Ch 4: Non-Sterile Compounding Flashcards
compounding practices
exempt from FDA drug approval process and current good manu practices (CGMPs). best practices set by USP
simple compounding
reconstituting powder suspensions or solutions (may not be considered compounding in all states)
moderate compounding
calculations or procedures required to determine quantities of each dose
complex compounding
special training, env, facilities, equip and procedures required.
personnel training
personnel (staff) training for compounding must be completed and documented for the type of compounding they will perform
space/area
compounding space must be separate from rest of pharmacy. sterile compounding area must be separate from nonsterile compounding area. all areas need adequate heating, AC, and ventilation. as well as washing facilities for washing hands (hot AND cold water)
conical graduate
wider the mouth, lower the accuracy
pipettes
volumetric pipette draws up a set volume. mohr pipette is graduated to measure different volumes.
class A balance
class III torsion balance
analytical balance
electronic balance. weighs small amounts accurately.
BUD nonaqueous formulation
not later than earliest exp of ingredients or 6 mo, whichever sooner. room temp
BUD water containing PO formulation
not later than 14 days when stored at controlled cold temp. store in fridge.
BUD water containing topical/dermal and mucosal liquid and semisolid forms (cream/lotion)
not later than 30 days. store at room temp.
label of compounded products
include BUD, storage/handling info, and aux laels.
glass mortar
liquids or compounds that are oily or can stain
wedgwood motars
rougher surface than porcelain, used for grinding dry crystals and hard powders
porcelain mortars
smoother surface, preferred for blending powders and pulverizing gummy consistencies
spatulas
stainless steel and plastic used commonly. do not use steel if mixture has metallic ions. use rubber if material is corrosive.
ointment mill
draws ointment or other semi-solid preparation between rollers to homogenize the ingredients, smoothes the ointment and removes grittiness
electric mortar/pestle
homogenizer, popular brand is the unguator.
master formulation record
recipe for ingred and instructions to prepare compounded product
compounding record
log book of all products made at pharmacy, in reference to the master formula. includes components with source, lot number, expiration dates, compounder, rph, etc, BUD, rx label, description of product. ADRs reported by pt are written here.
quality assurance
steps and mx of proper standards of compounded preps. includes the SOPs (standard operating procedures), how to perform routine and expected tasks.
comminution
reduce to a smaller average particle size by trituration (grinding with mortar and pestle/other) or levigation (wetting or levigating agent helps - mineral oil if oil based or glycerin if aqueous to turn compound into paste for ointment or susp)
geometric dilution
smooth and uniform mixture making. small amt of powder mixed into equal amt of other ingred. repeat adding equal amts and mixing together until all ingred are added.
certificate of analysis
for non-FDA registered facilities to confirm specification and quality requirements.
if component without exp date
be cautious and choose date no more than 3 yrs from date of receipt of the item, label should contain the date of receipt and the chosen esp date
Mg stearate
used in powder forms as glidant/lubricant and improve the flowability of a powder
Na lauryl sulfate
used in powder forms as surfactant to neutralize the static charge and keep powder from floating away
sieve
used to sift powder and ensure a uniform particleeutectic misxtures size. sometimes a brush or spatula is used to force particles thru the sieve. sieve number is amt holes per in.
eutectic mixture
melt at lower temp than the melting temps of the individual components. lubant powder can keep it dry - Mg oxid, Mg carbonate, or kaolin.
caps made of
gelatin (animal) or hypromellose (veg)
plasticizers for caps
glycerol and sorbitol to make caps less brittle and more flex
molding a tablet
most common in compounding (compressed tablet is most common for manu). use alcohol or water to moisten powder, forms a paste, mold into tab, allow to dry.
lozenge/troche
hard lozenge: sucrose or syrup base. soft lozenge: PE. chewable lozenge: glycerin or gelatin.
lotions
contain most water, more fluid than creams, pourable.
potable water
tap/drinking water. used for non sterile compounding, unless higher purity required. use for hand washing and equp cleaning
preservatives
prevent bacteria growth. chlorhexidine can be presevative or antiseptic for surgical scrubs. in opthalmics: EDTA, Na benzoate, benzoic acid, benzalkonium Cl, thimersosal
suppository base
stay intact for insertion but melt once inserted. hydrogenated veg oil or gelatin is used. also cocoa butter.
