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You're Passing the Exam Sis... This Isn't an Option > Compounding > Flashcards

Compounding Flashcards

1
Q

what is traditional compounding

A

process of combining or altering ingredients to create a medication. It is prepared by a pharmacist for an individual patient NOT in bulk. Not FDA approved. the dose or formulation is not commercially available as a manufactured product, so it must be compounded.

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2
Q

Who is USP

A

U.S. pharmacopeia - set the standards for compounding (ex: 797,795, 800

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3
Q

USP 797

A

minimum acceptable requirements for sterile compounding (797 is higher than 795, which is nonsterile)

ex: eye drops, IV drugs, ear drops, irrigations (something with antibiotic in it, used to rinse off affected areas), IM and SubQ drugs, Eye drops, Irrigations, Pulmonary inhalations

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4
Q

USP 795

A

minimum acceptable requirements for non sterile compounding

(ex: orals, topicals, nasals)

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5
Q

USP 800

A

USP sets the minimum acceptable requirements for handling of hazardous drugs (HDs)

USP doesn’t determine which drugs are hazardous. the NIOSH does (national institute for occupational safety and health)

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6
Q

pharmacopeia

A

a list of medicinal drugs with preparation instructions

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7
Q

API

A

active pharmaceutical ingredient

everything other than this is the excipient

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8
Q

aseptic

A

“free from contamination”

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9
Q

Hazardous criteria

A

carcinogenic, teratogenic, causes organ toxicity , genotoxic (damage dna and can lead to cancer)

all hormones are hazardous drugs

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10
Q

prior to handling hazardous material, hospital staff must do what

A

if they are of reproductive capacity, they have to confirm in writing that they understand risks

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11
Q

Reasons for nonsterile compounding and types

A

prepare a dose/formulation thats not commercially available, to remove an excipient the pt is allergic to, to add a flavor

usually for drugs administered by mouth, rectally, vaginally, topically, nasally, or in the ear

types:

simple - follow basic instructions (most of what we do)
moderate - requires calculations
complex - requires extra training/equipment

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12
Q

T or F: non sterile compunds require a hood

A

False. These can be made in room-air, but should be separated from the dispensing part of the pharmacy. They dont require a hood.

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13
Q

T or F. Ingredients used for compounded can be stored in boxes on the floor as long as they are labeled.

what else is required of nonsterile compounding spaces

A

false. all equipment, containers, and components must be off the floor.

The space should be clean and well lit with proper heating and ventilation to avoid drug deterioration.

There needs to be adequate plumbing and two types of water.
- potable - (tap water) for hand washing and cleaning equipment. sink should be easily accessible to compounding area, there should be soap, detergent, and a method for hand drying.
- purified (distilled) for use in water containing formulations and for rinsing equipment/utensils

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14
Q

PEC (primary engineering control) aka

A

the STERILE HOOD that has ISO 5 air for compounding.

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15
Q

SEC (secondary engineering control) aka

A

The air outside of the PEC (hood) in the room. aka the clean room or the buffer room where the sterile hood (PEC) is located. this has ISO 7 air. This i

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16
Q

CSP (compounded sterile products)

A

IV drugs

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17
Q

SVP (small volume parenteral)

A

IV bag </=100 ml

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18
Q

LVP (large volume parenteral)

A

IV bag or container with > 100 mL

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19
Q

don vs doff of PPE (personal protective equipment)

A

don - putting on PPE
doff - taking it off

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20
Q

LAFW (laminar air flow workbench)

A

Type of sterile hood (PEC); parallel air streams flow in one direction

positive air pressure in horizontal flow, no need for external exhaust

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21
Q

CSTD (closed system transfer device)

A

device that prevents the HD from leaking out

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22
Q

CVE (containment ventilated enclosure)

A

ventilated powder hood for nonsterile products. can be used for HD if USP 800 is met. usually this is for hormones.

