Chapter 17: Compounding III - Documentation and Preparation Flashcards
What is the master formula record
Recipe that is followed to compound a preparation
What is the compounding log (or record)
the log book of all products made at the pharmacy
What is the minimum PPE required when preparing non-sterile, non-hazardous preparations
Clean lab coat and gloves
The compounded product should be made using
the master formula
Unit-dose repackaging require beyond-use-dates, which should be:
the manufacturer’s expiration date from the original container or 6 months from the repackaging date, whichever is earlier
what is comminution?
To reduce particle size by grinding, crushing, milling, vibrating or other processes
After particles have been finely ground, it is placed into a ____
Sieve (or sifter)
They are used to ensure that particle size is uniform
The sieve number is based on
the number of holes per inch (e.g., #100 sieve has 100 openings/inch)
What are the 3 main methods of comminution
Trituration
Levigation
Pulverization
General term used to mean “mix thoroughly” (or make the product homogenous)
Trituration
can describe liquids too, e.g., triturating an emulsion by shaking it
What is levigating
Involves triturating the powder with a mortar and pestle by incorporating a small amount of liquid (called a levigating agent or wetting agent) to help with the grinding process
What is spatulation
Similar to levigation, but performed on an ointment slab with a spatula
What is pulverization by intervention
It is used for crystalline powders that will not crush easily. The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates. When the powder crystallizes, the particles are finer and easier to work with
What is the method used to ensure the ingredients are evenly distributed in a diluent or delivery vehicle
Geometric dilution
Approved substances for compounding should be manufactured at a(n)
FDA-registered facility
If any substance for compounding comes from a non-FDA registered facility, what should be obtained to confirm the specification and quality requirements
Certificate of Analysis (CoA)
If there is a component without an expiration date, the label should contain which 2 dates
Date of receipt and assigned expiration date
What is a type of surfactant used to incorporate an insoluble drug into a liquid, which makes a suspension
A wetting agent/levigating agent
What is a type of surfactant that is used to reduce the surface tension between oil and water & allows them to come closer together
An emulsifier
To make an emulsion, the emulsifier will need to be carefully chosen, according to
hydrophilic-lipophilic balance (HLB)
Examples of common emulsifiers
Acacia, PEG
Precipitation/sedimentation can happen with
Suspensions and emulsions
What is the initial step in preparing any solution?
To determine if the solute will dissolve in the solution
The dissolution rate of a solution can be used to determine the time it will take for the solute to dissolve and can be calculated using
Fick’s First Law of Diffusion
What can increase the dissolution rate of a solution
- Large surface area (i.e., smaller particles)
- stirring the preparation
- Using heat
To prepare an emulsion, the Continental gum method (aka ____) uses oil, water and an emulsifier in a ____ : ____ : ____ mixture in the order ____
Dry gum method
4:2:1
OWE (4 parts oil, 2 parts water, and 1 part emulsifier)
How to prepare an emulsion with the Continental gum method
- Levigate the gum with oil
- Ddd water all at once
- Triturate the mixture by shaking it until the cracking sound is heard and the mixture looks creamy white
- Add other ingredients up to the final volume
- Homogenize with machine
the continent is dry - so can add water all at once
To prepare an emulsion, the English gum method (aka ____) uses oil, water and an emulsifier in a ____ : ____ : ____ mixture in the order ____
The Wet Gum method
4:2:1
OWE (4 parts oil, 2 parts water, and 1 part emulsifier)
(same as dry gum)
rains a lot in england = wet method
How to prepare an emulsion with the English gum method
- Triturate the gum (emulsifier) and water to form a mucilage (which is thick and sticky)
- Add oil slowly while triturating (shaking) to form the emulsion
- Add other ingredients up to the final volume
- Homogenize with machine
Which excipient is used as a glidant/lubricant to improve the flowability of a powder
Magnesium stearate
Which excipient is used to neutralize the static charge and keep the powder from floating away
Sodium lauryl sulfate
For any formulation, if melting ingredients, melt the ingredient with the ___ melting point prior to adding the ingredients with the ___ melting point
Higher
lower
What is a eutectic mixture?
The combination of the ingredients (when mixed together) will melt at a lower temperature than either of the individual component’s melting temperatures
An adsorbent powder such as ___, ___ or ___ can be used to keep powder dry
Magnesium oxide
Magnesium carbonate
Kaolin
If the amount of powder per dose is very small, it will be necessary to add a(n) ____
inert filler (diluent)
What ingredients are used as plasticizers to make capsules less brittle and more flexible
Glycerol and Sorbitol
Powder is put into capsules by either hand filling (aka ____) or by using a machine
punch method
The ____ tablet is the most common tablet type made in compounding, and the ____ tablet is the most common type made in manufacturing
Molded
Compressed
A lozenge contains the active drug in what bases?
