Compounding II Flashcards
1
Q
What should be done for equipment used for HDs?
A
Equipment used for HDs including routine equipment such as counting trays and spatulas, should be dedicated for HD preparation and sanitized after use
2
Q
What is a cautionary note about calibration and equipment material?
A
Equipment must be calibrated regularly to confirm accuracy. Equipment should made of material that does not react with the compounding ingredients
3
Q
When measuring volume, what is recommended when selecting a device to measure?
A
When measuring, select a device that has a measuring capacity equal to or slightly larger than the amount being measured to get the most accurate measurement
4
Q
What system should measurements be made in?
A
Metric system
5
Q
What are graduates and what are some examples of graduates?
A
Graduates are measuring equipment with lines on the glass that are used to measure the volume, and include graduated cylinders, conical graduates, graduated beakers and graduated medication containers
6
Q
What is a graduated cylinder?
A
A graduated cylinder has the same diameter from the top to the bottom of the container and provides more accurate measurements than conical graduates, which have a wide mouth
7
Q
Describe the accuracy when the mouth of the graduate is wide
A
The wider the mouth, the lower the accuracy
8
Q
What are some important points about measuring volume using graduates?
A
- A graduate should not be used to measure volumes less than 20% of the graduate’s capacity (creates higher measuring error)
- To read the volume in a graduate, place it on a flat surface and view the height of the liquid in the cylinder at eye level
- The bottom of the meniscus, at the center is where the measurement is read
9
Q
What piece of equipment is most accurate for measuring small volumes?
A
Syringes are most accurate for measuring small volumes
10
Q
What are the advantages of using syringes to measure volume?
A
- They are especially useful for measuring viscous (thick) liquids, such as glycerin and mineral oil
- Patients receiving a liquid who require a very accurate dose should use an oral syringe for measurement rather than a small dosing cup, which has lower accuracy
11
Q
What are hypodermic syringes commonly used for?
A
Hypodermic syringes are commonly used for sterile compounding to transfer drugs and additives into IV bags
12
Q
When using syringes for sterile compounding, what should be done?
A
- All syringe packages should be wiped off with IPA 70% to remove contaminants and dust, prior to being brought into the SEC or PEC if working in a segregated compounding area
- Sterile syringes are individually wrapped, and must be opened along the seal to avoid shedding
13
Q
What is the danger associated with recapping needles?
A
Recapping needles leads to needle-stick injuries. Needle-stick injuries can injure the staff, cause contamination to the compounded sterile products and carry infection risk
14
Q
What are recommendations for preventing needle-stick injuries?
A
- In general, do not recap syringes
- It is preferable to use syringes with safety features, such as safety shields that cover the needle immediately after use
- If the needle must be recapped, it is safer to place the cap on the work surface (rather than holding it) and slip the tip of the needle into the cap, without letting the needle tip touch the work surface
15
Q
What is the advantage of using Luer Locks?
A
Luer locks make secure, leak-free connections between syringes, catheters and IV lines. They have male and female ends that screw together, forming a tight seal
16
Q
What do hypodermic syringes come with?
A
These come with cannulas (needles attached), or the cannula is separate and can be screwed onto the tip of the syringe
17
Q
How do you choose the correct size syringe?
A
For drawing up medication, do not use the exact size syringe needed because the plunger can easily become dislodged. Select the closest syringe size above the size needed. Do not add two different syringe sizes for a dose
18
Q
What should be done to separate between oral syringes and hypodermic syringes?
A
- Placing a “For Oral Use Only” sticker over the syringe cap
- Using a syringe design that prevents connection to an IV port
- Using oral syringes with brightly colored plungers/caps that differentiate them from IV syringes
- Clearly communicating the correct route of administration to the nurse
19
Q
What are pipettes?
A
Pipettes are thin plastic or glass tubes used to measure small volumes
20
Q
If a patient is using a pipette, what should the patient be counseled on?
A
If the pipette is being inserted into an opening such as a mouth or nose, it is important to keep the bulb squeezed after the dose is delivered and when withdrawing it, to avoid contaminating the inside of the pipette
21
Q
What is a volumetric pipette?
A
A volumetric pipette draws up a set volume only, which is the volume the pipette can hold
22
Q
What is a Mohr pipette?
A
A Mohr pipette is graduated and is used to measure different volumes. Mohr pipettes are commonly used in compounding
23
Q
How much water do graduated dropped that meet USP criteria release?
