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
what is an equivalent?
- a mole of mono-valent charge pairs
- a mole = avogadros # (6.022 x 10^23)
What is a suspension and its uses?
- liquid preparation that consists of solid pariticles dispersed throughout a liquid phase in which the particles are not soluble
- useful as oral, topical, ophthalmic & IM
what is the purpose of suspensions?
1) to provide a liquid form for H2O insoluble drugs
2) as an alternative to EtOH based solutions
why are oral suspensions prepared in and with an aqueous base?
1) physiology is water based
2) water is inexpensive and ubiquitous
advantages of suspensions with tablet/capsule drug source:
1) rapid decomposition
2) particle size already appropriate
disadvantages of suspensions with tablet/capsule drug source:
1) drug may be soluble in the solvent, could have made a solution where it not for the excipients
2) more expensive
advantages of suspensions over solutions
- 1) drugs contained therein are more stable
2) much higher drug concentrations are achievable
3) alcohol can be avoided in many cases *
disadvantages of suspensions w/ respect to solutions
- 1) suspending agents are usually required
2) compounding procedure is more complicated
3) cant QS in a graduated cylinder
4) must be shaken prior to administration!*
Levigation
- the wetting of INSOLUBLE powder agent in a minimal amount of qs media or levigating agent forming a smooth homogenous paste
- -> this is done via mortar and pestle, ointment slab and spatula
How do suspending agents work?
- 1) by increasing the products viscosity
2) thus decreasing particle settling rate*
examples of some suspending agents:
-acacia, bentonite, methylcellulose (ora plus), xanthan gum, tragacanth, carbomer etc
ratio strength (3:4)
- 3 g of ingredient in 4 total grams of product
- -> 3g/4g
parts notations (3:4)
- 3 g of ingredient PLUS 4 gram of ingredient
- total of 7 grams of product
- -> 3g/7g
nested sieves
-shaker apparatus that shakes the chamber in various frequencies –> designed so that any powders that we put in that are shifted down and become fractionated as they travel down to the bottom
Micron gauge
-limited compared to the nest of sieves, can tell us the smallest particle size we can achieve but it doesnt have the ability to fractionate those particle sizes into a series of ranges nor the ability to tell us anything other than what the SMALLEST PARTICLE SIZE is that weve been able to achieve
sedimentation rate in suspensions (3 things)
- -varies directly with particle size
- varies directly with particle density
- varies INDIRECTLY with suspension viscosity*
sedimentation time in suspensions (3 things)
- -varies indirectly with particle size
- varies indirectly with particle density
- varies. DIRECTLY with suspension viscosity*
deflocculated suspension
-long sedimentation time (advantage)
-dense, difficult cake formed (disadvantage)
(D= dat hard cake)
flocculated suspension
*-short sedimentation time (disadvantage)
-sediment redisperses easily (advantage) *
(flaccid penis is short)
10% rule in IVs
- if a volume to be added to an IV bag is greater than or equal to 10% of the bag’s rated capacity, a volume equivalent to the add must be removed from the bag prior to the addition.
- if the volume to be added is less than 10% of the bags rated capacity a corresponding withdrawal prior to the addition is not needed
emulsions
2 phase systems in which one liquid is dispersed throughout another in the form of small droplets
emulsification
added ENERGY through trituration or homogenization creating small droplets of one liquid phase in another and a static charge around those droplets
role of emulsifying agents
-promote the formulation of droplets and their charge based separations
creaming
migration (surfacing or settling) of droplets
cracking/coalescence
merging of droplets, separation of phases
-throw it out! no good!
internal phase of emulsions
- droplets and micelles
- usually contains active ingredient
- discontinuous
external phase of emulsions
- suspension medium
- continuous (droplets move around and have their mobility)
- interconnected
water-in-oil emulsions
-droplets of hydrophilic liquid in a lipophilic suspension medium, usually external ( w= wait outside)
oil-in-water emulsions
droplets of lipophilic liquid in an aqueous suspension medium
-internal use ( O = open your mouth)
active ingredients are most commonly dissolved or suspended in the internal phase. why?
since it tastes bad and hides that
When would active ingredients may also be dissolved or suspended in the external phase
When we want bioavailability to its max when dealing with an external emulsion
what determines emulsion type?
- the chemical nature of ingredients (whether its going to become oil in water or water in oil)
- by far the molecular geometry of the emulsifier is the greatest in the driving force as to whether or not the product is going to be oil in water or water in oil
what 2 tests can we use to determine they type of emulsions?
1) drop test/drop dissolution test
2) electrical conductiviity test
what type of emulsion is this:
“micelles form as spheres with polar head groups toward the outside and non-polar hydrocarbon chains on the inside”
oil in water
what type of emulsion is this:
“soap based emulsifiers usually form inside-out micelles”
water-in-oil
examples of emulsifiers
acacia, lecithin, tween 80, alcohols etc
what is a primary emulsion?
has no active ingredients and has no desired pharmacologic effect
what are gels?
- semi-solid emulsions
- consists of a matrix formed by hydrogen bonds: gel base/gel base, gel base/active ingredient & micelle/micelle
- organic matrix can be interrupted by heat; may be destroyed by alcohol
why are emulsions the most complex of all liquid dosage forms?
- -design
- calculation
- compounding procedure
- storage and administration*
electrical conductivity test: pass for oil-in water:
conducts electricity
electrical conductivity test: pass for water-in-oil
does not conduct electricity
what are some ways that the additions of energy is done in emulsions?