ointments
contain least amt of water. 5 types depending on base: oleaginous (oily), absorption, water-in-oil (w/o) emulsion bases, oil-in-water (o/w) emulsion bases, or water-soluble bases
making ointments
triturate the powders using levigating agent. mix using geometric dilution. some need heat so melt ingred with highest melting point then add the others in order of dec melting point.
gels
semisolids interpenetrated with liquid. PLO gel (pluronic lecithin organogel) is used for transdermal drug delivery (lipophilic base in a water and alcohol vehical)
vaginal suppositories
treat conditions inside the vagina
rectal suppositories
treat conditions that are systemic or local (inside rectum or GI)
emulsion
liquid dispersed in liquid. 2 phase heterogeneous mixture. oil in water (oil drops in water vehicle) or water in oil
emulsifier
surfactant or detergent used to reduce the surface tension between oil and water, allows the phases to come closer together. choose emulsifier (amphiphillic molecule) for emulsion based on HLB number (hydrophillic-lipophillic balance)
discontinuous phase
phase present as drops. aka dispersed aka internal phase
continuous phase
phase present in which drops are suspended aka external phase.
suspension
solid dispersed in liquid. 2 phase heterogenous mixture. wetting or levigating agent is the surfactant used to incorporate an insolu drug into a liquid
solution
solute dissolved in solvent. homogenous
precipitatation/sedimentation
dispersed phase settles/clumps together. shake or gently role to re-disperse.
HLB number
<10 for oil solu aka water in oil emulsions. >10 for water solu aka oil in water emulsions.
antifoaming agent
breaks up and inhibits the formation of foam. ex: Mg oxide/carbonate or kaolin
antioxidants
prevents oxidation. ex. ascorbic acid
coatings (regular)
prevent degradation d/t o2/light/moisture/mask taste. ex: shellac, gelatin, gluten
hydrophillic solvent
liquid used to dissolve solutes. high miscibility with water. ex: PEG, alcohols
hydrophobic solvent
liquid with low or no miscibility with water. used to dissolve solutes. oils or fats
glidant
improves flow of properties of powder mix in tab and cap forms by reducing interparticle friction. ex: colloidal silica, Mg stearate.
gelling (thickening) agent/stabilizer
inc viscosity of substance. gelatin and betonite used commonly. etc. also: agar, alginates, guar gums, acacia, tragacanth, carbomer, cellulose, starches
flavoring agent/sweetener
do not use phenylalanine with phenylketonuria. sugar free artificial: aspartame, saccharin. also: glycerin, dextrose, lactose, mannitol, sorbitol, phenylalanine, stevia, xylatol
enteric coating
cellulose acetate phthlate or shellac
emollient
softens and sooths skin, provides barrier, acts as drug delivery vehicle. ex. petroleum jelly.
disintegrant
PO products need to dissolve to be absorbed. ex: alginic acid, polacrilin potassium (amberlite), cellulose products, starches, compressible sugar (Nu-Tab)
diluents/fillers
add size. white lactose commonly used. liquid: water or glycerin. dry: starches, Ca salts, lactose, mannitol, sorbitol, cellulose
suppositories
oil-solu like cocoa butter (theobroma oil) or hydrogenated veg oils. water-solu like PEG or gelatin.
density factor
API will displace part of the base, density factor is the amount of base displaced
hand molding suppositories
cocoa butter used, not melted. small amt of suppositories
fusion molding suppositories
base gently heated, ingred are added, mixture is poured into room temp molds and left to congeal. if not congealed, may consider refrig (but not before d/t risk of cracking/splitting suppository)
compression molding suppositories
cold compression mold and density factor used
lubricants in suppositories
glycerin or propylene glycol for oil solu bases. mineral oil or veg oil spray for water solu bases.
continental gum method
dry gum method. 4 parts oil, 2 parts water, 1 part emulsifier. acacia is emulsifier. levigate hte gum with oil, add water all at once, qs and homogenize to make uniform
english gum method
wet gum method. 4 parts oil, 2 parts water, 1 part emulsifier. triturate gum and water to form mucilage, add the oil slowly. qs and homogenize to make uniform