A
Graduated droppers that meet USP criteria release drops of water that weight 45-55 mg, when held vertically
24
Q
What kind of water drop is released from non-graduated medicine droppers?
A
Non-graduated medicine droppers that meet the USP criteria release a similarly-sized drop
25
What are the two types of balances used to weight ingredients?
The older balance is the Class III torsion balance and the most commonly used balance is the electronic balance
26
How do Class III torsion balances work?
Class III torsion balances have internal weights, which are used to weight quantities < 1 gram. When weight > 1 gram, external weights are placed on one pan and the substance to be weighed is placed on the other
27
What is sensitivity requirement and minimal weighable quantity?
Torsion balances have a sensitivity requirement that is most often 6 mg, meaning 6 mg can be added or removed before the dial moves 1 division. The minimal weighable quantity (the minimum amount that can be weighed) is calculated based on the SR and acceptable error rate (typically 0.05 or 5%)
28
How do you calculate MWQ?
MWQ = SR/acceptable error rate
29
What is the benefit of top-loading electronic balances over class III torsion balances?
This type of balance is simple to use and has higher sensitivity. It is not necessary to calculate the MWQ with a modern electronic balance
30
How do you use an electronic balance?
When using an electronic balance, the compounder must "tare" or "zero out" the balance after placing the weight boat or glassine paper on the scale. This ensures that only the ingredients are weighed and the container or paper used to hold the ingredients are not included in the weight
31
What are requirements of weighing a product with both types of balances?
With either balance, never place material to be weighed directly on the balance. The material will be placed on a weight boat (a shallow dish) or on glassine weighing paper, which is coated to reduce moisture penetration
32
What is a mortar and pestle?
The mortar is the bowl and the pestle is the blunt, heavy stick
33
What is a mortar and pestle used for?
Mortars and pestles are used to grind substances into finer consistency and can be used to stir and mix small amounts of ingredients
34
What types of mortars and pestles are needed in a compounding pharmacy?
A compounding pharmacy needs at least one glass and one Wedgewood or porcelain mortar and pestle
35
What is the function of a glass mortar?
Glass mortars are used for liquids, such as suspensions and solutions, and for mixing compounds that are oily or can stain
36
What is the function of a wedgewood mortar?
Wedgewood mortars have a rough surface and are preferred for grinding drug crystals and hard powders
37
What is the function of porcelain mortars?
Porcelain mortars have a smooth surface, and are preferred for blending powders and pulverizing gummy consistencies
38
What are spatulas used for?
Spatulas are used to mix and transfer (move) ingredients from one place (such as an ointment slab) to another place (such as a container)
39
What does the flat part of the spatula do?
The flat part of the blade can be used to flatten and grind down ingredients, and to pack preparations such as ointments into containers
40
What are the different materials that spatulas can be made out of?
Spatulas are made of stainless steel, plastic or hard rubber
41
When should a steel spatula not be used?
A steel (metal) spatula would not be used if making a mixture that contains metallic ions
42
When is a rubber spatula used?
A rubber spatula is used to handle corrosive material
43
What is the main purpose of compounding (or ointment) slabs?
Ingredients are mixed into ointments on a compounding (or ointment) slab, which is flat board made of porcelain or glass
44
Why can ointment slabs also be used as a work surface?
Ointment slabs are used as a work surface for other purposes besides making ointments since the material is hard and non-reactive
45
When can disposable parchment ointment pads be used as a work surface?
Disposable parchment ointment pads can be used as a work surface if teh water content of the mixture will not cause the paper to tear
46
What are powder sieves and what is its purpose?
Sieves are sifters similar to those used in baking. After a powder has been ground fine, it is sifted in order to ensure a uniform particle size
47
What are some examples of electric mixing equipment?
Ointment mills, homogenizers and grinders are used to mix ingredients
48
How does an ointment mill work?
An ointment mill draws the ointment (or another semi-solid preparation) between rollers that grind and homogenize the ingredients in the preparations
49
How does a homogenizer work?
A homogenizer can be used to mix ointments, creams or other semi-solid preparations. The homogenizer is similar to a smoothie blender, although with more power, and at a higher cost
50
What is the function of a grinder?
A grinder is useful for grinding hard tablets down. The powder will need further preparation to produce a fine powder
51
How is a hot plate with a magnetic stirrer beneficial?
