Chapter 15-17: Compounding (NAPLEX) Flashcards

Question

The dots in the image below show the relevant amount of particles in the air. Ambient (room) air is not rated; if it were, most room air would be about ISO 9 (look at pic)

Answer 1

Apart from maintaining ISO air quality standards, ensuring appropriate air pressure differentials between spaces is crucial. Differentials regulate air movement, either containing it within a space or allowing it to flow into adjacent areas. **Positive air pressure is suitable for non-hazardous compounding areas like PECs and SECs**, preventing contamination without toxicity concerns. However, for **hazardous compounding, containment areas like C-PECs and C-SECs require negative pressure to confine toxic air**. Non-sterile hazardous compounding in non-ISO-rated spaces necessitates negative air pressure rooms.

Answer 2

- **Cleanroom suite**: one or more sterile hood (**ISO 5 PECs**) inside an **ISO 7 Buffer Room (SEC)** that is entered thru an adjacent anteroom - **Segregated compounding area (SCA)** with an **ISO 5 PEC**: a sterile hood, often an **isolator** (glovebox) with a closed front, located in a segregated space with **unclassified air**

Answer 3

It's an open front PEC where air flows out in parallel lines from HEPA filter, typically from back of hood (ie horizantal laminar airflow). Laminar airflow keeps cleaner air in PEC from mixing with dirty air in buffer room

Answer 4

it's a closed front PEC often located in the segregated compounding area (SCA). The clsoed front keeps unclassifed room air from mixng with clean air in the PEC

Answer 5

SEC is the room that contains PEC. SEC is sometimes called the buffer area (buffer of relativly clean air of ISO 7 around the PEC which is ISO 5)

Answer 6

SCA is an option when a cleanroom is not able to be installed. It's a designed area with unclassified air, such as a corner of that pharmacy. The max BUD for a CPS made in an SCA is 12 hours (room temp) and 24 hr (fridge)

Answer 7

- Carcinogenic - Teratogenic - Genotoxic - Toxic to organ - labeled by manufactures with special handling instructions

Answer 8

Series of safety documents required by OSHA to be accessible to all employees who are working with hazardous materials/ drugs.

Answer 9

Each facility must have desinated person responsible for creating worker safety procedures for handling hazardous drugs. This include a written plan for implementing safety measures, training, assessing competency, and maintaining documents. . Pharamcies must maintain a list of all HDs stocked, which should be reviewed annually or when new drugs or doseage forms are introduced. . Men and women capable of reproduction must provide written confirmation of their understanding of risk of handling HDs

Answer 10

**USP 797 and USP 800** have different definitions of risk. USP 797 focuses on the risk of contamination of sterile products, while USP 800 considers the risk of harm to workers exposed to hazardous drugs. . **USP 800** has extensive requirements for the safe handling of hazardous drugs, but some activities are considered **lower risk**, such as counting and packaging tablets. Pharmacies can conduct an **Assessment of Risk (AoR)** for lower-risk drugs and develop **Stand Operating procedures (SOPs)** to limit staff exposure. This includes using distinctive shelf bins, wearing appropriate gloves, dedicating counting trays and spatulas, and using sealable bags for prepared hazardous drug containers. If any manipulation of the low-risk hazardous drug is required, full USP 800 requirements must be followed. The AoR documents must be reviewed annually and documented.

Answer 11

1. Biological Safety Cabinets (BSCs): These cabinets have vertical laminar airflow that flows down from a HEPA filter at the top of the hood. They provide negative air pressure to protect the worker from exposure to hazardous drugs. Class II or Class III BSCs are required for sterile hazardous drug compounding. 2. Containment Ventilated Enclosures (CVEs): These are powder containment hoods with HEPA-filtered air and negative air pressure. They are used for non-sterile compounding only. 3. Compounding Aseptic Containment Isolators (CACIs): These closed-front C-PECs, also known as gloveboxes, can be located in a buffer room (C-SEC) but are often placed in a C-SCA.

Answer 12

While it's prefer to keep non sterile and sterile compounding space seperate, exceptions can be made if requirements are met: - C-SEC must maintain ISO 7 - if there are separate sterile amd non sterile C-PECs in the same C-SEC they must be 1 meter apart

Answer 13

**C-PECSs, C-SCAs, and C-SECs** must have negative air pressure

Answer 14

1. Space where non sterile HDs are compounded: at least 12 ACPH 2. Sterile C-SEC: at least 30 ACPH 3. C-SCA: at least 12 ACPH

Answer 15

1. Inital: includes didatic training, hands-on training which is observed by a desinated personin charge of compounding. 2. Continous: on-going training. When work is new or different, the staff must recieve that new training.

