharmacy, and the Joint Commission
USP Chapters:
-795: Nonsterile preparation
-797: Steile preparation
-800: Hazardous preparations
Nonsterile Compouding: Space Requirements
-Think about environment, equipment, cleanliness, etc.
- Specifically designated area away from dispensing area
- Can be performed in ambient air (room air)
- All equipment, ingredients, and containers must be stored off the floor
- Temperature should be monitored daily (or continuously)
- Spill kit available and personnel trained on use
- Adequate plumbing and clean, easily accessible skin with hot and cold water
- Purified water, distilled water, or reverse osmosis water needed for rinsing equipment and utensils
Nonsterile Compounding: Compounding Personnel: Training Requirements
-When must be completed
-What should the training include
-What personal hygiene must be done
When: initially and Q12 months
Personnel must have training with documentation and proficiency along with core competencies (hand hygiene, garbing, cleaning/sanitizing, use of equipment, measure/mixing, and documentation of compounding)
Personal Hygiene:
-Remove jewelry, hats, or headphones prior to compounding
-Notify designated person of any concerns for contamination (ex. URTI, rash, conjunctivitis)
-Proper hand hygiene: soap and water for at least 30 seconds rubbing hands, interlacing fingers, rubbing back of hands, and cleaning under fingernails
-Garb gloves and other PPE if needed
Weighing Equipment
1. Equipment must be ________ to confirm accuracy
- Equipment should be made out of material that does not __________.
- All measurements should be made in what measuring system?
- Calibrated
- React with compounding ingredients (ex. metal spatulas should NOT be used with compounds containing metal ions)
- Metric
Nonsterile compounding: what are the types of balances that can be used and how to use them?
Class III Torsion Balance (Class A balance)
-Less commonly used
-External weights used for weighing > 1 gram; internal weights used for
-Has sensitivity requirement (SR): most have 6mg (6mg can be added or removed before dial thrown off by 1)
-Has acceptable error rates usually of 0.05 (5%)
-Calculate minimum weighable quantity (MWQ) = SR / acceptable error rate
Electronic Balance (Analytical Balance):
-MOST common and simple to use
-Have higher sensitivity (MWQ does NOT need to be calculated)
-Tare or “zero out” balance prior to measuring
BOTH: Ingredients should never be placed directly on scale (place paper down first) –> helps avoid contamination and reduce moisture penetration into molecules
Measuring Volume:
1. Graduated cylinders are more accurate for measuring than ________ or ______ which would be used for stirring since they have wider mouths. In general, the wider the mouth, the ____(higher/lowering the accuracy.
- Measuring volumes that are smaller than ___% of the graduate’s capacity can cause measuring error.
- To read the volume in a graduate, place it on a flat surface and view the height at eye level, looking at the ______.
- Conical graduates; beakers; lower
- 20%
- Bottom of the meniscus (downward curve from both sides)
Measuring Volume:
1. When are syringes useful?
2 What should oral syringes be labeled with?
- What are pipettes? What is the difference between volumetric pipettes and Mohr pipettes?
- To most accurately measure small volumes, especially for viscous liquids (ex. glycerin, mineral oil)
- “For Oral Use Only” over the syringe cap
- Thin plastic or glass tubes to measure small volumes and release liquids in drops
-Volumetric pipette: draws up a set volume only
-Mohr pipette: graduated and can measure different volumes
Grinding, Mixing, Transferring, and Heating:
1. When to or not to use a steel vs. rubber spatula?
- When can ointment slabs be used?
- What is a homogenizer?
- When to use a water bath?
- Steel should NOT be used when making a mixture that contains metallic ions. Rubber should be used to handle corrosive materials.
- Mixing compounds into ointments, forming pills, or rolling out suppositories
-Can put paper down when mixtures don’t have too high of water content - Also called an electric mortar and pestle similar to a blender that mixes ointments, creams, or other semi-solid preparations
- When temperature needs to be carefully controlled - place ingredients into a container to place into larger container filled with water to avoid direct heat source and prevent burning
Explain when to use glass, wedgwood, and porclean mortars.
-Glass: glazed surface for liqiuds, compounds that are oily or stain/dye
-Wedgwood: rough surface for grinding dry crystals and hard powders
-Porcelain: smooth surface for blending powders and pulverizing gummy consistencies
Ingredients:
1. The medication is called the ______________ whereas the other ingredients that do NOT produce therapeutic effects are called _________.
