Compounding Requirements And Terminology Flashcards
What’s the relationship btw FDA-approved and regulated drugs and NDA, GML NDC number and expiration date?
They must have:
An approved NDA
Must be produced under Good Manufacturing Practices (GMP)
Have NDC numbers
And carry a set of expiration date (provided by pharmacy)
List gen non-sterile compounding rules
Compounding space should be separate and away from dispensing section
Ideally, use only USP or NF chemicals from FDA-inspected manufacturers
Req logs
Info for each compounded product
What expiration date should be on labels of Pharmacy-Compounded pdts wrt solids (non-aqueous) preparation?
Up to 6-months
OR
Date that’s no later than 25% of time left on manufacturers date
Use whichever is soonest
What expiration date should be on labels of Pharmacy-Compounded pdts wrt aqueous preparation?
No more than 14 days (if stored in refrigerator)
If compounding a rx that calls for alcohol and the type is not specified, what should u use?
USP 95% ethyl alcohol
List the pdts that must be compounded in a sterile environment
Injections
Inhalations
Wound and cavity irrigation baths
Eye drops and ointments
What type of water should be used in sterile compounding?
Sterile water for injection
OR
Bacteriostatic water for injection
Sterile compounding req personnel trained and evaluated ANNUALLY for competency in what areas?
Aseptic techniques
Environmental control
Quality assurance testing
End-pdt evaluation
Sterility testing
What’s the req of preparing an injectable?
Certified sterile compounding environment must be either:
ISO class 5 (class 100) laminar air flow hood
Within ISO class 7 (class 10,000) clean room with positive pressure differential relative to adjacent areas
OR a barrier isolator that provides a ISO class 5 (class 100) environment for compounding
Whats req to enter the clean room - ISO class 5 (class 100)?
Clean room garb (low-shedding coverall, head cover, face mask and shoe covers)
Hand, finger and wrist jewelry is NOT allowed
Head and facial hair have to be out of the way (tied up) and covered
Should u separate the sterile and non-sterile areas?
Yes
T/F? When measuring, select a deveined equal to or slightly larger than the amount to be measured
True
What should be used if the vol to be measured is viscous?
Syringe
What are pipettes used for?
Liquid that 1.5mL or less of liquids
Which is the most commonly used mortars and pestle?
Wedgewood or porcelain
What’s Wedgewood or porcelain best for?
Best for reducing particle size of dry powders and crystals
What mortar and pestle is preferred for blending powders or pulverizing soft material? Why?
Porcelain
Bcuz it has a Smoother surface than wedgewood
What type of mortar and pestle is used for liquids and chemicals that are oily or that may stain porcelain, including many chemo agents?
Glass mortar & pestle
What’s glass mortar & pestle preferred for?
For mixing liquids and semi-soft dosage forms
What’s glassine weighing paper used for?
Weighing ointments and some dry chemicals
What type and size of spatula blades are used?
Large metal (stainless steel) spatula blades
Small spatula (< 6 inches) blades are used for transferring pdt from large spatula to jars
What’s plastic spatulas used for?
Used for chemicals e.g. Potassium, iodine, that can react with stainless steel blades
What are compounding slabs also called? Use? Xtic?
Compounding slabs are also called Ointment slabs
They are gen glass
And have nonabsorbent surfaces
What’s levigation?
Process of reducing the size of a particle of solid by triturating it
What’s a wetting agent?
Small amt of liquid used during levigation in which the soiplid is NOT soluble
List the levigation agents used for aqueous systems (o/w dispersions)
Glycerin
Propylene glycol
Polyethylene glycol 80
List the levigation agents used for oleaginous systems (w/o dispersions)
Mineral oil (light & heavy)
Castor oil
Cottonseed oil
Tween 80
What’s trituration!
Process of REDUCING fracturable POWDER substances into FINE PARTICLES by rubbing (or grinding) them with a mortar & pestle or on an ointment slab
What’s extemporaneous compounding?
Extemporaneous compounding refers to a comp prepared WITHOUTa specific formula from an official compendium and made especially to fill the needs of a specific pt
What’s an emollient?
A SINGLE agent that’s used to soften and smooth the skin.
What’s an emulsion?
Emulsions are 2-phase system of 2 immiscible liquids, one of which is dispersed through the other as small droplets.
An emulsion could be oil in water or water in oil
What’s an emulsifier?
Emulsifiers (or emulgent) is used to stabilize the emulsion
Role of emulsifiers?
Emulsifiers are gen surfactants (used to reduce surface tension so that the 2 subst can move closer to each other)
Do emulsions from a suspension?
No! They are 2 immiscible liquids
List the most common emulsifiers
Lipophilic esters of sorbitan:
Arlacel
Span
List hydrophilic esters
Myrj
Tween
List other commonly used emulsifiers
Polyethylene glycol (PEG)
Acacia
Glyceryl monostearate
Sodium laurel sulfate
What’s the hydrophilic-lipophilic balance (HLB) number?
HLB determines how much surfactant will be req to form the mixture together
What’s the implication of a low HLB number?
Agents with low HLB number are more oil soluble
What’s the implication of a high HLB number?
Agents with high HLB number are more water soluble
Whats the HLB scale range? Midpoint?
0 - 20
10 (breakpt btw water and oil solubility)
T/F? A medication packaged in an ointment will have a higher potency than the same med packaged in a cream or lotion?
True
Mometasone (Elocon) ointment is high-potency and Mometasone (Elocon) cream is low-medium potency
What are lotions?
Lotions have the MOST water and are most often o/w (small amt of oil)
E.g.
Keri
Cetaphil
What are creams?
Emulsions of about half oil and half water
E.g. Terbinafine (Lamisil AT) antifungal cream,
Docosanol (Abreva) antiviral cream
What are ointments?
Ointments are ~ 80% oil and 20% water
What are ointments used for?
Occlusive benefit - they block (trap in) moisture (preferred for dry or dry/cracked skin)
E.g. Mupirocin (Bactroban) ointment NTG ointment Aquaphor Aquabase
What are pastes?
Thickest ointments and also used as protective barriers
E.g.
Triple paste medicated diaper rash ointment
List examples of gels
Benzoyl peroxide
Erythromycin topical acne gel (Benzamycin)
Uses of gels?
Used as thickeners
What are solutions?
Liquid preparations of soluble chemicals dissolved in solvents such as water, alcohol or propylene alcohol
Whats a suspension?
2- phased of finely divided solid in liquid medium
A suspension must be deflocculated. What does this mean?
This means that the repulsive forces btw particles predominate so that the particles in the suspension repel each other and remain as discrete, single particles
Xtics of a suspension?
Suspensions should;
Settle quickly
Re-dispense by gentle shaking
Have uniform particles that are of small size
What are suppositories?
Suppositories are solid dosage forms used to deliver medicine into rectum, vagina or urethra
What tablet formulation is the most common dispensed in everyday practice (often the least the expensive)?
Compressed tablets
What may tablets also contain?
Excipients (also called binders)
What’s the concern with using lactose as a binder (excipient)?
May present a problem for pts with lactose- intolerance
What should be applied to each compded pdt to determine expiry?
Beyond use dates
