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 1 year from the repackaging date, whichever is earlier
____ means to reduce particle size by grinding, crushing, milling, vibrating or other processes
Comminution
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
Ingredients that are acceptable for use in compounding will be listed where
The USP National Formulary (USP-NF)
The Food Chemicals Codex (FCC)
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 pharmacist will assign a conservative date that is no more than ___ from the date of receipt
3 years
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, then add 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 to make the emulsion uniform
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)
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 to make the emulsion uniform
Which excipient is used as a glidant/lubricant to improve the flowability of a powder
Magnesium stearate