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23
Q

RABS (restricted access barrier system)

A

glovebox with closed front sterile hood (includes CAI and CACIs)

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24
Q

CAI (compounding aseptic isolator)

A

glovebox, for non HDs, a closed front sterile hood
can be located in SEC but is often located in a segragated compounding area - a part of the pharmacy that is isolated from other things that could be contaminants. For these, USP just requires the gloves and the rest of the requirements are left to the manufacturer to say how the staff should be garbed. ( no hair cap is necessarily needed always)

no matter what, if it’s compounding for hazardous drugs, you must make sure there is negative pressure

positive pressure in the antechamber

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25
Q

CACI (compounding aseptic containment isolator)

A

glovebox, for HDs, a type of closed front C PEC
often located in a segragated compounding area - a part of the pharmacy that is isolated from other things that could be contaminants. For these, USP just requires the gloves and negative pressure ( if HD), the rest of the requirements are left to the manufacturer to say how the staff should be garbed. ( no hair cap is necessarily needed always)

no matter what, if it’s compounding for hazardous drugs, you must make sure there is negative pressure

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26
Q

C-SCA (containment segregated compounding area)

A

Ventilated (negative pressure room used for HDs, not in a clean room suite)
air is not ISO rated (unclassified)

These segregated compounding areas are typically installed when a clean room is not able to be installed. can be used for low risk CSPs (compounded sterile products) and BUD is always 12 hrs

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27
Q

C- SEC

A

ventilated (negative pressure) buffer room for HDs

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28
Q

BSC (biological safety cabinet)

A

chemo hood (Class 2 or 3 for sterile HD), a type of CPEC

NIOSH approved fit tested respirator needs to be used if the front cover is opened

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29
Q

CPEC (containment primary engineering control)

A

Ventilated, negative pressure, chemo hood used for HDs

aka biological safety cabinet

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30
Q

Which organization sets the standard for air quality

A

International Standards Organization

in critical areas closest to drugs and containers, air must be ISO 5 level (no more than 3,520 parts per cubic meter, Parts that are size 0.5 microns or larger)

ISO also says that the surfaces must be smooth, impervious, easy to clean, and easy to disinfect and they must meet temperature requirements as well.

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31
Q

which air is dirtiest

A

the further the air is from the PEC.

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32
Q

Hazardous antibiotic

A

chloramphenicol

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33
Q

hazardous abortion drug

A

mifepristone, misoprostol

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34
Q

hazardous anticoagulant

A

warfarin

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35
Q

hazardous antifungal

A

fluconazole, voriconazole

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36
Q

Hazardous anti-retroviral

A

abacavir, entecavir, zidovudine

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37
Q

hazardous antitviral

A

Cidofovir, Ganciclovir, Valgancyclovir

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38
Q

Hazardous acne medication

A

Isotrentinoin

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39
Q

Hazardous arrhythmia medication

A

Dronedarone

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40
Q

Hazardous meds for autoimmune conditions

A

acitretin, azathiopurine, leflunomide, fingolimod, teriflunomide

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41
Q

Hazardous meds for BPH

A

dutasteride, finasteride

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42
Q

Hazardous bisphosphonates

A

Pamidronate, Zolendroic acid

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43
Q

Hazardous heart chemoprotectant drug

A

Dexrazoxane

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44
Q

Hazardous depression drug

A

Paroxetine

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45
Q

Hazardous diabetes drugs

A

Exenatide, Liraglutide

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46
Q

Hazardous Dyslipidemia drug

A

Lomitapide

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47
Q

Hazardous Seizure/epilepsy drug

A

Clobazam, Clonazepam, carbamezapine, oxcarbazepine, eslicarbezapine, divalproex, fosphenytoin, phenytoin, topiramate, vigabatrin, zonisamide

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48
Q

Hazardous gout drugs

A

Colchicine

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49
Q

Hazardous heart failure drug

A

Ivabradine, Spironolactone

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50
Q

Hazardous Hepatitis Drug

A

Ribavirin

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51
Q

Hazardous hormonal agents

A

all androgens (testosterone) and estrogens
oxycontin, dinoprostone
Progesterones
SERD/SERMs (fulvestrant, tamoxifen)
Ulipristal

