non-sterile compounding (NAPLEX)

USP chapters are considered the ________ acceptable standards by the FDA.

minimal

How often must non-sterile compounding training be completed?

• Initially

• q12m

Torsion balance (class III balance)

• Not commonly used since we use the top loading electronic balance in lab

• Torsion balance has a 5% acceptable error rate

• MWQ (minimum weighable quanity) = SR (sensitivity requirement) / 5%

Measuring volumes that are <___% of the graduated cylinders capacity can cause a measure error.

20%

T/F: the measurement of a graduated cyclinder is read at the bottom of the meniscus (at the center)

True

What is API?

Active pharmaceutical ingredients

What is the USP-NF?

• USP - National Formulary

• Through the FDA and ensures purity and safety of the compound

What is a surfactant?

Lowers the surface tension between 2 ingredients in a preparation to make more miscible (easier to mix together)

- Neutralize static charge

Surfactants

A. Hydrophilic

B. Hydrophobic

C. Amphilic

C. Amphilic

They are both - ex is oil & water

What are wetting agents/levigating agents?

Reduce the surface tension between a liquid and a solid

- technique used to grind particles and make them smaller with a small amount of liquid

What are suspending agents?

• Keep solid particles from settling in a liquid

• Ora-plus, Ora-Sweet

What is simethicone an example of?

Anti-foaming agent

Example of surfactants

• Span

• Tween

• PEG

• Poloxamer

• Sodium lauryl sulfate

Examples of thickeners

• Acacia

• Agar

• Gelatin

What are emulsifiers?

• Used to mix ≥2 immiscible liquids

Used for liquids and mixing compounds that are oily or can stain

A. Glass mortar

B. Wedgewood mortarts

C. Porcleain mortars

A. Glass mortar

Have a rough surface and are preferred for grinding dry crystals & hard powders (ex: crushing a tablet)

A. Glass mortar

B. Wedgewood mortarts

C. Porcleain mortars

B. Wedgewood mortarts

Have a smooth surface and are preferred for blending powders and pulverizing gummy materials

A. Glass mortar

B. Wedgewood mortarts

C. Porcleain mortars

C. Porcleain mortars

HLB Value study gal **

• Surfactants with a low HLB value (<10) are more lipid-soluble and used in water-in-oil (w/o) emulsions

• Surfactants with a high HLB value (>10) are more water-soluble and used in oil-in-water (o/w) emulsions

- "Lower HLB - more Lipid soluble (w/o)"

- "Higher HLB - more H2O soluble (o/w)"

Scale 0-20

Magnesium stearate is an example of what?

Lubricant

What are some examples of sweetners? (7)

• Glycerin

• Dextrose

• Sorbitol

• Xylitol

• Stevia

• Aspartame (no cals)

• Sucralose (no cals)

What are the practical uses of sorbitol? (2)

• Sweetener

• Plasticizer for gelation caps

What are some expamples of preservatives? (8)

• Chlorhexidine

• Povidone-iodine

• Sodium benzoate/benzoic acid, benzalkonium chloride

• Soric acid/K sorbate

• Methyl/ethyl/propyl parabens

• EDTA

• Thimerosal

• Catylpyridinium Cl

What is benzoic acid an example of?

preservative

T/F: do not use preservatives in neonates

True

What is a humectant?

• Helps products maintain moisture

• Glycerin, glycerol, PEG, propylene glycol

What is an emollient?

• Moisturizer/cream that soften and smooths skin

• Humectants are put into many emollient formulations to pull water in from the atmosphere to moisturize skin

What are the 4 examples of ointments?

• Petrolatum

• Aquaphor

• Polybase

• Aquabase

"PAPA"

uworld Q

What ointment is an example of oleaginous (no water)?

Vaseline

What contains the most amount of water?

A. Lotions

B. Creams

C. Ointments

A. Lotions

What contains the most amount of oil?

A. Lotions

B. Creams

C. Ointments

C. Ointments

What data sheet is required for each bulk ingredient?

SDS (safety data sheet)

What is comminution?

Reduce particle size by grinding, crushing, milling, vibrating, etc.

- Includes trituration and levigation

What is trituration?

• Mix thoroughly or make the product homogenous

• Grind into a fine powder

What is levigation?

• Mix thoroughly with a wetting/levigating agent to make the product homogenous

What is geometric dilution?

Method of mixing ingredients to ensure ingredients are evenly distributed in a diluent or delivery vehicle

• Small amount of the drug is mixed into an equal amount of the diluent

What is an eutectic mixture?

• The combination of ingredients melts at a lower temp than either of the individual components melting temp

What is a SOLUTION?

• Solute dissolved in a solvent

• Homogenous (uniform throughout)

What are the different types of solutions (4)

• Syrups

• Elixirs

• Tinctures

• Spirits

"SETS"

What is a SUSPENSION?

• Solid dispersed in a liquid

• Heterogenous (not uniform)

What is an EMULSION?

• Liquid dispersed in liquid

• o/w, w/o

What is PRECIPITATION/SEDIMENTATION?

• Dispersed phase settles (clumps) together

How to prepare suspension?

• Gather ingredients

• Reduce particle size into fine powder

• Wet powder and levigate to form paste

• Add surfactant to keep suspension dispersed

- Will need to be redispersed (shaken) before use

An emulsion is __ parts oil + ___ parts water + __ parts gum (ex: acacia)

4 + 2 + 1

Steps to prepare emulsion with continental gum method (dry gum)

• Levigate the gum with oil

• Add water all at once

• Triturate until a cracking sound is heard and the mixture looks creamy white

• Add other ingredients & water sufficient to make the final volume

• Homogenize the emulsion

What can capsule shells be made out of? (2)

• Gelatin (animal product)

• Hypromellose (vegetable product)

What is another word for a lozenge?

troches

What is the lozenges base for hard loz vs. soft loz?

• Hard: sucrose or syrup

• Soft: PEG

suck it hard

How to prepare ointments?

• Titurate powder well using a levigating agent

• Mix into ointment base with geometric dilution

BUD CHART WRITE OUT (4) ****

• Nonpreserved aqueous (Aw ≥0.6) = 14 days fridge

• Preserved aqueous (Aw≥0.6) = 35 days

• Nonaqueous (Aw <0.6) oral liquid = 90 days

• Nonaquous (Aw <0.6) other non oral liquid dosage forms = 180 days

Based on USP 795, if any compounding ingredient does not have an expiration date, you can assign a dat no more than ____ years from the date receipt

3

What technique protects the ingredients from overheating and burning?

A. microwave

B. insulated beaker

C. sieve

D. water bath

E. homogenizer

D. water bath

Poloxamer gels are ____ at room temperature but ___ when refridgerated

gel, liquid

Steps for compounded molded tablets

• Measure & weight all ingredients

• Triturarte the dry ingredients

• Mix the ingredients using geometric dilution

• Add alcohol and/or water to moisten the powder mixture

• Compress the moist powder mixture into a tablet mold & allow to dry

The density factor is needed to prepare which formulation type?

A. Emulsion

B. Compressed tablet

C. Oral suspension

D. Troche

E. Suppository

E. Suppository

• The density factor indicates the amount of base that will be displaced by the drug

A pharmacist wishes to measure 7.5 mL of glycerin. Which measuring device would be preferable?

A. 10 mL syringe

B. 8 mL volumetric pipette

C. 3 mL Mohr pipette

D. 10 mL graduated cylinder

E. Tablespoon

A. 10 mL syringe

What does PLO stand for in PLO gel?

Pluronic lecithin organogel