naplex - Nonsterile Compounding

Compounding

the process of combining/altering ingredients to create a NON FDA-APPROVED medication for an individual based on a prescription

USP (U.S. Pharmacopeia)

organization that sets minimum acceptable standards for compounding required by the FDA, state boards of pharmacy, and the Joint Commission

USP 795

USP chapter focusing on non-sterile preparations

USP 797

USP chapter focusing on sterile preparations

USP 800

USP chapter focusing on hazardous drugs

Nonsterile Compounding

the preparation of products administered orally, via tube, rectally, vaginally, topically, nasally, or in the ear

what is NOT considered compounding?

**SPLITTING, REPACKAGING, OR RECONSTITUTING ARE NOT CONSIDERED COMPOUNDING**

Reasons for Nonsterile Compounding

typically to...

1. PREPARE A DOSE/FORMULATION THAT IS NOT COMMERCIALLY AVAILABLE

2. AVOID AN EXCIPIENT

3. ADD A FLAVOR

Space Requirements of Nonsterile Compounding

includes...

1. specifically designated OPEN-AIR area SEPARATE from dispensing area of the pharmacy

2. ingredients, equipment, and containers stored off the floor

3. daily/continuous temperature monitoring

4. easily accessible sink with HOT AND COLD WATER

5. PURIFIED WATER/DISTILLED WATER/REVERSE OSMOSIS WATER for rinsing equipment and utentils

Personnel Requirements of Nonsterile Compounding

includes...

1. specifically designated person responsible for overseeing performance and operation of compounding

2. core competency training INITIALLY & EVERY 12 MONTHS

non sterile compounding training must be done:

initially then

q12 mos

hand hygiene, garbing, etc

documentation of proficiency

Hand Hygiene:

non sterile garbing

Class III Torsion Balance (Class A Torsion Balance)

LESS COMMON and LESS PRECISE balance that has a lower sensitivity requirement and requires calculation of the minimum weighable quantity (MWQ) which calculates the smallest amount that can be weight on the balance

MWQ = SENSITIVITY REQUIREMENT / ACCEPTABLE ERROR RATE

MWQ formula

MWQ = SENSITIVITY REQUIREMENT / ACCEPTABLE ERROR RATE

Electronic (Analytical) Balance

MORE COMMON and MORE PRECISE balance that has a higher sensitivity requirement to allow very small amounts to be measured

Conical Graduated Cylinder

LESS PRECISE graduate

**THE WIDER THE MOUTH, THE LOWER THE ACCURACY**

conical graduated cyclinder, wider mouth = ____ accuracy

**THE WIDER THE MOUTH, THE LOWER THE ACCURACY**

Graduated Cylinder

MORE PRECISE graduate

20% rule

never measure volumes smaller than 20% of capacity

eg. measuring 5 ml in a 100 ml has higher risk of error than measuring 87 ml in 100 ml

the smallest amount of the graduate's total volume that can be measured without causing error

Syringes

equipment used to most accurately measure a SMALL VOLUME useful for measuring viscous/thick liquids

**CLEARLY LABEL ORAL SYRINGES WITH "FOR ORAL USE ONLY" STICKER OVER THE SYRINGE CAP**

Volumetric Pipette

equipment that draws up a set volume only and releases in drops

Mohr Pipette

equipment that draws up measured different volumes and releases in drops

Mortar and Pestle

equipment used to grind substances into a finer consistency or to stir and mix small amounts of ingredients

Glass Mortar

a type of mortar that is used for liquids

Wedgwood Mortar

a type of mortar that is used for GRINDING dry crystals and hard powders

Porcelain Mortar

a type of mortar that is used for BLENDING powders and PULVERIZING gummy consistencies

Spatula

equipment used to mix ingredients, flatten/grind ingredients, transfer ingredients, and pack preparations into containers

Metallic Ions should not be used with what spatulas

compounded mixtures that contain THIS should NEVER be handled with a steel/metal spatula

Ointment Slab

equipment used as a work surface for making ointments and other purposes

Sieve

equipment used to ensure uniform particle size

Electric Mixing Equipment

equipment that speeds up the mixing process such as...

1. OINTMENT MILL

2. HOMOGENIZER

3. GRINDER

ointment mill

mixes and reduces the particle size of powders to make ointments or creamsh

homogenizer

Electric mortar and pestle

Hot Plate

equipment that provides direct heat to soften/melt ingredients and hasten chemical reactions

Hot Plate with a Water Bath

technique used with hot plates that protects ingredients from overheating and burning for when temperatures need to be carefully controlled

Hot Plate with a Magnetic Stirrer

technique used with hot plates that continuously stirs ingredients to dissolve and mix them

Molds

equipment that helps to shape and prepare tablets, lozenges, troches, and suppositories

Tube Sealers

equipment that heats and squeezes the ends of tubes shut

compoudning ingredients =

active pharmaceuticals ingredients (drug)

+ excipients

Excipients

inactive ingredients that DO NOT PRODUCE ANY THERAPEUTIC EFFECT but make the dosage form stable, functional, and/or palatable

USP-NF

official list the ensures purity and safety of ingredients used in compounding such that ALL ingredients should be listed and come from an FDA-registered facility

Expiration Date

the last day a product is considered potent and non-toxic

if a product lacks an expiration date what should the expiration date be?