Answer 16

The gloved fingertip test is required annually for compounding low- and medium-risk CSPs, or semiannually for high-risk CSPs. The compounder's gloved fingertips are sampled using tryptic soy agar (TSA), which promotes microbial growth if contamination is present. After incubation for 2-3 days, any visible colony-forming units (CFUs) indicate glove contamination. . Passing a gloved fingertip test - inital: passing requires 3 consecutive gloved fingertip samples (with 0 CFU) - Ongoing: at least one sample taken from each hand immediately after completion of media fill test with goal of < 3 CFUs

Answer 17

The media-fill test is used to determine if a compounder is preparing CSPs in an aseptic manner. Test must be done initially and annually for low/med risk level compounding. . Tryptic soy broth (TSB) is taking the place of the drug in the preparation. TSB is a growth medium used by the organisms to replicate. A small Iv bad or vial can be used for the test. Multiple aseptic manipulations (transfers using the same syringe) are done and then the product is incubated and checked for bacterial growth. Turbidity/ cloudiness = contamination!. . Passing test: if the liquid stays clear after 14 days of incudation.

Answer 18

1. Buffer Room (SEC): The SEC should be checked once daily and maintained at a temperature of 20°C (68°F) or cooler. 2. Refrigerator: The refrigerator should be monitored daily, unless it contains vaccines. In that case, monitoring should be done twice daily. The temperature range for the refrigerator should be between 2°C and 8°C. 3. Freezer: If the freezer contains only compounded sterile preparations (CSPs) and no vaccines, the temperature should be maintained between -25°C and -10°C, as per USP 797 guidelines. However, if the freezer also stores vaccines, the required temperature range is -50°C to -15°C, according to CDC guidance.

Answer 19

1. Air sampling: preformed every 6 months 2. Surface sampling: perfromed periodically; areas touched most frequently should be tested at the end of the day. 3. Air pressure: preformed once daily (minimally or with every work shift, to confirm the correct differential pressure between 2 spacesand ensure that airflwo is unidirectional 4. Humidity testing: once daily (minimally)

Answer 20

All PECs and C-PECs should ideally remain operational to maintain clean surfaces. In the event of a power outage, compounding must cease, and PECs require cleaning with germicidal detergent followed by disinfection with sterile **70% isopropyl alcohol** before resuming activity. **C-PECs necessitate a more complex sanitization** process after power restoration. After power restoration, both PECs and C-PECs must be operational for at **least 30 minutes** before compounding resumes.

Answer 21

The PEC undergoes frequent cleaning throughout the day and a final cleaning at day's end before attending to the SEC and anteroom. Lint-free sterile wipes are utilized for cleaning, first with a germicidal detergent followed by 70% IPA disinfection. Pre-soaked wipes or a spray bottle can be employed, avoiding spraying inside the PEC. Cleaning involves unidirectional strokes with overlapping coverage, changing wipes regularly. PECs are cleaned from top to bottom, back to front . This means that the cleanest areas will be cleaned first, and the dirtiest areas will be cleaned last .

Answer 22

All areas and equipment handling Hazardous Drugs (HDs) require daily sanitation, involving deactivation, decontamination, and cleaning. Sterile compounding areas and equipment are disinfected last to prevent HD residue spread. **Wetted wipes** are preferred over spray bottles to avoid aerosolizing HD residue. Workers must **wear appropriate PPE**, including NIOSH-approved fit-tested respirators when opening containment devices. Commercial kits like Peridox RTU simplify the process, while bleach or peroxide can be used, but bleach may corrode stainless steel surfaces, necessitating neutralization with sodium thiosulfate or other agents. All HD-handling areas (receiving, compounding, administering, disposal) and reusable equipment must undergo routine **deactivation, decontamination, and cleaning** per USP 800 guidelines, with immediate decontamination required for spills.

Answer 23

Immediate action is crucial when a staff member experiences exposure, whether to a non-Hazardous Drug (HD), a workplace chemical, or an HD. The first 10 to 15 seconds post-exposure are critical. Urgent steps include removing the drug or chemical from the person promptly. Emergency protocols should be readily available in the pharmacy. Key actions to take include: -Removing contaminated garments. -Cleansing affected skin with soap and water. -Flushing eyes with water or an isotonic eyewash for at least 15 minutes. -Seeking medical attention as needed. -Documenting the exposure in the employee's record.

Answer 24

When unpacking Hazardous Drugs (HDs) without plastic containment, staff should wear an **elastomeric half-mask with a multi-gas cartridge and P100 filter** until packaging integrity is confirmed. While an **N95 respirator** is sufficient for most HD compounding, it doesn't protect against gases, vapors, or liquid splashes. Respiratory protection is necessary during direct HD exposure, such as: -Cleaning up spills requiring more supplies than provided by a spill kit. -Deactivating, decontaminating, and cleaning beneath the work surface of a C-PEC. -Known or suspected airborne exposure to HD powders or vapors. -Disposal of PPE contaminated with trace amounts of HDs. . For respiratory exposure risks, wear either a fit-tested respirator mask with attached gas canisters or a **powered air-purifying respirator (PAPR)**, which blows filtered air to the user. PAPRs are more comfortable but require a charged battery for proper operation.