A hot plate with a magnetic stirrer can save time by continuously stirring the mixture to dissolve and mix the ingredients
52
How does a hot plate with magnetic stirrer work?
The stirrer has a rotating magnet under the ceramic plate, which causes the stir bar (placed inside the glass) to spin and stir the components
53
How do hot plates work?
Hot plated provide direct heat to soften and melt ingredients, and to hasten chemical reactions
54
When is a water bath helpful for heating?
A water bath is helpful when the temperature needs to be carefully controlled. The water bath protects the ingredients from overheating and burning. The ingredients to be melted will be in a container that is placed into a larger container filled with water. The water in the outer container separates the inner container from the direct heat source, to prevent burning
55
What are molds used for?
Reusable or disposable molds are used to prepare tablets, lozenges/troches (orally-dissolving tablets) and suppositories. With soft delivery vehicles, the medication is often dispensed in a disposable plastic mold. This helps keep the product in the correct shape. Refrigeration helps soft products retain shape
56
What is a tablet press and how do you use it?
A tablet press is two plastic or metal plates used to compress damp powder into tablets. The compounder takes the pasty mass and uses the tablet press to form table shapes. After the mold shapes the tablets, the tablets are removed, and given time to dry
57
What can capsules be made out of?
Capsules can be soft gels or hard shells
58
What are hard shells made of?
The shells are made of gelatin, which is pork-derived, or from hypromellose or a similar plant-derived product
59
What are the range of capsule sizes?
Capsule sizes range from 000 (the largest size) to 5 (the smallest size)
60
What are tube sealers?
Tube-sealers heat and squeeze the ends of the tubes shut; the end will look similar to the crimped end of a toothpaste tube
61
What do all medications include?
All medications, whether compounded or not, include the drug/s (called the active pharmaceutical ingredients or APIs) and the excipients
62
What is the purpose of excipients?
Excipients do not produce therapeutic effect, but are needed to make the dosage form stable, functional and, with some oral dosage forms, palatable
63
Where can you find a list of high-quality ingredients recommended for use?
The USP National Formulary (USP-NF) and the Food Chemicals Codex (FCC) substances list
64
Preferable, where should ingredients be manufactured?
Preferably, ingredients should be manufactured at an FDA-registered facility. If any substance comes from a non-FDA registered facility, a Certificate of Analysis (CoA) should be obtained that confirms the specifications and quality
65
Why are expiration dates important?
Expiration dates are important to ensure that the product retains potency and is non-toxic
66
What should be done if there is an ingredient without an expiration date?
The pharmacist will assign a conservative (cautious) date that is no more than 3 years from the date of receipt (the day the pharmacy received the item). The label on the container should include the date of receipt and the assigned expiration date
67
What is the function of surfactants?
Surfactants lower the surface tension between two ingredients (or phases) in a preparation to make them more miscible (easier to mix together). The side of the phase that is close to the other phase is the "face" of the phase, and the interfacial tension is the tension at the interface. The surfactant lowers the interfacial tension, to help the phases move closer together
68
What is the MOA of a surfactant?
The common MOA of a surfactant involves forming a micellar structure which can reverse. If oil and water are mixed, the oil will interact with the lipophilic end of the surfactant, and the water will interact with the hydrophilic end of the surfactant. Surfactants are amphiphilic
69
What is a non-micelle MOA of surfactants?
Surfactants do not always form micelles; some form a film between the surfaces, or form and electrically-charged layer to keep the phases separate
70
What are other practical uses of surfactants?
By keeping the drug dispersed, a consistent dose is delivered. In manufacturing, the micelles formed by surfactants are used to facilitate gut absorption of lipophilic drugs and are used to control the rate of drug release. When the surface tension is lowered, it is easier to grind particles down, and to mix ingredients
71
What are wetting agents?
Wetting agents are substances that reduce the surface tension between a liquid and a solid to permit the substance to more easily spread
72
How would you use a wetting agent?
A fine powder that will be incorporated into a suspension is wetted with a wetting agent and stirred into a thick paste prior to being put into the delivery vehicle
73
What is an emulsion?
An emulsion is two or more liquids which are not able to be blended together (immiscible), such as water droplets dispersed in oil or oil droplets dispersed in water
74
What are emulsifiers?
Emulsifiers are added to an emulsion to help keep the liquid droplets dispersed throughout the liquid vehicle. This helps prevent the two liquids from separating into distinct (separate) phases
75
What is a suspension?