**IF A PRODUCT LACKS AN EXPIRATION DATE, SHOULD BE ≤ 3 YEARS FROM DATE OF RECEIPT**

Surfactants

excipient that LOWERS surface tension between two preparations through amphiphilic interactions to make them easier to mix together

Wetting Agent/Levigating Agent

a surfactant that reduces the surface tension between a LIQUID and a SOLID

Mineral Oil

a common wetting/levigating agent for LIPOPHILIC compounds

Glycerin or PEG

a common wetting/levigating agent for AQUEOUS compounds

Suspending Agent/Dispersing Agent

a surfactant that keeps solid particles from settling when added to a suspension

Ora-Plus, Ora-Sweet, and Ora-Blend

common suspending/dispersing agents commercially available

Foaming Agent

a surfactant that helps foam form to reduce the surface tension between dirt and water

eg. simethicone

glycols and gels

- Used as surfactant & delivery vehicles

eg. peg , plo

Emulsifier

a surfactant that helps keep liquid droplets dispersed throughout the liquid vehicle when added to an emulsion

HLB Number (Hydrophillic-Lipophilic Balance Number)

value that determines the type of surfactant required to make an emulsion

HLB < 10

describes surfactants that are LIPID-SOLUBLE for use in water-in-oil (w/o) emulsions

FOR EXAMPLE: glyceryl, Span 65

remember: Lower hlb makes it Like Lipids

HLB > 10

describes surfactants that are WATER-SOLUBLE for use in oil-in-water (o/w) emulsions

FOR EXAMPLE: PEG 400, Tween 85

remember: Higher hlb makes it Hug water

Based on the values below which surfactant(s) Should be used when compounding a water in oil emulsion?

hlb

Glyceryl monostearate 3.8

pegg 400 11.4

span 65 2.1

tween 81 10

tween 85 11

Lower = like lipids

want lower hlb <10

Binders

Allow contents of tablet to stick together to provide stability

EG. starch paste

Diluents/Fillers

To make something more dilute

fillers: To bulk up a small amount

Examples of Diluents/Fillers

lactose

starches

calcium salts

cellulose

topicals:petrolatum

Disintegrants

Flavorings & colorings

Lubricants

Examples of Lubricants

mag stearate

Preservatives

Examples of Preservatives

chlorhexidine

povidine iodine

Sodium benzoate, benzoic acid, benzalkonium chloride

Sorbic acid, potassium sorbate

Methyl/ethyl/propyl parabens

EDTA

THIMEROSAL

CETYLPYRIDINIUM chloride

Buffers

Adsorbents

Anti-Foaming Agents

Gelling Agents

Examples of Gelling Agents

agar

Alginates

various gums( GUAR Xanthan Acacia )

gelatins

bentonite

cellulose

starches

poloxamer (pluronic) gels

Examples of Humectants

glycerin or glycerol, propylene glycol, PEG

coatings

shellac, gelatin, gluten

cellulose acetate pthelate (enteric)

mask unpalateable taste or enteric

Hydrophilic solvents

Water

Sterile water

Alcohols (benzyl alcohol, IPA 70%)

Glycols (PEG 400, poly base)

Water

Purified Water

Water treated to remove chemicals in contaminants

types of purification include distillation deionization and reverse osmosis

Distilled Water

Used to reconstitute oral suspensions and in non-stero compounding

Potable Water

Drinking/tap water

has not undergone any sterilization processes

used for hand washing

bacteriostatic water for injection contains what

who should not use it

Sterile water with preservatives

neonates should not use

Alchohols

Dissolve water insoluble solute

Benzyl alcohol contains

Preservatives

fragrance

What is the preferred disinfectant for sterile compounding

ipa 70%

polybase

peg suppository base; good emulsifier

hydrophobic solvents

oils and fats (mineral oil)

Emollients

an excipient that softens and soothes the skin which includes ointments, creams, lotions, gels, and pastes

Ointments

an emollient used for extremely dry and thick skin that contains 0-20% water of which is separated into FOUR groups...

1. HYDROCARBON BASE

2. ABSORPTION BASE

3. WATER-REMOVABLE BASE

4. WATER-SOLUBLE BASE

Hydrocarbon Base in ointments

oleaginous ointments that CONTAIN NO WATER and are hard to wash off from greasy nature

eg petrolatum , vaseline

Absorption Base in ointments

ointments that can be used to form w/o emulsions

Water-Removable Base in ointments

ointments that are o/w emulsions more akin to CREAMS per USP

Water-Soluble Base in ointments

ointments that are o/w emulsions more akin to GELS per USP

Creams

an emollient used for normal and dry skin that contains 20-50% water

Lotions

an emollient used for oily skin that contains 50+% water

Gels

works well for transdermal

Pastes

an emollient that consists of a powder in an ointment base

Alcohol Avoidance

excipient to be avoided in children

Aspartame Avoidance

excipient to be avoided in patients with phenylketonuria from inability to metabolize phenylalanine

Gelatin Avoidance

excipient to be avoided in anyone looking to avoid animal products

Gluten AvoidanceS

excipient to be avoided in anyone looking to avoid gluten

Lactose Avoidance

excipient to be avoided in lactose intolerance/allergy

Preservative Avoidance

excipient to be avoided in neonates