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52
Q

Hazardous hyperthyroidism drugs

A

Methimazole, propylthiouracil (PTU)

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53
Q

Hazardous insomnia drugs

A

Temazepam, Triazolam

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54
Q

Hazardous Iron overload drugs

A

Deferiprone

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55
Q

Hazardous migraine drugs

A

dihydroergotamine

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56
Q

Hazardous parkinsons disease drugs

A

apomorphine, rasagiline

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57
Q

Hazardous pulmonary arterial hypertension drugs

A

ambrisentan, bosentan, macitentan, riociguat

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58
Q

Hazardous Schizophrenia drugs

A

Ziprasidone

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59
Q

Hazardous Transplant drugs

A

cyclosporine, mycophenolate, Tacrolimus, Sirolimus

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60
Q

Whenever you see the word “containment” or “C” its referring to

A

preparing hazardous drugs

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61
Q

What kind of air pressure is in CPEC and CSECs

A

negative air pressure and the air needs to be externally exhausted for sterile hazardous drugs. for non sterile, they don’t have to be externally exhausted (preferred), but they can be filtered out through redundant HEPA filters instead twice before it goes out.

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62
Q

What is required of the air changes in spaces where hazardous drugs are prepared

A

need at least 12 ACPH (air changes per hour) for the space where non sterile hazardous drugs are prepared.

and at least 30 ACPH in areas where sterile HD are prepared.

63
Q

what level air does the anteroom need to be

A

ISO 7 or 8 is acceptable if it opens into positive pressure area (HD non sterile compounding) since the air is being pushed out into the ante room, it doesn’t matter

but if it opens into negative pressure area (HD sterile compounding), then the anteroom needs to have pressure that matches the CSEC, which is 7, since the air from there is flowing inward.

64
Q

HEPA filter, what is it and where does airflow come from in LAFW, PEC, and CPEC

A

high efficiency particulate air filter. picks up particles when air runs through the filter. they are at least 99.97% efficient at removing particles as small as 0.3 microns

in CPEC, the air comes vertically, HEPA is at the top because this is dealing with hazardous drugs and we want to protect the staff

in LAFW and PEC, the air comes horizontally, the HEPA is at the back

65
Q

What is the DCA (direct compounding area)

A

This is the area where the air comes directly out of the HEPA filter and its called first air. This is where the air is the cleanest

66
Q

How often does a HEPA filter need to be recertified

A

every 6 months and every time a PEC is moved

67
Q

what type of alcohol must be used to clean the materials before putting them in the hood

A

70% isopropyl alcohol (IPA)

68
Q

Remember to open packages along the designated tear line rather than any other way… why

A

to prevent unnecesary particles from contaminating the air.

69
Q

True or false: its okay to let waste accumulate inside the PEC while compounding so that you don’t stick your hands in and out too often

A

false: remove waste as sooon as its created. never let it accumulate in the sterile hood.

70
Q

How many inches inside the hood do we need to compound

A

at least 6 in. to prevent exposing the compound to ISO 7 air

71
Q

what type of air pressure must be used in the CPEC or CSEC for compounding hazardous drugs

A

negative air pressure. this contains the toxic air in the space and protects the staff member

72
Q

What type of air pressure must be used in the PEC and SEC for compounding non hazardous drugs

A

positive pressure is fine

73
Q

T or F : objects that shed particles like cardboxes are not allowed in the clean room

A

true

74
Q

what is the line of demarcation

A

its in the anteroom/garb room and separates the clean from the dirty areas

shoe covers should be put on one at a time while crossing over the line

75
Q

what is the BUD of an IV drug compounded for an emergency with no time for aseptic technique

A

1 hour

76
Q

yellow containers

A

trace amounts of hazardous waste (including used syringes, sharps included)

(ex: IV bags, empty syringes, used PPE, including gowns, gloves, masks, and shoe covers)

77
Q

what is a class 2 biologic safety cabinet

A

its used for hazardous drugs aka known as a containment hood or a CPEC

78
Q

what is turbulent airflow vs laminar air flow

A

laminar - air that flows in parallel lines so that the particles in the air don’t bounce with each other

turbulent airflow is air that has particles that bump all around each other

79
Q

BUD for anything made in a compounding aseptic isolator (HD or Non-HD)

A

max is 12 hrs.