A suspension is a solid dispersed in a liquid
76
What are suspending agents?
Suspending agents are added to suspensions to help keep the solid particles from settling. Suspending agents do not keep suspensions separated for long, and suspensions must be shaken to redisperse the solid prior to use
77
What is a plasticizer?
A suspending agent can be a plasticizer, where plasticizer means that it will make the preparation easier to shape or mold.
78
What are some commercially available suspending agents?
Ora-plus and ora-sweet
79
Describe the properties of ora-plus
- Composed of a gel-like structure that keeps drug particles suspended and prevents settling
- Slightly acidic to prevent drug degradation through oxidation
- Bland taste; must be combined with Ora-Sweet for flavor
80
Describe the properties of Ora-Sweet.
- Similar to simple syrup
| - Provides flavor to Ora-Plus
81
What is the purpose of levigation and trituration?
Levigation and trituration are both used to grind down particles
82
What is the difference between levigation and trituration?
The difference is that levigation uses a levigating agent such as glycerin or mineral oil to aid in grinding. Trituration is the grinding of particles without the addition of a liquid
83
What are the most commonly used levigating agents?
Mineral oil is a commonly used levigating agent for lipophilic compounds and glycerin or propylene glycol are used for aqueous compounds
84
What is a foaming agent and how does it work?
Foaming agents help foam to form by lowering the surface tension of water
85
What are PEG and Poloxamer commonly used for?
Both delivery vehicles and surfactants
*Have both hydrophilic and hydrophobic parts, which makes them useful for a variety of preparations
86
What is the primary consideration in selecting the surfactant to use in an emulsion?
A primary consideration in selecting the surfactant to use in an emulsion will be whether the emulsion is a water-in-oil (w/o) emulsion or an oil-in-water (o/w) emulsion
87
What formulations are typically w/o formulations?
Topical formulations
88
What formulations are typically o/w formulations?
Oral formulations
89
What is the hydrophilic-lipophilic balance (HLB) number?
The hydrophilic-lipophilic balance number determines the type of surfactant required to make an emulsion/ The HLB scale range is 0-20 with the midpoint being 10
90
What does it mean when a surfactant has a low HLB number (<10)?
Surfactants with a low HLB number (< 10) are more lipid-soluble and are used for water-in-oil emulsions
91
What does it mean when a surfactant has a high HLB number (> 10)?
Surfactants with a high HLB number (> 10) are more water soluble and are used for oil-in water emulsions
92
How does USP define stability?
USP defines stability as the extent to which a product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics it possessed as the time it was made
93
What can affect the stability of a product and what can indicate instability?
The stability of compounded products can be easily compromised if they are not prepared or stored properly. This can be recognized by changes in texture, color, smell or development of precipitates
94
What is the most common cause of drug degradation?
Reactions involving the functional groups are common causes of drug degradation and can make the drug ineffective, unpalatable and toxic
95
What are the three types of chemical reactions that USP emphasizes causes most drug products to become unstable and degrade?
Oxidation-reduction, hydrolysis, photolysis
96
What happens when a compound is oxidized or reduced?
A compound is oxidized when it loses electrons and is reduced when it gains electrons
97
What is a redox reaction?
Oxidation and reduction reactions occur together, when one compound is oxidized, another must be reduced at the same time
98
Which compounds are likely to become oxidized?
The molecular structures most likely to oxidize are those with a hydroxyl (-OH) group directly bonded to an aromatic ring, such as catecholamines, phenolics and aldehydes
99
How can oxidation be prevented?
Oxidation is catalyzed by heat, light and metal ions. Changes in temperature and pH must be carefully controlled; either can exponentially increase oxidation
100
How can you provide light protection to prevent oxidation?
With amber glass, UV light blocking containers and protective sleeves (bags) for IV bags, IV lines and syringes
101
How can you provide adequate storage to prevent oxidation?
Temperature control with refrigeration, control of room temperatures and (occasionally) freezer storage
102
How can chelating agents prevent oxidation?
Use chelators to chelate metal ions that have an unshared electron in the outer shell. These are free radicals which can catalyze oxidation chain reactions. The chelating agent ties up the catalyst, preventing the reaction. Common chelators have the letters ED
103
How can antioxidants prevent oxidation?