Answer 25

When administering Hazardous Drugs (HDs), appropriate Personal Protective Equipment (**PPE**) is essential. Two pairs of **chemotherapy gloves** are necessary for all HD administrations. A **chemotherapy gown is required for IV HDs** and recommended for other routes (e.g., oral). **Closed-system drug transfer devices (CSTDs)** should be utilized during drug administration if available, along with chemotherapy pins to prevent aerosolization during reconstitution and administration. Closed-system transfer devices are encouraged to contain HDs during transfers, reducing leaks and spills. Avoid manipulating oral HDs whenever possible; if necessary, do so in a plastic bag to contain particles.

Answer 26

All Personal Protective Equipment (PPE) used during handling of Hazardous Drugs (HDs) is considered contaminated with trace amounts. Outer chemotherapy gloves worn during compounding are disposed of in a yellow trace chemotherapy waste bin inside the C-PEC or sealed in a bag if discarded outside. Remove outer gloves before handling and labeling compounded HDs. **Trace antineoplastic waste** (e.g., empty vials, syringes, IV bags, gloves, gowns, pads) is discarded in a **yellow container** for incineration.**Bulk antineoplastic waste**, including unused or partially empty IV bags, syringes, and vials, is disposed of in a **black container** for incineration.

Answer 27

Appropriate PPE is essential throughout HD handling processes, including receiving, storage, transportation, compounding, administration, sanitation, and spill control. Double ASTM D6978-rated (chemo rated) gloves are required for compounding and spill cleanup, while single gloves suffice for receiving and storage.

Answer 28

■ Double gloves, a gown, a mask and ■ A disposable pad to protect the work surface

Answer 29

■ Head covers, a face mask and (if applicable) beard covers ■ Two pairs of shoe covers ■ A gown impermeable to liquids ■ Two pairs of ASTM D6978(chemotherapy)-rated gloves ■ A full-facepiece respirator or a face shield with goggles when there is a risk for spills or splashes

Answer 30

1. Remove coats, rings, watches, bracelets, and makeup before entering the ante area. Artificial or long nails are not permitted. No makeup is allowed due to shedding. 2. Don head and facial hair covers, face masks, and shoe covers upon crossing the line of demarcation. Use a second pair of shoe covers for compounding HDs. Verify hair coverage using a mirror in the ante area. 3. Perform hand hygiene with soap and warm water, focusing on cleaning under fingernails and vigorously washing hands and forearms for 30 seconds. Dry with lint-free disposable towels. 4. Don a non-shedding gown that fits snugly around the wrists and has a neck enclosure. Disposable gowns are mandatory for HD compounding and preferred for non-HD compounding. Launder reusable gowns before reuse. 5. Enter the buffer area (SEC) and apply an alcohol-based surgical hand scrub for the recommended duration. Consider alternative options like povidone-iodine if allergic to chlorhexidine. 6. Don sterile, powder-free gloves, with two pairs of ASTM D6978-rated gloves required for compounding HDs. Tuck one pair under gown cuffs and place the second pair over cuffs. Routinely sanitize gloves with 70% IPA during compounding. 7. Ensure all garb is used when compounding with an isolator (glove box) unless the manufacturer states otherwise. 8. When leaving the compounding area, dispose of all garb except the gown if not visibly soiled. The gown can be kept on the clean side of the ante area for reuse within the shift but cannot leave the area. Replace all other garb and repeat hand hygiene upon re-entering the compounding area.

Answer 31

A graduate cylinder has the same diameter from top to bottom - which is more accurate than a conical graduate which has a wider mouth (making it easier for glass rod to mix) but the wider mouth has lower accuracy. . Some important things to consider/ keep in mind mind: - a graduate should not be used to measure volume **less than 20% of the graduates capacity** = higher error - To read volume must be view at **eye level** - The liquid can curve downward from both sides = this is called **meniscus** - The **bottom of the meniscus** (at the center) is the true volume!

Answer 32

- syringes are more accurate for smaller volumes - useful for measuring viscous liquids - If patient needs a VERY accurate dose, should use syringe - all syringe packages should be wiped off with isopro alcohol 70% - Recapping needles can lead to needle stick injuries. So in general, DO NOT recap syringes! It is preferred to use syringes with safety features

Answer 33

Pipettes are thin plastic/ glass tubes used to measure small volumes. . A volumetric pipette draws up a set volume only, which is the amount a pipette can hold . A mohr pipette is graduated and is used to measure different volumes

Answer 34

Older and not as common. These have sensitivity requirments and need calcualtion for the minimum weighable quantity (the amount that can be weighed) is calculated based on the **sensitivity requirement and the acceptable error rate (typically 0.05 or 5%)**

Answer 35

More commonly used. This balance is simple to use/ has higher sensitivity . When using, must remember to zero out (tare) the balance after placing a boat to ensure that you are only measuring the ingredients

