RxPrep Compounding III

master formulation record

recipe that's followed to compound a preparation

compounding record

log book of all products made at the pharmacy

true

True or False: The documentation in the compounding log must be detailed enough that another trained person can replicate the steps involved in the preparation.

processes, steps

The pharmacy must keep records of ________ and ________ that relate to a compounded product, such as equipment cleaning, calibration, and maintenance, temperature logs for the refrigerator, freezer, and room air, and records of chemicals, bulk drugs, and drug products.

Safety Data Sheets

Always review the ________ for each bulk ingredient to determine safety procedures, including the recommended PPE.

clean lab coat, gloves

What 2 things are part of the minimal PPE for preparing non-sterile, non-hazardous preparations?

comminution

to reduce particle size by grinding, crushing, milling, vibrating, or other processes (manual or mechanical); finely grinding powders into small particles

sieve

After a powder has been ground during comminution, it's placed into a(n) ________.

sifters

Sieves are also known as ________.

sieve

used to ensure that particle size is uniform

number of holes

The sieve number is based on the ________ per inch.

levigation/spatulation, pulverization by intervention, trituration

What are the 3 main methods of comminution?

trituration

general term used to mean "mix thoroughly" (or make the product homogenous); most commonly associated with grinding tablets with a mortar and pestle until a fine powder is achieves, but can describe liquids (such as shaking an emulsion)

levigation

involves triturating the powder with a mortar and pestle and incorporating a small amount of liquid to help with the grinding process and create a uniform paste

levigating agent

liquid incorporated during levigation

wetting agent

What's another term for levigating agent?

spatulation

similar to levigation but performed on an ointment slab with a spatula (not with a mortar and pestle)

pulverization by intervention

process used for crystalline powders that won't crush easily; crystals dissolved with an intervening solvent and mixed until the solvent evaporates; particles are finer when the powder recrystallizes

geometric dilution

method of mixing ingredients to ensure that ingredients are evenly distributed in a diluent or delivery vehicle; small amount of drug is mixed into an equal amount of diluent; after initial small amount is thoroughly mixed, another equal amount of the ingredients is mixed in

solution

a solute dissolved in a solvent

b

A(n) ________ is homogenous.

a) emulsion

b) solution

c) suspension

solutions

Syrups, elixirs, tinctures, and spirits are examples of ________.

c

Oral solutions with sucrose, other sugars, or artificial sugars

a) elixir

b) spirit

c) syrup

d) tincture

a

Sweet hydroalcoholic solutions used for drugs that would be insoluble in a purely aqueous formulation

a) elixir

b) spirit

c) syrup

d) tincture

d

Plant or animal extracts dissolved in alcohol or hydroalcohol

a) elixir

b) spirit

c) syrup

d) tincture

b

Alcohols or hydroalcohols of volatile, aromatic compounds such as camphor

a) elixir

b) spirit

c) syrup

d) tincture

volatile

vaporizes (evaporates) easily

suspension

solid dispersed in a liquid; particles can be redispersed easily by shaking

levigating agent

A(n) ________ is a type of surfactant used to incorporate an insoluble drug into a liquid, which makes a suspension.

emulsion

liquid dispersed in a liquid

emulsions

________ are either oil-in-water or water-in-oil.

emulsifier

A(n) ________ is a type of surfactant that's used to reduce the surface tension between two liquids, allowing the two phases to come closer together.

hydrophilic-lipophilic balance

To make an emulsion, the emulsifier will need to be carefully chosen according to the ________.

precipitation

when the dispersed phase settles (clumps) together

sedimentation

process of a solid settling on the bottom of a container

emulsions, suspensions

Precipitation/sedimentation occurs commonly in ________ and ________.

determine if solute will dissolve in solution

What is the initial step in preparing any solution?

dissolution rate

used to determine the time it will take for a solute to dissolve

Fick's First Law of Diffusion

What is used to calculate a dissolution rate?

heat, larger surface area, stirring

What 3 things will increase the dissolution rate?

buffer system

A(n) ________ may be needed to resist changes in pH when preparing a solution.

preservative

When preparing a solution or suspension, a(n) ________ may be needed to protect against microbial growth, including bacteria, fungi, and yeast.

homogenizer

A(n) ________ helps to make a uniform suspension.

surfactants; suspending agents

Even with ________ used as ________, suspensions are inherently unstable and will need to be redispersed prior to use.