Oxidation produces free radicals, which are highly reactive with other compounds, and cause a chain reaction that damages the compound. Autoxidation is when oxidation reactions occur routinely during preparation and storage. Antioxidants inhibit free radicals
104
How can controlling the pH prevent oxidation?
Maintain pH with a buffer
105
What is hydrolysis?
Hydrolysis occurs when water causes the cleavage of a bond in a molecule
106
What is recommended for compounds likely to undergo hydrolysis?
Compounds likely to undergo hydrolysis should not be exposed to moisture, Counseling should include to avoid storing products susceptible to hydrolysis in the bathroom and to close containers tightly. Desiccants are sometimes used to soak up any moisture that enters the container
107
What are the most common functional groups susceptible to hydrolysis?
Esters, amides and lactams
108
How can hydrolysis be prevented?
To reduce hydrolysis, the compound should be protected from moisture (water) exposure and other factors that favor degradation, including light exposure, metal ions and changes in temperature and pH
109
How can adsorbents prevent hydrolysis?
To adsorb any moisture that enters the container
110
How do lyophilized powders prevent hydrolysis?
Drugs can be stored as lyophilized powder instead of in solution
111
How does hygroscopic salt prevent hydrolysis?
Hygroscopic means water-absorbing. In some cases, a salt form of the drug can be chosen that is less hygroscopic, will absorb less water and will be less likely to degrade from hydrolysis
112
How does a prodrug formulation prevent hydrolysis?
Prodrugs that release the active drug by a hydrolysis reaction can be formulated
113
How does controlling the temperature prevent hydrolysis?
Control the temperature in which the product is stored; hydrolysis occurs more rapidly at higher temperatures
114
How does controlling pH prevent hydrolysis?
Maintain pH with a buffer
115
What is photolysis?
Many drugs are sensitive to UV light exposure, which causes photolysis (breakage) of covalent bonds and drug degradation
116
How can photolysis be prevented?
Light protection
117
Which compounds are likely to become degraded by light exposure?
Compounds that are sensitive to light include ascorbic acid, folic acid, nitroprusside and phytonadione injection
118
What are other reactions that degrade drugs?
Isomerization, epimerization, decarboxylation
119
What is isomerization?
When a compound changes into a form with the same atoms but an inactive structure
120
What is epimerization?
When a compound changes into an isomer that differs only in the configuration of the atoms. The two compounds are stereoisomers. Epimerization creates a chiral counterpart with the epimer being inactive or active
121
What is decarboxylation?
Decarboxylation can happen to compounds with dissolved carboxylic acids. When heated, the carbon dioxide is lost from the carboxyl group. Drugs at risk of decarboxylation can be kept refrigerated
122
What are examples of major excipients?
Binders, diluents and fillers, disintegrants, flavorings and coloring agents, lubricants, preservatives, buffers
123
What is the purpose of binders?
Binders allow the contents of a tablet to stick together while permitting the contents to be released once ingested. They can provide stability and strength
124
What are some examples of binders?
Acacia, starch paste, sucrose syrup, compressible sugar
125
What is the purpose of diluents and fillers?
Diluents (to make something more dilute) and fillers (to bulk up a small amount) add size to very small dosages. In liquids, the diluent helps suspend the drug and facilitates disintegration, which is required for absorption
126
What are some examples of diluents and fillers?
- Tablets/capsules: sugars (lactose, mannitol, sorbitol), starches, calcium salts, cellulose powder
- Liquids: water, glycerin, alcohol
- Topicals: petrolatum, mineral oil, lanolin, waxes
127
What is the purpose of disintegrants?
Facilitates the breakup of a tablet after oral administration. Oral products have to be dissolved in order to be absorbed in the small intestine, where most drugs are absorbed. Alginates and cellulose absorb water, causing the tablet to swell and release its contents
128
What are some examples of disintegrants?
Alginic acid, cellulose products, polacrilin potassium, starches
129
What is the purpose of flavorings?
Flavorings and coloring agents make the product look and taste better. Salty or sweet tastes mask a bitter flavor. Mint and spices mask poor flavor. Acids enhance fruit flavors
130
What are some examples of flavorings and coloring agents?
- Coloring agents: D&C Red No. 3, Yellow No. 6, Caramel, Ferric oxide (red)
- Sweeteners: non-caloric, artificial (Aspartame, Saccharin, Sucralose), glycerin, dextrose, sugar alcohols, stevia
131
What is the purpose of lubricants?