Answer 36

1. Glass Mortar: used for **liquids** (suspension/ solutions) that are oily and can statin 2. Wedgewood mortars: have a rough surface + preferred for grinding **dry crystals/ hard powder** 3. Porcelain mortars: smooth surface and are preferred for belding **powder/ pulverizing gummy** consistancy

Answer 37

Mixing can be done manually or with electric mixing equipment, which speeds up the process. Ointment mills, homogenizers, and grinders are used to mix ingredients. **Ointment mills and grinders** reduce particle size, increasing the surface area and rate of drug absorption. Ointment mills draw the preparation between rollers to grind and homogenize the ingredients. Homogenizers, similar to powerful blenders, are used to mix ointments and creams. They can be handheld and come in brands like Unguator, PharmaRAM, or Mazerustar Mixer. **Electric grinders**, similar to coffee bean grinders, can be used to grind hard tablets, but they should only be used for compounding purposes.

Answer 38

A **hot plate with a magnetic stirrer** can save time by continuously stirring the mixture to dissolve and mix the ingredients. **The stirrer** has a **rotating magnet** under the ceramic plate, which moves the stir bar inside the glass to spin and stir the components. Hot plates can also be used without the stir bar for heating purposes, and a glass stirring rod can be used to mix contents manually. . **Hot plates** provide direct heat to soften and melt ingredients, and they can be used with a water bath to carefully control the temperature and prevent burning. The water bath involves placing the container with the ingredients into a larger container filled with water, which acts as a barrier between the direct heat source and the ingredients.

Answer 39

Tablet -A tablet press is two plastic or metal plates used to compress damp powder into tablets . Capsule - capsules can be soft gel or hard shells. The shells are made from gelatin (which is pork derived) or hypromellose (plant derived). Capsules sizes used for human ranges from 000 (largest) to 5 (smallest)

Answer 40

Surfactants are used in preparations like salad dressings to prevent the separation of different phases, such as oil and water. When shaken, the oil and water in salad dressing quickly separate because of the high tension between their surfaces. **However, adding a surfactant lowers this tension** and keeps the phases from separating. **Surfactants work by reducing the surface tension between the ingredients**, making them more miscible and easier to mix together. They can form micelles, where the oil interacts with the lipophilic end of the surfactant and the water interacts with the hydrophilic end. Surfactants can also use other mechanisms, such as forming a film between the surfaces or creating an electrically-charged layer to keep the phases separate. In all cases, surfactants help with the preparation and stabilization of substances.

Answer 41

**1. Wetting Agents:** susbtance use to lower surface tension between liquid and solid, allowing liquid ti spread more easily. They are used to wet fine powder before mixing it in to suspension, creating a thick paste **2. Emulsifiers:** An emulsion is a mixture of two or more liquids which are not blendable (immiscible). Emulsifer is added to keep the liquid droplets dispersed throughout the liquid vehicle **3. Suspending Agent:** A suspension consists of solid particles dispersed in a liquid, like amoxicillin powder in water. Suspending agents are added to prevent settling, but they don't prevent separation for long. Before use, suspensions must be shaken to redistribute the solid. These agents can also be called dispersants or plasticizers, like sorbitol, which aids in shaping gelatin capsules.

Answer 42

**1. Levigating Agent**: Levigating agents, like glycerin or mineral oil, aid in grinding particles down in a process called levigation. Unlike trituration, which doesn't involve liquids, levigation uses these agents to facilitate grinding. **Mineral oil** is preferred for **lipophilic compounds**, while **glycerin** or propylene glycol are used for **water-soluble compounds**. **2. Foaming Agent**: Foaming agents reduce water's surface tension for foam formation, as in soap. Surfactants, like detergents, utilize this to clean dirt. In non-sterile compounding, anti-foaming agents like simethicone are used to control excessive foam.

Answer 43

the number determines the type of surfact required to make emulsion. The # ranges from 0-20. Lower HLB = more lipid soluble and Higher HLB is more H20 soluble. . Examples of sufactants and their HLB - Gyceryl monostearate: 3.8 - Polyox. monooleate: 11.4 - Sorbitan tris: 2.1

Answer 44

1. Oxidation-Reduction 2. Hydrolysis 3. Photolysis

Answer 45

**Oxidation involves the loss of electrons, while reduction involves gaining electrons**; these reactions occur simultaneously in redox reactions. Some drugs, like epinephrine, exhibit visible color changes during oxidation. Compounds with **hydroxyl groups directly bonded to aromatic rings, such as catecholamines and phenolics**, are prone to oxidation. For instance, epinephrine oxidation leads to an amber color.

