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NAPLEX EXAM WITH QUESTIONS AND ANSWERS ALREADY GRADED A T or F. Beyond use date must be applied to each compounded product using USP 795 guidelines for Nonaqueous Liquids and Solid formulation and for Water-containing Formulations. - ANSWERTrue Which of the following is considered with Non-Sterile Preparation? A. USP 795 B. USP 797 - ANSWERA Labels on Pharmacy-compounded products - Expiration Dates (Beyond Use Dates) - ANSWER* Water containing oral formulations * The beyond use date is no later than 14 days when stored at controlled cold temperature * Water containing topical/dermal/mucosal liquid and semisolid formulations * The beyond use date is no later than 30 days * Nonaqueous formulations* The beyond use date is no later than the time remaining until the earliest expiration date of any API (use no later than 25% of time of this api) or 6 months, whichever is earlier T or F. For capsules, the label must include mcg or mg/capsule? - ANSWERTrue - Does not require for tablet T or F. You can rinse compounding equipment with tap water? - ANSWERFalse - you can only rinse Purified water for rinsing equipment What is the best certified sterile compounding environment for injectable product? Which ISO? - ANSWERISO class 5 (class 100) laminar air flow hood within ISO class 7 (class 10,000) clean room * with positive air pressure * differential relative to adjacent areas. ISO class 5 (class 100) clean room with positive air pressure differential relative to adjacent areas or a barrier isolator that provides a ISO class 5 (class 100) environment for compounding T or F. Liquids in a container curve up, therefore measure at the top of the meniscus. - ANSWERFalse. Must measure at the bottom of meniscus What is the difference between glass and Wedge-wood/Porcelain(ceramic) Mortar and Pestle? - ANSWERwedge-wood or porcelain is used commonly and is best for reducing particle size of dry powders and crystals Glass is used for liquids or chemical that are oily or that will stain to the porcelain T or F. It is safe not to use ointment paper to prepare creams and lotions because these two formulation have the highest content of water. Water content will cause the paper to moisten, and possibly tear. - ANSWERTrue. we can use Glassine weighing paper Which of the following levigating agents are the best to prepare aqueous systems (O/W dispersions)? A. Glycerin B. Mineral oil C. Castor oil D. Cottonseed oil E. Tween 80 - ANSWERA. Glycerin Rest are good levigating agents used to prepare oleaginous systems (W/O) Additional agents used as levigating agents to prepare aqueous systems consist of Propylene glycol, polyethylene glycol 80 Sometimes heat is used to mix things easier, but it lead to over-heating which produce undesired chemical-reactions. What is the best way to prevent over-heating? - ANSWERA water bath will help prevent over-heating Fill in the blank ........................ refer to a compound prepared without a specific formula (not from an official compendium) and made specifically to fill the needs of an individual patient - ANSWERExtemporaneous Fill in the blank ...................... a single agent that is used to soften and smooth the skin. A moisturizer is sometimes referred to as ................, but the term ............ is used for single agent, and moisturizers often have coloring, scents, and other ingredients added - ANSWEREmollients Fill in the blank Oil in water , or water in Oil is example of ....... - ANSWEREmulsions Fill in the blank ............ Is used to stabilize the emulsion. ........... are usually surfactants (wetting agents) that reduce the surface tension between the two liquids so that the two different substances can move close to each other but they will not be mixed together - ANSWEREmulsifiers What is the difference between Continental or dry gum method and English, or wet gum method? - ANSWERBoth have same ingredients (oil, purified water and gum (such as acacia) in the ratio of 4:2:1 but the order of mixing is different. Dry method: gum is mixed rapidly with oil then water added all at once Wet method: gum is dissolved in water first, then oil is slowly added What you know about HLB (hydrophilic-Lipophilic balance) number? - ANSWER#s range from 0-20 with 10 being the mid-point means it is the break point between water and oil solubility. #10 means hydrophilic (water-soluble) and #10 means lipophilic (lipid-soluble) What is Eutectic Mixture? - ANSWERA eutectic mixture is two or more components that melt at a temperature lower than the melting temperature for the individual components. Which of the following are common preservatives? A. Benzalkonium chloride (BAK) B. Benzyl alcohol C. Chlorhexidine D. Thimerosal (contain mercury) E. Sodium benzoate F. Benzethonium chloride G. propylparaben - ANSWERAll of them Why preservative-free formulations if there is no harm from multi-dose vials? - ANSWERno scientifically conclusive evidence exists of harm from exposure to thimerosal preservative-containing vaccine, whereas evidence is accumulating of lack of any harm resulting from exposure to such vaccines. Therefore, the benefits of influenza vaccination outweigh the theoretical risk, if any, for thimerosal exposure through vaccination" (MMWR 54 [RR08]: 1-40, 2005). Nonetheless, FDA is in discussions with manufacturers of influenza vaccine encouraging them to further increase the supply of preservative-free formulations.

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NAPLEX EXAM WITH QUESTIONS AND ANSWERS ALREADY
GRADED A

T or F. Beyond use date must be applied to each compounded product using USP 795 guidelines for
Nonaqueous Liquids and Solid formulation and for Water-containing Formulations. - ANSWER>>True



Which of the following is considered with Non-Sterile Preparation? A. USP 795 B. USP 797 - ANSWER>>A



Labels on Pharmacy-compounded products - Expiration Dates (Beyond Use Dates) - ANSWER>>* Water
containing oral formulations *

> The beyond use date is no later than 14 days when stored at controlled cold temperature

* Water containing topical/dermal/mucosal liquid and semisolid formulations *

> The beyond use date is no later than 30 days

* Nonaqueous formulations*

> The beyond use date is no later than the time remaining until the earliest expiration date of any API
(use no later than 25% of time of this api) or 6 months, whichever is earlier



T or F. For capsules, the label must include mcg or mg/capsule? - ANSWER>>True - Does not require for
tablet



T or F. You can rinse compounding equipment with tap water? - ANSWER>>False - you can only rinse
Purified water for rinsing equipment



What is the best certified sterile compounding environment for injectable product? Which ISO? -
ANSWER>>ISO class 5 (class 100) laminar air flow hood within ISO class 7 (class 10,000) clean room *
with positive air pressure * differential relative to adjacent areas.