Can be called glidants or anti-adherents. Lubricants and anti-adherents prevent ingredients from sticking to each other and to equipment. This can be useful for tablet molds and punches, suppository molds and for capsule filling. Glidants improve powder flowability by reducing interparticle friction
132
What are some examples of lubricants?
Magnesium stearate, calcium stearate, stearic acid, colloidal silica, PEG, glycerin, mineral oil, talc
133
What is the purpose of preservatives?
Preservatives slow or prevent microorganism growth. They are required in most preparations except if sterile and used immediately or if sealed in single-use preparations
134
What are some notes about preservatives?
- Ophthalmic (eye) preparations in multi-dose containers need a preservative
- Do not use preservatives in neonates
- Alcohols and acids are often used as preservatives
135
What are some examples of preservatives?
Chlorhexidine, povidone iodine, sodium benzoate/benzoic acid, benzalkonium chloride, benzyl alcohol, sorbic acid/potassium sorbate, methyl/ethyl/propyl parabens, EDTA, thimerosal, cetylpyridinium chloride
136
What is the purpose of buffers?
Buffers keep the pH within a certain range, which can improve stability and solubility and decrease irritation to sensitive tissues in the body
137
What are some examples of buffers used to maintain acidic pH?
Hydrochloric acid, acetic acid/sodium acetate, citric acid/sodium citrate
138
What are some examples of buffers used to maintain alkaline pH?
Sodium hydroxide, boric acid/sodium borate, sodium bicarbonate/sodium carbonate
139
What are examples of buffers used to maintain neutral pH?
Sodium biphosphate/sodium phosphate, potassium phosphate/metaphosphate
140
What are some examples of solvents?
- Hydrophilic: water, sterile water, alcohols, glycols
| - Hydrophobic: oils and fats
141
What is the purpose of water as a solvent?
Water is commonly used as a solvent, as a delivery vehicle and for cleaning equipment and tools. As a delivery vehicle, water is used for oral liquid formulations, topicals and in all types of injectables
142
What is purified water used for?
Purified water has been treated to remove chemicals and contaminants. Types of purification include distillation, deionization, reverse osmosis and carbon filtration
143
What is distilled water used for?
Distilled water is used for reconstitution to prepare oral suspensions and in non-sterile compounding preparations
144
What is potable water used for?
Potable water (drinking/tap water) is safe to drink and used for hand washing and initial equipment cleaning
145
What are different examples of sterile water?
- Sterile water for injection: must be free of bacterial endotoxins
- Bacteriostatic water for injection: SWFI with antimicrobial preservatives
- Sterile water for irrigation: sterile water packaged in large containers for washing, rinsing, and dilution of products used for irrigating body cavities, wounds, urinary catheters or surgical drainage tubers
146
What is the purpose of alcohols?
Alcohols have high miscibility (mixes easily) with water and can be used to dissolve solutes that would be insoluble in water alone
147
What are some examples of alcohols?
- Benzyl alcohol: used as a solvent, preservative and for the aroma
- Alcohol USP: can be used as an alternative to fomepizole for methanol or ethylene glycol toxicity
- Methanol: fueled, used to make many chemicals
- IPA 70%: preferred disinfectant in sterile compounding
148
What is the purpose of glycols?
Glycols have a low freezing point (which makes antifreeze possible), a high boiling point and are water-soluble
149
What is a note about PEG?
PEG has low toxicity and low systemic absorption, making it a useful excipient. It is used as a surfactant, solvent, plasticizer, suppository base, ointment base, lubricant and troche base. It is water-soluble and water-miscible
150
What are some examples of glycols?
PEG 400, Polybase, Methoxy-polyethylene glycol, glycerin, propylene glycol, ethylene glycol
151
What is the purpose of oils and fatas?
Oils are used as delivery vehicles, for therapeutic or nutritional use, and some are used as scents and flavorings
152
What are some examples of oils and fats?
- Mineral oil: derived from petrolatum, and is the ingredient in Baby Oil
- Almond, borage, canola, castor, coconut
- Omega-3
- Omega-6
153
What are emollients?
An emollient refers to a product that softens and soothes the skin
154
What do occlusive ointments do and what are some examples?
Occlusive ointments, including petroleum jelly, theobroma oil, beeswax, paraffin and other waxes form a protective barrier to prevent the loss of water molecules from the top layer of the skin (epidermis)
155
What are humectants?