- -stirring
- mortar and pestle
- shaking
- homogenization (gay syringe/peepee hole touching)*
what is homogenuzation?
forcing 2 immiscible liquids through an orifice under high pressure for the purpose of mixing
what type of emulsion is used internally?
oil-in-water
what type of emulsion is used externally?
water-in-oil
what are the emulsifier components are in olive oil?
-oleic acid –> calcium oleate
what are the advantages of using surfactants?
- much more diverse than gums or soaps
- much more flexible than gums or soaps
- RPh has more control over internal/external phases
what are the disadvantages of using surfactants?
- low viscosity( this could be the advantage if looking for a low thin viscosity product)
- viscosity enhancers
- added levels of complexity
HLB values 1-9 define
water-in-oil
HLB vlaues 9-20 define
oil-in-water
Surfactants UBSOP general policy
when formulating a surfactant based emulsion, the emulsifier should represent 15% w/v of the emulsions internal phase
what are 4 peripheral access devices?
- butterflies
- angio catheters
- midlines
- subcutaneous catheters
butterflies and angio catheters
- both are inserted into small veins
- induration is 3-5 days
- infiltrate often so new lines must be placed
- must carefully consider drugs since they will be going to small veins
- irritant drugs are not ideal
midlines
- inserted into larger veins (from upper arm to bend of the elbow)
- long induration of up 3 months
- allow some drug flexibility since they are in larger veins & are easier to maintain
subcutaneous catheters
- placed in the tissue, generally in the belly (for adequate absorption)
- a short duration (no more than 7 days)
- therapies are limited- usually hydration or pain management
peripheral lines and positive pressure caps use:
SAS
central lines and implantable ports use:
SASH
factors in determining the choice of venous access device (5)
- patient location
- duration/type of therapy
- method of insertion
- drug characteristics
- maintenance of line
indications for TPN (4)
- intractable vomiting (pancreatitis, hyperemesis gravidarum)
- diarrhea (short or irritable bowel, radiation enteritis with weight loss)
- bowel obstruction or resection (adhesions/scleroderma)
- bowel rest (fistula, crohns disease, ulcerative colitis, anastomtic leak)
TPN components
- protein source (amino acid)
- carbohydrate source (dextrose)
- fat source (lipids)
- “condiments” - vitmanins, trace metals and electrolytes
- free water
additives added daily
- multivitamins
- trace metals
additives added as needed
- insulin
- vitamin K
how do you derive sensitivity when you know MWQ and accuracy?
sensitivity = (accuracy)(MWQ)
1 grain = ____mg
64.81mg
when do you add a dilauent?
- less than MWQ
- quantity of powder is too small
- doesnt fit properly in any capsule size
- improve ease of packing
- improve flow of powder
utility and cautions of ethyl alcohol as an ingredient in liquid dosage forms
- aid to solubilization
- preservative
- emulsifier
- sedative (undesired side effect)
cock shit
d. Female IBW: 45.5 + (2.3 x height in inches > 5 feet)
e. Male IBW: 50 + (2.3 x height in inches > 5 feet)
g. Creatinine Clearance= [(140-age)(body mass)]/ [72x serum creatine]
i. Female times 0.85
ii. Units ml/min
what is a lotion?
-liquid or semi-liquid preparations which contain one or more active ingredients in a suitable vehicle
where to lotions fit in?
- suspensions
- solutions
- emulsions
- NEVER syrups
what are intertriginous areas?
- skin touches skin
- gluteal fold
- abdominal fold
- beneath breasts
the composition of lime water is
- calcium hydroxide 3g
- purified water 1000 mL
1 gallon
3785ml
1 pint
16oz
professional judgment: is the Rx legally correct:
- signed by the prescriber
- properly dated
- DAW box correctly marked
professional judgment: is the prescribed dose consistent with:
- patient age
- patient weight
- indication
professional judgment: is the prescribed medication appropriate:
- the apparent indication
- patient allergy profile
- drug-drug interactions
Eutectics
-Camphor and Menthol can occur near room
temperature
-Lead and Tin can occur above room temperature
what is the minimum weighable quantity, if the sensitivity is =5mg and accuracy is 5%
sensitivity = (accuracy)(MWQ)
-The minimum weighable quantity(5mg/X) x100=5%
X=5mg/0.05
X=100mg
what is the minimum weighable quantity, if the sensitivity is =6mg and accuracy is 5%
sensitivity = (accuracy)(MWQ)
-The minimum weighable quantity(6mg/X) x100=5%
X=6mg/0.05
X=120mg
what not to do with Solutions
Do not shake
Equivalence
- May be applied to all dosage forms(solutions, suspensions, capsules.etc)
- Applicable to hydro-ionizable compounds upon dissolution
- Not applicable to un-ionizable compounds(such as sucrose, dextrose)
what factors must be optimized to yield a eutectic with the lowest possible melting point?
optimum ratio of masses
the composition of and the incorporation order of 4:2:1 emulsion
4: Mineral oil 2: water 1: Acacia
drop dissolution test
O/W: if you place a drop of water in and O/W emulsion, the emulsion would simply get diluted, indicating the water is in the external phase.
W/O: if you place a drop of water in W/O emulsion, the drop will be separated and it will be apparent because water is in the internal phase.
Extemporaneous compounding devices that assess the particle sizes
- visual
- sieves
- micron gauge
- feel
Specific Gravity in emulsion
the ratio of mass to that of an equivalent volume of water
Know some examples of commercially available pharmaceutical emulsions
-TPN, HAL lipid formulations (Intralipid, Liposyn)
-Amphotericin B (Ambisome, Ablecet)
-Propofol (Diprivan)
Examples: Hydrophilic petroleum, aquabase, aquaphor, hydrocream, eucerin, nivea, cold cream, dermabase, velcachol