Answer 46

1. light protection: amber class 2. Adequate Storage: fridge if needed 3. Chelating agents: There are free redical which can catalyze oxidation change reaction..chealating agents prevent this! Common chelators = EDTA 4. Antioxidants (free radical scavengers): vitamin C/ E 5. Control pH

Answer 47

Hydrolysis occurs when water cleaves bond between molecule. Common fuctional groups tha tcan be hydrolyized = ester, amides, lactams

Answer 48

compounds should be protected from moisture/ h2o, and other factors = light protection, metal ions, and changes in pH, and temp changes

Answer 49

Many drugs are sensitive to UV light exposure, which causes photolysis (breakage) of covalent bonds and drug degrade. This can be prevented by light protect. . Compounds that can likely be degraded by light: ascorbic acid, folic acid, nitropusside, and phytonadine

Answer 50

1. Binders: sugar, syrup, starch paste 2. Fillers: lactose, starches, petrolum 3. Disintegrants: starches, cellulose products 4. Flavoring 5. Lubricants: talc, oils 6. Preservatives: EDTA, parabens 7. Buffers

Answer 51

1. Water (sterile/ non sterile) 2. Alcohols 3. Glycerol (PEG) 4. Fat/ oils (hydrophobic)

Answer 52

1. Alcohol: children 2. Aspartame: this contains phenylalanine, so avoid in Phenylketonuria (PKU) - these patients cannot metabolize it 3. Gelatin - vegans/ vegtarians or anyone wishing to aovid pork 4. Lactose - lactose allergies

Answer 53

1. Preservatives (Benzyl alcohol): neonates 2. Sorbital (used as sweetener): IBS 3. Sucrose (table sugar): DM 4. Xylitol (used as sweetener): cannot use in DOGS! and can irritate GI in humans

Answer 54

Two crucial records for compounded products are the **master formula record** and the **compounding log**. **The master formula record serves as the recipe for compounding, while the compounding log documents all products made at the pharmacy in detail**.

Answer 55

Before compounding, the pharmacist assesses the prescription's suitability for the patient and the proposed formulation's stability and palatability. Standard **initial steps** involve equipment calibration and ingredient weighing. **Final steps** typically include packaging and quality control. However, the specific steps between these stages vary based on the formulation type. Quality ingredients are essential for a quality product, and it's imperative to review **Safety Data Sheets** for each ingredient to ensure staff safety and determine necessary personal protective equipment.

Answer 56

**1. Trituration**: Trituration is a process of thorough mixing to achieve homogeneity. It commonly involves grinding tablets with a mortar and pestle until a fine powder is obtained. However, trituration can also apply to liquids, such as shaking to triturate an emulsion. **2. Levigation and Spatulation:** Levigation incorporates a small amount of liquid, called a levigating agent or wetting agent, into the powder while triturating with a mortar and pestle. This process transforms the solid into a uniform paste. Spatulation, similar to levigation, is performed on an ointment slab using a spatula instead of a mortar and pestle. **3. Pulverization by Intervention:** This method is employed for crystalline powders resistant to crushing. Crystals are dissolved in a solvent and mixed until the solvent evaporates. Upon recrystallization, the particles become finer and easier to handle.

Answer 57

a method of mixing ingredient to ensure everything is evenly distributed in a diluent or delivery vehicle. A small amount of drug is mixed into an equal amount of dilutent...after the inital small amount is mixed...another equal amount of ingredients are mixed in again...and repeat !

Answer 58

A Solute dissolved in solvent (ie. NaCl dissolved in water)...Homogenous! . Include: Syrup, Elixirs, Tinctures (plant or animal extracts), Spirits (alcohol)

Answer 59

**Emulsions** is a liquid dispersed in liquid. It is a 2 phase heterogenous mixture...Emulsions are oil in water or water in oil...An emulsifier is a type of surfactant that is used to reduced surface tension 2 liquids (oil and water). To make an emulsion the emulsifier will need to be carefully picked according to the **hydrophillic lipophilic balance (HLB) number**

Answer 60

is a solid dispersed in a liquid...it is 2 phases - heterogenous. A wetting/ levigating agent is a type of surfactant used to incorporate an insoluble drug into liquid- which makes a suspension - redispered by shaking it!

Answer 61

when dispersed phase settles (clumps) together...this can happen with suspension and emulsions! so gently shake or roll to re-dispersed

Answer 62

1. prep the ingredient and reduce particle size to form a fine powder...initial step should be to determine if solute (drug) will dissolve in solution..drug should ramine soluble even at dif temp..if drug is not soluble in water? then a suspension or dif solvent is prefered. 2. Dissolution rate can be used to determine time it will take for solute to dissolve = Ficks First Law of Diffusion ( larger surface area "smaller particle" , stiring, and using heat will increase dissolution rate! 3. Solution may beed buffer system, preservative, flavoring, coloring, etc

Answer 63

1. Prep ingredients and reduce drug to fine powder. 2. Wet the powder, and levigate to form paste 3. Continue to add liquid in portions 4. Add a surfactant to help keep suspension dispersed 5. Transfer mixture to conical graduate or container in which it will be dispensed and QS to final volume..A homoginizer will help make a uniform suspension...a preservative may be needed as well as flavoring and such....suspension will need to be redispered/ shaken prior to use

Answer 64

Emulsion can be made by either continental or english gum method; mixing oil, water, an emulsifier (gum) in a 4:2:1 ratio

Answer 65

1. Levigate gum with oil 2. Add the water all at once! 3. Triturate by shaking in a bottle or mixing in a mortar until cracking sound is heard and mixture is creamy white 4. Add other ingredients by dissolving them first in solution and adding a quantity of water to make (QS) up to final volume 5. Homogenize (with a homogenizer machine)

Answer 66

1. Triturate the gum with water to form a mucilage (thick/sticky like mucus) 2. Add oil slowly while shaking or mixing 3. Add other ingredients as in dry gum method

Answer 67

1. Glidant/ Lubricant (Mg Stearate) to improve flow 2. Surfactant (sodium lauryl sulfate) to neutralize static charges and keep powder from floating away!