- Ingredients should be high quality to ensure purity and safety. You can find these ingredients listed in ________ which come from a FDA-registered facility. They also provide _______.
- If an ingredient comes without an expiration date, the pharmacist will assign a conservative date that is no more than ________ from the date of receipt and _______ should be written on the package.
- Active pharmaceutical ingredients (APIs); excipients
- USP National Formulary (USP-NF); monographs
- One year (book says 3?); date received
What is the purpose of adding surfactants to a compound?
Amphiphilic molecules (hydrophilic and hydrophoic) that lower surface tension between two ingredients (or phases) to make them more miscible
Surfactant types when to add and examples: Wetting Agents/Levigating Agents
-Use: reduce surface tension between liquid and solid (livegation = to grind particles with small amount of liquid)
-Ex. mineral oil for lipophilic compunds; glycerin or propylene glycol for aqueous compounds
Surfactant types when to add and examples: Suspending Agents
-Use: add to suspensions to help solid particles from settling, but suspensions should still be shaken to redisperse since the agent does not last too long
-Ex. sorbitol for glycerin capsules, Ora-plus (gel-like suspension, but bland in taste), Ora-sweet (similar to simple syrup, flavor added to Ora-plus), Ora-Blend (combination of Ora-sweet and Ora-plus)
Surfactant types when to add and examples: Foaming Agents
-Use: helps foam form often in soaps and detergents to reduce surface tension between dirt and water during cleaning process
-In compounding, anti-foaming agents more common (ex. simethicone)
Surfactant types when to add and examples: Glycols/gels
-Use: serve as delivery vehicles
-Ex. polyethylene glycol (PEG), poloxamer
Surfactants: Emulsifiers:
-Purpose
-w/o vs. o/w emulsions
-What is HLB?
Emulsifiers (“Emulgents”): added to emulsion (mixture of two or more liquids that do not blend together) to prevent separation
w/o: water-in-oil emulsion - typically not palpitable in taste and often topical
o/w: oil in water - typically oral products
HLB: hydrophilic-lipophilic balance: number that determines the type of surfactant required to make emulsion
-Scale is from 0-20 with 10 as midpoint
-<10 HLB: surfactant should be used in w/o emulsion –> “Lower HBL makes it Like Lipids”
->10 HLB: surfactant should be used in o/w emulsion –> “Higher HBL makes it Hug H20”
For the excipient, explain its role and examples: Binders
-Use: help ingredients stick together while permitting contents to be released once ingested (provide stability and strength)
-Ex. starch paste
For the excipient, explain its role and examples: Diluents, fillers
-Use: help make something more dilute and fill up size in very small dosages (liquids: help dissolve/suspend drug)
-Ex (tablets, capsules): lactose, starches, calcium salts, cellulose power
-Ex (liquids): water, glycerin, alcohol
-Ex (topicals): petrolatum
For the excipient, explain its role and examples Lubricants
-Use: prevent ingredients from sticking to equipment (glidants: help improve powder flowability by reduceing interparticle friction)
-Ex. magnesium stearate
For the excipient, explain its role and examples Preservatives
-Use: prevent or slow microbial growth. required in most compounds sterile or not
-do NOT use for neonates
-Ex. chlorhexidine, povidone iodine, sodium benzoate/benzoic acid, benzalkonium chloride, sorbic acid/propyl parabens, methyl/ethyl/propyl parabens, EDTA, thimerosal, cetylpyridinium chloride
For the excipient, explain its role and examples: Disintegrants
-Use: help breakup solids into smaller particles after ingestion or adding to liquid and speeds up absorption (alginates, cellulose: absorb water, causing tablet to swell)
-Ex. alginic acid, cellulose products, starches
For the excipient, explain its role and examples: Flavorings and coloring agents
-Use: improve taste or look of product
-Ex sweeteners (non-caloric): aspartame, sucralose
-Ex. sweeteners: glycerin, dextrose, mannitol, sorbitol, xylitol, stevia
For the excipient, explain its role and examples: Coatings
-Use: mask unpalatable taste and protect product from moisture, light, and oxygen (enteric coatings: can be used to prevent destruction from stomach acid)
-Ex. shellac, gelatin, gluten, cellulose acetate phthalate