4:2:1

Emulsions can be prepared by mixing oil, water, and an emulsifier in a(n) ________ ratio.

dry

The continental method for emulsion preparation is known as the (dry/wet) gum method.

wet

The English method for emulsion preparation is known as the (dry/wet) gum method.

continental

The (continental/English) method for emulsion preparation involves the following steps:

1. levigate the gum with oil

2. add the water all at once

3. triturate by shaking in a bottle or mixing in a mortar until a cracking sound is heard and mixture is creamy white

4. add other ingredients by dissolving them first in solution and adding a quantity of water sufficient to make up to the final volume

5. homogenize

English

The (continental/English) method for emulsion preparation involves the following steps:

1. triturate the gum with water to form a mucilage

2. add oil slowly while shaking or mixing

3. add other ingredients by dissolving them first in solution and adding a quantity of water sufficient to make up to the final volume

glidant

improves the flowability of a powder

lubricant

What's another term for glidant?

magnesium stearate

What's an example of a glidant?

surfactant

neutralizes the static charge and keeps the powder from floating away

sodium lauryl sulfate

What's an example of a surfactant excipient in a powder?

inert filler

If the amount of powder per dose is very small, it will be necessary to add a(n) ________.

highest; lower

If melting ingredients for any formulation, melt the ingredient with the (highest/lowest) melting point prior to adding the ingredient(s) with (higher/lower) melting points.

eutectic mixture

combination of the ingredients will melt at a lower temperature than either of the individual component's melting temperatures

adsorbent

A(n) ________ powder can be used to keep powder dry.

kaolin, magnesium carbonate, magnesium oxide

What are 3 examples of adsorbent powders?

gelatin

(Gelatin/Hypromellose) is an animal product.

hypromellose

(Gelatin/Hypromellose) is a vegetable product.

plasticizer

makes capsules less brittle and more flexible

glycerol, sorbitol

What are 2 examples of plasticizers?

punch

Capsule hand filling is also known as the "________ method."

hand filling

capsule preparation process where the powder is placed on powder paper or an ointment slab; pile of powder is smoothed with a spatula to a height about a third of the length of the capsule; open end of capsule is repeatedly "punched" into the pile of powder until the capsule is filled; when base is filled, it's fitted with the cap

manual capsule-filling machine

small device that helps pharmacist quickly load 50, 100, or 300 capsules; plates help sort capsule bodies and hold them upright and in place; powder is put above the capsules onto a plastic sheet where a plastic spreader is used to move the powder into the capsules; a comb or tamper and a spreader are used repeatedly until the powder is packed into the capsules then caps are put over bodies

000; 5

Common capsule sizes range from size ________ (largest) to size ________ (smallest).

molded

The (compressed/molded) tablet is the most common tablet type made in compounding.

compressed

The (compressed/molded) tablet is the most common tablet type made in manufacturing.

binders, diluents, disintegrants, lubricants

What are 4 types of excipients used in tablets?

troche

What's another term for lozenge?

lozenge

drug formulation generally used to deliver a medication that acts locally in the mouth

sucrose, syrup

A lozenge contains the active drug in a base of ________ or ________ for hard lozenges.

polyethylene glycol

What does PEG stand for?

PEG

A lozenge contains the active drug in a base of ________ for soft lozenges.

gelatin, glycerin

A lozenge contains the active drug in a base of ________ or ________ for chewable lozenges.

delivery vehicles

Creams, lotions, ointments, pastes, and gels are types of ________.

lotion

What type of delivery vehicle contains the most water?

ointment

What type of delivery vehicle contains the least water?

tubes, tubs

Ointments are packaged in either ________ or ________.

geometric dilution

What compounding method is used to mix powders into an ointment base?

levigating agent

When preparing an ointment, powders should be triturated well using a(n) ________.

fusion method

using heat to mix components of an ointment together well

pluronic lecithin organogel

What does PLO stand for?

PLO gel

What type of gel can be used for transdermal drug administration?

cocoa butter, hydrogenated vegetable oil

What are 2 examples of oil-soluble suppository bases?

theobroma oil

Cocoa butter is also known as ________.

gelatin, PEG

What are 2 examples of water-soluble suppository bases?

cocoa butter

If a suppository preparation softens or melts easily, such as with ________-based suppositories, the molds will need to be stored in the refrigerator.

base

The drug will displace part of the ________ of a suppository.

density factor

To calculate the amount of suppository base displaced by the drug, the ________ of the drug is needed.

weight of drug per suppository / (weight of suppository blank - weight of medicated suppository + weight of drug per suppository)

What is the equation used to determine the density factor of a drug?

compression molding, fusion molding, hand molding

What are 3 methods for preparing suppositories?

c

Method that can be used when only a few suppositories are to be prepared, using a cocoa butter base; cocoa butter grated and mixed with the drug(s) in a mortar and pestle or on a pill tile with a spatula; mass rolled into a cylinder which is cut into suppository-size pieces; tip is formed on one end to make insertion easier

a) compression molding

b) fusion molding

c) hand molding

b

Suppository preparation method where base is gently heated, ingredients are added, mixture poured into room temperature molds, and left to harden; often dispensed in molds with this method; suppositories are soft and easily damaged

a) compression molding

b) fusion molding

c) hand molding

a

Suppository preparation method where the pharmacist will need to know the weight of each mold and the drug's density factor; amount of base required to fill each mold is calculated, base is grated, mixed with drug, and put into a cold mold

a) compression molding

b) fusion molding

c) hand molding

opposite

If a lubricant is used to more easily remove a suppository from its mold, it must be the (opposite/same) of the suppository base in terms of solubility.

glycerin, propylene glycol

What are 2 good lubricants for suppositories made with oil-soluble suppository bases?

mineral oil, vegetable oil spray

What are 2 good lubricants for suppositories made with water-soluble suppository bases?

BUD

date or time after which the compounded product should not be used