Answer 68

1. Triturate the dry ingredients and geometrically mix with the fillers/ other excipients..Powder is put into capsule by either hand filling ("Punch Method") or by using capsule filling machine . HAND FILLING/ PUNCH METHOD: powder is placed on powder paper or ointment slab. Pile of powder is smoothed with spatula to a height that is 1/3 of the length of capsule. The open end of capsule is "punched" into pile of powderuntil capsule is filled. Then fitted with the cap . MANUAL CAPSULE FILLING MACHINE: Small devices that load 50, 100 or 300 capsules. Plate help sort capsule body and hold them upright..the plastic spreader is used to move powder into them. the ncap is put on capsule

Answer 69

Molded tablet = most common in COMPOUNDING . Compressed tablet = most common in MANUFACTURING

Answer 70

1. Triturate the dry ingredients and mix by geometric dilution. Alcohol and/ or water should be added to moisten powder 2. Pasty consistency = molded into tablets using molds 3. allowed to dry 4. coloring and coating may be added

Answer 71

Hard lozenges: sucrose or syrup . Soft lonzenges: Polyethylene glycol (PEG) . Chewable lonzenges: glycerin or gelatin

Answer 72

Lotions contain the most water, Ointment contain the least water, cream is in the middle

Answer 73

1. Powders should be triturated well, using levigating agent (levigating agent must be miscible with base) 2. The powder will be mixed into the ointment base, using geometric dilution 3. Certain ointment will require heat in order to mix the components together well (aka fusion method) - a water bath used to heat ointment will help prevent overheating

Answer 74

Poloxamer (Pluronic) lecithin organogel - can be used for transdermal drug admin. . It contains hydrophobic chain with 2 hydrophillic chains so it can be use for both hydrophillic/ hydrophobic drug delivery . it's liquid when refrigerated...and it forms a gel at room temp! changes form based on the temperature (i.e., thermoreversible)

Answer 75

Oil-soluble base: cocoa butter (theobroma oil), hydrogenated veggie oil . water-soluble base: PEG and gelatin

Answer 76

melts easiliy! mold need to be stored in fridge! Also, will melt in hand so need to be sotred in fridge before using!

Answer 77

used when only a few suppositories needed to be prepared using cocoa butter base. . Cocoa butter is not melt but it is grated and mized with drug in pestle/ mortar or on pill tile with spatula. The mass is rolled and cut into suppository pieces

Answer 78

Commonly used. . Base is gently heated, the ingredients are added, the mixture is poured into ROOM TEMP molds + left to harded (pouring into cold mold can cause suppository to crack and split). If suppository does not harden it can be put in fridge.

Answer 79

Will need to know the weight of each mold and drug's DENSITY FACTOR! . Amount of base is calculated, grated, mixed with drug, put into cold compression mold

Answer 80

Not later than 6 months (180 days). Store at room temp. . Eg. Diclofinac powder in PEG, progestrone suppository in oleginous base, topical prep of zinc in white petrolatum)

Answer 81

Not later than 14 days when stored at controlled cold temp. Store in fridge. . Eg. APAP oral suspension, nystain in strawberry flavored popsicles with purified water solution

Answer 82

Not later than 30 days stored at room temp . Eg. Calamine powder prepared with glycerin in 70% isopropyl alcohol for poison ivy; Lidocaine and diphenhydramine in poloxamer gel with lecithin/isopropyl palmitate; Ciprofloxacin and dexamethasone in Versabase lotion

Answer 83

Reducing particle size of substance into a fine power

Answer 84

Trituration in a mortar with a pestle or spatula on an ointment slab with a small amount of liquid in which the substance is insoluble to make a paste

Answer 85

Blending powders or substances on an ointment slab with a spatula

Answer 86

Crystals are dissolved in solvent and the nspread out on surface where solvent evaporates and the substance then recrystallized into smaller particles

Answer 87

diluent, disintegrate

Answer 88

Coating, dilutent, gelling agent

Answer 89

dilutent, sweeting agent, humectant, levigating agent, lubricant

Answer 90

dilutent, sweetener

Answer 91

Gildant, Lubricant

Answer 92

Levigating agent, lubricant

Answer 93

Hydrophilic solvent, levigating agent, lubricant, suppository base

Answer 94

humectant, levigating agent

Answer 95

Dry diluent, disintergrate, gelling agent

Answer 96

Coating, enteric coating

Answer 97

- **Purpose**: keep powder dry - **Ex**: Mg Oxide/carbonate; Kaolin

Answer 98

- **Purpose**: breaks up/ inhibit formation of foaming - **Ex**: Simethicone, Dimethacone