Humectants are put into many emollient formulations to pull in water from the atmosphere to moisturize the skin. They can be sticky-feeling, and are combined with other more soothing ingredients
156
What are some examples of humectants?
Humectants include glycerin or glycerol, propylene glycol, PEG, urea and hyaluronic acid
157
What is the oil and water content of ointments?
80-100% oil and 0-20% water
158
What are ointments best for?
Best for extremely dry skin and thick skin, such as on elbows and feet
159
What is the oil and water content of creams?
Creams are usually about half oil, half water (minimally greater than 20% water and up to 50% oil)
160
What are creams best for?
Best for normal and dry skin
161
What are lotions best for?
Lotions have the most water, and are the best for oily skin
162
What are the four different ointment groups?
Hydrocarbon bases, absorption bases, water-removable bases, water-soluble bases
163
What are ointments defined as?
Ointments are defined as semisolids, with 0-20% water hydrocarbons, waxes and/or polyols (compounds with multiple OH groups)
164
What is the purpose of ointments?
Provide a barrier to water loss from the skin and are used as vehicles for topical drug delivery
165
What is a note about ointments in general?
In some products the emollient components are mixed with humectants, which draw water into the skin, and make the product less greasy
166
What are some examples of common emollients?
Petrolatum, lanolin, mineral oil, dimethicone
167
What are some examples of common combination products of ointments?
- Polybase: PEG 400, PEG 8000, polysorbate 80 (water soluble and miscible)
- Aquaphor: 41% petrolatum, with mineral oil, lanolin, glycerin + other ingredients. occlusive barrier, less greasy than petrolatum
- Aquabase: similar to aquaphor
168
What is a note about hydrocarbon bases?
Called "oleaginous" ointments (oil-containing, no water); good for drug delivery and forming a protective barrier, hard to wash off/greasy
169
What are some examples of hydrocarbon based ointments?
White ointment, white petrolatum
170
What is a note about absorption bases?
Can be used to form water-in oil emulsions, useful as emollients
171
What are some examples of absorption bases?
Hydrophilic petrolatum, lanolin
172
What are some notes about water-removable bases?
Hydrophilic, oil-in-water emulsions Per USP, more correctly called creams; more correctly called creams; more easily diluted, and easier to wash off the skin
173
What is an example of a water-removable base?
Hydrophilic ointment
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What is a note about water-soluble bases?
Do not contain petrolatum; per USP, are more correctly called gels
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What is an example of a water-soluble base?
Polyethylene glycol ointment
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What are creams?
Creams are semi-solid preparations that have a soft, spreadable consistency. Most creams are water-in oil or oil-in water emulsions. Water-in-oil creams feel more greasy
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What are some examples of creams?
- Lipoderm cream
- Eucerin: water, petrolatum, mineral oil, ceresin, lanolin + other ingredients
- Cetaphil: water, glycerin, petrolatum, dimethicone, benzyl alcohol, PEG + other ingredients
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What are lotions?
Lotions can be aqueous or hydroalcoholic, with a small amount of alcohol added to solubilize ingredients, or to hasten evaporation of the solvent from the skin
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What is an example of a lotion?
Verbabase lotion
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What is a gel?
Gels are semisolid preparations of small inorganic particles or large organic molecules interpenetrated by a liquid. If the gel has small discrete particles in it, is classified as a two-phase system. If the particles are distributed uniformly so that the gel does not appear to have any discrete particles, it is a single-phase system
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What is the purpose of gels?
Gels can be used to administer medications by various routes, including topical, oral, intranasal, vaginal and rectal
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What are some notes about gels?
Aqueous solutions of poloxamers are liquid when refrigerated and form a gel at room temperature, in a reversible process. PLO gel is used often because of this property; compounds are easily mixed into the liquid (when taken form the refrigerator), which then forms a gel when stored at room temperature
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What are some examples of gels?
- Polyethylene + mineral oil (Plastibase, Jelene)
- Poloxamer 407NF
- Poloxamer (Pluronic) Lecithin Organogel (PLO) gel
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What is the content of poloxamers?
Poloxamers contain a hydrophobic chain of polyoxypropylene with two hydrophilic chains of polyoxyethylene. This means poloxamer gel can be used for hydrophobic or hydrophilic drug delivery
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What is the purpose of pastes?
Pastes contain powder in an ointment base
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What is an example of a paste?
