Chapter 17: Compounding III - Documentation and Preparation Flashcards by Kristin Kattoula

What is the master formula record

Recipe that is followed to compound a preparation

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What is the compounding log (or record)

the log book of all products made at the pharmacy

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What is the minimum PPE required when preparing non-sterile, non-hazardous preparations

Clean lab coat and gloves

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The compounded product should be made using

the master formula

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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

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____ means to reduce particle size by grinding, crushing, milling, vibrating or other processes

Comminution

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After particles have been finely ground, it is placed into a

Sieve (or sifter)

They are used to ensure that particle size is uniform

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The sieve number is based on

the number of holes per inch (e.g., #100 sieve has 100 openings/inch)

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What are the 3 main methods of comminution

Trituration
Levigation
Pulverization

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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

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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

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What is spatulation

Similar to levigation, but performed on an ointment slab with a spatula

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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

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What is the method used to ensure the ingredients are evenly distributed in a diluent or delivery vehicle

Geometric dilution

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Ingredients that are acceptable for use in compounding will be listed where

The USP National Formulary (USP-NF)

The Food Chemicals Codex (FCC)

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Approved substances for compounding should be manufactured at a(n)

FDA-registered facility

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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)

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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

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If there is a component without an expiration date, the label should contain which 2 dates

Date of receipt and assigned expiration date

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What is a type of surfactant used to incorporate an insoluble drug into a liquid, which makes a suspension

A wetting agent/levigating agent

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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

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To make an emulsion, the emulsifier will need to be carefully chosen, according to

hydrophilic-lipophilic balance (HLB)

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Examples of common emulsifiers

Acacia, PEG

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Precipitation/sedimentation can happen with

Suspensions and emulsions

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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

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 a base of ___ or __ for hard lozenges, ___ for soft lozenges and ___ or ___ for chewable lozenges

Hard: sucrose or syrup soft: PEG chewable: glycerin or gelatin

___ contain the most water, while ___ contain the least water

Lotions | Ointments

Which kind of gel can be used for tansdermal drug administration

Pluronic lecithin organogel

Poloxamer is ___ at low temperatures but forms a ____ at room temperature

liquid | gel

Oil-soluble bases include

cocoa butter (known as theobroma oil) and hydrogenated vegetable oils

Water soluble bases include

PEG and gelatin

To calculate the amount of base displaced in a suppository, the ____ of the drug is needed

density factor

What are the 3 ways to prepare suppositories

- Hand molding - Fusion molding - Compression molding

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 when stored at controlled cold temperatures Store in refrigerator

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

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

What is needed to remove glass from an ampule

Filter needle or filter straw

Vials that contain lyophilized or freeze-dried powder needs to be reconstituted by adding

sterile water

___ 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

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 away from you

Which technique should be used to inject HD vials

negative-pressure technique

___ sterilization is required for high-risk CSPs

Terminal sterilization (includes steam sterilization with an autoclave)

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

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-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

Examples of medium risk CSPs

PNs and making a batch of drugs

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

___ includes all solutes and ___ includes only the solutes that do not cross the vasculature

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 out of the ___ in an attempt to ___ the solute conc

RBCs | Dilute

Solutions with higher osmolarity should be administered via a

central line (to avoid phlebitis)