80
Q

black bin

A

bulk hazardous waste

81
Q

required testing and training

A
  • didactic training and hands on training
  • continuous training for new updates/equipment
  • hand hygiene + garbing and gloving technique glove = 3 consecutive fingerprint tests on each hand on [tryptic soy agar (TSA)] and incubated (heated) for 2-3 days. Passing = zero CFU’s on plates for both hands. Repeat annually if compounding low/med risk drugs (most common) or semiannually if high risk drugs
  • sterile drug preparation = media fill test. using tryptic soy broth (TSB) in an IV bag or small vial, pretend to aseptically make aseptic drug, and in 14 days, if there is no turbidity, you pass. Repeat at least annually for low/med risk drugs, repeat semi annually for high risk drugs
  • cleaning and disinfecting procedures for sterile space and equipment
82
Q

How often should different temperatures be monitored and documented in the SEC, where should be recorded, and what should temps be

A

The actual SEC room temp should be monitored once daily. temp should be at or lower than 20 degrees C or 68 F

all fridges and freezers should be documented twice a day
Fridge: 2-8 degrees C; 35-46 degrees F
Freezer : -50 to -15 degrees C; -58 to 5 degrees F

use a temp log

83
Q

air sampling needs to occur how often

A

q 6 months by a person certified or qualified

84
Q

surface sampling is required by USP how often

A

the book says “periodically”

TSA plate with polysorbate 80 and lectin (they neutralize the effect of disinfectants) is used to test samples AT THE END OF THE DAY when surfaces are in their poorest state. all surfaces regularly exposed to staff are to be tested and at least one sample needs to be from the ISO 5, ISO 7, and ISO 8 area. plates are incubated for 2-3 days

you should see LESS THAN 3 CFUs in ISO 5
less than 5 CFUs in ISO 7
and less than 100 CFUs in ISO 8

if more than the allowed amount is found, identify the organism using PCR and kill it. (ex: staphylocc. from people, pseudomonas from poor air conditioning)

85
Q

how often should air pressure be checked

A

each shift (preferrably) or daily at the minimum

some places have a pressure gauge in the room

all non haz prep rooms : positive pressure
all haz prep rooms: negative pressure

86
Q

how often should humidity be checked and what should it be below

A

humidity should be checked once daily and be below 60%

87
Q

t or false: every night, the PEC needs to be shut off.

A

False, we need to keep the PEC running at ALL TIMES to keep the surfaces clean.

88
Q

what do we do if a PEC is affected by a power outage

A

we need to stop all compounding. before re-initiating compounding, we need to clean it with GERMICIDAL DETERGENT (quat, ammonium, phenolics) and then disinfect it with 70% STERILE ISOPROPYL ALCOHOL and then let the hood run for at least 30 minutes before compounding can begin.

there are diff. rules for CPEC

89
Q

we should always clean from cleanest to dirtiest to avoid making clean spaces dirty

A

ex: from cleaning PEC to cleaning SEC

use lint free wipes and wipe in unidirectional, slightly overlapping strokes rather than circular motion

90
Q

true or false: we should clean the PEC with germicidal detergent, and spray 70% isopropyl alcohol inside the PEC and wipe with a lint free wipe in circular motions

A

false: we should use the same ingredients, but NEVER spray the alcohol in the PEC because it makes airflow turbulent.

always spray on the wipe first or use the already wet wipes. wipe in unidirectional, slightly overlapping strokes rather than circular motion.

clean from top to bottom back to front so the cleanest areas are cleaned first. Always flip the wipe over when cleaning different areas of the hood

