Chapter 17: Compounding III - Documentation and Preparation

Question 1

What is the master formula record

Answer 1

Recipe that is followed to compound a preparation

Question 2

What is the compounding log (or record)

Answer 2

the log book of all products made at the pharmacy

Question 3

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

Answer 3

Clean lab coat and gloves

Question 4

The compounded product should be made using

Answer 4

the master formula

Question 5

Unit-dose repackaging require beyond-use-dates, which should be:

Answer 5

the manufacturer’s expiration date from the original container or 6 months from the repackaging date, whichever is earlier

Question 6

what is comminution?

Answer 6

To reduce particle size by grinding, crushing, milling, vibrating or other processes

Question 7

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

Answer 7

Sieve (or sifter)
They are used to ensure that particle size is uniform

Question 8

The sieve number is based on

Answer 8

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

Question 9

What are the 3 main methods of comminution

Answer 9

Trituration
Levigation
Pulverization

Question 10

General term used to mean “mix thoroughly” (or make the product homogenous)

Answer 10

Trituration

can describe liquids too, e.g., triturating an emulsion by shaking it

Question 11

What is levigating

Answer 11

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

Question 12

What is spatulation

Answer 12

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

Question 13

What is pulverization by intervention

Answer 13

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

Question 14

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

Answer 14

Geometric dilution

Question 15

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

Answer 15

FDA-registered facility

Question 16

If any substance for compounding comes from a non-FDA registered facility, what should be obtained to confirm the specification and quality requirements

Answer 16

Certificate of Analysis (CoA)

Question 17

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

Answer 17

Date of receipt and assigned expiration date

Question 18

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

Answer 18

A wetting agent/levigating agent

Question 19

What is a type of surfactant that is used to reduce the surface tension between oil and water & allows them to come closer together

Answer 19

An emulsifier

Question 20

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

Answer 20

hydrophilic-lipophilic balance (HLB)

Question 21

Examples of common emulsifiers

Answer 21

Acacia, PEG

Question 22

Precipitation/sedimentation can happen with

Answer 22

Suspensions and emulsions

Question 23

What is the initial step in preparing any solution?

Answer 23

To determine if the solute will dissolve in the solution

Question 24

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

Answer 24

Fick’s First Law of Diffusion

Question 25

What can increase the dissolution rate of a solution

Answer 25

- Large surface area (i.e., smaller particles) - stirring the preparation - Using heat

Question 26

To prepare an emulsion, the Continental gum method (aka ____) uses oil, water and an emulsifier in a ____ : ____ : ____ mixture in the order ____

Answer 26

Dry gum method 4:2:1 OWE (4 parts oil, 2 parts water, and 1 part emulsifier)

Question 27

How to prepare an emulsion with the Continental gum method

Answer 27

- 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

Question 28

To prepare an emulsion, the English gum method (aka ____) uses oil, water and an emulsifier in a ____ : ____ : ____ mixture in the order ____

Answer 28

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

Question 29

How to prepare an emulsion with the English gum method

Answer 29

- 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

Question 30

Which excipient is used as a glidant/lubricant to improve the flowability of a powder

Answer 30

Magnesium stearate

Question 31

Which excipient is used to neutralize the static charge and keep the powder from floating away

Answer 31

Sodium lauryl sulfate

Question 32

For any formulation, if melting ingredients, melt the ingredient with the ___ melting point prior to adding the ingredients with the ___ melting point

Answer 32

Higher lower

Question 33

What is a eutectic mixture?

Answer 33

The combination of the ingredients (when mixed together) will melt at a lower temperature than either of the individual component's melting temperatures

Question 34

An adsorbent powder such as ___, ___ or ___ can be used to keep powder dry

Answer 34

Magnesium oxide Magnesium carbonate Kaolin

Question 35

If the amount of powder per dose is very small, it will be necessary to add a(n) ____

Answer 35

inert filler (diluent)

Question 36

What ingredients are used as plasticizers to make capsules less brittle and more flexible

Answer 36

Glycerol and Sorbitol

Question 37

Powder is put into capsules by either hand filling (aka ____) or by using a machine

Answer 37

punch method

Question 38

The ____ tablet is the most common tablet type made in compounding, and the ____ tablet is the most common type made in manufacturing

Answer 38

Molded Compressed

Question 39

A lozenge contains the active drug in what bases? 1. hard lozenges 2. soft lozenges 3. chewable lozenges

Answer 39

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

Question 40

Which kind of gel can be used for transdermal drug administration

Answer 40

Pluronic lecithin organogel

Question 41

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

Answer 41

liquid gel

Question 42

Oil-soluble bases for suppositories include

Answer 42

cocoa butter (known as theobroma oil) and hydrogenated vegetable oils Cocoa is brown like poop

Question 43

Water soluble bases for suppositories include

Answer 43

PEG and gelatin

Question 44

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

Answer 44

density factor

Question 45

How to calculate densitive factor

Answer 45

DF = B / (A-C+B) A = weight of suppository bank B = weight of medication per suppository C = weight of medicated suppository

Question 46

What are the 3 ways to prepare suppositories

Answer 46

- Hand molding (no heating) - Fusion molding (heating) - Compression molding (need weight of empty molds and DF)

