Chapter 16: Compounding II - Equipment, Stability & Excipients Flashcards by Emily Jansen

A graduate should not be used to measure anything < ___% of its volume

20%

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What are glass mortars used for?

Liquids such as suspensions and solutions & for compounds that are oily or can stain

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What are wedgwood mortars used for?

For grinding dry crystals and hard powders (rough edges like wood)

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What are porcelain mortars used for?

For blending powders and pulverizing gummy consistencies

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What compounds should you avoid using a metal spatula with?

a mixture containing metal ions (will react with each other)

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What is the largest and smallest size capsule

Largest: 000
Smallest: 5

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Recommended compounding ingredients are listed in reputable sources such as

USP National formulary (USP-NF)
The Food Chemicals Codex (FCC)

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If any substance comes from a non-FDA registered facility, a ____ should be obtained that confirms the specifications and quality

Certificate of Analysis (CoA)

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If there is an ingredient without an expiration date, the pharmacist will assign a conservative date that is no more than ____ from the date of receipt. The label on the container should include which 2 things

3 years

Date of receipt and assigned expiration date

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What is a surfactant used for?

To make two ingredients easier to mix together & keep the phases from quickly separating by lowering the surface tension (or the interfacial tension)

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What is a wetting agent?

A type of surfactant
Reduces the surface tension between a liquid and a solid to allow the substance to more easily spread

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Another name for wetting agent

Levigating agent

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What is an emulsifier?

A type of surfactant
2 or more liquids which are not able to be blended together (such as water in oil). An emulsifier is added to an emulsion to help keep the liquid droplets dispersed throughout the liquid vehicle

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What is a suspending agent?

A type of surfactant
A suspension is a solid in a liquid - to get the solid dispered suspending agents are used. These must still be shaken to redisperse before use

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What is a levigating agent?

examples: glycerin or mineral oil
helps aid in grinding

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What is added to suspensions to help keep the solid particles from settling?

Suspending agents (or dispersants or dispersing agents)

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A suspending agent can also be a plasticizer, which means ….

It will make the preparation easier to shape or mold

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Levigation and trituration are both used to …

grind down particles

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What is the difference between levigation and trituration

Levigation uses a levigating agent like glycerin or mineral oil to aid in grinding & trituration is the grinding of particles without the addition of a liquid (the powder stays dry)

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Mineral oil is a commonly used levigating agent for ____ compounds, and glycerin or propylene glycol are used for ____ compounds.

lipophilic (oil-soluble)
aqueous (water-soluble)

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The ____ number determines the type of surfactant required to make an emulsion

hydophilic-lipophilic balance (HLB)

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Surfactants with low HLB (<10) are more ____-soluble and are used for _____ (o/w or w/o)

Lipid (remember, Low = Lipid)
w/o (water-in-oil)

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Surfactants with high HLB (>10) are more ____-soluble and are used for _____ (o/w or w/o)

Water (remember, High = H2O)
o/w (oil-in-water)

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What is an example of a chelating agent to avoid metal ions from oxidating a drug?

Edetate disodium (EDTA)

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What happens when epinephrine is oxidized?

Changes color to be amber (yellow/orange)

oxidation usually occurs at which functional group?

-OH (hydroxyl)

how to protect from oxidation?

1. light protection 2. correct storage temperature 3. chelating agents 4. antioxidants (free radical scavengers) 5. control pH

What blocks metal ions from catalyzing oxidation reactions? provide an example

chelating agents (EDTA, EDetate calcium disodium)

What binds to free radicals?

antioxidants

What are common antioxidants

Ascorbic acid (Vitamin C) and tocopherols (Vitamin E)

How do you maintain pH to avoid drug oxidation & hydrolysis?

Using a buffer

How can you prevent hydrolysis?

1. avoid moisture 2. Adsorbents (desiccants) to absorb moisture that enters container 3. lyophilized (Free-dried) powder 4. light protection, chelating agents 5. hygroscopic salt (water absorbing) 6. prodrug formulation (release drug from hydrolysis) 7. control temperature 8. control pH

functional groups susceptible to hydrolysis

esters, amides, lactams

Drugs can be stored as a ____ powder instead of a solution to avoid hydrolysis.

lyophilized (freeze-dried) powder

What kind of salt form of a drug can you use to absorb less water and will be less likely to degrade from hydrolysis

a salt form with lower hygroscopic properties (hydroscopic = water-absorbing)

Hydrolysis occurs more rapidly at ____ (higher/lower) temperatures

Higher

compounds susceptible to UV light

ascorbic acid, nitroprusside, phytonadione (PM DEN = phynatodione, micafungin, doxycycline, epoprostenol, nitroprusside)

what are the 3 **other** reactions that degrade drugs?

1. isomerization 2. epimerization 3. decarboxylation

Binders role | example

add cohesion to powders/tablets to allow them to stick together | acacia

Diluent and fillers role

diluents: dilute fillers: bulk up small amount both add size

diluent/filler examples (tabs/caps, liquids, topicals)

- tabs/caps: lactulose, starches, calcium salts, cellulose - liquids: water, alcohol - topicals: petrolatum

Disintegrants role | exs

facilitates the breakup of a tablet after oral administration - aliginates and cellulose absorb water and cause tab to swell and burst | alginic acid, cellulose products polacrilin potassium, starches

disintegrant examples

alginic acid, cellulose products polacrilin potassium, starches

Sweeteners examples

aspartame, sucralose glycerin, dextrose, mannitol, sorbitol, xylitol, stevia

Lubricants role | example

prevent ingredients from sticking to each other and equipment (glidants improve powder flowability) | magnesium stearate