PECs are to be cleaned continuously throughout the day

91
Q

List the steps for how to clean a Laminar airflow PEC

A
  1. clean the ceiling of hood, back to front
  2. clean the grill over the HEPA filter, top to bottom
  3. clean the side walls from back to front top to bottom
  4. clean anything kept in the hood (ex: equipment)
  5. Clean the bottom surface starting from back to front

wait until all surfaces are dry to start compounding

92
Q

how often should the ceiling, walls, shelving, chairs, bins, and carts be cleaned in the SEC

A

monthly

93
Q

how often should ISO 5 PECs be cleaned

A

before each shift
q30 min while working
before and after each batch of CSPs
whenever needed (ex: after spills)

94
Q

when should we wipe off the outside container of all supplies

A

before entering the clean room

95
Q

what should we use to clean the counters and floors and how often

A

germicidal cleaner and sterile IPA 70% daily

96
Q

Sanitization is required for hazardous compounds. What are the steps for sanitization

A
  1. Deactivation and decontamination- 2% bleach or peroxide, this helps to reduce HD toxicity. neutralize the bleach to prevent corrosion of surfaces. decontamination is required everytime a spill occurs
  2. Clean with a germicidal detergent (quat), ammonium, phenolics
  3. Disinfection - sterile 70% IPA
97
Q

red bin

A

for non hazardous sharps

98
Q

higher risk defined for USP 797 & 795 vs 800

A

795 and 797 - anything with a higher chance of an unsafe preparation getting to PATIENT

800 - higher chance of causing harm to the WORKERS exposed to the drug

99
Q

For the lower risk HDs, all pharmacies should either always use ALL of USP 800’s requirements, or the pharmacy should conduct a

A

risk assessment to decide how they will handle the drugs but they need to make sure to obviously not mix up any equipment for regular drugs with hazardous drugs

100
Q

first thing to do with drug exposure

A

rip off clothing (first 10-15 sec after exposure are critical)
- rinse and clean with soap and water; if gets in eye, use an isotonic eye wash for 15 minutes depending on the chemical could be longer.

101
Q

if there is any risk for suspected exposure to spill or splash we need to wear

A

face shields and goggles.

102
Q

if HDs are unpacked and not contained in plastic we should wear

A

multi gas cartridge and P100 filter until we can verify there is no break.leakage

103
Q

N95 respirator doesnt provide adequate protection against gases vapors or liquid splashes. it is sufficient for most HDs compounding.

A

additional resp protection is needed if:
cleaning up spills that require more than whats in the spill kit
deactivating/decontaminating/and cleaning underneath CPEC workspace
when there is known or suspected Hazardous airborne exposure
when disposing of PPO from handling HDs

NEVER USE A SURGICAL MASK FOR HZD

104
Q

When there is risk of respiratory exposure to HDs, we need to wear

A

a respiratory mask with attached gas canisters ( “gas mask”)

OR

a powdered air purifying respirator (PAPR)

105
Q

What is a safety data sheet (SDS) previously called MSDS

A

safety documents required by OSHA (occupational safety and health administration) to be accessible to all employees who work with Hazardous materials and drugs.

It shares safety info about PPE, first aid, and spill clean up procedures

106
Q

Contents of a HDs spill clean up kit

A

protective gown
latex gloves
N96 respirator
googles with side shields
HD waste bag, scoop and scraper, chemo pads
HD spill report exposure form

107
Q

never use a brush to sweep up anything containing HDs, particles can become airborne

A

when it doubt, always avoid spraying any cleaners as well. moisten the towel with it too.

107
Q

never use a brush to sweep up anything containing HDs, particles can become airborne

A

when it doubt, always avoid spraying any cleaners as well. moisten the towel with the substance .

double glove with heavy duty gloves over ASTM D678 chemo rated gloves

108
Q

important notes about administering HDs

A

double glove - with ASTM D678 chemo rated gloves and put on chemo gown when giving IV. if not IV, its not required

use closed system drug transfer devices to avoid spills. recommended when compounding but required when administering chemo drugs

109
Q

avoid manipulating oral versions of HDs. If required, put it in a bag before crushing so the particles can be contained

A
110
Q

all PPE worm after handling HDs, use which bin

A

yello trace chemo waste bin

111
Q

all sterile HDs compounding requires

A
  • head cover
  • beard cover
  • two pairs booties
  • two pairs chemo rated gloves
  • impermeable gown (seals in back)
  • full face respirator or face shield with goggles when there is a risk for spills or splashes
112
Q

all sterile HDs compounding requires

A
  • one pair booties
  • disposable pad to protect work surface
  • double gloves
    gown
    mask
113
Q

all gloves used with ocmpounding must be sterile and powder free

A
114
Q

artificial/long nails, makeup, and all jewelry are not allowed

A

mirror is required in anteroom so ppl can make sure hair is covered when they put on their hair net.

