Final Exam (sem 1) Flashcards
1 oz = _____g
28.35g
1 z3 = _____g
31.1 g
1 oz & 1 z3 = ____ml
29.57ml
definition of compounding
the physical and/or chemical modification of a substance resulting in a drug/dosage form which is suitable for administration to a patient
reasons for compounding
- drug or dosage forms not available commercially
- dose unavailable, pt comfort and compliance
extemporaneous compounding
-compounding pursuant to: a specific patient, for a specific prescription, & for 1 dispensing of the medication
extemporaneous compounding does NOT apply to
batching, manufacturing & refills
batching
compounding “ahead of time” in anticipation of outstanding refills or unfilled oral Rxs
what is needed to be kept record of when batching (for all drug sources)?
- manufacturer’s name
- lot numbers
- expiration dates
- assign a pharmacy batch lot to each product
manufacturing
compounding for long term inventory and sale
what is NOT a part of manufacturing
not:
-pursuant to a particular patient
-pursuant to a particular RX
-within the scope of pharmacy practice
~need special license and manufacturing facility~
manufacturing is subject to _____ (3 things)
- -special law
- inspection
- industrial regulation*
what is a violation of manufacturing?
- batching more than you need*
- beyond the scope of hospital and/or community pharmacy practice
- can get fines, imprisonment, OPD, FDA, BCS, FBI, CIA, KGB etc.
Stability: the extent to which a Rx prep remains within specified limits in terms of …..(3)
- -chemical composition
- physical composition
- microbiologic activity/contamination
expiration date is a function of _____ (2)
- -stability
- storage conditions*
whats the most important consideration for storage of medications?
keep out of reach of children
what is room temp?
20C-25C
what is refrigerated temp?
2C-4C
what is trituration? (verb & noun)
verb- particle size reduction
noun- mixed powder product
which 4 products need to be pre-refined?
- salicylic acid
- calamine
- zinc oxide
- sulfur ppt
when is geometric combination needed?
-indicated when mass of powders to be mixed differ by a factor greater than 3
Define powders
USP: intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use
bulk powders
- external use
- medication dose is very non-specific due to highly subjective administration
what are unit dose powders?
- internal use: capsules & charts
- external use: antimicrobial otic powders
ways to reduce powder size:
- pulverization (mechanical, intervention)
- trituration (refinement, mixing)
Efflorescent powders:
- contain waters of hydration*
- due to hydrogen binding
- delicate crystal structures may be altered when exposed to: mechanical stress(trituration), changes in humidity or changes in temperature
hygroscopic powders
subject to moisturization from ambient humidity
h= getting hot/moist in here
deliquescent powders
hygroscopic yes but…will actually dissolve forming an H2O solution
(d = disappears into water)
what are eutectics?
- a combination of 2 or more substances where the melting point is less than that of any part when taken alone
- lowest melting point occurs at an optimum ratio of masses
powder papers aka charts
-contain a specific dose of medication: pt RX label should indicate quantity of active ingredient contained in one dose
lozenges
- solid oral dosage form
- designed to dissolve or disintegrate in the mouth
- intended primarily for local drug delivery and effect (analgesics, anesthetics, antimicrobials)
- can be a delivery vehicle for systemic medications as well
lozenges are also known as___ (2)
pastilles & troches
pills
- small, round/spherical
- have been replaced by other solid oral dosage forms
tablets
- prepared as: compressed unit-dose powders (most common) or solidification molded (less common)
- may be enteric-coated
- may be scored
Excipients
-INACTIVE ingredients used as fillers, binders and glidants
Disintegrates help for
aids to GI absorption
coloring agents and flavoring agents are used for:
pharmaceutical elegance and pt compliance
liquid content capsules
- not suitable when gelatin capsule dissolves in contents (H2O based compounds)
- OK when gelatin capsule is insoluble in contents: some alcohols (NOT ETOH), fixed oils & volatile oil
advantages of liquid content capsules
- extemporaneous prep (custom dosing, enhanced patient compliance)
- -easy to swallow
- taste concealment
- rapid drug release*
disadvantages of liquid content capsules
- liquid content is problematic: aqueous agents dissolve capsule shell, time consuming to make
- incompatible with hygroscopic and deliquescent materials: absorbs H2O from gelatin = brittleness!
Extemporaneous capsules
- gelatin capsules (hard): telescoping- body & cap
- may contain ~0.15% sulfur dioxide (gives glossy appearance & prevents decomposition)
gelatin capsule exposed to LOW humidity
-may become brittle due to gradient = gives up its water
gelatin capsule exposed to HIGH humidity
- may become soft
- -> hygroscopic: can absorb ~10x its mass in H2O
selecting a capsule size (general rule)
*as capsule size number increases, capsule content capacity decreases
what capsule sizes are used in adults?
optimum size = 2 or 3
what capsule size are used in children?
choose smaller of the 2 (cap size #3)
-if the capsule needs to be sprinkled - use size #1
solutions include:
syrups, elixirs, spirits, tinctures & lotions
advantages of liquid dosage forms
- precise dosing
- nonstandard dosing is easy (peds)
- easy to swallow
disadvantages of liquid dosage forms
- inconvenient dosing (need accurate measuring devices)
- prone to error
- unpleasant tastes can be difficult to mask
- specific storage conditions
- drug is often less stable than dry form
solutions
*molecular dispersion of a solute in a solvent which resulting product
solvent
*base liquid, pure or mixture of miscible liquids
solute
*substance which is dissolved in the solvent
Preservatives
- not commonly used in extemporaneous compounded oral solutions
- NEVER use with interthecal preparations
- commonly used with ophthalmics
advantages of solutions
- suspending agent is not required
- easily absorbed
disadvantages of solutions
-generally less stable than suspensions or dry dosage forms
FDA march 13 1996 alcohol ruling on alcohol concentrations
- children <6 –> 0.5%
- children 6-12 –> 5%
- children > 12 –> 10%
what is the 20% rule?
smallest volumetric measurement is 20% of the containers full rated volume