Answer 99

- **Purpose**: prevents oxidation - **Ex**: Ascorbic Acid, ascorbyl palmitate, vitamin E

Answer 100

- **Purpose**: Adhesive material used to hold powders together - **Ex**: Acacia, starch paste, sucrose syrup

Answer 101

- **Purpose**: Maintain pH range - **Ex**: Potassium phosphate, Sodium acetate/ citrate

Answer 102

- **Purpose**: Prevents degradation from light, oxygen, and moisture and mask bad taste - **Ex**: gelatin, gluten, shellac

Answer 103

- **Purpose**: Provides color - **Ex**: RD&Red No.3; Yellow No. 6; Caramel, Ferric Oxide (red)

Answer 104

- **Purpose**: adds volume to smaller doses - **Ex**: Liquid - water, glycerin, alcohol; Dry - starches, calcium salts, lactose (mannitol, sorbitol), cellulose, gelatin; Topical: mineral oil, petrolatum, lanolin

Answer 105

- **Purpose**: absorbs water to cause tablet to swell or burst - **Ex**: Alginic acid, polacrilin potassium (Amberlite), cellulose, starches/ compressible sugar (Nu-Tab)

Answer 106

- **Purpose**: Acid resistent protective layer that prevents dissolution in stomach - **Ex**: cellulose acetate phthalate, shellac

Answer 107

- **Purpose**: Give sweetness - **Ex**: Syrup, oils; sugercoating for tabs with sucrose and glucose; sugar free option: aspartame. saccharin; glycerin; dextrose; mannitol; sorbitol; phenylalanime, stevia, xylitol

Answer 108

- **Purpose**: increase viscosity - **Ex**: Agar, gums (guar, acacia, xantham); gelatins, tragacanth; bentonite, carbomer, cellulose, starches, Mg aluminum (Veegum); Poloxamer gels, polyvinyl alcohol (eye drops)

Answer 109

- **Purpose**: Improves flow of properties of the powder mixture by reducing friction - **Ex**: Mg stearate; colloidal silica

Answer 110

- **Purpose**: Prevents preparations from becoming dry - **Ex**: Glycerin, sorbitol, propylene Glycol

Answer 111

- **Purpose**: Liquid with high miscibility with water; use to dissolve solute - **Ex**: PEG, Alcohol, terpenes

Answer 112

- **Purpose**: Liquid with low miscibilioty with water; used to dissolve solute - **Ex**: Oils (borage, canola, coconut, castor); Fats (omegas)

Answer 113

- **Purpose**: Liquid used in process of reducing particle size ( to make paste!) - **Ex**: PEG, Mineral oil, glycerin, glycols

Answer 114

- **Purpose**: acts as a barrier and a vehicle for drug delivery (oleaginous - oil containing; aqueous - water-containing; water in oil or oil in water emulsion) - **Ex**: aquaphor, aquabase, vaseline, petroleum jelly (petrolatum), polybase, eucerin, cetaphil

Answer 115

- **Purpose**: Prevents ingredients from sticking to each other and equipment - **Ex**: Mg stearate; calcium; PEG; talc; mineral oil; glycerin; stearic acid

Answer 116

- **Purpose**: prevent bacterial/ pathogen growth - **Ex**: Oral (parabens; sodium benzonate; benzonic acid) Topical/nasal (alcohols, acids, chlorhexidine); Opthalamics (EDTA. sodium benzonate, benzonic acid, benzalkonium chloride, thimerosal

Answer 117

- **Purpose**: Stay intact for insertion but melts once inserted - **Ex**: cocoa butter (theobroma oil); veggie oil; PEG polymers; Glycerinated gelatin

Answer 118

POSITIVE! This will help protect the compounded sterile product (CSP) from contamination

Answer 119

NEGATIVE pressure! To contain and exhaust the toxic air in the space..Negative pressure protects the staffs

Answer 120

LAFW - open front PEC, air flows out parallel from HEPA which is in the BACK of the hood - horizontal laminar airflow. . CAI - closed front PEC...can be located in SEC but it's usually located in SCA! ...ie. Glove box!