____ are most accurate for measuring small volumes and viscous liquids

Syringes

All syringe packages should be wiped off with ___ prior to being brought into the SEC or PEC

70% IPA

T/F: syringes should be recapped to prevent needle-stick injuries

False - do not recap

Which part of the syringe should not be touched due to contamination risk

plunger

Providing a quick bolus dose into a vein or into a vein through the catheter is called

IV push

A ___ pipette draws up a set volume only, which is the volume the pipette can hold

Volumetric

A ____ pipette is graduated and is used to measure different volumes

Mohr

____ balances have internal weights, which are used to weight quantities ≤ 1 gram

Class III (Class A) torsion balances

Torsion balances have a ____ requirement

Sensitivity

The minimum weighable quantity (MWQ) on a torsion balance calculation

0.05 or 5% MWQ = SR / acceptable error rate (0.05 or 5%)

What is the most commonly used balance

electronic balance aka analytical balance or scale

Electronic balances are simple to use and have higher ____

sensitivity

A compounding pharmacy needs at least one ___ and one ____ mortar and pestle

1 glass | 1 Wedgwood or porcelain

What equipment can be used to mix ingredients

Ointment mills, homogenizers, and grinders

Small particle size and increased surface area = (increased or decreased) rate of absorption

Increased

What is an ointment mill

Draws the ointment or another semi-solid preparation between rollers that grind and homogenize (i.e., make non-gritty, smooth and uniform) the ingredients in the preparation

Capsule shells are made from

gelatin, which is pork-derived or hypromellose or a similar plant-derived product

What are examples of commercially available suspending agents

Ora-Plus & Ora-Sweet

Example of an anti-foaming agent used in non-sterile compounding

Simethicone

What are both PEG and poloxamer used for?

delivery vehicles and surfactants

Poloxamer is useful for ___ drug delivery

topical [poloxamer can be used to distribute ingredients in a preparation into the "like" phase (hydrophobic --> organic lipophilic phase)]

What are the 3 types of chemical reactions that can cause most drug products to become unstable and degrade

Oxidation-Reduction (OIL-RIG) Hydrolysis Photolysis

What are free radicals

metal ions that have an unshared electron. They can catalyze oxidation chain reactions. Chelators can be used to chelate the metal ions with the unshared electron

Examples of common fillers

Lactose, starches (many, including corn, rice, wheat), calcium salts, bentonite, cellulose, petrolatum

___ absorb water, causing tablets to swell and burst. ____ from plants can also absorb water well

Alginates | Cellulose

____ is a common anti-adherent and is used to improve powder flowability

Magnesium stearate

Examples of preservatives Do not use preservatives in what population?

Chlorhexadine (used as a surgical scrub also), Povidone iodine, Sodium benzoate/benzoic acid, benzalkonium chloride, sorbic acid/potassium sorbate, methyl/ethyl/propyl parabens, EDTA, thimerosal, cetylpyridium chloride NEONATES

____ compounds are more polar, which makes compounds more ___-soluble

Ionized | water-soluble

The pH of a buffer system can be calculated with

The Henderson-Hasselbalch equation

Types of purification (of water)

distillation, deionization, reverse osmosis

Distilled water is often used for

reconstitution to prepare **oral** suspensions and in **non-sterile** compounding preparations

sterile water must be free of ____ which is also known as ____

bacterial endotoxins = pyrogens

Alcohols have high miscibility (mixes easily) with ____

water

benzyl alcohol uses

solvent, preservative and fragrance

What is the preferred disinfectant in sterile compounding

IPA 70%

PEG is ___-soluble and ___-miscible

water water

PEG is used as a

surfactant, solvent and lubricant

When PEG is linked to a protein drug (pegylated), such as PEG-filgrastim, it increased the

half-life

___ is a PEG mixture that is commonly used as a suppository base and is a good emulsifier

Polybase

An emollient is a product that

softens and soothes the skin E mole on the skin

Purpose of occlusive ointments

form a **protective barrier** to prevent the loss of water molecules from the top layer of the skin

___ are put into many emollient formulations to pull in water from the atmosphere to moisturize the skin

Humectants

Examples of humectants

Glycerin or glycerol, propylene glycol and PEG

What percent of an ointment is water

0-20%

Ointments are best for

extremely dry skin and thick skin

Examples of ointments

petrolatum, polybase, aquaphor, aquabase

What is an oleaginous ointment? example?

contains no water petrolatum (vasoline)

Creams are greater than __% water and up to __% oil

20% 50% (about half and half)

Creams are best for

normal and dry skin

___ have the most water

Lotions - can have a small amount of alcohol to solubilize ingredients

What is best for oily skin

Lotions

What are the 4 ointment groups

- Hydrocarbon bases - aka oleaginous (contain no water; examples are Vaseline) - Absorption bases - Water-removable bases (creams) - Water-soluble bases (gels)

Aqueous solutions of poloxamers are ___ when refrigerated and ___ at room temp

liquid gel

what is Poloxamer Lecithin Organogel (PLO)?

gel - contains one hydrophobic and 2 hydrophilic chains - can be used for both phobic and philic drug delivery

polybase, hydrogenated vegetable oils and gelatin can be used as ____

suppository bases

Examples of adsorbents

Magnesium oxide/carbonate, kaolin

Shellac, gelatin, gluten are used for ____

regular coating

cellulose acetate phthalate is used for

enteric coating

Avoid these agents in what patients: 1. alcohol 2. aspartame 3. gelatin 4. gluten 5. lactose 6. preservatives 7. sorbitol 8. sucrose 9. xylitol

1. children 2. phenylketonuria 3. vegetarians and vegans (contains pork) 4. celiac 5. lactose intolerance 6. neonates 7. IBS 8. diabetes 9. dogs