Question 47

A ____ plan outlines the steps and actions that ensure the maintenance of proper standards for the compounded preparation

Answer 47

Quality assurance

Question 48

The QA plan includes the ____, which are itemized steps on how to perform routine and expected tasks

Answer 48

Standard Operating Procedures

Question 49

BUD for nonaqueous formulations (such as a drug in petrolatum)

Answer 49

not later than 6 months Store at room temp

Question 50

BUD for water-containaing oral formulations (such as an oral suspension)

Answer 50

Not later than 14 days Store in **refrigerator** (ALL water-containing oral formulations required by USP)

Question 51

BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations (such as a cream or lotion)

Answer 51

Not later than 30 days Store at room temperature

Question 52

Must know BUDs: 1. water-containing oral 2. water-containing topical 3. non-aqeuous

Answer 52

1. ≤ 14 days - REFRIGERATE 2. ≤ 30 days - room temp 3. ≤ 6 months - room temp

Question 53

What should be done if there is an ADR resulting from a compounded product

Answer 53

The patient should report it to the pharmacy and the pharmacist will need to record the ADR in the compounding record

Question 54

The pH of sterile preparations should be close to ___

Answer 54

neutral (7)

Question 55

___ bags should be used for IV medications that have leaching or sorption issues issues

Answer 55

Non-PVC bags | LATTIN = lorazepam, amiodarone, tacrolimus, taxanes, insulin, NTG

Question 56

What is needed to when drug is from an ampule

Answer 56

Filter needle or filter straw to remove broken glass pieces

Question 57

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

Answer 57

sterile water

Question 58

What mOsm/L is considered isotonic for the human body?

Answer 58

~285 mOsm/L

Question 59

___ are IV bags or syringes that contain a small volume (up to 50-100 mL)

Answer 59

Small volume parenterals

Question 60

What is an example of a ready-to-use vial/bag system

Answer 60

ADD-Vantage (used at bedside for immediate use)

Question 61

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

Answer 61

hazardous drugs from vials

Question 62

How should a glass ampule be opened

Answer 62

Snap the neck so sharp end away from you

Question 63

Which technique should be used to inject HD vials

Answer 63

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)

Question 64

___ sterilization is required for high-risk CSPs

Answer 64

Terminal sterilization most things - steam sterilization with an autoclave proteins - use 0.22 micron filter

Question 65

Which compounded sterile products are heat-labile

Answer 65

Hormones, insulin, other proteins

Question 66

compounded sterile products that are heat-labile can be sterilized with filtration using

Answer 66

a 0.22 micron filter

Question 67

If filtering is used, what test must be done to test the filter integrity

Answer 67

the bubble-point test (uses pressure to push out bubble)

Question 68

To avoid pyrogens from washing equipment with tap water, glassware and utensils should be rinsed with ___ and depyrogenated using ____ sterilization with an ____

Answer 68

sterile water and depyrogenated using dry-heat (steam) sterilization with an autoclave

Question 69

The reagent for the bacterial endotoxins test is called the

Answer 69

Limulus Amebocyte Lysate (LAL)

Question 70

USP categorizes CSPs by

Answer 70

risk of contamination (low, medium, high)

Question 71

**Low-risk sterile** compounding uses ____ - ____ components that are **supplied as sterile** from the manufacturer

Answer 71

1-3

Question 72

If more than ___ sterile components are injected into an IV bag, the CSP is medium risk

Answer 72

3

Question 73

Examples of medium risk CSPs

Answer 73

PNs and making a batch of drugs

Question 74

high-risk sterile compounding uses ____ ingredients and will need to be ____ before use

Answer 74

non-sterile ingredients sterilized

Question 75

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

Answer 75

**Tryptic soy broth** (TSB) or **fluid thioglycollate medium** (FTM) and include **bacterial endotoxin testing** prior to use

Question 76

The BUD is determined by USP ___ standards & the stability/expiration date of the individual ingredients, whichever is shorter

Answer 76

797

Question 77

The BUD is determined by the ____ and ___

Answer 77

CSP risk level and the storage temperature

Question 78

CSPs administration times of **low risk ** 1. room temp BUD 2. refrigerated BUD 3. frozen BUD

Answer 78

1. 48 hours 2. 14 days 3. 45 days

Question 79

CSPs administration times of **medium risk** 1. room temp BUD 2. refrigerated BUD 3. frozen BUD

Answer 79

1. 30 hours 2. 9 days 3. 45 days

Question 80

CSPs administration times of **high risk** 1. room temp BUD 2. refrigerated BUD 3. frozen BUD

Answer 80

1. 24h 2. 3d 3. 45d

Question 81

CSPs administration times of **low risk in SCA** (not cleanroom): 1. room temp BUD 2. refrigerated BUD

Answer 81

1. 12h 2. 12h

Question 82

CSPs administration times for emergency/immediate use at room temp BUD

Answer 82

1h

Question 83

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

Answer 83

Osmolarity Tonicity

Question 84

Saline concentrations that are greater than 0.9% are

Answer 84

hypertonic

Question 85

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

Answer 85

out dilute

Question 86

Solutions with higher osmolarity should be administered via a

Answer 86

central line (to avoid phlebitis)

Question 87

What labeling is required on CSPs

Answer 87

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