115
Q

order of garbing

A

head and facial hair covers
face mask
shoe covers (step over live of demarcation) (2 pairs if HDs)
hand wash with sap and warm water with a method for hand drying - clean under finger nails under warm water and rub circularly for 30 sec from fingertips to elbows
use lint free towels or hand dryer
- gown (can be reusable only if Non HD and must be washed)
- use alcohol based hand rub in SEC
- put on sterile powder free gloves
sanitize gloves with IPA 70%

  • garb should not be warn outside the anteroom. if you leave, you have to dispose them. you can take it off and reuse it. if you leave you need to redo the hygeine
116
Q

all garb must be used with compounding in an isolator (clovebox

A
117
Q

suspension means there is an ingredient that is not dissolving

A
118
Q

compounded products have beyond use dates, manufacturers use expiration dates.

A

master formula tells us instructions for making a specific compound order.

119
Q

when measuring , use devices that are slightly larger than the one you need to avoid error (ex; syringes and graduated cylinders)

A

always use equipment dedicated for hazardous drugs for HDs and make sure to always sanitize after use. if the equipment can’t be sanitized don’t use it

120
Q

avoid using a metal spatula when working with a compound that has metal ions.

A

oral syringe is more accurate than a measuring cup

all syringes are useful for measuring viscous fluids

121
Q

we use the metric system for measurement

A

the wider the mouth on a graduated tool, the less accurate the measurement
ex: graduated cylinder is more accurate than conical

122
Q

meniscus is that curve that liquid makes in measurement tools and we read the bottom part of it for accuracy

A

hypodermic injection syringes are aka parenteral syringes

123
Q

all syringe packages should be wiped off with isopropyl alcohol 70% to remove contaminants and dust before bringing into SEC or PEC

A

do not recap syringes for safety!!! if its required just slip the needle tip in and avoid touching any part

124
Q

do not touch the part of the syringe plunger that could cause contamination,

A

IV push = bolus dose being provided into a vein or into a vein through a catheter

125
Q

dont use a graduate to measure a volume < 20% of the capacity of that measurement tool

A

avoid using syringes with a luer lock (male to female part) design for non-oral medications to avoid medication error

126
Q

mohr pipette is used in compounding. medicine droppers can be used for pts- educate them to keep tip squeezed while administering and until removed to avoid contaminating pipette

A

Class 3 torsion balance aka class A balance is where we use MWQ (minimum amount that can be weighed) equation

sensitivity requirement of the torsion balances on it is often 6 mg

they are used to weigh things < /=1 gram

top loading electronic balance is more high tech and frequently used, requires zeroing out and glassine weighing paper

127
Q

a compounding pharmacy needs at least one wedgewood or porcelain mortal and pestle.

glass ones are for liquids/oils, stainable compounds

while wedgewood is best for dry crystals /hard powders and

porcelains are for bblending powders and pulverizing gummy consistency things

A

ointments are made on compounding slabs

128
Q

ointment mills, homogeonizers, and grinders are used to mix ingredients. homogenizers are like smoothie blenders, electric grinders are like coffee makers

A

to avoid burning a substance on a hot plate, can put it in a water bath on the hot plate

129
Q

ointment mills, homogeonizers, and grinders are used to mix ingredients. homogenizers are like smoothie blenders, electric grinders are like coffee makers

A

to avoid burning a substance on a hot plate, can put it in a water bath on the hot plate