Zinc oxide paste, used for diaper rash; zinc oxide is a desiccant (draws water from the baby's bottom)
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What is the purpose of suppository bases, made of various fats and glycols?
Suppository bases have to stay intact for insertion, and melt once inserted. Theobroma oil (cocoa butter) used to be a common base for suppositories, but it melts easily. Newer bases are now more popular
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What is an example of suppository base?
Polybase, cocoa butter theobroma oil), hydrogenated vegetable oils (palm, palm kernel, and coconut oils), PEG polymers, glycerinated gelatin
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What are some other excipients involved in compounding?
Adsorbents, anti-foaming agent, coatings (regular), emulsifiers, enteric-coating, gelling (thickening) agent, stabilizer, humectant, levigating (wetting agent)
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What is the purpose of adsorbents?
to keep powders drug, to prevent hydrolysis reactions
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What is an example of adsorbents?
Magnesium oxide/carbonate, kaoline
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What is the purpose of anti-foaming agents?
Breaks up and inhibits the formation of forms
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What are some examples of anti-foaming agents?
Simethicone, dimethicone
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What is the purpose of coatings (regular)?
Prevent degradation due to oxygen, light, moisture, mask unpalatable taste
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What are some examples of coatings (regular)?
Shellac, gelatin, gluten (food grade)
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What is the purpose of emulsifiers?
Reduce the surface tension between two liquids allowing the two phases to come closer together.
*Emulsifiers are a type of surfactant
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What are some examples of emulsifiers?
Acacia, agar, carbomers, glyceryl monostearate, pectin, PEG, sodium lauryl sulfate, sorbitan lipophilic esters, sorbitan hydrophilic esters
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What is the purpose of enteric-coating?
Most drugs dissolve in the stomach and are absorbed in the small intestine. Some drugs would be destroyed by stomach acid and require an acid-resistant (enteric-coated) protective layer to prevent dissolution in the stomach
*The coating can also be used to mask poor taste
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What is an example of enteric-coating?
Cellulose acetate phthalate, shellac
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What is the purpose of a gelling (thickening) agent?
Increases the viscosity of a substance; can stabilize the mixture. Gelatin, cellulose and bentonite are used commonly; they swell well when mixed with water
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What are some examples of gelling agents?
Agar, alginates, various gums, gelatins, bentonite, carbomer, cellulose, starches, tragacanth, acrylates, cetyl alcohol, magnesium aluminum silicate, poloxamer gels, polyvinyl alcohol, sorbitol
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What is the purpose of a humectant?
Prevents preparations from become dry and brittle, when put into emollients, draws water into the skin to moisturize
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What are some examples of humectants?
Glycerin or glycerol, propylene glycol, PEG, lecithin, urea, hyaluronic acid
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What is the purpose of a levigating (wetting) agent?
Liquid used in the process of reducing the particle size to reduce the surface tension
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What are some examples of levigating agents?
Mineral oil, glycerin, glycols, PEG, propylene glycol
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What population should the excipient of alcohol be avoided in?
Children
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What population should aspartame be avoid in?
Phenylketonuria (PKU), not able to metabolize phenylalanine
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What population should gelatin be avoided in?
Vegetarians and vegans, anyone who wishes to avoid pork
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What is an alternative to gelatin shells?
Hypromellose capsule shells are made from cellulose and are vegan (no meat or dairy) and vegetarian (no meat)
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What population should gluten be avoided in?
Celiac disease, anyone who wishes to avoid gluten
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What is an alternative to gluten?
Starch can come from non-gluten sources
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What population should lactose be avoided in?
Lactose intolerance or lactose allergy
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What is an alternative for lactose?
Lactose content may/may not cause symptoms (with intolerance) as the amount in compounded products can be small. Select an alternative depending on the purpose
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What population should preservatives be avoided in?
Neonates
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What should be used as an alternative to preservatives?
Use preservative-free formulations
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What population should sorbitol be avoided in?
Irritable bowel syndrome (IBS); sorbitol can cause GI distress in IBS
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What population should sucrose be avoided in?
Diabetes
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What is an alternative for sucrose?
The amount used may/may not cause the blood glucose to increase. Select alternative sweeteners
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What population should Xylitol be avoided in?
Do not use in dogs; it can cause xylitol toxicosis (hypoglycemia and liver damage). Xylitol can cause GI upset in humans
