notes Flashcards
sterile and non-sterile compounding best prsactices are set by what department?
USP
sterile and non-steruile compounding are exempt from what FDA rule?
exempt from FDA approval and cGMP
what is the difference between simple, moderate and complex compounding?
simple: reconstituting (adding one or two ingredients like water or alcohol)
moderate: requires calculation and procedures
complex: requires special training, facilities, equipment, etc.
personnel training rules
personnel must be trained for specific type of compounding and the training must be documented
garb attire rules
garb attire will depend on the type of compounding performed
how should the space be allocated?
compounding area must be separate from rest of pharmacy
non-sterile compounding area must be separate from sterile compounding area
manufactured drugs must follow what department rule?
FDA approval and cGMP
when selecting a measuring device, which should be used?
equal capacity or slightly larger
What is a graduate?
it is a measuring equipment with lines on the glass to measure volume
what is the difference from a graduated cylinder and a conical graduate?
graduated cylinder has equal diameter from top to bottom and is more accurate than the conical graduate
why is the conical graduate less accurate?
because wider the mouth, the less accurate
where should the measurement be read?
at the bottom center of the meniscus read at eye-level
What is the most accurate device for measuring small volumes?
oral or a hypodermic syringe
What measuring device is particularly useful for measuring viscous liquids?
oral or a hypodermic syringe
What is a mohr pipette?
It is a volumetric pipette (graduated) that draws up a set volume. It is useful for very small volumes.
What are the types of weighing equipment used?
electronic balance (analytical balance) class torsion III balance (Class A balance)
What is the difference between the weighing equipment?
analytical is simpler, has higher sensitivity, and can weigh small amounts accurately
If a powder is supposed to be weighed, what should the powder be placed on?
a weight boat or a coated glassine weighing paper
must zero out on scale before placing powder in
What is the sensitivity requirement and minimum weighable amount of the class III or class A weighing equipment?
Sensitivity requirement is 6mg
minimum weighable amount is 120mg
measured with a 5% acceptable error rate
What types of mortar & pestle should be in a pharmacy?
a glass mortar & pestle AND either a wedgewood or porcelain mortar & pestle
what is a glass mortar & pestle good for?
liquids and oily or staining compounds
what is a wedgewood mortar & pestle good for?
it has a rougher surface so grinding harder crystals or harder powders
what is a porcelain mortar & pestle good for?
has a smoother surface so good for blending powders or pulverizing gummy consistencies.
what does it mean to reduce particle size?
grinding to smaller and more uniform size particles
this increases SA therefore speeding up absorption
What types of spatula are used?
stainless steel
plastic
hard rubber
When would you NOT use a stainless steel spatula?
for mixtures that contain metallic ions
what is used to mix ointments or roll out pills?
ointmint slab, pill tiles, disposable parchment ointment pad
what is an ointment mill?
it is an electric device that draws the ointment between rollers for a smoother product
what is a homogenizer?
it is an electric mortar and pestle that can also mix ointment, creams or other semi solids
What is a hot plate and magnetic stirrer used for?
the magnet in the hot plate causes the stir bar to continually spin therefore it is good for dissolving ingredients
What are 2 documents that each compounded product must have
a master formulation record and a compounding record
What is a QA plan?
it is an itemized standard of procedures to ensure maintenances of expected standards in a pharmacy.
What should a QA program include?
periodic testing of the finished compounded preparation. can either be done in-house or sent to an outsourcing facility to conduct sterility testing.
patient counseling of ADRs to compounded products
should be reported to he pharmacy and the pharmacist must record in compounding log
what is communition?
it is to reduce particle size
What are two ways of communition? what is the difference?
trituration and levigation
trituration is grinding the powder into finer particles in a mortar & pestle
levigation is like trituration except a wetting gent or levigating agent is used to help with the grinding process
what is spatulation?
When a spatula is used instead of a pestle in a mortar
what is geometric dilution?
when a small amount of drug is mixed with equal parts of other ingredients. Once this is mixed then another small amount of drug is mixed with equal amounts of other ingredients. This is to make a uniform product.
Akin to adding dry to wet in small amounts to prevent lumps in baking.
where should the compounding ingredients come from?
preferable from a FDA registered facility. If it is not from a FDA registered facility, then a certificate of analysis (CoA) should be obtained.
What should the pharmacist do if a compounding component does not have an expiration date?
the pharmacist must write on the container the date of receipt (arrival to pharmacy) and the conservative approach which is up to 3 years expiration date from the date of receipt.
what is magnesium stearate?
It is a glidant/lubricant that improves flowability of powder
what is sodium lauryl sulfate?
it is a surfactant that neutralizes static charge to prevent powder from floating away
What does the sieve number signify?
of holes per inch
What are eutectic mixtures?
When ingredients combined melt at a lower temperature than the melting temperature of the individual components
What ingredients can keep eutectic mixtures dry?
magnesium carbonate
magnesium oxide
kaolin
what are capsule shells made of?
gelatin (animal)
hypromellose (vegetable)
what are glycerol and sorbitol used for in capsules?
they are plasticizers to make capsules less brittle and more flexible
What is the most common tablet type made in compounding?
molded tablet
active ingredients in hard lozenges are put into what base?
syrup or sucrose
active ingredients in soft lozenges are put into what base?