130
Q

capsule shells are made of gelatin which is pork derived, so avoid in those with restrictions

if made from hypromellose, thats a plant product

A
131
Q

where are high quality ingredients listed

A

USP national formulary (USP-NF) or food chemicals codex (FCC) substances list

132
Q

ingredients for compounding should be manufactured at an FDA regulated facility to be considered high quality , and if not, then a certificate of analysis (CoA) is required from wherever the drugs come from

A

if an ingredient doesn’t have an expiration date, pharmacist can assign a conservative one, no more than 3 years from the date of receipt

always include date or receipt and assigned expiration date on label

133
Q

surfactants lower surface tension between ingredients to make them more miscible (mixable). they form micelle structures (hydrophobic tail faces lipid part and vice versa) since they are ampiphillic

surfactants can stabilize emulsions so that oil droplets can stay dispersed longer. sometimes they do not form micelles, the form a film between surfaces and still help with stabilzation

A

types of surfactants

wetting agents (levigating agents)
emulsifers
suspending agents

134
Q

levigating agents aka wetting agents can be used to reduce surface tension between liquids and solids to allow the substance to be more easily spread

levigation and trituation both are used to grind down particles. levigation uses levigating agents (i.e. mineral oil, glycerin for lipophilic things and polyethylene glycol for hydrophillic things) but trituation is grinding of particles without addition of a liquid.

A

emulsifiers aka emulgents help keep liquid droplets dispersed throughout a liquid vehicle to prevent them from separating into phases (liquid and water). emulsifiers are types of surfactants

135
Q

suspension is a solid dispersed but not dissolved in a liquid. suspending agents are used in suspensions to prevent the particles from settling.

always shake suspensions to redisperse solids before use.

suspending agents can be plasticizers (something that makes preparations easier to mold, ex: sorbitol used for gelatin capsules)

A

examples of suspending agents:

ora plus , must be combined with ora- sweet for flavor (combination is ora-blend). it is slightly acidic to prevent drug degredation through oxidation and its a gel like substance that helps keep particles suspended rather than settling

136
Q

anti foaming agents are used in compounding (ex: simethicone)

foaming agents lower the surface tension of water

A

Glycols and gels are used as surfactants and delivery agents. most common are PEG and poloxamer . both of these are ampiphilic, so they can be used to distribute ingredients in their preparation into their like phase.

137
Q

oral formulations are typical oil/water
topical formulations are typically water/oil (these feel more greasy)

in order to make one or the other we have to use a surfactant with HLB (hydrophilic lipophilic balance) number that is higher than 10 (for more water soluble-ex: tween or PEG 400) or lower than 10 (for more lipid soluble, ex: span 65 and glyceryl monostearate)

HLB scale is 0-20

A

reactions involving functional groups are common causes of drug degredation and instability (oxidation, hydrolysis, photolysis)

most likely to oxidize = hydroxyl group directly bound to aromatic ring (ex: catecholamines like epinephrine, phenolics like phenylephrine, and aldehydes like flavoring substances)

when water is removed (evaporation) from a compound that means the OH group leaves and forms a carbonyl. and changes color

138
Q

oxidation = lose electrons
reduction = gain electrons (more negative)
the two happen simultaneously and are called redox reactions

oxidation can look like color change (epinephrine turning orangey yellow)f

A

we prevent oxidation with :

light protection ex: amber glass or other bags/sleeves
temp control- fridge
chelating agents - metal ions
antioxidants (oxidation produces free radicals and antioxidants like absorbic acid (vitamin c), tocopherols (vit E), help inhibit free radicals)
controling pH with buffer.