ISO class 5 (class 100) clean room with positive air pressure differential relative to adjacent areas or a
barrier isolator that provides a ISO class 5 (class 100) environment for compounding



T or F. Liquids in a container curve up, therefore measure at the top of the meniscus. - ANSWER>>False.
Must measure at the bottom of meniscus

,What is the difference between glass and Wedge-wood/Porcelain(ceramic) Mortar and Pestle? -
ANSWER>>wedge-wood or porcelain is used commonly and is best for reducing particle size of dry
powders and crystals

Glass is used for liquids or chemical that are oily or that will stain to the porcelain



T or F. It is safe not to use ointment paper to prepare creams and lotions because these two formulation
have the highest content of water. Water content will cause the paper to moisten, and possibly tear. -
ANSWER>>True. we can use Glassine weighing paper



Which of the following levigating agents are the best to prepare aqueous systems (O/W dispersions)?

A. Glycerin B. Mineral oil C. Castor oil D. Cottonseed oil E. Tween 80 - ANSWER>>A. Glycerin

> Rest are good levigating agents used to prepare oleaginous systems (W/O)

> Additional agents used as levigating agents to prepare aqueous systems consist of Propylene glycol,
polyethylene glycol 80



Sometimes heat is used to mix things easier, but it lead to over-heating which produce undesired
chemical-reactions. What is the best way to prevent over-heating? - ANSWER>>A water bath will help
prevent over-heating



Fill in the blank

........................ refer to a compound prepared without a specific formula (not from an official
compendium) and made specifically to fill the needs of an individual patient -
ANSWER>>Extemporaneous



Fill in the blank

...................... a single agent that is used to soften and smooth the skin. A moisturizer is sometimes
referred to as ................, but the term ............ is used for single agent, and moisturizers often have
coloring, scents, and other ingredients added - ANSWER>>Emollients



Fill in the blank

Oil in water , or water in Oil is example of ....... - ANSWER>>Emulsions



Fill in the blank

,............ Is used to stabilize the emulsion. ........... are usually surfactants (wetting agents) that reduce the
surface tension between the two liquids so that the two different substances can move close to each
other but they will not be mixed together - ANSWER>>Emulsifiers



What is the difference between Continental or dry gum method and English, or wet gum method? -
ANSWER>>Both have same ingredients (oil, purified water and gum (such as acacia) in the ratio of 4:2:1
but the order of mixing is different.

Dry method: gum is mixed rapidly with oil then water added all at once

Wet method: gum is dissolved in water first, then oil is slowly added



What you know about HLB (hydrophilic-Lipophilic balance) number? - ANSWER>>#s range from 0-20
with 10 being the mid-point means it is the break point between water and oil solubility. #>10 means
hydrophilic (water-soluble) and #<10 means lipophilic (lipid-soluble)



What is Eutectic Mixture? - ANSWER>>A eutectic mixture is two or more components that melt at a
temperature lower than the melting temperature for the individual components.



Which of the following are common preservatives?

A. Benzalkonium chloride (BAK)

B. Benzyl alcohol

C. Chlorhexidine

D. Thimerosal (contain mercury)

E. Sodium benzoate

F. Benzethonium chloride

G. propylparaben - ANSWER>>All of them



Why preservative-free formulations if there is no harm from multi-dose vials? - ANSWER>>no
scientifically conclusive evidence exists of harm from exposure to thimerosal preservative-containing
vaccine, whereas evidence is accumulating of lack of any harm resulting from exposure to such vaccines.
Therefore, the benefits of influenza vaccination outweigh the theoretical risk, if any, for thimerosal
exposure through vaccination" (MMWR 54 [RR08]: 1-40, 2005). Nonetheless, FDA is in discussions with
manufacturers of influenza vaccine encouraging them to further increase the supply of preservative-free
formulations.

, Is it safe for pregnant women to receive an influenza vaccine that contains thimerosal? - ANSWER>>Yes.
A study of influenza vaccination examining over 2,000 pregnant women demonstrated no adverse fetal
effects associated with influenza vaccine. Case reports and limited studies indicate that pregnancy can
increase the risk for serious medical complications of influenza. One study found that out of every
10,000 women in their third trimester of pregnancy during an average flu season, 25 will be hospitalized
for flu related complications.



Which of the following promote a better medication absorption? A. Lotions B. Creams C. Ointments D.
Pastes - ANSWER>>C. Ointments

They are not applied easily to hairy skin



Which of the following has higher potency? A. Elocon (mometasone) ointment B. Elocon (mometasone)
cream - ANSWER>>A. Elocon ointment is high potency and B is low-medium potency and reason behind
this is ointment is 80% oil



Which of the followings is 80% oil and 20% water?

A. Cream

B. Lotion

C. Ointment

D. Paste - ANSWER>>C. Ointment



Cream is 50% oil and 50% water

Lotion is mostly water

Paste are the thickest ointments and are also used as protective barriers Ex. Triple paste medicated
diaper rash ointment



List the 5 classes or types of ointment bases? - ANSWER>>Oleaginous bases such as white petrolatum

Absorption bases (such as lanolin, Aquaphor)

W/O emulsion bases

O/W emulsion bases (hydrophilic ointment, Dermabase)

Water soluble or water miscible bases (PEG ointment)

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