PEG
active ingredients in chewable lozenges are put into what base?
glycerin or gelatin
What type of compounded preparation contains most water?
lotions
what type of compounded preparation contains least amount of water?
ointment
What are the 5 types of ointment (dependent on base)?
oleaginous (oily/greasy) absorption base water in oil emulsion base oil in water emulsion base water soluble base
what is the fusion method and how should it be applied?
when heat is required to mix ingredients well especially in ointments
melt ingredient with highest melting point first then add ingredients as melting temperature decreases. use lowest temp possible.
What is the thickest ointment preparation?
paste
What is pluronic lecithin organogel? (PLO)
it is commonly used in transdermal delivery and is used in gel preparation.
What types of bases are suppositories?
either oleaginous (oil-soluble) or water soluble
What are oleaginous suppositories made of?
cocoa butter (theobroma oil) and hydrogenated vegetable oils (palm, palm kernel, coconut)
what are water soluble suppositories made of?
glycerinated gelatin and PEG
Why is density factor needed when compounding suppositories?
the drug can displace the base, higher density means less displacement and lower densify factor means more displacement
What is the paddock method?
density factor formula
density factor = B/A-C+B
B=weight of medication per suppository
A=weight of blank suppository
C=weight of medicated suppository
Which type of suppository molding method requires knowing the weight of the mold and DF of drug?
compression molding
what are the types of suppository molding?
hand molding
fusion molding
compression molding
which type of suppository molding requires gentle heating?
fusion molding
lubricants applied to mold make it easier to remove. What lubricants should be used for oil-based suppositories?
water-based?
oil-based: propylene glycerin or glycerin
water-based: vegetable oil spray or mineral oil
When fusion molding, why do the molds have to be room temperature?
If cold, it can cause cracking and splitting.
What type of base is used in hand molding?
cocoa butter
what is an emulsion?
a liquid dispersed in liquid mixture. It is a 2-phase heterogeneous mixture
What are emulsifiers?
a surfactant that reduces surface tension and allows two immiscible substances come closer together.
list the emulsifiers
acacia agar carbomer glyceryl monostearate pectin PEG sorbitan lipophilic esters (Arlacel, Span) sorbitan hydrophilic esters (Myri, Tween)
What is a suspension?
a solid dispersed in liquid. A two-phase heterogeneous mixture
What is used to incorporate a insoluble drug into a liquid?
wetting/levigating agents
list the levigating agents
glycerin
mineral oil
polyethylene glycol
propylene glycol
what is a solution?
a solute dissolved in a solvent
it is a homogenous mixture
what is precipitation/sedimentation?
when the dispersed phase settles together. Most often occurs with emulsions and suspensions.
How to use the HLB number to choose emulsifiers.
HLB <10 –> more oil-soluble & used for water in oil emulsions
HLB >10 –> more water-soluble & used for oil in water emulsions
What are the types of emulsion preparation methods? what is the difference?
continental (dry gum) method: 4:2:1 oil:water:emulsifier ratio. First levigate gum in oil then add water. shake and then add other ingredients in solution until QS.
english (wet gum) method: 4:2:1 oil:water:emulsifier ratio. Triturate gum in water and then slowly add oil while triturating. Then add other ingredients in solution until QS,
gum is acacia or other gum emulsifier
What is Polybase commonly used for?
as a base in suppositories. Also a good emulsifier.
What are the temperature definitions?
room: 68-77F or 20-25C
refrigerator: 36-46F or 2-8C
freezer: -10-14F or -25 - -10C
USP BUD
nonaqueous –> earliest expiration of API or 6 months, whichever is earlier in room temp
water-containing oral formulation –> 14 days in refrigerator
water-containing topical/dermal/mucosal –> 30 days in room temp
What labeling must be on all compounded products?
BUD
storage and handling info
label signifying that it is a compounded product
what labels do hazardous compounded products need?
hazardous labels
what labels do topical compounds need?
external use only
what label do suppositories, some troches, some suspensions need?
refrigerate
what label do suspensions/emulsions need?
shake well before use
what is simethicone?
anti-foaming agent
what are coating agents?
gluten, gelatin, shellac to mask unpalatable tastes, protect from oxygen, light, moisture
what is ascorbic acid
an antioxidant
what are diluents used for?
as a filler to add size to small dosages
what diluents (fillers) are used when making tablets or capsules?
starches, calcium salts, lactose, mannitol, sorbitol, cellulose
what are disintegrants used for?
allows for oral products to dissolve for absorption
list the disintegrants
cellulose alginic acid polacrilin potassium (e.g. Amberlite) compressible sugar (e.g. Nutab) starches
what are emollients
can be used to soothe skin or mucus membranes and can be used as a barrier
example of an emollient
petroleum jelly
what is used for enteric coating
cellulose acetate phthalate
shellac
what are the sweetening agents
sugar-free artificial: aspartame, saccharin
dextrose, lactose, mannitol, sorbitol, xylitol, stevia, phenylalanine, glycerin
what are thickening agents used for?
increase viscosity and stabilize mixtures
list the thickening agents
acacia agar alginic acid bentonite cellulose carbomer gelatin guar gum starches tragacanth
which thickening agents are used most commonly?
gelatin and bentonite
list glidants
magnesium stearate
colloidal silica
list hydrophilic solvents
PEG and alcohols
list hydrophobic solvents
oils: borage, coconut
fats: omega-3
list anti-adherent lubricant
magnesium stearate
list preservatives
topical/nasal: chlorhexidine
ophthalmic: benzoic acid, sodium benzoate, benzalkonium chloride, EDTA, thimerosal
generic name for tween
polysorbate
what is USP 800
for hazardous drugs
list the humectants
glycerin
sorbitol
propylene glycol
what type of agents are surfactants?
emulsifiers and wetting agents
