Compounding Theory

Who requires a risk assessment to be taken to identify the appropriate level of requirement to minimize contamination of each compounded product and to provide adequate protection for personnel.

NAPRA

What is compounding

The process in which the technician uses bulk ingredients to prepare a prescribe medication to treat a specific patients medical condition.

what is Manufacturing

when a pharmaceutical company makes a product, applies for a DIN, has an establishment license and notice of compliance

What are the three Levels of complexity

simple, moderate, and complex according to USP 795 standards

Define Complex compounding

requires special calculations, decision-making, training, procedures, equipment, environment

what is Moderate compounding

required some special calculations or procedures to determine

explain Simple Compounding

Reconstituting and combining commercial products; Making a preparation that has a USP compounding monograph that contains specific quantities of all components, procedures and required equipment

LEVEL A risk for nonsterile compounding

simple and moderate compounds as defined in USP 795

LEVEL B risk for nonsterile compounding

complex compounds as defined in USP 795; small quantities of ingredients or preparations that require ventilation and are compounded occasionally

LEVEL C risk for nonsterile compounding

Hazardous drugs classified by National Institute for occupational Safety and Health (NIOSH) as group one

who is a Pharmacy manager or pharmacy department head

is responsible for the development, organization and supervision of all activities related to compounding of non-sterile preparations in the pharmacy

who is a Nonsterile compounding supervisor

a pharmacist or pharmacy technician who develops, organizes and oversees all activities related to compounding of non- sterile preparations in the pharmacy

what is the BUD non later than for non-aqueous solutions

**time remaining until the earliest expiry date** of any ingredient or **6 months**,

what does MAWQ stand for

minimum accurately weighable quantity

Alcohol.

Varying proportions of alcohol and water combined are very effective solvents and vehicles for many products

denatured alcohol

denaturants are added to alcohol to make it unfit to use as a beverage. The denaturants in rubbing alcohol make it unpalatable but non-toxic

blending

The process of mixing powders to be incorporated into the final drug product.

**geometric dilution**

The process in compounding in which the smallest quantity is added first, followed by the next largest amount, until all ingredients are incorporated

Levigating

Add a small portion of a levigating agent, a liquid in which the solid material is insoluble, to a finely powdered drug(s) to form a paste. The paste is then triturated to reduce the particle size. The levigated paste is added to the ointment bases, making the mixture smooth and uniform.

trituration

Process of grinding a drug in a mortar and pestle, to reduce its particle size to obtain a fine powder. In order to product a product that is not gritty, the drug must be reduced to a very fine powder.

**nonvolumetric glassware**

glassware are not requiring precise measurement of volume or those occurring after or prior to volume measurement

tare weight

the weight of the material

settling

need a defined final concentration so we can’t change the density of the active ingredient BUT we can increase the density of the vehicle by adding sucrose, sorbitol, glucose, glycerin or other soluble non-toxic materials

caking

Development of deflocculated sediment which is not suspendable

photoaging

Occurs from UVA or UVB radiation. Ultraviolet radiation causes accelerated aging process in collagen, increasing the rate at which collagen breaks down. This effect produces a cascade of events that lead to wrinkles

injunction

a**bsorption of drugs is increased if the product is rubbed on the skin for sometime rather than just applied.**

why would patients want a oleaginous base

Stay on skin for long periods of time, do not allow escape of moisture from the skin and are greasy and hard to wash off with soap and water.

eutectic mixtures

When two crystalline substances are mixed together they melt into a liquid which can easily be incorporated into a base.

which profession allows the extemporaneous compounding of chemicals for therapeutic care?

pharmacy

what make a good compounding technician

one who is careful and concise

what should the work surface be wiped down with

isopropyl 70% alcohol

what should be the beyond use date for a water-containing mucosal liquid

no later than 30 days

much of the compounding done in a community pharmacy is considered extemporaneous compounding because it…

occurs for a specific need of the moment for a particular patient

what is an acceptable weigh on the electric balance

0\.001 - 0.03 g

the point on the graduated cylinder that coincided with the bottom of the curved surface of the liquid

meniscus

zeroing an electric balance

taring

used to remove particulate matter from a liquid

filter paper

pharmaceutical elegance

aesthetically pleasing both in application and appearance

incorporation

slowly mixing the active ingredient into the base by taking small amounts of each and combining them together until it is all incorporated

what liquid measuring device is useful for measuring more general amounts and for stirring a liquid

beaker

what would happed if you were to try and measure less than the least weighable quantity on a scale

unacceptable margin of error

what is the beyond use date for non-aqueous formulations

< 6 months

what device would be used for measuring liquid smaller than 1 milliliter

micropipette