Answer 121

Determines whihc drugs are hazardous

Answer 122

1. Mifepristone, Misoprostol 2. Chloramphenicol 3. Warfarin 4. Fluconazole, Voriconazole 5. Literally all chemo/ transplant drug 6. Abacavir, Entecavir, Zidovudine 7. Cidofovir, Ganciclovir, Valganciclovir 8. Isotretinoin 9. Dronedarone 10. Acitertin, Azathioprine, Leflunomide, Fingolimod 11. Finasteride, Dutasteride 12. Pamidronate, Zoledronic Acid 13. Dexrazoxone 14. Paroxitine 15. Exenatide, Liraglutide 16. Clobazam, Clonazepam, phenytoin, topiramate, etc...SZ drugs 17. Colchicine 18. Ivabradine, spirnolactone 19. Ribavirin 20. Hormone agents 21. Methimazole, Propylthiouracil 22. PAH drugs 23. ....etc

Answer 123

Series of safety documents reported by OSHA to be made accessible to all employee who are working with hazardous drug..provide drug specific safety infoincluding: PPE, first aid, spill clen up procedures

Answer 124

ISOTONIC to human blood! with osmol: ~285 mOsm/L

Answer 125

- only required items can be placed in hood - work must be done within the sterile hood at least 6 INCHES from front to prevent ISO5 hood air from mixing with ISO7 air from buffer - Place all items side-by-side - Nothing should be between the sterile object and the HEPA filter in a horizontal airflow hood - DO NOT tear open components (open along seal)

Answer 126

- for greatest accuracy - use smallest syringe that can hold desired amount - Powders are reconsitituded by introducting a dilutent like sterile water for injection - swab the rubber top of vial with 70% IPA - Inject a volume of air equal to volume of fluid to be removed (DO NOT INJECT AIR PRIOR TO REMOVING HAZARDOUS DRUG! negative pressure / close system transfer to be used) - puncture rubber top with bevel up at 45 degree. then bring needle straight up to 90 degree while penetrating stopper , empty air, then invert vial - Volume is measured between rubber piston and side of syringe barrel . Coring can occur when small peice of rubber aspirate into needle! So inspect that shit ... if med is from glass ample...break neck away from you and use a filtered needle...needled must be changed out before injecting syringe into IV bag

Answer 127

Should verify tha tthe correct volume of product is in the syringe before compounding. This is the safest method cuz the pharmacist can see the actual volume in the syringe.....Pull back method? that's verifying empty syringe after compounding is done...NOT RECOMMENEDED! CUZ THIS RELIES ON MEMORY! . Finished CSP are visually inspected agaisnt dark background, for particulates, cored pieces, cloudiness/ precipitates....lightly squeeze to check for leak

Answer 128

For CSPs that are compounded with any non-sterile ingredients. Methods include: Autoclave (steam), dry-heat, gas sterilization, and ionizing radiation. DO NOT USE HEAT FOR HEAT SENSITIVE DRUGS (ie Insulin, protiens, hormones - yes levothyroxine is a hormone)

Answer 129

CSP that are heat labile (protiens/ hormones) can be sterilized with filtration using 0.22 micron filter! . If filtering is used...need to do bubble point test = this test uses pressure to force liquid to "bubble" out of filter to test for FILTER INTEGRITY

Answer 130

The reagent for the bacterial endotoxins test (BET) is called the Limulus Amebocytes Lysate (LAL)

Answer 131

Immediate Use: Prep in emergency!!! THE HIGHEST OF RISK! . Category 1 (high risk): CSP prepared in ISO 5 PEC in SCA (glovebox) . Category 2: CSP prepared in cleanroom suite (ISO 5 PEC in ISO 7 SEC) . Category 3 (Lowest risk): CSP prepared in cleanroom suite (ISO 5 PEC in ISO 7 SEC) + additional requirements (eg. sterility testing required, enviromental monitoring, personnal requirement, etc)

Answer 132

- name/ amount of each ingredients - total volume - dosage form/ route - BUD - ID #/ barcode - Storage requirement - auxillary and or warnings

Answer 133

1. remove coats, rings, watches, makeup, bracelets (long nails/ nail polish not allowed) 2. Don head/ feet garb; apply head/ facial hair cover + face mask 3. Apply shoe cover (one at a time while stepping over line of demarcation) 4. wash hands with soap for 30 sec; wash up to elbow!/ under nails + dry with low lint towel 5. Don low lint gown (can be reused! in same shift) 6. Apply alcohol rub to hands 7. Apply sterile/ powder free gloves

Answer 134

Gowns must be changed per the manufacturer’s schedule. If no information is provided, gowns should be changed every 2–3 hours and immediately after a spill or splash. Since the shift is 12 hours and the gown must be changed at least every 3 hours, a **minimum of 4 gowns** will be needed during the shift.

Answer 135

An alternative option to an external exhaust for non-sterile, hazardous drug compounding is to use **redundant HEPA filters**. This is not an option for sterile hazardous drugs, which must be externally vented.

Answer 136

Activities that do not require manipulation, such as counting and packaging, can be covered under an AoR. If manipulation is required, the full USP 800 requirements must be followed.

Answer 137

performed routinely (e.g., initially as a benchmark and at least every **6 months**).

Answer 138

While compounding hazardous drugs, gloves should be changed **every 30 minutes** and additional times if torn, punctured or contaminated

Chapter 15-17: Compounding (NAPLEX) Flashcards

(169 cards)