Non sterile compounding

When can nonsterile compounding be utilized?

drugs administered orally, topically, or nasally

Contains solute dissolved in solvent:

solutions

Dissolved sugars or artificial sugar

syrups

Mixture of water and alcohol:

elixirs

Common routes of administration for nonsterile products:

topical

oral

vaginal

nasal

rectal

via NG tube

Common routes of administration for sterile compounding:

injection

opthalmically

USP 795:

nonsterile compounding

USP 797:

sterile preparations

USP 800:

hazardous drugs

How often must you train employees involved with compounding?

completed when they 1st get hires and then every 12 months

3 Cs of equipment cleaning:

Clean

Calibrated

Compatible

Class III : Class A balance/ Torsion balance:

ingredients never placed directly on the scale

Acceptible error rate:

0.05 or 5%

MWQ:

SR/ acceptable error rate

Electronic balance:

most common

higher sensitivity

ingredients never placed directly on scale

tare or zero out balance

Which graduated instrument is the most accurate?

graduated cylinder

Syringes:

most accurate for measuring small volumes

helpful when measuring viscous liquids

parenteral are used with needle

oral are used without needle

Mortar and Pestles:

used for grinding substances into finer consistency

made of different materials: glass, porcelain, wedgewood

Glass mortar:

for mixing liquids

for oily/compounds that stain

Porcelain mortar:

blending powders

gummy substances

Wedgewood mortar:

grinding dry crystals

hard powders

What are the use of spatulas in componding?

to mix and transfer ingredients

flat part can flatten or pack preparation

Ointment slabs:

compounding ointments, but can be used for various things

Powder sives: sifters

similar to sifters used in baking.

helps separate larger particles from finely ground up particles in a powder

ensures uniform particles in size

Homogenizer:

electric mortar and pestle

Grinders:

grinding hard tables to powder form

Ointment mills:

press ointments between rollers to make them smooth and uniform

Hot plates:

provide direct heat to soften and melt ingredients

can use water bath when temperature needs to be carefully controlled

Microwave ovens:

heats quickly and may not apply heat uniformly

Molds:

used for suppositories , troches, lozenges, and tablets

Capsule and capsule filling devices:

soft gels or hard shells

can be made of gelatin: pork derived or hypermellose: plant base

Use to help seal medication tubes ( ointment, gel, or cream):

tube sealers

What is the role of excipients in compounds?

make dosage form stable, functional or more palatable

Sufractants:

sufrace active agents

decrease surface tension between 2 ingredients or phases

used to make ingredients miscible: mix easier

How do surfactants work?

they are amphophilic : both hydrophilic and lipophilic

Decreases surface tension between liquid and solid:

wetting/levigating agent

Keeps solid particles from setting in liquid:

suspending agents

Creates bubbles to decrease surface tension between liquid and solid:

foaming agent

Can serve as delivery vehicles:

glycols and gels

Used to mix >2 immiscible liquids:

emulsifiers

Lower HLB :

are like lipids

Mix H20 in oil

High HLB:

hugs water

mix oil into water

Benefits of excipients:

strengthen stability

improve functionality

enhance palatability

Helps ingredients stick together and provide stability and strength

binders

Examples of binders

acacia

starch

paste

sucrose syrup

dilute compound/product fillers help bulk up compound/product

diluent/fillers

Examples of diluents/fillers:

topical: pertrolatum, mineral oil

Liquids: water, alcohol, glycerin

Tablets/capsules: lactose, starches, calcium salts, cellulose powder

Prevents ingredients from sticking to equipment and helps to improve powder flowability:

lubricants

Example of lubricants:

magnesium stearate

calcium stearate

stearic acid

glycerin

mineral oil

Prevent or slow microbial growth and avoided in neonates:

perservatives

Examples of perservatives:

BAK

EDTA

Parabens

povidone-iodine

chlorhexidine

benzoic acid

sodium benzoate

Helps to maintain pH within certain range:

buffers

Example of acid buffers:

HCl

acetic acid

citric acid

Example of base buffers:

sodium bicarbonate

sodium hydroxide

boric acid

Examples of neutral buffers:

potassium phosphate

sodium phosphate

Breaks up and inhibits formation of foam:

anti foaming agents

Keeps powders dry and prevents hydrolysis:

absorbents

Helps to products retain moisture and keeps products from becoming dry and brittle:

humectants

Examples of absorbents:

magnesium oxide/carbonate

kaolin

Example of humectants:

glycerin or glycerol

propylene glycol

PEG

lecithin

hyaluronic acid

Make products more viscous and swell when mixed with water:

gelling agents

Examples of gelling agents:

gelatin

cellulose

bentonite

agar

xanthan

acacia

starches

poloxamer gels

Distegrants:

helps breakup solids inot smaller particles after ingestion or adding to liquid

Examples of disintegrants:

alka-seltzer

cellulose

alginic acid

Helps products taste better:

flavorings/colorings

Mask unpalatable taste, protects products from moisture, light, and oxygen:

coatings

Purified Water:

distillation

deionized

reverse osmosis

Potable water:

can be used in early stages of washing equipments

Dissolves water soluble solutes:

alcohols

Ointments:

create a barrier to prevent water loss from the skin

contains 0-20% water

Creams:

contain 20-50% water

can be water in oil or oil in water

Lotions:

contains >50% water

Increase viscosity and thicken products

Gels

Poloxamers are gel at room temperature but liquid when:

refrigerated

Contains powder in ointment base

paste

Made of various fats and glycols

can melt easily, so store in fridge

suppository

In what patients do you avoid alcohols?

avoid in children

What population do you avoid perservatives?

avoid in neonates

In what patient population do you avoid gluten?

in celiac disease

Avoid in lactose intolerance

lactose

Avoid in irritable bowel syndrome:

sugar

Avoid in diabetes:

sucrose

Avoid in vegan, vegetarian and patients avoiding animal products:

gelatin

Avoid in dogs:

xylitol

What are the three steps in nonsterile compounding preparation?

preparation

compounding

final steps

Preparation stage:

gather, wash, and calibrate equipment

gather ingredients and calculate quantity needed

perform hand hygiene and proper garbing

SDS us used to know what garbing is required

measure out ingredients

Compounding step:

follow a master formulation record

use recommended mixing techniques

Final steps of compounding:

documentation of details in compounding record

package product and apply labeling

perform quality control checks

Comminution:

reduce particle size by grinding , crushing, milling, and vibrating

Trituration:

mixing thoroughly using a mortar and pestle

Levigation:

trituration with small amount of liquid to form a paste

Spatulation:

using a spatula to mix small amounts of liquid onto a compounding slab

Pulverization:

using a solvent to dissolve large crystals and then mix

What are the different ways to mix compounds?

traditional mixing

geometric dilution

melting point order

Geometric dilution:

mixing equal amounts of ingredients together and repeating process

Melting point order:

add ingredients one at a time to heated container :from highest to lowest melting point

Plant or chemical extracts dissolved in alcohol or hydroalcohols

tinctures

Alcohols or hydroalcohols of volatile aromatic compounds:

spirits/essences

How are solutions prepared?

male sure all of the solid is grounded into a fine powder

dissolve the powder in the solvent

add any required excipients

package appropriately : apply BUD and labels

Continental method: dry gum method

levigate gum with oil

add water all at once

mix using mortar and pestle or shake if a bottle : mix until it is creamy white and cracking sound heard

dissolve excipients into a solution and quantity sufficient with water

use homogenizer to mix final product