Chapter 16: Compounding II - Equipment, Stability & Excipients Flashcards
What are glass mortars used for?
Liquids such as suspensions and solutions
for compounds that are oily or can stain
What are wedgwood mortars used for?
For grinding dry crystals and hard powders
What are porcelain mortars used for?
For blending powders and pulverizing gummy consistencies
What is the largest and smallest size capsule
Largest: 000
Smallest: 5
Recommended compounding ingredients are listed in reputable sources such as
USP National formulary (USP-NF)
The Food Chemicals Codex (FCC)
If any substance comes from a non-FDA registered facility, a _____ should be obtained that confirms the specifications and quality
Certificate of Analysis (CoA)
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
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)
What is a wetting agent?
A type of surfactant
Substances that reduces the surface tension between a liquid and a solid to allow the substance to more easily spread
Another name for wetting agent
Levigating agent
What is an emulsion?
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
What is added to suspensions to help keep the solid particles from settling?
Suspending agents (or dispersants or dispersing agents)
A suspending agent can also be a plasticizer, which means ….
It will make the preparation easier to shape or mold
Levigation and trituration are both used to …
grind down particles
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)
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)
The ____ number determines the type of surfactant required to make an emulsion
hydophilic-lipophilic balance (HLB)
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)
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)
What is an example of a chelating agent to avoid metal ions from oxidating a drug?
Edetate disodium (EDTA)
What inhibits free radicals from forming during oxidation?
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?
Using adsorbents (desiccant) to adsorb any moisture that enters the container
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
Hygroscopic
Hydrolysis occurs more rapidly at ____ (higher/lower) temperatures
Higher
Binders add cohesion to powders to allow them to ____
Stick together
___ and ____ add size to very small dosages
Diluents and fillers
____ facilitates the breakup of a tablet after oral administration
Disintegrants
____ prevent ingredients from sticking to each other and equipment
Lubricants
Syringes are most accurate for measuring small volumes and ___ liquids
viscous
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 have a ____ requirement
Sensitivity
The minimum amount that can be weighed on a torsion balance (minimum weighable quantity) is calculated based on the sensitivity requirement and acceptable error rate which is typically __ or __%
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 two examples of delivery vehicles and surfactants
PEG and poloxamer
Poloxamer is useful for ___ drug delivery
topical
What are the 3 types of chemical reactions that can cause most drug products to become unstable and degrade
Oxidation-Reduction
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
Examples of flavorings & coloring agents
Non-caloric, artificial: aspartame, sucralose
Glycerin, dextrose, lactose, mannitol, sorbitol, phenylalanine, stevia, xylitol
____ is a common anti-adherent and is used to improve powder flowability
Magnesium stearate
Examples of preservatives
Chlorhexadine (used as a surgical scrub also)
Povidone iodine
Sodium benzoate/benzoic acid, sorbic acid/potassium sorbate, methyl/ethyl/propyl parabens, benzalkonium chloride, EDTA, thimerosal
____ compounds are more polar, which makes compounds more ___-soluble
Ionized
water-soluble
The pH of a buffer system can e calculated with
The Henderson-Hasselbalch equation
Types of purification
distillation, deionization, reverse osmosis
Distilled water is often used for
reconstitution to prepare oral suspensions and in non-sterile compounding preparations
Alcohols have high miscibility with ____
water
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
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
Creams are greater than __% water and up to __% oil
20%
50%
Creams are best for
normal and dry skin
___ have the most water
Lotions
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
- Water-soluble bases
Aqueous solutions of poloxamers are ___ when refrigerated and ___ at room temp
liquid
gel
Examples of adsorbents
Magnesium oxide/carbonate, kaolin
Examples of regular coating
Shellac, gelatin, gluten
Examples of enteric coating
cellulose acetate phthalate