139
Q

compounds subject to hydrolysis must be stored in cool dry places , sometimes desicants kept in bottle. bonds most likely to become hydrolyzed are
carbonyl bonded to OR group (ester)
carbonyl bonded to nitrogen (amide)
lactams/cyclic amides- like beta lactam abx

A

ways to prevent hydrolysis

storage as a freeze dried lyophylized powder instead of in solution
adsorbents (desicants)
chelating agents
hygroscopic salt (water absorbing salt)
prodrug formulation that require hydrolysis rxn (ex: acetylsalicylic acid is a prodrug that requires hydrolysis to be activated to salicylic acid and acetic acid)
control temp and light and pH

140
Q

UV light exposure can lead to photolysis breaks covalent bonds and leads to drug degredation

ascorbic acid (vitamin c)
folic acid
nitroprusside and phytonadione (increases vitamin K to enhance blood clotting) injections are sensitive to photolysis

A

isomerization - compounded changes form into inactive structure

epimerization - changes into the stereoisomer of the compound which could be inactive or active

decarboxylation
- when heated carbondioxide is lost. preventable with refrigeration

141
Q

do not use preservatives in neonates

ex: chlorhexidine (used in surgical scrubs), povidone iodine, dosium benzonate/benzoic acid/benzalkonium chloride, sorbic acid, potassium sorbate, methyl, ethyl, or propyl parabens
EDTA, thimerosal- contains mercury and is used in some vaccines, cetyl pyridiunium chloride

A

buffers used to maintain acidic pH

  • hydrochloric acid, acetic acid, sodium acetate, citric acid, sodium citrate

buffers used for alkaline pH
boric acid, sodium borate, sodium bicarb , sodium carbonate, sodium hydroxide

142
Q

distilled water is used for reconstitution, oral suspensions, and non sterile compounding

purified water has removal of chemicals and contaminants

potable water is tap water for cleaning and safe drinking

sterile water for injection (SWFI) is free from bacterial endoxins

A

alcohol has high miscibility so it can be used with water to dissolves solutes that would be insoluble alone in water

143
Q

glycols can be use as surfactants and lubricants and emulsifiers and suppository bases

A

diluents and fillers:
ex: lactose, petrolatum
starch , calcium salts, polacrillin potassium

144
Q

oils and fats are used as delivery vehicles

A

emollients are moisturizers

humectants are put into emollients to pull water from the atmosphere to moisturize the skin

ointments 80-100% oil and 0-20% water - best for dry skin
(ex: petrolatum, polybase, aquaphor, aquabase)
creams 50/50 oil and water (ex: lidoderm, water in oil - greasier, or oil in water, cetaphil, eucerin)
lotions have the most water and best for oily skin (small amount of alcohol can be added to solubilize the ingredients)

145
Q

gels are made of poloxamers which are liquid at fridge temp and gel when at room temp.
poloxamer lecithin organogel (PLO gel)]
‘
gels are pluronic because they are made of two joined polymer compunds (poly-oxy-ethylene and poly oxy propylene)

A

suppositories are usually made of polybase, hydrogenated vegetable oils, or gelatin, or PEG

146
Q

ANY TOPICAL COMPOUND MADE WITH WATER INSIDE SHOULD HAVE A BUD OF NO LONGER THAN 30 DAYS

A
147
Q

adsorbents

A

keep powders dry to prevent hydrolysis ex: mg oxide/carbonate, or kaolin

148
Q

coatings can prevent light degredation

A

made from gluten, shellac

149
Q

acacia and PEG are types of emulsifiers (surfactants)

A

gelling agents (gelatin, cellulose, bentonite)

humectant : glycerin, glycerol, propylene glycol, PEG, hyaluronic acid

150
Q

wetting agent

A

mineral oil, glycols, peg, propylene glycol

151
Q

antifoaming agent

A

simethicone, dimethicone

152
Q

avoid alcohol ingredients used as solvents in children

avoid aspartame as sweetener (contains phenylalanine) in phenylketonuria (PKY) cause they cant’ metabolize it

avoid gelatin in those who prefer no pork, hypermellose or cellulose are vegan alt.

acoid

A

avoid gluten in celiac pts, use starch instead

avoid lactulose as a sweetener in pts who have lactose allergy,

avoid preservatives in neonates ex; benzyl alcohol . should always use preservative free.

avoid sorbitol in IBS cause it can cause distress

avoid sucrose in DM or be cautious of amount

avoid xylitol sweetener in dogs (causes liver damager and hypoglycemia) and Gi upset in humans

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