1. hard lozenges
2. soft lozenges
3. chewable lozenges
Hard: sucrose or syrup
soft: PEG
chewable: glycerin or gelatin
Which kind of gel can be used for transdermal drug administration
Pluronic lecithin organogel
Poloxamer is ___ at low temperatures but forms a ____ at room temperature
liquid
gel
Oil-soluble bases for suppositories include
cocoa butter (known as theobroma oil) and hydrogenated vegetable oils
Cocoa is brown like poop
Water soluble bases for suppositories include
PEG and gelatin
To calculate the amount of base displaced in a suppository, the ____ of the drug is needed
density factor
How to calculate densitive factor
DF = B / (A-C+B)
A = weight of suppository bank
B = weight of medication per suppository
C = weight of medicated suppository
What are the 3 ways to prepare suppositories
- Hand molding (no heating)
- Fusion molding (heating)
- Compression molding (need weight of empty molds and DF)
A ____ plan outlines the steps and actions that ensure the maintenance of proper standards for the compounded preparation
Quality assurance
The QA plan includes the ____, which are itemized steps on how to perform routine and expected tasks
Standard Operating Procedures
BUD for nonaqueous formulations (such as a drug in petrolatum)
not later than 6 months
Store at room temp
BUD for water-containaing oral formulations (such as an oral suspension)
Not later than 14 days
Store in refrigerator (ALL water-containing oral formulations required by USP)
BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations (such as a cream or lotion)
Not later than 30 days
Store at room temperature
Must know BUDs:
1. water-containing oral
2. water-containing topical
3. non-aqeuous
- ≤ 14 days - REFRIGERATE
- ≤ 30 days - room temp
- ≤ 6 months - room temp
What should be done if there is an ADR resulting from a compounded product
The patient should report it to the pharmacy and the pharmacist will need to record the ADR in the compounding record
The pH of sterile preparations should be close to ___
neutral (7)
___ bags should be used for IV medications that have leaching or sorption issues issues
Non-PVC bags
LATTIN = lorazepam, amiodarone, tacrolimus, taxanes, insulin, NTG
What is needed to when drug is from an ampule
Filter needle or filter straw to remove broken glass pieces
Vials that contain lyophilized or freeze-dried powder needs to be reconstituted by adding ____
sterile water
What mOsm/L is considered isotonic for the human body?
~285 mOsm/L
___ are IV bags or syringes that contain a small volume (up to 50-100 mL)
Small volume parenterals
What is an example of a ready-to-use vial/bag system
ADD-Vantage
(used at bedside for immediate use)
Prior to withdrawing any liquid from a vial, inject a volume of air equal to the volume of fluid to be removed, with the exception of
hazardous drugs from vials
How should a glass ampule be opened
Snap the neck so sharp end away from you
Which technique should be used to inject HD vials
negative-pressure technique
(inject needle, invert, with needle in air part pull back to get air, move needle to liquid portion which will act as suction to pull liquid into syringe - do in small increments)
___ sterilization is required for high-risk CSPs
Terminal sterilization
most things - steam sterilization with an autoclave
proteins - use 0.22 micron filter
Which compounded sterile products are heat-labile
Hormones, insulin, other proteins
compounded sterile products that are heat-labile can be sterilized with filtration using
a 0.22 micron filter
If filtering is used, what test must be done to test the filter integrity
the bubble-point test
(uses pressure to push out bubble)
To avoid pyrogens from washing equipment with tap water, glassware and utensils should be rinsed with ___ and depyrogenated using ____ sterilization with an ____
sterile water and depyrogenated using dry-heat (steam) sterilization with an autoclave
The reagent for the bacterial endotoxins test is called the
Limulus Amebocyte Lysate (LAL)
USP categorizes CSPs by
risk of contamination (low, medium, high)
Low-risk sterile compounding uses ____ - ____ components that are supplied as sterile from the manufacturer
1-3
If more than ___ sterile components are injected into an IV bag, the CSP is medium risk
3
Examples of medium risk CSPs
PNs and making a batch of drugs
high-risk sterile compounding uses ____ ingredients and will need to be ____ before use
non-sterile ingredients
sterilized
Sterility testing for high-risk CSPs and CSPs intended for use beyond the recommended BUD must use either ___ or __, and include __ testing prior to use
Tryptic soy broth (TSB) or fluid thioglycollate medium (FTM) and include bacterial endotoxin testing prior to use
The BUD is determined by USP ___ standards & the stability/expiration date of the individual ingredients, whichever is shorter
797
The BUD is determined by the ____ and ___
CSP risk level and the storage temperature
CSPs administration times of **low risk **
1. room temp BUD
2. refrigerated BUD
3. frozen BUD
- 48 hours
- 14 days
- 45 days
CSPs administration times of medium risk
1. room temp BUD
2. refrigerated BUD
3. frozen BUD
- 30 hours
- 9 days
- 45 days
CSPs administration times of high risk
1. room temp BUD
2. refrigerated BUD
3. frozen BUD
- 24h
- 3d
- 45d
CSPs administration times of low risk in SCA (not cleanroom):
1. room temp BUD
2. refrigerated BUD
- 12h
- 12h
CSPs administration times for emergency/immediate use
at room temp BUD
1h
___ includes all solutes and ___ includes only the solutes that do not cross the vasculature (membranes)
Osmolarity
Tonicity
Saline concentrations that are greater than 0.9% are
hypertonic
When hypertonic saline is administered into a peripheral vein, the high conc of solutes relative to the conc in the blood will cause water to move ____ of the RBCs in an attempt to ___ the solute conc
out
dilute
Solutions with higher osmolarity should be administered via a
central line (to avoid phlebitis)
What labeling is required on CSPs
names and concentrations of ingredients
total volume
BUD
route of administration
storage requirements
+ HD need special HD label
+ auxillary label
+ high alert medications special lables
